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.

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.

Highway safety design workshops.

DOT National Transportation Integrated Search

2010-11-01

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

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.

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

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?

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

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

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.

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.

Impact of biomarker development on drug safety assessment

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

Marrer, Estelle, E-mail: estelle.marrer@novartis.co; Dieterle, Frank

2010-03-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative andmore » 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.« less

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.

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Lunar mission safety and rescue: Executive summary

NASA Technical Reports Server (NTRS)

1971-01-01

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

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.

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

NASA Astrophysics Data System (ADS)

Summerer, Leopold

2014-08-01

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

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...

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

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

Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

PubMed

Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

2007-05-01

Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

Annotated Bibliography of Rail Transit Safety, 1975-1980, with Emphasis on Safety Research and Development.

DOT National Transportation Integrated Search

1981-09-01

The bibliography provides a comprehensive review of published literature concerning rail transit safety and includes 186 annotated entries. The report covers domestic and foreign material on rail transit safety and related safety research and develop...

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

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.

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)

Development of a Comprehensive Database System for Safety Analyst

PubMed Central

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

2015-01-01

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

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.

Neutronic safety parameters and transient analyses for Poland's MARIA research reactor.

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

Bretscher, M. M.; Hanan, N. A.; Matos, J. E.

1999-09-27

Reactor kinetic parameters, reactivity feedback coefficients, and control rod reactivity worths have been calculated for the MARIA Research Reactor (Swierk, Poland) for M6-type fuel assemblies with {sup 235}U enrichments of 80% and 19.7%. Kinetic parameters were evaluated for family-dependent effective delayed neutron fractions, decay constants, and prompt neutron lifetimes and neutron generation times. Reactivity feedback coefficients were determined for fuel Doppler coefficients, coolant (H{sub 2}O) void and temperature coefficients, and for in-core and ex-core beryllium temperature coefficients. Total and differential control rod worths and safety rod worths were calculated for each fuel type. These parameters were used to calculate genericmore » transients for fast and slow reactivity insertions with both HEU and LEU fuels. The analyses show that the HEU and LEU cores have very similar responses to these transients.« less

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

PubMed

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

2017-03-01

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

Global road safety online course development.

DOT National Transportation Integrated Search

2017-06-01

The Global Road Safety Online Curriculum Development project involved the adaptation of in-person classroom materials and development of new materials to be used in an online setting. A short-course format was selected to pilot the course, and four t...

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

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

Development of decision support tools to assess pedestrian and bicycle safety : development of safety performance functions : final report.

DOT National Transportation Integrated Search

2016-11-15

While a number of studies have developed Safety Performance Functions (SPFs) for : motorized traffic, there has been a very limited focus on developing SPFs for non-motorized : traffic. Lack of exposure measures for pedestrians and bicyclists has bee...

Bounding criticality safety analyses for shipments of unconfigured spent nuclear fuel

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

Lichtenwalter, J.J.; Parks, C.V.

1998-06-01

In November 1996, a request was made to the US Department of Energy for a waiver for three shipments of spent nuclear fuel (SNF) from Oak Ridge National Laboratory (ORNL) to the Savannah River Site (SRS) in the US NRC certified BMI-1 cask (CoC 5957). Although the post-irradiation fissile mass (based on chemical assays) in each shipment was less than 800 g, a criticality safety analysis was needed because the pre-irradiation mass exceeded 800 g, the fissile material limit in the CoC. The analyses were performed on SNF consisting of aluminum-clad U{sub 3}O{sub 8}, UAl{sub x}, and U{sub 3}Si{sub 2}more » plates, fragments and pieces that had been irradiated at ORNL during the Reduced Enrichment Research and Test Reactor Program of the 1980s. The highlights of the approach used to analyze this unique SNF and the benefits of the waiver are presented in this paper.« less

Health and safety in clinical laboratories in developing countries: safety considerations.

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

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.

An evaluation of Winnipeg's photo enforcement safety program: results of time series analyses and an intersection camera experiment.

PubMed

Vanlaar, Ward; Robertson, Robyn; Marcoux, Kyla

2014-01-01

The objective of this study was to evaluate the impact of Winnipeg's photo enforcement safety program on speeding, i.e., "speed on green", and red-light running behavior at intersections as well as on crashes resulting from these behaviors. ARIMA time series analyses regarding crashes related to red-light running (right-angle crashes and rear-end crashes) and crashes related to speeding (injury crashes and property damage only crashes) occurring at intersections were conducted using monthly crash counts from 1994 to 2008. A quasi-experimental intersection camera experiment was also conducted using roadside data on speeding and red-light running behavior at intersections. These data were analyzed using logistic regression analysis. The time series analyses showed that for crashes related to red-light running, there had been a 46% decrease in right-angle crashes at camera intersections, but that there had also been an initial 42% increase in rear-end crashes. For crashes related to speeding, analyses revealed that the installation of cameras was not associated with increases or decreases in crashes. Results of the intersection camera experiment show that there were significantly fewer red light running violations at intersections after installation of cameras and that photo enforcement had a protective effect on speeding behavior at intersections. However, the data also suggest photo enforcement may be less effective in preventing serious speeding violations at intersections. Overall, Winnipeg's photo enforcement safety program had a positive net effect on traffic safety. Results from both the ARIMA time series and the quasi-experimental design corroborate one another. However, the protective effect of photo enforcement is not equally pronounced across different conditions so further monitoring is required to improve the delivery of this measure. Results from this study as well as limitations are discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Developing an industry-oriented safety curriculum using the Delphi technique.

PubMed

Chen, Der-Fa; Wu, Tsung-Chih; Chen, Chi-Hsiang; Chang, Shu-Hsuan; Yao, Kai-Chao; Liao, Chin-Wen

2016-09-01

In this study, we examined the development of industry-oriented safety degree curricula at a college level. Based on a review of literature on the practices and study of the development of safety curricula, we classified occupational safety and health curricula into the following three domains: safety engineering, health engineering, and safety and health management. We invited 44 safety professionals to complete a four-round survey that was designed using a modified Delphi technique. We used Chi-square statistics to test the panel experts' consensus on the significance of the items in the three domains and employed descriptive statistics to rank the participants' rating of each item. The results showed that the top three items for each of the three domains were Risk Assessment, Dangerous Machinery and Equipment, and Fire and Explosion Prevention for safety engineering; Ergonomics, Industrial Toxicology, and Health Risk Assessment for health engineering; and Industrial Safety and Health Regulations, Accident Investigation and Analysis, and Emergency Response for safety and health management. Only graduates from safety programmes who possess practical industry-oriented abilities can satisfy industry demands and provide value to the existence of college safety programmes.

Development of photovoltaic array and module safety requirements

NASA Technical Reports Server (NTRS)

1982-01-01

Safety requirements for photovoltaic module and panel designs and configurations likely to be used in residential, intermediate, and large-scale applications were identified and developed. The National Electrical Code and Building Codes were reviewed with respect to present provisions which may be considered to affect the design of photovoltaic modules. Limited testing, primarily in the roof fire resistance field was conducted. Additional studies and further investigations led to the development of a proposed standard for safety for flat-plate photovoltaic modules and panels. Additional work covered the initial investigation of conceptual approaches and temporary deployment, for concept verification purposes, of a differential dc ground-fault detection circuit suitable as a part of a photovoltaic array safety system.

Curriculum Development and Implementation of a National Interprofessional Fellowship in Patient Safety.

PubMed

Watts, Bradley V; Williams, Linda; Mills, Peter D; Paull, Douglas E; Cully, Jeffrey A; Gilman, Stuart C; Hemphill, Robin R

2018-06-15

Developing a workforce skilled in improving the safety of medical care has often been cited as an important means to achieve safer care. Although some educational programs geared toward patient safety have been developed, few advanced training programs have been described in the literature. We describe the development of a patient safety fellowship program. We describe the development and curriculum of an Interprofessional Fellowship in Patient Safety. The 1-year in residence fellowship focuses on domains such as leadership, spreading innovations, medical improvement, patient safety culture, reliability science, and understanding errors. Specific training in patient safety is available and has been delivered to 48 fellows from a wide range of backgrounds. Fellows have accomplished much in terms of improvement projects, educational innovations, and publications. After completing the fellowship program, fellows are obtaining positions within health-care quality and safety and are likely to make long-term contributions. We offer a curriculum and fellowship design for the topic of patient safety. Available evidence suggests that the fellowship results in the development of patient safety professionals.

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

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

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.

Transportation safety data and analysis : Volume 2, Calibration of the highway safety manual and development of new safety performance functions.

DOT National Transportation Integrated Search

2011-03-01

This report documents the calibration of the Highway Safety Manual (HSM) safety performance function (SPF) : for rural two-lane two-way roadway segments in Utah and the development of new models using negative : binomial and hierarchical Bayesian mod...

Development of a safety management protocol.

DOT National Transportation Integrated Search

2008-09-01

The UC Berkeley Traffic Safety Center (TSC) has produced this report under a contract from the California Department of Transportation : (Caltrans). The aim is to address workplace injuries and accidents among Caltrans employees and develop recommend...

Ares I-X Range Safety Flight Envelope Analysis

NASA Technical Reports Server (NTRS)

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

2011-01-01

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

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.

Microbiological food safety: a dilemma of developing societies.

PubMed

Akhtar, Saeed; Sarker, Mahfuzur R; Hossain, Ashfaque

2014-11-01

Current food safety issues are deleteriously reshaping the life style of the population in the developing world. Socioeconomic status of the population in poorer economies is one of the major determinants to delineate the availability of safe food to the vulnerable population. Assessment of the prevalence of foodborne illness in developing world is the most neglected area to control disease. Botulism, Shigellosis, Campylobacteriosis, Escherichia coli infection, Staphylococcus aureus infection, Salmonellosis, Listeriosis and Cholerae are extensively prevalent and pose a major threat to human health in underdeveloped communities. The existing food safety status of many African, South Asian, Central, and South American developing countries is distressing therefore; it seems much timely to highlight the areas for the improvement to ensure the supply of safe food to the population in these regions. Extensive literature search at PubMed, Science Direct and Medline was carried out during the current year to catch on relevant data from 1976 to date, using selective terms like food safety, South East Asia, Africa, Central and South America, and foodborne illness etc. Efforts were made to restrict the search to low income countries of these regions with reference to specific foodborne pathogens. This report briefly discusses the present food safety situation in these developing countries and associated consequences as prime issues, suggesting foodborne illness to be the most distressing threat for human health and economic growth.

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

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

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

1978-12-01

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

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...

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 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.

Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder

PubMed Central

Kratochvil, Christopher; Ghuman, Jaswinder; Camporeale, Angelo; Lipsius, Sarah; D'Souza, Deborah; Tanaka, Yoko

2015-01-01

Abstract Objectives: This extrapolation analysis qualitatively compared the efficacy and safety profile of atomoxetine from Lilly clinical trial data in 6–7-year-old patients with attention-deficit/hyperactivity disorder (ADHD) with that of published literature in 4–5-year-old patients with ADHD (two open-label [4–5-year-old patients] and one placebo-controlled study [5-year-old patients]). Methods: The main efficacy analyses included placebo-controlled Lilly data and the placebo-controlled external study (5-year-old patients) data. The primary efficacy variables used in these studies were the ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent:Inv) total score, or the Swanson, Nolan and Pelham (SNAP-IV) scale score. Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs. Descriptive statistics (means, percentages) are presented. Results: Acute atomoxetine treatment improved core ADHD symptoms in both 6–7-year-old patients (n=565) and 5-year-old patients (n=37) (treatment effect: −10.16 and −7.42). In an analysis of placebo-controlled groups, the mean duration of exposure to atomoxetine was ∼7 weeks for 6–7-year-old patients and 9 weeks for 5-year-old patients. Decreased appetite was the most common TEAE in atomoxetine-treated patients. The TEAEs observed at a higher rate in 5-year-old versus 6–7-year-old patients were irritability (36.8% vs. 3.6%) and other mood-related events (6.9% each vs. <3.0%). Blood pressure and pulse increased in both 4–5-year-old patients and 6–7-year-old patients, whereas a weight increase was seen only in the 6–7-year-old patients. Conclusions: Although limited by the small sample size of the external studies, these analyses suggest that in 5-year-old patients with ADHD, atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients. PMID:25265343

Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.

PubMed

Upadhyaya, Himanshu; Kratochvil, Christopher; Ghuman, Jaswinder; Camporeale, Angelo; Lipsius, Sarah; D'Souza, Deborah; Tanaka, Yoko

2015-12-01

This extrapolation analysis qualitatively compared the efficacy and safety profile of atomoxetine from Lilly clinical trial data in 6-7-year-old patients with attention-deficit/hyperactivity disorder (ADHD) with that of published literature in 4-5-year-old patients with ADHD (two open-label [4-5-year-old patients] and one placebo-controlled study [5-year-old patients]). The main efficacy analyses included placebo-controlled Lilly data and the placebo-controlled external study (5-year-old patients) data. The primary efficacy variables used in these studies were the ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent:Inv) total score, or the Swanson, Nolan and Pelham (SNAP-IV) scale score. Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs. Descriptive statistics (means, percentages) are presented. Acute atomoxetine treatment improved core ADHD symptoms in both 6-7-year-old patients (n=565) and 5-year-old patients (n=37) (treatment effect: -10.16 and -7.42). In an analysis of placebo-controlled groups, the mean duration of exposure to atomoxetine was ∼ 7 weeks for 6-7-year-old patients and 9 weeks for 5-year-old patients. Decreased appetite was the most common TEAE in atomoxetine-treated patients. The TEAEs observed at a higher rate in 5-year-old versus 6-7-year-old patients were irritability (36.8% vs. 3.6%) and other mood-related events (6.9% each vs. <3.0%). Blood pressure and pulse increased in both 4-5-year-old patients and 6-7-year-old patients, whereas a weight increase was seen only in the 6-7-year-old patients. Although limited by the small sample size of the external studies, these analyses suggest that in 5-year-old patients with ADHD, atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients.

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.

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

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving

An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses--Criticality (keff) Predictions

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

Scaglione, John M; Mueller, Don; Wagner, John C

2011-01-01

One of the most significant remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation - in particular, the availability and use of applicable measured data to support validation, especially for fission products. Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. U.S. Nuclear Regulatory Commission (NRC) staff have noted that the rationale for restricting their Interim Staff Guidance on burnup credit (ISG-8) to actinide-only ismore » based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issue of validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach (both depletion and criticality) for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the criticality (k{sub eff}) validation approach, and resulting observations and recommendations. Validation of the isotopic composition (depletion) calculations is addressed in a companion paper at this conference. For criticality validation, the approach is to utilize (1) available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion (HTC) program to support validation of the principal actinides and (2) calculated sensitivities, nuclear data uncertainties, and the limited available

The Development of Laboratory Safety Questionnaire for Middle School Science Teachers

ERIC Educational Resources Information Center

Akpullukcu, Simge; Cavas, Bulent

2017-01-01

The purpose of this paper is to develop a "valid and reliable laboratory safety questionnaire" which could be used to identify science teachers' understanding about laboratory safety issues during their science laboratory activities. The questionnaire was developed from a literature review and prior instruments developed on laboratory…

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

A conceptual framework to development of construction safety culture in Indonesia

NASA Astrophysics Data System (ADS)

Armyn Machfudiyanto, Rossy; Latief, Yusuf

2017-12-01

Working accidents in the construction industry are among the highest in the world, affecting the three levels of both macro (National) mezzo (Enterprise) and micro (Projects) that need to be integrated in building a safety culture. The purpose of this research is to develop a conceptual framework in improving safety culture in the construction industry in Indonesia. The methodology was developed using literature study and deductive analysis which then performed expert validation to ensure the concept developed. The result of this research is that policy and institution as input to build safety culture which need to be followed up with increasing of company maturity which have implication to safety performance and construction project performance.

Developing and Testing the Health Care Safety Hotline

PubMed Central

Schneider, Eric C.; Ridgely, M. Susan; Quigley, Denise D.; Hunter, Lauren E.; Leuschner, Kristin J.; Weingart, Saul N.; Weissman, Joel S.; Zimmer, Karen P.; Giannini, Robert C.

2017-01-01

Abstract This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers. PMID:28845353

Development of a Culturally Informed Child Safety Curriculum for American Indian Families.

PubMed

Berns, Ryan M; Tomayko, Emily J; Cronin, Kate A; Prince, Ronald J; Parker, Tassy; Adams, Alexandra K

2017-04-01

American Indian (AI) children are disproportionately affected by unintentional injuries, with injury mortality rates approximately 2.3 times higher than the combined rates for all children in the United States. Although multiple risk factors are known to contribute to these increased rates, a comprehensive, culturally informed curriculum that emphasizes child safety is lacking for this population. In response to this need, academic and tribal researchers, tribal community members, tribal wellness staff, and national child safety experts collaborated to develop a novel child safety curriculum. This paper describes its development and community delivery. We developed the safety curriculum as part of a larger randomized controlled trial known as Healthy Children, Strong Families 2 (HCSF2), a family-based intervention targeting obesity prevention in early childhood (2-5 years). During the development of the HCSF2 intervention, participating tribal communities expressed concern about randomizing enrolled families to a control group who would not receive an intervention. To address this concern and the significant disparities in injuries and unintentional death rates among AI children, we added an active control group (Safety Journey) that would utilize our safety curriculum. Satisfaction surveys administered at the 12-month time point of the intervention indicate 94% of participants (N = 196) were either satisfied or very satisfied with the child safety curriculum. The majority of participants (69%) reported spending more than 15 min with the curriculum materials each month, and 83% thought the child safety newsletters were either helpful or very helpful in making changes to improve their family's safety. These findings indicate these child safety materials have been well received by HCSF2 participants. The use of community-engaged approaches to develop this curriculum represents a model that could be adapted for other at-risk populations and serves as an initial

Scale development of safety management system evaluation for the airline industry.

PubMed

Chen, Ching-Fu; Chen, Shu-Chuan

2012-07-01

The airline industry relies on the implementation of Safety Management System (SMS) to integrate safety policies and augment safety performance at both organizational and individual levels. Although there are various degrees of SMS implementation in practice, a comprehensive scale measuring the essential dimensions of SMS is still lacking. This paper thus aims to develop an SMS measurement scale from the perspective of aviation experts and airline managers to evaluate the performance of company's safety management system, by adopting Schwab's (1980) three-stage scale development procedure. The results reveal a five-factor structure consisting of 23 items. The five factors include documentation and commands, safety promotion and training, executive management commitment, emergency preparedness and response plan and safety management policy. The implications of this SMS evaluation scale for practitioners and future research are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

Study on development and application of platform with students' safety based on SOA

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

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

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

PubMed

Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Development and Implementation of a Food Safety Knowledge Instrument

ERIC Educational Resources Information Center

Byrd-Bredbenner, Carol; Wheatley, Virginia; Schaffner, Donald; Bruhn, Christine; Blalock, Lydia; Maurer, Jaclyn

2007-01-01

Little is known about the food safety knowledge of young adults. In addition, few knowledge questionnaires and no comprehensive, criterion-referenced measure that assesses the full range of food safety knowledge could be identified. Without appropriate, valid, and reliable measures and baseline data, it is difficult to develop and implement…

Understanding adolescent development: implications for driving safety.

PubMed

Keating, Daniel P

2007-01-01

The implementation of Graduated Driver Licensing (GDL) programs has significantly improved the crash and fatality rates of novice teen drivers, but these rates remain unacceptably high. A review of adolescent development research was undertaken to identify potential areas of improvement. Research support for GDL was found to be strong, particularly regarding early acquisition of expertise in driving safety (beyond driving skill), and to limitations that reduce opportunities for distraction. GDL regimes are highly variable, and no US jurisdictions have implemented optimal regimes. Expanding and improving GDL to enhance acquisition of expertise and self-regulation are indicated for implementation and for applied research. Driver training that effectively incorporates safety goals along with driving skill is another target. The insurance industry will benefit from further GDL enhancements. Benefits may accrue to improved driver training, improved simulation devices during training, and automated safety feedback instrumentation.

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...

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

General aviation crash safety program at Langley Research Center

NASA Technical Reports Server (NTRS)

Thomson, R. G.

1976-01-01

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

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.

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

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).

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Development and Validation of a Safety Climate Scale for Manufacturing Industry

PubMed Central

Ghahramani, Abolfazl; Khalkhali, Hamid R.

2015-01-01

Background This paper describes the development of a scale for measuring safety climate. Methods This study was conducted in six manufacturing companies in Iran. The scale developed through conducting a literature review about the safety climate and constructing a question pool. The number of items was reduced to 71 after performing a screening process. Results The result of content validity analysis showed that 59 items had excellent item content validity index (≥ 0.78) and content validity ratio (> 0.38). The exploratory factor analysis resulted in eight safety climate dimensions. The reliability value for the final 45-item scale was 0.96. The result of confirmatory factor analysis showed that the safety climate model is satisfactory. Conclusion This study produced a valid and reliable scale for measuring safety climate in manufacturing companies. PMID:26106508

Person-centered endoscopy safety checklist: Development, implementation, and evaluation

PubMed Central

Dubois, Hanna; Schmidt, Peter T; Creutzfeldt, Johan; Bergenmar, Mia

2017-01-01

AIM To describe the development and implementation of a person-centered endoscopy safety checklist and to evaluate the effects of a “checklist intervention”. METHODS The checklist, based on previously published safety checklists, was developed and locally adapted, taking patient safety aspects into consideration and using a person-centered approach. This novel checklist was introduced to the staff of an endoscopy unit at a Stockholm University Hospital during half-day seminars and team training sessions. Structured observations of the endoscopy team’s performance were conducted before and after the introduction of the checklist. In addition, questionnaires focusing on patient participation, collaboration climate, and patient safety issues were collected from patients and staff. RESULTS A person-centered safety checklist was developed and introduced by a multi-professional group in the endoscopy unit. A statistically significant increase in accurate patient identity verification by the physicians was noted (from 0% at baseline to 87% after 10 mo, P < 0.001), and remained high among nurses (93% at baseline vs 96% after 10 mo, P = nonsignificant). Observations indicated that the professional staff made frequent attempts to use the checklist, but compliance was suboptimal: All items in the observed nurse-led “summaries” were included in 56% of these interactions, and physicians participated by directly facing the patient in 50% of the interactions. On the questionnaires administered to the staff, items regarding collaboration and the importance of patient participation were rated more highly after the introduction of the checklist, but this did not result in statistical significance (P = 0.07/P = 0.08). The patients rated almost all items as very high both before and after the introduction of the checklist; hence, no statistical difference was noted. CONCLUSION The intervention led to increased patient identity verification by physicians - a patient safety

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.

