Safety climate and culture: Integrating psychological and systems perspectives.

PubMed

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

2017-07-01

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

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

PubMed

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

2014-09-01

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

Functional Safety of Hybrid Laser Safety Systems - How can a Combination between Passive and Active Components Prevent Accidents?

NASA Astrophysics Data System (ADS)

Lugauer, F. P.; Stiehl, T. H.; Zaeh, M. F.

Modern laser systems are widely used in industry due to their excellent flexibility and high beam intensities. This leads to an increased hazard potential, because conventional laser safety barriers only offer a short protection time when illuminated with high laser powers. For that reason active systems are used more and more to prevent accidents with laser machines. These systems must fulfil the requirements of functional safety, e.g. according to IEC 61508, which causes high costs. The safety provided by common passive barriers is usually unconsidered in this context. In the presented approach, active and passive systems are evaluated from a holistic perspective. To assess the functional safety of hybrid safety systems, the failure probability of passive barriers is analysed and added to the failure probability of the active system.

Defining the pharmaceutical system to support proactive drug safety.

PubMed

Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

2013-02-01

The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

Making the Hubble Space Telescope servicing mission safe

NASA Technical Reports Server (NTRS)

Bahr, N. J.; Depalo, S. V.

1992-01-01

The implementation of the HST system safety program is detailed. Numerous safety analyses are conducted through various phases of design, test, and fabrication, and results are presented to NASA management for discussion during dedicated safety reviews. Attention is given to the system safety assessment and risk analysis methodologies used, i.e., hazard analysis, fault tree analysis, and failure modes and effects analysis, and to how they are coupled with engineering and test analysis for a 'synergistic picture' of the system. Some preliminary safety analysis results, showing the relationship between hazard identification, control or abatement, and finally control verification, are presented as examples of this safety process.

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

NASA Astrophysics Data System (ADS)

Barr, Douglas H.

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

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

DOT National Transportation Integrated Search

2011-06-01

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

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

DOT National Transportation Integrated Search

2011-06-01

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

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

DOT National Transportation Integrated Search

2010-08-01

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

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

DOT National Transportation Integrated Search

2011-01-01

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

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

DOT National Transportation Integrated Search

2011-01-01

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

Fault tree applications within the safety program of Idaho Nuclear Corporation

NASA Technical Reports Server (NTRS)

Vesely, W. E.

1971-01-01

Computerized fault tree analyses are used to obtain both qualitative and quantitative information about the safety and reliability of an electrical control system that shuts the reactor down when certain safety criteria are exceeded, in the design of a nuclear plant protection system, and in an investigation of a backup emergency system for reactor shutdown. The fault tree yields the modes by which the system failure or accident will occur, the most critical failure or accident causing areas, detailed failure probabilities, and the response of safety or reliability to design modifications and maintenance schemes.

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

DOT National Transportation Integrated Search

2010-12-01

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

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

DOT National Transportation Integrated Search

2010-12-01

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

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1989-01-01

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

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

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

Pugliese, S.M.

1977-02-01

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

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

Integrated Speed Limiter and Fatigue Analyzer System

NASA Astrophysics Data System (ADS)

Pranoto, Hadi; Leman, A. M.; Wahab, Abdi; Sebayang, Darwin

2018-03-01

The traffic accident increase in line with the growth of the vehicle, so the safety system must be developed to decrease the accident. This paper will purpose the integrated between speed limiter and fatigue analyser to improve the safety for vehicle, and also to analyse if there is an accident. The device and the software or application are developed and then integrated into one system. The testing held to prove the integrated between device and the application, and it show the system can work well. The next improvement for this system can be developing the server to collect data from internet, so the driver and the vehicle owner can monitor the system by internet.

Reflections on system safety and the law

NASA Technical Reports Server (NTRS)

Hayes, D. F., Sr.

1971-01-01

The application of law to the determination of what constitutes safeness is discussed. The numerous factors are analyzed which enter into the decisions of courts in deciding what is safe and what is unsafe. It is pointed out that as technology changes, legal interpretations of safety also change. Arguements are given for the use of system safety techniques and better engineering analyses as instruments of defense against liability.

Error Generation in CATS-Based Agents

NASA Technical Reports Server (NTRS)

Callantine, Todd

2003-01-01

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

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Exploring the roots of unintended safety threats associated with the introduction of hospital ePrescribing systems and candidate avoidance and/or mitigation strategies: a qualitative study.

PubMed

Mozaffar, Hajar; Cresswell, Kathrin M; Williams, Robin; Bates, David W; Sheikh, Aziz

2017-09-01

Hospital electronic prescribing (ePrescribing) systems offer a wide range of patient safety benefits. Like other hospital health information technology interventions, however, they may also introduce new areas of risk. Despite recent advances in identifying these risks, the development and use of ePrescribing systems is still leading to numerous unintended consequences, which may undermine improvement and threaten patient safety. These negative consequences need to be analysed in the design, implementation and use of these systems. We therefore aimed to understand the roots of these reported threats and identify candidate avoidance/mitigation strategies. We analysed a longitudinal, qualitative study of the implementation and adoption of ePrescribing systems in six English hospitals, each being conceptualised as a case study. Data included semistructured interviews, observations of implementation meetings and system use, and a collection of relevant documents. We analysed data first within and then across the case studies. Our dataset included 214 interviews, 24 observations and 18 documents. We developed a taxonomy of factors underlying unintended safety threats in: (1) suboptimal system design, including lack of support for complex medication administration regimens, lack of effective integration between different systems, and lack of effective automated decision support tools; (2) inappropriate use of systems-in particular, too much reliance on the system and introduction of workarounds; and (3) suboptimal implementation strategies resulting from partial roll-outs/dual systems and lack of appropriate training. We have identified a number of system and organisational strategies that could potentially avoid or reduce these risks. Imperfections in the design, implementation and use of ePrescribing systems can give rise to unintended consequences, including safety threats. Hospitals and suppliers need to implement short- and long-term strategies in terms of the technology and organisation to minimise the unintended safety risks. 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/.

Software system safety

NASA Technical Reports Server (NTRS)

Uber, James G.

1988-01-01

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

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.

System safety in Stirling engine development

NASA Technical Reports Server (NTRS)

Bankaitis, H.

1981-01-01

The DOE/NASA Stirling Engine Project Office has required that contractors make safety considerations an integral part of all phases of the Stirling engine development program. As an integral part of each engine design subtask, analyses are evolved to determine possible modes of failure. The accepted system safety analysis techniques (Fault Tree, FMEA, Hazards Analysis, etc.) are applied in various degrees of extent at the system, subsystem and component levels. The primary objectives are to identify critical failure areas, to enable removal of susceptibility to such failures or their effects from the system and to minimize risk.

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.

Quasi-Static Probabilistic Structural Analyses Process and Criteria

NASA Technical Reports Server (NTRS)

Goldberg, B.; Verderaime, V.

1999-01-01

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

Jerky driving--An indicator of accident proneness?

PubMed

Bagdadi, Omar; Várhelyi, András

2011-07-01

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

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

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

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

Internet of Things Based Combustible Ice Safety Monitoring System Framework

NASA Astrophysics Data System (ADS)

Sun, Enji

2017-05-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

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

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

PubMed

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

2015-01-01

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

Database management systems for process safety.

PubMed

Early, William F

2006-03-17

Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

Critical incident reporting and learning.

PubMed

Mahajan, R P

2010-07-01

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

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2010 CFR

2010-10-01

..., national, or international standards. (f) The reviewer shall analyze all Fault Tree Analyses (FTA), Failure... cited by the reviewer; (4) Identification of any documentation or information sought by the reviewer...) Identification of the hardware and software verification and validation procedures for the PTC system's safety...

SLUDGE TREATMENT PROJECT KOP CONCEPTUAL DESIGN CONTROL DECISION REPORT

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

CARRO CA

2010-03-09

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

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

Not Available

1992-03-01

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

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Hazard Analysis Guidelines for Transit Projects

DOT National Transportation Integrated Search

2000-01-01

These hazard analysis guidelines discuss safety critical systems and subsystems, types of hazard analyses, when hazard analyses should be performed, and the hazard analysis philosophy. These guidelines are published by FTA to assist the transit indus...

Accident Analyses in Support of the Sludge Water System Safety Analysis

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

FINFROCK, S.H.

This document quantifies the potential health effects of the unmitigated hazards identified Hey (2002) for retrieval of sludge from the KE basin. It also identifies potential controls and any supporting mitigative analyses.

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

DOE PAGES

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

2017-06-21

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

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

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

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

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

A System for Integrated Reliability and Safety Analyses

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Coumeri, Marc; Scheidler, Peter, Jr.; Bonesteel, Charles

1999-01-01

We present an integrated reliability and aviation safety analysis tool. The reliability models for selected infrastructure components of the air traffic control system are described. The results of this model are used to evaluate the likelihood of seeing outcomes predicted by simulations with failures injected. We discuss the design of the simulation model, and the user interface to the integrated toolset.

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

West, W.S.

Progress during the period includes completion of the SNAP 7C system tests, completion of safety analysis for the SNAP 7A and C systems, assembly and initial testing of SNAP 7A, assembly of a modified reliability model, and assembly of a 10-W generator. Other activities include completion of thermal and safety analyses for SNAP 7B and D generators and fuel processing for these generators. (J.R.D.)

Dialysis Facility Safety: Processes and Opportunities.

PubMed

Garrick, Renee; Morey, Rishikesh

2015-01-01

Unintentional human errors are the source of most safety breaches in complex, high-risk environments. The environment of dialysis care is extremely complex. Dialysis patients have unique and changing physiology, and the processes required for their routine care involve numerous open-ended interfaces between providers and an assortment of technologically advanced equipment. Communication errors, both within the dialysis facility and during care transitions, and lapses in compliance with policies and procedures are frequent areas of safety risk. Some events, such as air emboli and needle dislodgments occur infrequently, but are serious risks. Other adverse events include medication errors, patient falls, catheter and access-related infections, access infiltrations and prolonged bleeding. A robust safety system should evaluate how multiple, sequential errors might align to cause harm. Systems of care can be improved by sharing the results of root cause analyses, and "good catches." Failure mode effects and analyses can be used to proactively identify and mitigate areas of highest risk, and methods drawn from cognitive psychology, simulation training, and human factor engineering can be used to advance facility safety. © 2015 Wiley Periodicals, Inc.

Liquid Rocket Booster (LRB) for the Space Transportation System (STS) systems study, volume 2

NASA Technical Reports Server (NTRS)

1989-01-01

The Liquid Rocket Booster (LRB) Systems Definition Handbook presents the analyses and design data developed during the study. The Systems Definition Handbook (SDH) contains three major parts: the LRB vehicles definition; the Pressure-Fed Booster Test Bed (PFBTB) study results; and the ALS/LRB study results. Included in this volume are the results of all trade studies; final configurations with supporting rationale and analyses; technology assessments; long lead requirements for facilities, materials, components, and subsystems; operational requirements and scenarios; and safety, reliability, and environmental analyses.

Development of CO2 laser Doppler instrumentation for detection of clear air turbulence, volume 2: Appendices

NASA Technical Reports Server (NTRS)

Harris, C. E.; Jelalian, A. V.

1979-01-01

Analyses of the mounting and mount support systems of the clear air turbulence transmitters verify that satisfactory shock and vibration isolation are attained. The mount support structure conforms to flight crash safety requirements with high margins of safety. Restraint cables reinforce the mounts in the critical loaded forward direction limiting maximum forward system deflection to 1 1/4 inches.

NASA's Aviation Safety and Modeling Project

NASA Technical Reports Server (NTRS)

Chidester, Thomas R.; Statler, Irving C.

2006-01-01

The Aviation Safety Monitoring and Modeling (ASMM) Project of NASA's Aviation Safety program is cultivating sources of data and developing automated computer hardware and software to facilitate efficient, comprehensive, and accurate analyses of the data collected from large, heterogeneous databases throughout the national aviation system. The ASMM addresses the need to provide means for increasing safety by enabling the identification and correcting of predisposing conditions that could lead to accidents or to incidents that pose aviation risks. A major component of the ASMM Project is the Aviation Performance Measuring System (APMS), which is developing the next generation of software tools for analyzing and interpreting flight data.

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

PubMed

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

2017-03-01

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

[Patient safety and a culture of responsibility in ambulatory care: strategies for improving practice].

PubMed

Lichte, Thomas; Klement, Andreas; Herrmann, Markus

2009-01-01

The development of a medical safety culture is spreading beyond the hospital into the ambulatory setting. Patient safety defined as "absence of unwanted events" (primum non nocere) can serve as a starting point for the advancement of our ambulatory medical care system. Error analyses conducted in GP and specialist practices will identify gaps and traps in the system and provide ideas for the development and implementation of new safety strategies in ambulatory patient care. In the light of the structures and processes of GP medical care aspects of patient safety will be correlated to the outcome quality and examples will be discussed. Possible strategies for the improvement of patient safety in GP practice will be presented from the perspective of both patient- and practice individuality.

An approach to evaluating reactive airborne wind shear systems

NASA Technical Reports Server (NTRS)

Gibson, Joseph P., Jr.

1992-01-01

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

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.

The influence of authentic leadership on safety climate in nursing.

PubMed

Dirik, Hasan Fehmi; Seren Intepeler, Seyda

2017-07-01

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

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

PubMed

Foster, G

2007-01-01

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

Urban transport safety assessment in akure based on corresponding performance indicators

NASA Astrophysics Data System (ADS)

Oye, Adedamola; Aderinlewo, Olufikayo; Croope, Silvana

2013-03-01

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

Injury risks of EMS responders: evidence from the National Fire Fighter Near-Miss Reporting System

PubMed Central

Taylor, Jennifer A; Davis, Andrea L; Barnes, Brittany; Lacovara, Alicia V; Patel, Reema

2015-01-01

Objectives We analysed near-miss and injury events reported to the National Fire Fighter Near-Miss Reporting System (NFFNMRS) to investigate the workplace hazards and safety concerns of Emergency Medical Services (EMS) responders in the USA. Methods We reviewed 769 ‘non-fire emergency event’ reports from the NFFNMRS using a mixed methods approach. We identified 185 emergency medical calls and analysed their narrative text fields. We assigned Mechanism of Near-Miss/Injury and Nature of Injury codes and then tabulated frequencies (quantitative). We coded major themes regarding work hazards and safety concerns reported by the EMS responders (qualitative). Results Of the 185 emergency medical calls, the most commonly identified Mechanisms of Near-Miss/Injury to EMS responders was Assaults, followed by Struck-by Motor Vehicle, and Motor Vehicle Collision. The most commonly identified weapon used in an assault was a firearm. We identified 5 major domains of workplace hazards and safety concerns: Assaults by Patients, Risks from Motor Vehicles, Personal Protective Equipment, Relationships between Emergency Responders, and Policies, Procedures and Practices. Conclusions Narrative text from the NFFNMRS is a rich source of data that can be analysed quantitatively and qualitatively to provide insight into near-misses and injuries sustained by EMS responders. Near-miss reporting systems are critical components for occupational hazard surveillance. PMID:26068510

Near-misses are an opportunity to improve patient safety: adapting strategies of high reliability organizations to healthcare.

PubMed

Van Spall, Harriette; Kassam, Alisha; Tollefson, Travis T

2015-08-01

Near-miss investigations in high reliability organizations (HROs) aim to mitigate risk and improve system safety. Healthcare settings have a higher rate of near-misses and subsequent adverse events than most high-risk industries, but near-misses are not systematically reported or analyzed. In this review, we will describe the strategies for near-miss analysis that have facilitated a culture of safety and continuous quality improvement in HROs. Near-miss analysis is routine and systematic in HROs such as aviation. Strategies implemented in aviation include the Commercial Aviation Safety Team, which undertakes systematic analyses of near-misses, so that findings can be incorporated into Standard Operating Procedures (SOPs). Other strategies resulting from incident analyses include Crew Resource Management (CRM) for enhanced communication, situational awareness training, adoption of checklists during operations, and built-in redundancy within systems. Health care organizations should consider near-misses as opportunities for quality improvement. The systematic reporting and analysis of near-misses, commonplace in HROs, can be adapted to health care settings to prevent adverse events and improve clinical outcomes.

Safety analysis report for packaging, onsite, long-length contaminated equipment transport system

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

McCormick, W.A.

1997-05-09

This safety analysis report for packaging describes the components of the long-length contaminated equipment (LLCE) transport system (TS) and provides the analyses, evaluations, and associated operational controls necessary for the safe use of the LLCE TS on the Hanford Site. The LLCE TS will provide a standardized, comprehensive approach for the disposal of approximately 98% of LLCE scheduled to be removed from the 200 Area waste tanks.

Safety status system for operating room devices.

PubMed

Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

2014-01-01

Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

Development of Safety Analysis Code System of Beam Transport and Core for Accelerator Driven System

NASA Astrophysics Data System (ADS)

Aizawa, Naoto; Iwasaki, Tomohiko

2014-06-01

Safety analysis code system of beam transport and core for accelerator driven system (ADS) is developed for the analyses of beam transients such as the change of the shape and position of incident beam. The code system consists of the beam transport analysis part and the core analysis part. TRACE 3-D is employed in the beam transport analysis part, and the shape and incident position of beam at the target are calculated. In the core analysis part, the neutronics, thermo-hydraulics and cladding failure analyses are performed by the use of ADS dynamic calculation code ADSE on the basis of the external source database calculated by PHITS and the cross section database calculated by SRAC, and the programs of the cladding failure analysis for thermoelastic and creep. By the use of the code system, beam transient analyses are performed for the ADS proposed by Japan Atomic Energy Agency. As a result, the rapid increase of the cladding temperature happens and the plastic deformation is caused in several seconds. In addition, the cladding is evaluated to be failed by creep within a hundred seconds. These results have shown that the beam transients have caused a cladding failure.

[Infection control and safety culture in German hospitals].

PubMed

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

2016-07-01

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

Email triage is an effective, efficient and safe way of managing new referrals to a neurologist.

PubMed

Patterson, Victor; Humphreys, Jenny; Henderson, Mark; Crealey, Grainne

2010-10-01

Patients referred to secondary care in the UK often wait many months to be seen, and the UK government has announced various initiatives to address this issue. Since 2002, we have developed an email referral system which allows some neurological referrals to be managed by advice and investigations rather than by a conventional hospital clinic appointment. This system has previously been shown to reduce clinic attendances and to be acceptable to patients and their general practitioners (GPs). To analyse the effects of an email triage system on waiting times, cost of care and safety over 5 years. Referral numbers and waiting times for clinics using this system were analysed. Cost was determined by comparing detailed costs with those of conventional care. Safety was analysed by examining the GP records of all patients referred from a single practice who had been dealt with by advice or investigation, noting deaths, re-referrals and changes in diagnosis. Waiting times fell from 72 to 4 weeks, despite an increase in referrals. The cost per patient of email referral was about £100, compared with £152 for conventional care, a 35% reduction. Safety data on 120 individuals showed a minor change in diagnosis in three. This system is safe, effective (in reducing waiting times) and efficient. It enables neurologists to focus on patients with significant neurological disease and, if applied more widely, could reduce costs and waiting times for neurology services in the UK.

Electrical deaths in the US construction: an analysis of fatality investigations.

PubMed

Zhao, Dong; Thabet, Walid; McCoy, Andrew; Kleiner, Brian

2014-01-01

Electrocution is among the 'fatal four' in US construction according to the Occupational Safety and Health Administration. Learning from failures is believed to be an effective path to success, with deaths being the most serious system failures. This paper examined the failures in electrical safety by analysing all electrical fatality investigations (N = 132) occurring between 1989 and 2010 from the Fatality Assessment and Control Evaluation programme that is completed by the National Institute of Occupational Safety and Health. Results reveal the features of the electrical fatalities in construction and disclose the most common electrical safety challenges on construction sites. This research also suggests the sociotechnical system breakdowns and the less effectiveness of current safety training programmes may significantly contribute to worker's unsafe behaviours and electrical fatality occurrences.

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2017-01-01

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

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

PubMed

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

2017-03-01

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

The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

PubMed Central

2014-01-01

The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

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.

Patient safety in dentistry - state of play as revealed by a national database of errors.

PubMed

Thusu, S; Panesar, S; Bedi, R

2012-08-01

Modern dentistry has become increasingly invasive and sophisticated. Consequently the risk to the patient has increased. The aim of this study is to investigate the types of patient safety incidents (PSIs) that occur in dentistry and the accuracy of the National Patient Safety Agency (NPSA) database in identifying those attributed to dentistry. The database was analysed for all incidents of iatrogenic harm in the speciality of dentistry. A snapshot view using the timeframe January to December 2009 was used. The free text elements from the database were analysed thematically and reclassified according to the nature of the PSI. Descriptive statistics were provided. Two thousand and twelve incident reports were analysed and organised into ten categories. The commonest was due to clerical errors - 36%. Five areas of PSI were further analysed: injury (10%), medical emergency (6%), inhalation/ingestion (4%), adverse reaction (4%) and wrong site extraction (2%). There is generally low reporting of PSIs within the dental specialities. This may be attributed to the voluntary nature of reporting and the reluctance of dental practitioners to disclose incidences for fear of loss of earnings. A significant amount of iatrogenic harm occurs not during treatment but through controllable pre- and post-procedural checks. Incidences of iatrogenic harm to dental patients do occur but their reporting is not widely used. The use of a dental specific reporting system would aid in minimising iatrogenic harm and adhere to the Care Quality Commission (CQC) compliance monitoring system on essential standards of quality and safety in dental practices.

NASA Accident Precursor Analysis Handbook, Version 1.0

NASA Technical Reports Server (NTRS)

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

2011-01-01

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

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;

Reliability and Maintainability Engineering - A Major Driver for Safety and Affordability

NASA Technical Reports Server (NTRS)

Safie, Fayssal M.

2011-01-01

The United States National Aeronautics and Space Administration (NASA) is in the midst of an effort to design and build a safe and affordable heavy lift vehicle to go to the moon and beyond. To achieve that, NASA is seeking more innovative and efficient approaches to reduce cost while maintaining an acceptable level of safety and mission success. One area that has the potential to contribute significantly to achieving NASA safety and affordability goals is Reliability and Maintainability (R&M) engineering. Inadequate reliability or failure of critical safety items may directly jeopardize the safety of the user(s) and result in a loss of life. Inadequate reliability of equipment may directly jeopardize mission success. Systems designed to be more reliable (fewer failures) and maintainable (fewer resources needed) can lower the total life cycle cost. The Department of Defense (DOD) and industry experience has shown that optimized and adequate levels of R&M are critical for achieving a high level of safety and mission success, and low sustainment cost. Also, lessons learned from the Space Shuttle program clearly demonstrated the importance of R&M engineering in designing and operating safe and affordable launch systems. The Challenger and Columbia accidents are examples of the severe impact of design unreliability and process induced failures on system safety and mission success. These accidents demonstrated the criticality of reliability engineering in understanding component failure mechanisms and integrated system failures across the system elements interfaces. Experience from the shuttle program also shows that insufficient Reliability, Maintainability, and Supportability (RMS) engineering analyses upfront in the design phase can significantly increase the sustainment cost and, thereby, the total life cycle cost. Emphasis on RMS during the design phase is critical for identifying the design features and characteristics needed for time efficient processing, improved operational availability, and optimized maintenance and logistic support infrastructure. This paper discusses the role of R&M in a program acquisition phase and the potential impact of R&M on safety, mission success, operational availability, and affordability. This includes discussion of the R&M elements that need to be addressed and the R&M analyses that need to be performed in order to support a safe and affordable system design. The paper also provides some lessons learned from the Space Shuttle program on the impact of R&M on safety and affordability.

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

NASA Astrophysics Data System (ADS)

Hou, Baoyue; Chen, Fei

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

An Innovative Hybrid Loop-Pool SFR Design and Safety Analysis Methods: Today and Tomorrow

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

Hongbin Zhang; Haihua Zhao; Vincent Mousseau

2008-04-01

Investment in commercial sodium cooled fast reactor (SFR) power plants will become possible only if SFRs achieve economic competitiveness as compared to light water reactors and other Generation IV reactors. Toward that end, we have launched efforts to improve the economics and safety of SFRs from the thermal design and safety analyses perspectives at Idaho National Laboratory. From the thermal design perspective, an innovative hybrid loop-pool SFR design has been proposed. This design takes advantage of the inherent safety of a pool design and the compactness of a loop design to further improve economics and safety. From the safety analysesmore » perspective, we have initiated an effort to develop a high fidelity reactor system safety code.« less

Quality management and perceptions of teamwork and safety climate in European hospitals.

PubMed

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Spaceborne power systems preference analyses. Volume 1: Summary

NASA Technical Reports Server (NTRS)

Smith, J. H.; Feinberg, A.; Miles, R. F., Jr.

1985-01-01

Sixteen alternative spaceborne nuclear power system concepts were ranked using multiattribute decision analysis to identify promising concepts for further technology development. Four groups interviewed were: safety, systems definition and design, technology assessment, and mission analysis. The ranking results were consistent from group and for different utility function models for individuals.

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

PubMed

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

2015-01-01

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

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

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

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

2013-11-07

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

STS safety approval process for small self-contained payloads

NASA Technical Reports Server (NTRS)

Gum, Mary A.

1988-01-01

The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

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

NASA Astrophysics Data System (ADS)

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

2018-02-01

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

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

Sociology, systems and (patient) safety: knowledge translations in healthcare policy.

PubMed

Jensen, Casper Bruun

2008-03-01

In 2000 the American Institute of Medicine, adviser to the federal government on policy matters relating to the health of the public, published the report To Err is Human: Building a Safer Health System, which was to become a call to arms for improving patient safety across the Western world. By re-conceiving healthcare as a system, it was argued that it was possible to transform the current culture of blame, which made individuals take defensive precautions against being assigned responsibility for error - notably by not reporting adverse events, into a culture of safety. The IOM report draws on several prominent social scientists in accomplishing this re-conceptualisation. But the analyses of these authors are not immediately relevant for health policy. It requires knowledge translation to make them so. This paper analyses the process of translation. The discussion is especially pertinent due to a certain looping effect between social science research and policy concerns. The case here presented is thus doubly illustrative: exemplifying first how social science is translated into health policy and secondly how the transformation required for this to function is taken as an analytical improvement that can in turn be redeployed in social research.

Maintenance: organizational modes, activities and health and safety. Use of a French national survey and in-situ analyses.

PubMed

Grusenmeyer, Corinne

2014-12-01

Maintenance activities are identified as critical both to operator safety and to systems safety and reliability. However, it is still difficult to identify maintenance workers in French occupational accident and disease statistics. Moreover, few analyses of these activities and of organizational changes in this field have been conducted. This paper presents two different approaches to this same issue. Analyses were aimed firstly at identifying the occupational exposures of these operators and at comparing them with occupational exposures of production staff and, secondly at developing understanding of normal real maintenance activities, i.e. maintenance activities that are normally actually carried out, while taking into account the socio-technical system and maintenance organization within which they lie. The use of the French SUMER 2003 survey shows that occupational exposures of maintenance staff to various constraints are more frequent than occupational exposures of their production colleagues. However, maintenance staff appear to have greater independence. Analyses were also conducted in a subcontracting urban public transport company, who outsources some maintenance work. Those analyses highlight a complex network of companies involved in maintenance activities, a substantial number of work interruptions and a significant fragmentation of the internal technicians' activities that can be cognitively costly, reduce anticipation possibilities and lead to incidents or accidents. Above all they underline internal technicians' contributions to the completion of outsourced interventions and interdependent relationships between the activities of the internal and the external technicians. Outsourcing maintenance interventions thus raises the question of risks associated with the interdependence of actual work activities undertaken by the different types of staff, since they contribute to the same maintenance intervention. This study therefore pinpoints the need to integrate inter-organizational interactions in order to understand the variability of maintenance activities and its relationships with reliability and safety. In this respect, some suggestions are provided with a prevention aim. Copyright © 2014 Elsevier Ltd. All rights reserved.

Advanced Computational Thermal Fluid Physics (CTFP) and Its Assessment for Light Water Reactors and Supercritical Reactors

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

D.M. McEligot; K. G. Condie; G. E. McCreery

2005-10-01

Background: The ultimate goal of the study is the improvement of predictive methods for safety analyses and design of Generation IV reactor systems such as supercritical water reactors (SCWR) for higher efficiency, improved performance and operation, design simplification, enhanced safety and reduced waste and cost. The objective of this Korean / US / laboratory / university collaboration of coupled fundamental computational and experimental studies is to develop the supporting knowledge needed for improved predictive techniques for use in the technology development of Generation IV reactor concepts and their passive safety systems. The present study emphasizes SCWR concepts in the Generationmore » IV program.« less

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

PubMed

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

2013-01-01

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

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

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.

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

NASA Technical Reports Server (NTRS)

Huang, Zhaofeng; Safie, Fayssal

2016-01-01

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

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

PubMed

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

2014-10-01

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

Software Dependability and Safety Evaluations ESA's Initiative

NASA Astrophysics Data System (ADS)

Hernek, M.

ESA has allocated funds for an initiative to evaluate Dependability and Safety methods of Software. The objectives of this initiative are; · More extensive validation of Safety and Dependability techniques for Software · Provide valuable results to improve the quality of the Software thus promoting the application of Dependability and Safety methods and techniques. ESA space systems are being developed according to defined PA requirement specifications. These requirements may be implemented through various design concepts, e.g. redundancy, diversity etc. varying from project to project. Analysis methods (FMECA. FTA, HA, etc) are frequently used during requirements analysis and design activities to assure the correct implementation of system PA requirements. The criticality level of failures, functions and systems is determined and by doing that the critical sub-systems are identified, on which dependability and safety techniques are to be applied during development. Proper performance of the software development requires the development of a technical specification for the products at the beginning of the life cycle. Such technical specification comprises both functional and non-functional requirements. These non-functional requirements address characteristics of the product such as quality, dependability, safety and maintainability. Software in space systems is more and more used in critical functions. Also the trend towards more frequent use of COTS and reusable components pose new difficulties in terms of assuring reliable and safe systems. Because of this, its dependability and safety must be carefully analysed. ESA identified and documented techniques, methods and procedures to ensure that software dependability and safety requirements are specified and taken into account during the design and development of a software system and to verify/validate that the implemented software systems comply with these requirements [R1].

Research planning criteria for regenerative life-support systems applicable to space habitats

NASA Technical Reports Server (NTRS)

Spurlock, J.; Cooper, W.; Deal, P.; Harlan, A.; Karel, M.; Modell, M.; Moe, P.; Phillips, J.; Putnam, D.; Quattrone, P.

1979-01-01

The second phase of analyses that were conducted by the Life Support Systems Group of the 1977 NASA Ames Summer Study is described. This phase of analyses included a preliminary review of relevant areas of technology that can contribute to the development of closed life-support systems for space habitats, the identification of research options in these areas of technology, and the development of guidelines for an effective research program. The areas of technology that were studied included: (1) nutrition, diet, and food processing; (2) higher plant agriculture; (3) animal agriculture; (4) waste conversion and resource recovery; and (5) system stability and safety. Results of these analyses, including recommended research options and criteria for establishing research priorities among these many options, are discussed.

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

[Organisational responsibility versus individual responsibility: safety culture? About the relationship between patient safety and medical malpractice law].

PubMed

Hart, Dieter

2009-01-01

The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.

Waste Isolation Safety Assessment Program. Technical progress report for FY-1978

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

Brandstetter, A.; Harwell, M.A.; Howes, B.W.

