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.

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.

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

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

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

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

None

1997-03-01

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

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

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

PubMed

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

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.

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

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

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

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).

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

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

PubMed

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

2018-04-01

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

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

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

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.

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.

[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.

Final safety analysis report for the Galileo Mission: Volume 2, Book 2: Accident model document: Appendices

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

Not Available

1988-12-15

This section of the Accident Model Document (AMD) presents the appendices which describe the various analyses that have been conducted for use in the Galileo Final Safety Analysis Report II, Volume II. Included in these appendices are the approaches, techniques, conditions and assumptions used in the development of the analytical models plus the detailed results of the analyses. Also included in these appendices are summaries of the accidents and their associated probabilities and environment models taken from the Shuttle Data Book (NSTS-08116), plus summaries of the several segments of the recent GPHS safety test program. The information presented in thesemore » appendices is used in Section 3.0 of the AMD to develop the Failure/Abort Sequence Trees (FASTs) and to determine the fuel releases (source terms) resulting from the potential Space Shuttle/IUS accidents throughout the missions.« less

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

Steiner, J.L.; Lime, J.F.; Elson, J.S.

One dimensional TRAC transient calculations of the process inherent ultimate safety (PIUS) advanced reactor design were performed for a pump-trip SCRAM. The TRAC calculations showed that the reactor power response and shutdown were in qualitative agreement with the one-dimensional analyses presented in the PIUS Preliminary Safety Information Document (PSID) submitted by Asea Brown Boveri (ABB) to the US Nuclear Regulatory Commission for preapplication safety review. The PSID analyses were performed with the ABB-developed RIGEL code. The TRAC-calculated phenomena and trends were also similar to those calculated with another one-dimensional PIUS model, the Brookhaven National Laboratory developed PIPA code. A TRACmore » pump-trip SCRAM transient has also been calculated with a TRAC model containing a multi-dimensional representation of the PIUS intemal flow structures and core region. The results obtained using the TRAC fully one-dimensional PIUS model are compared to the RIGEL, PIPA, and TRAC multi-dimensional results.« less

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

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

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

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

77 FR 66638 - The Standard on Process Safety Management of Highly Hazardous Chemicals; Extension of the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... analyses and the development of other elements of the standard; developing a written action plan for..., revalidating and retaining the process hazard analysis; developing and implementing written operating [[Page 66639

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

PubMed

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

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.

The development and validation of a psychological contract of safety scale.

PubMed

Walker, Arlene

2010-08-01

This paper builds on previous research by the author and describes the development and validation of a new measure of the psychological contract of safety. The psychological contract of safety is defined as the beliefs of individuals about reciprocal safety obligations inferred from implicit and explicit promises. A psychological contract is established when an individual believes that perceived employer and employee safety obligations are contingent on each other. A pilot test of the measure is first undertaken with participants from three different occupations: nurses, construction workers, and meat processing workers (N=99). Item analysis is used to refine the measure and provide initial validation of the scale. A larger validation study is then conducted with a participant sample of health care workers (N=424) to further refine the measure and to determine the psychometric properties of the scale. Item and correlational analyses produced the final employer and employee obligations scales, consisting of 21 and 17 items, respectively. Factor analyses identified two underlying dimensions in each scale comparable to that previously established in the organizational literature. These transactional and relational-type obligations provided construct validity of the scale. Internal consistency ratings using Cronbach's alpha found the components of the psychological contract of safety measure to be reliable. The refined and validated psychological contract of safety measure will allow investigation of the positive and negative outcomes associated with fulfilment and breach of the psychological contract of safety in future research. 2010 Elsevier Ltd. All rights reserved.

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

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.

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.

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

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.

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

PubMed Central

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

2016-01-01

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

75 FR 2438 - Safety Zone; Havasu Landing Annual Regatta; Colorado River, Lake Havasu Landing, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-15

... proposed rulemaking (NPRM) with respect to this rule because it was impracticable since the logistical... the Port, or his designated representative. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses...

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.

Quantitative and Qualitative Analysis of Nutrition and Food Safety Information in School Science Textbooks of India

ERIC Educational Resources Information Center

Subba Rao, G. M.; Vijayapushapm, T.; Venkaiah, K.; Pavarala, V.

2012-01-01

Objective: To assess quantity and quality of nutrition and food safety information in science textbooks prescribed by the Central Board of Secondary Education (CBSE), India for grades I through X. Design: Content analysis. Methods: A coding scheme was developed for quantitative and qualitative analyses. Two investigators independently coded the…

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.

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

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-17

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

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

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

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

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.

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.

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.

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

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

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

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.

Determinants of debit cards acceptance: An empirical investigation

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

Ismail, Shafinar; Adnan, Azimah; Azizi, Amsyar

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300more » respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.« less

Determinants of debit cards acceptance: An empirical investigation

NASA Astrophysics Data System (ADS)

Ismail, Shafinar; Bakri, Mohamed Hariri; Zulkepli, Jafri; Adnan, Azimah; Azizi, Amsyar

2014-12-01

These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300 respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-15

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

75 FR 55270 - Safety Zone; NASSCO Launching of USNS Washington Chambers, San Diego Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-10

... rulemaking (NPRM) with respect to this rule because it was impracticable since the logistical details of the... will be subject to both criminal and civil penalties. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

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

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.

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.

Zero-gravity atmospheric Cloud Physics Experiment Laboratory; Programmatics report

NASA Technical Reports Server (NTRS)

1974-01-01

The programmatics effort included comprehensive analyses in four major areas: (1) work breakdown structure, (2) schedules, (3) costs, and (4) supporting research and technology. These analyses are discussed in detail in the following sections which identify and define the laboratory project development schedule, cost estimates, funding distributions and supporting research and technology requirements. All programmatics analyses are correlated among themselves and with the technical analyses by means of the work breakdown structure which serves as a common framework for program definition. In addition, the programmatic analyses reflect the results of analyses and plans for reliability, safety, test, and maintenance and refurbishment.

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

40 CFR 68.83 - Employee participation.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.83 Employee participation. (a... their representatives on the conduct and development of process hazards analyses and on the development of the other elements of process safety management in this rule. (c) The owner or operator shall...

Safety climate and firefighting: Focus group results.

PubMed

DeJoy, David M; Smith, Todd D; Dyal, Mari-Amanda

2017-09-01

Firefighting is a hazardous occupation and there have been numerous calls for fundamental changes in how fire service organizations approach safety and balance safety with other operational priorities. These calls, however, have yielded little systematic research. As part of a larger project to develop and test a model of safety climate for the fire service, focus groups were used to identify potentially important dimensions of safety climate pertinent to firefighting. Analyses revealed nine overarching themes. Competency/professionalism, physical/psychological readiness, and that positive traits sometimes produce negative consequences were themes at the individual level; cohesion and supervisor leadership/support at the workgroup level; and politics/bureaucracy, resources, leadership, and hiring/promotion at the organizational level. A multi-level perspective seems appropriate for examining safety climate in firefighting. Safety climate in firefighting appears to be multi-dimensional and some dimensions prominent in the general safety climate literature also seem relevant to firefighting. These results also suggest that the fire service may be undergoing transitions encompassing mission, personnel, and its fundamental approach to safety and risk. These results help point the way to the development of safety climate measures specific to firefighting and to interventions for improving safety performance. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Impact of economic incentives on costs and benefits of occupational health and safety.

PubMed

Pawłowska, Z; Rzepecki, J

2000-01-01

The most common type of economic incentive used in the field of health and safety is experience rating of insurance premiums. The impact of this incentive on occupational health and safety (OHS) costs in the company was analysed by comparing insurance costs with other OHS costs associated with inadequate working conditions, such as accident costs borne by a company. Accident costs were estimated on the basis of research carried out in 10 companies. Insurance costs and their adjustments according to the health and safety level in a company were calculated according to an experience rating model developed in the Central Institute for Labour Protection.

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

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

Value of shared preclinical safety studies - The eTOX database.

PubMed

Briggs, Katharine; Barber, Chris; Cases, Montserrat; Marc, Philippe; Steger-Hartmann, Thomas

2015-01-01

A first analysis of a database of shared preclinical safety data for 1214 small molecule drugs and drug candidates extracted from 3970 reports donated by thirteen pharmaceutical companies for the eTOX project (www.etoxproject.eu) is presented. Species, duration of exposure and administration route data were analysed to assess if large enough subsets of homogenous data are available for building in silico predictive models. Prevalence of treatment related effects for the different types of findings recorded were analysed. The eTOX ontology was used to determine the most common treatment-related clinical chemistry and histopathology findings reported in the database. The data were then mined to evaluate sensitivity of established in vivo biomarkers for liver toxicity risk assessment. The value of the database to inform other drug development projects during early drug development is illustrated by a case study.

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

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

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).

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...

Safety in numbers: the development of Leapfrog's composite patient safety score for U.S. hospitals.

PubMed

Austin, J Matthew; D'Andrea, Guy; Birkmeyer, John D; Leape, Lucian L; Milstein, Arnold; Pronovost, Peter J; Romano, Patrick S; Singer, Sara J; Vogus, Timothy J; Wachter, Robert M

2014-03-01

To develop a composite patient safety score that provides patients, health-care providers, and health-care purchasers with a standardized method to evaluate patient safety in general acute care hospitals in the United States. The Leapfrog Group sought guidance from a panel of national patient safety experts to develop the composite score. Candidate patient safety performance measures for inclusion in the score were identified from publicly reported national sources. Hospital performance on each measure was converted into a "z-score" and then aggregated using measure-specific weights. A reference mean score was set at 3, with scores interpreted in terms of standard deviations above or below the mean, with above reflecting better than average performance. Twenty-six measures were included in the score. The mean composite score for 2652 general acute care hospitals in the United States was 2.97 (range by hospital, 0.46-3.94). Safety scores were slightly lower for hospitals that were publicly owned, rural in location, or had a larger percentage of patients with Medicaid as their primary insurance. The Leapfrog patient safety composite provides a standardized method to evaluate patient safety in general acute care hospitals in the United States. While constrained by available data and publicly reported scores on patient safety measures, the composite score reflects the best available evidence regarding a hospital's efforts and outcomes in patient safety. Additional analyses are needed, but the score did not seem to have a strong bias against hospitals with specific characteristics. The composite score will continue to be refined over time as measures of patient safety evolve.

Developing a 'critical' approach to patient and public involvement in patient safety in the NHS: learning lessons from other parts of the public sector?

PubMed

Ocloo, Josephine E; Fulop, Naomi J

2012-12-01

There has been considerable momentum within the NHS over the last 10 years to develop greater patient and public involvement (PPI). This commitment has been reflected in numerous policy initiatives. In patient safety, the drive to increase involvement has increasingly been seen as an important way of building a safety culture. Evidence suggests, however, that progress has been slow and even more variable than in health care generally. Given this context, the paper analyses some of the key underlying drivers for involvement in the wider context of health and social care and makes some suggestions on what lessons can be learned for developing the PPI agenda in patient safety. To develop PPI further, it is argued that a greater understanding is needed of the contested nature of involvement in patient safety and how this has similarities to the emergence of user involvement in other parts of the public services. This understanding has led to the development of a range of critical theories to guide involvement that also make more explicit the underlying factors that support and hinder involvement processes, often related to power inequities and control. Achieving greater PPI in patient safety is therefore seen to require a more critical framework for understanding processes of involvement that can also help guide and evaluate involvement practices. © 2011 Blackwell Publishing Ltd.

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.

Leadership style and patient safety: implications for nurse managers.

PubMed

Merrill, Katreena Collette

2015-06-01

The purpose of this study was to explore the relationship between nurse manager (NM) leadership style and safety climate. Nursing leaders are needed who will change the environment and increase patient safety. Hospital NMs are positioned to impact day-to-day operations. Therefore, it is essential to inform nurse executives regarding the impact of leadership style on patient safety. A descriptive correlational study was conducted in 41 nursing departments across 9 hospitals. The hospital unit safety climate survey and multifactorial leadership questionnaire were completed by 466 staff nurses. Bivariate and regression analyses were conducted to determine how well leadership style predicted safety climate. Transformational leadership style was demonstrated as a positive contributor to safety climate, whereas laissez-faire leadership style was shown to negatively contribute to unit socialization and a culture of blame. Nursing leaders must concentrate on developing transformational leadership skills while also diminishing negative leadership styles.

Towards a Competency-based Vision for Construction Safety Education

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

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.

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

Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

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

Brown, Nicholas R.; Pointer, William David; Sieger, Matt

2016-04-01

The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

Validation of a pre-existing safety climate scale for the Turkish furniture manufacturing industry.

PubMed

Akyuz, Kadri Cemil; Yildirim, Ibrahim; Gungor, Celal

2018-03-22

Understanding the safety climate level is essential to implement a proactive safety program. The objective of this study is to explore the possibility of having a safety climate scale for the Turkish furniture manufacturing industry since there has not been any scale available. The questionnaire recruited 783 subjects. Confirmatory factor analysis (CFA) tested a pre-existing safety scale's fit to the industry. The CFA indicated that the structures of the model present a non-satisfactory fit with the data (χ 2  = 2033.4, df = 314, p ≤ 0.001; root mean square error of approximation = 0.08, normed fit index = 0.65, Tucker-Lewis index = 0.65, comparative fit index = 0.69, parsimony goodness-of-fit index = 0.68). The results suggest that a new scale should be developed and validated to measure the safety climate level in the Turkish furniture manufacturing industry. Due to the hierarchical structure of organizations, future studies should consider a multilevel approach in their exploratory factor analyses while developing a new scale.

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/.

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.

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

PubMed

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

2017-03-01

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

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

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.

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

PubMed

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

2015-12-01

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

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

PubMed

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

2014-01-01

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

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/.

Meeting the global demand of sports safety: the intersection of science and policy in sports safety.

PubMed

Timpka, Toomas; Finch, Caroline F; Goulet, Claude; Noakes, Tim; Yammine, Kaissar

2008-01-01

Sports and physical activity are transforming, and being transformed by, the societies in which they are practised. From the perspectives of both competitive and non-competitive sports, the complexity of their integration into today's society has led to neither sports federations nor governments being able to manage the safety problem alone. In other words, these agencies, whilst promoting sport and physical activity, deliver policy and practices in an uncoordinated way that largely ignores the need for a concurrent overall policy for sports safety. This article reviews and analyses the possibility of developing an overall sports safety policy from a global viewpoint. Firstly, we describe the role of sports in today's societies and the context within which much sport is delivered. We then discuss global issues related to injury prevention and safety in sports, with practical relevance to this important sector, including an analysis of critical policy issues necessary for the future development of the area and significant safety gains for all. We argue that there is a need to establish the sports injury problem as a critical component of general global health policy agendas, and to introduce sports safety as a mandatory component of all sustainable sports organizations. We conclude that the establishment of an explicit intersection between science and policy making is necessary for the future development of sports and the necessary safety gains required for all participants around the world. The Safe Sports International safety promotion programme is outlined as an example of an international organization active within this arena.

Passenger rail vehicle safety assessment methodology. Volume II, Detailed analyses and simulation results.

DOT National Transportation Integrated Search

2000-04-01

This report presents detailed analytic tools and results on dynamic response which are used to develop the safe dynamic performance limits of commuter passenger vehicles. The methodology consists of determining the critical parameters and characteris...

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].

14 CFR 415.204-415.400 - [Reserved

Code of Federal Regulations, 2011 CFR

2011-01-01

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

14 CFR 415.204-415.400 - [Reserved

Code of Federal Regulations, 2012 CFR

2012-01-01

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

14 CFR 415.204-415.400 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

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.

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.

Granite disposal of U.S. high-level radioactive waste.

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

Freeze, Geoffrey A.; Mariner, Paul E.; Lee, Joon H.

This report evaluates the feasibility of disposing U.S. high-level radioactive waste in granite several hundred meters below the surface of the earth. The U.S. has many granite formations with positive attributes for permanent disposal. Similar crystalline formations have been extensively studied by international programs, two of which, in Sweden and Finland, are the host rocks of submitted or imminent repository license applications. This report is enabled by the advanced work of the international community to establish functional and operational requirements for disposal of a range of waste forms in granite media. In this report we develop scoping performance analyses, basedmore » on the applicable features, events, and processes (FEPs) identified by international investigators, to support generic conclusions regarding post-closure safety. Unlike the safety analyses for disposal in salt, shale/clay, or deep boreholes, the safety analysis for a mined granite repository depends largely on waste package preservation. In crystalline rock, waste packages are preserved by the high mechanical stability of the excavations, the diffusive barrier of the buffer, and favorable chemical conditions. The buffer is preserved by low groundwater fluxes, favorable chemical conditions, backfill, and the rigid confines of the host rock. An added advantage of a mined granite repository is that waste packages would be fairly easy to retrieve, should retrievability be an important objective. The results of the safety analyses performed in this study are consistent with the results of comprehensive safety assessments performed for sites in Sweden, Finland, and Canada. They indicate that a granite repository would satisfy established safety criteria and suggest that a small number of FEPs would largely control the release and transport of radionuclides. In the event the U.S. decides to pursue a potential repository in granite, a detailed evaluation of these FEPs would be needed to inform site selection and safety assessment.« less

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

PubMed Central

West, Jonathan; Ogston, Simon; Foerster, John

2016-01-01

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

Responsibility for the Violation of Ecological Safety Requirements

NASA Astrophysics Data System (ADS)

Selivanovskaya, J. I.; Gilmutdinova, I.

2018-01-01

The article deals with the problems of responsibility for the violation of ecological safety requirements from the point of view of sustainable development of the state. Such types of responsibility as property, disciplinary, financial, administrative and criminal responsibility in the area are analysed. Suggestions on the improvement of legislation are put forward. Among other things it is suggested to introduce criminal sanctions against legal bodies (enterprises) for ecological crimes with punishments in the form of fines, suspension or discontinuation of activities.

Crash Outcome Data Evaluation System (CODES) Project Safety Belt and Helmet Analyses

DOT National Transportation Integrated Search

1996-02-15

Analyses of the benefits of safety belt and helmet use were undertaken for a : Report that was sent to Congress February, 1996. NHTSA awarded grants to link : crash and injury state data and perform the analyses upon which the report was : based. The...

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.

Targeting the UPR to Circumvent Endocrine Resistance in Breast Cancer

DTIC Science & Technology

2014-10-01

activity relationship analyses ( QSAR ) to develop rationally designed NPPTA analogs with increased potency and optimized pharmacologic properties...vitro, with the strongest candidates being studied in vivo to provide preclinical safety, efficacy, and toxicology data to support later first-in-human

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

PubMed

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

2012-09-01

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

Does Employee Safety Matter for Patients Too? Employee Safety Climate and Patient Safety Culture in Health Care.

PubMed

Mohr, David C; Eaton, Jennifer Lipkowitz; McPhaul, Kathleen M; Hodgson, Michael J

2015-04-22

We examined relationships between employee safety climate and patient safety culture. Because employee safety may be a precondition for the development of patient safety, we hypothesized that employee safety culture would be strongly and positively related to patient safety culture. An employee safety climate survey was administered in 2010 and assessed employees' views and experiences of safety for employees. The patient safety survey administered in 2011 assessed the safety culture for patients. We performed Pearson correlations and multiple regression analysis to examine the relationships between a composite measure of employee safety with subdimensions of patient safety culture. The regression models controlled for size, geographic characteristics, and teaching affiliation. Analyses were conducted at the group level using data from 132 medical centers. Higher employee safety climate composite scores were positively associated with all 9 patient safety culture measures examined. Standardized multivariate regression coefficients ranged from 0.44 to 0.64. Medical facilities where staff have more positive perceptions of health care workplace safety climate tended to have more positive assessments of patient safety culture. This suggests that patient safety culture and employee safety climate could be mutually reinforcing, such that investments and improvements in one domain positively impacts the other. Further research is needed to better understand the nexus between health care employee and patient safety to generalize and act upon findings.

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient panel will provide steering to the research. The PMOS and PIRT aim to provide a reliable means of eliciting patient views about patient safety. Both interventions are likely to have relevance and practical utility for all NHS hospital trusts.

Toward the Replacement of Animal Experiments through the Bioinformatics-driven Analysis of 'Omics' Data from Human Cell Cultures.

PubMed

Grafström, Roland C; Nymark, Penny; Hongisto, Vesa; Spjuth, Ola; Ceder, Rebecca; Willighagen, Egon; Hardy, Barry; Kaski, Samuel; Kohonen, Pekka

2015-11-01

This paper outlines the work for which Roland Grafström and Pekka Kohonen were awarded the 2014 Lush Science Prize. The research activities of the Grafström laboratory have, for many years, covered cancer biology studies, as well as the development and application of toxicity-predictive in vitro models to determine chemical safety. Through the integration of in silico analyses of diverse types of genomics data (transcriptomic and proteomic), their efforts have proved to fit well into the recently-developed Adverse Outcome Pathway paradigm. Genomics analysis within state-of-the-art cancer biology research and Toxicology in the 21st Century concepts share many technological tools. A key category within the Three Rs paradigm is the Replacement of animals in toxicity testing with alternative methods, such as bioinformatics-driven analyses of data obtained from human cell cultures exposed to diverse toxicants. This work was recently expanded within the pan-European SEURAT-1 project (Safety Evaluation Ultimately Replacing Animal Testing), to replace repeat-dose toxicity testing with data-rich analyses of sophisticated cell culture models. The aims and objectives of the SEURAT project have been to guide the application, analysis, interpretation and storage of 'omics' technology-derived data within the service-oriented sub-project, ToxBank. Particularly addressing the Lush Science Prize focus on the relevance of toxicity pathways, a 'data warehouse' that is under continuous expansion, coupled with the development of novel data storage and management methods for toxicology, serve to address data integration across multiple 'omics' technologies. The prize winners' guiding principles and concepts for modern knowledge management of toxicological data are summarised. The translation of basic discovery results ranged from chemical-testing and material-testing data, to information relevant to human health and environmental safety. 2015 FRAME.

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.

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.

Industrial Instrument Mechanic. Occupational Analyses Series.

ERIC Educational Resources Information Center

Dean, Ann; Zagorac, Mike; Bumbaka, Nick

This analysis covers tasks performed by an industrial instrument mechanic, an occupational title some provinces and territories of Canada have also identified as industrial instrumentation and instrument mechanic. A guide to analysis discusses development, structure, and validation method; scope of the occupation; trends; and safety. To facilitate…

A data storage and retrieval model for Louisiana traffic operations data : final report.

DOT National Transportation Integrated Search

1995-09-01

The type and amount of data managed by the Louisiana Department of Transportation and Development (DOTD) are huge. In many cases, these data are used to perform traffic engineering studies and highway safety analyses, among others. At the present tim...

The Assessment of Motivation within Maslow's Framework.

ERIC Educational Resources Information Center

Haymes, Michael; Green, Logan

1982-01-01

Reports progress in the development of the Needsort, a research tool, for the assessment of the three developmentally earliest, within Maslow's framework, conative needs (physiological, safety, belongingness). Discusses item analyses, item selection methods, reliability studies, and validation studies across a broad range of populations. (Author)

Patient safety in psychiatric inpatient care: a literature review.

PubMed

Kanerva, A; Lammintakanen, J; Kivinen, T

2013-08-01

Patient safety is widely discussed, but little has been written from the perspective of psychiatric inpatient care, nor on which factors create its patient safety. This paper seeks to understand the concept of patient safety and its intension in psychiatric inpatient care, and to identify factors in organization management, staff and patients' roles which constitute patient safety in such units. A literature search was conducted, and the articles selected were analysed by identifying factors defined to be connected to patient safety and classifying them according to their connection to organization management, staff and patient roles. According to the literature, organization safety culture is present in all aspects of patient safety. Organization management has the main role in patient safety within the organization culture, for example, through leadership, safety practices and creating good working conditions and environment for the staff. Staff's role is influenced by management, but has more individual input in different areas, while the patient's role is more that of an informant so that care can be planned according to the patient's preferences. When developing patient safety it is important to remember the diversity of the concept so that all areas are considered in the developmental work. © 2012 John Wiley & Sons Ltd.