Development of an evaluation framework for African-European hospital patient safety partnerships.

PubMed

Rutter, Paul; Syed, Shamsuzzoha B; Storr, Julie; Hightower, Joyce D; Bagheri-Nejad, Sepideh; Kelley, Edward; Pittet, Didier

2014-04-01

Patient safety is recognised as a significant healthcare problem worldwide, and healthcare-associated infections are an important aspect. African Partnerships for Patient Safety is a WHO programme that pairs hospitals in Africa with hospitals in Europe with the objective to work together to improve patient safety. To describe the development of an evaluation framework for hospital-to-hospital partnerships participating in the programme. The framework was structured around the programme's three core objectives: facilitate strong interhospital partnerships, improve in-hospital patient safety and spread best practices nationally. Africa-based clinicians, their European partners and experts in patient safety were closely involved in developing the evaluation framework in an iterative process. The process defined six domains of partnership strength, each with measurable subdomains. We developed a questionnaire to measure these subdomains. Participants selected six indicators of hospital patient safety improvement from a short-list of 22 based on their relevance, sensitivity to intervention and measurement feasibility. Participants proposed 20 measures of spread, which were refined into a two-part conceptual framework, and a data capture tool created. Taking a highly participatory approach that closely involved its end users, we developed an evaluation framework and tools to measure partnership strength, patient safety improvements and the spread of best practice.

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

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

System safety engineering in the development of advanced surface transportation vehicles

NASA Technical Reports Server (NTRS)

Arnzen, H. E.

1971-01-01

Applications of system safety engineering to the development of advanced surface transportation vehicles are described. As a pertinent example, the paper describes a safety engineering efforts tailored to the particular design and test requirements of the Tracked Air Cushion Research Vehicle (TACRV). The test results obtained from this unique research vehicle provide significant design data directly applicable to the development of future tracked air cushion vehicles that will carry passengers in comfort and safety at speeds up to 300 miles per hour.

Development of Large-Scale Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Ruff, Gary A.; Urban, David; Fernandez-Pello, A. Carlos; T'ien, James S.; Torero, Jose L.; Legros, Guillaume; Eigenbrod, Christian; Smirnov, Nickolay; Fujita, Osamu; Cowlard, Adam J.;

Advancing a sociotechnical systems approach to workplace safety--developing the conceptual framework.

PubMed

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels.

Transit safety retrofit package development : final report.

DOT National Transportation Integrated Search

2014-07-01

This report provides a summary of the Transit Safety Retrofit Package (TRP) Development project and its results. The report documents results of each project phase, and provides recommended next steps as well as a vision for a next generation TRP. Th...

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

PubMed

Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

The impact of nursing leadership on patient safety in a developing country.

PubMed

Stewart, Lee; Usher, Kim

2010-11-01

This article is a report of a study to identify the ways nursing leaders and managers in a developing country have an impact on patient safety. The attempt to address the problem of patient safety in health care is a global issue. Literature addressing the significant impact that nursing leadership has on patient safety is extensive and focuses almost exclusively on the developed world. A critical ethnography was conducted with senior registered nursing leaders and managers throughout the Fiji Islands, specifically those in the Head Office of the Fiji Ministry of Health and the most senior nurse in a hospital or community health service. Semi-structured interviews were conducted with senior nursing leaders and managers in Fiji. Thematic analysis of the interviews was undertaken from a critical theory perspective, with reference to the macro socio-political system of the Fiji Ministry of Health. Four interrelated issues regarding the nursing leaders and managers' impact on patient safety emerged from the study. Empowerment of nursing leaders and managers, an increased focus on the patient, the necessity to explore conditions for front-line nurses and the direct relationship between improved nursing conditions and increased patient safety mirrored literature from developed countries. The findings have significant implications for developing countries and it is crucial that support for patient safety in developing countries become a focus for the international nursing community. Nursing leaders and managers' increased focus on their own place in the hierarchy of the health care system and on nursing conditions as these affect patient safety could decrease adverse patient outcomes. The findings could assist the global nursing community to better support developing countries in pursuing a patient safety agenda. © 2010 Blackwell Publishing Ltd.

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

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.

A System for Integrated Reliability and Safety Analyses

NASA Technical Reports Server (NTRS)

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

1999-01-01

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

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

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.

Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey.

PubMed

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-10-01

To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's alpha coefficients ranged from 0.50 to 0.89. It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes.

10 CFR 851.11 - Development and approval of worker safety and health program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Development and approval of worker safety and health program. 851.11 Section 851.11 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.11 Development and approval of worker safety and health program. (a) Preparation and...

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

Evans, Bronwyn; Glendon, A Ian; Creed, Peter A

2007-01-01

A need was identified for a consistent set of safety climate factors to provide a basis for aviation industry benchmarking. Six broad safety climate themes were identified from the literature and consultations with industry safety experts. Items representing each of the themes were prepared and administered to 940 Australian commercial pilots. Data from half of the sample (N=468) were used in an exploratory factor analysis that produced a 3-factor model of Management commitment and communication, Safety training and equipment, and Maintenance. A confirmatory factor analysis on the remaining half of the sample showed the 3-factor model to be an adequate fit to the data. The results of this study have produced a scale of safety climate for aviation that is both reliable and valid. This study developed a tool to assess the level of perceived safety climate, specifically of pilots, but may also, with minor modifications, be used to assess other groups' perceptions of safety climate.

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

PubMed

Mascherek, Anna C; Schwappach, David L B

2017-01-01

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

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

PubMed Central

Mascherek, Anna C.

2017-01-01

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

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India.

PubMed

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G V

2014-07-01

The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. A competency-based training needs assessment was conducted before undertaking the development of the training materials. THE TRAINING PROGRAM FOR FOOD SAFETY OFFICERS WAS DESIGNED TO COMPRISE OF FIVE MODULES TO INCLUDE: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting.

Subsurface safety valves: safety asset or safety liability

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

Busch, J.M.; Llewelyn, D.C.G.; Policky, B.J.

1983-10-01

This paper summarizes the methods used to compare the risk of a blowout for a well completed with a subsurface safety valve (SSSV) vs. a completion without an SSSV. These methods, which could be applied to any field, include a combination of SSSV reliability and conventional risk analyses. The Kuparuk River Unit Working Interest Owners recently formed a group to examine the risks associated with installing and maintaining SSSV's in the Kuparuk field. The group was charged with answering the question: ''Assuming Kuparuk field operating conditions, are SSSV's a safety asset, or do numerous operating and maintenance procedures make themmore » a safety liability.'' The results indicate that for the Kuparuk River Unit, an SSSV becomes a safety liability when the mean time between SSSV failures is less than one year. Since current SSSV mean time to failure (MTTF) at Kuparuk is approximately 1000 days, they are considered a safety asset.« less

AHRQ's hospital survey on patient safety culture: psychometric analyses.

PubMed

Blegen, Mary A; Gearhart, Susan; O'Brien, Roxanne; Sehgal, Niraj L; Alldredge, Brian K

2009-09-01

This project analyzed the psychometric properties of the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (HSOPSC) including factor structure, interitem reliability and intraclass correlations, usefulness for assessment, predictive validity, and sensitivity. The survey was administered to 454 health care staff in 3 hospitals before and after a series of multidisciplinary interventions designed to improve safety culture. Respondents (before, 434; after, 368) included nurses, physicians, pharmacists, and other hospital staff members. Factor analysis partially confirmed the validity of the HSOPSC subscales. Interitem consistency reliability was above 0.7 for 5 subscales; the staffing subscale had the lowest reliability coefficients. The intraclass correlation coefficients, agreement among the members of each unit, were within recommended ranges. The pattern of high and low scores across the subscales of the HSOPSC in the study hospitals were similar to the sample of Pacific region hospitals reported by the Agency for Healthcare Research and Quality and corresponded to the proportion of items in each subscale that are worded negatively (reverse scored). Most of the unit and hospital dimensions were correlated with the Safety Grade outcome measure in the tool. Overall, the tool was shown to have moderate-to-strong validity and reliability, with the exception of the staffing subscale. The usefulness in assessing areas of strength and weakness for hospitals or units among the culture subscales is questionable. The culture subscales were shown to correlate with the perceived outcomes, but further study is needed to determine true predictive validity.

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.

Development of instruction in hospital electrical safety for medical education.

PubMed

Yoo, J H; Broderick, W A

1978-01-01

Although hospital electrical safety is receiving increased attention in the literature of engineers, it is not, at present, reflected in the curricula of medical schools. A possible reason for this omission is that biomedical and/or clinical engineers knowledgeable in electrical safety are not usually trained to teach. One remedy for this problem is to combine the knowledge of engineers with that of instructional developers to design a systematic curriculum for a course in hospital electrical safety. This paper describes such an effort at the University of Texas Health Science Center at San Antonio (UTHSCSA). A biomedical engineer and an instructional developer designed an instructional module in hospital electrical safety; the engineer taught the module, and both evaluated the results. The process and outcome of their collaboration are described. This model was effectively applied in the classroom as a four-hour segment in hospital electrical safety for first-year medical students at UTHSCSA. It is hoped that an additional benefit of this system will be that it offers an opportunity for continuing improvement in this kind of instruction at other medical schools and hospitals.

Transit safety retrofit package development : applications requirements document.

DOT National Transportation Integrated Search

2014-05-01

This Application Requirements Document for the Transit Safety Retrofit Package (TRP) Development captures the system, hardware and software requirements towards fulfilling the technical objectives stated within the contract. To achieve the objective ...

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.

Development of a British Road Safety Education Support Materials Curriculum.

ERIC Educational Resources Information Center

Bouck, Linda H.

Road safety education needs to be a vital component in the school curriculum. This paper describes a planned road safety education support materials curriculum developed to aid educators in the Wiltshire County (England) primary schools. Teaching strategies include topic webs, lecture, class discussion, group activities, and investigative learning…

The Development and Deployment of a Maintenance Operations Safety Survey.

PubMed

Langer, Marie; Braithwaite, Graham R

2016-11-01

Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. © 2016, Human Factors and Ergonomics Society.

The Development and Deployment of a Maintenance Operations Safety Survey

PubMed Central

Langer, Marie; Braithwaite, Graham R.

2016-01-01

Objective: Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Background: Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. Method: In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. Results: In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. Conclusion: This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. Application: MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. PMID:27411354

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-03-28

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

Extending Safety Culture Development through Communication - 12366

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

Sneve, M.K.; Kiselev, M.; Shandala, N.K.