1979-07-01

Associated with commercial nuclear power production in the United States is the generation of potentially hazardous radioactive wastes. The Department of Energy (DOE) is seeking to develop nuclear waste isolation systems in geologic formations that will preclude contact with the biosphere of waste radionuclides in concentrations which are sufficient to cause deleterious impact on humans or their environments. Comprehensive analyses of specific isolation systems are needed to assess the expectations of meeting that objective. The Waste Isolation Safety Assessment Program (WISAP) has been established at the Pacific Northwest Laboratory (operated by Battelle Memorial Institute) for developing the capability of makingmore » those analyses. Progress on the following tasks is reported: release scenario analysis, waste form release rate analysis, release consequence analysis, sorption-desorption analysis, and societal acceptance analysis. (DC)« less

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

NASA Astrophysics Data System (ADS)

Klicker, M.; Putzer, H.

2012-01-01

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

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

PubMed

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

2010-05-01

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

Evolution of the central safety factor during stabilized sawtooth instabilities at KSTAR

NASA Astrophysics Data System (ADS)

Messmer, M. C. C.; Ko, J.; Chung, J.; Woo, M. H.; Lee, K.-D.; Jaspers, R. J. E.

2018-01-01

A motional Stark effect (MSE) diagnostic has recently been installed in the KSTAR tokamak. A difficulty faced at KSTAR and common to other MSE diagnostics is calibration of the system for absolute measurements. In this report we present our novel calibration routine and discuss first results, evaluating the evolution of the the central safety factor during sawtooth instabilities. The calibration scheme ensures that the bandpass filters typically used in MSE systems are aligned correctly and identifies and removes systematic offsets present in the measurement. This is verified by comparing the reconstructed safety factor profile against various discharges where the locations of rational q surfaces have been obtained from MHD markers. The calibration is applied to analyse the evolution of q 0 in a shot where the sawteeth are stabilized by neutral beam injection. Within the analysed sawtooth periods q 0 drops below unity during the quiescent phase and relaxes close to or slightly above unity at the sawtooth crash. This finding is in line with the classical Kadomtsev model of full magnetic reconnection and earlier findings at JET.

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

PubMed

Etchegaray, Jason M; Thomas, Eric J

2012-06-01

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

Using computer graphics to enhance astronaut and systems safety

NASA Technical Reports Server (NTRS)

Brown, J. W.

1985-01-01

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

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

DOT National Transportation Integrated Search

2016-08-01

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

Trust, temporality and systems: how do patients understand patient safety in primary care? A qualitative study.

PubMed

Rhodes, Penny; Campbell, Stephen; Sanders, Caroline

2016-04-01

Patient safety research has tended to focus on hospital settings, although most clinical encounters occur in primary care, and to emphasize practitioner errors, rather than patients' own understandings of safety. To explore patients' understandings of safety in primary care. Qualitative interviews were conducted with patients recruited from general practices in northwest England. Participants were asked basic socio-demographic information; thereafter, topics were largely introduced by interviewees themselves. Transcripts were coded and analysed using NVivo10 (qualitative data software), following a process of constant comparison. Thirty-eight people (14 men, 24 women) from 19 general practices in rural, small town and city locations were interviewed. Many of their concerns (about access, length of consultation, relationship continuity) have been discussed in terms of quality, but, in the interviews, were raised as matters of safety. Three broad themes were identified: (i) trust and psycho-social aspects of professional-patient relationships; (ii) choice, continuity, access, and the temporal underpinnings of safety; and (iii) organizational and systems-level tensions constraining safety. Conceptualizations of safety included common reliance on a bureaucratic framework of accreditation, accountability, procedural rules and regulation, but were also individual and context-dependent. For patients, safety is not just a property of systems, but personal and contingent and is realized in the interaction between doctor and patient. However, it is the systems approach that has dominated safety thinking, and patients' individualistic and relational conceptualizations are poorly accommodated within current service organization. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

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

PubMed Central

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

2016-01-01

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

Proposed system safety design and test requirements for the microlaser ordnance system

NASA Technical Reports Server (NTRS)

Stoltz, Barb A.; Waldo, Dale F.

1993-01-01

Safety for pyrotechnic ignition systems is becoming a major concern for the military. In the past twenty years, stray electromagnetic fields have steadily increased during peacetime training missions and have dramatically increased during battlefield missions. Almost all of the ordnance systems in use today depend on an electrical bridgewire for ignition. Unfortunately, the bridgewire is the cause of the majority of failure modes. The common failure modes include the following: broken bridgewires; transient RF power, which induces bridgewire heating; and cold temperatures, which contracts the explosive mix away from the bridgewire. Finding solutions for these failure modes is driving the costs of pyrotechnic systems up. For example, analyses are performed to verify that the system in the environment will not see more energy than 20 dB below the 'No-fire' level. Range surveys are performed to determine the operational, storage, and transportation RF environments. Cryogenic tests are performed to verify the bridgewire to mix interface. System requirements call for 'last minute installation,' 'continuity checks after installation,' and rotating safety devices to 'interrupt the explosive train.' As an alternative, MDESC has developed a new approach based upon our enabling laser diode technology. We believe that Microlaser initiated ordnance offers a unique solution to the bridgewire safety concerns. For this presentation, we will address, from a system safety viewpoint, the safety design and the test requirements for a Microlaser ordnance system. We will also review how this system could be compliant to MIL-STD-1576 and DOD-83578A and the additional necessary requirements.

Systems Engineering of Electric and Hybrid Vehicles

NASA Technical Reports Server (NTRS)

Kurtz, D. W.; Levin, R. R.

1986-01-01

Technical paper notes systems engineering principles applied to development of electric and hybrid vehicles such that system performance requirements support overall program goal of reduced petroleum consumption. Paper discusses iterative design approach dictated by systems analyses. In addition to obvious peformance parameters of range, acceleration rate, and energy consumption, systems engineering also considers such major factors as cost, safety, reliability, comfort, necessary supporting infrastructure, and availability of materials.

Probability of loss of assured safety in temperature dependent systems with multiple weak and strong links.

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

Johnson, Jay Dean; Oberkampf, William Louis; Helton, Jon Craig

2004-12-01

Relationships to determine the probability that a weak link (WL)/strong link (SL) safety system will fail to function as intended in a fire environment are investigated. In the systems under study, failure of the WL system before failure of the SL system is intended to render the overall system inoperational and thus prevent the possible occurrence of accidents with potentially serious consequences. Formal developments of the probability that the WL system fails to deactivate the overall system before failure of the SL system (i.e., the probability of loss of assured safety, PLOAS) are presented for several WWSL configurations: (i) onemore » WL, one SL, (ii) multiple WLs, multiple SLs with failure of any SL before any WL constituting failure of the safety system, (iii) multiple WLs, multiple SLs with failure of all SLs before any WL constituting failure of the safety system, and (iv) multiple WLs, multiple SLs and multiple sublinks in each SL with failure of any sublink constituting failure of the associated SL and failure of all SLs before failure of any WL constituting failure of the safety system. The indicated probabilities derive from time-dependent temperatures in the WL/SL system and variability (i.e., aleatory uncertainty) in the temperatures at which the individual components of this system fail and are formally defined as multidimensional integrals. Numerical procedures based on quadrature (i.e., trapezoidal rule, Simpson's rule) and also on Monte Carlo techniques (i.e., simple random sampling, importance sampling) are described and illustrated for the evaluation of these integrals. Example uncertainty and sensitivity analyses for PLOAS involving the representation of uncertainty (i.e., epistemic uncertainty) with probability theory and also with evidence theory are presented.« less

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

An Interactive Logistics Centre Information Integration System Using Virtual Reality

NASA Astrophysics Data System (ADS)

Hong, S.; Mao, B.

2018-04-01

The logistics industry plays a very important role in the operation of modern cities. Meanwhile, the development of logistics industry has derived various problems that are urgent to be solved, such as the safety of logistics products. This paper combines the study of logistics industry traceability and logistics centre environment safety supervision with virtual reality technology, creates an interactive logistics centre information integration system. The proposed system utilizes the immerse characteristic of virtual reality, to simulate the real logistics centre scene distinctly, which can make operation staff conduct safety supervision training at any time without regional restrictions. On the one hand, a large number of sensor data can be used to simulate a variety of disaster emergency situations. On the other hand, collecting personnel operation data, to analyse the improper operation, which can improve the training efficiency greatly.

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

NASA Astrophysics Data System (ADS)

Malyshev, Mikhail; Kreimer, Johannes

2013-09-01

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

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

PubMed

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

2017-09-25

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

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

PubMed

Ball, Brita; Wilcock, Anne; Aung, May

2009-06-01

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

The role of individual diligence in improving safety.

PubMed

Corbett, Angus; Travaglia, Jo; Braithwaite, Jeffrey

2011-01-01

This paper aims to be a theoretical examination of the role of individuals in sponsoring and facilitating effective, systemic change in organisations. Using reports of a number of high-profile initiatives to improve patient safety, it seeks to analyse the role of individual health care professionals in developing and facilitating new systems of care that improve safety and quality. The paper uses recent work in sociology that is concerned with the phenomenon of "sociological citizenship". The authors test whether successful initiators of change in health care can be described as sociological citizens. This notion of sociological citizens is applied to a number of highly successful initiatives to improve safety and quality to extrapolate the factors associated with individual clinician leadership, which may have affected the success of such endeavours. In each of the examples analysed the initiators of change can be characterised as sociological citizens. In reviewing the roles of these charismatic individuals it is evident that they see the relational interdependence between the individuals and organisations and that they use this information to achieve both professional and organisational objectives. The paper uses a case study method to investigate the usefulness of the role of sociological citizenship in interventions that aim to improve patient safety. The paper reviews the key concepts and uses of the concept of sociological citizenship to produce a framework against which the case studies were assessed. The authors suggest that a goal of policy for improving patient safety should be directed to the problem of how hospitals and health care organisations can create the conditions for encouraging the individual diligence and care that is needed to support reliable, safe health care practices. Improving the safety and quality of health care is an important public health initiative. It has also proven to be difficult to achieve sustained reductions in the harm caused by the occurrence of adverse events in health care. The process of linking individual diligence with service outcomes may help to overcome one of the enduring struggles of health care systems around the world: the policy-practice divide. The paper directs attention towards the role of sociological citizenship in health care systems and organisations.

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

PubMed

Zhu, Junya

2018-06-11

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

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-12-02

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

A hierarchical factor analysis of a safety culture survey.

PubMed

Frazier, Christopher B; Ludwig, Timothy D; Whitaker, Brian; Roberts, D Steve

2013-06-01

Recent reviews of safety culture measures have revealed a host of potential factors that could make up a safety culture (Flin, Mearns, O'Connor, & Bryden, 2000; Guldenmund, 2000). However, there is still little consensus regarding what the core factors of safety culture are. The purpose of the current research was to determine the core factors, as well as the structure of those factors that make up a safety culture, and establish which factors add meaningful value by factor analyzing a widely used safety culture survey. A 92-item survey was constructed by subject matter experts and was administered to 25,574 workers across five multi-national organizations in five different industries. Exploratory and hierarchical confirmatory factor analyses were conducted revealing four second-order factors of a Safety Culture consisting of Management Concern, Personal Responsibility for Safety, Peer Support for Safety, and Safety Management Systems. Additionally, a total of 12 first-order factors were found: three on Management Concern, three on Personal Responsibility, two on Peer Support, and four on Safety Management Systems. The resulting safety culture model addresses gaps in the literature by indentifying the core constructs which make up a safety culture. This clarification of the major factors emerging in the measurement of safety cultures should impact the industry through a more accurate description, measurement, and tracking of safety cultures to reduce loss due to injury. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Traffic flow characteristic and capacity in intelligent work zones.

DOT National Transportation Integrated Search

2009-10-15

Intellgent transportation system (ITS) technologies are utilized to manage traffic flow and safety in : highway work zones. Traffic management plans for work zones require queuing analyses to determine : the anticipated traffic backups, but the predi...

[Patient safety in management contracts].

PubMed

Campillo-Artero, C

2012-01-01

Patient safety is becoming commonplace in management contracts. Since our experience in patient safety still falls short of other clinical areas, it is advisable to review some of its characteristics in order to improve its inclusion in these contracts. In this paper opinions and recommendations concerning the design and review of contractual clauses on safety are given, as well as reflections drawn from methodological papers and informal opinions of clinicians, who are most familiar with the nuances of safe and unsafe practices. After reviewing some features of these contracts, criteria for prioritizing and including safety objectives and activities in them, and key points for their evaluation are described. The need to replace isolated activities by systemic and multifaceted ones is emphasized. Errors, limitations and improvement opportunities observed when contracts are linked to indicators, information and adverse event reporting systems are analysed. Finally, the influence of the rules of the game, and clinicians behaviour are emphasised. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

An Overview of INEL Fusion Safety R&D Facilities

NASA Astrophysics Data System (ADS)

McCarthy, K. A.; Smolik, G. R.; Anderl, R. A.; Carmack, W. J.; Longhurst, G. R.

1997-06-01

The Fusion Safety Program at the Idaho National Engineering Laboratory has the lead for fusion safety work in the United States. Over the years, we have developed several experimental facilities to provide data for fusion reactor safety analyses. We now have four major experimental facilities that provide data for use in safety assessments. The Steam-Reactivity Measurement System measures hydrogen generation rates and tritium mobilization rates in high-temperature (up to 1200°C) fusion relevant materials exposed to steam. The Volatilization of Activation Product Oxides Reactor Facility provides information on mobilization and transport and chemical reactivity of fusion relevant materials at high temperature (up to 1200°C) in an oxidizing environment (air or steam). The Fusion Aerosol Source Test Facility is a scaled-up version of VAPOR. The ion-implanta-tion/thermal-desorption system is dedicated to research into processes and phenomena associated with the interaction of hydrogen isotopes with fusion materials. In this paper we describe the capabilities of these facilities.

Comparisons of RELAP5-3D Analyses to Experimental Data from the Natural Convection Shutdown Heat Removal Test Facility

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

Bucknor, Matthew; Hu, Rui; Lisowski, Darius

2016-04-17

The Reactor Cavity Cooling System (RCCS) is an important passive safety system being incorporated into the overall safety strategy for high temperature advanced reactor concepts such as the High Temperature Gas- Cooled Reactors (HTGR). The Natural Convection Shutdown Heat Removal Test Facility (NSTF) at Argonne National Laboratory (Argonne) reflects a 1/2-scale model of the primary features of one conceptual air-cooled RCCS design. The project conducts ex-vessel, passive heat removal experiments in support of Department of Energy Office of Nuclear Energy’s Advanced Reactor Technology (ART) program, while also generating data for code validation purposes. While experiments are being conducted at themore » NSTF to evaluate the feasibility of the passive RCCS, parallel modeling and simulation efforts are ongoing to support the design, fabrication, and operation of these natural convection systems. Both system-level and high fidelity computational fluid dynamics (CFD) analyses were performed to gain a complete understanding of the complex flow and heat transfer phenomena in natural convection systems. This paper provides a summary of the RELAP5-3D NSTF model development efforts and provides comparisons between simulation results and experimental data from the NSTF. Overall, the simulation results compared favorably to the experimental data, however, further analyses need to be conducted to investigate any identified differences.« less

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

PubMed

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

2014-01-30

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

Reliability and Maintainability Data for Lead Lithium Cooling Systems

DOE PAGES

Cadwallader, Lee

2016-11-16

This article presents component failure rate data for use in assessment of lead lithium cooling systems. Best estimate data applicable to this liquid metal coolant is presented. Repair times for similar components are also referenced in this work. These data support probabilistic safety assessment and reliability, availability, maintainability and inspectability analyses.

LOFT L2-3 blowdown experiment safety analyses D, E, and G; LOCA analyses H, K, K1

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

Perryman, J.L.; Keeler, C.D.; Saukkoriipi, L.O.

1978-12-01

Three calculations using conservative off-nominal conditions and evaluation model options were made using RELAP4/MOD5 for blowdown-refill and RELAP4/MOD6 for reflood for Loss-of-Fluid Test Experiment L2-3 to support the experiment safety analysis effort. The three analyses are as follows: Analysis D: Loss of commercial power during Experiment L2-3; Analysis E: Hot leg quick-opening blowdown valve (QOBV) does not open during Experiment L2-3; and Analysis G: Cold leg QOBV does not open during Experiment L2-3. In addition, the results of three LOFT loss-of-coolant accident (LOCA) analyses using a power of 56.1 MW and a primary coolant system flow rate of 3.6 millionmore » 1bm/hr are presented: Analysis H: Intact loop 200% hot leg break; emergency core cooling (ECC) system B unavailable; Analysis K: Pressurizer relief valve stuck in open position; ECC system B unavailable; and Analysis K1: Same as analysis K, but using a primary coolant system flow rate of 1.92 million 1bm/hr (L2-4 pre-LOCE flow rate). For analysis D, the maximum cladding temperature reached was 1762/sup 0/F, 22 sec into reflood. In analyses E and G, the blowdowns were slower due to one of the QOBVs not functioning. The maximum cladding temperature reached in analysis E was 1700/sup 0/F, 64.7 sec into reflood; for analysis G, it was 1300/sup 0/F at the start of reflood. For analysis H, the maximum cladding temperature reached was 1825/sup 0/F, 0.01 sec into reflood. Analysis K was a very slow blowdown, and the cladding temperatures followed the saturation temperature of the system. The results of analysis K1 was nearly identical to analysis K; system depressurization was not affected by the primary coolant system flow rate.« less

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

PubMed

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

2018-04-16

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

The European space suit, a design for productivity and crew safety.

PubMed

Skoog, A I; Berthier, S; Ollivier, Y

1991-01-01

In order to fulfill the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today--and will be for several years--a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: easy donning/doffing thru rear entry, suit ergonomy optimisation, display of operational information in alpha-numerical and graphical form, and voice processing for operations and safety critical information. Concerning crew safety the major design features are: a lower R-factor for emergency EVA operations thru increased suit pressure, zero prebreath conditions for normal operations, visual and voice processing of all safety critical functions, and an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

Probabilistic assessment of dynamic system performance. Part 3

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

Belhadj, Mohamed

1993-01-01

Accurate prediction of dynamic system failure behavior can be important for the reliability and risk analyses of nuclear power plants, as well as for their backfitting to satisfy given constraints on overall system reliability, or optimization of system performance. Global analysis of dynamic systems through investigating the variations in the structure of the attractors of the system and the domains of attraction of these attractors as a function of the system parameters is also important for nuclear technology in order to understand the fault-tolerance as well as the safety margins of the system under consideration and to insure a safemore » operation of nuclear reactors. Such a global analysis would be particularly relevant to future reactors with inherent or passive safety features that are expected to rely on natural phenomena rather than active components to achieve and maintain safe shutdown. Conventionally, failure and global analysis of dynamic systems necessitate the utilization of different methodologies which have computational limitations on the system size that can be handled. Using a Chapman-Kolmogorov interpretation of system dynamics, a theoretical basis is developed that unifies these methodologies as special cases and which can be used for a comprehensive safety and reliability analysis of dynamic systems.« less

The impact of safety organizing, trusted leadership, and care pathways on reported medication errors in hospital nursing units.

PubMed

Vogus, Timothy J; Sutcliffe, Kathleen M

2011-01-01

Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.

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

Optimizing the Design of Preprinted Orders for Ambulatory Chemotherapy: Combining Oncology, Human Factors, and Graphic Design

PubMed Central

Jeon, Jennifer; White, Rachel E.; Hunt, Richard G.; Cassano-Piché, Andrea L.; Easty, Anthony C.

2012-01-01

Purpose: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Methods: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. Results: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Conclusion: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards. PMID:23077436

Optimizing the design of preprinted orders for ambulatory chemotherapy: combining oncology, human factors, and graphic design.

PubMed

Jeon, Jennifer; White, Rachel E; Hunt, Richard G; Cassano-Piché, Andrea L; Easty, Anthony C

2012-03-01

To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.

Safety Effects of the Conversion of Rural Two-Lane Roadways to Four-Lane Roadways

DOT National Transportation Integrated Search

2012-08-01

This report presents the analyses and conclusions from work focused on analyzing multiple options for organizational and operational models for certificate management entities (CMEs) within the connected vehicle system. The report discusses all funct...

Measuring the effects of aborted takeoffs and landings on traffic flow at JFK

DOT National Transportation Integrated Search

2012-10-14

The FAA Office of Accident Investigation and Prevention (AVP) supports research, analysis and demonstration of quantitative air traffic analyses to estimate safety performance and benefits of the Next Generation Air Transportation System (NextGen). T...

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

PubMed

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

2006-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

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

The Morality and Economics of Safety in Defence Procurement

NASA Astrophysics Data System (ADS)

Clement, Tim

Ministry of Defence policy is to conform as closely as possible to UK health and safety legislation in all its operations. We consider the implications of the law and the guidance provided by the Health and Safety Executive for the arguments we need to make for the safety of defence procurements, and extract four general principles to help in answering the questions that arise when considering the safety of systems with complex behaviour. One of these principles is analysed further to identify how case law and the guidance interpret the requirement for risks to be reduced so far as is reasonably practicable. We then apply the principles to answer some questions that have arisen in our work as Independent Safety Auditors, including the limits to the tolerability of risk to armed forces personnel and civilians in wartime, and the acceptability of the transfer of risk from one group to another when controls on risk are introduced.

A closer look at associations between hospital leadership walkrounds and patient safety climate and risk reduction: a cross-sectional study.

PubMed

Schwendimann, René; Milne, Judy; Frush, Karen; Ausserhofer, Dietmar; Frankel, Allan; Sexton, J Bryan

2013-01-01

Leadership walkrounds (WRs) are widely used in health care organizations to improve patient safety. This retrospective, cross-sectional study evaluated the association between WRs and caregiver assessments of patient safety climate and patient safety risk reduction across 49 hospitals in a nonprofit health care system. Linear regression analyses using units' participation in WRs were conducted. Survey results from 706 hospital units revealed that units with ≥ 60% of caregivers reporting exposure to at least 1 WR had a significantly higher safety climate, greater patient safety risk reduction, and a higher proportion of feedback on actions taken as a result of WRs compared with those units with <60% of caregivers reporting exposure to WRs. WR participation at the unit level reflects a frequency effect as a function of units with none/low, medium, and high leadership WR exposure.

A Guide to the Application of Probability Risk Assessment Methodology and Hazard Risk Frequency Criteria as a Hazard Control for the Use of the Mobile Servicing System on the International Space Station

NASA Astrophysics Data System (ADS)

D'silva, Oneil; Kerrison, Roger

2013-09-01

A key feature for the increased utilization of space robotics is to automate Extra-Vehicular manned space activities and thus significantly reduce the potential for catastrophic hazards while simultaneously minimizing the overall costs associated with manned space. The principal scope of the paper is to evaluate the use of industry standard accepted Probability risk/safety assessment (PRA/PSA) methodologies and Hazard Risk frequency Criteria as a hazard control. This paper illustrates the applicability of combining the selected Probability risk assessment methodology and hazard risk frequency criteria, in order to apply the necessary safety controls that allow for the increased use of the Mobile Servicing system (MSS) robotic system on the International Space Station. This document will consider factors such as component failure rate reliability, software reliability, and periods of operation and dormancy, fault tree analyses and their effects on the probability risk assessments. The paper concludes with suggestions for the incorporation of existing industry Risk/Safety plans to create an applicable safety process for future activities/programs

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

PubMed

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

2012-01-01

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

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

PubMed

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

2016-08-02

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

Cognitive process modelling of controllers in en route air traffic control.

PubMed

Inoue, Satoru; Furuta, Kazuo; Nakata, Keiichi; Kanno, Taro; Aoyama, Hisae; Brown, Mark

2012-01-01

In recent years, various efforts have been made in air traffic control (ATC) to maintain traffic safety and efficiency in the face of increasing air traffic demands. ATC is a complex process that depends to a large degree on human capabilities, and so understanding how controllers carry out their tasks is an important issue in the design and development of ATC systems. In particular, the human factor is considered to be a serious problem in ATC safety and has been identified as a causal factor in both major and minor incidents. There is, therefore, a need to analyse the mechanisms by which errors occur due to complex factors and to develop systems that can deal with these errors. From the cognitive process perspective, it is essential that system developers have an understanding of the more complex working processes that involve the cooperative work of multiple controllers. Distributed cognition is a methodological framework for analysing cognitive processes that span multiple actors mediated by technology. In this research, we attempt to analyse and model interactions that take place in en route ATC systems based on distributed cognition. We examine the functional problems in an ATC system from a human factors perspective, and conclude by identifying certain measures by which to address these problems. This research focuses on the analysis of air traffic controllers' tasks for en route ATC and modelling controllers' cognitive processes. This research focuses on an experimental study to gain a better understanding of controllers' cognitive processes in air traffic control. We conducted ethnographic observations and then analysed the data to develop a model of controllers' cognitive process. This analysis revealed that strategic routines are applicable to decision making.

Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study

PubMed Central

Kiene, Helmut; Ziegler, Renatus; Tröger, Wilfried; Meinecke, Christoph; Schnürer, Christof; Vögler, Hendrik; Glockmann, Anja; Kienle, Gunver Sophia

2014-01-01

Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS incorporated two features proposed for the evaluation of integrative therapy systems: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement. PMID:24753995

Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study.

PubMed

Hamre, Harald Johan; Kiene, Helmut; Ziegler, Renatus; Tröger, Wilfried; Meinecke, Christoph; Schnürer, Christof; Vögler, Hendrik; Glockmann, Anja; Kienle, Gunver Sophia

2014-01-01

Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS INCORPORATED TWO FEATURES PROPOSED FOR THE EVALUATION OF INTEGRATIVE THERAPY SYSTEMS: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement.

23 CFR 972.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2013 CFR

2013-04-01

... as signs, delineators, and guardrails (including terminals); (iii) Traffic information including...-rail crossing warning devices, signs, highway elements, and operational features where appropriate; and...., data collection, analyses, and standards) for low volume roads may be tailored to be consistent with...

23 CFR 972.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2014 CFR

2014-04-01

... as signs, delineators, and guardrails (including terminals); (iii) Traffic information including...-rail crossing warning devices, signs, highway elements, and operational features where appropriate; and...., data collection, analyses, and standards) for low volume roads may be tailored to be consistent with...

23 CFR 972.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2012 CFR

2012-04-01

... as signs, delineators, and guardrails (including terminals); (iii) Traffic information including...-rail crossing warning devices, signs, highway elements, and operational features where appropriate; and...., data collection, analyses, and standards) for low volume roads may be tailored to be consistent with...

23 CFR 972.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2011 CFR

2011-04-01

... as signs, delineators, and guardrails (including terminals); (iii) Traffic information including...-rail crossing warning devices, signs, highway elements, and operational features where appropriate; and...., data collection, analyses, and standards) for low volume roads may be tailored to be consistent with...

More than meets the eye: Using cognitive work analysis to identify design requirements for future rail level crossing systems.

PubMed

Salmon, Paul M; Lenné, Michael G; Read, Gemma J M; Mulvihill, Christine M; Cornelissen, Miranda; Walker, Guy H; Young, Kristie L; Stevens, Nicholas; Stanton, Neville A

2016-03-01

An increasing intensity of operations means that the longstanding safety issue of rail level crossings is likely to become worse in the transport systems of the future. It has been suggested that the failure to prevent collisions may be, in part, due to a lack of systems thinking during design, crash analysis, and countermeasure development. This paper presents a systems analysis of current active rail level crossing systems in Victoria, Australia that was undertaken to identify design requirements to improve safety in future rail level crossing environments. Cognitive work analysis was used to analyse rail level crossing systems using data derived from a range of activities. Overall the analysis identified a range of instances where modification or redesign in line with systems thinking could potentially improve behaviour and safety. A notable finding is that there are opportunities for redesign outside of the physical rail level crossing infrastructure, including improved data systems, in-vehicle warnings and modifications to design processes, standards and guidelines. The implications for future rail level crossing systems are discussed. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Sample Return Primer and Handbook

NASA Technical Reports Server (NTRS)

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

Lunar mission safety and rescue: Executive summary

NASA Technical Reports Server (NTRS)

1971-01-01

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

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

Sarrack, A.G.

The purpose of this report is to document fault tree analyses which have been completed for the Defense Waste Processing Facility (DWPF) safety analysis. Logic models for equipment failures and human error combinations that could lead to flammable gas explosions in various process tanks, or failure of critical support systems were developed for internal initiating events and for earthquakes. These fault trees provide frequency estimates for support systems failures and accidents that could lead to radioactive and hazardous chemical releases both on-site and off-site. Top event frequency results from these fault trees will be used in further APET analyses tomore » calculate accident risk associated with DWPF facility operations. This report lists and explains important underlying assumptions, provides references for failure data sources, and briefly describes the fault tree method used. Specific commitments from DWPF to provide new procedural/administrative controls or system design changes are listed in the ''Facility Commitments'' section. The purpose of the ''Assumptions'' section is to clarify the basis for fault tree modeling, and is not necessarily a list of items required to be protected by Technical Safety Requirements (TSRs).« less

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

NASA Astrophysics Data System (ADS)

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

2013-09-01

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

Systemic Analysis Approaches for Air Transportation

NASA Technical Reports Server (NTRS)

Conway, Sheila

2005-01-01

Air transportation system designers have had only limited success using traditional operations research and parametric modeling approaches in their analyses of innovations. They need a systemic methodology for modeling of safety-critical infrastructure that is comprehensive, objective, and sufficiently concrete, yet simple enough to be used with reasonable investment. The methodology must also be amenable to quantitative analysis so issues of system safety and stability can be rigorously addressed. However, air transportation has proven itself an extensive, complex system whose behavior is difficult to describe, no less predict. There is a wide range of system analysis techniques available, but some are more appropriate for certain applications than others. Specifically in the area of complex system analysis, the literature suggests that both agent-based models and network analysis techniques may be useful. This paper discusses the theoretical basis for each approach in these applications, and explores their historic and potential further use for air transportation analysis.

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

PubMed

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

2017-06-15

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

The European space suit, a design for productivity and crew safety

NASA Astrophysics Data System (ADS)

Skoog, A. Ingemar; Berthier, S.; Ollivier, Y.

In order to fulfil the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today - and will be for several years - a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: • easy donning/doffing thru rear entry, • suit ergonomy optimisation, • display of operational information in alpha-numerical and graphical from, and • voice processing for operations and safety critical information. Concerning crew safety the major design features are: • a lower R-factor for emergency EVA operations thru incressed suit pressure, • zero prebreath conditions for normal operations, • visual and voice processing of all safety critical functions, and • an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

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

PubMed Central

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

2017-01-01

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

Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

PubMed

Edwards, Brian; Hugman, Bruce; Tobin, Mary; Whalen, Matthew

2012-04-01

Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees' concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products.

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

NASA Technical Reports Server (NTRS)

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

I-40 trucking operations and safety analyses and strategic planning initiatives.

DOT National Transportation Integrated Search

2010-04-01

Interstate 40 composes a major link of this system. This highway is a major eastwest : freeway that spans a length of 2,559 miles. Interstate 40 originates near I- : 15 in Barstow, California and then passes through Arizona, New Mexico, Texas, : Okla...

Safety of High Ground Transportation Systems - Human Factors Phase I: Function Analyses and Theoretical Considerations

DOT National Transportation Integrated Search

1994-10-01

Although the speed of guided ground transportation continues to increase, the reaction : time as well as the sensory and information processing capacities of on- and off-board : operators remain constant. This report, the first of two examining criti...

10 CFR 54.4 - Scope.

Code of Federal Regulations, 2011 CFR

2011-01-01

... COMMISSION (CONTINUED) REQUIREMENTS FOR RENEWAL OF OPERATING LICENSES FOR NUCLEAR POWER PLANTS General Provisions § 54.4 Scope. (a) Plant systems, structures, and components within the scope of this part are— (1..., and components relied on in safety analyses or plant evaluations to perform a function that...

10 CFR 54.4 - Scope.

Code of Federal Regulations, 2013 CFR

2013-01-01

... COMMISSION (CONTINUED) REQUIREMENTS FOR RENEWAL OF OPERATING LICENSES FOR NUCLEAR POWER PLANTS General Provisions § 54.4 Scope. (a) Plant systems, structures, and components within the scope of this part are— (1..., and components relied on in safety analyses or plant evaluations to perform a function that...