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

Analyses of transients for an 800 MW-class accelerator driven transmuter with fertile-free fuels

NASA Astrophysics Data System (ADS)

Maschek, Werner; Suzuki, Tohru; Chen, Xue-Nong; Rineiski, Andrei; Matzerath Boccaccini, Claudia; Mori, Magnus; Morita, Koji

2006-06-01

In the FUTURE Program, the development and application of fertile-free fuels for Accelerator Driven Transmuters (ADTs) has been advanced. To assess the reactor performance and safety behavior of an ADT with so-called dedicated fuels, various transient cases for an 800 MW-class Pb/Bi-cooled ADT were investigated using the SIMMER-III code. The FUTURE ADT also served as vehicle to develop and test ideas on a safety concept for such transmuters. After an extensive ranking procedure, a CERCER fuel with an MgO matrix and a CERMET fuel with a Mo-92 matrix were chosen. The transient scenarios shown here are: spurious beam trip (BT), unprotected loss of flow (ULOF) and unprotected blockage accident (UBA). Since the release of fission gas and helium after cladding failure could induce a significant positive reactivity, the gas-blowdown was investigated for the transient scenarios. The present analyses showed that power excursions could be avoided by the fuel sweep-out from the core under severe accident conditions.

The translation of sports injury prevention and safety promotion knowledge: insights from key intermediary organisations.

PubMed

Bekker, Sheree; Paliadelis, Penny; Finch, Caroline F

2017-03-28

A recognised research-to-practice gap exists in the health research field of sports injury prevention and safety promotion. There is a need for improved insight into increasing the relevancy, accessibility and legitimacy of injury prevention and safety promotion research knowledge for sport settings. The role of key organisations as intermediaries in the process of health knowledge translation for sports settings remains under-explored, and this paper aims to determine, and describe, the processes of knowledge translation undertaken by a set of key organisations in developing and distributing injury prevention and safety promotion resources. The National Guidance for Australian Football Partnerships and Safety (NoGAPS) project provided the context for this study. Representatives from five key NoGAPS organisations participated in individual face-to-face interviews about organisational processes of knowledge translation. A qualitative descriptive methodology was used to analyse participants' descriptions of knowledge translation activities undertaken at their respective organisations. Several themes emerged around health knowledge translation processes and considerations, including (1) identifying a need for knowledge translation, (2) developing and disseminating resources, and (3) barriers and enablers to knowledge translation. This study provides insight into the processes that key organisations employ when developing and disseminating injury prevention and safety promotion resources within sport settings. The relevancy, accessibility and legitimacy of health research knowledge is foregrounded, with a view to increasing the influence of research on the development of health-related resources suitable for community sport settings.

Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

PubMed

Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

2018-05-01

We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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.

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

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.

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%.

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.

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

PubMed

Zikos, Dimitrios; Diomidous, Marianna; Mantas, John

2010-01-01

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

Application of metagenomics technologies for antimicrobial resistance and food safety research and beyond

USDA-ARS?s Scientific Manuscript database

Current developments in the field of metagenomics in biological sciences have demonstrated the need and potential usefulness of taxonomical and functional analyses of meta-omics data generated by genomics, transcriptomics, proteomics, and metabolomics. This review will provide a general overview of...

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...

Bricklayer. Occupational Analyses Series.

ERIC Educational Resources Information Center

Cap, Orest; Cap, Ihor; Semenovych, Viktor

This analysis covers tasks performed by a bricklayer, an occupational title some provinces and territories of Canada have also identified as bricklayer-mason, brick and stone mason, and mason. A guide to analysis discusses development, structure, and validation method; scope of the occupation; trends; and safety. To facilitate understanding the…

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.

PubMed

Goebel, Carsten; Aeby, Pierre; Ade, Nadège; Alépée, Nathalie; Aptula, Aynur; Araki, Daisuke; Dufour, Eric; Gilmour, Nicola; Hibatallah, Jalila; Keller, Detlef; Kern, Petra; Kirst, Annette; Marrec-Fairley, Monique; Maxwell, Gavin; Rowland, Joanna; Safford, Bob; Schellauf, Florian; Schepky, Andreas; Seaman, Chris; Teichert, Thomas; Tessier, Nicolas; Teissier, Silvia; Weltzien, Hans Ulrich; Winkler, Petra; Scheel, Julia

2012-06-01

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

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.

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.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

PubMed

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-08-18

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853. © 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.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

PubMed

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

PubMed Central

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina

2017-01-01

Purpose Standardised MedDRA Queries (SMQs) have been developed since the early 2000’s and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). Methods We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. Results A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with “narrow terms” to enhance specificity over strategies using “broad terms” to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. Conclusions SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions. PMID:28570569

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.

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.

Universal first-order reliability concept applied to semistatic structures

NASA Technical Reports Server (NTRS)

Verderaime, V.

1994-01-01

A reliability design concept was developed for semistatic structures which combines the prevailing deterministic method with the first-order reliability method. The proposed method surmounts deterministic deficiencies in providing uniformly reliable structures and improved safety audits. It supports risk analyses and reliability selection criterion. The method provides a reliability design factor derived from the reliability criterion which is analogous to the current safety factor for sizing structures and verifying reliability response. The universal first-order reliability method should also be applicable for air and surface vehicles semistatic structures.

Universal first-order reliability concept applied to semistatic structures

NASA Astrophysics Data System (ADS)

Verderaime, V.

1994-07-01

A reliability design concept was developed for semistatic structures which combines the prevailing deterministic method with the first-order reliability method. The proposed method surmounts deterministic deficiencies in providing uniformly reliable structures and improved safety audits. It supports risk analyses and reliability selection criterion. The method provides a reliability design factor derived from the reliability criterion which is analogous to the current safety factor for sizing structures and verifying reliability response. The universal first-order reliability method should also be applicable for air and surface vehicles semistatic structures.

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.

Insulator (Heat and Frost). Occupational Analyses Series.

ERIC Educational Resources Information Center

McRory, Aline; Ally, Mohamed

This analysis covers tasks performed by an insulator, an occupational title some provinces and territories of Canada have also identified as heat and frost insulator. A guide to analysis discusses development, structure, and validation method; scope of the occupation; trends; and safety. To facilitate understanding the nature of the occupation,…

A research agenda on patient safety in primary care. Recommendations by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Verstappen, Wim; Gaal, Sander; Bowie, Paul; Parker, Diane; Lainer, Miriam; Valderas, Jose M; Wensing, Michel; Esmail, Aneez

2015-09-01

Healthcare can cause avoidable serious harm to patients. Primary care is not an exception, and the relative lack of research in this area lends urgency to a better understanding of patient safety, the future research agenda and the development of primary care oriented safety programmes. To outline a research agenda for patient safety improvement in primary care in Europe and beyond. The LINNEAUS collaboration partners analysed existing research on epidemiology and classification of errors, diagnostic and medication errors, safety culture, and learning for and improving patient safety. We discussed ideas for future research in several meetings, workshops and congresses with LINNEAUS collaboration partners, practising GPs, researchers in this field, and policy makers. This paper summarizes and integrates the outcomes of the LINNEAUS collaboration on patient safety in primary care. It proposes a research agenda on improvement strategies for patient safety in primary care. In addition, it provides background information to help to connect research in this field with practicing GPs and other healthcare workers in primary care. Future research studies should target specific primary care domains, using prospective methods and innovative methods such as patient involvement.

Integrating environmental management into food safety and food packaging in Malaysia: review of the food regulation 1985

NASA Astrophysics Data System (ADS)

Nordin, N. H.; Hara, H.; Kaida, N.

2017-05-01

Food safety is an important issue that is related to public safety to prevent the toxicity threats of the food. Management through legal approach has been used in Malaysia as one of the predominant approaches to manage the environment. In this regard, the Food Regulation 1985 has been one of the mechanisms of environmental management through legal approach in controlling the safety of packaged food in food packaging industry in Malaysia. The present study aims to analyse and to explain the implementation of the Food Regulation 1985 in controlling the safety of packaged food in Malaysia and to integrate the concept of environmental management into the food safety issue. Qualitative analysis on the regulation document revealed that there are two main themes, general and specific, while their seven sub themes are included harmful packages, safety packages, reuse packages, polyvinyl chloride (PVC), alcoholic bottle, toys, money and others and iron powder. The implementation of the Food Regulation 1985 in controlling the safety of packaged food should not be regarded solely for regulation purposes but should be further developed for a broader sense of food safety from overcoming the food poisoning.

A research agenda on patient safety in primary care. Recommendations by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Verstappen, Wim; Gaal, Sander; Bowie, Paul; Parker, Diane; Lainer, Miriam; Valderas, Jose M.; Wensing, Michel; Esmail, Aneez

2015-01-01

ABSTRACT Background: Healthcare can cause avoidable serious harm to patients. Primary care is not an exception, and the relative lack of research in this area lends urgency to a better understanding of patient safety, the future research agenda and the development of primary care oriented safety programmes. Objective: To outline a research agenda for patient safety improvement in primary care in Europe and beyond. Methods: The LINNEAUS collaboration partners analysed existing research on epidemiology and classification of errors, diagnostic and medication errors, safety culture, and learning for and improving patient safety. We discussed ideas for future research in several meetings, workshops and congresses with LINNEAUS collaboration partners, practising GPs, researchers in this field, and policy makers. Results: This paper summarizes and integrates the outcomes of the LINNEAUS collaboration on patient safety in primary care. It proposes a research agenda on improvement strategies for patient safety in primary care. In addition, it provides background information to help to connect research in this field with practicing GPs and other healthcare workers in primary care. Conclusion: Future research studies should target specific primary care domains, using prospective methods and innovative methods such as patient involvement. PMID:26339841

Green Schoolyards in Low-Income Urban Neighborhoods: Natural Spaces for Positive Youth Development Outcomes.

PubMed

Bates, Carolyn R; Bohnert, Amy M; Gerstein, Dana E

2018-01-01

Children from low-income families are increasingly growing up in urban areas with limited access to nature. In these environments, strategies that promote access to natural outdoor spaces, such as green schoolyards, may enhance positive youth development outcomes by promoting physical activity (PA) and prosocial behavior, as well as increasing perceptions of safety. The current study examines children's PA and social interactions, as well as caregiver and teacher perceptions of safety, injuries, teasing/bullying, and gang activity on three newly renovated green schoolyards in low-income urban neighborhoods. A multi-method strategy, including behavioral mapping and caregiver- and teacher-reported surveys, was utilized at three time points to examine positive youth development outcomes and maintenance of effects over time. Analyses revealed that children evidenced a range of PA on the green schoolyards and demonstrated significant decreases in sedentary activity over time. The majority of children were engaged in social interactions with peers on the green schoolyards when observed. Less than 3% of interactions were negative and follow-up analyses found significant increases in positive interactions on the green schoolyards up to 24 months post-renovation. Caregivers and teachers reported increased perceptions of safety, fewer injuries, less teasing/bullying, and less gang-related activity on the renovated green schoolyards in comparison to the pre-renovation schoolyards, and these effects were maintained up to 32 months post-renovation. Overall, the study suggests that green schoolyards may promote positive development outcomes among youth living in urban, low-income neighborhoods by providing natural and safe spaces for PA and prosocial behavior.

Perceived safety and teen risk taking in online chat sites.

PubMed

McCarty, Cheryl; Prawitz, Aimee D; Derscheid, Linda E; Montgomery, Bette

2011-03-01

Framed by theories of adolescent development, this study explored relationships among adolescents' perceptions of chat-site safety, time spent chatting, and risky online behaviors. Tenth graders (N = 139) in rural Midwestern U.S. schools completed surveys. Factor analysis produced three factors each for perception of safety and risk-taking behaviors. Regression analyses revealed that perception of safety factors were useful in predicting online risk-taking behaviors. Teens with more social discomfort and those who thought it was safe to reveal personal information and trust chat-site "friends" were more likely to take risks. As time spent in chat sites increased, so did risk-taking behaviors. Implications for educators and parents are discussed, such as initiation of conversations about safe Internet use, parental participation in chat sites as teens' invited "friends," and school programs to teach safe online practices.

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

PubMed

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

Road safety in a globalised and more sustainable world: current issues and future challenges.

PubMed

Daniels, Stijn; Risser, Ralf

2014-01-01

Although many countries have had considerable success in reducing traffic injuries over recent decades, there are still some fundamental problems in this area. At the same time, there is increasing focus on road safety research and policy development in the context of globalisation, sustainability, liveability and health. This special section presents a selection of papers that were presented at the annual ICTCT workshop held on the 8th and 9th of November 2012 in Hasselt, Belgium, and accepted for publication in Accident Analysis and Prevention following the journal's reviewing procedure. The aim of the ICTCT workshop was to analyse road safety facts, data and visions for the future in the wider context of current issues and future challenges in road safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

14 CFR 414.11 - Application.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

14 CFR 414.11 - Application.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

14 CFR 414.11 - Application.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

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...

Renal Safety Pharmacology in Drug Discovery and Development.

PubMed

Benjamin, Amanda; Nogueira da Costa, Andre; Delaunois, Annie; Rosseels, Marie-Luce; Valentin, Jean-Pierre

2015-01-01

The kidney is a complex excretory organ playing a crucial role in various physiological processes such as fluid and electrolyte balance, control of blood pressure, removal of waste products, and drug disposition. Drug-induced kidney injury (DIKI) remains a significant cause of candidate drug attrition during drug development. However, the incidence of renal toxicities in preclinical studies is low, and the mechanisms by which drugs induce kidney injury are still poorly understood. Although some in vitro investigational tools have been developed, the in vivo assessment of renal function remains the most widely used methodology to identify DIKI. Stand-alone safety pharmacology studies usually include assessment of glomerular and hemodynamic function, coupled with urine and plasma analyses. However, as renal function is not part of the ICH S7A core battery, such studies are not routinely conducted by pharmaceutical companies. The most common approach consists in integrating renal/urinary measurements in repeat-dose toxicity studies. In addition to the standard analyses and histopathological examination of kidneys, novel promising urinary biomarkers have emerged over the last decade, offering greater sensitivity and specificity than traditional renal parameters. Seven of these biomarkers have been qualified by regulatory agencies for use in rat toxicity studies.

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...

A test of safety, violence prevention, and civility climate domain-specific relationships with relevant workplace hazards.

PubMed

Gazica, Michele W; Spector, Paul E

2016-01-01

Safety climate, violence prevention climate, and civility climate were independently developed and linked to domain-specific workplace hazards, although all three were designed to promote the physical and psychological safety of workers. To test domain specificity between conceptually related workplace climates and relevant workplace hazards. Data were collected from 368 persons employed in various industries and descriptive statistics were calculated for all study variables. Correlational and relative weights analyses were used to test for domain specificity. The three climate domains were similarly predictive of most workplace hazards, regardless of domain specificity. This study suggests that the three climate domains share a common higher order construct that may predict relevant workplace hazards better than any of the scales alone.

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

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

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

Lunar mission safety and rescue: Technical summary

NASA Technical Reports Server (NTRS)

1971-01-01

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

14 CFR 414.11 - Application.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

14 CFR 414.11 - Application.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

Disability in Occupations in a National Sample.

ERIC Educational Resources Information Center

Leigh, J. Paul; Fries, James F.

1992-01-01

Develops lists of jobs in which workers report functional disabilities, using 6,096 females and 3,653 males from the National Health and Nutrition Examination Survey I Epidemiological Follow-Up and attrition and mortality analyses for 6,911 women and 4,723 men. Occupational safety and health are critical to understanding functional disability…

[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.

A Survey of Residents' Perceptions of the Effect of Large-Scale Economic Developments on Perceived Safety, Violence, and Economic Benefits.

PubMed

Fabio, Anthony; Geller, Ruth; Bazaco, Michael; Bear, Todd M; Foulds, Abigail L; Duell, Jessica; Sharma, Ravi

2015-01-01

Emerging research highlights the promise of community- and policy-level strategies in preventing youth violence. Large-scale economic developments, such as sports and entertainment arenas and casinos, may improve the living conditions, economics, public health, and overall wellbeing of area residents and may influence rates of violence within communities. To assess the effect of community economic development efforts on neighborhood residents' perceptions on violence, safety, and economic benefits. Telephone survey in 2011 using a listed sample of randomly selected numbers in six Pittsburgh neighborhoods. Descriptive analyses examined measures of perceived violence and safety and economic benefit. Responses were compared across neighborhoods using chi-square tests for multiple comparisons. Survey results were compared to census and police data. Residents in neighborhoods with the large-scale economic developments reported more casino-specific and arena-specific economic benefits. However, 42% of participants in the neighborhood with the entertainment arena felt there was an increase in crime, and 29% of respondents from the neighborhood with the casino felt there was an increase. In contrast, crime decreased in both neighborhoods. Large-scale economic developments have a direct influence on the perception of violence, despite actual violence rates.

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.

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.

Safety vs. privacy: elderly persons' experiences of a mobile safety alarm.

PubMed

Melander-Wikman, Anita; Fältholm, Ylva; Gard, Gunvor

2008-07-01

The demographic development indicates an increased elderly population in Sweden in the future. One of the greatest challenges for a society with an ageing population is to provide high-quality health and social care. New information and communication technology and services can be used to further improve health care. To enable elderly persons to stay at home as long as possible, various kinds of technology, such as safety alarms, are used at home. The aim of this study was to describe the experiences of elderly persons through testing a mobile safety alarm and their reasoning about safety, privacy and mobility. The mobile safety alarm tested was a prototype in development. Five elderly persons with functional limitations and four healthy elderly persons from a pensioner's organisation tested the alarm. The mobile alarm with a drop sensor and a positioning device was tested for 6 weeks. This intervention was evaluated with qualitative interviews, and analysed with latent content analysis. The result showed four main categories: feeling safe, being positioned and supervised, being mobile, and reflecting on new technology. From these categories, the overarching category 'Safety and mobility are more important than privacy' emerged. The mobile safety alarm was perceived to offer an increased opportunity for mobility in terms of being more active and as an aid for self-determination. The fact that the informants were located by means of the positioning device was not experienced as violating privacy as long as they could decide how to use the alarm. It was concluded that this mobile safety alarm was experienced as a tool to be active and mobile. As a way to keep self-determination and empowerment, the individual has to make a 'cost-benefit' analysis where privacy is sacrificed to the benefit of mobility and safety. The participants were actively contributing to the development process.

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.

A Toolset for Supporting Iterative Human Automation: Interaction in Design

NASA Technical Reports Server (NTRS)

Feary, Michael S.

2010-01-01

The addition of automation has greatly extended humans' capability to accomplish tasks, including those that are difficult, complex and safety critical. The majority of Human - Automation Interacton (HAl) results in more efficient and safe operations, ho,,:,ever ertain unpected atomatlon behaviors or "automation surprises" can be frustrating and, In certain safety critical operations (e.g. transporttion, manufacturing control, medicine), may result in injuries or. the loss of life.. (Mellor, 1994; Leveson, 1995; FAA, 1995; BASI, 1998; Sheridan, 2002). This papr describes he development of a design tool that enables on the rapid development and evaluation. of automaton prototypes. The ultimate goal of the work is to provide a design platform upon which automation surprise vulnerability analyses can be integrated.

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

PubMed

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

2016-11-29

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

Exploring the relationship between development and road traffic injuries: a case study from India.

PubMed

Garg, Nitin; Hyder, Adnan A

2006-10-01

Road traffic injuries (RTI) are a major cause of mortality and disability in the world. Only after significant losses have communities in developed nations taken necessary steps to prevent crashes and their consequences. Increase in road safety is related to increasing socio-economic development. We aim to study the trends in injury and death rates in a developing country, India, define sub-national variations, and analyse these trends in relation to economic and population growth. Public sector data from India were used to develop a standardized database on traffic injuries and indicator of economic development. The data were analysed using linear regression models to test the a priori hypothesis of a positive relationship between net domestic product (NDP), and injury and death rates from road crashes across states. The absolute burden of RTI in India has been consistently rising over the past three decades. The reported rates are lower than those estimated by global health agencies and may reflect under-reporting. Population-based rates provide a better assessment of the public health burden of RTI than vehicle-based rates. There is an inverted U-shaped relationship between NDP and injury and death rates. Even with the limited data, Kuznets phenomenon is evident for within-country level comparisons. India and other developing countries could learn from the experience of highly motorized nations to avoid the expected rise in RTI and deaths with economic development, by currently investing in road safety and prevention measures.

Numerical and experimental analyses of lighting columns in terms of passive safety

NASA Astrophysics Data System (ADS)

Jedliński, Tomasz Ireneusz; Buśkiewicz, Jacek

2018-01-01

Modern lighting columns have a very beneficial influence on road safety. Currently, the columns are being designed to keep the driver safe in the event of a car collision. The following work compares experimental results of vehicle impact on a lighting column with FEM simulations performed using the Ansys LS-DYNA program. Due to high costs of experiments and time-consuming research process, the computer software seems to be very useful utility in the development of pole structures, which are to absorb kinetic energy of the vehicle in a precisely prescribed way.

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

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.

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.

Method of operator safety assessment for underground mobile mining equipment

NASA Astrophysics Data System (ADS)

Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

2018-01-01

The paper presents a method of assessing the safety of operators of mobile mining equipment (MME), which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM). As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

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...

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

DOT National Transportation Integrated Search

2009-10-01

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

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

PubMed

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

2016-03-01

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

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

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…

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

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

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

2013-07-01

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

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

PubMed

Liu, Yan-de; Jin, Tan-tan

2015-09-01

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

Microbial food safety in Ghana: a meta-analysis.

PubMed

Saba, Courage K S; Gonzalez-Zorn, Bruno

2012-12-16

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

Primary cooling check valve steam generator and loose parts events of November 1985

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

Not Available

1985-12-23

On November 10, 1985, a primary coolant check valve, CV-3-8, was opened for inspection. The valve flapper and mounting bracket were found to have become detached from the valve body and were resting in the bottom of the valve. Normally, the bracket is secured to the valve body with three studs and nuts. All three sets of studs, nuts and stud retainers were missing. As part of the effort to locate the missing valve parts, the primary side of the No. 2A steam generator was opened for inspection. Three cap screws and an associated locking bar used to secure certainmore » internals were found to be missing. In response, the Director, Reactor Engineering Department was assigned lead responsibility for developing and directing the implementation of a plan to correct deficiencies and ready the plant to return to operation. Next, a Special Safety Assessment Team was established to provide a structured assessment of the safety aspect of the component failures and the implications of such failures to other components in the primary coolant system. This structured assessment was to result in the development of an action plan that included the development of specific safety criteria, and identification and conduct of special investigations and analyses required for recovery from the event. Finally, an independent Management Review Team was created. The purpose of this report is to document the work of the Management Review Team, including the causal factors analyses, and various reviews required to support the recovery process.« less

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.

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

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study.

PubMed

Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-02-16

The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. 34 elderly medical wards within a northern region of England, UK. Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced when conducting the first stage of the positive deviance approach. UK Clinical Research Network Portfolio (reference-18050). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study

PubMed Central

Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-01-01

Objective The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. Design A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. Setting 34 elderly medical wards within a northern region of England, UK. Participants Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Results Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. Conclusions This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced when conducting the first stage of the positive deviance approach. Trial registration number UK Clinical Research Network Portfolio (reference-18050). PMID:29453303

Life, performance and safety of Grace rechargeable lithium-titanium disulfide cells

NASA Astrophysics Data System (ADS)

Zuckerbrod, D.; Giovannoni, R. T.; Grossman, K. R.

The development of rechargeable Li-TiS2 cells is discussed. This proprietary process produces thin, flexible TiS2 cathodes with a life in excess of 500 cycles. TiS2 utilization of 93 percent is typically achieved at a C/5 discharge rate. A life of 200 cycles has been achieved for AA-size cells at a C/5 discharge rate and 60 cycles at the C rate. The practical energy density is 115 Wh/kg. Safety testing is underway. Vibration and high altitude did not cause venting. Crushing did not result in ignition or temperature rise. Forced overcharge and overdischarge did not result in skin temperatures above 40 C. The peak skin temperature during the short-circuit test was 120 C. Safety analyses point to the need for careful control of electrolyte volume and the benefits of a fusible separator. Grace is developing such a separator, which would shut down the electrochemical cell reaction at a temperature of 130 C.

A test of safety, violence prevention, and civility climate domain-specific relationships with relevant workplace hazards

PubMed Central

Spector, Paul E.