2012-07-01

The Norwegian Radiation Protection Authority has been implementing a regulatory support program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective is the enhancement of safety culture. The project outputs have included appropriate regulatory threat assessments, to determine the hazardous activities which are most in need of enhanced regulatory supervision; and development of the norms, standards and regulatory procedures, necessary to address the often abnormal conditions at nuclear legacy sites. Project outputs have been prepared and subsequently confirmed asmore » official regulatory documents of the Russian Federation. The continuing program of work focuses on practical application of the enhanced regulatory framework as applied to legacy sites, including safe management of radioactive wastes arising in the process of site remediation. One of the lessons learnt from this practical application is the importance of effective communication at all levels: - between managers and shop workers; - between different operators - e.g. waste producers and waste disposal organisations; - between operators and regulators; - between nuclear safety regulators, radiation protection regulators and other pollution and safety regulators; - between scientists, policy makers and wider stakeholders; and - between all of those mentioned above. A key message from this work is that it is not just an issue of risk communication; rather all aspects of communication can contribute to safety culture enhancement to support effective and efficient risk management, including the role of regulatory supervision. (authors)« less

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India

PubMed Central

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G. V.

2014-01-01

Context: The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. Aims: 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. Settings and Design: The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. Materials and Methods: A competency-based training needs assessment was conducted before undertaking the development of the training materials. Results: The training program for Food Safety Officers was designed to comprise of five modules to include: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. Conclusion: The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting. PMID:25136155

Workforce Perceptions of Hospital Safety Culture: Development and Validation of the Patient Safety Climate in Healthcare Organizations Survey

PubMed Central

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-01-01

Objective To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Data Sources/Study Setting Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Study Design Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. Data Collection We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). Principal Findings We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's α coefficients ranged from 0.50 to 0.89. Conclusions It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes. PMID:17850530

Developing an educational safety program for pharmacy employees.

PubMed

Hayman, J N

1980-02-01

The need for developing educational safety programs for pharmacy employees is discussed. A three-part program is offered as a guide for structuring a departmental safety program. Part I deals with environmental hazards such as wet floors, poor lighting, and cluttered walk areas. Precautions that should be taken to avoid accidental exposure to patients with communicable diseases are also included. Hazards that may result from improper handling of materials or equipment are addressed in Part II. Included are precautions for handling chemicals, needles, ladders, and electrical equipment. Proper methods of lifting heavy objects are also discussed. Part III details plans to protect staff members in the event of a fire. Plans for reporting fires and evacuating the pharmacy and hospital are discussed. The outlined program requires self-study by staff members during initial employee orientation, followed by annual retraining. Employees are tested and graded on safety topics, and training records are filed for future reference. The program outlined is thought to offer a simple yet effective means of acquainting staff members with established institutional and departmental safety procedures.

Development of a Medication Safety and Quality Survey for Small Rural Hospitals.

PubMed

Winterstein, Almut G; Johns, Thomas E; Campbell, Kyle N; Libby, Joel; Pannell, Bob

2017-12-01

We summarize the development and initial implementation of a survey tool to assess medication safety in small rural hospitals. As part of an ongoing rural hospital medication safety improvement program, we developed a survey tool in all 13 critical access hospitals (CAHs) in Florida. The survey was compiled from existing medication safety assessments and standards, clinical practice guidelines, and published literature. Survey items were selected based on considerations regarding practicality and relevance to the CAH setting.The final survey instrument included 134 items representing 17 medication safety domains. Overall hospital scores ranged from 41% to 95%, with a median of 59%. Most hospitals showed large variation in scores across domains, with 5 hospitals having at least 1 domain with scores less than 10%. Highest scores across all facilities were seen for safety procedures concerning high-alert or look-alike medications and the assembly of emergency carts. The lowest median scores included availability and consistent use of standardized order sets and the effective implementation of medication safety committees. Most hospitals used the survey results to identify and prioritize quality improvement activities. The survey can be used to conduct a short medication safety assessment specific to a limited number of areas and services in CAHs. It showed good ability to discriminate medication safety levels across participating sites and highlighted opportunities for improvement. It may need modification if case mix or services differ in other states or if the status quo of medication safety in CAHs or related standards advance. The described process of survey development might be helpful to support such modifications.

Development of E-Learning Materials for Machining Safety Education

NASA Astrophysics Data System (ADS)

Nakazawa, Tsuyoshi; Mita, Sumiyoshi; Matsubara, Masaaki; Takashima, Takeo; Tanaka, Koichi; Izawa, Satoru; Kawamura, Takashi

We developed two e-learning materials for Manufacturing Practice safety education: movie learning materials and hazard-detection learning materials. Using these video and sound media, students can learn how to operate machines safely with movie learning materials, which raise the effectiveness of preparation and review for manufacturing practice. Using these materials, students can realize safety operation well. Students can apply knowledge learned in lectures to the detection of hazards and use study methods for hazard detection during machine operation using the hazard-detection learning materials. Particularly, the hazard-detection learning materials raise students‧ safety consciousness and increase students‧ comprehension of knowledge from lectures and comprehension of operations during Manufacturing Practice.

Measuring cross-cultural patient safety: identifying barriers and developing performance indicators.

PubMed

Walker, Roger; St Pierre-Hansen, Natalie; Cromarty, Helen; Kelly, Len; Minty, Bryanne

2010-01-01

Medical errors and cultural errors threaten patient safety. We know that access to care, quality of care and clinical safety are all impacted by cultural issues. Numerous approaches to describing cultural barriers to patient safety have been developed, but these taxonomies do not provide a useful set of tools for defining the nature of the problem and consequently do not establish a sound base for problem solving. The Sioux Lookout Meno Ya Win Health Centre has implemented a cross-cultural patient safety (CCPS) model (Walker 2009). We developed an analytical CCPS framework within the organization, and in this article, we detail the validation process for our framework by way of a literature review and surveys of local and international healthcare professionals. We reinforce the position that while cultural competency may be defined by the service provider, cultural safety is defined by the client. In addition, we document the difficulties surrounding the measurement of cultural competence in terms of patient outcomes, which is an underdeveloped dimension of the field of patient safety. We continue to explore the correlation between organizational performance and measurable patient outcomes.

Legislative history of recent primary safety belt laws

DOT National Transportation Integrated Search

1999-01-01

This document summarizes the strategies that supported or opposed new legislative provisions and the barriers encountered in modifying safety belt laws prior to December 1997. This study developed legislative analyses of six jurisdictions that upgrad...

Supervisor Health and Safety Support: Scale Development and Validation

PubMed Central

Butts, Marcus M.; Hurst, Carrie S.; Eby, Lillian T.

2013-01-01

Executive Summary Two studies were conducted to develop a psychometrically sound measure of supervisor health and safety support (SHSS). We identified three dimensions of supervisor support (physical health, psychological health, safety) and used Study 1 to develop items and establish content validity. Study 2 was used to establish the dimensionality of the new measure and provide criterion-related and discriminant validity evidence of the measure using supervisor and subordinate data. The measure had incremental validity in predicting employee performance and psychological strain outcomes above and beyond general work support variables. Implications of these findings and for workplace support theory and practice are discussed. PMID:24771991

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...

The patient safety climate in healthcare organizations (PSCHO) survey: Short-form development.

PubMed

Benzer, Justin K; Meterko, Mark; Singer, Sara J

2017-08-01

Measures of safety climate are increasingly used to guide safety improvement initiatives. However, cost and respondent burden may limit the use of safety climate surveys. The purpose of this study was to develop a 15- to 20-item safety climate survey based on the Patient Safety Climate in Healthcare Organizations survey, a well-validated 38-item measure of safety climate. The Patient Safety Climate in Healthcare Organizations was administered to all senior managers, all physicians, and a 10% random sample of all other hospital personnel in 69 private sector hospitals and 30 Veterans Health Administration hospitals. Both samples were randomly divided into a derivation sample to identify a short-form subset and a confirmation sample to assess the psychometric properties of the proposed short form. The short form consists of 15 items represented 3 overarching domains in the long-form scale-organization, work unit, and interpersonal. The proposed short form efficiently captures 3 important sources of variance in safety climate: organizational, work-unit, and interpersonal. The short-form development process was a practical method that can be applied to other safety climate surveys. This safety climate short form may increase response rates in studies that involve busy clinicians or repeated measures. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

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.

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.

The development and psychometric evaluation of a safety climate measure for primary care.

PubMed

de Wet, C; Spence, W; Mash, R; Johnson, P; Bowie, P

2010-12-01

Building a safety culture is an important part of improving patient care. Measuring perceptions of safety climate among healthcare teams and organisations is a key element of this process. Existing measurement instruments are largely developed for secondary care settings in North America and many lack adequate psychometric testing. Our aim was to develop and test an instrument to measure perceptions of safety climate among primary care teams in National Health Service for Scotland. Questionnaire development was facilitated through a steering group, literature review, semistructured interviews with primary care team members, a modified Delphi and completion of a content validity index by experts. A cross-sectional postal survey utilising the questionnaire was undertaken in a random sample of west of Scotland general practices to facilitate psychometric evaluation. Statistical methods, including exploratory and confirmatory factor analysis, and Cronbach and Raykov reliability coefficients were conducted. Of the 667 primary care team members based in 49 general practices surveyed, 563 returned completed questionnaires (84.4%). Psychometric evaluation resulted in the development of a 30-item questionnaire with five safety climate factors: leadership, teamwork, communication, workload and safety systems. Retained items have strong factor loadings to only one factor. Reliability coefficients was satisfactory (α = 0.94 and ρ = 0.93). This study is the first stage in the development of an appropriately valid and reliable safety climate measure for primary care. Measuring safety climate perceptions has the potential to help primary care organisations and teams focus attention on safety-related issues and target improvement through educational interventions. Further research is required to explore acceptability and feasibility issues for primary care teams and the potential for organisational benchmarking.

Advancing a sociotechnical systems approach to workplace safety – developing the conceptual framework

PubMed Central

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Practitioner Summary: Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels. PMID:25831959

Child Development Associate. Safety for Young Children.

ERIC Educational Resources Information Center

Oscar Rose Junior Coll., Midwest City, OK.

This Child Development Associate (CDA) training module, one of a series of 18, provides a guide to establishing a safe and healthy preschool environment and promoting health and safety practices among preschool children. Upon completion of the module, CDA trainees are expected to be able to create a safe learning environment for children,…

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.

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS

EPA Science Inventory

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS
Pastoor, Timothy1, Barton, Hugh2
1 Syngenta Crop Protection, Greensboro, NC, USA.
2 EPA, Office of Research and Development-NHEERL, RTP, NC, USA.

A multi-stakeholder series of discussions d...

User-Centered Collaborative Design and Development of an Inpatient Safety Dashboard.

PubMed

Mlaver, Eli; Schnipper, Jeffrey L; Boxer, Robert B; Breuer, Dominic J; Gershanik, Esteban F; Dykes, Patricia C; Massaro, Anthony F; Benneyan, James; Bates, David W; Lehmann, Lisa S

2017-12-01

Patient safety remains a key concern in hospital care. This article summarizes the iterative participatory development, features, functions, and preliminary evaluation of a patient safety dashboard for interdisciplinary rounding teams on inpatient medical services. This electronic health record (EHR)-embedded dashboard collects real-time data covering 13 safety domains through web services and applies logic to generate stratified alerts with an interactive check-box function. The technological infrastructure is adaptable to other EHR environments. Surveyed users perceived the tool as highly usable and useful. Integration of the dashboard into clinical care is intended to promote communication about patient safety and facilitate identification and management of safety concerns. Copyright © 2017 The Joint Commission. All rights reserved.

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.

Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

PubMed

Schneider, Eric C; Ridgely, M Susan; Quigley, Denise D; Hunter, Lauren E; Leuschner, Kristin J; Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C

2017-06-01

This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

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.

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.