10 CFR 54.4 - Scope.

Code of Federal Regulations, 2012 CFR

2012-01-01

... COMMISSION (CONTINUED) REQUIREMENTS FOR RENEWAL OF OPERATING LICENSES FOR NUCLEAR POWER PLANTS General Provisions § 54.4 Scope. (a) Plant systems, structures, and components within the scope of this part are— (1..., and components relied on in safety analyses or plant evaluations to perform a function that...

10 CFR 54.4 - Scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... COMMISSION (CONTINUED) REQUIREMENTS FOR RENEWAL OF OPERATING LICENSES FOR NUCLEAR POWER PLANTS General Provisions § 54.4 Scope. (a) Plant systems, structures, and components within the scope of this part are— (1..., and components relied on in safety analyses or plant evaluations to perform a function that...

10 CFR 54.4 - Scope.

Code of Federal Regulations, 2014 CFR

2014-01-01

... COMMISSION (CONTINUED) REQUIREMENTS FOR RENEWAL OF OPERATING LICENSES FOR NUCLEAR POWER PLANTS General Provisions § 54.4 Scope. (a) Plant systems, structures, and components within the scope of this part are— (1..., and components relied on in safety analyses or plant evaluations to perform a function that...

An Analysis of the Relationship between Casualty Risk Per Crash and Vehicle Mass and Footprint for Model Year 2003-2010 Light-Duty Vehicles

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

Wenzel, Tom P.

The Department of Energy’s (DOE) Vehicle Technologies Office funds research on development of technologies to improve the fuel economy of both light- and heavy-duty vehicles, including advanced combustion systems, improved batteries and electric drive systems, and new lightweight materials. Of these approaches to increase fuel economy and reduce fuel consumption, reducing vehicle mass through more extensive use of strong lightweight materials is perhaps the easiest and least expensive method; however, there is a concern that reducing vehicle mass may lead to more fatalities. Lawrence Berkeley National Laboratory (LBNL) has conducted several analyses to better understand the relationship between vehicle mass,more » size and safety, in order to ameliorate concerns that down-weighting vehicles will inherently lead to more fatalities. These analyses include recreating the regression analyses conducted by the National Highway Traffic Safety Administration (NHTSA) that estimate the relationship between mass reduction and U.S. societal fatality risk per vehicle mile of travel (VMT), while holding vehicle size (i.e. footprint, wheelbase times track width) constant; these analyses are referred to as LBNL Phase 1 analysis. In addition, LBNL has conducted additional analysis of the relationship between mass and the two components of risk per VMT, crash frequency (crashes per VMT) and risk once a crash has occurred (risk per crash); these analyses are referred to as LBNL Phase 2 analysis.« less

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

PubMed

Hoffmann, Susanne; Frei, Irena Anna

2017-01-01

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

The Impact of Operating Parameters and Correlated Parameters for Extended BWR Burnup Credit

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

Ade, Brian J.; Marshall, William B. J.; Ilas, Germina

Applicants for certificates of compliance for spent nuclear fuel (SNF) transportation and dry storage systems perform analyses to demonstrate that these systems are adequately subcritical per the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Parts 71 and 72. For pressurized water reactor (PWR) SNF, these analyses may credit the reduction in assembly reactivity caused by depletion of fissile nuclides and buildup of neutron-absorbing nuclides during power operation. This credit for reactivity reduction during depletion is commonly referred to as burnup credit (BUC). US Nuclear Regulatory Commission (NRC) staff review BUC analyses according to the guidancemore » in the Division of Spent Fuel Storage and Transportation Interim Staff Guidance (ISG) 8, Revision 3, Burnup Credit in the Criticality Safety Analyses of PWR Spent Fuel in Transportation and Storage Casks.« less

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

NASA Technical Reports Server (NTRS)

Manderscheid, J. M.; Kaufman, A.

1985-01-01

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

Cryptographically supported NFC tags in medication for better inpatient safety.

PubMed

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

2014-08-01

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

Vision 20/20: Automation and advanced computing in clinical radiation oncology.

PubMed

Moore, Kevin L; Kagadis, George C; McNutt, Todd R; Moiseenko, Vitali; Mutic, Sasa

2014-01-01

This Vision 20/20 paper considers what computational advances are likely to be implemented in clinical radiation oncology in the coming years and how the adoption of these changes might alter the practice of radiotherapy. Four main areas of likely advancement are explored: cloud computing, aggregate data analyses, parallel computation, and automation. As these developments promise both new opportunities and new risks to clinicians and patients alike, the potential benefits are weighed against the hazards associated with each advance, with special considerations regarding patient safety under new computational platforms and methodologies. While the concerns of patient safety are legitimate, the authors contend that progress toward next-generation clinical informatics systems will bring about extremely valuable developments in quality improvement initiatives, clinical efficiency, outcomes analyses, data sharing, and adaptive radiotherapy.

The assessment of exploitation process of power for access control system

NASA Astrophysics Data System (ADS)

Wiśnios, Michał; Paś, Jacek

2017-10-01

The safety of public utility facilities is a function not only of effectiveness of the electronic safety systems, used for protection of property and persons, but it also depends on the proper functioning of their power supply systems. The authors of the research paper analysed the power supply systems, which are used in buildings for the access control system that is integrated with the closed-circuit TV. The Access Control System is a set of electronic, electromechanical and electrical devices and the computer software controlling the operation of the above-mentioned elements, which is aimed at identification of people, vehicles allowed to cross the boundary of the reserved area, to prevent from crossing the reserved area and to generate the alarm signal informing about the attempt of crossing by an unauthorised entity. The industrial electricity with appropriate technical parameters is a basis of proper functioning of safety systems. Only the electricity supply to the systems is not equivalent to the operation continuity provision. In practice, redundant power supply systems are used. In the carried out reliability analysis of the power supply system, various power circuits of the system were taken into account. The reliability and operation requirements for this type of system were also included.

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.

Understanding safety and production risks in rail engineering planning and protection.

PubMed

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

Medical-Information-Management System

NASA Technical Reports Server (NTRS)

Alterescu, Sidney; Friedman, Carl A.; Frankowski, James W.

1989-01-01

Medical Information Management System (MIMS) computer program interactive, general-purpose software system for storage and retrieval of information. Offers immediate assistance where manipulation of large data bases required. User quickly and efficiently extracts, displays, and analyzes data. Used in management of medical data and handling all aspects of data related to care of patients. Other applications include management of data on occupational safety in public and private sectors, handling judicial information, systemizing purchasing and procurement systems, and analyses of cost structures of organizations. Written in Microsoft FORTRAN 77.

Program level evaluation of ASAP diagnosis, referral and rehabilitation efforts. Volume 3, Analysis of ASAP rehabilitation countermeasures effectiveness

DOT National Transportation Integrated Search

1976-09-01

The present report describes the client flow through rehabilitation systems of the 35 NHTSA funded Alcohol Safety Action Projects (ASAPs) during the 1972-1974 period of project operations, summarizes project initiated analyses of treatment program ef...

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

DOT National Transportation Integrated Search

1997-06-01

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

Safety of High Speed Guided Ground Transportation Systems: Human Factors Phase I: Function Analyses and Theoretical Considerations

DOT National Transportation Integrated Search

1994-10-01

Although the speed of guided ground transportation continues to increase, the reaction : time as well as the sensory and information processing capacities of on- and off-board : operators remain constant. This report, the first of two examining criti...

How to improve laparoscopic access safety: ENDOTIP.

PubMed

2001-01-01

To improve laparoscopic port safety, an observational study was conducted where tissue dynamics at port-site, during use of conventional push-through trocars, were analysed. Specific performance shaping factors (PSF) were identified that individually and collectively infer added risk to port creation. Having determined weaknesses of closed and open laparoscopic port insertion, a new interactive visual cannula insertion and removal system is presented and ergonomic instrument designed. This second generation access system avoids the identified PSFs and can anticipate danger. Error is recognised and corrected before patient harm occurs. With renewed interest in the US Congress to curb incidence of inadvertent medical error, endoscopists should revisit the fundamental first steps of laparoscopy, when more than half of all serious complications occur. Our culture of 'blaming the human' must evolve into a culture of safety and transparency, as inadvertent laparoscopic error is now less tolerated. Evidently, most serious laparoscopic access injuries are generally a system problem, and less of a surgeon or instrument issue.

[Experience feedback committee: a method for patient safety improvement].

PubMed

François, P; Sellier, E; Imburchia, F; Mallaret, M-R

2013-04-01

An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Video techniques and data compared with observation in emergency trauma care

PubMed Central

Mackenzie, C; Xiao, Y

2003-01-01

Video recording is underused in improving patient safety and understanding performance shaping factors in patient care. We report our experience of using video recording techniques in a trauma centre, including how to gain cooperation of clinicians for video recording of their workplace performance, identify strengths of video compared with observation, and suggest processes for consent and maintenance of confidentiality of video records. Video records are a rich source of data for documenting clinician performance which reveal safety and systems issues not identified by observation. Emergency procedures and video records of critical events identified patient safety, clinical, quality assurance, systems failures, and ergonomic issues. Video recording is a powerful feedback and training tool and provides a reusable record of events that can be repeatedly reviewed and used as research data. It allows expanded analyses of time critical events, trauma resuscitation, anaesthesia, and surgical tasks. To overcome some of the key obstacles in deploying video recording techniques, researchers should (1) develop trust with video recorded subjects, (2) obtain clinician participation for introduction of a new protocol or line of investigation, (3) report aggregated video recorded data and use clinician reviews for feedback on covert processes and cognitive analyses, and (4) involve multidisciplinary experts in medicine and nursing. PMID:14645896

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors.

PubMed

Kostopoulou, Olga; Delaney, Brendan

2007-04-01

To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: "situation assessment and response selection" was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm.

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors

PubMed Central

Kostopoulou, Olga; Delaney, Brendan

2007-01-01

Objective To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Methods Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. Results 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: “situation assessment and response selection” was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Conclusions Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm. PMID:17403753

Fault Detection and Safety in Closed-Loop Artificial Pancreas Systems

PubMed Central

2014-01-01

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

The Effect of Power Protection Equipment on Explosion Hazards and on the Reliability of Power Supply to Longwall Systems

NASA Astrophysics Data System (ADS)

Boron, Sergiusz

2017-06-01

Operational safety of electrical machines and equipment depends, inter alia, on the hazards resulting from their use and on the scope of applied protective measures. The use of insufficient protection against existing hazards leads to reduced operational safety, particularly under fault conditions. On the other hand, excessive (in relation to existing hazards) level of protection may compromise the reliability of power supply. This paper analyses the explosion hazard created by earth faults in longwall power supply systems and evaluates existing protection equipment from the viewpoint of its protective performance, particularly in the context of explosion hazards, and also assesses its effect on the reliability of power supply.

Aerospace technology and commercial nuclear power; Proceedings of the Workshop Conference, Williamsburg, VA, November 18-20, 1981

NASA Technical Reports Server (NTRS)

Grey, J. (Editor)

1982-01-01

An attempt has been made to compare the technologies, institutions and procedures of the aerospace and commercial nuclear power industries, in order to characterize similarities and contrasts as well as to identify the most fruitful means by which to transfer information, technology, and procedures between the two industries. The seven working groups involved in this study took as their topics powerplant design formulation and effectiveness, plant safety and operations, powerplant control technology and integration, economic and financial analyses, public relations, and the management of nuclear waste and spent fuel. Consequential differences are noted between the two industries in matters of certification and licencing procedures, assignment of responsibility for both safety and financial performance, and public viewpoint. Areas for beneficial interaction include systems management and control and safety system technology. No individual items are abstracted in this volume

Safety and Liability Aspects of Solar Power Satellites

NASA Astrophysics Data System (ADS)

Jakhu, Ram S.; Howard, Diane

2010-09-01

It is an undisputed fact that the global need for energy will grow exponentially in the future and the search for alternative energy sources will intensify. One alternative source will be space based solar power(SSP), to be collected in space and transmitted to Earth by solar power satellites(SPS). As the appropriate technology becomes proven, the economic and operational viability for the launch of SPS system(s) will, to a large extent, depend upon favorable political and legal determinants. One of such determinants relates to safety risks and possible liability of the operator(s) of SPS system(s). This paper identifies safety risks of, and analyses liability for, damage caused by SPS. Issues, specifically analyzed mainly under international law, include damage caused(in outer space, in the air and on the Earth) by electronic transmission, and mechanisms to manage liability including inter alia insurance coverage, waivers of liability, and dispute settlement mechanisms. The paper contains recommendations for the concerned governments(and their respective private entities) to take regulatory precautions in order to avoid the risks of possible liability and thereby enhances the chances for launch and operation of SPS system(s).

Thermal hydraulic feasibility assessment of the hot conditioning system and process

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

Heard, F.J.

1996-10-10

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

Semi-Markov Approach to the Shipping Safety Modelling

NASA Astrophysics Data System (ADS)

Guze, Sambor; Smolarek, Leszek

2012-02-01

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

Integrated therapy safety management system

PubMed Central

Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

2013-01-01

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

Application of patient safety indicators internationally: a pilot study among seven countries.

PubMed

Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

2009-08-01

To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

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

PubMed

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

2016-02-01

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

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

Safety illusion and error trap in a collectively-operated machine accident.

PubMed

de Almeida, Ildeberto Muniz; Nobre, Hildeberto; do Amaral Dias, Maria Dionísia; Vilela, Rodolfo Andrade Gouveia

2012-01-01

Workplace accidents involving machines are relevant for their magnitude and their impacts on worker health. Despite consolidated critical statements, explanation centered on errors of operators remains predominant with industry professionals, hampering preventive measures and the improvement of production-system reliability. Several initiatives were adopted by enforcement agencies in partnership with universities to stimulate production and diffusion of analysis methodologies with a systemic approach. Starting from one accident case that occurred with a worker who operated a brake-clutch type mechanical press, the article explores cognitive aspects and the existence of traps in the operation of this machine. It deals with a large-sized press that, despite being endowed with a light curtain in areas of access to the pressing zone, did not meet legal requirements. The safety devices gave rise to an illusion of safety, permitting activation of the machine when a worker was still found within the operational zone. Preventive interventions must stimulate the tailoring of systems to the characteristics of workers, minimizing the creation of traps and encouraging safety policies and practices that replace judgments of behaviors that participate in accidents by analyses of reasons that lead workers to act in that manner.

30 CFR 250.916 - What are the CVA's primary duties during the design phase?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Stress analyses; (vi) Material designations; (vii) Soil and foundation conditions; (viii) Safety factors... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Platforms and... pipeline risers, and riser tensioning systems; (ii) Turrets and turret-and-hull interfaces; (iii...

Object-Oriented Algorithm For Evaluation Of Fault Trees

NASA Technical Reports Server (NTRS)

Patterson-Hine, F. A.; Koen, B. V.

1992-01-01

Algorithm for direct evaluation of fault trees incorporates techniques of object-oriented programming. Reduces number of calls needed to solve trees with repeated events. Provides significantly improved software environment for such computations as quantitative analyses of safety and reliability of complicated systems of equipment (e.g., spacecraft or factories).

The Relationship between Using Electronic Health Records and Meeting Accreditation Standards for Client Safety in Residential Aged Care Homes.

PubMed

Jiang, Tao; Yu, Ping

2015-01-01

This study aims to identify the benefits of using electronic health records (EHR) for client safety in residential aged care (RAC) homes. The aged care accreditation reports published between 27 April 2011 and 3 December 2013 were downloaded and analysed. It could be seen from these reports that only 1,031(37.45%) RAC homes in Australia had adopted an EHR system by 2013. 13 RAC homes failed one or more accreditation standards. Only one of these was using an EHR system and this one met the accreditation standards on information systems. Our study provides empirical evidence to suggest that adopting and using EHR can be one of the effective organisational mechanisms to meeting accreditation standards in RAC homes.

A fully-implicit high-order system thermal-hydraulics model for advanced non-LWR safety analyses

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

Hu, Rui

An advanced system analysis tool is being developed for advanced reactor safety analysis. This paper describes the underlying physics and numerical models used in the code, including the governing equations, the stabilization schemes, the high-order spatial and temporal discretization schemes, and the Jacobian Free Newton Krylov solution method. The effects of the spatial and temporal discretization schemes are investigated. Additionally, a series of verification test problems are presented to confirm the high-order schemes. Furthermore, it is demonstrated that the developed system thermal-hydraulics model can be strictly verified with the theoretical convergence rates, and that it performs very well for amore » wide range of flow problems with high accuracy, efficiency, and minimal numerical diffusions.« less

A fully-implicit high-order system thermal-hydraulics model for advanced non-LWR safety analyses

DOE PAGES

Hu, Rui

2016-11-19

An advanced system analysis tool is being developed for advanced reactor safety analysis. This paper describes the underlying physics and numerical models used in the code, including the governing equations, the stabilization schemes, the high-order spatial and temporal discretization schemes, and the Jacobian Free Newton Krylov solution method. The effects of the spatial and temporal discretization schemes are investigated. Additionally, a series of verification test problems are presented to confirm the high-order schemes. Furthermore, it is demonstrated that the developed system thermal-hydraulics model can be strictly verified with the theoretical convergence rates, and that it performs very well for amore » wide range of flow problems with high accuracy, efficiency, and minimal numerical diffusions.« less

Creating a culture of safety by coaching clinicians to competence.

PubMed

Duff, Beverley

2013-10-01

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

Impact of Performance Obstacles on Intensive Care Nurses‘ Workload, Perceived Quality and Safety of Care, and Quality of Working Life

PubMed Central

Gurses, Ayse P; Carayon, Pascale; Wall, Melanie

2009-01-01

Objectives To study the impact of performance obstacles on intensive care nurses‘ workload, quality and safety of care, and quality of working life (QWL). Performance obstacles are factors that hinder nurses‘ capacity to perform their job and that are closely associated with their immediate work system. Data Sources/Study Setting Data were collected from 265 nurses in 17 intensive care units (ICUs) between February and August 2004 via a structured questionnaire, yielding a response rate of 80 percent. Study Design A cross-sectional study design was used. Data were analyzed by correlation analyses and structural equation modeling. Principal Findings Performance obstacles were found to affect perceived quality and safety of care and QWL of ICU nurses. Workload mediated the impact of performance obstacles with the exception of equipment-related issues on perceived quality and safety of care as well as QWL. Conclusions Performance obstacles in ICUs are a major determinant of nursing workload, perceived quality and safety of care, and QWL. In general, performance obstacles increase nursing workload, which in turn negatively affect perceived quality and safety of care and QWL. Redesigning the ICU work system to reduce performance obstacles may improve nurses‘ work. PMID:19207589

Study of the Continuous Improvement Trend for Health, Safety and Environmental Indicators, after Establishment of Integrated Management System (IMS) in a Pharmaceutical Industry in Iran.

PubMed

Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj; Marioryad, Hossein

2015-10-01

Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead.

Study of the Continuous Improvement Trend for Health, Safety and Environmental Indicators, after Establishment of Integrated Management System (IMS) in a Pharmaceutical Industry in Iran

PubMed Central

Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj

2015-01-01

Background Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. Aim This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. Materials and Methods First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Results Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Conclusion Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead. PMID:26557547

Three-dimensional time-dependent STAR reactor kinetics analyses coupled with RETRAN and MCPWR system response

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

Feltus, M.A.

1989-11-01

The operation of a nuclear power plant must be regularly supported by various reactor dynamics and thermal-hydraulic analyses, which may include final safety analysis report (FSAR) design-basis calculations, and conservative and best-estimate analyses. The development and improvement of computer codes and analysis methodologies provide many advantages, including the ability to evaluate the effect of modeling simplifications and assumptions made in previous reactor kinetics and thermal-hydraulic calculations. This paper describes the results of using the RETRAN, MCPWR, and STAR codes in a tandem, predictive-corrective manner for three pressurized water reactor (PWR) transients: (a) loss of feedwater (LOF) anticipated transient without scrammore » (ATWS), (b) station blackout ATWS, and (c) loss of total reactor coolant system (RCS) flow with a scram.« less

Vision 20/20: Automation and advanced computing in clinical radiation oncology

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

Moore, Kevin L., E-mail: kevinmoore@ucsd.edu; Moiseenko, Vitali; Kagadis, George C.

This Vision 20/20 paper considers what computational advances are likely to be implemented in clinical radiation oncology in the coming years and how the adoption of these changes might alter the practice of radiotherapy. Four main areas of likely advancement are explored: cloud computing, aggregate data analyses, parallel computation, and automation. As these developments promise both new opportunities and new risks to clinicians and patients alike, the potential benefits are weighed against the hazards associated with each advance, with special considerations regarding patient safety under new computational platforms and methodologies. While the concerns of patient safety are legitimate, the authorsmore » contend that progress toward next-generation clinical informatics systems will bring about extremely valuable developments in quality improvement initiatives, clinical efficiency, outcomes analyses, data sharing, and adaptive radiotherapy.« less

Vision 20/20: Automation and advanced computing in clinical radiation oncology

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

Moore, Kevin L., E-mail: kevinmoore@ucsd.edu; Moiseenko, Vitali; Kagadis, George C.

2014-01-15

This Vision 20/20 paper considers what computational advances are likely to be implemented in clinical radiation oncology in the coming years and how the adoption of these changes might alter the practice of radiotherapy. Four main areas of likely advancement are explored: cloud computing, aggregate data analyses, parallel computation, and automation. As these developments promise both new opportunities and new risks to clinicians and patients alike, the potential benefits are weighed against the hazards associated with each advance, with special considerations regarding patient safety under new computational platforms and methodologies. While the concerns of patient safety are legitimate, the authorsmore » contend that progress toward next-generation clinical informatics systems will bring about extremely valuable developments in quality improvement initiatives, clinical efficiency, outcomes analyses, data sharing, and adaptive radiotherapy.« less

MOD-0A 200 kW wind turbine generator design and analysis report

NASA Astrophysics Data System (ADS)

Anderson, T. S.; Bodenschatz, C. A.; Eggers, A. G.; Hughes, P. S.; Lampe, R. F.; Lipner, M. H.; Schornhorst, J. R.

1980-08-01

The design, analysis, and initial performance of the MOD-OA 200 kW wind turbine generator at Clayton, NM is documented. The MOD-OA was designed and built to obtain operation and performance data and experience in utility environments. The project requirements, approach, system description, design requirements, design, analysis, system tests, installation, safety considerations, failure modes and effects analysis, data acquisition, and initial performance for the wind turbine are discussed. The design and analysis of the rotor, drive train, nacelle equipment, yaw drive mechanism and brake, tower, foundation, electricl system, and control systems are presented. The rotor includes the blades, hub, and pitch change mechanism. The drive train includes the low speed shaft, speed increaser, high speed shaft, and rotor brake. The electrical system includes the generator, switchgear, transformer, and utility connection. The control systems are the blade pitch, yaw, and generator control, and the safety system. Manual, automatic, and remote control are discussed. Systems analyses on dynamic loads and fatigue are presented.

MOD-0A 200 kW wind turbine generator design and analysis report

NASA Technical Reports Server (NTRS)

Anderson, T. S.; Bodenschatz, C. A.; Eggers, A. G.; Hughes, P. S.; Lampe, R. F.; Lipner, M. H.; Schornhorst, J. R.

1980-01-01

The design, analysis, and initial performance of the MOD-OA 200 kW wind turbine generator at Clayton, NM is documented. The MOD-OA was designed and built to obtain operation and performance data and experience in utility environments. The project requirements, approach, system description, design requirements, design, analysis, system tests, installation, safety considerations, failure modes and effects analysis, data acquisition, and initial performance for the wind turbine are discussed. The design and analysis of the rotor, drive train, nacelle equipment, yaw drive mechanism and brake, tower, foundation, electricl system, and control systems are presented. The rotor includes the blades, hub, and pitch change mechanism. The drive train includes the low speed shaft, speed increaser, high speed shaft, and rotor brake. The electrical system includes the generator, switchgear, transformer, and utility connection. The control systems are the blade pitch, yaw, and generator control, and the safety system. Manual, automatic, and remote control are discussed. Systems analyses on dynamic loads and fatigue are presented.

Operational Performance Risk Assessment in Support of A Supervisory Control System

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

Denning, Richard S.; Muhlheim, Michael David; Cetiner, Sacit M.

Supervisory control system (SCS) is developed for multi-unit advanced small modular reactors to minimize human interventions in both normal and abnormal operations. In SCS, control action decisions made based on probabilistic risk assessment approach via Event Trees/Fault Trees. Although traditional PRA tools are implemented, their scope is extended to normal operations and application is reversed; success of non-safety related system instead failure of safety systems this extended PRA approach called as operational performance risk assessment (OPRA). OPRA helps to identify success paths, combination of control actions for transients and to quantify these success paths to provide possible actions without activatingmore » plant protection system. In this paper, a case study of the OPRA in supervisory control system is demonstrated within the context of the ALMR PRISM design, specifically power conversion system. The scenario investigated involved a condition that the feed water control valve is observed to be drifting to the closed position. Alternative plant configurations were identified via OPRA that would allow the plant to continue to operate at full or reduced power. Dynamic analyses were performed with a thermal-hydraulic model of the ALMR PRISM system using Modelica to evaluate remained safety margins. Successful recovery paths for the selected scenario are identified and quantified via SCS.« less

Ethics and safety in home care: perspectives on home support workers.

PubMed

Storch, Janet; Curry, Cherie Geering; Stevenson, Lynn; Macdonald, Marilyn; Lang, Ariella

2014-03-01

Home support workers (HSWs) encounter unique safety issues in their provision of home care. These issues raise ethical concerns, affecting the care workers provide to seniors and other recipients. This paper is derived from a subproject of a larger Canada-wide study, Safety at Home: A Pan-Canadian Home Care Safety Study, released in June 2013 by the Canadian Patient Safety Institute. Semi-structured, face-to-face, audiotaped interviews were conducted with providers, clients and informal caregivers in British Columbia, Manitoba and New Brunswick to better understand their perceptions of patient safety in home care. Using the BC data only, we then compared our findings to findings of other BC studies focusing on safety in home care that were conducted over the past decade. Through our interviews and comparative analyses it became clear that HSWs experienced significant inequities in providing home care. Utilizing a model depicting concerns of and for HSWs developed by Craven and colleagues (2012), we were able to illustrate the physical, spatial, interpersonal and temporal concerns set in the context of system design that emphasized the ethical dilemmas of HSWs in home care. Our data suggested the necessity of adding a fifth domain, organizational (system design). In this paper, we issue a call for stronger advocacy for home care and improved collaboration and resource equity between institutional care and community care.

Are Child Passengers Bringing Up the Rear? Evidence For Differential Improvements in Injury Risk Between Drivers and their Child Passengers

PubMed Central

Winston, Flaura K; Xie, Dawei; Durbin, Dennis R; Elliott, Michael R

2007-01-01

Since nearly half of children fatally injured in automobile crashes were restrained, optimizing occupant protection systems for children is essential to reducing morbidity and mortality. Data from the Partners for Child Passenger Safety study were used to compare the differential injury risk between drivers and their child passengers in the same crash, with a focus on vehicle model year. A matched cohort design and conditional logistic regression model were used in the analyses. Overall, injury risk for drivers was higher than for children, but the risk difference was largest for the oldest model year vehicles, particularly for children aged 4–8 in seat belts. While drivers experienced significant benefits in safety with increasing model years, children restrained by safety belts alone derived less safety benefit from newer vehicles. PMID:18184488

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

PubMed

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

2016-11-01

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

The safety of maternal immunization

PubMed Central

Regan, Annette K.

2016-01-01

ABSTRACT Maternal vaccination offers the opportunity to protect pregnant women and their infants against potentially serious disease. As both pregnant women and their newborns are vulnerable to severe illness, the potential public health impact of mass maternal vaccination programs is remarkable. Several high-income countries recommend seasonal influenza and acellular pertussis vaccines, and many developing countries recommend immunization against tetanus during pregnancy. There is a significant amount of literature supporting the safety of vaccination during pregnancy. As other vaccines are newly introduced for pregnant women, routine systems for monitoring vaccine safety in pregnant women are needed. To facilitate meta-analyses and comparison across systems and studies, future research and surveillance initiatives should utilize the same criteria for defining adverse events following immunization among pregnant women. At least 2 areas require further exploration: 1) identification of pregnancy outcomes associated with concomitant and closely spaced vaccines; 2) evaluation of possible improvement in birth outcomes associated with maternal vaccination. Given the public health impact of maternal vaccination, the existing evidence supporting the safety of vaccination during pregnancy should be used to reassure pregnant women and their providers and improve vaccine uptake in pregnancy. PMID:27541370

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.

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual basis but to consider measures of aggregate safety risk and to ensure wherever possible that there be quantitative measures for evaluating how effective the controls are in reducing these aggregate risks. The term aggregate risk, when used in this handbook, refers to the accumulation of risks from individual scenarios that lead to a shortfall in safety performance at a high level: e.g., an excessively high probability of loss of crew, loss of mission, planetary contamination, etc. Without aggregated quantitative measures such as these, it is not reasonable to expect that safety has been optimized with respect to other technical and programmatic objectives. At the same time, it is fully recognized that not all sources of risk are amenable to precise quantitative analysis and that the use of qualitative approaches and bounding estimates may be appropriate for those risk sources. Second, the handbook stresses the necessity of developing confidence that the controls derived for the purpose of achieving system safety not only handle risks that have been identified and properly characterized but also provide a general, more holistic means for protecting against unidentified or uncharacterized risks. For example, while it is not possible to be assured that all credible causes of risk have been identified, there are defenses that can provide protection against broad categories of risks and thereby increase the chances that individual causes are contained. Third, the handbook strives at all times to treat uncertainties as an integral aspect of risk and as a part of making decisions. The term "uncertainty" here does not refer to an actuarial type of data analysis, but rather to a characterization of our state of knowledge regarding results from logical and physical models that approximate reality. Uncertainty analysis finds how the output parameters of the models are related to plausible variations in the input parameters and in the modeling assumptions. The evaluation of unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that derive from the safety objectives of the organization. The safety claims are developed from a hierarchy of safety objectives and are therefore hierarchical themselves. Assurance that all the claims are true within acceptable risk tolerance limits implies that all of the safety objectives have been satisfied, and therefore that the system is safe. The acceptable risk tolerance limits are provided by the authority who must make the decision whether or not to proceed to the next step in the life cycle. These tolerances are therefore referred to as the decision maker's risk tolerances. In general, the safety claims address two fundamental facets of safety: 1) whether required safety thresholds or goals have been achieved, and 2) whether the safety risk is as low as possible within reasonable impacts on cost, schedule, and performance. The latter facet includes consideration of controls that are collective in nature (i.e., apply generically to broad categories of risks) and thereby provide protection against unidentified or uncharacterized risks.

[Patient safety and errors in medicine: development, prevention and analyses of incidents].

PubMed

Rall, M; Manser, T; Guggenberger, H; Gaba, D M; Unertl, K

2001-06-01

"Patient safety" and "errors in medicine" are issues gaining more and more prominence in the eyes of the public. According to newer studies, errors in medicine are among the ten major causes of death in association with the whole area of health care. A new era has begun incorporating attention to a "systems" approach to deal with errors and their causes in the health system. In other high-risk domains with a high demand for safety (such as the nuclear power industry and aviation) many strategies to enhance safety have been established. It is time to study these strategies, to adapt them if necessary and apply them to the field of medicine. These strategies include: to teach people how errors evolve in complex working domains and how types of errors are classified; the introduction of critical incident reporting systems that are free of negative consequences for the reporters; the promotion of continuous medical education; and the development of generic problem-solving skills incorporating the extensive use of realistic simulators wherever possible. Interestingly, the field of anesthesiology--within which realistic simulators were developed--is referred to as a model for the new patient safety movement. Despite this proud track record in recent times though, there is still much to be done even in the field of anesthesiology. Overall though, the most important strategy towards a long-term improvement in patient safety will be a change of "culture" throughout the entire health care system. The "culture of blame" focused on individuals should be replaced by a "safety culture", that sees errors and critical incidents as a problem of the whole organization. The acceptance of human fallability and an open-minded non-punitive analysis of errors in the sense of a "preventive and proactive safety culture" should lead to solutions at the systemic level. This change in culture can only be achieved with a strong commitment from the highest levels of an organization. Patient safety must have the highest priority in the goals of the institution: "Primum nihil nocere"--"First, do not harm".