2016-01-01

Background Safety climate, violence prevention climate, and civility climate were independently developed and linked to domain-specific workplace hazards, although all three were designed to promote the physical and psychological safety of workers. Purpose To test domain specificity between conceptually related workplace climates and relevant workplace hazards. Methods Data were collected from 368 persons employed in various industries and descriptive statistics were calculated for all study variables. Correlational and relative weights analyses were used to test for domain specificity. Results The three climate domains were similarly predictive of most workplace hazards, regardless of domain specificity. Discussion This study suggests that the three climate domains share a common higher order construct that may predict relevant workplace hazards better than any of the scales alone. PMID:27110930

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

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

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

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

Condition of Safe Environment Creation in Preschool Educational Institutions and Its Development Prospects

ERIC Educational Resources Information Center

Braslauskiene, Rasa; Vismantiene, Reda; Thorsteinsson, Gisli

2010-01-01

Educators should attempt to create a common and solid strategy in preschool educational institutions in order to sufficiently ensure a safe social environment of children. A research examining health and safety issues in Lithuanian preschools was carried out in Klaipeda. The aim of this paper was to analyse the conditions of safe environment…

Space station (modular) mission analysis. Volume 1: Mission analysis

NASA Technical Reports Server (NTRS)

1971-01-01

The mission analysis on the modular space station considers experimental requirements and options characterized by low initial cost and incremental manning. Features that affect initial development and early operating costs are identified and their impacts on the program are assessed. Considered are the areas of experiment, mission, operations, information management, and long life and safety analyses.

Model of cyclist accident characteristics in the city of Malang and Blitar

NASA Astrophysics Data System (ADS)

Arifin, M. Z.; Agustin, I. W.

2018-01-01

Utilization of bicycles as an environmentally friendly mode of transportation is reconcerned as the development of sustainable transportation programs. The use of bicycles in some developed countries such as the Netherlands is 27 per cent of total travel, while for developing countries such as Indonesia, cyclists are less than 1% of total travel with low educated characteristics (65 per cent) and low income (48 per cent). Cyclist reduces dependencies on petroleum and environmental pollution as well as lessen the occurrence of congestion and traffic accidents involving motor vehicles. It was necessary to know the behavior and interaction of bicycle riders with other vehicle users in a heterogeneous traffic flow. The main purpose of the research is to create a model of bicycle accidents to increase the road traffic safety in Malang city and Blitar city. The research used analyses of frequency, the road’s level of service, and multiple linear regression. The results showed that there was a need for a development basis of a special lane for bicycle. It aims to reduce the level and number of cyclist accidents and to achieve transportation safety as well as to raise public awareness in traffic safety.

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...

Using the Job Demands-Resources model to investigate risk perception, safety climate and job satisfaction in safety critical organizations.

PubMed

Nielsen, Morten Birkeland; Mearns, Kathryn; Matthiesen, Stig Berge; Eid, Jarle

2011-10-01

Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.

Relationship between ethical leadership and organisational commitment of nurses with perception of patient safety culture.

PubMed

Lotfi, Zahra; Atashzadeh-Shoorideh, Foroozan; Mohtashami, Jamileh; Nasiri, Maliheh

2018-03-12

To determine the relationship between ethical leadership, organisational commitment of nurses and their perception of patient safety culture. Patient safety, organisational commitment and ethical leadership styles are very important for improving the quality of nursing care. In this descriptive-correlational study, 340 nurses were selected using random sampling from the hospitals in Tehran in 2016. Data were analysed using descriptive and inferential statistics in SPSS v.20. There was a significant positive relationship between the ethical leadership of nursing managers, perception of patient safety culture and organisational commitment. The regression analysis showed that nursing managers' ethical leadership and nurses' organisational commitment is a predictor of patient safety culture and confirms the relationship between the variables. Regarding the relationship between the nurses' safety performance, ethical leadership and organisational commitment, it seems that the optimisation of the organisational commitment and adherence to ethical leadership by administrators and managers in hospitals could improve the nurses' performance in terms of patient safety. Implementing ethical leadership seems to be one feasible strategy to improve nurses' organisational commitment and perception of patient safety culture. Efforts by nurse managers to develop ethical leadership reinforce organisational commitment to improve patient outcomes. Nurse managers' engagement and performance in this process is vital for a successful result. © 2018 John Wiley & Sons Ltd.

The International Safety Framework for nuclear power source applications in outer space-Useful and substantial guidance

NASA Astrophysics Data System (ADS)

Summerer, L.; Wilcox, R. E.; Bechtel, R.; Harbison, S.

2015-06-01

In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space was adopted, following a multi-year process that involved all major space faring nations under the auspices of a partnership between the UN Committee on the Peaceful Uses of Outer Space and the International Atomic Energy Agency. The Safety Framework reflects an international consensus on best practices to achieve safety. Following the 1992 UN Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second attempt by the international community to draft guidance promoting the safety of applications of nuclear power sources in space missions. NPS applications in space have unique safety considerations compared with terrestrial applications. Mission launch and outer space operational requirements impose size, mass and other space environment limitations not present for many terrestrial nuclear facilities. Potential accident conditions could expose nuclear power sources to extreme physical conditions. The Safety Framework is structured to provide guidance for both the programmatic and technical aspects of safety. In addition to sections containing specific guidance for governments and for management, it contains technical guidance pertinent to the design, development and all mission phases of space NPS applications. All sections of the Safety Framework contain elements directly relevant to engineers and space mission designers for missions involving space nuclear power sources. The challenge for organisations and engineers involved in the design and development processes of space nuclear power sources and applications is to implement the guidance provided in the Safety Framework by integrating it into the existing standard space mission infrastructure of design, development and operational requirements, practices and processes. This adds complexity to the standard space mission and launch approval processes. The Safety Framework is deliberately generic to remain relevantly independent of technological progress, of national organisational setups and of space mission types. Implementing its guidance therefore leaves room for interpretation and adaptation. Relying on reported practices, we analyse the guidance particularly relevant to engineers and space mission designers.

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

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.

The European ASAMPSA_E project : towards guidance to model the impact of high amplitude natural hazards in the probabilistic safety assessment of nuclear power plants. Information on the project progress and needs from the geosciences.

NASA Astrophysics Data System (ADS)

Raimond, Emmanuel; Decker, Kurt; Guigueno, Yves; Klug, Joakim; Loeffler, Horst

2015-04-01

The Fukushima nuclear accident in Japan resulted from the combination of two correlated extreme external events (earthquake and tsunami). The consequences, in particular flooding, went beyond what was considered in the initial engineering design design of nuclear power plants (NPPs). Such situations can in theory be identified using probabilistic safety assessment (PSA) methodology. PSA results may then lead industry (system suppliers and utilities) or Safety Authorities to take appropriate decisions to reinforce the defence-in-depth of the NPP for low probability event but high amplitude consequences. In reality, the development of such PSA remains a challenging task. Definitions of the design basis of NPPs, for example, require data on events with occurrence probabilities not higher than 10-4 per year. Today, even lower probabilities, down to 10-8, are expected and typically used for probabilistic safety analyses (PSA) of NPPs and the examination of so-called design extension conditions. Modelling the combinations of natural or man-made hazards that can affect a NPP and affecting some meaningful probability of occurrence seems to be difficult. The European project ASAMPSAE (www.asampsa.eu) gathers more than 30 organizations (industry, research, safety control) from Europe, US and Japan and aims at identifying some meaningful practices to extend the scope and the quality of the existing probabilistic safety analysis developed for nuclear power plants. It offers a framework to discuss, at a technical level, how "extended PSA" can be developed efficiently and be used to verify if the robustness of Nuclear Power Plants (NPPs) in their environment is sufficient. The paper will present the objectives of this project, some first lessons and introduce which type of guidance is being developed. It will explain the need of expertise from geosciences to support the nuclear safety assessment in the different area (seismotectonic, hydrological, meteorological and biological hazards, …).

How to make the most of failure mode and effect analysis.

PubMed

Stalhandske, Erik; DeRosier, Joseph; Patail, Bryanne; Gosbee, John

2003-01-01

Current accreditation standards issued by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) require hospitals to carry out a proactive risk assessment on at least 1 high-risk activity each year for each accredited program. Because hospital risk managers and patient safety managers generally do not have the knowledge or level of comfort for conducting a proactive risk assessment, they will appreciate the expertise offered by biomedical equipment technicians (BMETs), occupational safety and health professionals, and others. The skills that have been developed by BMETs and others while conducting job safety analyses or failure mode effect analysis can now be applied to a health care proactive analysis. This article touches on the Health Care Failure Mode and Effect Analysis (HFMEA) model that the Department of Veterans Affairs (VA) National Center for Patient Safety developed for proactive risk assessment within the health care community. The goal of this article is to enlighten BMETs and others on the growth of proactive risk assessment within health care and also on the support documents and materials produced by the VA. For additional information on HFMEA, visit the VA website at www.patientsafety.gov/HFMEA.html.

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.

Efficacy and safety of metformin in the management of type 2 diabetes mellitus in older adults: a systematic review for the development of recommendations to reduce potentially inappropriate prescribing.

PubMed

Schlender, Lisa; Martinez, Yolanda V; Adeniji, Charles; Reeves, David; Faller, Barbara; Sommerauer, Christina; Al Qur'an, Thekraiat; Woodham, Adrine; Kunnamo, Ilkka; Sönnichsen, Andreas; Renom-Guiteras, Anna

2017-10-16

Metformin is usually prescribed as first line therapy for type 2 diabetes mellitus (DM2). However, the benefits and risks of metformin may be different for older people. This systematic review examined the available evidence on the safety and efficacy of metformin in the management of DM2 in older adults. The findings were used to develop recommendations for the electronic decision support tool of the European project PRIMA-eDS. The systematic review followed a staged approach, initially searching for systematic reviews and meta-analyses first, and then individual studies when prior searches were inconclusive. The target population was older people (≥65 years old) with DM2. Studies were included if they reported safety or efficacy outcomes with metformin (alone or in combination) for the management of DM2 compared to placebo, usual or no treatment, or other antidiabetics. Using the evidence identified, recommendations were developed using GRADE methodology. Fifteen studies were included (4 intervention and 11 observational studies). In ten studies at least 80% of participants were 65 years or older and 5 studies reported subgroup analyses by age. Comorbidities were reported by 9 studies, cognitive status was reported by 4 studies and functional status by 1 study. In general, metformin showed similar or better safety and efficacy than other specific or non-specific active treatments. However, these findings were mainly based on retrospective observational studies. Four recommendations were developed suggesting to discontinue the use of metformin for the management of DM2 in older adults with risk factors such as age > 80, gastrointestinal complaints during the last year and/or GFR ≤60 ml/min. On the evidence available, the safety and efficacy profiles of metformin appear to be better, and certainly no worse, than other treatments for the management of DM2 in older adults. However, the quality and quantity of the evidence is low, with scarce data on adverse events such as gastrointestinal complaints or renal failure. Further studies are needed to more reliably assess the benefits and risks of metformin in very old (>80), cognitively and functionally impaired older people.

Child passenger safety practices in the U.S.: disparities in light of updated recommendations.

PubMed

Macy, Michelle L; Freed, Gary L

2012-09-01

Children are best protected in motor vehicle collisions when properly using the appropriate restraint and sitting in a rear row. Racial and ethnic disparities have been reported in injury statistics and use of any restraint; however, predictors of safety seat use, being unrestrained, and sitting in the front seat have not been explored previously. To determine factors associated with child passenger safety practices by race/ethnicity in a national sample of child passengers aged <13 years. Secondary analysis conducted in 2011 of the 2007, 2008, and 2009 National Survey of the Use of Booster Seats in which child passenger restraint use was observed directly. Age-stratified, survey-weighted chi-square and logistic regression analyses were conducted. Restraint use was observed for 21,476 children aged <13 years. A decline in child safety seat use and increase in being unrestrained were observed with increasing child age. In multivariate analyses, race/ethnicity, unrestrained drivers, and sitting in the front seat were associated with lower odds of child safety seat use among children aged <8 years. Older child age was associated with sitting in the front seat and being unrestrained. The presence of multiple child passengers was associated with lower odds of sitting in the front but higher odds of being unrestrained. Few children use the recommended child passenger restraints. Understanding the reasons for the suboptimal child passenger restraint practices identified in this study is essential for the development of effective programs to reduce or eliminate preventable motor vehicle collision-related injuries. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Fabrication and Testing of Ceramic Matrix Composite Rocket Propulsion Components

NASA Technical Reports Server (NTRS)

Effinger, M. R.; Clinton, R. C., Jr.; Dennis, J.; Elam, S.; Genge, G.; Eckel, A.; Jaskowiak, M. H.; Kiser, J. D.; Lang, J.

2001-01-01

NASA has established goals for Second and Third Generation Reusable Launch Vehicles. Emphasis has been placed on significantly improving safety and decreasing the cost of transporting payloads to orbit. Ceramic matrix composites (CMC) components are being developed by NASA to enable significant increases in safety and engineer performance, while reducing costs. The development of the following CMC components are being pursued by NASA: (1) Simplex CMC Blisk; (2) Cooled CMC Nozzle Ramps; (3) Cooled CMC Thrust Chambers; and (4) CMC Gas Generator. These development efforts are application oriented, but have a strong underpinning of fundamental understanding of processing-microstructure-property relationships relative to structural analyses, nondestructive characterization, and material behavior analysis at the coupon and component and system operation levels. As each effort matures, emphasis will be placed on optimizing and demonstrating material/component durability, ideally using a combined Building Block Approach and Build and Bust Approach.

Integral throat entrance development, qualification and production for the Antares 3 nozzle

NASA Technical Reports Server (NTRS)

Clayton, F. I.; Dirling, R. B.; Eitman, D. A.; Loomis, W. C.

1982-01-01

Although design analyses of a G-90 graphite integral throat entrance for the Antares 3 solid rocket motor nozzle indicated acceptable margins of safety, the nozzle throat insert suffered a thermostructural failure during the first development firing. Subsequent re-analysis using properties measured on material from the same billet as the nozzle throat insert showed negative margins. Carbon-carbon was investigated and found to result in large positive margins of safety. The G-90 graphite was replaced by SAI fast processed 4-D material which uses Hercules HM 10000 fiber as the reinforcement. Its construction allows powder filling of the interstices after preform fabrication which accelerates the densification process. Allied 15V coal tar pitch is then used to complete densification. The properties were extensively characterized on this material and six nozzles were subjected to demonstration, development and qualification firings.

Anthropotechnological analysis of industrial accidents in Brazil.

PubMed Central

Binder, M. C.; de Almeida, I. M.; Monteau, M.

1999-01-01

The Brazilian Ministry of Labour has been attempting to modify the norms used to analyse industrial accidents in the country. For this purpose, in 1994 it tried to make compulsory use of the causal tree approach to accident analysis, an approach developed in France during the 1970s, without having previously determined whether it is suitable for use under the industrial safety conditions that prevail in most Brazilian firms. In addition, opposition from Brazilian employers has blocked the proposed changes to the norms. The present study employed anthropotechnology to analyse experimental application of the causal tree method to work-related accidents in industrial firms in the region of Botucatu, São Paulo. Three work-related accidents were examined in three industrial firms representative of local, national and multinational companies. On the basis of the accidents analysed in this study, the rationale for the use of the causal tree method in Brazil can be summarized for each type of firm as follows: the method is redundant if there is a predominance of the type of risk whose elimination or neutralization requires adoption of conventional industrial safety measures (firm representative of local enterprises); the method is worth while if the company's specific technical risks have already largely been eliminated (firm representative of national enterprises); and the method is particularly appropriate if the firm has a good safety record and the causes of accidents are primarily related to industrial organization and management (multinational enterprise). PMID:10680249

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.

A Survey of Residents' Perceptions of the Effect of Large-Scale Economic Developments on Perceived Safety, Violence, and Economic Benefits

PubMed Central

Geller, Ruth; Bear, Todd M.; Foulds, Abigail L.; Duell, Jessica; Sharma, Ravi

2015-01-01

Background. Emerging research highlights the promise of community- and policy-level strategies in preventing youth violence. Large-scale economic developments, such as sports and entertainment arenas and casinos, may improve the living conditions, economics, public health, and overall wellbeing of area residents and may influence rates of violence within communities. Objective. To assess the effect of community economic development efforts on neighborhood residents' perceptions on violence, safety, and economic benefits. Methods. Telephone survey in 2011 using a listed sample of randomly selected numbers in six Pittsburgh neighborhoods. Descriptive analyses examined measures of perceived violence and safety and economic benefit. Responses were compared across neighborhoods using chi-square tests for multiple comparisons. Survey results were compared to census and police data. Results. Residents in neighborhoods with the large-scale economic developments reported more casino-specific and arena-specific economic benefits. However, 42% of participants in the neighborhood with the entertainment arena felt there was an increase in crime, and 29% of respondents from the neighborhood with the casino felt there was an increase. In contrast, crime decreased in both neighborhoods. Conclusions. Large-scale economic developments have a direct influence on the perception of violence, despite actual violence rates. PMID:26273310

Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes.

PubMed

Tanniou, Julien; van der Tweel, Ingeborg; Teerenstra, Steven; Roes, Kit C B

2016-02-18

It is well recognized that treatment effects may not be homogeneous across the study population. Subgroup analyses constitute a fundamental step in the assessment of evidence from confirmatory (Phase III) clinical trials, where conclusions for the overall study population might not hold. Subgroup analyses can have different and distinct purposes, requiring specific design and analysis solutions. It is relevant to evaluate methodological developments in subgroup analyses against these purposes to guide health care professionals and regulators as well as to identify gaps in current methodology. We defined four purposes for subgroup analyses: (1) Investigate the consistency of treatment effects across subgroups of clinical importance, (2) Explore the treatment effect across different subgroups within an overall non-significant trial, (3) Evaluate safety profiles limited to one or a few subgroup(s), (4) Establish efficacy in the targeted subgroup when included in a confirmatory testing strategy of a single trial. We reviewed the methodology in line with this "purpose-based" framework. The review covered papers published between January 2005 and April 2015 and aimed to classify them in none, one or more of the aforementioned purposes. In total 1857 potentially eligible papers were identified. Forty-eight papers were selected and 20 additional relevant papers were identified from their references, leading to 68 papers in total. Nineteen were dedicated to purpose 1, 16 to purpose 4, one to purpose 2 and none to purpose 3. Seven papers were dedicated to more than one purpose, the 25 remaining could not be classified unambiguously. Purposes of the methods were often not specifically indicated, methods for subgroup analysis for safety purposes were almost absent and a multitude of diverse methods were developed for purpose (1). It is important that researchers developing methodology for subgroup analysis explicitly clarify the objectives of their methods in terms that can be understood from a patient's, health care provider's and/or regulator's perspective. A clear operational definition for consistency of treatment effects across subgroups is lacking, but is needed to improve the usability of subgroup analyses in this setting. Finally, methods to particularly explore benefit-risk systematically across subgroups need more research.

The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice.

PubMed

Ginsburg, Liane; Castel, Evan; Tregunno, Deborah; Norton, Peter G

2012-08-01

Enhancing competency in patient safety at entry to practice requires introduction and integration of patient safety into health professional education. As efforts to include patient safety in health professional education increase, it is important to capture new health professionals' perspectives of their own patient safety competence at entry to practice. Existing instruments to measure patient safety knowledge, skills and attitudes have been developed largely to examine the impact of specific patient safety curricular initiatives and the psychometric analyses of the instruments used thus far have been exploratory in nature. Confirmatory factor analytic approaches are used to extensively test the Health Professional Education in Patient Safety Survey (H-PEPSS), a newly designed survey rooted in a patient safety competency framework and designed to measure health professionals' self-reported patient safety competence around the time of entry to practice. The H-PEPSS focuses primarily on the socio-cultural aspects of patient safety including culture, teamwork, communication, managing risk and understanding human factors. Results support a parsimonious six-factor measurement model of health professionals' perceptions of patient safety competency. These results support the validity of a reduced version of the H-PEPSS and suggest it can be appropriately used at or near training completion with a variety of health professional groups. Given increased demands for patient safety competency among health professionals at entry to practice and slow, but emerging changes in health professional education, ongoing research to understand the extent of patient safety competency among health professionals around the time of entry to practice will be important.

The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice

PubMed Central

Castel, Evan; Tregunno, Deborah; Norton, Peter G

2012-01-01

Background Enhancing competency in patient safety at entry to practice requires introduction and integration of patient safety into health professional education. As efforts to include patient safety in health professional education increase, it is important to capture new health professionals' perspectives of their own patient safety competence at entry to practice. Existing instruments to measure patient safety knowledge, skills and attitudes have been developed largely to examine the impact of specific patient safety curricular initiatives and the psychometric analyses of the instruments used thus far have been exploratory in nature. Methods Confirmatory factor analytic approaches are used to extensively test the Health Professional Education in Patient Safety Survey (H-PEPSS), a newly designed survey rooted in a patient safety competency framework and designed to measure health professionals' self-reported patient safety competence around the time of entry to practice. The H-PEPSS focuses primarily on the socio-cultural aspects of patient safety including culture, teamwork, communication, managing risk and understanding human factors. Results Results support a parsimonious six-factor measurement model of health professionals' perceptions of patient safety competency. These results support the validity of a reduced version of the H-PEPSS and suggest it can be appropriately used at or near training completion with a variety of health professional groups. Conclusions Given increased demands for patient safety competency among health professionals at entry to practice and slow, but emerging changes in health professional education, ongoing research to understand the extent of patient safety competency among health professionals around the time of entry to practice will be important. PMID:22562876

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,...

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

PubMed

Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B

2008-05-01

Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.

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.

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.

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.

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

PubMed

Dozza, Marco; González, Nieves Pañeda

2013-11-01

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

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

PubMed

Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

2018-06-01

Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

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.

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.

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

DOT National Transportation Integrated Search

2001-01-01

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

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...

The Safety Attitudes of Senior Managers in the Chinese Coal Industry

PubMed Central

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-01-01

Introduction: Senior managers’ attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers′ attitudes towards safety in the Chinese coal industry. Method: We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions: Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers′ safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers′ unions not playing their role effectively. Practical Applications: We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry. PMID:27869654

The Safety Attitudes of Senior Managers in the Chinese Coal Industry.

PubMed

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-11-17

Introduction: Senior managers' attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers' attitudes towards safety in the Chinese coal industry. Method : We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions : Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers' safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers' unions not playing their role effectively. Practical Applications : We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry.

[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.

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

PubMed

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

2016-02-12

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

Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

DOE PAGES

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

2014-11-01

This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application ofmore » the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.« less

Human factors in waste management - potential and reality

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

Thompson, J.S.

There is enormous potential for human factors contributions in the realm of waste management. The reality, however, is very different from the potential. This is particularly true for low-level and low-level mixed-waste management. The hazards are less severe; therefore, health and safety requirements (including human factors) are not as rigorous as for high-level waste. High-level waste management presents its own unique challenges and opportunities. Waste management is strongly driven by regulatory compliance. When regulations are flexible and open to interpretation and the environment is driven so strongly by regulatory compliance, standard practice is to drop {open_quotes}nice to have{close_quotes} features, likemore » a human factors program, to save money for complying with other requirements. The challenge is to convince decision makers that human factors can help make operations efficient and cost-effective, as well as improving safety and complying with regulations. A human factors program should not be viewed as competing with compliance efforts; in fact, it should complement them and provide additional cost-effective means of achieving compliance with other regulations. Achieving this synergy of human factors with ongoing waste management operations requires educating program and facility managers and other technical specialists about human factors and demonstrating its value {open_quotes}through the back door{close_quotes} on existing efforts. This paper describes ongoing projects at Los Alamos National Laboratory (LANL) in support of their waste management groups. It includes lessons learned from hazard and risk analyses, safety analysis reports, job and task analyses, operating procedure development, personnel qualification/certification program development, and facility- and job-specific training program and course development.« less

Safety of Gadobutrol

PubMed Central

Endrikat, Jan; Vogtlaender, Kai; Dohanish, Susan; Balzer, Thomas; Breuer, Josy

2016-01-01

Objective The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. Materials and Methods Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998–2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups. Results In the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups. The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea. For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded. Conclusions Gadobutrol is well tolerated and has a favorable safety profile for patients of all age groups. PMID:26964075

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.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

PubMed

Ward, Denham S; Williams, Mark R; Berkenbosch, John W; Bhatt, Maala; Carlson, Douglas; Chappell, Phillip; Clark, Randall M; Constant, Isabelle; Conway, Aaron; Cravero, Joseph; Dahan, Albert; Dexter, Franklin; Dionne, Raymond; Dworkin, Robert H; Gan, Tong J; Gozal, David; Green, Steven; Irwin, Michael G; Karan, Suzanne; Kochman, Michael; Lerman, Jerrold; Lightdale, Jenifer R; Litman, Ronald S; Mason, Keira P; Miner, James; O'Connor, Robert E; Pandharipande, Pratik; Riker, Richard R; Roback, Mark G; Sessler, Daniel I; Sexton, Anne; Tobin, Joseph R; Turk, Dennis C; Twersky, Rebecca S; Urman, Richard D; Weiss, Mark; Wunsch, Hannah; Zhao-Wong, Anna

2018-05-17

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

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

Can incident reporting improve safety? Healthcare practitioners' views of the effectiveness of incident reporting.