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

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

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

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism

PubMed Central

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

2016-01-01

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors’ expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers’ caring and communication (CCC) and coworkers’ role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry. PMID:27834823

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism.

PubMed

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

2016-11-08

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors' expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers' caring and communication (CCC) and coworkers' role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry.

Development of safety performance functions for North Carolina.

DOT National Transportation Integrated Search

2011-12-06

"The objective of this effort is to develop safety performance functions (SPFs) for different types of facilities in North Carolina : and illustrate how they can be used to improve the decision making process. The prediction models in Part C of the H...

Internet of Things Based Combustible Ice Safety Monitoring System Framework

NASA Astrophysics Data System (ADS)

Sun, Enji

2017-05-01

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

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes

Development and Analyses of the Coping Stress Inventory

ERIC Educational Resources Information Center

Gadzella, Bernadette M.; Pierce, Devin; Young, Adena

2008-01-01

This is a report on the development of a coping stress inventory and the analyses of the data collected from 344 participants. The Coping Stress Inventory, CSI, with 16 items intercorrelated in the categories (Behavioral, Emotional, and Cognitive Appraisal). The internal consistency for the CSI was 0.77. Responses to the CSI were compared (a)…

Nuclear-safety institution in France: emergence and development

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

Vallet, B.M.

1986-01-01

This research work examines the social construction of the nuclear-safety institution in France, and the concurrent increased focus on the nuclear-risk issue. Emphasis on risk and safety, as primarily technical issues, can partly be seen as a strategy. Employed by power elites in the nuclear technostructure, this diverts emphasis away from controversial and normative questions regarding the political and social consequences of technology to questions of technology that appear to be absolute to the technology itself. Nuclear safety, which started from a preoccupation with risk related to the nuclear energy research and development process, is examined using the analytic conceptmore » of field. As a social arena patterned to achieve specific tasks, this field is dominated by a body of state engineers recognized to have high-level scientific and administrative competences. It is structured by procedures and administrative hierarchies as well as by technical rules, norms, and standards. These are formalized and rationalized through technical, economic, political, and social needs; over time; they consolidate the field into an institution. The study documents the nuclear-safety institution as an integral part of the nuclear technostructure, which has historically used the specificity of its expertise as a buffer against outside interference.« less

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.

The development and efficacy of safety training for commercial fishermen.

PubMed

Dzugan, Jerry

2010-10-01

Commercial fishing is still the most dangerous occupation in the United States. Efforts to have more stringent safety regulations in this industry beginning in the 1960s, culminated in the Commercial Fishing Vessel Safety Act of 1988. The purpose of this paper is to provide a short history of the development of safety training in the United States and the current training infrastructure. This paper will also review studies available regarding the effectiveness of safety training in reducing fatalities among fishermen. The lack of familiarity and practice with marine survival equipment such as life rafts, immersion suits, and emergency-locating beacons has been noted in National Transportation Safety Board and US Coast Guard casualty reports as a contributing factor in fatalities. These reports have demonstrated the importance of not just having survival equipment onboard, but training in how to use it effectively in an emergency. There is evidence that safety training has made a measurable impact in surviving an emergency at sea and that recent training (within 5 years) is most effective in saving lives. More recently, studies have been completed to understand how skills may diminish over time since initial training.

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.; Moses, Kelly

2004-01-01

This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

10 CFR 851.11 - Development and approval of worker safety and health program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... workers at multi-contractor workplaces. (3) The worker safety and health program must describe how the... may be performed at a covered workplace unless an approved worker safety and health program is in... 10 Energy 4 2010-01-01 2010-01-01 false Development and approval of worker safety and health...

Design and development of food safety knowledge and attitude scales for consumer food safety education.

PubMed

Medeiros, Lydia C; Hillers, Virginia N; Chen, Gang; Bergmann, Verna; Kendall, Patricia; Schroeder, Mary

2004-11-01

The objective of this study was to design and develop food safety knowledge and attitude scales based on food-handling guidelines developed by a national panel of food safety experts. Knowledge (n=43) and attitude (n=49) questions were developed and pilot-tested with a variety of consumer groups. Final questions were selected based on item analysis and on validity and reliability statistical tests. Knowledge questions were tested in Washington State with participants in low-income nutrition education programs (pretest/posttest n=58, test/retest n=19) and college students (pretest/posttest n=34). Attitude questions were tested in Ohio with nutrition education program participants (n=30) and college students (non-nutrition majors n=138, nutrition majors n=57). Item analysis, paired sample t tests, Pearson's correlation coefficients, and Cronbach's alpha were used. Reliability and validity tests of individual items and the question sets were used to reduce the scales to 18 knowledge questions and 10 attitude questions. The knowledge and attitude scales covered topics ranked as important by a national panel of experts and met most validity and reliability standards. The 18-item knowledge questionnaire had instructional sensitivity (mean score increase of more than three points after instruction), internal reliability (Cronbach's alpha >.75), and produced similar results in test-retest without intervention (coefficient of stability=.81). Knowledge of correct procedures for hand washing and avoiding cross-contamination was widespread before instruction. Knowledge was limited regarding avoiding food preparation while ill, cooking hamburgers, high-risk foods, and whether cooked rice and potatoes could be stored at room temperature. The 10-item attitude scale had an appropriate range of responses (item difficulty) and produced similar results in test-retest ( P safety is

Memantine in patients with Alzheimer's disease receiving donepezil: new analyses of efficacy and safety for combination therapy.

PubMed

Atri, Alireza; Molinuevo, José L; Lemming, Ole; Wirth, Yvonne; Pulte, Irena; Wilkinson, David

2013-01-01

Memantine and cholinesterase inhibitors potentially offer additional benefits in Alzheimer's disease (AD) when used together. This study assessed the efficacy and safety of combination treatment with memantine added to stable donepezil in patients with moderate to severe AD, and in a subset with moderate AD. Post hoc meta-analyses of data combined from two 24-week, randomised, double-blind, placebo-controlled trials of memantine 20 mg/day versus placebo, added to a stable cholinesterase inhibitor, were conducted. Data were included for all patients receiving donepezil 10 mg/day with Mini-Mental State Examination (MMSE) scores < 20 (n = 510). Efficacy was assessed using measures of cognition, function, and global status. Furthermore, marked clinical worsening, defined as concurrent deterioration from baseline in the three main efficacy domains, and safety, measured by treatment-emergent adverse events, were assessed. Analyses were performed for patients with moderate to severe AD (MMSE 5-19; MOD-SEV subgroup), and also for patients with moderate AD (MMSE 10-19; MOD subgroup; n = 367). At week 24, in the MOD-SEV subgroup, patients receiving memantine added to donepezil significantly outperformed those receiving placebo added to donepezil in measures of cognition (P < 0.0001), function (P = 0.02), and global status (P = 0.010), with standardised mean differences (SMDs) of 0.36, 0.21, and 0.23, respectively (all last observation carried forward). Similarly, in the MOD subgroup, significant benefits were observed for cognition (P = 0.008), function (P = 0.04) and global status (P = 0.008), with SMDs of 0.28, 0.21, and 0.28, respectively. Significantly fewer patients receiving memantine added to donepezil showed marked clinical worsening than those receiving placebo added to donepezil, in both subgroups (MOD-SEV: 8.7% versus 20.4%, P = 0.0002; MOD: 5.9% versus 15.0%, P = 0.006). The incidence of adverse events was similar between treatment groups. These results support

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

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 Exposure Index: Developing firefighter safety performance measures

Treesearch

Dave Calkin; John Phipps; Tom Holmes; Jon Rieck; Matt Thompson

2011-01-01

A cornerstone of effective institutional learning and accountability is the development, tracking, and analysis of informative performance measures. In a previous issue of Fire Management Today ("A New Look at Risk Management," Winter 2011), a series of articles highlighted the importance of organizational safety and risk management and the challenges of...

Framework Development Supporting the Safety Portal

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

Prescott, Steven Ralph; Kvarfordt, Kellie Jean; Vang, Leng

2015-07-01

In a collaborating scientific research arena it is important to have an environment where analysts have access to a shared repository of information, documents, and software tools, and be able to accurately maintain and track historical changes in models. The new Safety Portal cloud-based environment will be accessible remotely from anywhere regardless of computing platforms given that the platform has available Internet access and proper browser capabilities. Information stored at this environment would be restricted based on user assigned credentials. This report discusses current development of a cloud-based web portal for PRA tools.

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

PubMed Central

Laverty, HG; Benson, C; Cartwright, EJ; Cross, MJ; Garland, C; Hammond, T; Holloway, C; McMahon, N; Milligan, J; Park, BK; Pirmohamed, M; Pollard, C; Radford, J; Roome, N; Sager, P; Singh, S; Suter, T; Suter, W; Trafford, A; Volders, PGA; Wallis, R; Weaver, R; York, M; Valentin, JP

2011-01-01

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing ‘Cardiovascular Toxicity of Medicines’. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process. Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome. Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data. Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes. Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers. PMID:21306581

Development of the Oregon traffic safety data archive : phases 1 and 2.

DOT National Transportation Integrated Search

2012-03-01

"This report describes the preliminary work to develop the Oregon Traffic Safety Data Archive (OrTSDA). The mission of OrTSDA is to build : the knowledge base of traffic safety data in Oregon. The archive hopes to become a valuable traffic safe...

Railway safety climate: a study on organizational development.

PubMed

Cheng, Yung-Hsiang

2017-09-07

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

Development a Comprehensive Food Safety System in Serbia- A Narrative Review Article

PubMed Central

RADOVIĆ, Vesela; KEKOVIĆ, Zoran; AGIĆ, Samir

2014-01-01

Abstract Background Food safety issues are not a new issue in science, but due to the dynamic changes in the modern world it is as equally important as decades ago. The aim of the study was to address the efforts in the development of a comprehensive food safety system in Serbia, and make specific recommendations regarding the improvement of epidemiological investigation capacity as a useful tool which contributes to improving the public health by joint efforts of epidemiologists and law enforcement. Methods We used the methodology appropriate for social sciences. Results The findings show the current state-of-affairs in the area of food safety and health care system and present some most important weaknesses which have to be overcome. Policy makers need timely and reliable information so that they can make informed decisions to improve the population health in an ongoing process of seeking full membership in the European Union. Conclusion Serbia has to apply significant changes in practice because the current state-of-affairs in the area of food safety and health care system is not so favourable due to numerous both objective and subjective factors. Hence, the policy-makers must work on the development of epidemiological investigation capacities as a firm basis for greater efficiency and effectiveness. Epidemiologists would not stay alone in their work. Law enforcement as well as many other stakeholders should recognize their new role in the process of the development of epidemiological investigation capacity as a tool for the development of a comprehensive food safety system in Serbia. PMID:25909057

Bicycle Facilities That Address Safety, Crime, and Economic Development: Perceptions from Morelia, Mexico.