A flooding induced station blackout analysis for a pressurized water reactor using the RISMC toolkit

DOE PAGES

Mandelli, Diego; Prescott, Steven; Smith, Curtis; ...

2015-05-17

In this paper we evaluate the impact of a power uprate on a pressurized water reactor (PWR) for a tsunami-induced flooding test case. This analysis is performed using the RISMC toolkit: the RELAP-7 and RAVEN codes. RELAP-7 is the new generation of system analysis codes that is responsible for simulating the thermal-hydraulic dynamics of PWR and boiling water reactor systems. RAVEN has two capabilities: to act as a controller of the RELAP-7 simulation (e.g., component/system activation) and to perform statistical analyses. In our case, the simulation of the flooding is performed by using an advanced smooth particle hydrodynamics code calledmore » NEUTRINO. The obtained results allow the user to investigate and quantify the impact of timing and sequencing of events on system safety. The impact of power uprate is determined in terms of both core damage probability and safety margins.« less

Evaluation of safety climate and employee injury rates in healthcare.

PubMed

Cook, Jacqueline M; Slade, Martin D; Cantley, Linda F; Sakr, Carine J

2016-09-01

Safety climates that support safety-related behaviour are associated with fewer work-related injuries, and prior research in industry suggests that safety knowledge and motivation are strongly related to safety performance behaviours; this relationship is not well studied in healthcare settings. We performed analyses of survey results from a Veterans Health Administration (VHA) Safety Barometer employee perception survey, conducted among VHA employees in 2012. The employee perception survey assessed 6 safety programme categories, including management participation, supervisor participation, employee participation, safety support activities, safety support climate and organisational climate. We examined the relationship between safety climate from the survey results on VHA employee injury and illness rates. Among VHA facilities in the VA New England Healthcare System, work-related injury rate was significantly and inversely related to overall employee perception of safety climate, and all 6 safety programme categories, including employee perception of employee participation, management participation, organisational climate, supervisor participation, safety support activities and safety support climate. Positive employee perceptions of safety climate in VHA facilities are associated with lower work-related injury and illness rates. Employee perception of employee participation, management participation, organisational climate, supervisor participation, safety support activities and safety support climate were all associated with lower work-related injury rates. Future implications include fostering a robust safety climate for patients and healthcare workers to reduce healthcare worker injuries. 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/

30 CFR 250.1911 - What criteria for hazards analyses must my SEMS program meet?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Safety...., mobile offshore drilling units; floating production systems; floating production, storage and offloading... transportation activities for oil, gas, or sulphur from areas leased in the OCS. Facilities also include DOI...

SCALE: A modular code system for performing Standardized Computer Analyses for Licensing Evaluation. Volume 1, Part 2: Control modules S1--H1; Revision 5

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

NONE

SCALE--a modular code system for Standardized Computer Analyses Licensing Evaluation--has been developed by Oak Ridge National Laboratory at the request of the US Nuclear Regulatory Commission. The SCALE system utilizes well-established computer codes and methods within standard analysis sequences that (1) allow an input format designed for the occasional user and/or novice, (2) automated the data processing and coupling between modules, and (3) provide accurate and reliable results. System development has been directed at problem-dependent cross-section processing and analysis of criticality safety, shielding, heat transfer, and depletion/decay problems. Since the initial release of SCALE in 1980, the code system hasmore » been heavily used for evaluation of nuclear fuel facility and package designs. This revision documents Version 4.3 of the system.« less

Guidance, Navigation, and Control System Design in a Mass Reduction Exercise

NASA Technical Reports Server (NTRS)

Crain, Timothy; Begly, Michael; Jackson, Mark; Broome, Joel

2008-01-01

Early Orion GN&C system designs optimized for robustness, simplicity, and utilization of commercially available components. During the System Definition Review (SDR), all subsystems on Orion were asked to re-optimize with component mass and steady state power as primary design metrics. The objective was to create a mass reserve in the Orion point of departure vehicle design prior to beginning the PDR analysis cycle. The Orion GN&C subsystem team transitioned from a philosophy of absolute 2 fault tolerance for crew safety and 1 fault tolerance for mission success to an approach of 1 fault tolerance for crew safety and risk based redundancy to meet probability allocations of loss of mission and loss of crew. This paper will discuss the analyses, rationale, and end results of this activity regarding Orion navigation sensor hardware, control effectors, and trajectory design.

Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

PubMed

Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

2016-09-12

This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Former food products safety: microbiological quality and computer vision evaluation of packaging remnants contamination.

PubMed

Tretola, M; Di Rosa, A R; Tirloni, E; Ottoboni, M; Giromini, C; Leone, F; Bernardi, C E M; Dell'Orto, V; Chiofalo, V; Pinotti, L

2017-08-01

The use of alternative feed ingredients in farm animal's diets can be an interesting choice from several standpoints, including safety. In this respect, this study investigated the safety features of selected former food products (FFPs) intended for animal nutrition produced in the framework of the IZS PLV 06/14 RC project by an FFP processing plant. Six FFP samples, both mash and pelleted, were analysed for the enumeration of total viable count (TVC) (ISO 4833), Enterobacteriaceae (ISO 21528-1), Escherichia coli (ISO 16649-1), coagulase-positive Staphylococci (CPS) (ISO 6888), presumptive Bacillus cereus and its spores (ISO 7932), sulphite-reducing Clostridia (ISO 7937), yeasts and moulds (ISO 21527-1), and the presence in 25 g of Salmonella spp. (ISO 6579). On the same samples, the presence of undesired ingredients, which can be identified as remnants of packaging materials, was evaluated by two different methods: stereomicroscopy according to published methods; and stereomicroscopy coupled with a computer vision system (IRIS Visual Analyzer VA400). All FFPs analysed were safe from a microbiological point of view. TVC was limited and Salmonella was always absent. When remnants of packaging materials were considered, the contamination level was below 0.08% (w/w). Of note, packaging remnants were found mainly from the 1-mm sieve mesh fractions. Finally, the innovative computer vision system demonstrated the possibility of rapid detection for the presence of packaging remnants in FFPs when combined with a stereomicroscope. In conclusion, the FFPs analysed in the present study can be considered safe, even though some improvements in FFP processing in the feeding plant can be useful in further reducing their microbial loads and impurity.

Demonstration of fully coupled simplified extended station black-out accident simulation with RELAP-7

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

Zhao, Haihua; Zhang, Hongbin; Zou, Ling

2014-10-01

The RELAP-7 code is the next generation nuclear reactor system safety analysis code being developed at the Idaho National Laboratory (INL). The RELAP-7 code develop-ment effort started in October of 2011 and by the end of the second development year, a number of physical components with simplified two phase flow capability have been de-veloped to support the simplified boiling water reactor (BWR) extended station blackout (SBO) analyses. The demonstration case includes the major components for the primary system of a BWR, as well as the safety system components for the safety relief valve (SRV), the reactor core isolation cooling (RCIC)more » system, and the wet well. Three scenar-ios for the SBO simulations have been considered. Since RELAP-7 is not a severe acci-dent analysis code, the simulation stops when fuel clad temperature reaches damage point. Scenario I represents an extreme station blackout accident without any external cooling and cooling water injection. The system pressure is controlled by automatically releasing steam through SRVs. Scenario II includes the RCIC system but without SRV. The RCIC system is fully coupled with the reactor primary system and all the major components are dynamically simulated. The third scenario includes both the RCIC system and the SRV to provide a more realistic simulation. This paper will describe the major models and dis-cuss the results for the three scenarios. The RELAP-7 simulations for the three simplified SBO scenarios show the importance of dynamically simulating the SRVs, the RCIC sys-tem, and the wet well system to the reactor safety during extended SBO accidents.« less

Healthcare system-wide implementation of opioid-safety guideline recommendations: the case of urine drug screening and opioid-patient suicide- and overdose-related events in the Veterans Health Administration.

PubMed

Brennan, Penny L; Del Re, Aaron C; Henderson, Patricia T; Trafton, Jodie A

2016-12-01

This study provides an example of how healthcare system-wide progress in implementation of opioid-therapy guideline recommendations can be longitudinally assessed and then related to subsequent opioid-prescribed patient health and safety outcomes. Using longitudinal linear mixed effects analyses, we determined that in the Department of Veterans Affairs (VA) healthcare system (n = 141 facilities), over the 4-year interval from 2010 to 2013, a key opioid therapy guideline recommendation, urine drug screening (UDS), increased from 29 to 42 %, with an average within-facility increase rate of 4.5 % per year. Higher levels of UDS implementation from 2010 to 2013 were associated with lower risk of suicide and drug overdose events among VA opioid-prescribed patients in 2013, even after adjusting for patients' 2012 demographic characteristics and medical and mental health comorbidities. Findings suggest that VA clinicians and healthcare policymakers have been responsive to the 2010 VA/Department of Defense (DOD) UDS treatment guideline recommendation, resulting in improved patient safety for VA opioid-prescribed patients.

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

PubMed

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

2017-03-01

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

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

Panayotov, Dobromir; Poitevin, Yves; Grief, Andrew

'Fusion for Energy' (F4E) is designing, developing, and implementing the European Helium-Cooled Lead-Lithium (HCLL) and Helium-Cooled Pebble-Bed (HCPB) Test Blanket Systems (TBSs) for ITER (Nuclear Facility INB-174). Safety demonstration is an essential element for the integration of these TBSs into ITER and accident analysis is one of its critical components. A systematic approach to accident analysis has been developed under the F4E contract on TBS safety analyses. F4E technical requirements, together with Amec Foster Wheeler and INL efforts, have resulted in a comprehensive methodology for fusion breeding blanket accident analysis that addresses the specificity of the breeding blanket designs, materials,more » and phenomena while remaining consistent with the approach already applied to ITER accident analyses. Furthermore, the methodology phases are illustrated in the paper by its application to the EU HCLL TBS using both MELCOR and RELAP5 codes.« less

A preliminary analysis of incident investigation reports of an integrated steel plant: some reflection.

PubMed

Verma, A; Maiti, J; Gaikwad, V N

2018-06-01

Large integrated steel plants employ an effective safety management system and gather a significant amount of safety-related data. This research intends to explore and visualize the rich database to find out the key factors responsible for the occurrences of incidents. The study was carried out on the data in the form of investigation reports collected from a steel plant in India. The data were processed and analysed using some of the quality management tools like Pareto chart, control chart, Ishikawa diagram, etc. Analyses showed that causes of incidents differ depending on the activities performed in a department. For example, fire/explosion and process-related incidents are more common in the departments associated with coke-making and blast furnace. Similar kind of factors were obtained, and recommendations were provided for their mitigation. Finally, the limitations of the study were discussed, and the scope of the research works was identified.

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

PubMed

Fassett, William E

2011-10-10

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

The National Aviation Operational Monitoring Service (NAOMS): A Documentation of the Development of a Survey Methodology

NASA Technical Reports Server (NTRS)

Connors, Mary M.; Mauro, Robert; Statler, Irving C.

2012-01-01

The National Aviation Operational Monitoring Service (NAOMS) was a research project under NASA s Aviation Safety Program during the years from 2000 to 2005. The purpose of this project was to develop a methodology for gaining reliable information on changes over time in the rates-of-occurrence of safety-related events as a means of assessing the safety of the national airspace. The approach was a scientifically designed survey of the operators of the aviation system concerning their safety-related experiences. This report presents the results of the methodology developed and a demonstration of the NAOMS concept through a survey of nearly 20,000 randomly selected air-carrier pilots. Results give evidence that the NAOMS methodology can provide a statistically sound basis for evaluating trends of incidents that could compromise safety. The approach and results are summarized in the report and supporting documentation and complete analyses of results are presented in 14 appendices.

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

NASA Technical Reports Server (NTRS)

Vesely, William E.; Colon, Alfredo E.

2010-01-01

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

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.

Inherent Safety Characteristics of Advanced Fast Reactors

NASA Astrophysics Data System (ADS)

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

2017-01-01

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

Descriptions of verbal communication errors between staff. An analysis of 84 root cause analysis-reports from Danish hospitals.

PubMed

Rabøl, Louise Isager; Andersen, Mette Lehmann; Østergaard, Doris; Bjørn, Brian; Lilja, Beth; Mogensen, Torben

2011-03-01

Poor teamwork and communication between healthcare staff are correlated to patient safety incidents. However, the organisational factors responsible for these issues are unexplored. Root cause analyses (RCA) use human factors thinking to analyse the systems behind severe patient safety incidents. The objective of this study is to review RCA reports (RCAR) for characteristics of verbal communication errors between hospital staff in an organisational perspective. Two independent raters analysed 84 RCARs, conducted in six Danish hospitals between 2004 and 2006, for descriptions and characteristics of verbal communication errors such as handover errors and error during teamwork. Raters found description of verbal communication errors in 44 reports (52%). These included handover errors (35 (86%)), communication errors between different staff groups (19 (43%)), misunderstandings (13 (30%)), communication errors between junior and senior staff members (11 (25%)), hesitance in speaking up (10 (23%)) and communication errors during teamwork (8 (18%)). The kappa values were 0.44-0.78. Unproceduralized communication and information exchange via telephone, related to transfer between units and consults from other specialties, were particularly vulnerable processes. With the risk of bias in mind, it is concluded that more than half of the RCARs described erroneous verbal communication between staff members as root causes of or contributing factors of severe patient safety incidents. The RCARs rich descriptions of the incidents revealed the organisational factors and needs related to these errors.

Thermal-hydraulic analysis capabilities and methods development at NYPA

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

Feltus, M.A.

1987-01-01

The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less

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

Collaborating with nurse leaders to develop patient safety practices.

PubMed

Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna

2017-07-03

Purpose The organisational level and leadership development are crucial elements in advancing patient safety, because patient safety weaknesses are often caused by system failures. However, little is known about how frontline leader and director teams can be supported to develop patient safety practices. The purpose of this study is to describe the patient safety development process carried out by nursing leaders and directors. The research questions were: how the chosen development areas progressed in six months' time and how nursing leaders view the participatory development process. Design/methodology/approach Participatory action research was used to engage frontline nursing leaders and directors into developing patient safety practices. Semi-structured group interviews ( N = 10) were used in data collection at the end of a six-month action cycle, and data were analysed using content analysis. Findings The participatory development process enhanced collaboration and gave leaders insights into patient safety as a part of the hospital system and their role in advancing it. The chosen development areas advanced to different extents, with the greatest improvements in those areas with simple guidelines to follow and in which the leaders were most participative. The features of high-reliability organisation were moderately identified in the nursing leaders' actions and views. For example, acting as a change agent to implement patient safety practices was challenging. Participatory methods can be used to support leaders into advancing patient safety. However, it is important that the participants are familiar with the method, and there are enough facilitators to steer development processes. Originality/value Research brings more knowledge of how leaders can increase their effectiveness in advancing patient safety and promoting high-reliability organisation features in the healthcare organisation.

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

Dobromir Panayotov; Andrew Grief; Brad J. Merrill

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

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

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

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

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

PubMed

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

2015-01-01

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

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

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

NASA Technical Reports Server (NTRS)

Kosko, Jerome

1992-01-01

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

Roadway safety design workbook.

DOT National Transportation Integrated Search

2009-07-01

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

Highway safety design workshops.

DOT National Transportation Integrated Search

2010-11-01

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

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation challenges and user experiences of telecare with the help of a human factors systems approach to patient safety.

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

Code of Federal Regulations, 2013 CFR

2013-01-01

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

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

Code of Federal Regulations, 2014 CFR

2014-01-01

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

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

Gougar, Hans

This document outlines the development of a high fidelity, best estimate nuclear power plant severe transient simulation capability that will complement or enhance the integral system codes historically used for licensing and analysis of severe accidents. As with other tools in the Risk Informed Safety Margin Characterization (RISMC) Toolkit, the ultimate user of Enhanced Severe Transient Analysis and Prevention (ESTAP) capability is the plant decision-maker; the deliverable to that customer is a modern, simulation-based safety analysis capability, applicable to a much broader class of safety issues than is traditional Light Water Reactor (LWR) licensing analysis. Currently, the RISMC pathway’s majormore » emphasis is placed on developing RELAP-7, a next-generation safety analysis code, and on showing how to use RELAP-7 to analyze margin from a modern point of view: that is, by characterizing margin in terms of the probabilistic spectra of the “loads” applied to systems, structures, and components (SSCs), and the “capacity” of those SSCs to resist those loads without failing. The first objective of the ESTAP task, and the focus of one task of this effort, is to augment RELAP-7 analyses with user-selected multi-dimensional, multi-phase models of specific plant components to simulate complex phenomena that may lead to, or exacerbate, severe transients and core damage. Such phenomena include: coolant crossflow between PWR assemblies during a severe reactivity transient, stratified single or two-phase coolant flow in primary coolant piping, inhomogeneous mixing of emergency coolant water or boric acid with hot primary coolant, and water hammer. These are well-documented phenomena associated with plant transients but that are generally not captured in system codes. They are, however, generally limited to specific components, structures, and operating conditions. The second ESTAP task is to similarly augment a severe (post-core damage) accident integral analyses code with high fidelity simulations that would allow investigation of multi-dimensional, multi-phase containment phenomena that are only treated approximately in established codes.« less

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

PubMed Central

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

2012-01-01

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

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

PubMed

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

2012-01-01

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

Development of safety performance monitoring procedures.

DOT National Transportation Integrated Search

2010-02-01

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

Quantifying Safety Margin Using the Risk-Informed Safety Margin Characterization (RISMC)

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

Grabaskas, David; Bucknor, Matthew; Brunett, Acacia

2015-04-26

The Risk-Informed Safety Margin Characterization (RISMC), developed by Idaho National Laboratory as part of the Light-Water Reactor Sustainability Project, utilizes a probabilistic safety margin comparison between a load and capacity distribution, rather than a deterministic comparison between two values, as is usually done in best-estimate plus uncertainty analyses. The goal is to determine the failure probability, or in other words, the probability of the system load equaling or exceeding the system capacity. While this method has been used in pilot studies, there has been little work conducted investigating the statistical significance of the resulting failure probability. In particular, it ismore » difficult to determine how many simulations are necessary to properly characterize the failure probability. This work uses classical (frequentist) statistics and confidence intervals to examine the impact in statistical accuracy when the number of simulations is varied. Two methods are proposed to establish confidence intervals related to the failure probability established using a RISMC analysis. The confidence interval provides information about the statistical accuracy of the method utilized to explore the uncertainty space, and offers a quantitative method to gauge the increase in statistical accuracy due to performing additional simulations.« less

Causal Factors and Adverse Events of Aviation Accidents and Incidents Related to Integrated Vehicle Health Management

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Briggs, Jeffrey L.; Evans, Joni K.; Jones, Sharon M.; Kurtoglu, Tolga; Leone, Karen M.; Sandifer, Carl E.

2011-01-01

Causal factors in aviation accidents and incidents related to system/component failure/malfunction (SCFM) were examined for Federal Aviation Regulation Parts 121 and 135 operations to establish future requirements for the NASA Aviation Safety Program s Integrated Vehicle Health Management (IVHM) Project. Data analyzed includes National Transportation Safety Board (NSTB) accident data (1988 to 2003), Federal Aviation Administration (FAA) incident data (1988 to 2003), and Aviation Safety Reporting System (ASRS) incident data (1993 to 2008). Failure modes and effects analyses were examined to identify possible modes of SCFM. A table of potential adverse conditions was developed to help evaluate IVHM research technologies. Tables present details of specific SCFM for the incidents and accidents. Of the 370 NTSB accidents affected by SCFM, 48 percent involved the engine or fuel system, and 31 percent involved landing gear or hydraulic failure and malfunctions. A total of 35 percent of all SCFM accidents were caused by improper maintenance. Of the 7732 FAA database incidents affected by SCFM, 33 percent involved landing gear or hydraulics, and 33 percent involved the engine and fuel system. The most frequent SCFM found in ASRS were turbine engine, pressurization system, hydraulic main system, flight management system/flight management computer, and engine. Because the IVHM Project does not address maintenance issues, and landing gear and hydraulic systems accidents are usually not fatal, the focus of research should be those SCFMs that occur in the engine/fuel and flight control/structures systems as well as power systems.

Estimation of Inherent Safety Margins in Loaded Commercial Spent Nuclear Fuel Casks

DOE PAGES

Banerjee, Kaushik; Robb, Kevin R.; Radulescu, Georgeta; ...

2016-06-15

We completed a novel assessment to determine the unquantified and uncredited safety margins (i.e., the difference between the licensing basis and as-loaded calculations) available in as-loaded spent nuclear fuel (SNF) casks. This assessment was performed as part of a broader effort to assess issues and uncertainties related to the continued safety of casks during extended storage and transportability following extended storage periods. Detailed analyses crediting the actual as-loaded cask inventory were performed for each of the casks at three decommissioned pressurized water reactor (PWR) sites to determine their characteristics relative to regulatory safety criteria for criticality, thermal, and shielding performance.more » These detailed analyses were performed in an automated fashion by employing a comprehensive and integrated data and analysis tool—Used Nuclear Fuel-Storage, Transportation & Disposal Analysis Resource and Data System (UNF-ST&DARDS). Calculated uncredited criticality margins from 0.07 to almost 0.30 Δk eff were observed; calculated decay heat margins ranged from 4 to almost 22 kW (as of 2014); and significant uncredited transportation dose rate margins were also observed. The results demonstrate that, at least for the casks analyzed here, significant uncredited safety margins are available that could potentially be used to compensate for SNF assembly and canister structural performance related uncertainties associated with long-term storage and subsequent transportation. The results also suggest that these inherent margins associated with how casks are loaded could support future changes in cask licensing to directly or indirectly credit the margins. Work continues to quantify the uncredited safety margins in the SNF casks loaded at other nuclear reactor sites.« less

Environmental and economic comparisons of the satellite power system and six alternative energy technologies

NASA Astrophysics Data System (ADS)

Whitfield, R. G.; Habegger, L. J.; Levine, E. P.; Tanzman, E.

1981-04-01

The satellite power system (SPS) was compared with alternative systems on life cycle cost and environmental impacts. Environmental and economic effects are evaluated and subdivided into the following issue areas: human health and safety, environmental welfare, resources (land, materials, energy, water, labor), macroeconomics, socioeconomics, and institutional. These evaluations are based on technology characterization data and alternative futures scenarios, developed as part of CDEP. The technologies and the scenarios are described. The cost and performance of the SPS and the alternative technologies provide the basis of the macroeconomic analyses.

International SAMPE Symposium and Exhibition, 35th, Anaheim, CA, Apr. 2-5, 1990, Proceedings. Books 1 2

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

Janicki, G.; Bailey, V.; Schjelderup, H.

The present conference discusses topics in the fields of ultralightweight structures, producibility of thermoplastic composites, innovation in sandwich structures, composite failure processes, toughened materials, metal-matrix composites, advanced materials for future naval systems, thermoplastic polymers, automated composites manufacturers, advanced adhesives, emerging processes for aerospace component fabrication, and modified resin systems. Also discussed are matrix behavior for damage tolerance, composite materials repair, testing for damage tolerance, composite strength analyses, materials workplace health and safety, cost-conscious composites, bismaleimide systems, and issues facing advanced composite materials suppliers.

Space Transfer Vehicle Concepts and Requirements Study. Volume 2, Book 2: System and Program Requirements Trade Studies

NASA Technical Reports Server (NTRS)

Weber, Gary A.

1991-01-01

During the 90-day study, support was provided to NASA in defining a point-of-departure space transfer vehicle (STV). The resulting STV concept was performance optimized with a two-stage LTV/LEV configuration. Appendix A reports on the effort during this period of the study. From the end of the 90-day study until the March Interim Review, effort was placed on optimizing the two-stage vehicle approach identified in the 90-day effort. After the March Interim Review, the effort was expanded to perform a full architectural trade study with the intent of developing a decision database to support STV system decisions in response to changing SEI infrastructure concepts. Several of the architecture trade studies were combined in a System Architecture Trade Study. In addition to this trade, system optimization/definition trades and analyses were completed and some special topics were addressed. Program- and system-level trade study and analyses methodologies and results are presented in this section. Trades and analyses covered in this section are: (1) a system architecture trade study; (2) evolution; (3) safety and abort considerations; (4) STV as a launch vehicle upper stage; and (5) optimum crew and cargo split.

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

NASA Astrophysics Data System (ADS)

Murray, Daniel P.; Weil, Andre

2010-09-01

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

Probabilistic risk assessment of the Space Shuttle. Phase 3: A study of the potential of losing the vehicle during nominal operation. Volume 5: Auxiliary shuttle risk analyses

NASA Technical Reports Server (NTRS)

Fragola, Joseph R.; Maggio, Gaspare; Frank, Michael V.; Gerez, Luis; Mcfadden, Richard H.; Collins, Erin P.; Ballesio, Jorge; Appignani, Peter L.; Karns, James J.

1995-01-01

Volume 5 is Appendix C, Auxiliary Shuttle Risk Analyses, and contains the following reports: Probabilistic Risk Assessment of Space Shuttle Phase 1 - Space Shuttle Catastrophic Failure Frequency Final Report; Risk Analysis Applied to the Space Shuttle Main Engine - Demonstration Project for the Main Combustion Chamber Risk Assessment; An Investigation of the Risk Implications of Space Shuttle Solid Rocket Booster Chamber Pressure Excursions; Safety of the Thermal Protection System of the Space Shuttle Orbiter - Quantitative Analysis and Organizational Factors; Space Shuttle Main Propulsion Pressurization System Probabilistic Risk Assessment, Final Report; and Space Shuttle Probabilistic Risk Assessment Proof-of-Concept Study - Auxiliary Power Unit and Hydraulic Power Unit Analysis Report.

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

PubMed

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

2012-03-01

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

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2010-09-01

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

10 CFR Appendix B to Part 52 - Design Certification Rule for the System 80+ Design

Code of Federal Regulations, 2010 CFR

2010-01-01

.... Paragraph (f)(2)(viii) of 10 CFR 50.34—Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved... or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex-vessel...) There is a substantial increase in the probability of an ex-vessel severe accident such that a...

10 CFR Appendix B to Part 52 - Design Certification Rule for the System 80+ Design

Code of Federal Regulations, 2014 CFR

2014-01-01

.... Paragraph (f)(2)(viii) of 10 CFR 50.34—Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved... or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex-vessel...) There is a substantial increase in the probability of an ex-vessel severe accident such that a...

10 CFR Appendix B to Part 52 - Design Certification Rule for the System 80+ Design

Code of Federal Regulations, 2011 CFR

2011-01-01

.... Paragraph (f)(2)(viii) of 10 CFR 50.34—Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved... or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex-vessel...) There is a substantial increase in the probability of an ex-vessel severe accident such that a...

10 CFR Appendix B to Part 52 - Design Certification Rule for the System 80+ Design

Code of Federal Regulations, 2012 CFR

2012-01-01

.... Paragraph (f)(2)(viii) of 10 CFR 50.34—Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved... or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex-vessel...) There is a substantial increase in the probability of an ex-vessel severe accident such that a...

10 CFR Appendix B to Part 52 - Design Certification Rule for the System 80+ Design

Code of Federal Regulations, 2013 CFR

2013-01-01

.... Paragraph (f)(2)(viii) of 10 CFR 50.34—Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved... or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex-vessel...) There is a substantial increase in the probability of an ex-vessel severe accident such that a...

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

Code of Federal Regulations, 2012 CFR

2012-01-01

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

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

Code of Federal Regulations, 2011 CFR

2011-01-01

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

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

Grabaskas, David; Brunett, Acacia J.; Passerini, Stefano

GE Hitachi Nuclear Energy (GEH) and Argonne National Laboratory (Argonne) participated in a two year collaboration to modernize and update the probabilistic risk assessment (PRA) for the PRISM sodium fast reactor. At a high level, the primary outcome of the project was the development of a next-generation PRA that is intended to enable risk-informed prioritization of safety- and reliability-focused research and development. A central Argonne task during this project was a reliability assessment of passive safety systems, which included the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedbacks of the metal fuel core. Both systems were examinedmore » utilizing a methodology derived from the Reliability Method for Passive Safety Functions (RMPS), with an emphasis on developing success criteria based on mechanistic system modeling while also maintaining consistency with the Fuel Damage Categories (FDCs) of the mechanistic source term assessment. This paper provides an overview of the reliability analyses of both systems, including highlights of the FMEAs, the construction of best-estimate models, uncertain parameter screening and propagation, and the quantification of system failure probability. In particular, special focus is given to the methodologies to perform the analysis of uncertainty propagation and the determination of the likelihood of violating FDC limits. Additionally, important lessons learned are also reviewed, such as optimal sampling methodologies for the discovery of low likelihood failure events and strategies for the combined treatment of aleatory and epistemic uncertainties.« less

Exploration of Heterogeneity in Distributed Research Network Drug Safety Analyses

ERIC Educational Resources Information Center

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

2014-01-01

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

Technical basis for nuclear accident dosimetry at the Oak Ridge National Laboratory

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

Kerr, G.D.; Mei, G.T.

The Oak Ridge National Laboratory (ORNL) Environmental, Safety, and Health Emergency Response Organization has the responsibility of providing analyses of personnel exposures to neutrons and gamma rays from a nuclear accident. This report presents the technical and philosophical basis for the dose assessment aspects of the nuclear accident dosimetry (NAD) system at ORNL. The issues addressed are regulatory guidelines, ORNL NAD system components and performance, and the interpretation of dosimetric information that would be gathered following a nuclear accident.

System cost performance analysis (study 2.3). Volume 1: Executive summary. [unmanned automated payload programs and program planning

NASA Technical Reports Server (NTRS)

Campbell, B. H.

1974-01-01

A study is described which was initiated to identify and quantify the interrelationships between and within the performance, safety, cost, and schedule parameters for unmanned, automated payload programs. The result of the investigation was a systems cost/performance model which was implemented as a digital computer program and could be used to perform initial program planning, cost/performance tradeoffs, and sensitivity analyses for mission model and advanced payload studies. Program objectives and results are described briefly.

Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study.

PubMed

Merrill, Joan T; Wallace, Daniel J; Petri, Michelle; Kirou, Kyriakos A; Yao, Yihong; White, Wendy I; Robbie, Gabriel; Levin, Robert; Berney, Seth M; Chindalore, Vishala; Olsen, Nancy; Richman, Laura; Le, Chenxiong; Jallal, Bahija; White, Barbara

2011-11-01

Type I interferons (IFNs) appear to play a central role in disease pathogenesis in systemic lupus erythematosus (SLE), making them potential therapeutic targets. Safety profile, pharmacokinetics, immunogenicity, pharmacodynamics and clinical activity of sifalimumab, an anti-IFNα monoclonal antibody, were assessed in a phase I, multicentre, randomised, double-blind, dose-escalation study with an open-label extension in adults with moderately active SLE. received one intravenous dose of sifalimumab (n=33 blinded phase, 0.3, 1, 3, 10 or 30 mg/kg; n=17 open-label, 1, 3, 10 or 30 mg/kg) or placebo (n=17). Each phase lasted 84 days. Adverse events (AEs) were similar between groups; about 97% of AEs were grade 1 or 2. All grade 3 and 4 AEs and all serious AEs (2 placebo, 1 sifalimumab) were deemed unrelated to the study drug. No increase in viral infections or reactivation was observed. Sifalimumab caused dose-dependent inhibition of type I IFN-induced mRNAs (type I IFN signature) in whole blood and corresponding changes in related proteins in affected skin. Exploratory analyses showed consistent trends toward improvement in disease activity in sifalimumab-treated versus placebo-treated subjects. A lower proportion of sifalimumab-treated subjects required new or increased immunosuppressive treatments (12% vs 41%; p=0.03) and had fewer Systemic Lupus Erythematosus Disease Activity Index flares (3% vs 29%; p=0.014). Sifalimumab had a safety profile that supports further clinical development. This trial demonstrated that overexpression of type I IFN signature in SLE is at least partly driven by IFNα, and exploratory analyses suggest that IFNα inhibition may be associated with clinical benefit in SLE. Trial registration number NCT00299819.