PubMed

Anderson, Janet E; Kodate, Naonori; Walters, Rhiannon; Dodds, Anneliese

2013-04-01

Recent critiques of incident reporting suggest that its role in managing safety has been over emphasized. The objective of this study was to examine the perceived effectiveness of incident reporting in improving safety in mental health and acute hospital settings by asking staff about their perceptions and experiences. Qualitative research design using documentary analysis and semi-structured interviews. Two large teaching hospitals in London; one providing acute and the other mental healthcare. Sixty-two healthcare practitioners with experience of reporting and analysing incidents. Incident reporting was perceived as having a positive effect on safety, not only by leading to changes in care processes but also by changing staff attitudes and knowledge. Staff discussed examples of both instrumental and conceptual uses of the knowledge generated by incident reports. There are difficulties in using incident reports to improve safety in healthcare at all stages of the incident reporting process. Differences in the risks encountered and the organizational systems developed in the two hospitals to review reported incidents could be linked to the differences we found in attitudes to incident reporting between the two hospitals. Incident reporting can be a powerful tool for developing and maintaining an awareness of risks in healthcare practice. Using incident reports to improve care is challenging and the study highlighted the complexities involved and the difficulties faced by staff in learning from incident data.

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.

Undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkship.

PubMed

Lee, Hoo-Yeon; Hahm, Myung-Il; Lee, Sang Gyu

2018-04-04

The purpose of this study was to examine undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkships. Cross-sectional study administered in face-to-face interviews using modified the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS) from three colleges of medicine in Korea. We assessed medical students' perceptions of the cultures ('safety', 'teamwork', and 'error disclosure'), 'behavioural intentions' concerning patient safety issues and 'overall patient safety'. Confirmatory factor analysis and Spearman's correlation analyses was performed. In total, 194(91.9%) of the 211 third-year undergraduate students participated. 78% of medical students reported that the quality of care received by patients was impacted by teamwork during clinical rotations. Regarding error disclosure, positive scores ranged from 10% to 74%. Except for one question asking whether the disclosure of medical errors was an important component of patient safety (74%), the percentages of positive scores for all the other questions were below 20%. 41.2% of medical students have intention to disclose it when they saw a medical error committed by another team member. Many students had difficulty speaking up about medical errors. Error disclosure guidelines and educational efforts aimed at developing sophisticated communication skills are needed. This study may serve as a reference for other institutions planning patient safety education in their curricula. Assessing student perceptions of safety culture can provide clerkship directors and clinical service chiefs with information that enhances the educational environment and promotes patient safety.

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

PubMed

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

2013-10-01

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

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

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.

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

PubMed

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

2015-01-01

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

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

[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.

Not all risks are created equal: A twin study and meta-analyses of risk taking across seven domains.

PubMed

Wang, X T Xiao-Tian; Zheng, Rui; Xuan, Yan-Hua; Chen, Jie; Li, Shu

2016-11-01

Humans routinely deal with both traditional and novel risks. Different kinds of risks have been a driving force for both evolutionary adaptations and personal development. This study explored the genetic and environmental influences on human risk taking in different task domains. Our approach was threefold. First, we integrated several scales of domain-specific risk-taking propensity and developed a synthetic scale, including both evolutionarily typical and modern risks in the following 7 domains: cooperation/competition, safety, reproduction, natural/physical risk, moral risk, financial risk, and gambling. Second, we conducted a twin study using the scale to estimate the contributions of genes and environment to risk taking in each of these 7 domains. Third, we conducted a series of meta-analyses of extant twin studies across the 7 risk domains. The results showed that individual differences in risk-taking propensity and its consistency across domains were mainly regulated by additive genetic influences and individually unique environmental experiences. The heritability estimates from the meta-analyses ranged from 29% in financial risk taking to 55% in safety. Supporting the notion of risk-domain specificity, both the behavioral and genetic correlations among the 7 domains were generally low. Among the relatively few correlations between pairs of risk domains, our analysis revealed a common genetic factor that regulates moral, financial, and natural/physical risk taking. This is the first effort to separate genetic and environmental influences on risk taking across multiple domains in a single study and integrate the findings of extant twin studies via a series of meta-analyses conducted in different task domains. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

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.

Risk-Informed External Hazards Analysis for Seismic and Flooding Phenomena for a Generic PWR

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

Parisi, Carlo; Prescott, Steve; Ma, Zhegang

This report describes the activities performed during the FY2017 for the US-DOE Light Water Reactor Sustainability Risk-Informed Safety Margin Characterization (LWRS-RISMC), Industry Application #2. The scope of Industry Application #2 is to deliver a risk-informed external hazards safety analysis for a representative nuclear power plant. Following the advancements occurred during the previous FYs (toolkits identification, models development), FY2017 focused on: increasing the level of realism of the analysis; improving the tools and the coupling methodologies. In particular the following objectives were achieved: calculation of buildings pounding and their effects on components seismic fragility; development of a SAPHIRE code PRA modelsmore » for 3-loops Westinghouse PWR; set-up of a methodology for performing static-dynamic PRA coupling between SAPHIRE and EMRALD codes; coupling RELAP5-3D/RAVEN for performing Best-Estimate Plus Uncertainty analysis and automatic limit surface search; and execute sample calculations for demonstrating the capabilities of the toolkit in performing a risk-informed external hazards safety analyses.« less

[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".

Use of Commercial Electrical, Electronic and Electromechanical (EEE) Parts in NASA's Commercial Crew Program (CCP)

NASA Technical Reports Server (NTRS)

Gonzalex, Oscar

2012-01-01

NASA's Commercial Crew and Cargo Program (CCP) is stimulating efforts within the private sector to develop and demonstrate safe, reliable, and cost-effective space transportation capabilities. One initiative involves investigating the use of commercial electronic parts. NASA's CCP asked the NASA Engineering and Safety Center (NESC) to collect data to help frame the technical, cost, and schedule risk trades associated with electrical, electronic and electromechanical (EEE) parts selection and specifically expressed desire of some of the CCP partners to employ EEE parts of a lower grade than traditionally used in most NASA safety-critical applications. This document contains the outcome from the NESC's review and analyses.

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.

Safety assessment and detection method of genetically modified Chinese Kale (Brassica oleracea cv. alboglabra ).

PubMed

Lin, Chih-Hui; Lu, Chien-Te; Lin, Hsin-Tang; Pan, Tzu-Ming

2009-03-11

Sporamins are tuberous storage proteins and account for 80% of soluble protein in sweet potato tubers with trypsin-inhibitory activity. The expression of sporamin protein in transgenic Chinese kale (line BoA 3-1) conferred insecticidal activity toward corn earworm [ Helicoverpa armigera (Hubner)] in a previous report. In this study, we present a preliminary safety assessment of transgenic Chinese kale BoA 3-1. Bioinformatic and simulated gastric fluid (SGF) analyses were performed to evaluate the allergenicity of sporamin protein. The substantial equivalence between transgenic Chinese kale and its wild-type host has been demonstrated by the comparison of important constituents. A reliable real-time polymerase chain reaction (PCR) detection method was also developed to control sample quality. Despite the results of most evaluations in this study being negative, the safety of sporamin in transgenic Chinese kale BoA 3-1 was uncluded because of the allergenic risk revealed by bioinformatic analysis.

Applications of artificial neural networks (ANNs) in food science.

PubMed

Huang, Yiqun; Kangas, Lars J; Rasco, Barbara A

2007-01-01

Artificial neural networks (ANNs) have been applied in almost every aspect of food science over the past two decades, although most applications are in the development stage. ANNs are useful tools for food safety and quality analyses, which include modeling of microbial growth and from this predicting food safety, interpreting spectroscopic data, and predicting physical, chemical, functional and sensory properties of various food products during processing and distribution. ANNs hold a great deal of promise for modeling complex tasks in process control and simulation and in applications of machine perception including machine vision and electronic nose for food safety and quality control. This review discusses the basic theory of the ANN technology and its applications in food science, providing food scientists and the research community an overview of the current research and future trend of the applications of ANN technology in the field.

An observational analysis of surgical team compliance with perioperative safety practices after crew resource management training.

PubMed

France, Daniel J; Leming-Lee, Susie; Jackson, Tom; Feistritzer, Nancye R; Higgins, Michael S

2008-04-01

Acknowledging the need to improve team communication and coordination among health care providers, health care administrators and improvement officers have been quick to endorse and invest in aviation crew resource management (CRM). Despite the increased interest in CRM there exists limited data on the effectiveness of CRM to change team behavior and performance in clinical settings. Direct observational analyses were performed on 30 surgical teams (15 neurosurgery cases and 15 cardiac cases) to evaluate surgical team compliance with integrated safety and CRM practices after extensive CRM training. Observed surgical teams were compliant with only 60% of the CRM and perioperative safety practices emphasized in the training program. The results highlight many of the challenges the health care industry faces in its efforts to adapt CRM from aviation to medicine. Additional research is needed to develop and test new team training methods and performance feedback mechanisms for clinical teams.

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.

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

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...

Investigation of a supplementary tool to assist in the prioritization of emphasis areas in North American strategic highway safety plans.

PubMed

Park, Peter Y; Young, Jason

2012-03-01

An important potential benefit of a jurisdiction developing an upper-level traffic safety policy statement, such as a strategic highway safety plan (SHSP) or a traffic safety action plan, is the creation of a manageable number of focus areas, known as emphasis areas. The responsible agencies in the jurisdiction can then direct their finite resources in a systematic and strategic way designed to maximize the effort to reduce the number and severity of roadway collisions. In the United States, the federal government through AASHTO has suggested 22 potential emphasis areas. In Canada, CCMTA's 10 potential emphasis areas have been listed for consideration. This study reviewed the SHSP and traffic safety action plan of 53 jurisdictions in North America, and conducted descriptive data analyses to clarify the issues that currently affect the selection and prioritization process of jurisdiction-specific emphasis areas. We found that the current process relies heavily on high-level collision data analysis and communication among the SHSP stakeholders, but may not be the most efficient and effective way of selecting and prioritizing the emphasis areas and allocating safety improvement resources. This study then formulated a formal collision diagnosis test, known as the beta-binomial test, to clarify and illuminate the selection and the prioritization of jurisdiction-specific emphasis areas. We developed numerical examples to demonstrate how engineers can apply the proposed diagnosis test to improve the selection and prioritization of individual jurisdictions' emphasis areas. Copyright © 2011 Elsevier Ltd. All rights reserved.

Shuttle freezer conceptual design

NASA Technical Reports Server (NTRS)

Proctor, B. W.; Russell, D. J.

1975-01-01

A conceptual design for a kit freezer for operation onboard shuttle was developed. The freezer features a self-contained unit which can be mounted in the orbiter crew compartment and is capable of storing food at launch and returning with medical samples. Packaging schemes were investigated to provide the optimum storage capacity with a minimum weight and volume penalty. Several types of refrigeration systems were evaluated to select one which would offer the most efficient performance and lowest hazard of safety to the crew. Detailed performance data on the selected, Stirling cycle principled refrigeration unit were developed to validate the feasibility of its application to this freezer. Thermal analyses were performed to determine the adequacy of the thermal insulation to maintain the desired storage temperature with the design cooling capacity. Stress analyses were made to insure the design structure integrity could be maintained over the shuttle flight regime. A proposed prototype freezer development plan is presented.

Applying U.S. EOP Analytical Justification Experience for VVER Plants in the Ukraine

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

Linn, Paul A.; Julian, Harold V.; Chapman, James R.

2002-07-01

The foundation for new Emergency Operating Instructions (EOIs) being developed at several plants in the Ukraine is the Westinghouse Owners Group (WOG) Emergency Response Guidelines (ERGs) developed in the U.S. The ERGs were chosen as a base for the new EOIs for several reasons. First the overall structure and format was adaptable to VVER Pressurized Water Reactor (PWR) designs. Second, the ERGs have served as a base for many plant EOIs in both the U.S. and internationally. Third, key information supporting the ERGs was available. This paper describes the method used at one of the Ukrainian plants to provide anmore » analytical justification for their EOIs. The method being employed by a second plant is very similar, differing only slightly in how it is implemented. The WOG ERG development program, which started shortly after the accident at Three Mile Island Unit 2, used many sources of technical information on plant and system transient response, which were available in support of the plant design and licensing efforts. In addition, operating experience from many operating PWR plants in the U.S. and around the world was used. For example, design basis accident (DBA) analyses, documented in a plant's Safety Analysis Report (SAR) and other design documents, had been performed by Nuclear Steam Supply System (NSSS) vendors, utilities, or the Architect/Engineer. All relevant sources were considered in the development of the ERGs. Limited Probabilistic Risk Assessment (PRA) analyses were available during that time period. When a technical basis for a recovery strategy and associated operator actions was not available, an analysis was defined and performed. In general, these analyses were performed on a generic basis, and addressed the different categories of design (e.g., number of reactor coolant loops and/or low/high pressure safety injection system design). U.S. Nuclear Power plants that were in the WOG program were responsible for implementing the generic ERGs. This required the utilities to review the generic analyses to ensure that they were applicable and to justify any deviations from the ERG methodology. Modern PRA analyses are similar to the analyses supporting the ERGs since they address multiple failures and assume better estimate or expected assumptions for equipment availability and operator performance. The process being employed by Ukrainian plants is similar to the WOG. That is, available analyses and operating experience are being reviewed and pertinent information extracted to assist in the analytical justification of the EOIs. This includes the use of recently updated PRA and DBA analyses, other 'original' design information and operating experience. A systematic review of the EOIs is being conducted to identify items requiring analytical justification. For each analysis identified, the specific purpose of the analysis is being documented. The analysis needs are then compared to the available analyses and operating experience. From this review, new analyses needed to justify the EOIs are developed, and a basis for using existing analyses is established. The work is being conducted in two phases. The first phase performs all of the reviews and assessments necessary to determine the new analyses required to justify the EOIs. In the second phase, these new analyses will be conducted and documented, and the EOI Analytical Justification (AJ) report will be written. (authors)« less

A formative evaluation of the implementation of a medication safety data collection tool in English healthcare settings: A qualitative interview study using normalisation process theory.

PubMed

Rostami, Paryaneh; Ashcroft, Darren M; Tully, Mary P

2018-01-01

Reducing medication-related harm is a global priority; however, impetus for improvement is impeded as routine medication safety data are seldom available. Therefore, the Medication Safety Thermometer was developed within England's National Health Service. This study aimed to explore the implementation of the tool into routine practice from users' perspectives. Fifteen semi-structured interviews were conducted with purposely sampled National Health Service staff from primary and secondary care settings. Interview data were analysed using an initial thematic analysis, and subsequent analysis using Normalisation Process Theory. Secondary care staff understood that the Medication Safety Thermometer's purpose was to measure medication safety and improvement. However, other uses were reported, such as pinpointing poor practice. Confusion about its purpose existed in primary care, despite further training, suggesting unsuitability of the tool. Decreased engagement was displayed by staff less involved with medication use, who displayed less ownership. Nonetheless, these advocates often lacked support from management and frontline levels, leading to an overall lack of engagement. Many participants reported efforts to drive scale-up of the use of the tool, for example, by securing funding, despite uncertainty around how to use data. Successful improvement was often at ward-level and went unrecognised within the wider organisation. There was mixed feedback regarding the value of the tool, often due to a perceived lack of "capacity". However, participants demonstrated interest in learning how to use their data and unexpected applications of data were reported. Routine medication safety data collection is complex, but achievable and facilitates improvements. However, collected data must be analysed, understood and used for further work to achieve improvement, which often does not happen. The national roll-out of the tool has accelerated shared learning; however, a number of difficulties still exist, particularly in primary care settings, where a different approach is likely to be required.

A formative evaluation of the implementation of a medication safety data collection tool in English healthcare settings: A qualitative interview study using normalisation process theory

PubMed Central

Ashcroft, Darren M.; Tully, Mary P.

2018-01-01

Background Reducing medication-related harm is a global priority; however, impetus for improvement is impeded as routine medication safety data are seldom available. Therefore, the Medication Safety Thermometer was developed within England’s National Health Service. This study aimed to explore the implementation of the tool into routine practice from users’ perspectives. Method Fifteen semi-structured interviews were conducted with purposely sampled National Health Service staff from primary and secondary care settings. Interview data were analysed using an initial thematic analysis, and subsequent analysis using Normalisation Process Theory. Results Secondary care staff understood that the Medication Safety Thermometer’s purpose was to measure medication safety and improvement. However, other uses were reported, such as pinpointing poor practice. Confusion about its purpose existed in primary care, despite further training, suggesting unsuitability of the tool. Decreased engagement was displayed by staff less involved with medication use, who displayed less ownership. Nonetheless, these advocates often lacked support from management and frontline levels, leading to an overall lack of engagement. Many participants reported efforts to drive scale-up of the use of the tool, for example, by securing funding, despite uncertainty around how to use data. Successful improvement was often at ward-level and went unrecognised within the wider organisation. There was mixed feedback regarding the value of the tool, often due to a perceived lack of “capacity”. However, participants demonstrated interest in learning how to use their data and unexpected applications of data were reported. Conclusion Routine medication safety data collection is complex, but achievable and facilitates improvements. However, collected data must be analysed, understood and used for further work to achieve improvement, which often does not happen. The national roll-out of the tool has accelerated shared learning; however, a number of difficulties still exist, particularly in primary care settings, where a different approach is likely to be required. PMID:29489842

Current and anticipated uses of thermal-hydraulic codes in Germany

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

Teschendorff, V.; Sommer, F.; Depisch, F.

1997-07-01

In Germany, one third of the electrical power is generated by nuclear plants. ATHLET and S-RELAP5 are successfully applied for safety analyses of the existing PWR and BWR reactors and possible future reactors, e.g. EPR. Continuous development and assessment of thermal-hydraulic codes are necessary in order to meet present and future needs of licensing organizations, utilities, and vendors. Desired improvements include thermal-hydraulic models, multi-dimensional simulation, computational speed, interfaces to coupled codes, and code architecture. Real-time capability will be essential for application in full-scope simulators. Comprehensive code validation and quantification of uncertainties are prerequisites for future best-estimate analyses.

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

PubMed

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

2018-03-27

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

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.

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.

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

PubMed

Dirik, Hasan Fehmi; Intepeler, Seyda Seren

2017-05-01

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

Posttraumatic stress disorder, alcohol use, and perceived safety after the terrorist attack on the pentagon.

PubMed

Grieger, Thomas A; Fullerton, Carol S; Ursano, Robert J

2003-10-01

The authors examined posttraumatic stress disorder (PTSD), alcohol use, and perceptions of safety in a sample of survivors of the September 11, 2001, terrorist attack on the Pentagon. Analyses were conducted to examine the effect of past traumatic experience, trauma exposure, initial emotional response, and peritraumatic dissociation on probable PTSD, substance use, and perceived safety among 77 survivors seven months after the attack. Eleven respondents (14 percent) had PTSD. Those with PTSD reported higher levels of initial emotional response and peritraumatic dissociation. Ten respondents (13 percent) reported increased use of alcohol. Women were more than five times as likely as men to have PTSD and almost seven times as likely to report increased use of alcohol. Persons with higher peritraumatic dissociation were more likely to develop PTSD and report increased alcohol use. Those with lower perceived safety at seven months had higher initial emotional response and greater peritraumatic dissociation and were more likely to have PTSD, to have increased alcohol use, and to be female. The association of perceived safety with gender, the presence of PTSD, and increased alcohol use among survivors of the terrorist attack on the Pentagon warrants further study.

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

Flutter Analysis of the Shuttle Tile Overlay Repair Concept

NASA Technical Reports Server (NTRS)

Bey, Kim S.; Scott, Robert C.; Bartels, Robert E.; Waters, William A.; Chen, Roger

2007-01-01

The Space Shuttle tile overlay repair concept, developed at the NASA Johnson Space Center, is designed for on-orbit installation over an area of damaged tile to permit safe re-entry. The thin flexible plate is placed over the damaged area and secured to tile at discreet points around its perimeter. A series of flutter analyses were performed to determine if the onset of flutter met the required safety margins. Normal vibration modes of the panel, obtained from a simplified structural analysis of the installed concept, were combined with a series of aerodynamic analyses of increasing levels of fidelity in terms of modeling the flow physics to determine the onset of flutter. Results from these analyses indicate that it is unlikely that the overlay installed at body point 1800 will flutter during re-entry.

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 ...

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

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

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

Visual analytics for aviation safety: A collaborative approach to sensemaking

NASA Astrophysics Data System (ADS)

Wade, Andrew

Visual analytics, the "science of analytical reasoning facilitated by interactive visual interfaces", is more than just visualization. Understanding the human reasoning process is essential for designing effective visualization tools and providing correct analyses. This thesis describes the evolution, application and evaluation of a new method for studying analytical reasoning that we have labeled paired analysis. Paired analysis combines subject matter experts (SMEs) and tool experts (TE) in an analytic dyad, here used to investigate aircraft maintenance and safety data. The method was developed and evaluated using interviews, pilot studies and analytic sessions during an internship at the Boeing Company. By enabling a collaborative approach to sensemaking that can be captured by researchers, paired analysis yielded rich data on human analytical reasoning that can be used to support analytic tool development and analyst training. Keywords: visual analytics, paired analysis, sensemaking, boeing, collaborative analysis.

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

PubMed

Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

2017-09-11

The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development reached by drugs represents a specific risk factor for failures. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Assessment of 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.

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

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence

PubMed Central

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-01-01

Introduction Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. Methods and analysis A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in ‘patient safety’ and ‘economic analyses’ has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. Trial registration number CRD42017057853. PMID:28821527

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.

Validation of the French version of the Hospital Survey on Patient Safety Culture questionnaire.

PubMed

Occelli, P; Quenon, J-L; Kret, M; Domecq, S; Delaperche, F; Claverie, O; Castets-Fontaine, B; Amalberti, R; Auroy, Y; Parneix, P; Michel, P

2013-09-01

To assess the psychometric properties of the French version of the Hospital Survey on Patient Safety Culture questionnaire (HSOPSC) and study the hierarchical structure of the measured dimensions. Cross-sectional survey of the safety culture. 18 acute care units of seven hospitals in South-western France. Full- and part-time healthcare providers who worked in the units. None. Item responses measured with 5-point agreement or frequency scales. Data analyses A principal component analysis was used to identify the emerging components. Two structural equation modeling methods [LInear Structural RELations (LISREL) and Partial Least Square (PLS)] were used to verify the model and to study the relative importance of the dimensions. Internal consistency of the retained dimensions was studied. A test-retest was performed to assess reproducibility of the items. Overall response rate was 77% (n = 401). A structure in 40 items grouped in 10 dimensions was proposed. The LISREL approach showed acceptable data fit of the proposed structure. The PLS approach indicated that three dimensions had the most impact on the safety culture: 'Supervisor/manager expectations & actions promoting safety' 'Organizational learning-continuous improvement' and 'Overall perceptions of safety'. Internal consistency was above 0.70 for six dimensions. Reproducibility was considered good for four items. The French HSOPSC questionnaire showed acceptable psychometric properties. Classification of the dimensions should guide future development of safety culture improving action plans.

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.

Drivers' safety needs, behavioural adaptations and acceptance of new driving support systems.

PubMed

Saad, Farida; Van Elslande, Pierre

2012-01-01

The aim of this paper is to discuss the contribution of two complementary approaches for designing and evaluating new driver support systems likely to improve the operation and safety of the road traffic system. The first approach is based on detailed analyses of traffic crashes so as to estimate drivers' needs for assistance and the situational constraints that safety functions should address to be efficient. The second approach is based on in depth-analyses of behavioral adaptations induced by the usage of new driver support systems in regular driving situations and on drivers' acceptance of the assistance provided by the systems.