PubMed

Alveano-Aguerrebere, Inés; Javier Ayvar-Campos, Francisco; Farvid, Maryam; Lusk, Anne

2017-12-22

México is a developing nation and, in the city of Morelia, the concept of the bicyclist as a road user appeared only recently in the Municipal Traffic Regulations. Perhaps the right bicycle infrastructure could address safety, crime, and economic development. To identify the best infrastructure, six groups in Morelia ranked and commented on pictures of bicycle environments that exist in bicycle-friendly nations. Perceptions about bike paths, but only those with impossible-to-be-driven-over solid barriers, were associated with safety from crashes, lowering crime, and contributing to economic development. Shared use paths were associated with lowering the probability of car/bike crashes but lacked the potential to deter crime and foster the local economy. Joint bus and bike lanes were associated with lower safety because of the unwillingness by Mexican bus drivers to be courteous to bicyclists. Gender differences about crash risk biking in the road with the cars (6 best/0 worst scenario) were statistically significant (1.4 for male versus 0.69 for female; p < 0.001). For crashes, crime, and economic development, perceptions about bicycle infrastructure were different in this developing nation perhaps because policy, institutional context, and policing (ticketing for unlawful parking) are not the same as in a developed nation. Countries such as Mexico should consider building cycle tracks with solid barriers to address safety, crime, and economic development.

Bicycle Facilities That Address Safety, Crime, and Economic Development: Perceptions from Morelia, Mexico

PubMed Central

Alveano-Aguerrebere, Inés; Farvid, Maryam; Lusk, Anne

2017-01-01

México is a developing nation and, in the city of Morelia, the concept of the bicyclist as a road user appeared only recently in the Municipal Traffic Regulations. Perhaps the right bicycle infrastructure could address safety, crime, and economic development. To identify the best infrastructure, six groups in Morelia ranked and commented on pictures of bicycle environments that exist in bicycle-friendly nations. Perceptions about bike paths, but only those with impossible-to-be-driven-over solid barriers, were associated with safety from crashes, lowering crime, and contributing to economic development. Shared use paths were associated with lowering the probability of car/bike crashes but lacked the potential to deter crime and foster the local economy. Joint bus and bike lanes were associated with lower safety because of the unwillingness by Mexican bus drivers to be courteous to bicyclists. Gender differences about crash risk biking in the road with the cars (6 best/0 worst scenario) were statistically significant (1.4 for male versus 0.69 for female; p < 0.001). For crashes, crime, and economic development, perceptions about bicycle infrastructure were different in this developing nation perhaps because policy, institutional context, and policing (ticketing for unlawful parking) are not the same as in a developed nation. Countries such as Mexico should consider building cycle tracks with solid barriers to address safety, crime, and economic development. PMID:29271873

Finite mixture modeling approach for developing crash modification factors in highway safety analysis.

PubMed

Park, Byung-Jung; Lord, Dominique; Wu, Lingtao

2016-10-28

This study aimed to investigate the relative performance of two models (negative binomial (NB) model and two-component finite mixture of negative binomial models (FMNB-2)) in terms of developing crash modification factors (CMFs). Crash data on rural multilane divided highways in California and Texas were modeled with the two models, and crash modification functions (CMFunctions) were derived. The resultant CMFunction estimated from the FMNB-2 model showed several good properties over that from the NB model. First, the safety effect of a covariate was better reflected by the CMFunction developed using the FMNB-2 model, since the model takes into account the differential responsiveness of crash frequency to the covariate. Second, the CMFunction derived from the FMNB-2 model is able to capture nonlinear relationships between covariate and safety. Finally, following the same concept as those for NB models, the combined CMFs of multiple treatments were estimated using the FMNB-2 model. The results indicated that they are not the simple multiplicative of single ones (i.e., their safety effects are not independent under FMNB-2 models). Adjustment Factors (AFs) were then developed. It is revealed that current Highway Safety Manual's method could over- or under-estimate the combined CMFs under particular combination of covariates. Safety analysts are encouraged to consider using the FMNB-2 models for developing CMFs and AFs. Copyright © 2016 Elsevier Ltd. All rights reserved.

An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses-Isotopic Composition Predictions

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

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

2011-01-01

The expanded use of burnup credit in the United States (U.S.) for storage and transport casks, particularly in the acceptance of credit for fission products, has been constrained by the availability of experimental fission product data to support code validation. The U.S. Nuclear Regulatory Commission (NRC) staff has noted that the rationale for restricting the Interim Staff Guidance on burnup credit for storage and transportation casks (ISG-8) to actinide-only is based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address themore » issues of burnup credit criticality validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the isotopic composition (depletion) validation approach and resulting observations and recommendations. Validation of the criticality calculations is addressed in a companion paper at this conference. For isotopic composition validation, the approach is to determine burnup-dependent bias and uncertainty in the effective neutron multiplication factor (keff) due to bias and uncertainty in isotopic predictions, via comparisons of isotopic composition predictions (calculated) and measured isotopic compositions from destructive radiochemical assay utilizing as much assay data as is available, and a best-estimate Monte Carlo based method. This paper (1) provides a detailed description of the burnup credit isotopic validation approach and its technical bases, (2) describes the application of the

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

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].

Michigan urban trunkline intersections safety performance functions (SPFs) development and support.

DOT National Transportation Integrated Search

2015-06-01

This study involves the development of safety performance functions (SPFs) for signalized and stop-controlled intersections : located along urban and suburban arterials in the state of Michigan. Extensive databases were developed that resulted in the...

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

PubMed

Fassett, William E

2011-10-10

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

Development of a conceptual integrated traffic safety problem identification database

DOT National Transportation Integrated Search

1999-12-01

The project conceptualized a traffic safety risk management information system and statistical database for improved problem-driver identification, countermeasure development, and resource allocation. The California Department of Motor Vehicles Drive...

What can nanosafety learn from drug development? The feasibility of "safety by design".

PubMed

Hjorth, Rune; van Hove, Lilian; Wickson, Fern

2017-04-01

"Safety by design" (SbD) is an intuitively appealing concept that is on the rise within nanotoxicology and nanosafety research, as well as within nanotechnology research policy. It leans on principles established within drug discovery and development (DDD) and seeks to address safety early, as well as throughout product development. However, it remains unclear what the concept of SbD exactly entails for engineered nanomaterials (ENMs) or how it is envisioned to be implemented. Here, we review the concept as it is emerging in European research and compare its resemblance with the safety testing and assessment practices in DDD. From this comparison, it is clear that "safety" is not obtained through DDD, and that SbD should be considered a starting point rather than an end, meaning that products will still need to progress through thorough safety evaluations and regulation. We conclude that although risk reduction is clearly desirable, the way SbD is currently communicated tends to treat safety as an inherent material property and that this is fundamentally problematic as it represents a recasting and reduction of societal issues into technical problems. SbD therefore faces a multitude of challenges, from practical implementation to unrealistic stakeholder expectations.

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 Development of a Vocational Safety Guide for Missouri's Practitioners. Final Report.

ERIC Educational Resources Information Center

Dyrenfurth, Michael; Linhardt, Richard

A project was conducted to develop a comprehensive vocational education safety guide for local administrators and teachers. To generate the guide, the following steps were completed: (1) a review of key related research, literature, and federal and state legislation, including vocational safety guides from 18 states; reference material from the…

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,...

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

NASA Astrophysics Data System (ADS)

Murray, Daniel P.; Weil, Andre

2010-09-01

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

The need for strategic development of safety sciences.

PubMed

Busquet, Francois; Hartung, Thomas

2017-01-01

The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i.e., a need for Regulatory Science or, perhaps better, Safety Science. While some of this is emerging on the US side as strategic reports, e.g., from the National Academies, the NIH and the regulatory agencies, especially the EPA and the FDA, such strategic developments beyond technological developments are largely lacking in Europe or have started only recently at EFSA, ECHA or within the flagship project EU-ToxRisk. This article provides a rationale for the creation of a European Safety Sciences Institute (ESSI) based on regulatory and scientific needs, political context and current EU missions. Moreover, the possible modus operandi of ESSI will be described along with possible working formats as well as anticipated main tasks and duties. This mirrors the triple alliance on the American side (US EPA, NIH and FDA) in revamping regulatory sciences. Moreover, this could fit the political agenda of the European Commission for better implementation of existing EU legislation rather than creating new laws.

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

PubMed

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

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

School Bus Fleet Safety: Planning and Development.

ERIC Educational Resources Information Center

Bieber, Robert M.

1984-01-01

To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

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.

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

PubMed

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

2017-09-01

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

Development and Execution of the RUNSAFE Runway Safety Bayesian Belief Network Model

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2015-01-01

One focus area of the National Aeronautics and Space Administration (NASA) is to improve aviation safety. Runway safety is one such thrust of investigation and research. The two primary components of this runway safety research are in runway incursion (RI) and runway excursion (RE) events. These are adverse ground-based aviation incidents that endanger crew, passengers, aircraft and perhaps other nearby people or property. A runway incursion is the incorrect presence of an aircraft, vehicle or person on the protected area of a surface designated for the landing and take-off of aircraft; one class of RI events simultaneously involves two aircraft, such as one aircraft incorrectly landing on a runway while another aircraft is taking off from the same runway. A runway excursion is an incident involving only a single aircraft defined as a veer-off or overrun off the runway surface. Within the scope of this effort at NASA Langley Research Center (LaRC), generic RI, RE and combined (RI plus RE, or RUNSAFE) event models have each been developed and implemented as a Bayesian Belief Network (BBN). Descriptions of runway safety issues from the literature searches have been used to develop the BBN models. Numerous considerations surrounding the process of developing the event models have been documented in this report. The event models were then thoroughly reviewed by a Subject Matter Expert (SME) panel through multiple knowledge elicitation sessions. Numerous improvements to the model structure (definitions, node names, node states and the connecting link topology) were made by the SME panel. Sample executions of the final RUNSAFE model have been presented herein for baseline and worst-case scenarios. Finally, a parameter sensitivity analysis for a given scenario was performed to show the risk drivers. The NASA and LaRC research in runway safety event modeling through the use of BBN technology is important for several reasons. These include: 1) providing a means to clearly

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

Development of a safety decision-making scenario to measure worker safety in agriculture.

PubMed

Mosher, G A; Keren, N; Freeman, S A; Hurburgh, C R

2014-04-01

Human factors play an important role in the management of occupational safety, especially in high-hazard workplaces such as commercial grain-handling facilities. Employee decision-making patterns represent an essential component of the safety system within a work environment. This research describes the process used to create a safety decision-making scenario to measure the process that grain-handling employees used to make choices in a safety-related work task. A sample of 160 employees completed safety decision-making simulations based on a hypothetical but realistic scenario in a grain-handling environment. Their choices and the information they used to make their choices were recorded. Although the employees emphasized safety information in their decision-making process, not all of their choices were safe choices. Factors influencing their choices are discussed, and implications for industry, management, and workers are shared.

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

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

Pugliese, S.M.

1977-02-01

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

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

Development of safety information materials and media plans for elderly pedestrians

DOT National Transportation Integrated Search

1993-06-01

The objectives of this study were to: 1) develop pedestrian safety messages which will have a countermeasure effect on the specific types of accidents occurring to elderly pedestrians and 2) develop media plans for use by NHTSA in disseminating the i...

Individual safety performance in the construction industry: development and validation of two short scales.