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

PubMed

Clarke, John R

2013-12-01

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

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

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Patient complaints in healthcare systems: a systematic review and coding taxonomy

PubMed Central

Reader, Tom W; Gillespie, Alex; Roberts, Jane

2014-01-01

Background Patient complaints have been identified as a valuable resource for monitoring and improving patient safety. This article critically reviews the literature on patient complaints, and synthesises the research findings to develop a coding taxonomy for analysing patient complaints. Methods The PubMed, Science Direct and Medline databases were systematically investigated to identify patient complaint research studies. Publications were included if they reported primary quantitative data on the content of patient-initiated complaints. Data were extracted and synthesised on (1) basic study characteristics; (2) methodological details; and (3) the issues patients complained about. Results 59 studies, reporting 88 069 patient complaints, were included. Patient complaint coding methodologies varied considerably (eg, in attributing single or multiple causes to complaints). In total, 113 551 issues were found to underlie the patient complaints. These were analysed using 205 different analytical codes which when combined represented 29 subcategories of complaint issue. The most common issues complained about were ‘treatment’ (15.6%) and ‘communication’ (13.7%). To develop a patient complaint coding taxonomy, the subcategories were thematically grouped into seven categories, and then three conceptually distinct domains. The first domain related to complaints on the safety and quality of clinical care (representing 33.7% of complaint issues), the second to the management of healthcare organisations (35.1%) and the third to problems in healthcare staff–patient relationships (29.1%). Conclusions Rigorous analyses of patient complaints will help to identify problems in patient safety. To achieve this, it is necessary to standardise how patient complaints are analysed and interpreted. Through synthesising data from 59 patient complaint studies, we propose a coding taxonomy for supporting future research and practice in the analysis of patient complaint data. PMID:24876289

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

PubMed Central

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

2015-01-01

Introduction There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. Material and methods A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. Results 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. Conclusions We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement. PMID:26525595

Development of a patient safety climate survey for Chinese hospitals: cross-national adaptation and psychometric evaluation.

PubMed

Zhu, Junya; Li, Liping; Zhao, Hailei; Han, Guangshu; Wu, Albert W; Weingart, Saul N

2014-10-01

Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries. To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals. Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety. The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items. The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

PubMed

Qureshi, Zaina P; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Stevenson, Kurt B; Szeinbach, Sheryl L

2011-07-01

Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal. There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals). Approximately one in seven approved NMEs were discontinued from the market in the period of 1980-2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society. Copyright © 2011 John Wiley & Sons, Ltd.

Validation and verification of the laser range safety tool (LRST)

NASA Astrophysics Data System (ADS)

Kennedy, Paul K.; Keppler, Kenneth S.; Thomas, Robert J.; Polhamus, Garrett D.; Smith, Peter A.; Trevino, Javier O.; Seaman, Daniel V.; Gallaway, Robert A.; Crockett, Gregg A.

2003-06-01

The U.S. Dept. of Defense (DOD) is currently developing and testing a number of High Energy Laser (HEL) weapons systems. DOD range safety officers now face the challenge of designing safe methods of testing HEL's on DOD ranges. In particular, safety officers need to ensure that diffuse and specular reflections from HEL system targets, as well as direct beam paths, are contained within DOD boundaries. If both the laser source and the target are moving, as they are for the Airborne Laser (ABL), a complex series of calculations is required and manual calculations are impractical. Over the past 5 years, the Optical Radiation Branch of the Air Force Research Laboratory (AFRL/HEDO), the ABL System Program Office, Logicon-RDA, and Northrup-Grumman, have worked together to develop a computer model called teh Laser Range Safety Tool (LRST), specifically designed for HEL reflection hazard analyses. The code, which is still under development, is currently tailored to support the ABL program. AFRL/HEDO has led an LRST Validation and Verification (V&V) effort since 1998, in order to determine if code predictions are accurate. This paper summarizes LRST V&V efforts to date including: i) comparison of code results with laboratory measurements of reflected laser energy and with reflection measurements made during actual HEL field tests, and ii) validation of LRST's hazard zone computations.

Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation.

PubMed

Shaw, B E; Chapman, J; Fechter, M; Foeken, L; Greinix, H; Hwang, W; Phillips-Johnson, L; Korhonen, M; Lindberg, B; Navarro, W H; Szer, J

2013-11-01

Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.

Distributed improvisation: a systems perspective of improvisation 'epics' by led outdoor activity leaders.

PubMed

Trotter, Margaret J; Salmon, Paul M; Goode, Natassia; Lenné, Michael G

2018-02-01

Improvisation represents the spontaneous and real-time conception and execution of a novel response to an unanticipated situation. In order to benefit from the positive safety potential of this phenomenon, it is necessary to understand what influences its appropriateness and effectiveness. This study has applied the system-based methodology Impromaps to analysing accounts of improvisation aimed at mitigating adverse safety outcomes. These accounts were obtained from led outdoor activity (LOA) leaders through critical decision method interviews. Influencing factors and interactions have been identified across all system levels. The factors most influential to leaders' ability to improvise are 'Policy, procedures and rules', 'Organisation culture', 'Training', 'Role responsibilities', 'Communication/instruction/demonstration', 'Situation awareness', 'Leader experience', 'Mental simulation', 'Equipment, clothing & PPE' and 'Terrain/physical environment'. To enhance the likelihood of effective, appropriate improvisation, LOA providers are recommended to focus on higher level factors over which they are able to exert greater control. Practitioner Summary: To enhance resilience in safety-critical situations, organisations need to understand what influences appropriate, effective improvisation. To elucidate this, the Impromaps methodology is applied to in-depth interview data. The Impromap affords a graphical depiction of the influencing factors and interactions across the system, providing a basis for the development of interventions.

Physicians' and nurses' perceptions of patient safety risks in the emergency department.

PubMed

Källberg, Ann-Sofie; Ehrenberg, Anna; Florin, Jan; Östergren, Jan; Göransson, Katarina E

2017-07-01

The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians' perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians' experiences with regard to patient safety risks. Semi-structured interviews were conducted with 10 physicians and 10 registered nurses from two emergency departments. Interviews were analysed by inductive content analysis. The experiences reflect the complexities involved in the daily operation of a professional practice, and the perception of risks due to a high workload, lack of control, communication and organizational failures. The results reflect a complex system in which high workload was perceived as a risk for patient safety and that, in a combination with other risks, was thought to further jeopardize patient safety. Emergency department staff should be involved in the development of patient safety procedures in order to increase knowledge regarding risk factors as well as identify strategies which can facilitate the maintenance of patient safety during periods in which the workload is high. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2009-10-01

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

Progress of IRSN R&D on ITER Safety Assessment

NASA Astrophysics Data System (ADS)

Van Dorsselaere, J. P.; Perrault, D.; Barrachin, M.; Bentaib, A.; Gensdarmes, F.; Haeck, W.; Pouvreau, S.; Salat, E.; Seropian, C.; Vendel, J.

2012-08-01

The French "Institut de Radioprotection et de Sûreté Nucléaire" (IRSN), in support to the French "Autorité de Sûreté Nucléaire", is analysing the safety of ITER fusion installation on the basis of the ITER operator's safety file. IRSN set up a multi-year R&D program in 2007 to support this safety assessment process. Priority has been given to four technical issues and the main outcomes of the work done in 2010 and 2011 are summarized in this paper: for simulation of accident scenarios in the vacuum vessel, adaptation of the ASTEC system code; for risk of explosion of gas-dust mixtures in the vacuum vessel, adaptation of the TONUS-CFD code for gas distribution, development of DUST code for dust transport, and preparation of IRSN experiments on gas inerting, dust mobilization, and hydrogen-dust mixtures explosion; for evaluation of the efficiency of the detritiation systems, thermo-chemical calculations of tritium speciation during transport in the gas phase and preparation of future experiments to evaluate the most influent factors on detritiation; for material neutron activation, adaptation of the VESTA Monte Carlo depletion code. The first results of these tasks have been used in 2011 for the analysis of the ITER safety file. In the near future, this R&D global programme may be reoriented to account for the feedback of the latter analysis or for new knowledge.

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

The Italian National Health Service expenditure on workplace prevention and safety (2006-2013): a national-level analysis.

PubMed

Signorelli, C; Riccò, M; Odone, A

2016-01-01

The World Health Organization (WHO) stated that countries' health policies should give high priority to primary prevention of occupational health hazards. Scant data are available on health expenditure on workplace prevention and safety services and on its impact on occupational health outcomes in Italy and in other European countries. objective of the present study was to systematically retrieve, analyse and critically appraise the available national-level data on public health expenditure on workplace prevention and safety services as well as to correlate them with occupational health outcomes. National-level data on total public health expenditure on prevention services, its share spent on workplace prevention and safety services as well as on number of workers receiving appropriate health surveillance were derived from the national public health expenditure monitoring system over a 8-year study period (2006-2013). An analytic approach was adopted to explore the association between health expenditure and occupational health services supply. The Italian National Health Service spends almost € 5 billion per year on preventive care, of which 13.3% are spent on workplace prevention and safety programmes (€ 645 million, € 10.6 per capita). There is wide heterogeneity between Italian regions. Our findings are useful for health systems and policies analysis, national and international comparisons as well as for health policy makers to plan, implement and monitor occupational health prevention programmes.

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

PubMed

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

2017-05-01

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

Qualitative Research for Patient Safety Using ICTs: Methodological Considerations in the Technological Age.

PubMed

Yee, Kwang Chien; Wong, Ming Chao; Turner, Paul

2017-01-01

Considerable effort and resources have been dedicated to improving the quality and safety of patient care through health information systems, but there is still significant scope for improvement. One contributing factor to the lack of progress in patient safety improvement especially where technology has been deployed relates to an over-reliance on purely objective, quantitative, positivist research paradigms as the basis for generating and validating evidence of improvement. This paper argues the need for greater recognition and accommodation of evidence of improvement generated through more subjective, qualitative and pragmatic research paradigms to aid patient safety especially where technology is deployed. This paper discusses how acknowledging the role and value of more subjective ontologies and pragmatist epistemologies can support improvement science research. This paper illustrates some challenges and benefits from adopting qualitative research methods in patient safety improvement projects, particularly focusing challenges in the technological era. While adopting methods that can more readily capture, analyse and interpret direct user experiences, attitudes, insights and behaviours in their contextual settings, patient safety can be enhanced 'on the ground' and errors reduced and/or mitigated, challenges of using these methods with the younger "technologically-centred" healthcare professionals and patients needs to recognised.

Key factors contributing to accident severity rate in construction industry in Iran: a regression modelling approach.

PubMed

Soltanzadeh, Ahmad; Mohammadfam, Iraj; Moghimbeigi, Abbas; Ghiasvand, Reza

2016-03-01

Construction industry involves the highest risk of occupational accidents and bodily injuries, which range from mild to very severe. The aim of this cross-sectional study was to identify the factors associated with accident severity rate (ASR) in the largest Iranian construction companies based on data about 500 occupational accidents recorded from 2009 to 2013. We also gathered data on safety and health risk management and training systems. Data were analysed using Pearson's chi-squared coefficient and multiple regression analysis. Median ASR (and the interquartile range) was 107.50 (57.24- 381.25). Fourteen of the 24 studied factors stood out as most affecting construction accident severity (p<0.05). These findings can be applied in the design and implementation of a comprehensive safety and health risk management system to reduce ASR.

Space Transportation System Liftoff Debris Mitigation Process Overview

NASA Technical Reports Server (NTRS)

Mitchell, Michael; Riley, Christopher

2011-01-01

Liftoff debris is a top risk to the Space Shuttle Vehicle. To manage the Liftoff debris risk, the Space Shuttle Program created a team with in the Propulsion Systems Engineering & Integration Office. The Shutt le Liftoff Debris Team harnesses the Systems Engineering process to i dentify, assess, mitigate, and communicate the Liftoff debris risk. T he Liftoff Debris Team leverages off the technical knowledge and expe rtise of engineering groups across multiple NASA centers to integrate total system solutions. These solutions connect the hardware and ana lyses to identify and characterize debris sources and zones contribut ing to the Liftoff debris risk. The solutions incorporate analyses sp anning: the definition and modeling of natural and induced environmen ts; material characterizations; statistical trending analyses, imager y based trajectory analyses; debris transport analyses, and risk asse ssments. The verification and validation of these analyses are bound by conservative assumptions and anchored by testing and flight data. The Liftoff debris risk mitigation is managed through vigilant collab orative work between the Liftoff Debris Team and Launch Pad Operation s personnel and through the management of requirements, interfaces, r isk documentation, configurations, and technical data. Furthermore, o n day of launch, decision analysis is used to apply the wealth of ana lyses to case specific identified risks. This presentation describes how the Liftoff Debris Team applies Systems Engineering in their proce sses to mitigate risk and improve the safety of the Space Shuttle Veh icle.

[Changing of the patient safety culture in the pilot institutes of the Hungarian accreditation program].

PubMed

Lám, Judit; Merész, Gergő; Bakacsi, Gyula; Belicza, Éva; Surján, Cecília; Takács, Erika

2016-10-01

The accreditation system for health care providers was developed in Hungary aiming to increase safety, efficiency, and efficacy of care and optimise its organisational operation. The aim of this study was to assess changes of organisational culture in pilot institutes of the accreditation program. 7 volunteer pilot institutes using an internationally validated questionnaire were included. The impact study was performed in 2 rounds: the first before the introduction of the accreditation program, and the second a year later, when the standards were already known. Data were analysed using descriptive statistics and logistic regression models. Statistically significant (p<0.05) positive changes were detected in hospitals in three dimensions: organisational learning - continuous improvement, communication openness, teamwork within the unit while in outpatient clinics: overall perceptions of patient safety, and patient safety within the unit. Organisational culture in the observed institutes needs improvement, but positive changes already point to a safer care. Orv. Hetil., 2016, 157(42), 1667-1673.

High-Explosives Applications Facility (HEAF)

NASA Astrophysics Data System (ADS)

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

1989-03-01

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

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

PubMed

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

2015-01-01

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

A methodology for accident analysis of fusion breeder blankets and its application to helium-cooled lead–lithium blanket

DOE PAGES

Panayotov, Dobromir; Poitevin, Yves; Grief, Andrew; ...

2016-09-23

'Fusion for Energy' (F4E) is designing, developing, and implementing the European Helium-Cooled Lead-Lithium (HCLL) and Helium-Cooled Pebble-Bed (HCPB) Test Blanket Systems (TBSs) for ITER (Nuclear Facility INB-174). Safety demonstration is an essential element for the integration of these TBSs into ITER and accident analysis is one of its critical components. A systematic approach to accident analysis has been developed under the F4E contract on TBS safety analyses. F4E technical requirements, together with Amec Foster Wheeler and INL efforts, have resulted in a comprehensive methodology for fusion breeding blanket accident analysis that addresses the specificity of the breeding blanket designs, materials,more » and phenomena while remaining consistent with the approach already applied to ITER accident analyses. Furthermore, the methodology phases are illustrated in the paper by its application to the EU HCLL TBS using both MELCOR and RELAP5 codes.« less

The magnetic navigation system allows safety and high efficacy for ablation of arrhythmias.

PubMed

Bauernfeind, Tamas; Akca, Ferdi; Schwagten, Bruno; de Groot, Natasja; Van Belle, Yves; Valk, Suzanne; Ujvari, Barbara; Jordaens, Luc; Szili-Torok, Tamas

2011-07-01

We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities. In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15±9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P=0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P=0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P=ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P<0.05). Less fluoroscopy was used in group MNS (30±20 vs. 35±25 min, P<0.01). There were no differences in procedure times and recurrence rates for the overall groups (168±67 vs. 159±75 min, P=ns; 14 vs. 11%, P=ns; respectively). Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

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

Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

NASA Technical Reports Server (NTRS)

Stamatelatos,Michael; Dezfuli, Homayoon; Apostolakis, George; Everline, Chester; Guarro, Sergio; Mathias, Donovan; Mosleh, Ali; Paulos, Todd; Riha, David; Smith, Curtis;

Evaluating oversight systems for emerging technologies: a case study of genetically engineered organisms.

PubMed

Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel

2009-01-01

The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.

The safety of women health workers at the frontlines.

PubMed

Dasgupta, Jashodhara; Velankar, Jayashree; Borah, Pritisha; Nath, Gangotri Hazarika

2017-01-01

This article, based on the report of the fact-finding team on the gang rape and death of an accredited social health activist (ASHA) in Muzaffarnagar in January 2016, attempts to analyse the issues of the safety and mobility of front-line women health workers. It argues that although the National Health Mission is often alluded to as a flagship programme of the government, it has failed in its basic responsibility as an ethical employer, since there is no support and back-up system that can be easily accessed by ASHAs in terms of dealing with the fallout of their social role as "change agents" in rural areas, and community reactions to their mobility and public exposure. The report stresses the need to consider the deeply patriarchal system within which ASHAs function in states such as Uttar Pradesh. It also discusses the fact that the workforce is increasingly shifting from the formal to the informal sector, which has given rise to an assumption that the employer is no longer accountable for women workers' safety at the workplace.

Lessons learned from the Space Flyer Unit (SFU) mission.

PubMed

Kuriki, Kyoichi; Ninomiya, Keiken; Takei, Mitsuru; Matsuoka, Shinobu

2002-11-01

The Space Flyer Unit (SFU) system and mission chronology are briefly introduced. Lessons learned from the SFU mission are categorized as programmatic and engineering lessons. In the programmatic category are dealt with both international and domestic collaborations. As for the engineering lessons safety design, orbital operation, in-flight anomaly, and post flight analyses are the major topics reviewed. c2002 Elsevier Science Ltd. All rights reserved.

Research Assessment Exercise Results and Research Funding in the United Kingdom: A Regional-Territorial Analysis

ERIC Educational Resources Information Center

Chatterji, Monojit; Seaman, Paul

2007-01-01

A considerable sum of money is allocated to UK universities on the basis of Research Assessment Exercise performance. In this paper we analyse the impact of the two main funding models on the intra-territorial and intra-regional allocation of funds. We also examine the effect of the present system of territorial safety nets and discuss the impact…

Booster Main Engine Selection Criteria for the Liquid Fly-Back Booster

NASA Technical Reports Server (NTRS)

Ryan, Richard M.; Rothschild, William J.; Christensen, David L.

1998-01-01

The Liquid Fly-Back Booster (LFBB) Program seeks to enhance the Space Shuttle system safety performance and economy of operations through the use of an advanced, liquid propellant Booster Main Engine (BME). There are several viable BME candidates that could be suitable for this application. The objective of this study was to identify the key criteria to be applied in selecting among these BME candidates. This study involved an assessment of influences on the overall LFBB utility due to variations in the candidate rocket engines' characteristics. This includes BME impacts on vehicle system weight, perfortnance,design approaches, abort modes, margins of safety, engine-out operations, and maintenance and support concepts. Systems engineering analyses and trade studies were performed to identify the LFBB system level sensitivities to a wide variety of BME related parameters. This presentation summarizes these trade studies and the resulting findings of the LFBB design teams regarding the BME characteristics that most significantly affect the LFBB system. The resulting BME choice should offer the best combination of reliability, performance, reusability, robustness, cost, and risk for the LFBB program.

Booster Main Engine Selection Criteria for the Liquid Fly-Back Booster

NASA Technical Reports Server (NTRS)

Ryan, Richard M.; Rothschild, William J.; Christensen, David L.

1998-01-01

The Liquid Fly-Back Booster (LFBB) Program seeks to enhance the Space Shuttle system safety, performance and economy of operations through the use of an advanced, liquid propellant Booster Main Engine (BME). There are several viable BME candidates that could be suitable for this application. The objective of this study was to identify the key Criteria to be applied in selecting among these BME candidates. This study involved an assessment of influences on the overall LFBB utility due to variations in the candidate rocket-engines characteristics. This includes BME impacts on vehicle system weight, performance, design approaches, abort modes, margins of safety, engine-out operations, and maintenance and support concepts. Systems engineering analyses and trade studies were performed to identify the LFBB system level sensitivities to a wide variety of BME related parameters. This presentation summarizes these trade studies and the resulting findings of the LFBB design teams regarding the BME characteristics that most significantly affect the LFBB system. The resulting BME choice should offer the best combination of reliability, performance, reusability, robustness, cost, and risk for the LFBB program.

Can fire safety in hotels be improved? Results from the survey of a panel of experts in Spain.

PubMed

Rubio-Romero, Juan Carlos; Márquez-Sierra, Francisco; Suárez-Cebador, Manuel

2016-06-08

The hotel industry is an important driver of the European labour market with over 250,000 hotels employing some 2 million people. In Spain, 240 workers were injured by fires in hotels from 2004 to 2008. Fire is considered to be the most important risk in the hotel industry, but the lack of an EU-wide data recording system for hotels makes it difficult to give exact figures for fire events. We analysed the state of fire prevention systems in hotels in Spain with the aim of proposing strategies to improve fire safety. A 10-item questionnaire was administered from 2007 to 2009 to 15 Spanish experts in fire safety. The questions were measured using a Likert scale and classified into 4 sections: current state of installations, influence of establishment characteristics, application of regulations and priority ranking of actions. Descriptive statistics summarized the data and t-tests evaluated the agreement foreach statement in the questionnaire. The statistical analysis showed homogeneity in the responses by the experts in all four categories: current state of fire safety installations, influence of establishment characteristics, application of regulations, and priority of actions. There was consensus among the experts over the necessity to improve the enforcement of regulations and also regarding the existence of an association between the hotel category (in Spain they are ranked using a 1 to 5 "star" rating system) and the level of fire safety; hotels with a higher category had higher levels of safety. There is a need to identify ways to apply fire safety standards to older hotels so that they comply with new regulations, to standardize regulations for different regions and countries, to improve the maintenance of installations and equipment, to increase the effectiveness of inspections conducted by government bodies, and to raise the general awareness of stakeholders involved in hotel fire prevention.

Advanced Vehicle Concepts and Implications for NextGen

NASA Technical Reports Server (NTRS)

Blake, Matt; Smith, Jim; Wright, Ken; Mediavilla Ricky; Kirby, Michelle; Pfaender, Holger; Clarke, John-Paul; Volovoi, Vitali; Dorbian, Christopher; Ashok, Akshay;

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

PubMed

Yang, Feng; Pai, Yi-Chung

2011-08-11

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

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

PubMed Central

Yang, Feng; Pai, Yi-Chung

2012-01-01

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

Survey of Cancer Patient Safety Culture: A Comparison of Chemotherapy and Oncology Departments of Teaching Hospitals of Tehran

PubMed Central

Raeissi, Pouran; Sharifi, Marziye; Khosravizadeh, Omid; Heidari, Mohammad

2017-01-01

Background: Patient safety culture plays an important role in healthcare systems, especially in chemotherapy and oncology departments (CODs), and its assessment can help to improve quality of services and hospital care. Objective: This study aimed to evaluate and compare items and dimensions of patient safety culture in the CODs of selected teaching hospitals of Iran and Tehran University of Medical Sciences. Materials and Methods: This descriptive-analytical cross-sectional survey was conducted during a six-month period on 270 people from chemotherapy and oncology departments selected through a cluster sampling method. All participants answered the standard questionnaire for “Hospital Survey of Patient Safety Culture” (HSOPSC). Statistical analyses were performed using SPSS/18 software. Results: The average score for patient safety culture was three for the majority of the studied CODs. Statistically significant differences were observed for supervisor actions, teamwork within various units, feedback and communications about errors, and the level of hospital management support. (p<0.05). Relationships between studied hospitals and patient safety culture were not statistically significant (p>0.05). Conclusion: Our results showed that the overall status of patient safety culture is not good in the studied CODs. In particular, teamwork across different units and organizational learning with continuous improvement were the only two properly operating items among 12 dimensions of patient safety culture. Therefore, systematic interventions are strongly required to promote communication. PMID:29072411

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

EPA Science Inventory

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

Students' corner: using Te Tiriti O Waitangi to identify and address racism, and achieve cultural safety in nursing.

PubMed

Oda, Keiko; Rameka, Maria

2012-12-01

Racism is an idea and belief that some races are superior to others (Harris et al., 2006a). This belief justifies institutional and individual practices that create and reinforce oppressive systems, inequality among racial or ethnic groups, and this creates racial hierarchy in society (Harris et al., 2006a). Recent studies have emphasised the impact of racism on ethnic health inequality (Harris et al., 2006a). In this article we analyse and discuss how nurses can challenge and reduce racism at interpersonal and institutional levels, and improve Māori health outcomes by understanding and using cultural safety in nursing practice and understanding Te Tiriti O Waitangi.

Building confidence in quantitative systems pharmacology models: An engineer's guide to exploring the rationale in model design and development.

PubMed

Timmis, J; Alden, K; Andrews, P; Clark, E; Nellis, A; Naylor, B; Coles, M; Kaye, P

2017-03-01

This tutorial promotes good practice for exploring the rationale of systems pharmacology models. A safety systems engineering inspired notation approach provides much needed rigor and transparency in development and application of models for therapeutic discovery and design of intervention strategies. Structured arguments over a model's development, underpinning biological knowledge, and analyses of model behaviors are constructed to determine the confidence that a model is fit for the purpose for which it will be applied. © 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

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

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

Bowman, Stephen M

2008-09-01

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

Ares I-X Range Safety Analyses Overview

NASA Technical Reports Server (NTRS)

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

2011-01-01

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

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

PubMed

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

2014-02-01

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

GPs' understanding and practice of safety netting for potential cancer presentations: a qualitative study in primary care.

PubMed

Evans, Julie; Ziebland, Sue; MacArtney, John I; Bankhead, Clare R; Rose, Peter W; Nicholson, Brian D

2018-05-08

Safety netting is a diagnostic strategy used in UK primary care to ensure patients are monitored until their symptoms or signs are explained. Despite being recommended in cancer diagnosis guidelines, little evidence exists about which components are effective and feasible in modern-day primary care. To understand the reality of safety netting for cancer in contemporary primary care. A qualitative study of GPs in Oxfordshire primary care. In-depth interviews with a purposive sample of 25 qualified GPs were undertaken. Interviews were recorded and transcribed verbatim, and analysed thematically using constant comparison. GPs revealed uncertainty about which aspects of clinical practice are considered safety netting. They use bespoke personal strategies, often developed from past mistakes, without knowledge of their colleagues' practice. Safety netting varied according to the perceived risk of cancer, the perceived reliability of each patient to follow advice, GP working patterns, and time pressures. Increasing workload, short appointments, and a reluctance to overburden hospital systems or create unnecessary patient anxiety have together led to a strategy of selective active follow-up of patients perceived to be at higher risk of cancer or less able to act autonomously. This left patients with low-risk-but-not-no-risk symptoms of cancer with less robust or absent safety netting. GPs would benefit from clearer guidance on which aspects of clinical practice contribute to effective safety netting for cancer. Practice systems that enable active follow-up of patients with low-risk-but-not-no-risk symptoms, which could represent malignancy, could reduce delays in cancer diagnosis without increasing GP workload. © British Journal of General Practice 2018.

Modeling of a Flooding Induced Station Blackout for a Pressurized Water Reactor Using the RISMC Toolkit

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

Mandelli, Diego; Prescott, Steven R; Smith, Curtis L

2011-07-01

In the Risk Informed Safety Margin Characterization (RISMC) approach we want to understand not just the frequency of an event like core damage, but how close we are (or are not) to key safety-related events and how might we increase our safety margins. The RISMC Pathway uses the probabilistic margin approach to quantify impacts to reliability and safety by coupling both probabilistic (via stochastic simulation) and mechanistic (via physics models) approaches. This coupling takes place through the interchange of physical parameters and operational or accident scenarios. In this paper we apply the RISMC approach to evaluate the impact of amore » power uprate on a pressurized water reactor (PWR) for a tsunami-induced flooding test case. This analysis is performed using the RISMC toolkit: RELAP-7 and RAVEN codes. RELAP-7 is the new generation of system analysis codes that is responsible for simulating the thermal-hydraulic dynamics of PWR and boiling water reactor systems. RAVEN has two capabilities: to act as a controller of the RELAP-7 simulation (e.g., system activation) and to perform statistical analyses (e.g., run multiple RELAP-7 simulations where sequencing/timing of events have been changed according to a set of stochastic distributions). By using the RISMC toolkit, we can evaluate how power uprate affects the system recovery measures needed to avoid core damage after the PWR lost all available AC power by a tsunami induced flooding. The simulation of the actual flooding is performed by using a smooth particle hydrodynamics code: NEUTRINO.« less

Use of headspace gas chromatographic/FTIR for the monitoring of volatiles in commercial brand coffees

NASA Astrophysics Data System (ADS)

Compton, Senja V.; Compton, David A.

1989-12-01

Recently, the area of food analysis and product safety has become of major concern to consumers. Therefore, companies involved in the quality assurance of theirproducts have been encouraged to perform extensive analyses to guarantee safety and satisfaction. One of the largest consumer products in the beverage marketplace is coffee. Much emphasis has been placed upon the safety of the decaffeination processes used by various manufacturers; these involve extraction of the caffeine by a solvent system that may be aqueous or organic, and is sometimes,super-critical. Additionally, aroma (fragrance) of brewing coffee has been found to be of major concern to the individual by the marketing departments of the coffee companies. The heads ace analysis of coffees can be used to discover the species retained after the decaffeination of coffee, as well as to distinguish the volatile species released upon treatment of the coffee at boiling water temperatures.

Structural verification for GAS experiments

NASA Technical Reports Server (NTRS)

Peden, Mark Daniel

1992-01-01

The purpose of this paper is to assist the Get Away Special (GAS) experimenter in conducting a thorough structural verification of its experiment structural configuration, thus expediting the structural review/approval process and the safety process in general. Material selection for structural subsystems will be covered with an emphasis on fasteners (GSFC fastener integrity requirements) and primary support structures (Stress Corrosion Cracking requirements and National Space Transportation System (NSTS) requirements). Different approaches to structural verifications (tests and analyses) will be outlined especially those stemming from lessons learned on load and fundamental frequency verification. In addition, fracture control will be covered for those payloads that utilize a door assembly or modify the containment provided by the standard GAS Experiment Mounting Plate (EMP). Structural hazard assessment and the preparation of structural hazard reports will be reviewed to form a summation of structural safety issues for inclusion in the safety data package.

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

PubMed

Liang, Huakang; Zhang, Shoujian; Su, Yikun

2018-03-29

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

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.

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

DOT National Transportation Integrated Search

2012-11-01

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

Traffic accidents on expressways: new threat to China.