Towards an International Classification for Patient Safety: a Delphi survey.

PubMed

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-02-01

Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. International web-based survey of expert opinion. Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur.

Towards an International Classification for Patient Safety: a Delphi survey

PubMed Central

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-01-01

Objective Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Design Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. Setting International web-based survey of expert opinion. Participants Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. Results In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. Conclusions The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur. PMID:19147596

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

Translating New Science Into the Drug Review Process

PubMed Central

Rouse, Rodney; Kruhlak, Naomi; Weaver, James; Burkhart, Keith; Patel, Vikram; Strauss, David G.

2017-01-01

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. The Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry. The Division is able to rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. This article reviews the Division’s recent work and future directions, highlighting development and validation of biomarkers; novel humanized animal models; translational predictive safety combining in vitro, in silico, and in vivo clinical biomarkers; chemical and biomedical informatics tools for safety predictions; novel approaches to speed the development of complex generic drugs, biosimilars, and antibiotics; and precision medicine. PMID:29568713

Green Propellant Landing Demonstration at U.S. Range

NASA Technical Reports Server (NTRS)

Mulkey, Henry W.; Miller, Joseph T.; Bacha, Caitlin E.

2016-01-01

The Green Propellant Loading Demonstration (GPLD) was conducted December 2015 at Wallops Flight Facility (WFF), leveraging work performed over recent years to bring lower toxicity hydrazine replacement green propellants to flight missions. The objective of this collaboration between NASA Goddard Space Flight Center (GSFC), WFF, the Swedish National Space Board (SNSB), and Ecological Advanced Propulsion Systems (ECAPS) was to successfully accept LMP-103S propellant at a U.S. Range, store the propellant, and perform a simulated flight vehicle propellant loading. NASA GSFC Propulsion (Code 597) managed all aspects of the operation, handling logistics, preparing the procedures, and implementing the demonstration. In addition to the partnership described above, Moog Inc. developed an LMP-103S propellant-compatible titanium rolling diaphragm flight development tank and loaned it to GSFC to act as the GPLD flight vessel. The flight development tank offered the GPLD an additional level of flight-like propellant handling process and procedures. Moog Inc. also provided a compatible latching isolation valve for remote propellant expulsion. The GPLD operation, in concert with Moog Inc. executed a flight development tank expulsion efficiency performance test using LMP-103S propellant. As part of the demonstration work, GSFC and WFF documented Range safety analyses and practices including all elements of shipping, storage, handling, operations, decontamination, and disposal. LMP-103S has not been previously handled at a U.S. Launch Range. Requisite for this activity was an LMP-103S Risk Analysis Report and Ground Safety Plan. GSFC and WFF safety offices jointly developed safety documentation for application into the GPLD operation. The GPLD along with the GSFC Propulsion historical hydrazine loading experiences offer direct comparison between handling green propellant versus safety intensive, highly toxic hydrazine propellant. These described motives initiated the GPLD operation in order to investigate the handling and process safety variances in project resources between LMP-103S and typical in-space propellants. The GPLD risk reduction operation proved successful for many reasons including handling the green propellant at a U.S. Range, loading and pressurizing a flight-like tank, expelling the propellant, measuring the tank expulsion efficiency, and most significantly, GSFC propulsion personnel's new insight into the LMP-103S propellant handling details.

Green Propellant Loading Demonstration at U.S. Range

NASA Technical Reports Server (NTRS)

Mulkey, Henry W.; Miller, Joseph T.; Bacha, Caitlin E.

2016-01-01

The Green Propellant Loading Demonstration (GPLD) was conducted December 2015 at Wallops Flight Facility (WFF), leveraging work performed over recent years to bring lower toxicity hydrazine replacement green propellants to flight missions. The objective of this collaboration between NASA Goddard Space Flight Center (GSFC), WFF, the Swedish National Space Board (SNSB), and Ecological Advanced Propulsion Systems (ECAPS) was to successfully accept LMP-103S propellant at a U.S. Range, store the propellant, and perform a simulated flight vehicle propellant loading. NASA GSFC Propulsion (Code 597) managed all aspects of the operation, handling logistics, preparing the procedures, and implementing the demonstration. In addition to the partnership described above, Moog Inc. developed an LMP-103S propellant-compatible titanium rolling diaphragm flight development tank and loaned it to GSFC to act as the GPLD flight vessel. The flight development tank offered the GPLD an additional level of flight-like propellant handling process and procedures. Moog Inc. also provided a compatible latching isolation valve for remote propellant expulsion. The GPLD operation, in concert with Moog Inc. executed a flight development tank expulsion efficiency performance test using LMP-103S propellant. As part of the demonstration work, GSFC and WFF documented Range safety analyses and practices including all elements of shipping, storage, handling, operations, decontamination, and disposal. LMP-103S has not been previously handled at a U.S. Launch Range. Requisite for this activity was an LMP-103S Risk Analysis Report and Ground Safety Plan. GSFC and WFF safety offices jointly developed safety documentation for application into the GPLD operation. The GPLD along with the GSFC Propulsion historical hydrazine loading experiences offer direct comparison between handling green propellant versus safety intensive, highly toxic hydrazine propellant. These described motives initiated the GPLD operation in order to investigate the handling and process safety variances in project resources between LMP-103S and typical in-space propellants. The GPLD risk reduction operation proved successful for many reasons including handling the green propellant at a U.S. Range, loading and pressurizing a flight-like tank, expelling the propellant, measuring the tank expulsion efficiency, and most significantly, GSFC propulsion personnel's new insight into the LMP-103S propellant handling details.

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

PubMed

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

2012-09-01

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

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

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.

The role of the PIRT process in identifying code improvements and executing code development

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

Wilson, G.E.; Boyack, B.E.

1997-07-01

In September 1988, the USNRC issued a revised ECCS rule for light water reactors that allows, as an option, the use of best estimate (BE) plus uncertainty methods in safety analysis. The key feature of this licensing option relates to quantification of the uncertainty in the determination that an NPP has a {open_quotes}low{close_quotes} probability of violating the safety criteria specified in 10 CFR 50. To support the 1988 licensing revision, the USNRC and its contractors developed the CSAU evaluation methodology to demonstrate the feasibility of the BE plus uncertainty approach. The PIRT process, Step 3 in the CSAU methodology, wasmore » originally formulated to support the BE plus uncertainty licensing option as executed in the CSAU approach to safety analysis. Subsequent work has shown the PIRT process to be a much more powerful tool than conceived in its original form. Through further development and application, the PIRT process has shown itself to be a robust means to establish safety analysis computer code phenomenological requirements in their order of importance to such analyses. Used early in research directed toward these objectives, PIRT results also provide the technical basis and cost effective organization for new experimental programs needed to improve the safety analysis codes for new applications. The primary purpose of this paper is to describe the generic PIRT process, including typical and common illustrations from prior applications. The secondary objective is to provide guidance to future applications of the process to help them focus, in a graded approach, on systems, components, processes and phenomena that have been common in several prior applications.« less

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...

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.

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

PubMed

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

2014-02-24

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

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

PubMed Central

2014-01-01

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

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

PubMed

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

2016-06-01

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

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.

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.

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...

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.

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.

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.

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.

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

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

PubMed

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

2015-08-01

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

Prevalence and occupational predictors of psychological distress in the offshore petroleum industry: a prospective study.

PubMed

Nielsen, Morten Birkeland; Tvedt, Sturle Danielsen; Matthiesen, Stig Berge

2013-11-01

This study investigates the prevalence of psychological distress and stressors in the work environment as prospective predictors of distress, among employees in the offshore petroleum industry. Correlation and logistic regression analyses were employed to examine longitudinal relationships between stressors and distress in a randomly drawn sample of 741 employees from the Norwegian petroleum offshore industry. Time lag between baseline and follow-up was 6 months. Work environment stressors included safety factors, leadership, and job characteristics. The prevalence of psychological distress was 9 % at baseline and 8 % at follow-up. All investigated work environment factors correlated with subsequent distress. In bivariate logistic regression analyses, caseness of distress was predicted by baseline distress, near miss accidents, risk perception, poor safety climate, tyrannical leadership, laissez-faire leadership, job demands, and workplace bullying. After adjustment for baseline distress, control variables, and other predictors, laissez-faire leadership (OR = 1.69; 95 % CI: 1.12-2.54) and exposure to bullying (OR = 1.49; 95 % CI: 1.07-2.10) emerged as the most robust predictors of subsequent distress. The findings show that the prevalence of psychological distress is lower among offshore employees than in the general population. Although offshore workers operate in a physically challenging context, their mental health is mainly influenced by stressors in the psychosocial work environment. This highlights the importance of developing and implementing psychosocial safety interventions within the offshore industry.

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

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

NONE

1998-07-01

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

Human papillomavirus vaccine and demyelinating diseases-A systematic review and meta-analysis.

PubMed

Mouchet, Julie; Salvo, Francesco; Raschi, Emanuel; Poluzzi, Elisabetta; Antonazzo, Ippazio Cosimo; De Ponti, Fabrizio; Bégaud, Bernard

2018-06-01

Approved in 2006, human papillomavirus (HPV) vaccines were initially targeted for girls aged 9-14 years. Although the safety of these vaccines has been monitored through post-licensure surveillance programmes, cases of neurological events have been reported worldwide. The present study aimed to assess the risk of developing demyelination after HPV immunization by meta-analysing risk estimates from pharmacoepidemiologic studies. A systematic review was conducted in Medline, Embase, ISI Web of Science and the Cochrane Library from inception to 10 May 2017, without language restriction. Only observational studies including a control group were retained. Study selection was performed by two independent reviewers with disagreements solved through discussion. This meta-analysis was performed using a generic inverse variance random-effect model. Outcomes of interest included a broad category of central demyelination, multiple sclerosis (MS), optic neuritis (ON), and Guillain-Barré syndrome (GBS), each being considered independently. Heterogeneity was investigated; sensitivity and subgroup analyses were performed when necessary. In parallel, post-licensure safety studies were considered for a qualitative review. This study followed the PRISMA statement and the MOOSE reporting guideline. Of the 2,863 references identified, 11 articles were selected for meta-analysis. No significant association emerged between HPV vaccination and central demyelination, the pooled odds ratio being 0.96 [95% CI 0.77-1.20], with a moderate but non-significant heterogeneity (I 2  = 29%). Similar results were found for MS and ON. Sensitivity analyses did not alter our conclusions. Findings from qualitative review of 14 safety studies concluded in an absence of a relevant signal. Owing to limited data on GBS, no meta-analysis was performed for this outcome. This study strongly supports the absence of association between HPV vaccines and central demyelination. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

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.

Development of Cognitive Bias Modification (CBM) Tools to Promote Adjustment During Reintegration Following Deployment

DTIC Science & Technology

2015-11-01

addressed in Study 1, was to measure the associations between state and trait anger and biases in anger-related attention and interpretation. This aim was...presented in the recent MOMRP conference, and physiological SCR data are in the last stages of analyses. 15. SUBJECT TERMS anger, aggression, attention ...threat conditions, ranging from safety to acute danger, considerable plasticity in threat-related attention and threat interpretation is required

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

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

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.

WHO policy development processes for a new vaccine: case study of malaria vaccines.

PubMed

Milstien, Julie; Cárdenas, Vicky; Cheyne, James; Brooks, Alan

2010-06-24

Recommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine. The decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions. WHO policy formulation related to use of intermittent preventive treatment in infancy (IPTi) and the following vaccine interventions: Haemophilus influenzae type b conjugate vaccine (Hib), pneumococcal conjugate vaccine (PCV), rotavirus vaccine (RV), and human papillomavirus vaccine (HPV), five interventions which had relatively recently been through systematic WHO policy development processes as currently constituted, was analysed. Required information was categorized in three areas defined by a recent WHO publication on development of guidelines: safety and efficacy in relevant populations, implications for costs and population health, and localization of data to specific epidemiological situations. Data needs for a malaria vaccine include safety; the demonstration of efficacy in a range of epidemiological settings in the context of other malaria prevention interventions; and information on potential rebound in which disease increases subsequent to the intervention. In addition, a malaria vaccine would require attention to additional factors, such as costs and cost-effectiveness, supply and demand, impact of use on other interventions, and distribution issues. Although policy issues may be more complex for future vaccines, the lead-time between the date of product regulatory approval and a recommendation for its use in developing countries is decreasing. This study presents approaches to define in advance core data needs to support evidence-based decisions, to further decrease this lead-time, accelerating the availability of a malaria vaccine. Specific policy areas for which information should be collected are defined, including studying its use within the context of other malaria interventions.

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

Gauglitz, Phillip A.; Bontha, Jagannadha R.; Daniel, Richard C.

The Hanford Waste Treatment and Immobilization Plant (WTP) is currently being designed and constructed to pretreat and vitrify a large portion of the waste in the 177 underground waste storage tanks at the Hanford Site. A number of technical issues related to the design of the pretreatment facility (PTF) of the WTP have been identified. These issues must be resolved prior to the U.S. Department of Energy (DOE) Office of River Protection (ORP) reaching a decision to proceed with engineering, procurement, and construction activities for the PTF. One of the issues is Technical Issue T1 - Hydrogen Gas Release frommore » Vessels (hereafter referred to as T1). The focus of T1 is identifying controls for hydrogen release and completing any testing required to close the technical issue. In advance of selecting specific controls for hydrogen gas safety, a number of preliminary technical studies were initiated to support anticipated future testing and to improve the understanding of hydrogen gas generation, retention, and release within PTF vessels. These activities supported the development of a plan defining an overall strategy and approach for addressing T1 and achieving technical endpoints identified for T1. Preliminary studies also supported the development of a test plan for conducting testing and analysis to support closing T1. Both of these plans were developed in advance of selecting specific controls, and in the course of working on T1 it was decided that the testing and analysis identified in the test plan were not immediately needed. However, planning activities and preliminary studies led to significant technical progress in a number of areas. This report summarizes the progress to date from the preliminary technical studies. The technical results in this report should not be used for WTP design or safety and hazards analyses and technical results are marked with the following statement: “Preliminary Technical Results for Planning – Not to be used for WTP Design or Safety Analyses.”« less

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.

Recent progress in the development of polysaccharide conjugates of docetaxel and paclitaxel

PubMed Central

Roy, Aniruddha; Bhattacharyya, Mousumi; Ernsting, Mark J.; May, Jonathan P; Li, Shyh-Dar

2014-01-01

Taxanes are one of the most potent and broadest spectrum chemotherapeutics used clinically, but also induce significant side effects. Different strategies have been developed to produce a safer taxane formulation. Development of polysaccharide drug conjugates has increased in the recent years due to the demonstrated biocompatibility, biodegradability, safety and low cost of the biopolymers. This review focuses on polysaccharide taxane conjugates and provides an overview on various conjugation strategies and their effect on the efficacy. Detailed analyses on the designing factors of an effective polysaccharide drug conjugate are provided with a discussion on the future direction of this field. PMID:24652678

The Royal Australian and New Zealand College of Radiologists (RANZCR) relative value unit workload model, its limitations and the evolution to a safety, quality and performance framework.

PubMed

Pitman, A; Jones, D N; Stuart, D; Lloydhope, K; Mallitt, K; O'Rourke, P

2009-10-01

The study reports on the evolution of the Australian radiologist relative value unit (RVU) model of measuring radiologist reporting workloads in teaching hospital departments, and aims to outline a way forward for the development of a broad national safety, quality and performance framework that enables value mapping, measurement and benchmarking. The Radiology International Benchmarking Project of Queensland Health provided a suitable high-level national forum where the existing Pitman-Jones RVU model was applied to contemporaneous data, and its shortcomings and potential avenues for future development were analysed. Application of the Pitman-Jones model to Queensland data and also a Victorian benchmark showed that the original recommendation of 40,000 crude RVU per full-time equivalent consultant radiologist (97-98 baseline level) has risen only moderately, to now lie around 45,000 crude RVU/full-time equivalent. Notwithstanding this, the model has a number of weaknesses and is becoming outdated, as it cannot capture newer time-consuming examinations particularly in CT. A significant re-evaluation of the value of medical imaging is required, and is now occurring. We must rethink how we measure, benchmark, display and continually improve medical imaging safety, quality and performance, throughout the imaging care cycle and beyond. It will be necessary to ensure alignment with patient needs, as well as clinical and organisational objectives. Clear recommendations for the development of an updated national reporting workload RVU system are available, and an opportunity now exists for developing a much broader national model. A more sophisticated and balanced multidimensional safety, quality and performance framework that enables measurement and benchmarking of all important elements of health-care service is needed.

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

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.

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...

Medical Device Safety

MedlinePlus

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

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.

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.

Measuring safety culture in Dutch primary care: psychometric characteristics of the SCOPE-PC questionnaire.

PubMed

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

2013-09-17

Patient safety has been a priority in primary healthcare in the last years. The prevailing culture is seen as an important condition for patient safety in practice and several tools to measure patient safety culture have therefore been developed. Although Dutch primary care consists of different professions, such as general practice, dental care, dietetics, physiotherapy and midwifery, a safety culture questionnaire was only available for general practices. The purpose of this study was to modify and validate this existing questionnaire to a generic questionnaire for all professions in Dutch primary care. A validated Dutch questionnaire for general practices was modified to make it usable for all Dutch primary care professions. Subsequently, this questionnaire was administered to a random sample of 2400 practices from eleven primary care professions. The instrument's factor structure, reliability and validity were examined using confirmatory and explorative factor analyses. 921 questionnaires were returned. Of these, 615 were eligible for factor analysis. The resulting SCOPE-PC questionnaire consisted of seven dimensions: 'open communication and learning from errors', 'handover and teamwork', 'adequate procedures and working conditions', 'patient safety management', 'support and fellowship', 'intention to report events' and 'organisational learning' with a total of 41 items. All dimensions had good reliability with Cronbach's alphas ranging from 0.70-0.90, and the questionnaire had a good construct validity. The SCOPE-PC questionnaire has sound psychometric characteristics for use by the different professions in Dutch primary care to gain insight in their safety culture.

Communication elements supporting patient safety in psychiatric inpatient care.

PubMed

Kanerva, A; Kivinen, T; Lammintakanen, J

2015-06-01

Communication is important for safe and quality health care. The study provides needed insight on the communication elements that support patient safety from the psychiatric care view. Fluent information transfer between the health care professionals and care units is important for care planning and maintaining practices. Information should be documented and implemented accordingly. Communication should happen in an open communication culture that enables discussion, the opportunity to have debriefing discussions and the entire staff can feel they are heard. For effective communication, it is also important that staff are active themselves in information collecting about the essential information needed in patient care. In mental health nursing, it is important to pay attention to all elements of communication and to develop processes concerning communication in multidisciplinary teams and across unit boundaries. The study aims to describe which communication elements support patient safety in psychiatric inpatient care from the viewpoint of the nursing staff. Communication is an essential part of care and one of the core competencies of the psychiatric care. It enables safe and quality patient care. Errors in health care are often connected with poor communication. The study brings needed insight from the psychiatric care view to the topic. The data were gathered from semi-structured interviews in which 26 nurses were asked to describe the elements that constitute patient safety in psychiatric inpatient care. The data were analysed inductively from the viewpoint of communication. The descriptions connected with communication formed a main category of communication elements that support patient safety; this main category was made up of three subcategories: fluent information transfer, open communication culture and being active in information collecting. Fluent information transfer consists of the practical implementation of communication; open communication culture is connected with the cultural issues of communication; and being active in information collecting is related to a nurse's personal working style, which affects communication. It is important to pay attention to all the three areas and use this knowledge in developing patient safety practices and strategies where communication aspect and culture are noted and developed. In mental health nursing, it is important to develop processes concerning communication in multidisciplinary teams and across unit boundaries. © 2015 John Wiley & Sons Ltd.

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.

First-order reliability application and verification methods for semistatic structures

NASA Astrophysics Data System (ADS)

Verderaime, V.

1994-11-01

Escalating risks of aerostructures stimulated by increasing size, complexity, and cost should no longer be ignored in conventional deterministic safety design methods. The deterministic pass-fail concept is incompatible with probability and risk assessments; stress audits are shown to be arbitrary and incomplete, and the concept compromises the performance of high-strength materials. A reliability method is proposed that combines first-order reliability principles with deterministic design variables and conventional test techniques to surmount current deterministic stress design and audit deficiencies. Accumulative and propagation design uncertainty errors are defined and appropriately implemented into the classical safety-index expression. The application is reduced to solving for a design factor that satisfies the specified reliability and compensates for uncertainty errors, and then using this design factor as, and instead of, the conventional safety factor in stress analyses. The resulting method is consistent with current analytical skills and verification practices, the culture of most designers, and the development of semistatic structural designs.

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.

Balancing efficacy against safety in sublingual immunotherapy with inhalant allergens: what is the best approach?

PubMed

Caminati, Marco; Dama, Annarita; Schiappoli, Michele; Senna, Gianenrico

2013-10-01

Over the last 20 years, studies and clinical trials have demonstrated efficacy, safety and cost-effectiveness of sublingual immunotherapy (SLIT) for respiratory allergic diseases. Nevertheless, it seems to be mostly used as a second-line therapeutic option, and adherence to treatment is not always optimal. Selective literature research was done in Medline and PubMed, including guidelines, position papers and Cochrane meta-analyses concerning SLIT in adult patients. The most recent reviews confirm SLIT as viable and efficacious treatment especially for allergic rhinitis, even if the optimal dosage, duration, schedule are not clearly established for most of the products. Despite an optimal safety profile, tolerability and patient-reported outcomes concerning SLIT have received poor attention until now. Recently, new tools have been specifically developed in order to investigate these aspects. Regular assessment of tolerability profile and SLIT-related patient-reported outcomes will allow balancing efficacy with tolerability and all the other patient-related variables that may affect treatment effectiveness beyond its efficacy.

Feedback facilitates transfer of training with US Hispanic workers in a healthcare laundry linen facility.

PubMed

Lebbon, Angela R; Lee, Sin Chien; Johnson, Douglas A

2015-12-01

This study aimed to increase safety knowledge and behaviour of US Hispanic custodial workers in healthcare through a culturally appropriate training and monitoring process. A single-group, repeated-measures, pre-test and post-test design was used to examine training effectiveness across four sets of behaviours with 23 Spanish-speaking workers. Small group, lecture-style training in Spanish with pictures and video resulted in significant improvements in knowledge and behaviour. However, additional analyses show that behavioural feedback was the critical component in improving safety behaviour during transfer of training. Findings from reaction, knowledge, behaviour and results measures suggest that group training and graphic feedback is culturally appropriate and effective with Hispanic workers. Further investigation is needed to understand cultural factors that facilitate effective development and delivery of safety training and feedback to US Hispanic workers. 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/

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.

A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment

PubMed Central

Nel, Andre E.; Nasser, Elina; Godwin, Hilary; Avery, David; Bahadori, Tina; Bergeson, Lynn; Beryt, Elizabeth; Bonner, James C.; Boverhof, Darrell; Carter, Janet; Castranova, Vince; DeShazo, J. R.; Hussain, Saber M.; Kane, Agnes B.; Klaessig, Fred; Kuempel, Eileen; Lafranconi, Mark; Landsiedel, Robert; Malloy, Timothy; Miller, Mary Beth; Morris, Jeffery; Moss, Kenneth; Oberdorster, Gunter; Pinkerton, Kent; Pleus, Richard C.; Shatkin, Jo Anne; Thomas, Rusty; Tolaymat, Thabet; Wang, Amy; Wong, Jeffrey

2014-01-01

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles to discuss the utility of ATS for decision-making analyses of ENMs. After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. PMID:23924032

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.

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.

Cardiac rehabilitation and the therapeutic environment: the importance of physical, social, and symbolic safety for programme participation among women.