PubMed

DeArmond, Sarah; Smith, April E; Wilson, Christina L; Chen, Peter Y; Cigularov, Konstantin P

2011-05-01

In the current research a short measure of safety performance is developed for use in the construction industry and the relationships between different components of safety performance and safety outcomes (e.g., occupational injuries and work-related pain) are explored within the construction context. This research consists of two field studies. In the first, comprehensive measures of safety compliance and safety participation were shortened and modified to be appropriate for use in construction. Evidence of reliability and validity is provided. Both safety compliance and safety participation were negatively related to occupational injuries, yet these two correlations were not statistically different. In the second study, we investigated the relationships between these two components of safety performance and work-related pain frequency, in addition to replicating Study 1. Safety compliance had a stronger negative relationship with pain than safety participation. Implications for research are discussed. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2016-01-01

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

Developing the radiation protection safety culture in the UK.

PubMed

Cole, P; Hallard, R; Broughton, J; Coates, R; Croft, J; Davies, K; Devine, I; Lewis, C; Marsden, P; Marsh, A; McGeary, R; Riley, P; Rogers, A; Rycraft, H; Shaw, A

2014-06-01

In the UK, as elsewhere, there is potential to improve how radiological challenges are addressed through improvement in, or development of, a strong radiation protection (RP) safety culture. In preliminary work in the UK, two areas have been identified as having a strong influence on UK society: the healthcare and nuclear industry sectors. Each has specific challenges, but with many overlapping common factors. Other sectors will benefit from further consideration.In order to make meaningful comparisons between these two principal sectors, this paper is primarily concerned with cultural aspects of RP in the working environment and occupational exposures rather than patient doses.The healthcare sector delivers a large collective dose to patients each year, particularly for diagnostic purposes, which continues to increase. Although patient dose is not the focus, it must be recognised that collective patient dose is inevitably linked to collective occupational exposure, especially in interventional procedures.The nuclear industry faces major challenges as work moves from operations to decommissioning on many sites. This involves restarting work in the plants responsible for the much higher radiation doses of the 1960/70s, but also performing tasks that are considerably more difficult and hazardous than those original performed in these plants.Factors which influence RP safety culture in the workplace are examined, and proposals are considered for a series of actions that may lead to an improvement in RP culture with an associated reduction in dose in many work areas. These actions include methods to improve knowledge and awareness of radiation safety, plus ways to influence management and colleagues in the workplace. The exchange of knowledge about safety culture between the nuclear industry and medical areas may act to develop RP culture in both sectors, and have a wider impact in other sectors where exposures to ionising radiations can occur.

[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.

Development of the Consumer Refrigerator Safety Questionnaire: A Measure of Consumer Perceptions and Practices.

PubMed

Cairnduff, Victoria; Dean, Moira; Koidis, Anastasios

2016-09-01

Food preparation and storage behaviors in the home deviating from the "best practice" food safety recommendations may result in foodborne illnesses. Currently, there are limited tools available to fully evaluate the consumer knowledge, perceptions, and behavior in the area of refrigerator safety. The current study aimed to develop a valid and reliable tool in the form of a questionnaire, the Consumer Refrigerator Safety Questionnaire (CRSQ), for assessing systematically all these aspects. Items relating to refrigerator safety knowledge (n =17), perceptions (n =46), and reported behavior (n =30) were developed and pilot tested by an expert reference group and various consumer groups to assess face and content validity (n =20), item difficulty and consistency (n =55), and construct validity (n =23). The findings showed that the CRSQ has acceptable face and content validity with acceptable levels of item difficulty. Item consistency was observed for 12 of 15 in refrigerator safety knowledge. Further, all 5 of the subscales of consumer perceptions of refrigerator safety practices relating to risk of developing foodborne disease showed acceptable internal consistency (Cronbach's α value > 0.8). Construct validity of the CRSQ was shown to be very good (P = 0.022). The CRSQ exhibited acceptable test-retest reliability at 14 days with the majority of knowledge items (93.3%) and reported behavior items (96.4%) having correlation coefficients of greater than 0.70. Overall, the CRSQ was deemed valid and reliable in assessing refrigerator safety knowledge and behavior; therefore, it has the potential for future use in identifying groups of individuals at increased risk of deviating from recommended refrigerator safety practices, as well as the assessment of refrigerator safety knowledge and behavior for use before and after an intervention.

Development of a Nevada Statewide Database for Safety Analyst Software

DOT National Transportation Integrated Search

2017-02-02

Safety Analyst is a software package developed by the Federal Highway Administration (FHWA) and twenty-seven participating state and local agencies including the Nevada Department of Transportation (NDOT). The software package implemented many of the...

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.

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.

Analysis of developed transition road safety barrier systems.

PubMed

Soltani, Mehrtash; Moghaddam, Taher Baghaee; Karim, Mohamed Rehan; Sulong, N H Ramli

2013-10-01

Road safety barriers protect vehicles from roadside hazards by redirecting errant vehicles in a safe manner as well as providing high levels of safety during and after impact. This paper focused on transition safety barrier systems which were located at the point of attachment between a bridge and roadside barriers. The aim of this study was to provide an overview of the behavior of transition systems located at upstream bridge rail with different designs and performance levels. Design factors such as occupant risk and vehicle trajectory for different systems were collected and compared. To achieve this aim a comprehensive database was developed using previous studies. The comparison showed that Test 3-21, which is conducted by impacting a pickup truck with speed of 100 km/h and angle of 25° to transition system, was the most severe test. Occupant impact velocity and ridedown acceleration for heavy vehicles were lower than the amounts for passenger cars and pickup trucks, and in most cases higher occupant lateral impact ridedown acceleration was observed on vehicles subjected to higher levels of damage. The best transition system was selected to give optimum performance which reduced occupant risk factors using the similar crashes in accordance with Test 3-21. Copyright © 2013 Elsevier Ltd. All rights reserved.

78 FR 52941 - Cooperative Research and Development Agreement: Next Generation Arctic Navigational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... Development Agreement: Next Generation Arctic Navigational Safety Information System AGENCY: Coast Guard, DHS... technology approach to the ``Next Generation Arctic Maritime Navigational Safety Information System,'' which... their voyage risks, as they transit the remote and hostile waters of the U.S. Arctic Exclusive Economic...

Patient safety in phlebology: The ACP Phlebology Safety Checklist.

PubMed

Collares, Felipe Birchal; Sonde, Mehru; Harper, Kenneth; Armitage, Michael; Neuhardt, Diana L; Fronek, Helane S

2018-05-01

Objectives To assess the current use of safety checklists among the American College of Phlebology (ACP) members and their interest in implementing a checklist supported by the ACP on their clinical practices; and to develop a phlebology safety checklist. Method Online surveys were sent to ACP members, and a phlebology safety checklist was developed by a multispecialty team through the ACP Leadership Academy. Results Forty-seven percent of respondents are using a safety checklist in their practices; 23% think that a phlebology safety checklist would interfere or disrupt workflow; 79% answered that a phlebology safety checklist could improve procedure outcomes or prevent complications; and 85% would be interested in implementing a phlebology safety checklist approved by the ACP. Conclusion A phlebology safety checklist was developed with the intent to increase awareness on patient safety and improve outcome in phlebology practice.

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.

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.

Vitrectomy for floaters: prospective efficacy analyses and retrospective safety profile.

PubMed

Sebag, Jerry; Yee, Kenneth M P; Wa, Christianne A; Huang, Laura C; Sadun, Alfredo A

2014-06-01

Floaters impact vision but the mechanism is unknown. We hypothesize that floaters reduce contrast sensitivity function, which can be normalized by vitrectomy, and that minimally invasive vitrectomy will have lower incidences of retinal tears (reported at 30%) and cataracts (50-76%). Seventy-six eyes (34 phakic) with floaters were evaluated in 2 separate studies. Floater etiologies were primarily posterior vitreous detachment in 61 of 76 eyes (80%) and myopic vitreopathy in 24 of 76 eyes (32%). Minimally invasive 25G vitrectomy was performed without posterior vitreous detachment induction, leaving anterior vitreous, and using nonhollow probes for cannula extraction. Efficacy was studied prospectively (up to 9 months) in 16 floater cases with Freiburg Acuity Contrast Testing (Weber index [%W] reproducibility = 92.1%) and the National Eye Institute Visual Function Questionnaire. Safety was separately evaluated in 60 other cases followed up on an average of 17.5 months (range, 3-51 months). Floater eyes had 67% contrast sensitivity function attenuation (4.0 ± 2.3 %W; control subjects = 2.4 ± 0.9 %W, P < 0.013). After vitrectomy, contrast sensitivity function normalized in each case at 1 week (2.0 ± 1.4 %W, P < 0.01) and remained normal at 1 month (2.0 ± 1.0 %W, P < 0.003) and 3 months to 9 months (2.2 ± 1.5 %W, P < 0.018). Visual Function Questionnaire was 28.3% lower in floater patients (73.2 ± 15.6, N = 16) than in age-matched control subjects (93.9 ± 8.0, N = 12, P < 0.001), and postoperatively improved by 29.2% (P < 0.001). In the safety study of 60 floater cases treated with vitrectomy, none developed retinal breaks, infection, or glaucoma after a mean follow-up of 17.5 months. Only 8 of 34 cases (23.5%) required cataract surgery (none younger than 53 years) at an average of 15 months postvitrectomy. Floaters lower contrast sensitivity function, which normalizes after vitrectomy. Visual Function Questionnaire quantified improvement in satisfaction. Not

The Analysing Children's Creative Thinking Framework: Development of an Observation-Led Approach to Identifying and Analysing Young Children's Creative Thinking

ERIC Educational Resources Information Center

Robson, Sue

2014-01-01

Increased international recognition of the value of supporting creative thinking suggests the value of development of approaches to its identification in children. Development of an observation-led framework, the Analysing Children's Creative Thinking (ACCT) framework, is described, and a case made for the validity of inferring creative thinking…

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.

Safety assessment of foods from genetically modified crops in countries with developing economies.

PubMed

Delaney, Bryan

2015-12-01

Population growth particularly in countries with developing economies will result in a need to increase food production by 70% by the year 2050. Biotechnology has been utilized to produce genetically modified (GM) crops for insect and weed control with benefits including increased crop yield and will also be used in emerging countries. A multicomponent safety assessment paradigm has been applied to individual GM crops to determine whether they as safe as foods from non-GM crops. This paper reviews methods to assess the safety of foods from GM crops for safe consumption from the first generation of GM crops. The methods can readily be applied to new products developed within country and this paper will emphasize the concept of data portability; that safety data produced in one geographic location is suitable for safety assessment regardless of where it is utilized. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Evaluating training programs on occupational health and safety: questionnaire development].

PubMed

Zhou, Xiao-Yan; Wang, Zhi-Ming; Wang, Mian-Zhen

2006-03-01

To develop a questionnaire to evaluate the quality of training programs on occupational health and safety. A questionnaire comprising five subscales and 21 items was developed. The reliability and validity of the questionnaire was tested. Final validation of the questionnaire was undertaken in 700 workers in an oil refining company. The Cronbach's alpha coefficients of the five subscales ranged from 0.6194 to 0.6611. The subscale-scale Pearson correlation coefficients ranged from 0.568 to 0.834 . The theta coefficients of the five subscales were greater than 0.7. The factor loadings of the five subscales in the principal component analysis ranged from 0.731 to 0.855. Use of the questionnaire in the 700 workers produced a good discriminability, with excellent, good, fair and poor comprising 22.2%, 31.2%, 32.4% and 14.1 respectively. Given the fact that 18.7% of workers had never been trained and 29.7% of workers got one-off training only, the training program scored an average of 57.2. The questionnaire is suitable to be used in evaluating the quality of training programs on occupational health and safety. The oil refining company needs to improve training for their workers on occupational health and safety.