PubMed

Zhao, Jinbao; Deng, Wei

2012-01-01

As China is building one of the largest expressway systems in the world, expressway safety problems have become serious concerns to China. This article analyzed the trends in expressway accidents in China from 1995 to 2010 and examined the characteristics of these accidents. Expressway accident data were obtained from the Annual Report for Road Traffic Accidents published by the Ministry of Public Security of China. Expressway mileage data were obtained from the National Statistics Yearbook published by the National Bureau of Statistics of China. Descriptive statistical analyses were conducted based on these data. Expressway deaths increased by 10.2-fold from 616 persons in 1995 to 6300 persons in 2010, and the average annual increase was 17.9 percent over the past 15 years, and the overall other road traffic deaths was -0.33 percent. China's expressway mileage accounted for only 1.85 percent of highway mileage driven in 2010, but expressway deaths made up 13.54 percent of highway traffic deaths. The average annual accident lethality rate [accident deaths/(accident deaths + accident injuries)] for China's expressways was 27.76 percent during the period 1995 to 2010, which was 1.33 times higher than the accident lethality rate of highway traffic accidents. China's government should pay attention to expressway construction and safety interventions during the rapid development period of expressways. Related causes, such as geographic patterns, speeding, weather conditions, and traffic flow composition, need to be studied in the near future. An effective and scientific expressway safety management services system, composed of a speed monitoring system, warning system, and emergency rescue system, should be established in developed and underdeveloped provinces in China to improve safety on expressway.

Assessing driver's mental representation of Adaptive Cruise Control (ACC) and its possible effects on behavioural adaptations.

PubMed

Piccinini, Giulio Francesco; Simões, Anabela; Rodrigues, Carlos Manuel; Leitão, Miguel

2012-01-01

The introduction of Adaptive Cruise Control (ACC) could be very helpful for making the longitudinal driving task more comfortable for the drivers and, as a consequence, it could have a global beneficial effect on road safety. However, before or during the usage of the device, due to several reasons, drivers might generate in their mind incomplete or flawed mental representations about the fundamental operation principles of ACC; hence, the resulting usage of the device might be improper, negatively affecting the human-machine interaction and cooperation and, in some cases, leading to negative behavioural adaptations to the system that might neutralise the desirable positive effects on road safety. Within this context, this paper will introduce the methodology which has been developed in order to analyse in detail the topic and foresee, in the future, adequate actions for the recovery of inaccurate mental representations of the system.

Safety assessment of underground vehicles passing over highly resilient curved tracks in the presence of a broken rail

NASA Astrophysics Data System (ADS)

Suárez, B.; Rodriguez, P.; Vázquez, M.; Fernández, I.

2012-01-01

Vehicle-track interaction for a new resilient slab track designed to reduce noise and vibration levels was analysed, in order to assess the derailment risk on a curved track when encountering a broken rail. Sensitivity of the rail support spacing of the relative position of the rail breakage between two adjacent rail supports and of running speed were analysed for two different elasticities of the rail fastening system. In none of the cases analysed was observed an appreciable difference between either of the elastic systems. As was expected, the most unfavourable situations were those with greater rail support spacing and those with greater distance from the breakage to the nearest rail support, although in none of the simulations performed did a derailment occur when running over the broken rail. When varying the running speed, the most favourable condition was obtained for an intermediate speed, due to the superposition of two antagonistic effects.

Subsystem Hazard Analysis Methodology for the Ares I Upper Stage Source Controlled Items

NASA Technical Reports Server (NTRS)

Mitchell, Michael S.; Winner, David R.

2010-01-01

This article describes processes involved in developing subsystem hazard analyses for Source Controlled Items (SCI), specific components, sub-assemblies, and/or piece parts, of the NASA ARES I Upper Stage (US) project. SCIs will be designed, developed and /or procured by Boeing as an end item or an off-the-shelf item. Objectives include explaining the methodology, tools, stakeholders and products involved in development of these hazard analyses. Progress made and further challenges in identifying potential subsystem hazards are also provided in an effort to assist the System Safety community in understanding one part of the ARES I Upper Stage project.

Thermal Structure Analysis of SIRCA Tile for X-34 Wing Leading Edge TPS

NASA Technical Reports Server (NTRS)

Milos, Frank S.; Squire, Thomas H.; Rasky, Daniel J. (Technical Monitor)

1997-01-01

This paper will describe in detail thermal/structural analyses of SIRCA tiles which were performed at NASA Ames under the The Tile Analysis Task of the X-34 Program. The analyses used the COSMOS/M finite element software to simulate the material response in arc-jet tests, mechanical deflection tests, and the performance of candidate designs for the TPS system. Purposes of the analysis were to verify thermal and structural models for the SIRCA tiles, to establish failure criteria for stressed tiles, to simulate the TPS response under flight aerothermal and mechanical load, and to confirm that adequate safety margins exist for the actual TPS design.

Problems with health information technology and their effects on care delivery and patient outcomes: a systematic review.

PubMed

Kim, Mi Ok; Coiera, Enrico; Magrabi, Farah

2017-03-01

To systematically review studies reporting problems with information technology (IT) in health care and their effects on care delivery and patient outcomes. We searched bibliographic databases including Scopus, PubMed, and Science Citation Index Expanded from January 2004 to December 2015 for studies reporting problems with IT and their effects. A framework called the information value chain, which connects technology use to final outcome, was used to assess how IT problems affect user interaction, information receipt, decision-making, care processes, and patient outcomes. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Of the 34 studies identified, the majority ( n  = 14, 41%) were analyses of incidents reported from 6 countries. There were 7 descriptive studies, 9 ethnographic studies, and 4 case reports. The types of IT problems were similar to those described in earlier classifications of safety problems associated with health IT. The frequency, scale, and severity of IT problems were not adequately captured within these studies. Use errors and poor user interfaces interfered with the receipt of information and led to errors of commission when making decisions. Clinical errors involving medications were well characterized. Issues with system functionality, including poor user interfaces and fragmented displays, delayed care delivery. Issues with system access, system configuration, and software updates also delayed care. In 18 studies (53%), IT problems were linked to patient harm and death. Near-miss events were reported in 10 studies (29%). The research evidence describing problems with health IT remains largely qualitative, and many opportunities remain to systematically study and quantify risks and benefits with regard to patient safety. The information value chain, when used in conjunction with existing classifications for health IT safety problems, can enhance measurement and should facilitate identification of the most significant risks to patient safety. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

The relationship between external and local governance systems: the case of health care associated infections and medication errors in one NHS trust.

PubMed

Ramsay, Angus; Magnusson, Carin; Fulop, Naomi

2010-12-01

'Organisational governance'--the systems, processes, behaviours and cultures by which an organisation leads and controls its functions to achieve its objectives--is seen as an important influence on patient safety. The features of 'good' governance remain to be established, partly because the relationship between governance and safety requires more investigation. To describe external governance systems--for example, national targets and regulatory bodies--and an NHS Trust's formal governance systems for Health Care Associated Infections (HCAIs) and medication errors; to consider the relationships between these systems. External governance systems and formal internal governance systems for both medication errors and HCAIs were analysed based on documentary analysis and interviews with relevant hospital staff. Nationally, HCAIs appeared to be a higher priority than medication errors, reflected in national targets and the focus of regulatory bodies. Locally, HCAIs were found to be the focus of committees at all levels of the organisation and, unlike medication errors, a central component of the Trust's performance management system; medication errors were discussed in appropriate governance committees, but most governance of medication errors took place at divisional or ward level. The data suggest a relationship between national and local prioritisation of the safety issues examined: national targets on HCAIs influence the behaviour of regulators and professional organisations; and these, in turn, have a significant impact on Trust activity. A contributory factor might be that HCAIs are more amenable to measurement than medication errors, meaning HCAIs lend themselves better to target-setting.

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

NASA Astrophysics Data System (ADS)

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

2017-12-01

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

Reaction Control System Thruster Cracking Consultation: NASA Engineering and Safety Center (NESC) Materials Super Problem Resolution Team (SPRT) Findings

NASA Technical Reports Server (NTRS)

MacKay, Rebecca A.; Smith, Stephen W.; Shah, Sandeep R.; Piascik, Robert S.

2005-01-01

The shuttle orbiter s reaction control system (RCS) primary thruster serial number 120 was found to contain cracks in the counter bores and relief radius after a chamber repair and rejuvenation was performed in April 2004. Relief radius cracking had been observed in the 1970s and 1980s in seven thrusters prior to flight; however, counter bore cracking had never been seen previously in RCS thrusters. Members of the Materials Super Problem Resolution Team (SPRT) of the NASA Engineering and Safety Center (NESC) conducted a detailed review of the relevant literature and of the documentation from the previous RCS thruster failure analyses. It was concluded that the previous failure analyses lacked sufficient documentation to support the conclusions that stress corrosion cracking or hot-salt cracking was the root cause of the thruster cracking and lacked reliable inspection controls to prevent cracked thrusters from entering the fleet. The NESC team identified and performed new materials characterization and mechanical tests. It was determined that the thruster intergranular cracking was due to hydrogen embrittlement and that the cracking was produced during manufacturing as a result of processing the thrusters with fluoride-containing acids. Testing and characterization demonstrated that appreciable environmental crack propagation does not occur after manufacturing.

Investigated serious occupational accidents in the Netherlands, 1998-2009.

PubMed

Bellamy, Linda J; Manuel, Henk Jan; Oh, Joy I H

2014-01-01

Since 2003, a project has been underway to analyse the most serious occupational accidents in The Netherlands. All the serious occupational accidents investigated by the Dutch Labour Inspectorate for the 12 years of 1998-2009 inclusive have been entered into a database, a total of 20 030 investigations. This database uses a model of safety barriers supported by barrier tasks and management delivery systems such that, when combined with sector and year information, trends in the data can be analysed for their underlying causes. The trend analyses show that while the number of victims of serious reportable accidents is significantly decreasing, this is due to specific sectors, hazards and underlying causes. The significant results could not easily be directly associated with any specific regulation or action undertaken in The Netherlands although there have been many different approaches to reducing accidents during the period analysed, which could be contributing to the effect.

Conceptual design of a crewed reusable space transportation system aimed at parabolic flights: stakeholder analysis, mission concept selection, and spacecraft architecture definition

NASA Astrophysics Data System (ADS)

Fusaro, Roberta; Viola, Nicole; Fenoglio, Franco; Santoro, Francesco

2017-03-01

This paper proposes a methodology to derive architectures and operational concepts for future earth-to-orbit and sub-orbital transportation systems. In particular, at first, it describes the activity flow, methods, and tools leading to the generation of a wide range of alternative solutions to meet the established goal. Subsequently, the methodology allows selecting a small number of feasible options among which the optimal solution can be found. For the sake of clarity, the first part of the paper describes the methodology from a theoretical point of view, while the second part proposes the selection of mission concepts and of a proper transportation system aimed at sub-orbital parabolic flights. Starting from a detailed analysis of the stakeholders and their needs, the major objectives of the mission have been derived. Then, following a system engineering approach, functional analysis tools as well as concept of operations techniques allowed generating a very high number of possible ways to accomplish the envisaged goals. After a preliminary pruning activity, aimed at defining the feasibility of these concepts, more detailed analyses have been carried out. Going on through the procedure, the designer should move from qualitative to quantitative evaluations, and for this reason, to support the trade-off analysis, an ad-hoc built-in mission simulation software has been exploited. This support tool aims at estimating major mission drivers (mass, heat loads, manoeuverability, earth visibility, and volumetric efficiency) as well as proving the feasibility of the concepts. Other crucial and multi-domain mission drivers, such as complexity, innovation level, and safety have been evaluated through the other appropriate analyses. Eventually, one single mission concept has been selected and detailed in terms of layout, systems, and sub-systems, highlighting also logistic, safety, and maintainability aspects.

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.

[What Surgeons Should Know about Risk Management].

PubMed

Strametz, R; Tannheimer, M; Rall, M

2017-02-01

Background: The fact that medical treatment is associated with errors has long been recognized. Based on the principle of "first do no harm", numerous efforts have since been made to prevent such errors or limit their impact. However, recent statistics show that these measures do not sufficiently prevent grave mistakes with serious consequences. Preventable mistakes such as wrong patient or wrong site surgery still frequently occur in error statistics. Methods: Based on insight from research on human error, in due consideration of recent legislative regulations in Germany, the authors give an overview of the clinical risk management tools needed to identify risks in surgery, analyse their causes, and determine adequate measures to manage those risks depending on their relevance. The use and limitations of critical incident reporting systems (CIRS), safety checklists and crisis resource management (CRM) are highlighted. Also the rationale for IT systems to support the risk management process is addressed. Results/Conclusion: No single tool of risk management can be effective as a standalone instrument, but unfolds its effect only when embedded in a superordinate risk management system, which integrates tailor-made elements to increase patient safety into the workflows of each organisation. Competence in choosing adequate tools, effective IT systems to support the risk management process as well as leadership and commitment to constructive handling of human error are crucial components to establish a safety culture in surgery. Georg Thieme Verlag KG Stuttgart · New York.

Concept analysis of safety climate in healthcare providers.

PubMed

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

2017-06-01

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

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

PubMed

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

2016-01-29

To explore general practitioner (GP) team perceptions and experiences of participating in a large-scale safety and improvement pilot programme to develop and test a range of interventions that were largely new to this setting. Qualitative study using semistructured interviews. Data were analysed thematically. Purposive sample of multiprofessional study participants from 11 GP teams based in 3 Scottish National Health Service (NHS) Boards. 27 participants were interviewed. 3 themes were generated: (1) programme experiences and benefits, for example, a majority of participants referred to gaining new theoretical and experiential safety knowledge (such as how unreliable evidence-based care can be) and skills (such as how to search electronic records for undetected risks) related to the programme interventions; (2) improvements to patient care systems, for example, improvements in care systems reliability using care bundles were reported by many, but this was an evolving process strongly dependent on closer working arrangements between clinical and administrative staff; (3) the utility of the programme improvement interventions, for example, mixed views and experiences of participating in the safety climate survey and meeting to reflect on the feedback report provided were apparent. Initial theories on the utilisation and potential impact of some interventions were refined based on evidence. The pilot was positively received with many practices reporting improvements in safety systems, team working and communications with colleagues and patients. Barriers and facilitators were identified related to how interventions were used as the programme evolved, while other challenges around spreading implementation beyond this pilot were highlighted. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

NASA Astrophysics Data System (ADS)

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

2017-11-01

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

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

PubMed Central

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

2016-01-01

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

Evaluation of a community based childhood injury prevention program.

PubMed Central

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

1997-01-01

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

General aviation crash safety program at Langley Research Center

NASA Technical Reports Server (NTRS)

Thomson, R. G.

1976-01-01

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

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

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

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

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

Understanding Medicare Hospital Readmission Rates And Differing Penalties Between Safety-Net And Other Hospitals.

PubMed

Sheingold, Steven H; Zuckerman, Rachael; Shartzer, Adele

2016-01-01

Since the implementation of Medicare's Hospital Readmissions Reduction Program in 2012, concerns have been raised about the effect its payment penalties for excess readmissions may have on safety-net hospitals. A number of policy solutions have been proposed to ensure that the program does not unfairly penalize safety-net institutions, which treat a disproportionate number of patients with low socioeconomic status. We examined the extent to which the program's current risk-adjustment factors, measures of patient socioeconomic status, and hospital-level factors explain the observed differences in readmission rates between safety-net and other hospitals. Our analyses suggest that patient socioeconomic status can explain some of the difference in readmission rates but that unmeasured factors such as hospitals' performance may also play a role. We also found that safety-net hospitals have experienced only slightly higher readmission penalties under the program than other hospitals have. Together, these findings suggest the need for a careful evaluation of policy alternatives that factor socioeconomic status into penalty calculations for excess readmissions to determine whether such alternatives could have a significant impact on penalties while remaining consistent with overall objectives for delivery system transformation. Project HOPE—The People-to-People Health Foundation, Inc.

Management capacity to promote nurse workplace health and safety.

PubMed

Fang, Yaxuan; McDonald, Tracey

2018-04-01

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

SCALE: A modular code system for performing standardized computer analyses for licensing evaluation. Functional modules F1--F8 -- Volume 2, Part 1, Revision 4

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

Greene, N.M.; Petrie, L.M.; Westfall, R.M.

SCALE--a modular code system for Standardized Computer Analyses Licensing Evaluation--has been developed by Oak Ridge National Laboratory at the request of the US Nuclear Regulatory Commission. The SCALE system utilizes well-established computer codes and methods within standard analysis sequences that (1) allow an input format designed for the occasional user and/or novice, (2) automate the data processing and coupling between modules, and (3) provide accurate and reliable results. System development has been directed at problem-dependent cross-section processing and analysis of criticality safety, shielding, heat transfer, and depletion/decay problems. Since the initial release of SCALE in 1980, the code system hasmore » been heavily used for evaluation of nuclear fuel facility and package designs. This revision documents Version 4.2 of the system. The manual is divided into three volumes: Volume 1--for the control module documentation; Volume 2--for functional module documentation; and Volume 3--for documentation of the data libraries and subroutine libraries.« less

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

PubMed Central

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

2013-01-01

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

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

PubMed

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

2017-07-01

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

Food Safety Informatics: A Public Health Imperative

PubMed Central

Tucker, Cynthia A.; Larkin, Stephanie N.; Akers, Timothy A.

2011-01-01

To date, little has been written about the implementation of utilizing food safety informatics as a technological tool to protect consumers, in real-time, against foodborne illnesses. Food safety outbreaks have become a major public health problem, causing an estimated 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths in the U.S. each year. Yet, government inspectors/regulators that monitor foodservice operations struggle with how to collect, organize, and analyze data; implement, monitor, and enforce safe food systems. Currently, standardized technologies have not been implemented to efficiently establish “near-in-time” or “just-in-time” electronic awareness to enhance early detection of public health threats regarding food safety. To address the potential impact of collection, organization and analyses of data in a foodservice operation, a wireless food safety informatics (FSI) tool was pilot tested at a university student foodservice center. The technological platform in this test collected data every six minutes over a 24 hour period, across two primary domains: time and temperatures within freezers, walk-in refrigerators and dry storage areas. The results of this pilot study briefly illustrated how technology can assist in food safety surveillance and monitoring by efficiently detecting food safety abnormalities related to time and temperatures so that efficient and proper response in “real time” can be addressed to prevent potential foodborne illnesses. PMID:23569605

Dynamic models to analyse the influence of the seat belt in a frontal collision

NASA Astrophysics Data System (ADS)

Oana, Oţăt; Nicolae, Dumitru; Ilie, Dumitru

2017-10-01

Traffic accidents are influenced by various factors, yet, the highest impacting ones are related to vehicle impact speed and collision type. Also, passive vehicle safety systems play a significant role upon the injuries suffered by vehicle occupants. Under the circumstances, a particularly important aspect to consider when using such systems is the position of the vehicle’s driver and its occupants. In what follows we embark upon an in-depth analysis in order to investigate the contact effects between the seat belt and the driver, under a dynamic regime. We set out to identify the variation of the kinematic and dynamic parameters for both the driver and the seat belt via comparative analyses between the normal position of the driver and some other out of position instances, considered as critical.

Impact of workstations on criticality analyses at ABB combustion engineering

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

Tarko, L.B.; Freeman, R.S.; O'Donnell, P.F.

1993-01-01

During 1991, ABB Combustion Engineering (ABB C-E) made the transition from a CDC Cyber 990 mainframe for nuclear criticality safety analyses to Hewlett Packard (HP)/Apollo workstations. The primary motivation for this change was improved economics of the workstation and maintaining state-of-the-art technology. The Cyber 990 utilized the NOS operating system with a 60-bit word size. The CPU memory size was limited to 131 100 words of directly addressable memory with an extended 250000 words available. The Apollo workstation environment at ABB consists of HP/Apollo-9000/400 series desktop units used by most application engineers, networked with HP/Apollo DN10000 platforms that use 32-bitmore » word size and function as the computer servers and network administrative CPUS, providing a virtual memory system.« less

Adenoviral production of interleukin-2 at the tumor site removes the need for systemic postconditioning in adoptive cell therapy.

PubMed

Santos, Joao Manuel; Havunen, Riikka; Siurala, Mikko; Cervera-Carrascon, Víctor; Tähtinen, Siri; Sorsa, Suvi; Anttila, Marjukka; Karell, Pauliina; Kanerva, Anna; Hemminki, Akseli

2017-10-01

Systemic high dose interleukin-2 (IL-2) postconditioning has long been utilized in boosting the efficacy of T cells in adoptive cell therapy (ACT) of solid tumors. The resulting severe off-target toxicity of these regimens renders local production at the tumor an attractive concept with possible safety gains. We evaluated the efficacy and safety of intratumorally administered IL-2-coding adenoviruses in combination with tumor-infiltrating lymphocyte therapy in syngeneic Syrian hamsters bearing HapT1 pancreatic tumors and with T cell receptor transgenic ACT in B16.OVA melanoma bearing C57BL/6 mice. The models are complementary: hamsters are semi-permissive for human oncolytic adenovirus, whereas detailed immunological analyses are possible in mice. In both models, local production of IL-2 successfully replaced the need for systemic recombinant IL-2 (rIL-2) administration and increased the efficacy of the cell therapy. Furthermore, vectored delivery of IL-2 significantly enhanced the infiltration of CD8+ T cells, M1-like macrophages, and B-cells while systemic rIL-2 increased CD25 + FoxP3+ T cells at the tumor. In contrast with vectored delivery, histopathological analysis of systemic rIL-2-treated animals revealed significant changes in lungs, livers, hearts, spleens, and kidneys. In summary, local IL-2 production results in efficacy and safety gains in the context of ACT. These preclinical assessments provide the rationale for ongoing clinical translation. © 2017 UICC.

Development of a Reduced-Order Three-Dimensional Flow Model for Thermal Mixing and Stratification Simulation during Reactor Transients

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

Hu, Rui

2017-09-03

Mixing, thermal-stratification, and mass transport phenomena in large pools or enclosures play major roles for the safety of reactor systems. Depending on the fidelity requirement and computational resources, various modeling methods, from the 0-D perfect mixing model to 3-D Computational Fluid Dynamics (CFD) models, are available. Each is associated with its own advantages and shortcomings. It is very desirable to develop an advanced and efficient thermal mixing and stratification modeling capability embedded in a modern system analysis code to improve the accuracy of reactor safety analyses and to reduce modeling uncertainties. An advanced system analysis tool, SAM, is being developedmore » at Argonne National Laboratory for advanced non-LWR reactor safety analysis. While SAM is being developed as a system-level modeling and simulation tool, a reduced-order three-dimensional module is under development to model the multi-dimensional flow and thermal mixing and stratification in large enclosures of reactor systems. This paper provides an overview of the three-dimensional finite element flow model in SAM, including the governing equations, stabilization scheme, and solution methods. Additionally, several verification and validation tests are presented, including lid-driven cavity flow, natural convection inside a cavity, laminar flow in a channel of parallel plates. Based on the comparisons with the analytical solutions and experimental results, it is demonstrated that the developed 3-D fluid model can perform very well for a wide range of flow problems.« less

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

PubMed

Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

2017-03-01

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12.

PubMed

Iqbal, Shahed; Shi, Jing; Seib, Katherine; Lewis, Paige; Moro, Pedro L; Woo, Emily J; Shimabukuro, Tom; Orenstein, Walter A

2015-10-01

Safety data from countries with experience in the use of inactivated poliovirus vaccine (IPV) are important for the global polio eradication strategy to introduce IPV into the immunisation schedules of all countries. In the USA, IPV has been included in the routine immunisation schedule since 1997. We aimed to analyse adverse events after IPV administration reported to the US Vaccine Adverse Event Reporting System (VAERS). We analysed all VAERS data associated with IPV submitted between Jan 1, 2000, and Dec 31, 2012, either as individual or as combination vaccines, for all age and sex groups. We analysed the number and event type (non-serious, non-fatal serious, and death reports) of individual reports, and explored the most commonly coded event terms to describe the adverse event. We classified death reports according to previously published body-system categories (respiratory, cardiovascular, neurological, gastrointestinal, other infectious, and other non-infectious) and reviewed death reports to identify the cause of death. We classified sudden infant death syndrome as a separate cause of death considering previous concerns about sudden infant syndrome after vaccines. We used empirical Bayesian data mining methods to identify disproportionate reporting of adverse events for IPV compared with other vaccines. Additional VAERS data from 1991 to 2000 were analysed to compare the safety profiles of IPV and oral poliovirus vaccine (OPV). Of the 41,792 adverse event reports submitted, 39,568 (95%) were for children younger than 7 years. 38,381 of the reports for children in this age group (97%) were for simultaneous vaccination with IPV and other vaccines (most commonly pneumococcal and acellular pertussis vaccines), whereas standalone IPV vaccines accounted for 0·5% of all reports. 34,880 reports were for non-serious events (88%), 3905 reports were for non-fatal serious events (10%), and 783 reports were death reports (2%). Injection-site erythema was the most commonly coded term for non-serious events (29%), and pyrexia for non-fatal serious events (38%). Most deaths (96%) were in children aged 12 months or younger; most (52%) had sudden infant death syndrome as the reported cause of death. The safely profiles of combined IPV and whole-cell pertussis vaccines, OPV and whole-cell pertussis vaccines, and OPV and acellular pertussis vaccines were similar. We noted no indication of disproportionate reporting of adverse events after immunisation with IPV-containing vaccines compared with other vaccines between 1990 and 2013. Fairly few adverse events were reported for the more than 250 million IPV doses distributed between 2000 and 2012. Sudden infant death syndrome reports after IPV were consistent with reporting patterns for other vaccines. No new or unexpected vaccine safety problems were identified for fatal, non-fatal serious, and non-serious reports in this assessment of adverse events after IPV. None. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Aviation Performance Measuring System (APMS): An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Connor, Mary M. (Technical Monitor)

1998-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data, The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS offers to the air transport community an open, voluntary standard for flight-data-analysis software; a standard that will help to ensure suitable functionality and data interchangeability among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs-of aircrews in mind. APMS tools must serve the needs of the government and air carriers, as well as aircrews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but also through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the aircrew.

Life Cycle Systems Engineering Approach to NASA's 2nd Generation Reusable Launch Vehicle

NASA Technical Reports Server (NTRS)

Thomas, Dale; Smith, Charles; Safie, Fayssal; Kittredge, Sheryl

2002-01-01

The overall goal of the 2nd Generation RLV Program is to substantially reduce technical and business risks associated with developing a new class of reusable launch vehicles. NASA's specific goals are to improve the safety of a 2nd- generation system by 2 orders of magnitude - equivalent to a crew risk of 1 -in- 10,000 missions - and decrease the cost tenfold, to approximately $1,000 per pound of payload launched. Architecture definition is being conducted in parallel with the maturating of key technologies specifically identified to improve safety and reliability, while reducing operational costs. An architecture broadly includes an Earth-to-orbit reusable launch vehicle, on-orbit transfer vehicles and upper stages, mission planning, ground and flight operations, and support infrastructure, both on the ground and in orbit. The systems engineering approach ensures that the technologies developed - such as lightweight structures, long-life rocket engines, reliable crew escape, and robust thermal protection systems - will synergistically integrate into the optimum vehicle. Given a candidate architecture that possesses credible physical processes and realistic technology assumptions, the next set of analyses address the system's functionality across the spread of operational scenarios characterized by the design reference missions. The safety/reliability and cost/economics associated with operating the system will also be modeled and analyzed to answer the questions "How safe is it?" and "How much will it cost to acquire and operate?" The systems engineering review process factors in comprehensive budget estimates, detailed project schedules, and business and performance plans, against the goals of safety, reliability, and cost, in addition to overall technical feasibility. This approach forms the basis for investment decisions in the 2nd Generation RLV Program's risk-reduction activities. Through this process, NASA will continually refine its specialized needs and identify where Defense and commercial requirements overlap those of civil missions.

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

NASA Astrophysics Data System (ADS)

Summerer, Leopold

2014-08-01

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

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

PubMed

Ersoy, Metin; Yesilkaya, Liyaddin

2016-01-01

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

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

PubMed

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

2014-02-01

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

Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

PubMed Central

Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

2016-01-01

Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27804174

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

Not Available

This final safety evaluation report (FSER) documents the technical review of the System 80+ standard design by the US Nuclear Regulatory Commission (NRC) staff. The application for the System 80+ design was submitted by Combustion Engineering, Inc., now Asea Brown Boveri-Combustion Engineering (ABB-CE) as an application for design approval and subsequent design certification pursuant to 10 CFR {section} 52.45. System 80+ is a pressurized water reactor with a rated power of 3914 megawatts thermal (MWt) and a design power of 3992 MWt at which accidents are analyzed. Many features of the System 80+ are similar to those of Abb-CE`s Systemmore » 80 design from which it evolved. Unique features of the System 80+ design included: a large spherical, steel containment; an in-containment refueling water storage tank; a reactor cavity flooding system, hydrogen ignitors, and a safety depressurization system for severe accident mitigation; a combustion gas turbine for an alternate ac source; and an advanced digitally based control room. On the basis of its evaluation and independent analyses, the NRC staff concludes that ABB-CE`s application for design certification meets the requirements of Subpart B of 10 CFR Part 52 that are applicable and technically relevant to the System 80+ standard design. This document, Volume 1, contains Chapters 1 through 14 of this report.« less

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

Not Available

This final safety evaluation report (FSER) documents the technical review of the System 80+ standard design by the US Nuclear Regulatory Commission (NRC) staff. The application for the system 80+ design was submitted by Combustion Engineering, Inc., now Asea Brown Boveri-Combustion Engineering (ABB-CE) as an application for design approval and subsequent design certification pursuant to 10 CFR {section} 52.45. System 80+ is a pressurized water reactor with a rated power of 3914 megawatts thermal (MWt) and a design power of 3992 MWt at which accidents are analyzed. Many features of the System 80+ are similar to those of ABB-CE`s Systemmore » 80 design from which it evolved. Unique features of the System 80+ design include: a large spherical, steel containment; an in-containment refueling water storage tank; a reactor cavity flooding system, hydrogen ignitors and a safety depressurization system for severe accident mitigation; a combustion gas turbine for an alternate ac source; and an advanced digitally based control room. On the basis of its evaluation and independent analyses, the NRC staff concludes that ABB-CE`s application for design certification meets the requirements of Subpart B of 10 CFR Part 52 that are applicable and technically relevant to the System 80+ standard design. This document, Volume 2, contains Chapters 15 through 22 and Appendices A through E.« less

Predictive microbiology: Quantitative science delivering quantifiable benefits to the meat industry and other food industries.

PubMed

McMeekin, T A

2007-09-01

Predictive microbiology is considered in the context of the conference theme "chance, innovation and challenge", together with the impact of quantitative approaches on food microbiology, generally. The contents of four prominent texts on predictive microbiology are analysed and the major contributions of two meat microbiologists, Drs. T.A. Roberts and C.O. Gill, to the early development of predictive microbiology are highlighted. These provide a segue into R&D trends in predictive microbiology, including the Refrigeration Index, an example of science-based, outcome-focussed food safety regulation. Rapid advances in technologies and systems for application of predictive models are indicated and measures to judge the impact of predictive microbiology are suggested in terms of research outputs and outcomes. The penultimate section considers the future of predictive microbiology and advances that will become possible when data on population responses are combined with data derived from physiological and molecular studies in a systems biology approach. Whilst the emphasis is on science and technology for food safety management, it is suggested that decreases in foodborne illness will also arise from minimising human error by changing the food safety culture.

[Adverse events management. Methods and results of a development project].

PubMed

Rabøl, Louise Isager; Jensen, Elisabeth Brøgger; Hellebek, Annemarie H; Pedersen, Beth Lilja

2006-11-27

This article describes the methods and results of a project in the Copenhagen Hospital Corporation (H:S) on preventing adverse events. The aim of the project was to raise awareness about patients' safety, test a reporting system for adverse events, develop and test methods of analysis of events and propagate ideas about how to prevent adverse events. H:S developed an action plan and a reporting system for adverse events, founded an organization and developed an educational program on theories and methods of learning from adverse events for both leaders and employees. During the three-year period from 1 January 2002 to 31 December 2004, the H:S staff reported 6011 adverse events. In the same period, the organization completed 92 root cause analyses. More than half of these dealt with events that had been optional to report, the other half events that had been mandatory to report. The number of reports and the front-line staff's attitude towards reporting shows that the H:S succeeded in founding a safety culture. Future work should be centred on developing and testing methods that will prevent adverse events from happening. The objective is to suggest and complete preventive initiatives which will help increase patient safety.

Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

PubMed

Chrischilles, Elizabeth A; Gagne, Joshua J; Fireman, Bruce; Nelson, Jennifer; Toh, Sengwee; Shoaibi, Azadeh; Reichman, Marsha E; Wang, Shirley; Nguyen, Michael; Zhang, Rongmei; Izem, Rima; Goulding, Margie R; Southworth, Mary Ross; Graham, David J; Fuller, Candace; Katcoff, Hannah; Woodworth, Tiffany; Rogers, Catherine; Saliga, Ryan; Lin, Nancy D; McMahill-Walraven, Cheryl N; Nair, Vinit P; Haynes, Kevin; Carnahan, Ryan M

2018-03-01

The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71). This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety. Copyright © 2018 John Wiley & Sons, Ltd.

The influence of car registration year on driver casualty rates in Great Britain.

PubMed

Broughton, Jeremy

2012-03-01

A previous paper analysed data from the British national road accident reporting system to investigate the influence upon car driver casualty rates of the general type of car being driven and its year of first registration. A statistical model was fitted to accident data from 2001 to 2005, and this paper updates the principal results using accident data from 2003 to 2007. Attention focuses upon the role of year of first registration since this allows the influence of developments in car design upon occupant casualty numbers to be evaluated. Three additional topics are also examined with these accident data. Changes over time in frontal and side impacts are compared. Changes in the combined risk for the two drivers involved in a car-car collision are investigated, being the net result of changes in secondary safety and aggressivity. Finally, the results of the new model relating to occupant protection are related to an index that had been developed previously to analyse changes over time in the secondary safety of the car fleet. Copyright © 2011 Elsevier Ltd. All rights reserved.

A STRONGLY COUPLED REACTOR CORE ISOLATION COOLING SYSTEM MODEL FOR EXTENDED STATION BLACK-OUT ANALYSES

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

Zhao, Haihua; Zhang, Hongbin; Zou, Ling

2015-03-01

The reactor core isolation cooling (RCIC) system in a boiling water reactor (BWR) provides makeup cooling water to the reactor pressure vessel (RPV) when the main steam lines are isolated and the normal supply of water to the reactor vessel is lost. The RCIC system operates independently of AC power, service air, or external cooling water systems. The only required external energy source is from the battery to maintain the logic circuits to control the opening and/or closure of valves in the RCIC systems in order to control the RPV water level by shutting down the RCIC pump to avoidmore » overfilling the RPV and flooding the steam line to the RCIC turbine. It is generally considered in almost all the existing station black-out accidents (SBO) analyses that loss of the DC power would result in overfilling the steam line and allowing liquid water to flow into the RCIC turbine, where it is assumed that the turbine would then be disabled. This behavior, however, was not observed in the Fukushima Daiichi accidents, where the Unit 2 RCIC functioned without DC power for nearly three days. Therefore, more detailed mechanistic models for RCIC system components are needed to understand the extended SBO for BWRs. As part of the effort to develop the next generation reactor system safety analysis code RELAP-7, we have developed a strongly coupled RCIC system model, which consists of a turbine model, a pump model, a check valve model, a wet well model, and their coupling models. Unlike the traditional SBO simulations where mass flow rates are typically given in the input file through time dependent functions, the real mass flow rates through the turbine and the pump loops in our model are dynamically calculated according to conservation laws and turbine/pump operation curves. A simplified SBO demonstration RELAP-7 model with this RCIC model has been successfully developed. The demonstration model includes the major components for the primary system of a BWR, as well as the safety system components such as the safety relief valve (SRV), the RCIC system, the wet well, and the dry well. The results show reasonable system behaviors while exhibiting rich dynamics such as variable flow rates through RCIC turbine and pump during the SBO transient. The model has the potential to resolve the Fukushima RCIC mystery after adding the off-design two-phase turbine operation model and other additional improvements.« less

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

PubMed

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

2013-12-01

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

The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

PubMed

Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

2015-05-01

Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.

PubMed

Raschi, Emanuel; Girardi, Anna; Poluzzi, Elisabetta; Forcesi, Emanuele; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio

2018-03-26

Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still incompletely characterized. We described and compared adverse events (AEs) associated with RYR products submitted to reporting systems maintained by the Food and Drug Administration (FDA), with a focus on liver and muscular events. We extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% confidence interval (CI) calculation and case-by-case inspection were performed, with a focus on muscular and hepatic AEs. One thousand three hundred AEs were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). In FAERS, a large number of reports emerged for "general disorders and administration site conditions," whereas CAERS received also a high number of reports for "investigations" and "musculoskeletal and connective tissue disorders". Disproportionality analyses confirmed higher reporting of serious muscular and liver injuries: in FAERS, five cases of hepatic disorders (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy (8.44; 5.44-13.10). Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

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

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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

Code of Federal Regulations, 2011 CFR

2011-10-01

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

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

Code of Federal Regulations, 2013 CFR

2013-10-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

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

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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 ...

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

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

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

1992-04-01

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

Small reactor power systems for manned planetary surface bases

NASA Technical Reports Server (NTRS)

Bloomfield, Harvey S.

1987-01-01

A preliminary feasibility study of the potential application of small nuclear reactor space power systems to manned planetary surface base missions was conducted. The purpose of the study was to identify and assess the technology, performance, and safety issues associated with integration of reactor power systems with an evolutionary manned planetary surface exploration scenario. The requirements and characteristics of a variety of human-rated modular reactor power system configurations selected for a range of power levels from 25 kWe to hundreds of kilowatts is described. Trade-off analyses for reactor power systems utilizing both man-made and indigenous shielding materials are provided to examine performance, installation and operational safety feasibility issues. The results of this study have confirmed the preliminary feasibility of a wide variety of small reactor power plant configurations for growth oriented manned planetary surface exploration missions. The capability for power level growth with increasing manned presence, while maintaining safe radiation levels, was favorably assessed for nominal 25 to 100 kWe modular configurations. No feasibility limitations or technical barriers were identified and the use of both distance and indigenous planetary soil material for human rated radiation shielding were shown to be viable and attractive options.

On modeling human reliability in space flights - Redundancy and recovery operations

NASA Astrophysics Data System (ADS)

Aarset, M.; Wright, J. F.

The reliability of humans is of paramount importance to the safety of space flight systems. This paper describes why 'back-up' operators might not be the best solution, and in some cases, might even degrade system reliability. The problem associated with human redundancy calls for special treatment in reliability analyses. The concept of Standby Redundancy is adopted, and psychological and mathematical models are introduced to improve the way such problems can be estimated and handled. In the past, human reliability has practically been neglected in most reliability analyses, and, when included, the humans have been modeled as a component and treated numerically the way technical components are. This approach is not wrong in itself, but it may lead to systematic errors if too simple analogies from the technical domain are used in the modeling of human behavior. In this paper redundancy in a man-machine system will be addressed. It will be shown how simplification from the technical domain, when applied to human components of a system, may give non-conservative estimates of system reliability.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

PubMed

Makam, Raghavendra Charan P; Hoaglin, David C; McManus, David D; Wang, Victoria; Gore, Joel M; Spencer, Frederick A; Pradhan, Richeek; Tran, Hoang; Yu, Hong; Goldberg, Robert J

2018-01-01

Direct oral anticoagulants (DOACs) have emerged as promising alternatives to vitamin K antagonists (VKAs) for patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs. We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE. Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR) 0.76, 95% Confidence Interval (CI) (0.68-0.84)], any stroke (0.80, 0.73-0.88), systemic embolism (0.56, 0.34-0.93), and total mortality (0.89, 0.84-0.95). Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB). Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03), recurrent DVT (0.83, 0.66-1.05), recurrent non-fatal PE (0.97, 0.75-1.25), and total mortality (0.94, 0.79-1.12). Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB. Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

Addressing Unison and Uniqueness of Reliability and Safety for Better Integration

NASA Technical Reports Server (NTRS)

Huang, Zhaofeng; Safie, Fayssal

2015-01-01

For a long time, both in theory and in practice, safety and reliability have not been clearly differentiated, which leads to confusion, inefficiency, and sometime counter-productive practices in executing each of these two disciplines. It is imperative to address the uniqueness and the unison of these two disciplines to help both disciplines become more effective and to promote a better integration of the two for enhancing safety and reliability in our products as an overall objective. There are two purposes of this paper. First, it will investigate the uniqueness and unison of each discipline and discuss the interrelationship between the two for awareness and clarification. Second, after clearly understanding the unique roles and interrelationship between the two in a product design and development life cycle, we offer suggestions to enhance the disciplines with distinguished and focused roles, to better integrate the two, and to improve unique sets of skills and tools of reliability and safety processes. From the uniqueness aspect, the paper identifies and discusses the respective uniqueness of reliability and safety from their roles, accountability, nature of requirements, technical scopes, detailed technical approaches, and analysis boundaries. It is misleading to equate unreliable to unsafe, since a safety hazard may or may not be related to the component, sub-system, or system functions, which are primarily what reliability addresses. Similarly, failing-to-function may or may not lead to hazard events. Examples will be given in the paper from aerospace, defense, and consumer products to illustrate the uniqueness and differences between reliability and safety. From the unison aspect, the paper discusses what the commonalities between reliability and safety are, and how these two disciplines are linked, integrated, and supplemented with each other to accomplish the customer requirements and product goals. In addition to understanding the uniqueness in reliability and safety, a better understanding of unison and commonalities will further help in understanding the interaction between reliability and safety. This paper discusses the unison and uniqueness of reliability and safety. It presents some suggestions for better integration of the two disciplines in terms of technical approaches, tools, techniques, and skills to enhance the role of reliability and safety in supporting a product design and development life cycle. The paper also discusses eliminating the redundant effort and minimizing the overlap of reliability and safety analyses for an efficient implementation of the two disciplines.

Comparisons of Wilks’ and Monte Carlo Methods in Response to the 10CFR50.46(c) Proposed Rulemaking

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

Zhang, Hongbin; Szilard, Ronaldo; Zou, Ling

The Nuclear Regulatory Commission (NRC) is proposing a new rulemaking on emergency core system/loss-of-coolant accident (LOCA) performance analysis. In the proposed rulemaking, designated as 10CFR50.46(c), the US NRC put forward an equivalent cladding oxidation criterion as a function of cladding pre-transient hydrogen content. The proposed rulemaking imposes more restrictive and burnup-dependent cladding embrittlement criteria; consequently nearly all the fuel rods in a reactor core need to be analyzed under LOCA conditions to demonstrate compliance to the safety limits. New analysis methods are required to provide a thorough characterization of the reactor core in order to identify the locations of themore » limiting rods as well as to quantify the safety margins under LOCA conditions. With the new analysis method presented in this work, the limiting transient case and the limiting rods can be easily identified to quantify the safety margins in response to the proposed new rulemaking. In this work, the best-estimate plus uncertainty (BEPU) analysis capability for large break LOCA with the new cladding embrittlement criteria using the RELAP5-3D code is established and demonstrated with a reduced set of uncertainty parameters. Both the direct Monte Carlo method and the Wilks’ nonparametric statistical method can be used to perform uncertainty quantification. Wilks’ method has become the de-facto industry standard to perform uncertainty quantification in BEPU LOCA analyses. Despite its widespread adoption by the industry, the use of small sample sizes to infer statement of compliance to the existing 10CFR50.46 rule, has been a major cause of unrealized operational margin in today’s BEPU methods. Moreover the debate on the proper interpretation of the Wilks’ theorem in the context of safety analyses is not fully resolved yet, even more than two decades after its introduction in the frame of safety analyses in the nuclear industry. This represents both a regulatory and application risk in rolling out new methods. With the 10CFR50.46(c) proposed rulemaking, the deficiencies of the Wilks’ approach are further exacerbated. The direct Monte Carlo approach offers a robust alternative to perform uncertainty quantification within the context of BEPU analyses. In this work, the Monte Carlo method is compared with the Wilks’ method in response to the NRC 10CFR50.46(c) proposed rulemaking.« less

[ISMP-Spain questionnaire and strategy for improving good medication practices in the Andalusian health system].

PubMed

Padilla-Marín, V; Corral-Baena, S; Domínguez-Guerrero, F; Santos-Rubio, M D; Santana-López, V; Moreno-Campoy, E

2012-01-01

To describe the strategy employed by Andalusian public health service hospitals to foster safe medication use. The self-evaluation questionnaire on drug system safety in hospitals, adapted by the Spanish Institute for Safe Medication Practices was used as a fundamental tool to that end. The strategy is developed in several phases. We analyse the report evaluating drug system safety in Andalusian public hospitals published by the Spanish Ministry of Health and Consumption in 2008 and establish a grading system to assess safe medication practices in Andalusian hospitals and prioritise areas needing improvement. We developed a catalogue of best practices available in the web environment belonging to the Andalusian health care quality agency's patient safety observatory. We publicised the strategy through training seminars and implemented a system allowing hospitals to evaluate the degree of compliance for each of the best practices, and based on that system, we were able to draw up a map of centres of reference. We found areas for improvement among several of the questionnaire's fundamental criteria. These areas for improvement were related to normal medication procedures in daily clinical practice. We therefore wrote 7 best practice guides that provide a cross-section of the assessment components of the questionnaire related to the clinical process needing improvement. The self-evaluation questionnaire adapted by ISMP-Spain is a good tool for designing a systematic, rational intervention to promote safe medication practices and intended for a group of hospitals that share the same values. Copyright © 2011 SEFH. Published by Elsevier Espana. All rights reserved.

Cohort study comparing prostate photovaporisation with XPS 180W and HPS 120W laser.

PubMed

López, B; Capitán, C; Hernández, V; de la Peña, E; Jiménez-Valladolid, I; Guijarro, A; Pérez-Fernández, E; Llorente, C

2016-01-01

Prostate photovaporisation with Greenlight laser for the surgical treatment of benign prostate hyperplasia has rapidly evolve to the new XPS 180W. We have previously demonstrated the safety and efficacy of the HPS 120W. The aim of this study was to assess the functional and safety results, with a year of follow-up, of photovaporisation using the XPS 180W laser compared with its predecessor. A cohort study was conducted with a series of 191 consecutive patients who underwent photovaporisation between 1/2008 and 5/2013. The inclusion criteria were an international prostate symptom score (IPSS) >15 after medical failure, a prostate volume <80 cm(3) and a maximum flow <15 mL/s. We assessed preoperative and intraoperative variables (energy used, laser time and total surgical time), complications, catheter hours, length of stay and functional results (maximum flow, IPSS, prostate-specific antigen and prostate volume) at 3, 6 and 12 months. We analysed the homogeneity in preoperative characteristics of the 2 groups through univariate analysis techniques. The postoperative functional results were assessed through an analysis of variance of repeated measures with mixed models. A total of 109 (57.1%) procedures were performed using HPS 120W, and 82 (42.9%) were performed using XPS. There were no differences between the preoperative characteristics. We observed significant differences both in the surgical time and effective laser time in favour of the XPS system. This advantage was 11% (48 ± 15.7 vs. 53.8 ± 16.2, p<.05) and 9% (32.8 ± 11.7 vs. 36 ± 11.6, p<.05), respectively. There were no statistically significant differences in the rest of the analysed parameters. The technical improvements in the XPS 180W system help reduce surgical time, maintaining the safety and efficacy profile offered by the HPS 120W system, with completely superimposable results at 1 year of follow-up. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Association of perceived neighborhood characteristics, socioeconomic status and rural residency with health outcomes in Egyptian patients with systemic lupus erythematosus: one center study.

PubMed

Abdul-Sattar, Amal B; Abou El Magd, Sahar

2017-12-01

To investigate the role of perceived neighborhood characteristics, socioeconomic status (SES) and rural residency in influencing the health status outcome of Egyptian patients with systemic lupus erythematosus (SLE). Eighty patients affected with SLE were consecutively included in this a single-center cross-sectional study from July, 2011 to July, 2013. Outcome measures included the Systemic Lupus Activity Questionnaire (SLAQ) score, the Medical Outcomes Study Short Form-36 Health Survey physical functioning score and Center for Epidemiologic Studies-Depression (CES-D score of ≥ 19 points). Multivariate logistic regression analyses were conducted. Results from multivariate logistic regression analyses, a separate adjusted model of each perceived neighborhood characteristic, indicate associations of worse perceived social cohesion with higher SLAQ scores (P < 0.01) and associations of worse perceived neighborhood aesthetics and safety with lower SF-36 physical functioning scores after adjusting for covariates (P < 0.01). Regarding the association of socioeconomic status and rural residency with health status outcomes, the results found association of poor socioeconomic status with the three health status outcome measures and association between rural residency and depression symptoms. Individuals had increased odds of depressive symptoms if they perceived worse neighborhood social cohesion (odds ratio [OR]: 2.14; CI: 1.42-2.80), if they perceived worse neighborhood safety (OR: 1.64; CI: 1.02-2.40) and if they perceived worse neighborhood aesthetic characteristics (OR: 2.79; CI: 1.84-3.38). Study findings indicate that poor socioeconomic status, rural residency and perceived neighborhood characteristics are associated with depression; worse perceived neighborhood aesthetics and safety are associated with lower SF-36 physical functioning, and worse neighborhood social cohesion is associated with higher disease activity among patients with SLE. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

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

NASA Technical Reports Server (NTRS)

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

2012-01-01

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

Understanding the Link between Social Organization and Crime in Rural Communities

PubMed Central

Chilenski, Sarah M.; Syvertsen, Amy K.; Greenberg, Mark T.

2015-01-01

Rural communities make up much of America's heartland, yet we know little about their social organization, and how elements of their social organization relate to crime rates. The current study sought to remedy this gap by examining the associations between two measures of social organization – collective efficacy and social trust – with a number of structural community characteristics, local crime rates, and perceptions of safety in a sample of 27 rural and small town communities in two states. Measures of collective efficacy, social trust, and perceived safety, were gathered from key community members in 2006; other measures were drawn from the 2000 Census and FBI Uniform Crime Reporting system. A series of competing hypotheses were tested to examine the relative importance of social trust and collective efficacy in predicting local crime rates. Results do not support the full generalization of the social disorganization model. Correlational analyses showed that neither collective efficacy nor social trust had a direct association with community crime, nor did they mediate the associations between community structural characteristics and crime. However, perceived safety mediated the association between community crime and both measures of social organization. Analyses suggest that social trust may be more important than collective efficacy when understanding the effect of crime on a community's culture in rural areas. Understanding these associations in rural settings can aid decision makers in shaping policies to reduce crime and juvenile delinquency. PMID:26120326

Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system).

PubMed

Arenas Jiménez, María Dolores; Ferre, Gabriel; Álvarez-Ude, Fernando

Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

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

PubMed

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

2018-06-01

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

Safety effects of unsignalized superstreets in North Carolina.

PubMed

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

2012-03-01

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

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

PubMed

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

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

Study on the Influence of Elevation of Tailing Dam on Stability

NASA Astrophysics Data System (ADS)

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

2017-12-01

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

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

DOT National Transportation Integrated Search

2001-10-01

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

Opportunities for improved diabetes care among patients of safety net practices: a safety net providers' strategic alliance study.

PubMed

Reichsman, Ann; Werner, James; Cella, Peggi; Bobiak, Sarah; Stange, Kurt C

2009-01-01

To identify barriers and opportunities for quality diabetes care in safety net practices. In 3 federally qualified health centers and 1 free clinic, 19 primary care clinicians profiled patient and visit characteristics and quality of care measures for 181 consecutive visits by adult type 2 diabetic patients. Open-ended questions assessed patient and clinician perception of barriers to diabetes care and patient report of enabling factors. A multidisciplinary team identified themes from open-ended responses. Logistic regression analyses assessed the association of the identified barriers/enablers with 2 measures of quality care: glycosylated hemoglobin and prophylactic aspirin use. Ranked barriers noted by patients included adherence (40%), financial/insurance (23%), and psychosocial (13%) factors. Clinicians ranked systemic factors, including financial/ insurance (32%) and cultural/psychosocial (29%) factors, as important to adherence (29%) in determining quality diabetes care. Patients reported dietary and medical adherence (37%) and family/health care worker support (17%) as helpful factors. Among 175 patients with available data, glycosylated hemoglobin levels were associated with patient report of financial/insurance factors both as a barrier when visits and medications were unaffordable and as an opportunity when free or low-cost medications and services were provided. Patients' adherence with aspirin prophylaxis was strongly associated with African American race, prior prescription of aspirin and distribution of aspirin at the practice site (p<.001). Patients were less likely than clinicians to identify systemic and contextual factors contributing to poor diabetes care. From the front line's perspective, enabling patient self-management and systemic support is a target for improving diabetes care in safety net practices.

The Necessity of Functional Analysis for Space Exploration Programs

NASA Technical Reports Server (NTRS)

Morris, A. Terry; Breidenthal, Julian C.

2011-01-01

As NASA moves toward expanded commercial spaceflight within its human exploration capability, there is increased emphasis on how to allocate responsibilities between government and commercial organizations to achieve coordinated program objectives. The practice of program-level functional analysis offers an opportunity for improved understanding of collaborative functions among heterogeneous partners. Functional analysis is contrasted with the physical analysis more commonly done at the program level, and is shown to provide theoretical performance, risk, and safety advantages beneficial to a government-commercial partnership. Performance advantages include faster convergence to acceptable system solutions; discovery of superior solutions with higher commonality, greater simplicity and greater parallelism by substituting functional for physical redundancy to achieve robustness and safety goals; and greater organizational cohesion around program objectives. Risk advantages include avoidance of rework by revelation of some kinds of architectural and contractual mismatches before systems are specified, designed, constructed, or integrated; avoidance of cost and schedule growth by more complete and precise specifications of cost and schedule estimates; and higher likelihood of successful integration on the first try. Safety advantages include effective delineation of must-work and must-not-work functions for integrated hazard analysis, the ability to formally demonstrate completeness of safety analyses, and provably correct logic for certification of flight readiness. The key mechanism for realizing these benefits is the development of an inter-functional architecture at the program level, which reveals relationships between top-level system requirements that would otherwise be invisible using only a physical architecture. This paper describes the advantages and pitfalls of functional analysis as a means of coordinating the actions of large heterogeneous organizations for space exploration programs.

The magnetic navigation system allows safety and high efficacy for ablation of arrhythmias

PubMed Central

Bauernfeind, Tamas; Akca, Ferdi; Schwagten, Bruno; de Groot, Natasja; Van Belle, Yves; Valk, Suzanne; Ujvari, Barbara; Jordaens, Luc; Szili-Torok, Tamas

2011-01-01

Aims We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities. Methods and results In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15 ± 9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P = 0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P = 0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P = ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P < 0.05). Less fluoroscopy was used in group MNS (30 ± 20 vs. 35 ± 25 min, P < 0.01). There were no differences in procedure times and recurrence rates for the overall groups (168 ± 67 vs. 159 ± 75 min, P = ns; 14 vs. 11%, P = ns; respectively). Conclusions Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs. PMID:21508006

Systemic antifungals to treat onychomycosis in children: a systematic review.

PubMed

Gupta, Aditya K; Paquet, Maryse

2013-01-01

Because of the low prevalence of onychomycosis in children, little is known about the efficacy and safety of systemic antifungals in this population. PubMed and Embase databases and the references of related publications were searched in March 2012 for clinical trials (CTs), retrospective analyses (RAs), and case reports (CRs) on the use of systemic antifungals for onychomycosis in children (<18 years). Twenty-six studies (5 CTs, 3 RAs, and 18 CRs) were published between 1976 and 2011. Most of these studies reported the use of systemic terbinafine and itraconazole for the treatment of onychomycosis in children. Therapy with systemic antifungals alone in children ages 1 to 17 years resulted in a complete cure rate of 70.8% (n = 151), whereas combined systemic and topical antifungal therapy in one infant and 19 children age 8 and older resulted in a complete cure rate of 80.0% (n = 20). The efficacy and safety profiles of terbinafine, itraconazole, griseofulvin, and fluconazole in children were similar to those previously reported for adults. In conclusion, based on the little information available on onychomycosis in children, systemic antifungal therapies in children are safe and cure rates are similar to the rates achieved in adults. © 2012 Wiley Periodicals, Inc.

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

PubMed

Pozo Muñoz, F; Padilla Marín, V

2013-01-01

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

Hybrid propulsion technology program: Phase 1. Volume 3: Thiokol Corporation Space Operations

NASA Technical Reports Server (NTRS)

Schuler, A. L.; Wiley, D. R.

1989-01-01

Three candidate hybrid propulsion (HP) concepts were identified, optimized, evaluated, and refined through an iterative process that continually forced improvement to the systems with respect to safety, reliability, cost, and performance criteria. A full scale booster meeting Advanced Solid Rocket Motor (ASRM) thrust-time constraints and a booster application for 1/4 ASRM thrust were evaluated. Trade studies and analyses were performed for each of the motor elements related to SRM technology. Based on trade study results, the optimum HP concept for both full and quarter sized systems was defined. The three candidate hybrid concepts evaluated are illustrated.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

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

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement. Results will be disseminated to study participants as well as through peer-reviewed outputs. PMID:24833698

Patient safety culture and associated factors: A quantitative and qualitative study of healthcare workers' view in Jimma zone Hospitals, Southwest Ethiopia.

PubMed

Wami, Sintayehu Daba; Demssie, Amsalu Feleke; Wassie, Molla Mesele; Ahmed, Ansha Nega

2016-09-20

Patient safety culture is an important aspect for quality healthcare delivery and is an issue of high concern globally. In Ethiopia health system little is known and information is limited in scope about patient safety culture. Therefore, the aim of this study was to assess the level of patient safety culture and associated factors in Jimma zone Hospitals, southwest Ethiopia. Facility based cross sectional quantitative study triangulated with qualitative approaches was employed from March to April 30/2015. Stratified sampling technique was used to select 637 study participants among 4 hospitals. The standardized tool which measures 12 patient safety culture composites was used for data collection. Bivariate and multivariate linear regression analyses were performed using SPSS version 20. Significance level was obtained at 95 % CI and p-value < 0.05. Semi structured guide in depth interview was used to collect the qualitative data. Content analysis of the interview was performed. The overall level of patient safety culture was 46.7 % (95 % CI: 43.0, 51.2). Hours worked per week (β =-0.06, 95 % CI:-0.12,-0.001), reporting adverse event (β = 3.34, 95 % CI: 2.12, 4.57), good communication (β = 2.78, 95 % CI: 2.29, 3.28), teamwork within hospital (β = 1.91, 95 % CI: 1.37, 2.46), level of staffing (β = 1.32, 95 % CI: 0.89, 1.75), exchange of feedback about error (β = 1.37, 95 % CI: 0.91, 1.83) and participation in patient safety program (β = 1.3, 95 % CI: 0.57, 2.03) were factors significantly associated with the patient safety culture. The in depth interview indicated incident reporting, resources, healthcare worker attitude and patient involvement as important factors that influence patient safety culture. The overall level of patient safety culture was low. Working hours, level of staffing, teamwork, communications openness, reporting an event and exchange of feedback about error were associated with patient safety culture. Therefore, interventions of systemic approach through facilitating opportunities for communication openness, cooperation and exchange of ideas between healthcare workers are needed to improve the level of patient safety culture.

MELCOR Analysis of OSU Multi-Application Small Light Water Reactor (MASLWR) Experiment

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

Yoon, Dhongik S.; Jo, HangJin; Fu, Wen

A multi-application small light water reactor (MASLWR) conceptual design was developed by Oregon State University (OSU) with emphasis on passive safety systems. The passive containment safety system employs condensation and natural circulation to achieve the necessary heat removal from the containment in case of postulated accidents. Containment condensation experiments at the MASLWR test facility at OSU are modeled and analyzed with MELCOR, a system-level reactor accident analysis computer code. The analysis assesses its ability to predict condensation heat transfer in the presence of noncondensable gas for accidents where high-energy steam is released into the containment. This work demonstrates MELCOR’s abilitymore » to predict the pressure-temperature response of the scaled containment. Our analysis indicates that the heat removal rates are underestimated in the experiment due to the limited locations of the thermocouples and applies corrections to these measurements by conducting integral energy analyses along with CFD simulation for confirmation. Furthermore, the corrected heat removal rate measurements and the MELCOR predictions on the heat removal rate from the containment show good agreement with the experimental data.« less

Hybrid propulsion technology program: Phase 1, volume 2

NASA Technical Reports Server (NTRS)

Schuler, A. L.; Wiley, D. R.

1989-01-01

The program objectives of developing hybrid propulsion technology (HPT) to enable its application for manned and unmanned high thrust, high performance space launch vehicles are examined. The studies indicate that the hybrid propulsion (HP) is very attractive, especially when applied to large boosters for programs such as the Advanced Launch System (ALS) and the second generation Space Shuttle. Some of the advantages of HP are identified. Space launch vehicles using HP are less costly than those flying today because their propellant and insulation costs are much less and there are fewer operational restraints due to reduced safety requirements. Boosters using HP have safety features that are highly desirable, particularly for manned flights. HP systems will have a clean exhaust and high performance. Boosters using HP readily integrate with launch vehicles and their launch operations, because they are very compact for the amount of energy contained. Hybrid propulsion will increase the probability of mission success. In order to properly develop the technologies of HP, preliminary HP concepts are evaluated. System analyses and trade studies were performed to identify technologies applicable to HP.

MELCOR Analysis of OSU Multi-Application Small Light Water Reactor (MASLWR) Experiment

DOE PAGES

Yoon, Dhongik S.; Jo, HangJin; Fu, Wen; ...

2017-05-23

A multi-application small light water reactor (MASLWR) conceptual design was developed by Oregon State University (OSU) with emphasis on passive safety systems. The passive containment safety system employs condensation and natural circulation to achieve the necessary heat removal from the containment in case of postulated accidents. Containment condensation experiments at the MASLWR test facility at OSU are modeled and analyzed with MELCOR, a system-level reactor accident analysis computer code. The analysis assesses its ability to predict condensation heat transfer in the presence of noncondensable gas for accidents where high-energy steam is released into the containment. This work demonstrates MELCOR’s abilitymore » to predict the pressure-temperature response of the scaled containment. Our analysis indicates that the heat removal rates are underestimated in the experiment due to the limited locations of the thermocouples and applies corrections to these measurements by conducting integral energy analyses along with CFD simulation for confirmation. Furthermore, the corrected heat removal rate measurements and the MELCOR predictions on the heat removal rate from the containment show good agreement with the experimental data.« less

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

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

Computer Aided Method for System Safety and Reliability Assessments

DTIC Science & Technology

2008-09-01

program between 1998 and 2003. This tool was not marketed in the public domain after the CRV program ended. The other tool is called eXpress, and it...support Government reviewed and approved analyses methodologies which can 5 then be shared with other government agencies and industry partners...Documented for B&R, UP&L, EPRI 30 DEC 80 GO IBM Version Enhanced at UCC , Dallas, Descriptors, Facility to Alter Array Sizes, Explanation of Use 1 SEP 82

Attitudes toward the large-scale implementation of an incident reporting system.

PubMed

Braithwaite, Jeffrey; Westbrook, Mary; Travaglia, Joanne

2008-06-01

An electronic Incident Information Management System implemented system-wide by the Department of Health, New South Wales, Australia was evaluated. We hypothesized that health professionals (i) would support the system via utilization and favourable attitudes and (ii) that their usage and attitudes would vary according to profession with nurses being most, and doctors least, favourably disposed. An online, anonymous questionnaire survey of 2185 health practitioners. Undertaking system training, satisfaction with training, reporting incidents, incident reporting rates since system introduction and attitude questions focusing on use, security and evaluation of the system and workplace safety cultures. The first hypothesis received partial support. The majority of respondents had undertaken training and rated it highly. Most had reported incidents and maintained their previous reporting levels. Most attitudes regarding using the system and its security were favourable. Mixed attitudes were held about workplace safety cultures and the value of the system. Deficiencies in quality of reporting, feedback on incident reports and resources to analyse incident data were problems identified. The second hypothesis was confirmed. Nurses were most, and doctors least, likely to undertake training, report incidents and express favourable attitudes. Allied health responses were intermediate to those of the other professions. The system implementation was relatively successful, but more so with some professions. Problems identified indicated that expectations as to the goals achievable in the short term were optimistic, but these are amenable to planned interventions.