PubMed

Sutton, Erica J; Rolfe, Danielle E; Landry, Mireille; Sternberg, Leonard; Price, Jennifer A D

2012-08-01

To report an exploration of the multidimensionality of safety in cardiac rehabilitation programmes as perceived by women who were enrolled in the Women's Cardiovascular Health Initiative in Toronto, Canada. Cardiovascular disease is the leading cause of death among women. Although cardiac rehabilitation is clinically effective, significantly fewer women than men participate in available programmes. The literature identifies factors affecting women's cardiac rehabilitation participation, and provides possible explanations for this gender disparity. Although safety is mentioned among the barriers to women's cardiac rehabilitation participation, the extent to which safety contributes to programme participation, completion, and maintenance remains under-explored in the cardiac rehabilitation literature. We conducted an exploratory qualitative study to examine the role safety and place play for women engaged in cardiac prevention and rehabilitation at the Women's Cardiovascular Health Initiative. Methods.  From 2005-2006, 14 participants engaged in semi-structured, qualitative interviews lasting 30-90 minutes. Discussions addressed women's experiences at the Women's Cardiovascular Health Initiative. Interview transcripts were analysed using thematic analysis. Three themes were developed: 'Safety', which was sub-categorized according to physical, social, and symbolic interpretations of safety, 'searching for a sense of place', and 'confidence and empowerment'. Feeling physically, socially, and symbolically safe in one's cardiac rehabilitation environment may contribute to programme adherence and exercise maintenance for women. Focusing on comprehensive notions of safety in future cardiac rehabilitation research could offer insight into why many women do not maintain an exercise regimen in currently structured cardiac rehabilitation and community programmes. © 2012 Blackwell Publishing Ltd.

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

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.

Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: Results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study.

PubMed

Ajani, J A; Buyse, M; Lichinitser, M; Gorbunova, V; Bodoky, G; Douillard, J Y; Cascinu, S; Heinemann, V; Zaucha, R; Carrato, A; Ferry, D; Moiseyenko, V

2013-11-01

The aim of developing oral fluorouracil (5-FU) is to provide a more convenient administration route with similar efficacy and the best achievable tolerance. S-1, a novel oral fluoropyrimidine, was specifically designed to overcome the limitations of intravenous fluoropyrimidine therapies. A multicentre, randomised phase 3 trial was undertaken to compare S-1/cisplatin (CS) with infusional 5-FU/cisplatin (CF) in 1053 patients with untreated, advanced gastric/gastroesophageal adenocarcinoma. This report discusses a post-hoc noninferiority overall survival (OS) and safety analyses. Results (1029 treated; CS = 521/CF = 508) revealed OS in CS (8.6 months) was statistically noninferior to CF (7.9 months) [hazard ratio (HR) = 0.92 (two-sided 95% confidence interval (CI), 0.80-1.05)] for any margin equal to or greater than 1.05. Statistically significant safety advantages for the CS arm were observed [G3/4 neutropenia (CS, 18.6%; CF, 40.0%), febrile neutropenia (CS, 1.7%; CF, 6.9%), G3/4 stomatitis (CS, 1.3%; CF, 13.6%), diarrhoea (all grades: CS, 29.2%; CF, 38.4%) and renal adverse events (all grades: CS, 18.8%; CF, 33.5%)]. Hand-foot syndrome, infrequently reported, was mainly grade 1/2 in both arms. Treatment-related deaths were significantly lower in the CS arm than the CF arm (2.5% and 4.9%, respectively; P<0.047). CS is noninferior to CF with a better safety profile and provides a new treatment option for patients with advanced gastric carcinoma. Copyright © 2013 Elsevier Ltd. All rights reserved.

Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia (the ADvance Trial): A Two Year Follow-up Including Results of Delayed Activation.

PubMed

Leoutsakos, Jeannie-Marie S; Yan, Haijuan; Anderson, William S; Asaad, Wael F; Baltuch, Gordon; Burke, Anna; Chakravarty, M Mallar; Drake, Kristen E; Foote, Kelly D; Fosdick, Lisa; Giacobbe, Peter; Mari, Zoltan; McAndrews, Mary Pat; Munro, Cynthia A; Oh, Esther S; Okun, Michael S; Pendergrass, Jo Cara; Ponce, Francisco A; Rosenberg, Paul B; Sabbagh, Marwan N; Salloway, Stephen; Tang-Wai, David F; Targum, Steven D; Wolk, David; Lozano, Andres M; Smith, Gwenn S; Lyketsos, Constantine G

2018-06-09

Given recent challenges in developing new treatments for Alzheimer dementia (AD), it is vital to explore alternate treatment targets, such as neuromodulation for circuit dysfunction. We previously reported an exploratory Phase IIb double-blind trial of deep brain stimulation targeting the fornix (DBS-f) in mild AD (the ADvance trial). We reported safety but no clinical benefits of DBS-f versus the delayed-on (sham) treatment in 42 participants after one year. However, secondary post hoc analyses of the one-year data suggested a possible DBS-f benefit for participants≥65 years. To examine the long-term safety and clinical effects of sustained and delayed-on DBS-f treatment of mild AD after two years. 42 participants underwent implantation of DBS-f electrodes, with half randomized to active DBS-f stimulation (early on) for two years and half to delayed-on (sham) stimulation after 1 year to provide 1 year of active DBS-f stimulation (delayed on). We evaluated safety and clinical outcomes over the two years of the trial. DBS-f had a favorable safety profile with similar rates of adverse events across both trial phases (years 1 and 2) and between treatment arms. There were no differences between treatment arms on any primary clinical outcomes. However, post-hoc age group analyses suggested a possible benefit among older (>65) participants. DBS-f was safe. Additional study of mechanisms of action and methods for titrating stimulation parameters will be needed to determine if DBS has potential as an AD treatment. Future efficacy studies should focus on patients over age 65.

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

PubMed Central

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

2015-01-01

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

Empirical Model Development for Predicting Shock Response on Composite Materials Subjected to Pyroshock Loading

NASA Technical Reports Server (NTRS)

Gentz, Steven J.; Ordway, David O; Parsons, David S.; Garrison, Craig M.; Rodgers, C. Steven; Collins, Brian W.

2015-01-01

The NASA Engineering and Safety Center (NESC) received a request to develop an analysis model based on both frequency response and wave propagation analyses for predicting shock response spectrum (SRS) on composite materials subjected to pyroshock loading. The model would account for near-field environment (approx. 9 inches from the source) dominated by direct wave propagation, mid-field environment (approx. 2 feet from the source) characterized by wave propagation and structural resonances, and far-field environment dominated by lower frequency bending waves in the structure. This report documents the outcome of the assessment.

Empirical Model Development for Predicting Shock Response on Composite Materials Subjected to Pyroshock Loading. [Appendices

NASA Technical Reports Server (NTRS)

Gentz, Steven J.; Ordway, David O.; Parsons, David S.; Garrison, Craig M.; Rodgers, C. Steven; Collins, Brian W.

2015-01-01

The NASA Engineering and Safety Center (NESC) received a request to develop an analysis model based on both frequency response and wave propagation analyses for predicting shock response spectrum (SRS) on composite materials subjected to pyroshock loading. The model would account for near-field environment (9 inches from the source) dominated by direct wave propagation, mid-field environment (approximately 2 feet from the source) characterized by wave propagation and structural resonances, and far-field environment dominated by lower frequency bending waves in the structure. This document contains appendices to the Volume I report.

Analogue Study of Actinide Transport at Sites in Russia

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

Novikov, A P; Simmons, A M; Halsey, W G

2003-02-12

The U. S. Department of Energy (DOE) and the Russian Academy of Sciences (RAS) are engaged in a three-year cooperative study to observe the behavior of actinides in the natural environment at selected disposal sites and/or contamination sites in Russia. The purpose is to develop experimental data and models for actinide speciation, mobilization and transport processes in support of geologic repository design, safety and performance analyses. Currently at the mid-point of the study, the accomplishments to date include: evaluation of existing data and data needs, site screening and selection, initial data acquisition, and development of preliminary conceptual models.

Empirical Model Development for Predicting Shock Response on Composite Materials Subjected to Pyroshock Loading: Appendices

NASA Technical Reports Server (NTRS)

Gentz, Steven J.; Ordway, David O.; Parsons, David S.; Garrison, Craig M.; Rodgers, C. Steven; Collins, Brian W.

2015-01-01

The NASA Engineering and Safety Center (NESC) received a request to develop an analysis model based on both frequency response and wave propagation analyses for predicting shock response spectrum (SRS) on composite materials subjected to pyroshock loading. The model would account for near-field environment (approx. 9 inches from the source) dominated by direct wave propagation, mid-field environment (approx. 2 feet from the source) characterized by wave propagation and structural resonances, and far-field environment dominated by lower frequency bending waves in the structure. This document contains appendices to the Volume I report.

Investigating Reports of Complex Regional Pain Syndrome: An Analysis of HPV-16/18-Adjuvanted Vaccine Post-Licensure Data

PubMed Central

Huygen, Frank; Verschueren, Kristin; McCabe, Candida; Stegmann, Jens-Ulrich; Zima, Julia; Mahaux, Olivia; Van Holle, Lionel; Angelo, Maria-Genalin

2015-01-01

Complex regional pain syndrome (CRPS) is a chronic pain disorder that typically follows trauma or surgery. Suspected CRPS reported after vaccination with human papillomavirus (HPV) vaccines led to temporary suspension of proactive recommendation of HPV vaccination in Japan. We investigated the potential CRPS signal in relation to HPV-16/18-adjuvanted vaccine (Cervarix®) by database review of CRPS cases with independent expert confirmation; a disproportionality analysis and analyses of temporality; an observed versus expected analysis using published background incidence rates; systematic reviews of aggregate safety data, and a literature review. The analysis included 17 case reports of CRPS: 10 from Japan (0.14/100,000 doses distributed) and seven from the United Kingdom (0.08/100,000). Five cases were considered by independent experts to be confirmed CRPS. Quantitative analyses did not suggest an association between CRPS and HPV-16/18-adjuvanted vaccine. Observed CRPS incidence after HPV-16/18 vaccination was statistically significantly below expected rates. Systematic database reviews using search terms varying in specificity and sensitivity did not identify new cases. No CRPS was reported during clinical development and no unexpected results found in the literature. There is not sufficient evidence to suggest an increased risk of developing CRPS following vaccination with HPV-16/18-adjuvanted vaccine. Post-licensure safety surveillance confirms the acceptable benefit-risk of HPV-16/18 vaccination. PMID:26501109

Safety evaluation of filamentous fungi isolated from industrial doenjang koji.

PubMed

Lee, Jin Hee; Jo, Eun Hye; Hong, Eun Jin; Kim, Kyung Min; Lee, Inhyung

2014-10-01

A few starters have been developed and used for doenjang fermentation but often without safety evaluation. Filamentous fungi were isolated from industrial doenjang koji, and their potential for mycotoxin production was evaluated. Two fungi were isolated; one was more dominantly present (90%). Both greenish (SNU-G) and whitish (SNU-W) fungi showed 97% and 95% internal transcribed spacer sequence identities to Aspergillus oryzae/flavus, respectively. However, the SmaI digestion pattern of their genomic DNA suggested that both belong to A. oryzae. Moreover, both fungi had morphological characteristics similar to that of A. oryzae. SNU-G and SNU-W did not form sclerotia, which is a typical characteristic of A. oryzae. Therefore, both fungi were identified to be A. oryzae. In aflatoxin gene cluster analysis, both fungi had norB-cypA genes similar to that of A. oryzae. Consistent with this, aflatoxins were not detected in SNU-G and SNU-W using ammonia vapor, TLC, and HPLC analyses. Both fungi seemed to have a whole cyclopiazonic acid (CPA) gene cluster based on PCR of the maoA, dmaT, and pks-nrps genes, which are key genes for CPA biosynthesis. However, CPA was not detected in TLC and HPLC analyses. Therefore, both fungi seem to be safe to use as doenjang koji starters and may be suitable fungal candidates for further development of starters for traditional doenjang fermentation.

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

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

Analyses in support of risk-informed natural gas vehicle maintenance facility codes and standards :

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

Ekoto, Isaac W.; Blaylock, Myra L.; LaFleur, Angela Christine

2014-03-01

Safety standards development for maintenance facilities of liquid and compressed gas fueled large-scale vehicles is required to ensure proper facility design and operation envelopes. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase I work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest. Finally, scenario analyses were performed using detailed simulations and modeling to estimate the overpressure hazardsmore » from HAZOP defined scenarios. The results from Phase I will be used to identify significant risk contributors at NGV maintenance facilities, and are expected to form the basis for follow-on quantitative risk analysis work to address specific code requirements and identify effective accident prevention and mitigation strategies.« less

Advances in Fatigue and Fracture Mechanics Analyses for Aircraft Structures

NASA Technical Reports Server (NTRS)

Newman, J. C., Jr.

1999-01-01

This paper reviews some of the advances that have been made in stress analyses of cracked aircraft components, in the understanding of the fatigue and fatigue-crack growth process, and in the prediction of residual strength of complex aircraft structures with widespread fatigue damage. Finite-element analyses of cracked structures are now used to determine accurate stress-intensity factors for cracks at structural details. Observations of small-crack behavior at open and rivet-loaded holes and the development of small-crack theory has lead to the prediction of stress-life behavior for components with stress concentrations under aircraft spectrum loading. Fatigue-crack growth under simulated aircraft spectra can now be predicted with the crack-closure concept. Residual strength of cracked panels with severe out-of-plane deformations (buckling) in the presence of stiffeners and multiple-site damage can be predicted with advanced elastic-plastic finite-element analyses and the critical crack-tip-opening angle (CTOA) fracture criterion. These advances are helping to assure continued safety of aircraft structures.

Advances in Fatigue and Fracture Mechanics Analyses for Metallic Aircraft Structures

NASA Technical Reports Server (NTRS)

Newman, J. C., Jr.

2000-01-01

This paper reviews some of the advances that have been made in stress analyses of cracked aircraft components, in the understanding of the fatigue and fatigue-crack growth process, and in the prediction of residual strength of complex aircraft structures with widespread fatigue damage. Finite-element analyses of cracked metallic structures are now used to determine accurate stress-intensity factors for cracks at structural details. Observations of small-crack behavior at open and rivet-loaded holes and the development of small-crack theory has lead to the prediction of stress-life behavior for components with stress concentrations under aircraft spectrum loading. Fatigue-crack growth under simulated aircraft spectra can now be predicted with the crack-closure concept. Residual strength of cracked panels with severe out-of-plane deformations (buckling) in the presence of stiffeners and multiple-site damage can be predicted with advanced elastic-plastic finite-element analyses and the critical crack-tip-opening angle (CTOA) fracture criterion. These advances are helping to assure continued safety of aircraft structures.

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

PubMed

Custer, Brian; Janssen, Mart P

2015-08-01

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

Analysis of adulterants in a traditional herbal medicinal product using liquid chromatography-mass spectrometry-mass spectrometry.

PubMed

Lau, Aik-Jiang; Holmes, Michael J; Woo, Soo-On; Koh, Hwee-Ling

2003-02-26

Adulterations with synthetic drugs are common problems with herbal medicine and this can potentially cause serious adverse effects. It is therefore important to determine the presence of synthetic drugs in herbal medicine to ensure patients' safety. The objective of this study was to develop sensitive and specific methods to analyse phenylbutazone, caffeine and oxyphenbutazone present in a traditional Indonesian herbal product. Liquid chromatography-mass spectrometry-mass spectrometry (LC-MS-MS) methods in the selected reaction-monitoring (SRM) mode were developed. It was found that the sample contained 0.53% w/w (n=3, RSD=7.56%) phenylbutazone and 0.04% w/w (n=3, RSD=8.39%) caffeine. This corresponded to 43.17 mg phenylbutazone and 3.23 mg caffeine in each sachet of powder. The methods were validated for linearity, precision, accuracy, LOD and LOQ. LOD and LOQ were found to be 3.69 and 12.29 ng/ml, respectively for phenylbutazone. For caffeine, the LOD and LOQ were 0.84 and 2.80 ng/ml, respectively. Oxyphenbutazone in the sample was found to be present at a level below the quantification level of 10.2 ng/ml. With better methods developed for analysis of adulterants in herbal medicine, the quality and safety of these medicines can be better controlled and regulated to ensure patients' safety.

Priority needs and wisdom strategy for blood transfusion safety in developing low-resource countries.

PubMed

Abdelrazik, Abeer Mohamed; Ezzat Ahmed, Ghada M

2016-02-01

To evaluate the implementation of alternative safety measures that reduce the risk of transfusion transmissible infections as an affordable measure in low resource countries. It is still difficult in developing countries with limited resources to mandate nucleic acid testing due to its high cost. Although NAT reduces the window period of infection, the developing countries are still in need of an efficient and effective transfusion programme before implementing the complex high cost NAT. Two thousand eight hundred eighty sero-negative first-time and repeat donations from Fayoum University Hospital blood bank were individually analysed by NAT for HIV, HBV and HCV. Only discriminatory-positive NAT were classified comparing the non-remunerated and family replacement donations. Significant discriminatory-positive differences were observed for HBV NAT results, 2 remunerated donations compared to 0 non-remunerated sero-negative donations. The discriminatory positive differences were also significant for HCV NAT results, 4 remunerated donations compared to 1 non-remunerated sero-negative donation. No sero-negative, discriminatory-positive NAT HIV case was found. Seven out of 8 discriminatory positive cases were from first time donations. In order to ensure blood safety, the recruitment and retention of voluntary, non-remunerated repeat donors should be a major commitment for low resource countries in which NAT implementation is costly and not feasible. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Lane detection algorithm for an onboard camera

NASA Astrophysics Data System (ADS)

Bellino, Mario; Lopez de Meneses, Yuri; Ryser, Peter; Jacot, Jacques

2005-02-01

After analysing the major causes of injuries and death on roads, it is understandable that one of the main goals in the automotive industry is to increase vehicle safety. The European project SPARC (Secure Propulsion using Advanced Redundant Control) is developing the next generation of trucks that will fulfil these aims. The main technologies that will be used in the SPARC project to achieve the desiderated level of safety will be presented. In order to avoid accidents in critical situations, it is necessary to have a representation of the environment of the vehicle. Thus, several solutions using different sensors will be described and analysed. Particularly, a division of this project aims to integrate cameras in automotive vehicles to increase security and prevent driver's mistakes. Indeed, with this vision platform it would be possible to extract the position of the lane with respect to the vehicle, and thus, help the driver to follow the optimal trajectory. A definition of lane is proposed, and a lane detection algorithm is presented. In order to improve the detection, several criteria are explained and detailed. Regrettably, such an embedded camera is subject to the vibration of the truck, and the resulting sequence of images is difficult to analyse. Thus, we present different solutions to stabilize the images and particularly a new approach developed by the "Laboratoire de Production Microtechnique". Indeed, it was demonstrated in previous works that the presence of noise can be used, through a phenomenon called Stochastic Resonance. Thus, instead of decreasing the influence of noise in industrial applications, which has non negligible costs, it is perhaps interesting to use this phenomenon to reveal some useful information, such as for example the contour of the objects and lanes.

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.

Cerebrospinal fluid protein and glucose examinations and tuberculosis:
Will laboratory safety regulations force a change of practice?

PubMed

Tormey, William P; O'Hagan, Christopher

2015-01-01

Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.

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.

Food and Feed Safety Assessment: The Importance of Proper Sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-03-24

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

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.

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

PubMed

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

2014-02-01

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

Potential for recycling of slightly radioactive metals arising from decommissioning within nuclear sector in Slovakia.

PubMed

Hrncir, Tomas; Strazovec, Roman; Zachar, Matej

2017-09-07

The decommissioning of nuclear installations represents a complex process resulting in the generation of large amounts of waste materials containing various concentrations of radionuclides. Selection of an appropriate strategy of management of the mentioned materials strongly influences the effectiveness of decommissioning process keeping in mind safety, financial and other relevant aspects. In line with international incentives for optimization of radioactive material management, concepts of recycling and reuse of materials are widely discussed and applications of these concepts are analysed. Recycling of some portion of these materials within nuclear sector (e.g. scrap metals or concrete rubble) seems to be highly desirable from economical point of view and may lead to conserve some disposal capacity. However, detailed safety assessment along with cost/benefit calculations and feasibility study should be developed in order to prove the safety, practicality and cost effectiveness of possible recycling scenarios. Paper discussed the potential for recycling of slightly radioactive metals arising from decommissioning of NPPs within nuclear sector in Slovakia. Various available recycling scenarios are introduced and method for overall assessment of various recycling scenarios is outlined including the preliminary assessment of safety and financial aspects. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Food and feed safety assessment: the importance of proper sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-01-01

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

The teamwork in assertive community treatment (TACT) scale: development and validation.

PubMed

Wholey, Douglas R; Zhu, Xi; Knoke, David; Shah, Pri; Zellmer-Bruhn, Mary; Witheridge, Thomas F

2012-11-01

Team design is meticulously specified for assertive community treatment (ACT) teams, yet performance can vary across ACT teams, even those with high fidelity. By developing and validating the Teamwork in Assertive Community Treatment (TACT) scale, investigators examined the role of team processes in ACT performance. The TACT scale measuring ACT teamwork was developed from a conceptual model grounded in organizational research and adapted for the ACT and mental health context. TACT subscales were constructed after exploratory and confirmatory factor analyses. The reliability, discriminant validity, predictive validity, temporal stability, internal consistency, and within-team agreement were established with surveys from approximately 300 members of 26 Minnesota ACT teams who completed the questionnaire three times, at six-month intervals. Nine TACT subscales emerged from the analyses: exploration, exploitation of new and existing knowledge, psychological safety, goal agreement, conflict, constructive controversy, information accessibility, encounter preparedness, and consumer-centered care. These nine subscales demonstrated fit and temporal stability (confirmatory factor analysis), high internal consistency (Cronbach's alpha), and within-team agreement and between-team differences (rwg and intraclass correlations). Correlational analyses of the subscales revealed that they measure related yet distinctive aspects of ACT team processes, and regression analyses demonstrated predictive validity (encounter preparedness is related to staff outcomes). The TACT scale demonstrated high reliability and validity and can be included in research and evaluation of teamwork in ACT and mental health teams.

Correlation of causal factors that influence construction safety performance: A model.

PubMed

Rodrigues, F; Coutinho, A; Cardoso, C

2015-01-01

The construction sector has presented positive development regarding the decrease in occupational accident rates in recent years. Regardless, the construction sector stands out systematically from other industries due to its high number of fatalities. The aim of this paper is to deeply understand the causality of construction accidents from the early design phase through a model. This study reviewed several research papers presenting various analytical models that correlate the contributing factors to occupational accidents in this sector. This study also analysed different construction projects and conducted a survey of design and site supervision teams. This paper proposes a model developed from the analysis of existing ones, which correlates the causal factors through all the construction phases. It was concluded that effective risk prevention can only be achieved by a global correlation of causal factors including not only production ones but also client requirements, financial climate, design team competence, project and risk management, financial capacity, health and safety policy and early planning. Accordingly, a model is proposed.

A probabilistic safety analysis of incidents in nuclear research reactors.

PubMed

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

2012-06-01

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

Video analysis of head blows leading to concussion in competition Taekwondo.

PubMed

Koh, Jae O; Watkinson, E Jane; Yoon, Yong-Jin

2004-12-01

To analyse the situational and contextual factors surrounding concussions and head blows in Taekwondo. Prospective design. Direct observation, subject interview and videotape recording used. A total of 2328 competitors participated in the 2001 tournament, South Korea. All matches were recorded on videotape. All recipients of head blows were interviewed by athletic therapists and the researcher immediately after the match. The videotapes of concussions and head blows were analysed. A total of 1009 head blows including concussions were analysed. Head blows and concussions were most evident when the attacker was situated in a closed stance and received a single roundhouse kick. The most frequent anatomical site of the head impact was the temporal region. The frequency of head blows and concussions is high in Taekwondo. Development of blocking skills, safety education, rigorous enforcement of the competition rules and improvement of head-gear are recommended.

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

Bence, A.E.; Burns, W.A.

A procedure has been developed that discriminates Exxon Valdez crude from other sources of hydrocarbons found in Prince Williams Sound and the Gulf of Alaska. The procedure uses polycyclic aromatic hydrocarbon (PAH) distributions, measured by gas chromatography/mass spectrometry (GC/MS), to fingerprint sample extracts. The relative abundances of alkylated phenanthrenes, dibenzothiophenes, and chrysenes are used to differentiate Exxon Valdez crude and its weathering products from other hydrocarbons. Saturate fraction distributions are used to confirm the PAH identification whenever possible. The procedure has been applied to the more than 1,500 PAH analyses of tissues reported by the Oil Spill Health Task Force,more » formed after the spill to assess subsistence food safety, and nearly 4,700 PAH analyses of biological samples in PWSOIL, the government`s damage-assessment chemistry database. These two datasets constitute the largest collection of hydrocarbon analyses of biological samples form the spill-impact zone. 70 refs., 14 figs., 8 tabs.« less

Safety climate in Swiss hospital units: Swiss version of the Safety Climate Survey

PubMed Central

Gehring, Katrin; Mascherek, Anna C.; Bezzola, Paula

2015-01-01

Abstract Rationale, aims and objectives Safety climate measurements are a broadly used element of improvement initiatives. In order to provide a sound and easy‐to‐administer instrument for the use in Swiss hospitals, we translated the Safety Climate Survey into German and French. Methods After translating the Safety Climate Survey into French and German, a cross‐sectional survey study was conducted with health care professionals (HCPs) in operating room (OR) teams and on OR‐related wards in 10 Swiss hospitals. Validity of the instrument was examined by means of Cronbach's alpha and missing rates of the single items. Item‐descriptive statistics group differences and percentage of ‘problematic responses’ (PPR) were calculated. Results 3153 HCPs completed the survey (response rate: 63.4%). 1308 individuals were excluded from the analyses because of a profession other than doctor or nurse or invalid answers (n = 1845; nurses = 1321, doctors = 523). Internal consistency of the translated Safety Climate Survey was good (Cronbach's alpha G erman = 0.86; Cronbach's alpha F rench = 0.84). Missing rates at item level were rather low (0.23–4.3%). We found significant group differences in safety climate values regarding profession, managerial function, work area and time spent in direct patient care. At item level, 14 out of 21 items showed a PPR higher than 10%. Conclusions Results indicate that the French and German translations of the Safety Climate Survey might be a useful measurement instrument for safety climate in Swiss hospital units. Analyses at item level allow for differentiating facets of safety climate into more positive and critical safety climate aspects. PMID:25656302

Characteristics of unit-level patient safety culture in hospitals in Japan: a cross-sectional study.

PubMed

Fujita, Shigeru; Seto, Kanako; Kitazawa, Takefumi; Matsumoto, Kunichika; Hasegawa, Tomonori

2014-10-22

Patient safety culture (PSC) has an important role in determining safety and quality in healthcare. Currently, little is known about the status of unit-level PSC in hospitals in Japan. To develop appropriate strategies, characteristics of unit-level PSC should be investigated. Work units may be classified according to the characteristics of PSC, and common problems and appropriate strategies may be identified for each work unit category. This study aimed to clarify the characteristics of unit-level PSC in hospitals in Japan. In 2012, a cross-sectional study was conducted at 18 hospitals in Japan. The Hospital Survey on Patient Safety Culture questionnaire, developed by the United States Agency for Healthcare Research and Quality, was distributed to all healthcare workers (n =12,076). Percent positive scores for 12 PSC sub-dimensions were calculated for each unit, and cluster analysis was used to categorise the units according to the percent positive scores. A generalised linear mixed model (GLMM) was used to analyse the results of the cluster analysis, and odds ratios (ORs) for categorisation as high-PSC units were calculated for each unit type. A total of 9,124 respondents (75.6%) completed the questionnaire, and valid data from 8,700 respondents (72.0%) were analysed. There were 440 units in the 18 hospitals. According to the percent positive scores for the 12 sub-dimensions, the 440 units were classified into 2 clusters: high-PSC units (n =184) and low-PSC units (n =256). Percent positive scores for all PSC sub-dimensions for high-PSC units were significantly higher than those for low-PSC units. The GLMM revealed that the combined unit type of 'Obstetrics and gynaecology ward, perinatal ward or neonatal intensive care unit' was significantly more likely to be categorised as high-PSC units (OR =9.7), and 'Long-term care ward' (OR =0.2), 'Rehabilitation unit' (OR =0.2) and 'Administration unit' (OR =0.3) were significantly less likely to be categorised as high-PSC units. Our study findings demonstrate that PSC varies considerably among different unit types in hospitals in Japan. Factors contributing to low PSC should be identified and possible measures for improving PSC should be developed and initiated.

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.

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

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

PubMed

Gyekye, Seth Ayim; Haybatollahi, Mohammad

2014-01-01

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

Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

PubMed Central

2013-01-01

Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute the current levels of patient safety to a broad range of factors and believe that many different solutions can contribute to enhanced patient safety in the future, suggesting that this work must be multifactorial. PMID:23391301

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

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

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

Safety Study of Double-Decker Motorcoaches with Rear Luggage Compartment : Technology Brief

DOT National Transportation Integrated Search

2017-12-01

The study was conducted through a combination of analyses and tests with a double-decker motorcoach. State transportation safety and law enforcement officials were consulted, and the study plan was revised according to their comments. An exemplar mot...

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...

Health And Safety In Maintenance Activities

NASA Astrophysics Data System (ADS)

Ungureanu, Nicolae Stelian; Daraba, Dinu; Moraru, Roland Iosif

2015-07-01

The paper examines some aspects of health and safety at work in maintenance activities. It was analysed the occurrence of accidents, statistically, in maintenance work. There have been identified a number of causes of accidents and there have been proposed some measures to reduce them.

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...

Columbus safety and reliability

NASA Astrophysics Data System (ADS)

Longhurst, F.; Wessels, H.

1988-10-01

Analyses carried out to ensure Columbus reliability, availability, and maintainability, and operational and design safety are summarized. Failure modes/effects/criticality is the main qualitative tool used. The main aspects studied are fault tolerance, hazard consequence control, risk minimization, human error effects, restorability, and safe-life design.

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2013 CFR

2013-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2014 CFR

2014-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...

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.

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.

Improvements and applications of COBRA-TF for stand-alone and coupled LWR safety analyses

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

Avramova, M.; Cuervo, D.; Ivanov, K.

2006-07-01

The advanced thermal-hydraulic subchannel code COBRA-TF has been recently improved and applied for stand-alone and coupled LWR core calculations at the Pennsylvania State Univ. in cooperation with AREVA NP GmbH (Germany)) and the Technical Univ. of Madrid. To enable COBRA-TF for academic and industrial applications including safety margins evaluations and LWR core design analyses, the code programming, numerics, and basic models were revised and substantially improved. The code has undergone through an extensive validation, verification, and qualification program. (authors)

Waste Sampling & Characterization Facility (WSCF) Complex Safety Analysis

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

MELOY, R.T.

2002-04-01

This document was prepared to analyze the Waste Sampling and Characterization Facility for safety consequences by: Determining radionuclide and highly hazardous chemical inventories; Comparing these inventories to the appropriate regulatory limits; Documenting the compliance status with respect to these limits; and Identifying the administrative controls necessary to maintain this status. The primary purpose of the Waste Sampling and Characterization Facility (WSCF) is to perform low-level radiological and chemical analyses on various types of samples taken from the Hanford Site. These analyses will support the fulfillment of federal, Washington State, and Department of Energy requirements.

An Operational Safety and Certification Assessment of a TASAR EFB Application

NASA Technical Reports Server (NTRS)

Koczo, Stefan; Wing, David

2013-01-01

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

Patterns and perspectives in applied fracture mechanics

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

Merkle, J.G.

1994-12-31

This lecture begins with a overview of applied fracture mechanics pertinent to safety of pressure vessels. It then progresses to a chronological panorama of experimental and analytical results. To be useful and dependable in safety analysis of real structures, new analysis developments must be physically realistic, which means that they must accurately describe physical cause and effect. Consequently, before mathematical modeling can begin, cause and effect must be established from experimental data. This can be difficult and time consuming, but worth the effort. Accordingly, the theme of this paper is that the search for patterns is constant and vital. Thismore » theme is illustrated by the development of small, single-specimen, fracture toughness testing techniques. It is also illustrated by the development, based on two different published large-strain, elastic-plastic, three-dimensional finite-element analyses, of a hypothesis concerning three-dimensional loss of constraint. When a generalization of Irwin`s thickness-normalized plastic-zone parameter, reaches a value close to 2{pi}, the through-thickness contraction strain at the apex of the near-tip logarithmic-spiral slip-line region becomes the dominant negative strain accommodating crack opening. Because slip lines passing from the midplane to the stress-free side surfaces do not have to curve, once these slip lines are established, stresses near the crack tip are only elevated by strain hardening and constraint becomes significantly relaxed. This hypothesis, based on published three-dimensional elastic-plastic analyses, provides a potentially valuable means for gaining additional insight into constraint effects on fracture toughness by considering the roles played by the plastic strains as well as the stresses that develop near a crack tip.« less

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.

The interplay between teamwork, clinicians' emotional exhaustion, and clinician-rated patient safety: a longitudinal study.

PubMed

Welp, Annalena; Meier, Laurenz L; Manser, Tanja

2016-04-19

Effectively managing patient safety and clinicians' emotional exhaustion are important goals of healthcare organizations. Previous cross-sectional studies showed that teamwork is associated with both. However, causal relationships between all three constructs have not yet been investigated. Moreover, the role of different dimensions of teamwork in relation to emotional exhaustion and patient safety is unclear. The current study focused on the long-term development of teamwork, emotional exhaustion, and patient safety in interprofessional intensive care teams by exploring causal relationships between these constructs. A secondary objective was to disentangle the effects of interpersonal and cognitive-behavioral teamwork. We employed a longitudinal study design. Participants were 2100 nurses and physicians working in 55 intensive care units. They answered an online questionnaire on interpersonal and cognitive-behavioral aspects of teamwork, emotional exhaustion, and patient safety at three time points with a 3-month lag. Data were analyzed with cross-lagged structural equation modeling. We controlled for professional role. Analyses showed that emotional exhaustion had a lagged effect on interpersonal teamwork. Furthermore, interpersonal and cognitive-behavioral teamwork mutually influenced each other. Finally, cognitive-behavioral teamwork predicted clinician-rated patient safety. The current study shows that the interrelations between teamwork, clinician burnout, and clinician-rated patient safety unfold over time. Interpersonal and cognitive-behavioral teamwork play specific roles in a process leading from clinician emotional exhaustion to decreased clinician-rated patient safety. Emotionally exhausted clinicians are less able to engage in positive interpersonal teamwork, which might set in motion a vicious cycle: negative interpersonal team interactions negatively affect cognitive-behavioral teamwork and vice versa. Ultimately, ineffective cognitive-behavioral teamwork negatively impacts clinician-rated patient safety. Thus, reducing clinician emotional exhaustion is an important prerequisite of managing teamwork and patient safety. From a practical point of view, team-based interventions targeting patient safety are less likely to be effective when clinicians are emotionally exhausted.

Identification of the mechanical properties of bicycle tyres for modelling of bicycle dynamics

NASA Astrophysics Data System (ADS)

Doria, Alberto; Tognazzo, Mauro; Cusimano, Gianmaria; Bulsink, Vera; Cooke, Adrian; Koopman, Bart

2013-03-01

Advanced simulation of the stability and handling properties of bicycles requires detailed road-tyre contact models. In order to develop these models, in this study, four bicycle tyres are tested by means of a rotating disc machine with the aim of measuring the components of tyre forces and torques that influence the safety and handling of bicycles. The effect of inflation pressure and tyre load is analysed. The measured properties of bicycle tyres are compared with those of motorcycle tyres.

Development of the Sanofi Pasteur tetravalent dengue vaccine: One more step forward.

PubMed

Guy, Bruno; Briand, Olivier; Lang, Jean; Saville, Melanie; Jackson, Nicholas

2015-12-10

Sanofi Pasteur has developed a recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) that is in late-stage development. The present review summarizes the different steps in the development of this dengue vaccine, with a particular focus on the clinical data from three efficacy trials, which includes one proof-of-concept phase IIb (NCT00842530) and two pivotal phase III efficacy trials (NCT01373281 and NCT01374516). Earlier studies showed that the CYD-TDV candidate had a satisfactory safety profile and was immunogenic across the four vaccine serotypes in both in vitro and in vivo preclinical tests, as well as in initial phase I to phase II clinical trials in both flavivirus-naïve and seropositive individuals. Data from the 25 months (after the first injection) active phase of the two pivotal phase III efficacy studies shows that CYD-TDV (administered at 0, 6, and 12 months) is efficacious against virologically-confirmed disease (primary endpoint) and has a good safety profile. Secondary analyses also showed efficacy against all four dengue serotypes and protection against severe disease and hospitalization. The end of the active phases in these studies completes more than a decade of development of CYD-TDV, but considerable activities and efforts remain to address outstanding scientific, clinical, and immunological questions, while preparing for the introduction and use of CYD-TDV. Additional safety observations were recently reported from the first complete year of hospital phase longer term surveillance for two phase 3 studies and the first and second completed years for one phase 2b study, demonstrating the optimal age for intervention from 9 years. Dengue is a complex disease, and both short-term and long-term safety and efficacy will continue to be addressed by ongoing long-term follow-up and future post-licensure studies. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Organizational factors affecting safety implementation in food companies in Thailand.

PubMed

Chinda, Thanwadee

2014-01-01

Thai food industry employs a massive number of skilled and unskilled workers. This may result in an industry with high incidences and accident rates. To improve safety and reduce the accident figures, this paper investigates factors influencing safety implementation in small, medium, and large food companies in Thailand. Five factors, i.e., management commitment, stakeholders' role, safety information and communication, supportive environment, and risk, are found important in helping to improve safety implementation. The statistical analyses also reveal that small, medium, and large food companies hold similar opinions on the risk factor, but bear different perceptions on the other 4 factors. It is also found that to improve safety implementation, the perceptions of safety goals, communication, feedback, safety resources, and supervision should be aligned in small, medium, and large companies.

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

PubMed Central

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

2015-01-01

Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity involving mental health may be a key driver of safety incidents, which has important implication for the design and targeting of interventions to improve safety. High quality studies examining the mechanisms of patient safety incidents in patients with multimorbidity are needed, with the goal of promoting effective service delivery and ameliorating threats to safety in this group of patients. PMID:26317435

Delivering on the Promise of CLER: A Patient Safety Rotation That Aligns Resident Education With Hospital Processes.

PubMed

Patel, Ekta; Muthusamy, Veena; Young, John Q

2018-06-01

Residency programs must provide training in patient safety. Yet, significant gaps exist among published patient safety curricula. The authors developed a rotation designed to be scalable to an entire residency, built on sound pedagogy, aligned with hospital safety processes, and effective in improving educational outcomes. From July 2015 to May 2017, each second-year resident completed the two-week rotation. Residents engaged the foundational science asynchronously via multiple modalities and then practiced applying key concepts during a mock root cause analysis. Next, each resident performed a special review of an actual adverse patient event and presented findings to the hospital's Special Review Committee (SRC). Multiple educational outcomes were assessed, including resident satisfaction and attitudes (postrotation survey), changes in knowledge via pre- and posttest, quality of the residents' written safety analyses and oral presentations (per survey of SRC members), and organizational changes that resulted from the residents' reviews. Twenty-two residents completed the rotation. Most components were rated favorably; 80% (12/15 respondents) indicated interest in future patient safety work. Knowledge improved by 44.3% (P < .0001; pretest mean 23.7, posttest mean 34.2). Compared to faculty, SRC members rated the quality of residents' written reviews as superior and the quality of the rated oral presentations as either comparable or superior. The reviews identified a variety of safety vulnerabilities and led to multiple corrective actions. The authors will evaluate the curriculum in a controlled trial with better measures of change in behavior. Further tests of the curriculum's scalability to other contexts are needed.

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.

Patient safety culture in China: a case study in an outpatient setting in Beijing

PubMed Central

Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

2014-01-01

Objectives To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. Methods A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. Results The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of ‘communication openness’ was identified as a major safety culture problem, and a perception of ‘penalty’ was the greatest barrier to the encouragement of error reporting. Cohesive ‘teamwork within units’, while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. Conclusions This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong ‘teamwork within units’, a common area of strength, could fuel the concealment of errors. PMID:24351971

The culture of patient safety in an Iranian intensive care unit.

PubMed

Abdi, Zhaleh; Delgoshaei, Bahram; Ravaghi, Hamid; Abbasi, Mohsen; Heyrani, Ali

2015-04-01

To explore nurses' and physicians' attitudes and perceptions relevant to safety culture and to elicit strategies to promote safety culture in an intensive care unit. A strong safety culture is essential to ensure patient safety in the intensive care unit. This case study adopted a mixed method design. The Safety Attitude Questionnaire (SAQ-ICU version), assessing the safety climate through six domains, was completed by nurses and physicians (n = 42) in an academic intensive care unit. Twenty semi-structured interviews and document analyses were conducted as well. Interviews were analysed using a framework analysis method. Mean scores across the six domains ranged from 52.3 to 72.4 on a 100-point scale. Further analysis indicated that there were statistically significant differences between physicians' and nurses' attitudes toward teamwork (mean scores: 64.5/100 vs. 52.6/100, d = 1.15, t = 3.69, P < 0.001) and job satisfaction (mean scores: 78.2/100 vs. 57.7/100, d = 1.5, t = 4.8, P < 0.001). Interviews revealed several safety challenges including underreporting, failure to learn from errors, lack of speaking up, low job satisfaction among nurses and ineffective nurse-physician communication. The results indicate that all the domains need improvements. However, further attention should be devoted to error reporting and analysis, communication and teamwork among professional groups, and nurses' job satisfaction. Nurse managers can contribute to promoting a safety culture by encouraging staff to report errors, fostering learning from errors and addressing inter-professional communication problems. © 2013 John Wiley & Sons Ltd.

Use of a safety climate questionnaire in UK health care: factor structure, reliability and usability.

PubMed

Hutchinson, A; Cooper, K L; Dean, J E; McIntosh, A; Patterson, M; Stride, C B; Laurence, B E; Smith, C M

2006-10-01

To explore the factor structure, reliability, and potential usefulness of a patient safety climate questionnaire in UK health care. Four acute hospital trusts and nine primary care trusts in England. The questionnaire used was the 27 item Teamwork and Safety Climate Survey. Thirty three healthcare staff commented on the wording and relevance. The questionnaire was then sent to 3650 staff within the 13 NHS trusts, seeking to achieve at least 600 responses as the basis for the factor analysis. 1307 questionnaires were returned (36% response). Factor analyses and reliability analyses were carried out on 897 responses from staff involved in direct patient care, to explore how consistently the questions measured the underlying constructs of safety climate and teamwork. Some questionnaire items related to multiple factors or did not relate strongly to any factor. Five items were discarded. Two teamwork factors were derived from the remaining 11 teamwork items and three safety climate factors were derived from the remaining 11 safety items. Internal consistency reliabilities were satisfactory to good (Cronbach's alpha > or =0.69 for all five factors). This is one of the few studies to undertake a detailed evaluation of a patient safety climate questionnaire in UK health care and possibly the first to do so in primary as well as secondary care. The results indicate that a 22 item version of this safety climate questionnaire is useable as a research instrument in both settings, but also demonstrates a more general need for thorough validation of safety climate questionnaires before widespread usage.

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

PubMed Central

Liberati, Alessandro; Altman, Douglas G; Tetzlaff, Jennifer; Mulrow, Cynthia; Gøtzsche, Peter C; Ioannidis, John P A; Clarke, Mike; Devereaux, P J; Kleijnen, Jos; Moher, David

2009-01-01

Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses. PMID:19622552

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;

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...

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

A multilevel examination of affective job insecurity climate on safety outcomes.

PubMed

Jiang, Lixin; Probst, Tahira M

2016-07-01

Previous research has established a causal link between individual perceptions of job insecurity and safety outcomes. However, whether job insecurity climate is associated with safety outcomes has not been studied. The purpose of the current study was to explore the main and cross-level interaction effects of affective job insecurity climate on safety outcomes, including behavioral safety compliance, reporting attitudes, workplace injuries, experienced safety events, unreported safety events, and accident underreporting, beyond individual affective job insecurity. With 171 employees nested in 40 workgroups, multilevel analyses revealed that the negative impacts of individual affective job insecurity on safety outcomes are exacerbated when they occur in a climate of high affective job insecurity. These results are interpreted in light of safety management efforts and suggest that efforts to create a secure climate within one's workgroup may reap safety-related benefits. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The quality improvement attitude survey: Development and preliminary psychometric characteristics.

PubMed

Dunagan, Pamela B

2017-12-01

To report the development of a tool to measure nurse's attitudes about quality improvement in their practice setting and to examine preliminary psychometric characteristics of the Quality Improvement Nursing Attitude Scale. Human factors such as nursing attitudes of complacency have been identified as root causes of sentinel events. Attitudes of nurses concerning use of Quality and Safety Education for nurse's competencies can be most challenging to teach and to change. No tool has been developed measuring attitudes of nurses concerning their role in quality improvement. A descriptive study design with preliminary psychometric evaluation was used to examine the preliminary psychometric characteristics of the Quality Improvement Nursing Attitude Scale. Registered bedside clinical nurses comprised the sample for the study (n = 57). Quantitative data were analysed using descriptive statistics and Cronbach's alpha reliability. Total score and individual item statistics were evaluated. Two open-ended items were used to collect statements about nurses' feelings regarding their experience in quality improvement efforts. Strong support for the internal consistency reliability and face validity of the Quality Improvement Nursing Attitude Scale was found. Total scale scores were high indicating nurse participants valued Quality and Safety Education for Nurse competencies in practice. However, item-level statistics indicated nurses felt powerless when other nurses deviate from care standards. Additionally, the sample indicated they did not consistently report patient safety issues and did not have a feeling of value in efforts to improve care. Findings suggested organisational culture fosters nurses' reporting safety issues and feeling valued in efforts to improve care. Participants' narrative comments and item analysis revealed the need to generate new items for the Quality Improvement Nursing Attitude Scale focused on nurses' perception of their importance in quality and safety and their power to enact principles. The Quality Improvement Nursing Attitude Scale-Revised edition was designed to help in understanding nurses' attitudes and values. It can be used to further explore broad concepts of quality improvement efforts. © 2017 John Wiley & Sons Ltd.

Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

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

O'Hara, J.M.; Plott, C.; Milanski, J.

2009-09-30

The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance tomore » support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.« less

Estimation of integrated public risks for nonseismic external events affecting the Savannah River Site

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

Durant, W.S.; robinette, R.J.; Kirchner, J.R.

1994-03-01

In essence, this study was envisioned as the ``combination`` of existing accident dose and risk calculations from safety analyses of individual facilities. However, because of the extended time period over which the safety analyses were prepared, calculational assumptions and methodologies differed between the analyses. The scope of this study therefore included the standardization of assumptions and calculations as necessary to insure that the analytical logic was consistent for all the facilities. Each of the nonseismic external events considered in the analyses are addressed in individual sections in this report. In Section 2, extreme straight-line winds are examined. Section 3 addressesmore » tornadoes, and Section 4 addresses other external events [floods, other extreme weather events (lightning, hail, and extremes in temperature or precipitation), vehicle impact, accidents involving adjacent facilities, aircraft impact, and meteorite impact]. Section 5 provides a summary of the general conclusions of the report.« less

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.

The advancement of a new human factors report--'The Unique Report'--facilitating flight crew auditing of performance/operations as part of an airline's safety management system.

PubMed

Leva, M C; Cahill, J; Kay, A M; Losa, G; McDonald, N

2010-02-01

This paper presents the findings of research relating to the specification of a new human factors report, conducted as part of the work requirements for the Human Integration into the Lifecycle of Aviation Systems project, sponsored by the European Commission. Specifically, it describes the proposed concept for a unique report, which will form the basis for all operational and safety reports completed by flight crew. This includes all mandatory and optional reports. Critically, this form is central to the advancement of improved processes and technology tools, supporting airline performance management, safety management, organisational learning and knowledge integration/information-sharing activities. Specifically, this paper describes the background to the development of this reporting form, the logic and contents of this form and how reporting data will be made use of by airline personnel. This includes a description of the proposed intelligent planning process and the associated intelligent flight plan concept, which makes use of airline operational and safety analyses information. Primarily, this new reporting form has been developed in collaboration with a major Spanish airline. In addition, it has involved research with five other airlines. Overall, this has involved extensive field research, collaborative prototyping and evaluation of new reports/flight plan concepts and a number of evaluation activities. Participants have included both operational and management personnel, across different airline flight operations processes. Statement of Relevance: This paper presents the development of a reporting concept outlined through field research and collaborative prototyping within an airline. The resulting reporting function, embedded in the journey log compiled at the end of each flight, aims at enabling employees to audit the operations of the company they work for.