Analysis of Operational Hazards and Safety Requirements for Traffic Aware Strategic Aircrew Requests (TASAR)

NASA Technical Reports Server (NTRS)

Koczo, Stefan, Jr.

2013-01-01

Safety analyses of the Traffic Aware Strategic Aircrew Requests (TASAR) Electronic Flight Bag (EFB) application are provided to establish its Failure Effects Classification which affects certification and operational approval requirements. TASAR was developed by NASA Langley Research Center to offer flight path improvement opportunities to the pilot during flight for operational benefits (e.g., reduced fuel, flight time). TASAR, using own-ship and network-enabled information concerning the flight and its environment, including weather and Air Traffic Control (ATC) system constraints, provides recommended improvements to the flight trajectory that the pilot can choose to request via Change Requests to ATC for revised clearance. This study reviews the Change Request process of requesting updates to the current clearance, examines the intended function of TASAR, and utilizes two safety assessment methods to establish the Failure Effects Classification of TASAR. Considerable attention has been given in this report to the identification of operational hazards potentially associated with TASAR.

Systemic safety project selection tool.

DOT National Transportation Integrated Search

2013-07-01

"The Systemic Safety Project Selection Tool presents a process for incorporating systemic safety planning into traditional safety management processes. The Systemic Tool provides a step-by-step process for conducting systemic safety analysis; conside...

Vehicle familiarity and safety

DOT National Transportation Integrated Search

1983-07-01

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

APMS: An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Lynch, Robert E.; Connors, Mary M. (Technical Monitor)

1997-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

APMS: An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C. (Technical Monitor)

1997-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions . APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

APMS: An Integrated Set of Tools for Measuring Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Reynard, William D. (Technical Monitor)

1996-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

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

ERIC Educational Resources Information Center

Cooper, M. Dominic

2006-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-23

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

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

DOT National Transportation Integrated Search

2001-10-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-11-01

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

Patient Safety Outcomes in Small Urban and Small Rural Hospitals

ERIC Educational Resources Information Center

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

2010-01-01

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

Chemical plant innovative safety investments decision-support methodology.

PubMed

Reniers, G L L; Audenaert, A

2009-01-01

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

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

PubMed

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

2017-12-18

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

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

NASA Technical Reports Server (NTRS)

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

2008-01-01

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

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The safety management system must document the responsible person's— (1) Safety and pollution prevention...

Chlamydia trachomatis infection: the efficacy and safety of a fast-track referral and treatment system.

PubMed

Sethupathi, M; Blackwell, A

2009-03-01

We introduced a Nurse/Health Advisor-led fast-track service for treating patients diagnosed with chlamydia outside a genitourinary medicine setting and contacts of chlamydia/non-specific urethritis/cervicitis wherever diagnosed. Asymptomatic patients were treated without initial testing and asked to return for full screening at four to six weeks. We assessed the efficacy and safety of the system and need for follow-up after treatment. Case-notes of 226 patients (121 men and 105 women) were analysed, of whom 140 attended follow-up. With the exception of one case of gonorrhoea, no other serious sexually transmitted infection was detected. Twenty-seven (19.2%) patients were re-treated for either chlamydia (six patients, 4.4%) or non-specific genital infection or because of having unprotected intercourse with untreated or partially treated partners. We conclude that in our relatively low-risk population, our fast-track service is safe and effective. Test of cure for chlamydia seems essential because of the high percentage of patients requiring re-treatment.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

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

Are root cause analyses recommendations effective and sustainable? An observational study.

PubMed

Hibbert, Peter D; Thomas, Matthew J W; Deakin, Anita; Runciman, William B; Braithwaite, Jeffrey; Lomax, Stephanie; Prescott, Jonathan; Gorrie, Glenda; Szczygielski, Amy; Surwald, Tanja; Fraser, Catherine

2018-03-01

To assess the strength of root cause analysis (RCA) recommendations and their perceived levels of effectiveness and sustainability. All RCAs related to sentinel events (SEs) undertaken between the years 2010 and 2015 in the public health system in Victoria, Australia were analysed. The type and strength of each recommendation in the RCA reports were coded by an expert patient safety classifier using the US Department of Veteran Affairs type and strength criteria. Thirty-six public health services. The proportion of RCA recommendations which were classified as 'strong' (more likely to be effective and sustainable), 'medium' (possibly effective and sustainable) or 'weak' (less likely to be effective and sustainable). There were 227 RCAs in the period of study. In these RCAs, 1137 recommendations were made. Of these 8% were 'strong', 44% 'medium' and 48% were 'weak'. In 31 RCAs, or nearly 15%, only weak recommendations were made. In 24 (11%) RCAs five or more weak recommendations were made. In 165 (72%) RCAs no strong recommendations were made. The most frequent recommendation types were reviewing or enhancing a policy/guideline/documentation, and training and education. Only a small proportion of recommendations arising from RCAs in Victoria are 'strong'. This suggests that insights from the majority of RCAs are not likely to inform practice or process improvements. Suggested improvements include more human factors expertise and independence in investigations, more extensive application of existing tools that assist teams to prioritize recommendations that are likely to be effective, and greater use of observational and simulation techniques to understand the underlying systems factors. Time spent in repeatedly investigating similar incidents may be better spent aggregating and thematically analysing existing sources of information about patient safety.

What do you feel if I apply transcranial electric stimulation? Safety, sensations and secondary induced effects.

PubMed

Fertonani, Anna; Ferrari, Clarissa; Miniussi, Carlo

2015-11-01

The goals of this work are to report data regarding a large number of stimulation sessions and to use model analyses to explain the similarities or differences in the sensations induced by different parameters of tES application. We analysed sensation data relative to 693 different tES sessions. In particular, we studied the effects on sensations induced by different types of current, categories of polarity and frequency, different timing, levels of current density and intensity, different electrode sizes and different electrode locations (areas). The application of random or fixed alternating current stimulation (i.e., tRNS and tACS) over the scalp induced less sensation compared with transcranial direct current stimulation (tDCS), regardless of the application parameters. Moreover, anodal tDCS induced more annoyance in comparison to other tES. Additionally, larger electrodes induced stronger sensations compared with smaller electrodes, and higher intensities were more strongly perceived. Timing of stimulation, montage and current density did not influence sensations perception. The analyses demonstrated that the induced sensations could be clustered on the basis of the type of somatosensory system activated. Finally and most important no adverse events were reported. Induced sensations are modulated by electrode size and intensity and mainly pertain to the cutaneous receptor activity of the somatosensory system. Moreover, the procedure currently used to perform placebo stimulation may not be totally effective when compared with anodal tDCS. The reported observations enrich the literature regarding the safety aspects of tES, confirming that it is a painless and safe technique. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Livestock production systems in developing countries: status, drivers, trends.

PubMed

Steinfeld, H; Wassenaar, T; Jutzi, S

2006-08-01

This paper describes and assesses the current status of livestock production systems, the drivers of global livestock production, and the major trends in such production. The analysis covers the six major livestock species: cattle and buffaloes, goats and sheep, pigs and chickens. Global drivers of the livestock sector include economic growth and income, demographic and land use changes, dietary adjustments and technological change. The rate of change and direction of livestock development vary greatly among world regions, with Asia showing the most rapid growth and structural change. The paper also examines system dynamics, by analysing the ways livestock production has adjusted to external forces. A brief discussion of how these trends link to food safety concludes the paper.

Graphics enhanced computer emulation for improved timing-race and fault tolerance control system analysis. [of Centaur liquid-fuel booster

NASA Technical Reports Server (NTRS)

Szatkowski, G. P.

1983-01-01

A computer simulation system has been developed for the Space Shuttle's advanced Centaur liquid fuel booster rocket, in order to conduct systems safety verification and flight operations training. This simulation utility is designed to analyze functional system behavior by integrating control avionics with mechanical and fluid elements, and is able to emulate any system operation, from simple relay logic to complex VLSI components, with wire-by-wire detail. A novel graphics data entry system offers a pseudo-wire wrap data base that can be easily updated. Visual subsystem operations can be selected and displayed in color on a six-monitor graphics processor. System timing and fault verification analyses are conducted by injecting component fault modes and min/max timing delays, and then observing system operation through a red line monitor.

Application of reliability-centered-maintenance to BWR ECCS motor operator valve performance

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

Feltus, M.A.; Choi, Y.A.

1993-01-01

This paper describes the application of reliability-centered maintenance (RCM) methods to plant probabilistic risk assessment (PRA) and safety analyses for four boiling water reactor emergency core cooling systems (ECCSs): (1) high-pressure coolant injection (HPCI); (2) reactor core isolation cooling (RCIC); (3) residual heat removal (RHR); and (4) core spray systems. Reliability-centered maintenance is a system function-based technique for improving a preventive maintenance program that is applied on a component basis. Those components that truly affect plant function are identified, and maintenance tasks are focused on preventing their failures. The RCM evaluation establishes the relevant criteria that preserve system function somore » that an RCM-focused approach can be flexible and dynamic.« less

Impact of patient outcomes and cost aspects on reimbursement recommendations in Poland in 2012-2014.

PubMed

Malinowski, Krzysztof Piotr; Kawalec, Paweł; Trąbka, Wojciech

2016-11-01

The aim of this study was to assess the influence of different factors on the final reimbursement recommendations for drugs in Poland and to identify the correlation between these factors and the probability of a positive reimbursement recommendation for an applicant drug issued by the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT). We analysed all recommendations for the period of 2012-2014 in Poland, three years following the launch of the new Reimbursement Act of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices. For each recommendation we collected data on efficacy, safety, cost of therapy, cost-effectiveness, quality of evidence, orphan drug status and others. Logistic regression was used to identify factors that increase the odds of a positive reimbursement recommendation. We analysed 221 recommendations for drugs, of which 78% were positive. We observed significant associations of all selected factors with positive recommendations. Proven efficacy and safety were associated with much greater odds for a positive reimbursement recommendation (123.5 and 42.6, respectively) than cost factors, which may suggest that patient outcome is much more important than the results of the cost-effectiveness analysis (odds ratio of 3.5) and the general cost of therapy (odds ratio of 3) in the analysed period. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Safer Systems: A NextGen Aviation Safety Strategic Goal

NASA Technical Reports Server (NTRS)

Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

2008-01-01

The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

Modelling safety of multistate systems with ageing components

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

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

Legislative history of recent primary safety belt laws

DOT National Transportation Integrated Search

1999-01-01

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

Automatic Analysis of Critical Incident Reports: Requirements and Use Cases.

PubMed

Denecke, Kerstin

2016-01-01

Increasingly, critical incident reports are used as a means to increase patient safety and quality of care. The entire potential of these sources of experiential knowledge remains often unconsidered since retrieval and analysis is difficult and time-consuming, and the reporting systems often do not provide support for these tasks. The objective of this paper is to identify potential use cases for automatic methods that analyse critical incident reports. In more detail, we will describe how faceted search could offer an intuitive retrieval of critical incident reports and how text mining could support in analysing relations among events. To realise an automated analysis, natural language processing needs to be applied. Therefore, we analyse the language of critical incident reports and derive requirements towards automatic processing methods. We learned that there is a huge potential for an automatic analysis of incident reports, but there are still challenges to be solved.

Safety of ceftriaxone in paediatrics: a systematic review protocol.

PubMed

Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

2017-08-21

Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Achievements in the development of the Water Cooled Solid Breeder Test Blanket Module of Japan to the milestones for installation in ITER

NASA Astrophysics Data System (ADS)

Tsuru, Daigo; Tanigawa, Hisashi; Hirose, Takanori; Mohri, Kensuke; Seki, Yohji; Enoeda, Mikio; Ezato, Koichiro; Suzuki, Satoshi; Nishi, Hiroshi; Akiba, Masato

2009-06-01

As the primary candidate of ITER Test Blanket Module (TBM) to be tested under the leadership of Japan, a water cooled solid breeder (WCSB) TBM is being developed. This paper shows the recent achievements towards the milestones of ITER TBMs prior to the installation, which consist of design integration in ITER, module qualification and safety assessment. With respect to the design integration, targeting the detailed design final report in 2012, structure designs of the WCSB TBM and the interfacing components (common frame and backside shielding) that are placed in a test port of ITER and the layout of the cooling system are presented. As for the module qualification, a real-scale first wall mock-up fabricated by using the hot isostatic pressing method by structural material of reduced activation martensitic ferritic steel, F82H, and flow and irradiation test of the mock-up are presented. As for safety milestones, the contents of the preliminary safety report in 2008 consisting of source term identification, failure mode and effect analysis (FMEA) and identification of postulated initiating events (PIEs) and safety analyses are presented.

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

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

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

Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark.

PubMed

Aagaard, Lise; Stenver, Doris Irene; Hansen, Ebba Holme

2008-10-01

To explore the organisational structure and processes of the Danish and Australian spontaneous ADR reporting systems with a view to how information is generated about new ADRs. The Danish and Australian spontaneous ADR reporting systems. Qualitative analyses of documentary material, descriptive interviews with key informants, and observations were made. We analysed the organisational structure of the Danish and Australian ADR reporting systems with respect to structures and processes, including information flow and exchange of ADR data. The analysis was made based on Scott's adapted version of Leavitt's diamond model, with the components: goals/tasks, social structure, technology and participants, within a surrounding environment. The main differences between the systems were: (1) PARTICIPANTS: Outsourcing of ADR assessments to the pharmaceutical companies complicates maintenance of scientific skills within the Danish Medicines Agency (DKMA), as it leaves the handling of spontaneous ADR reports purely administrative within the DKMA, and the knowledge creation process remains with the pharmaceutical companies, while in Australia senior scientific staff work with evaluation of the ADR report; (2) Goals/tasks: In Denmark, resources are targeted at evaluating Periodic Safety Update Reports (PSUR) submitted by the companies, while the resources in Australia are focused on single case assessment resulting in faster and more proactive medicine surveillance; (3) Social structure: Discussions between scientific staff about ADRs take place in Australia, while the Danish system primarily focuses on entering and forwarding ADR data to the relevant pharmaceutical companies; (4) Technology: The Danish system exchanges ADR data electronically with pharmaceutical companies and the other EU countries, while Australia does not have a system for electronic exchange of ADR data; and (5) ENVIRONMENT: The Danish ADR system is embedded in the routines of cooperation within European pharmacovigilance network while the Australian system is acting alone, although they communicate with other systems. The two systems differ with regard to reporting requirements, report handling, resources being spent and information exchange with the environment. In Denmark, learning about ADRs primarily takes place in the safety divisions of the pharmaceutical companies and the authorities have no control over the knowledge creation process. In Australia, more learning and control of the knowledge is present than in Denmark.

SAGES TAVAC safety and effectiveness analysis: da Vinci ® Surgical System (Intuitive Surgical, Sunnyvale, CA).

PubMed

Tsuda, Shawn; Oleynikov, Dmitry; Gould, Jon; Azagury, Dan; Sandler, Bryan; Hutter, Matthew; Ross, Sharona; Haas, Eric; Brody, Fred; Satava, Richard

2015-10-01

The da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci(®) Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted. The SAGES da Vinci(®) TAVAC sub-committee performed a literature review of the da Vinci(®) Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval. Several conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy. Gastrointestinal surgery with the da Vinci(®) Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci(®) Surgical System; further analyses are needed.

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.

A magnetic induction heating system with multi-cascaded coils and adjustable magnetic circuit for hyperthermia.

PubMed

Huang, Chi-Fang; Chao, Hsuan-Yi; Chang, Hsun-Hao; Lin, Xi-Zhang

2016-01-01

Based on the characteristics of cancer cells that cannot survive in an environment with temperature over 42 °C, a magnetic induction heating system for cancer treatment is developed in this work. First, the methods and analyses for designing the multi-cascaded coils magnetic induction hyperthermia system are proposed, such as internal impedance measurement of power generator, impedance matching of coils, and analysis of the system. Besides, characteristics of the system are simulated by a full-wave package for engineering optimization. Furthermore, by considering the safety factor of patients, a two-sectional needle is designed for hyperthermia. Finally, this system is employed to test the liver of swine in ex-vivo experiments, and through Hematoxylin and Eosin (H&E) stain and NADPH oxidase activity assay, the feasibility of this system is verified.

Analysis For Monitoring the Earth Science Afternoon Constellation

NASA Technical Reports Server (NTRS)

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

2005-01-01

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

Exploring Concepts of Operations for On-Demand Passenger Air Transportation

NASA Technical Reports Server (NTRS)

Nneji, Victoria Chibuogu; Stimpson, Alexander; Cummings, Mary; Goodrich, Kenneth H.

2017-01-01

In recent years, a surge of interest in "flying cars" for city commutes has led to rapid development of new technologies to help make them and similar on-demand mobility platforms a reality. To this end, this paper provides analyses of the stakeholders involved, their proposed operational concepts, and the hazards and regulations that must be addressed. Three system architectures emerged from the analyses, ranging from conventional air taxi to revolutionary fully autonomous aircraft operations, each with vehicle safety functions allocated differently between humans and machines. Advancements for enabling technologies such as distributed electric propulsion and artificial intelligence have had major investments and initial experimental success, but may be some years away from being deployed for on-demand passenger air transportation at scale.

Engineering evaluation of SSME dynamic data from engine tests and SSV flights

NASA Technical Reports Server (NTRS)

1986-01-01

An engineering evaluation of dynamic data from SSME hot firing tests and SSV flights is summarized. The basic objective of the study is to provide analyses of vibration, strain and dynamic pressure measurements in support of MSFC performance and reliability improvement programs. A brief description of the SSME test program is given and a typical test evaluation cycle reviewed. Data banks generated to characterize SSME component dynamic characteristics are described and statistical analyses performed on these data base measurements are discussed. Analytical models applied to define the dynamic behavior of SSME components (such as turbopump bearing elements and the flight accelerometer safety cut-off system) are also summarized. Appendices are included to illustrate some typical tasks performed under this study.

Structural analysis of the space shuttle solid rocket booster/external tank attach ring

NASA Technical Reports Server (NTRS)

Dorsey, John T.

1988-01-01

An External Tank (ET) attach ring is used in the Space Shuttle System to transfer lateral loads between the ET and the Solid Rocket Booster (SRB). Following the Challenger (51-L) accident, the flight performance of the ET attach ring was reviewed, and negative margins of safety and failed bolts in the attach ring were subsequently identified. The analyses described in this report were performed in order to understand the existing ET attach ring structural response to motor case internal pressurization as well as to aid in an ET attach ring redesign effort undertaken by NASA LaRC. The finite element model as well as the results from linear and nonlinear static structural analyses are described.

Preliminary post-emplacement safety analysis of the subseabed disposal of high-level nuclear waste

NASA Astrophysics Data System (ADS)

Kaplan, M. F.; Koplik, C. M.; Klett, R. D.

1984-09-01

The radiological hazard from the disposal of high-level nuclear waste within the deep ocean sediments is evaluated, on a preliminary basis, for locations in the central North Pacific and in the northwestern Atlantic. Radio-nuclide transport in the sediment and water column and by marine organisms is considered. Peak doses to an individual are approximately five orders of magnitude below background levels for both sites. Sensitivity analyses for most aspects of the post-emplacement systems models are included.

An International Survey of Transport Airplane Pilots’ Experiences and Perspectives of Lateral/Directional Control Events and Rudder Issues in Transport Airplanes (Rudder Survey)

DTIC Science & Technology

2010-10-01

Analyses revealed the sample to be representative of turbojet op- erations but not of turboprops. Turboprops are 19% of worldwide transport aircraft , but...Transportation Safety Board requested that the FAA explore certain elements of transport aircraft and rudder usage, including but not limited to...Respondents did not seem to be concerned with differences among control system designs across aircraft . Given these findings, a set of recommendations is

Space shuttle hypergolic bipropellant RCS engine design study, Bell model 8701

NASA Technical Reports Server (NTRS)

1974-01-01

A research program was conducted to define the level of the current technology base for reaction control system rocket engines suitable for space shuttle applications. The project consisted of engine analyses, design, fabrication, and tests. The specific objectives are: (1) extrapolating current engine design experience to design of an RCS engine with required safety, reliability, performance, and operational capability, (2) demonstration of multiple reuse capability, and (3) identification of current design and technology deficiencies and critical areas for future effort.

Seismic Safety Of Simple Masonry Buildings

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

Guadagnuolo, Mariateresa; Faella, Giuseppe

2008-07-08

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

Using the event analysis of systemic teamwork (EAST) to explore conflicts between different road user groups when making right hand turns at urban intersections.

PubMed

Salmon, Paul M; Lenne, Michael G; Walker, Guy H; Stanton, Neville A; Filtness, Ashleigh

2014-01-01

Collisions between different types of road users at intersections form a substantial component of the road toll. This paper presents an analysis of driver, cyclist, motorcyclist and pedestrian behaviour at intersections that involved the application of an integrated suite of ergonomics methods, the Event Analysis of Systemic Teamwork (EAST) framework, to on-road study data. EAST was used to analyse behaviour at three intersections using data derived from an on-road study of driver, cyclist, motorcyclist and pedestrian behaviour. The analysis shows the differences in behaviour and cognition across the different road user groups and pinpoints instances where this may be creating conflicts between different road users. The role of intersection design in creating these differences in behaviour and resulting conflicts is discussed. It is concluded that currently intersections are not designed in a way that supports behaviour across the four forms of road user studied. Interventions designed to improve intersection safety are discussed. Practitioner Summary: Intersection safety currently represents a key road safety issue worldwide. This paper presents a novel application of a framework of ergonomics methods for studying differences in road user behaviour at intersections. The findings support development of interventions that consider all road users as opposed to one group in isolation.

Safety and capacity evaluation for interstates in Kentucky.

DOT National Transportation Integrated Search

2005-04-01

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

An error taxonomy system for analysis of haemodialysis incidents.

PubMed

Gu, Xiuzhu; Itoh, Kenji; Suzuki, Satoshi

2014-12-01

This paper describes the development of a haemodialysis error taxonomy system for analysing incidents and predicting the safety status of a dialysis organisation. The error taxonomy system was developed by adapting an error taxonomy system which assumed no specific specialty to haemodialysis situations. Its application was conducted with 1,909 incident reports collected from two dialysis facilities in Japan. Over 70% of haemodialysis incidents were reported as problems or complications related to dialyser, circuit, medication and setting of dialysis condition. Approximately 70% of errors took place immediately before and after the four hours of haemodialysis therapy. Error types most frequently made in the dialysis unit were omission and qualitative errors. Failures or complications classified to staff human factors, communication, task and organisational factors were found in most dialysis incidents. Device/equipment/materials, medicine and clinical documents were most likely to be involved in errors. Haemodialysis nurses were involved in more incidents related to medicine and documents, whereas dialysis technologists made more errors with device/equipment/materials. This error taxonomy system is able to investigate incidents and adverse events occurring in the dialysis setting but is also able to estimate safety-related status of an organisation, such as reporting culture. © 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2017-10-01

Long-term care (LTC) residents with cognitive impairments frequently experience limited mobility and participation in preferred activities. Although a power wheelchair could mitigate some of these mobility and participation challenges, this technology is often not prescribed for this population due to safety concerns. An intelligent power wheelchair (IPW) system represents a potential intervention that could help to overcome these concerns. The purpose of this study was to explore a) how residents experienced an IPW that used three different modes of control and b) what perceived effect the IPW would have on their daily lives. We interviewed 10 LTC residents with mild or moderate cognitive impairment twice, once before and once after testing the IPW. Interviews were conducted using a semi-structured interview guide, audio recorded and transcribed verbatim for thematic analyses. Our analyses identified three overarching themes: (1) the difference an IPW would make, (2) the potential impact of the IPW on others and (3) IPW-related concerns. Findings from this study confirm the need for and potential benefits of IPW use in LTC. Future studies will involve testing IPW improvements based on feedback and insights from this study. Implications for rehabilitation Intelligent power wheelchairs may enhance participation and improve safety and feelings of well-being for long-term care residents with cognitive impairments. Intelligent power wheelchairs could potentially have an equally positive impact on facility staff, other residents, and family and friends by decreasing workload and increasing safety.

Collapse Mechanisms Of Masonry Structures

NASA Astrophysics Data System (ADS)

Zuccaro, G.; Rauci, M.

2008-07-01

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

Collapse Mechanisms Of Masonry Structures

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

Zuccaro, G.; Rauci, M.

2008-07-08

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

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

PubMed

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

2017-05-01

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

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

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Systems-based accident analysis in the led outdoor activity domain: application and evaluation of a risk management framework.

PubMed

Salmon, P; Williamson, A; Lenné, M; Mitsopoulos-Rubens, E; Rudin-Brown, C M

2010-08-01

Safety-compromising accidents occur regularly in the led outdoor activity domain. Formal accident analysis is an accepted means of understanding such events and improving safety. Despite this, there remains no universally accepted framework for collecting and analysing accident data in the led outdoor activity domain. This article presents an application of Rasmussen's risk management framework to the analysis of the Lyme Bay sea canoeing incident. This involved the development of an Accimap, the outputs of which were used to evaluate seven predictions made by the framework. The Accimap output was also compared to an analysis using an existing model from the led outdoor activity domain. In conclusion, the Accimap output was found to be more comprehensive and supported all seven of the risk management framework's predictions, suggesting that it shows promise as a theoretically underpinned approach for analysing, and learning from, accidents in the led outdoor activity domain. STATEMENT OF RELEVANCE: Accidents represent a significant problem within the led outdoor activity domain. This article presents an evaluation of a risk management framework that can be used to understand such accidents and to inform the development of accident countermeasures and mitigation strategies for the led outdoor activity domain.

Conditions for the successful integration of Human and Organizational Factors (HOF) in the nuclear safety analysis.

PubMed

Tosello, Michèle; Lévêque, Françoise; Dutillieu, Stéphanie; Hernandez, Guillaume; Vautier, Jean-François

2012-01-01

This communication presents some elements which come from the experience feedback at CEA about the conditions for the successful integration of HOF in the nuclear safety analysis. To point out some of these conditions, one of the concepts proposed by Edgar Morin to describe the functioning of "complex" systems: the dialogical principle has been used. The idea is to look for some dialogical pairs. The elements of this kind of pair are both complementary and antagonist to one another. Three dialogical pairs are presented in this communication. The first two pairs are related to the organization of the HOF network and the last one is related to the methods which are used to analyse the working situations. The three pairs are: specialist - non-specialist actors of the network, centralized - distributed human resources in the network and microscopic - macroscopic levels of HOF methods to analyse the working situations. To continuously improve these three dialogical pairs, it is important to keep the differences which exist between the two elements of a pair and to find and maintain a balance between the two elements of the pairs.

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children.

PubMed

Stassijns, Jorgen; Bollaerts, Kaatje; Baay, Marc; Verstraeten, Thomas

2016-02-03

New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children. We carried out a systematic search for safety data from published clinical trials on newly adjuvanted vaccines in children ≤10 years of age. Serious adverse events (SAEs), solicited AEs, unsolicited AEs and AEs of special interest were evaluated for four new adjuvants: the immuno-stimulants containing adjuvant systems AS01 and AS02, and the squalene containing oil-in-water emulsions AS03 and MF59. Relative risks (RR) were calculated, comparing children receiving newly adjuvanted vaccines to children receiving other vaccines with a variety of antigens, both adjuvanted and unadjuvanted. Twenty-nine trials were included in the meta-analysis, encompassing 25,056 children who received at least one dose of the newly adjuvanted vaccines. SAEs did not occur more frequently in adjuvanted groups (RR 0.85, 95%CI 0.75-0.96). Our meta-analyses showed higher reactogenicity following administration of newly adjuvanted vaccines, however, no consistent pattern of solicited AEs was observed across adjuvant systems. Pain was the most prevalent AE, but often mild and of short duration. No increased risks were found for unsolicited AEs, febrile convulsions, potential immune mediated diseases and new onset of chronic diseases. Our meta-analysis did not show any safety concerns in clinical trials of the newly adjuvanted vaccines in children ≤10 years of age. An unexplained increase of meningitis in one Phase III AS01-adjuvanted malaria trial and the link between narcolepsy and the AS03-adjuvanted pandemic vaccine illustrate that continued safety monitoring is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

NASA Technical Reports Server (NTRS)

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

2012-01-01

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

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

Information processing requirements for on-board monitoring of automatic landing

NASA Technical Reports Server (NTRS)

Sorensen, J. A.; Karmarkar, J. S.

1977-01-01

A systematic procedure is presented for determining the information processing requirements for on-board monitoring of automatic landing systems. The monitoring system detects landing anomalies through use of appropriate statistical tests. The time-to-correct aircraft perturbations is determined from covariance analyses using a sequence of suitable aircraft/autoland/pilot models. The covariance results are used to establish landing safety and a fault recovery operating envelope via an event outcome tree. This procedure is demonstrated with examples using the NASA Terminal Configured Vehicle (B-737 aircraft). The procedure can also be used to define decision height, assess monitoring implementation requirements, and evaluate alternate autoland configurations.

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.

Proceedings of the Nuclear Criticality Technology Safety Workshop

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

Rene G. Sanchez

1998-04-01

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

Spaceborne power systems preference analyses. Volume 2: Decision analysis

NASA Technical Reports Server (NTRS)

Smith, J. H.; Feinberg, A.; Miles, R. F., Jr.

1985-01-01

Sixteen alternative spaceborne nuclear power system concepts were ranked using multiattribute decision analysis. The purpose of the ranking was to identify promising concepts for further technology development and the issues associated with such development. Four groups were interviewed to obtain preference. The four groups were: safety, systems definition and design, technology assessment, and mission analysis. The highest ranked systems were the heat-pipe thermoelectric systems, heat-pipe Stirling, in-core thermionic, and liquid-metal thermoelectric systems. The next group contained the liquid-metal Stirling, heat-pipe Alkali Metal Thermoelectric Converter (AMTEC), heat-pipe Brayton, liquid-metal out-of-core thermionic, and heat-pipe Rankine systems. The least preferred systems were the liquid-metal AMTEC, heat-pipe thermophotovoltaic, liquid-metal Brayton and Rankine, and gas-cooled Brayton. The three nonheat-pipe technologies selected matched the top three nonheat-pipe systems ranked by this study.

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

PubMed

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

2017-01-01

Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A system of safety management practices and worker engagement for reducing and preventing accidents: an empirical and theoretical investigation.

PubMed

Wachter, Jan K; Yorio, Patrick L

2014-07-01

The overall research objective was to theoretically and empirically develop the ideas around a system of safety management practices (ten practices were elaborated), to test their relationship with objective safety statistics (such as accident rates), and to explore how these practices work to achieve positive safety results (accident prevention) through worker engagement. Data were collected using safety manager, supervisor and employee surveys designed to assess and link safety management system practices, employee perceptions resulting from existing practices, and safety performance outcomes. Results indicate the following: there is a significant negative relationship between the presence of ten individual safety management practices, as well as the composite of these practices, with accident rates; there is a significant negative relationship between the level of safety-focused worker emotional and cognitive engagement with accident rates; safety management systems and worker engagement levels can be used individually to predict accident rates; safety management systems can be used to predict worker engagement levels; and worker engagement levels act as mediators between the safety management system and safety performance outcomes (such as accident rates). Even though the presence of safety management system practices is linked with incident reduction and may represent a necessary first-step in accident prevention, safety performance may also depend on mediation by safety-focused cognitive and emotional engagement by workers. Thus, when organizations invest in a safety management system approach to reducing/preventing accidents and improving safety performance, they should also be concerned about winning over the minds and hearts of their workers through human performance-based safety management systems designed to promote and enhance worker engagement. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.