Use of safety management practices for improving project performance.

PubMed

Cheng, Eddie W L; Kelly, Stephen; Ryan, Neal

2015-01-01

Although site safety has long been a key research topic in the construction field, there is a lack of literature studying safety management practices (SMPs). The current research, therefore, aims to test the effect of SMPs on project performance. An empirical study was conducted in Hong Kong and the data collected were analysed with multiple regression analysis. Results suggest that 3 of the 15 SMPs, which were 'safety committee at project/site level', 'written safety policy', and 'safety training scheme' explained the variance in project performance significantly. Discussion about the impact of these three SMPs on construction was provided. Assuring safe construction should be an integral part of a construction project plan.

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.

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

PubMed

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

2015-01-01

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

Sun safety in construction: a U.K. intervention study.

PubMed

Houdmont, J; Madgwick, P; Randall, R

2016-01-01

Interventions to promote sun safety in the U.K. construction sector are warranted given the high incidence of skin cancer attributable to sun exposure relative to other occupational groups. To evaluate change in sun safety knowledge and practices among construction workers in response to an educational intervention. A baseline questionnaire was administered, followed by a bespoke sector-specific DVD-based intervention. At 12-month follow-up, participants completed a further questionnaire. Analyses were conducted on a sample of 120 workers (intervention group, n = 70; comparison group, n = 50). At follow-up, the proportion of intervention group participants that reported correct sun safety knowledge was not significantly greater than at baseline. However, the intervention group demonstrated significant positive change on 9 out of 10 behavioural measures, the greatest change being use of a shade/cover when working in the sun followed by regularly checking skin for moles or unusual changes. Exposure to this intervention was linked to some specific positive changes in construction workers' self-reported sun safety practices. These findings highlight the potential for educational interventions to contribute to tackling skin cancer in the UK construction sector. The findings support the development of bespoke educational interventions for other high-risk outdoor worker groups. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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.

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.

The role of eye protection in work-related eye injuries.

PubMed

Fong, L P; Taouk, Y

1995-05-01

A recent survey of general hospitals by the Victorian Injury Surveillance System found that ocular trauma represented 15% of work-related injuries. As circumstances surrounding occupational eye injuries have been poorly documented previously, their associations to occupation, industry and work-safety practices, including safety eyewear use, need to be identified to develop appropriate preventive strategies for high-risk groups. From a prospective cross-sectional survey of all eye injuries treated at the Royal Victorian Eye and Ear Hospital, work-related cases were analysed for demographic, occupational and safety eye-wear information. Hospital-based data were supplemented by information from WorkCover Authorities and Labour Force statistics to derive incidence and cost estimates. There were 9390 eye injuries during the 18-month survey period; 42% (n=3923) of total and 29% (n=52) of penetrating ocular injuries occurred at work. The most frequently injured were metal, automotive and building trades workers grinding and drilling (41% of outpatients) and hammering (53% of penetrating eye injuries). Automotive workers had the highest frequency for penetrating injuries, and most were exposed to hammering and were also the least likely to wear safety eye-wear. Eye injuries are frequent (10% of work-related injuries) and highly preventable by the correct use of safety eye-wear, a cost-effective intervention that may result in cost savings of $59 million for work-type activities in the occupational and domestic settings in Australia each year.

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.

75 FR 68781 - Workforce Guidelines for Home Energy Upgrades

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-09

... Work Specifications (SWSs), Job Task Analyses (JTAs) and essential Knowledge, Skills and Abilities..., organized labor, healthy homes and worker safety experts, and other professionals in the building trades and... reviews, a healthy homes review coordinated by the EPA, and a worker health and safety review coordinated...

The Operations Security Concept for Future ESA Earth Observation Missions

NASA Astrophysics Data System (ADS)

Fischer, D.; Bargellini, P.; Merri, M.

2008-08-01

Next-generation European earth observation missions will play a critical role in public safety and security infrastructures. This makes it necessary for ESA to protect the communication infrastructure of these missions in order to guarantee their service availability. In this paper, we discuss the development process for a generic earth observation security concept. This concept has been developed as part of a GMES Flight Operation Segment security study with the objective to analyse and select a number of high level security requirements for the missions. Further, we studied the impact of an implementation for these requirements on the operational infrastructure of current earth observation missions.

Ionic Liquids in Lithium-Ion Batteries.

PubMed

Balducci, Andrea

2017-04-01

Lithium-ion batteries are among the most widespread energy storage devices in our society. In order to introduce these devices in new key applications such as transportation, however, their safety and their operative temperature range need to be significantly improved. These improvements can be obtained only by developing new electrolytes. Ionic liquids are presently considered among the most attractive electrolytes for the development of advanced and safer lithium-ion batteries. In this manuscript, the use of various types of ionic liquids, e.g. aprotic and protic, in lithium-ion batteries is considered. The advantages and the limits associated to the use of these innovative electrolytes are critically analysed.

Empirical Model Development for Predicting Shock Response on Composite Materials Subjected to Pyroshock Loading. Volume 2, Part 1; Appendices

NASA Technical Reports Server (NTRS)

Gentz, Steven J.; Ordway, David O.; Parsons, David S.; Garrison, Craig M.; Rodgers, C. Steven; Collins, Brian W.

2015-01-01

The NASA Engineering and Safety Center (NESC) received a request to develop an analysis model based on both frequency response and wave propagation analyses for predicting shock response spectrum (SRS) on composite materials subjected to pyroshock loading. The model would account for near-field environment (approximately 9 inches from the source) dominated by direct wave propagation, mid-field environment (approximately 2 feet from the source) characterized by wave propagation and structural resonances, and far-field environment dominated by lower frequency bending waves in the structure. This document contains appendices to the Volume I report.

Impact of human development on safety consciousness in construction.

PubMed

Baradan, Selim; Dikmen, Seyyit Umit; Akboga Kale, Ozge

2018-05-03

The International Labour Organization (ILO) reports that the risk of fatal occupational injuries in developing countries is almost twice as high as in developed countries, indicating a potential relationship between the fatality rates and the development level. The human development index (HDI), based on life expectancy, knowledge level and purchasing power parity, endorsed by the United Nations Development Programme, is a widely accepted measure of the development level. This study investigates the relationship between the HDI and the fatality rates reported by the ILO. A 23-country data set is used to demonstrate the general trend of the relationship followed by country-specific analyses for Australia, Spain, Hungary and Turkey. The study conducted is limited to fatal occupational injuries in construction, where the accidents are notoriously high. The results demonstrate a statistically significant inverse relationship between the fatality rates and the HDI.

[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.

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

PubMed

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

2017-06-01

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

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

PubMed

Welp, Annalena; Manser, Tanja

2016-07-19

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

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

PubMed

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

2015-12-01

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

78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... methodological issues that arise in the use of meta-analyses to evaluate safety risks, followed by a discussion... design, conduct and use of meta-analysis. Although many external stakeholders conduct meta-analyses, FDA... meeting. FDA expects that this meeting will build upon prior stakeholder feedback on the design, conduct...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2010 CFR

2010-01-01

... Analysis Reports for Nuclear Power Plants, or successor document. (2) A DOE nonreactor nuclear facility... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., the public and the environment from adverse consequences. These analyses and hazard controls...

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.

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

PubMed

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

2011-06-01

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

Patient safety culture in China: a case study in an outpatient setting in Beijing.

PubMed

Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

2014-07-01

To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of 'communication openness' was identified as a major safety culture problem, and a perception of 'penalty' was the greatest barrier to the encouragement of error reporting. Cohesive 'teamwork within units', while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong 'teamwork within units', a common area of strength, could fuel the concealment of errors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

Ares I Static Tests Design

NASA Technical Reports Server (NTRS)

Carson, William; Lindemuth, Kathleen; Mich, John; White, K. Preston; Parker, Peter A.

2009-01-01

Probabilistic engineering design enhances safety and reduces costs by incorporating risk assessment directly into the design process. In this paper, we assess the format of the quantitative metrics for the vehicle which will replace the Space Shuttle, the Ares I rocket. Specifically, we address the metrics for in-flight measurement error in the vector position of the motor nozzle, dictated by limits on guidance, navigation, and control systems. Analyses include the propagation of error from measured to derived parameters, the time-series of dwell points for the duty cycle during static tests, and commanded versus achieved yaw angle during tests. Based on these analyses, we recommend a probabilistic template for specifying the maximum error in angular displacement and radial offset for the nozzle-position vector. Criteria for evaluating individual tests and risky decisions also are developed.

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;

The Earth Science Afternoon Constellation Contingency Procedures

NASA Technical Reports Server (NTRS)

Case, Warren F.; Richon, Karen

2005-01-01

The Earth Science Afternoon Constellation comprises NASA missions Aqua, Aura, CloudSat and the Orbiting Carbon Observatory (OCO), the joint NASA/CNES mission CALIPSO and the CNES mission PARASOL. Both NASA and CNES offices are responsible for ensuring that contingency plans or other arrangements exist to cope with contingencies within their respective jurisdictions until the conclusion of all Afternoon Constellation operations. The Mission Operations Working Group, comprised of members from each of the missions, has developed the high-level procedures for maintaining the safety of this constellation. Each contingency situation requires detailed analyses before any decisions are made. This paper describes these procedures, and includes defining what constitutes a contingency situation, the pertinent parameters involved in the contingency analysis and guidelines for the actions required, based on the results of the contingency analyses.

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

Marshall, William BJ J; Rearden, Bradley T

The validation of neutron transport methods used in nuclear criticality safety analyses is required by consensus American National Standards Institute/American Nuclear Society (ANSI/ANS) standards. In the last decade, there has been an increased interest in correlations among critical experiments used in validation that have shared physical attributes and which impact the independence of each measurement. The statistical methods included in many of the frequently cited guidance documents on performing validation calculations incorporate the assumption that all individual measurements are independent, so little guidance is available to practitioners on the topic. Typical guidance includes recommendations to select experiments from multiple facilitiesmore » and experiment series in an attempt to minimize the impact of correlations or common-cause errors in experiments. Recent efforts have been made both to determine the magnitude of such correlations between experiments and to develop and apply methods for adjusting the bias and bias uncertainty to account for the correlations. This paper describes recent work performed at Oak Ridge National Laboratory using the Sampler sequence from the SCALE code system to develop experimental correlations using a Monte Carlo sampling technique. Sampler will be available for the first time with the release of SCALE 6.2, and a brief introduction to the methods used to calculate experiment correlations within this new sequence is presented in this paper. Techniques to utilize these correlations in the establishment of upper subcritical limits are the subject of a companion paper and will not be discussed here. Example experimental uncertainties and correlation coefficients are presented for a variety of low-enriched uranium water-moderated lattice experiments selected for use in a benchmark exercise by the Working Party on Nuclear Criticality Safety Subgroup on Uncertainty Analysis in Criticality Safety Analyses. The results include studies on the effect of fuel rod pitch on the correlations, and some observations are also made regarding difficulties in determining experimental correlations using the Monte Carlo sampling technique.« less

A psychometric evaluation of the Chinese version of the nursing home survey on patient safety culture.

PubMed

Lin, Shu-Yuan; Tseng, Wei Ting; Hsu, Miao-Ju; Chiang, Hui-Ying; Tseng, Hui-Chen

2017-12-01

To test the psychometric properties of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among staff in long-term care facilities. The Nursing Home Survey on Patient Safety Culture scale is a standard tool for safety culture assessment in nursing homes. Extending its application to different types of long-term care facilities and varied ethnic populations is worth pursuing. A national random survey. A total of 306 managers and staff completed the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among 30 long-term care facilities in Taiwan. Content validity and construct validity were tested by content validity index (CVI) and principal axis factor analysis (PAF) with Promax rotation. Concurrent validity was tested through correlations between the scale and two overall rating items. Reliability was computed by intraclass correlation coefficient and Cronbach's α coefficients. Statistical analyses such as descriptive, Pearson's and Spearman's rho correlations and PAF were completed. Scale-level and item-level CVIs (0.91-0.98) of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale were satisfactory. Four-factor construct and merged item composition differed from the Nursing Home Survey on Patient Safety Culture scale, and it accounted for 53% of variance. Concurrent validity was evident by existing positive correlations between the scale and two overall ratings of resident safety. Cronbach's α coefficients of the subscales and the Chinese version of the Nursing Home Survey on Patient Safety Culture scale ranged from .76-.94. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale identified essential dimensions to reflect the important features of a patient safety culture in long-term care facilities. The researchers introduced the Chinese version of the Nursing Home Survey on Patient Safety Culture for safety culture assessment in long-term care facilities, but further testing of the reliability of the scale in a large Chinese sample and in different long-term care facilities was recommended. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale was developed to increase the users' intention towards safety culture assessment. It can identify areas for improvement, understand safety culture changes over time and evaluate the effectiveness of interventions. © 2017 John Wiley & Sons Ltd.

Personalized medicine in human space flight: using Omics based analyses to develop individualized countermeasures that enhance astronaut safety and performance.

PubMed

Schmidt, Michael A; Goodwin, Thomas J

2013-01-01

Space flight is one of the most extreme conditions encountered by humans. Advances in Omics methodologies (genomics, transcriptomics, proteomics, and metabolomics) have revealed that unique differences exist between individuals. These differences can be amplified in extreme conditions, such as space flight. A better understanding of individual differences may allow us to develop personalized countermeasure packages that optimize the safety and performance of each astronaut. In this review, we explore the role of "Omics" in advancing our ability to: (1) more thoroughly describe the biological response of humans in space; (2) describe molecular attributes of individual astronauts that alter the risk profile prior to entering the space environment; (3) deploy Omics techniques in the development of personalized countermeasures; and (4) develop a comprehensive Omics-based assessment and countermeasure platform that will guide human space flight in the future. In this review, we advance the concept of personalized medicine in human space flight, with the goal of enhancing astronaut safety and performance. Because the field is vast, we explore selected examples where biochemical individuality might significantly impact countermeasure development. These include gene and small molecule variants associated with: (1) metabolism of therapeutic drugs used in space; (2) one carbon metabolism and DNA stability; (3) iron metabolism, oxidative stress and damage, and DNA stability; and (4) essential input (Mg and Zn) effects on DNA repair. From these examples, we advance the case that widespread Omics profiling should serve as the foundation for aerospace medicine and research, explore methodological considerations to advance the field, and suggest why personalized medicine may become the standard of care for humans in space.

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

PubMed

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

2018-05-02

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

Measuring school climate in high schools: a focus on safety, engagement, and the environment.

PubMed

Bradshaw, Catherine P; Waasdorp, Tracy E; Debnam, Katrina J; Johnson, Sarah Lindstrom

2014-09-01

School climate has been linked to multiple student behavioral, academic, health, and social-emotional outcomes. The US Department of Education (USDOE) developed a 3-factor model of school climate comprised of safety, engagement, and environment. This article examines the factor structure and measurement invariance of the USDOE model. Drawing upon 2 consecutive waves of data from over 25,000 high school students (46% minority), a series of exploratory and confirmatory factor analyses examined the fit of the Maryland Safe and Supportive Schools Climate Survey with the USDOE model. The results indicated adequate model fit with the theorized 3-factor model of school climate, which included 13 subdomains: safety (perceived safety, bullying and aggression, and drug use); engagement (connection to teachers, student connectedness, academic engagement, school connectedness, equity, and parent engagement); environment (rules and consequences, physical comfort, and support, disorder). We also found consistent measurement invariance with regard to student sex, grade level, and ethnicity. School-level interclass correlation coefficients ranged from 0.04 to .10 for the scales. Findings supported the USDOE 3-factor model of school climate and suggest measurement invariance and high internal consistency of the 3 scales and 13 subdomains. These results suggest the 56-item measure may be a potentially efficient, yet comprehensive measure of school climate. © 2014, American School Health Association.

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

PubMed

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

2005-07-01

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

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.

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.

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.

Safety improvement and preservation of typical sensory qualities of traditional dry fermented sausages using autochthonous starter cultures.

PubMed

Talon, Régine; Leroy, Sabine; Lebert, Isabelle; Giammarinaro, Philippe; Chacornac, Jean-Paul; Latorre-Moratalla, Mariluz; Vidal-Carou, Carmen; Zanardi, Emanuela; Conter, Mauro; Lebecque, Annick

2008-08-15

Traditional dry fermented sausages are manufactured without addition of starter cultures in small-scale processing units, their fermentation relying on indigenous microflora. Characterisation and control of these specific bacteria are essential for the sensory quality and the safety of the sausages. The aim of this study was to develop an autochthonous starter culture that improves safety while preserving the typical sensory characteristics of traditional sausages. An autochthonous starter composed of Lactobacillus sakei, Staphylococcus equorum and Staphylococcus succinus isolated from a traditional fermented sausage was developed. These strains were tested for their susceptibility to antibiotics and their production of biogenic amines. This starter was evaluated in situ at the French traditional processing unit where the strains had been isolated. Effects of the autochthonous starter were assessed by analysing the microbial, physico-chemical, biochemical and sensory characteristics of the sausages. Inoculation with the chosen species was confirmed using known species-specific PCR assays for L. sakei and S. equorum and a species-specific PCR assay developed in this study for S. succinus. Strains were monitored by pulse-field gel electrophoresis typing. Addition of autochthonous microbial starter cultures improved safety compared with the traditional natural fermentation of sausages, by inhibiting the pathogen Listeria monocytogenes, decreasing the level of biogenic amines and by limiting fatty acid and cholesterol oxidation. Moreover, autochthonous starter did not affect the typical sensory quality of the traditional sausages. This is the first time to our knowledge that selection, development and validation in situ of autochthonous starter cultures have been carried out, and also the first time that S. equorum together with S. succinus have been used as starter cultures for meat fermentation. Use of autochthonous starter cultures is an effective tool for limiting the formation of unsafe compounds in traditional sausage while preserving their original and specific sensory quality.

Trends and advances in food analysis by real-time polymerase chain reaction.

PubMed

Salihah, Nur Thaqifah; Hossain, Mohammad Mosharraf; Lubis, Hamadah; Ahmed, Minhaz Uddin

2016-05-01

Analyses to ensure food safety and quality are more relevant now because of rapid changes in the quantity, diversity and mobility of food. Food-contamination must be determined to maintain health and up-hold laws, as well as for ethical and cultural concerns. Real-time polymerase chain reaction (RT-PCR), a rapid and inexpensive quantitative method to detect the presence of targeted DNA-segments in samples, helps in determining both accidental and intentional adulterations of foods by biological contaminants. This review presents recent developments in theory, techniques, and applications of RT-PCR in food analyses, RT-PCR addresses the limitations of traditional food analyses in terms of sensitivity, range of analytes, multiplexing ability, cost, time, and point-of-care applications. A range of targets, including species of plants or animals which are used as food ingredients, food-borne bacteria or viruses, genetically modified organisms, and allergens, even in highly processed foods can be identified by RT-PCR, even at very low concentrations. Microfluidic RT-PCR eliminates the separate sample-processing step to create opportunities for point-of-care analyses. We also cover the challenges related to using RT-PCR for food analyses, such as the need to further improve sample handling.

Criticality safety evaluation for the Advanced Test Reactor enhanced low enriched uranium fuel elements

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

Montierth, Leland M.

2016-07-19

The Global Threat Reduction Initiative (GTRI) convert program is developing a high uranium density fuel based on a low enriched uranium (LEU) uranium-molybdenum alloy. Testing of prototypic GTRI fuel elements is necessary to demonstrate integrated fuel performance behavior and scale-up of fabrication techniques. GTRI Enhanced LEU Fuel (ELF) elements based on the ATR-Standard Size elements (all plates fueled) are to be fabricated for testing in the Advanced Test Reactor (ATR). While a specific ELF element design will eventually be provided for detailed analyses and in-core testing, this criticality safety evaluation (CSE) is intended to evaluate a hypothetical ELF element designmore » for criticality safety purposes. Existing criticality analyses have analyzed Standard (HEU) ATR elements from which controls have been derived. This CSE documents analysis that determines the reactivity of the hypothetical ELF fuel elements relative to HEU ATR elements and whether the existing HEU ATR element controls bound the ELF element. The initial calculations presented in this CSE analyzed the original ELF design, now referred to as Mod 0.1. In addition, as part of a fuel meat thickness optimization effort for reactor performance, other designs have been evaluated. As of early 2014 the most current conceptual designs are Mk1A and Mk1B, that were previously referred to as conceptual designs Mod 0.10 and Mod 0.11, respectively. Revision 1 evaluates the reactivity of the ATR HEU Mark IV elements for a comparison with the Mark VII elements.« less

The Worry Behaviors Inventory: Assessing the behavioral avoidance associated with generalized anxiety disorder.

PubMed

Mahoney, Alison E J; Hobbs, Megan J; Newby, Jill M; Williams, Alishia D; Sunderland, Matthew; Andrews, Gavin

2016-10-01

Understanding behavioral avoidance associated with generalized anxiety disorder (GAD) has implications for the classification, theoretical conceptualization, and clinical management of the disorder. This study describes the development and preliminary psychometric evaluation of a self-report measure of avoidant behaviors associated with GAD: the Worry Behaviors Inventory (WBI). The WBI was administered to treatment-seeking patients (N=1201). Convergent validity was assessed by correlating the WBI with measures of GAD symptom severity. Divergent validity was assessed by correlating the WBI with measures of general disability and measures of depression, social anxiety and panic disorder symptom severity. Exploratory and confirmatory factor analyses supported a two-factor structure (Safety Behaviors and Avoidance). Internal reliability was acceptable for the 10-item WBI scale (α=.86), Safety Behaviors (α=.85) and Avoidance subscales (α=.75). Evidence of convergent, divergent, and discriminant validity is reported. WBI subscales demonstrated differential associations with measures of symptom severity. The Safety Behaviors subscale was more strongly associated with GAD symptoms than symptoms of other disorders, whereas the Avoidance subscale was as strongly correlated with GAD severity as it was with depression, social anxiety and panic disorder severity. Structured diagnostic interviews were not conducted therefor validity analyses are limited to probable diagnoses based on self-report. The cross-sectional design precluded examination of the WBI's temporal stability and treatment sensitivity. Preliminary evidence supports the use of the WBI in research and clinical settings and may assist clinicians to identify behaviors that are theorized to maintain GAD and that can be targeted during psychological treatment. Copyright © 2016 Elsevier B.V. All rights reserved.

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

PubMed

Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross; Vohra, Sunita

2016-09-01

The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers. Copyright © 2016. Published by Elsevier Inc.

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

Safety in home care: A research protocol for studying medication management

PubMed Central

2010-01-01

Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS), we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange throughout the study with the use of participatory data collection methods. PMID:20525363

Paraffin-related injury in low-income South African communities: knowledge, practice and perceived risk

PubMed Central

Swart, Dehran; Hui, Siu-kuen Azor; Simpson, Jennifer; Hobe, Phumla

2009-01-01

Abstract Objective To explore what individuals at risk of injury from using paraffin (also known as kerosene) know about paraffin safety, what they do to protect themselves and their families from paraffin-related injury, and how they perceive their risk for such injury. Also, to explore interrelations between these factors and age, sex, education and income. Methods A sample of 238 individuals was randomly recruited from low-income housing districts near Cape Town, South Africa in 2007. Trained research assistants interviewed participants to explore their knowledge about paraffin-related safety and their perceived risk of injury from using paraffin. Researchers inspected participants’ homes to evaluate paraffin safety practices. Descriptive and correlational analyses were conducted. Findings Participants had relatively low levels of knowledge about paraffin-related safety. They had high levels of unsafe practice and their perceived risk of injury was moderate. Knowledge of paraffin safety and safe practices were positively correlated with each other. Greater knowledge showed a negative correlation with the perception of being at risk for injury, but safe practices showed no correlation with perceived risk of injury. Formal education, the number of children in the home and frequency of paraffin use were positively correlated with knowledge but not with safe practices. The only significant correlate to safe practices was greater income, perhaps a reflection of the impact of financial resources on paraffin safety practices. Conclusion To develop successful paraffin safety interventions, it is necessary to understand baseline levels of knowledge, practice and perceived risk of injury among at-risk populations. Our findings could be of value for designing interventions that will increase knowledge, improve safe practices and lead to the accurate perception of the risk of injury from using paraffin. PMID:19784450

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.