Development and psychometric testing of an instrument to measure safety climate perceptions in community pharmacy.

PubMed

Newham, Rosemary; Bennie, Marion; Maxwell, David; Watson, Anne; de Wet, Carl; Bowie, Paul

2014-12-01

A positive and strong safety culture underpins effective learning from patient safety incidents in health care, including the community pharmacy (CP) setting. To build this culture, perceptions of safety climate must be measured with context-specific and reliable instruments. No pre-existing instruments were specifically designed or suitable for CP within Scotland. We therefore aimed to develop a psychometrically sound instrument to measure perceptions of safety climate within Scottish CPs. The first stage, development of a preliminary instrument, comprised three steps: (i) a literature review; (ii) focus group feedback; and (iii) content validation. The second stage, psychometric testing, consisted of three further steps: (iv) a pilot survey; (v) a survey of all CP staff within a single health board in NHS Scotland; and (vi) application of statistical methods, including principal components analysis and calculation of Cronbach's reliability coefficients, to derive the final instrument. The preliminary questionnaire was developed through a process of literature review and feedback. This questionnaire was completed by staff in 50 CPs from the 131 (38%) sampled. 250 completed questionnaires were suitable for analysis. Psychometric evaluation resulted in a 30-item instrument with five positively correlated safety climate factors: leadership, teamwork, safety systems, communication and working conditions. Reliability coefficients were satisfactory for the safety climate factors (α > 0.7) and overall (α = 0.93). The robust nature of the technical design and testing process has resulted in the development of an instrument with sufficient psychometric properties, which can be implemented in the community pharmacy setting in NHS Scotland. © 2014 John Wiley & Sons, Ltd.

Latest developments in cryogenic safety

NASA Astrophysics Data System (ADS)

Webster, T. J.

1983-03-01

The Cryogenic Safety Manual, sponsored by the British Cryogenics Council, was published over 10 years ago. A new updated version is now available. Some general aspects of cryogenic safety are highlighted, and attention is drawn to some of the more unusual hazardous situations. An awareness of the physical properties of the cryogenic fluids being dealt with is important in directing attention to hazardous situations which may arise. Because of this, the more important properties of the cryogenic fluids are given, such as molecular weight, boiling point and freezing point. From these properties, hazardous situations can be deduced. There are hidden dangers that are not always easy to spot. Some of the unexpected hazards, most of which have led to deaths, are: asphyxiation (anoxia), frost bites and hypothermia, explosions, and combustion. The aim of this publication is to help bring about increased safety in the production and use of cryogenic products through a deeper appreciation of the scientific, technological and administrative steps which must be made if accidents, some fatal, are to be voided in the future.

Latest developments in cryogenic safety

NASA Technical Reports Server (NTRS)

Webster, T. J.

1983-01-01

The Cryogenic Safety Manual, sponsored by the British Cryogenics Council, was published over 10 years ago. A new updated version is now available. Some general aspects of cryogenic safety are highlighted, and attention is drawn to some of the more unusual hazardous situations. An awareness of the physical properties of the cryogenic fluids being dealt with is important in directing attention to hazardous situations which may arise. Because of this, the more important properties of the cryogenic fluids are given, such as molecular weight, boiling point and freezing point. From these properties, hazardous situations can be deduced. There are hidden dangers that are not always easy to spot. Some of the unexpected hazards, most of which have led to deaths, are: asphyxiation (anoxia), frost bites and hypothermia, explosions, and combustion. The aim of this publication is to help bring about increased safety in the production and use of cryogenic products through a deeper appreciation of the scientific, technological and administrative steps which must be made if accidents, some fatal, are to be voided in the future.

Developing safety performance functions incorporating reliability-based risk measures.

PubMed

Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

2011-11-01

Current geometric design guides provide deterministic standards where the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from these standards. Several studies have advocated probabilistic geometric design where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a risk measure of the implication of deviation from design standards. However, there is currently no link between measures of design reliability and the quantification of safety using collision frequency. The analysis presented in this paper attempts to bridge this gap by incorporating a reliability-based quantitative risk measure such as the probability of non-compliance (P(nc)) in safety performance functions (SPFs). Establishing this link will allow admitting reliability-based design into traditional benefit-cost analysis and should lead to a wider application of the reliability technique in road design. The present application is concerned with the design of horizontal curves, where the limit state function is defined in terms of the available (supply) and stopping (demand) sight distances. A comprehensive collision and geometric design database of two-lane rural highways is used to investigate the effect of the probability of non-compliance on safety. The reliability analysis was carried out using the First Order Reliability Method (FORM). Two Negative Binomial (NB) SPFs were developed to compare models with and without the reliability-based risk measures. It was found that models incorporating the P(nc) provided a better fit to the data set than the traditional (without risk) NB SPFs for total, injury and fatality (I+F) and property damage only (PDO) collisions. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

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

Development and evaluation of a university campus-based food safety media campaign for young adults.

PubMed

Abbot, Jaclyn Maurer; Policastro, Peggy; Bruhn, Christine; Schaffner, Donald W; Byrd-Bredbenner, Carol

2012-06-01

Food safety information campaigns are more likely to be most effective if the messages are tailored to the needs of a specific audience. Designing effective campaigns involves careful study of the target population and working with them using a community-based participatory research model. Thus, the development of the campaign materials for a university campus-based food safety media campaign for young adults followed intense efforts of working with the target audience to gather the baseline data needed to characterize this audience, to identify the most salient messages for college students, and to create materials and events that would resonate with them. This campaign was implemented and evaluated on eight university campuses in the United States. The results indicate that the campaign significantly increased self-ratings of food safety knowledge and skill, actual food safety knowledge, food safety self-efficacy, stage of change for safe food handling, and reported hand washing behaviors of a geographically and racially diverse group of college students. The positive study outcomes support the value of engaging in these research and development efforts and reflect the usefulness of the audience-specific materials and activities developed for the campaign. The findings also demonstrate the versatility and utility of the materials on different campuses. Developing health media campaigns specifically for unique populations is key to ensuring health messages reach the target audience and, even more importantly, appeal to them. The detailed overview of the development of a food safety media campaign aimed at young adults presented in this article illustrates how health professionals can work with their target population to develop a focused, effective health promotion campaign.

Development of Food Safety Psychosocial Questionnaires for Young Adults

ERIC Educational Resources Information Center

Byrd-Bredbenner, C.; Wheatley, V.; Schaffner, D.; Bruhn, C.; Blalock, L.; Maurer, J.

2007-01-01

Food mishandling is thought to be more acute among young adults; yet little is known about why they may engage in risky food handling behaviors. The purpose of this study was to create valid, reliable instruments for assessing key food safety psychosocial measures. Development of the measures began by examining published studies and behavior…

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.

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

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.

Risky play and children's safety: balancing priorities for optimal child development.

PubMed

Brussoni, Mariana; Olsen, Lise L; Pike, Ian; Sleet, David A

2012-08-30

Injury prevention plays a key role in keeping children safe, but emerging research suggests that imposing too many restrictions on children's outdoor risky play hinders their development. We explore the relationship between child development, play, and conceptions of risk taking with the aim of informing child injury prevention. Generational trends indicate children's diminishing engagement in outdoor play is influenced by parental and societal concerns. We outline the importance of play as a necessary ingredient for healthy child development and review the evidence for arguments supporting the need for outdoor risky play, including: (1) children have a natural propensity towards risky play; and, (2) keeping children safe involves letting them take and manage risks. Literature from many disciplines supports the notion that safety efforts should be balanced with opportunities for child development through outdoor risky play. New avenues for investigation and action are emerging seeking optimal strategies for keeping children "as safe as necessary," not "as safe as possible." This paradigm shift represents a potential for epistemological growth as well as cross-disciplinary collaboration to foster optimal child development while preserving children's safety.

Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.

PubMed

Ulrich, Peter; Blaich, Guenter; Baumann, Andreas; Fagg, Rajni; Hey, Adam; Kiessling, Andrea; Kronenberg, Sven; Lindecrona, Rikke Hvid; Mohl, Silke; Richter, Wolfgang F; Tibbitts, Jay; Crameri, Flavio; Weir, Lucinda

2018-04-01

Biological drugs comprise a wide field of different modalities with respect to structure, pharmacokinetics and pharmacological function. Considerable non-clinical experience in the development of proteins (e.g. insulin) and antibodies has been accumulated over the past thirty years. In order to improve the efficacy and the safety of these biotherapeutics, Fc modifications (e.g. Fc silent antibody versions), combinations (antibody-drug conjugates, protein-nanoparticle combinations), and new constructs (darpins, fynomers) have been introduced. In the last decade, advanced therapy medicinal products (ATMPs) in research and development have become a considerable and strongly growing part of the biotherapeutic portfolio. ATMPs consisting of gene and cell therapy modalities or even combinations of them, further expand the level of complexity, which already exists in non-clinical development strategies for biological drugs and has thereby led to a further diversification of expertise in safety and PKPD assessment of biological drugs. It is the fundamental rationale of the BioSafe meetings, held yearly in the EU and in the US, to convene experts on a regular basis and foster knowledge exchange and mutual understanding in this fast growing area. In order to reflect at least partially the variety of the biotherapeutics field, the 2016 EU BioSafe meeting addressed the following topics in six sessions: (i) In vitro Meets in vivo to Leverage Biologics Development (ii) New developments and regulatory considerations in the cell and gene therapy field (iii) CMC Challenges with Biologics development (iv) Minipigs in non-clinical safety assessment (v) Opportunities of PKPD Assessment in Less Common Administration Routes In the breakout sessions the following questions were discussed: (i) Cynomolgus monkey as a reprotoxicology Species: Impact of Immunomodulators on Early Pregnancy Maintenance (ii) Safety Risk of Inflammation and Autoimmunity Induced by Immunomodulators (iii

Collaborative Approaches in Developing Environmental and Safety Management Systems for Commercial Space Transportation

NASA Technical Reports Server (NTRS)

Zee, Stacey; Murray, D.

2009-01-01

The Federal Aviation Administration (FAA), Office of Commercial Space Transportation (AST) licenses and permits U.S. commercial space launch and reentry activities, and licenses the operation of non-federal launch and reentry sites. ASTs mission is to ensure the protection of the public, property, and the national security and foreign policy interests of the United States during commercial space transportation activities and to encourage, facilitate, and promote U.S. commercial space transportation. AST faces unique challenges of ensuring the protection of public health and safety while facilitating and promoting U.S. commercial space transportation. AST has developed an Environmental Management System (EMS) and a Safety Management System (SMS) to help meet its mission. Although the EMS and SMS were developed independently, the systems share similar elements. Both systems follow a Plan-Do-Act-Check model in identifying potential environmental aspects or public safety hazards, assessing significance in terms of severity and likelihood of occurrence, developing approaches to reduce risk, and verifying that the risk is reduced. This paper will describe the similarities between ASTs EMS and SMS elements and how AST is building a collaborative approach in environmental and safety management to reduce impacts to the environment and risks to the public.

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.

Community development--improving patient safety by enhancing the use of health services.

PubMed

Baum, Fran; Freeman, Toby; Lawless, Angela; Jolley, Gwyneth

2012-06-01

Community development plays an important role in increasing the access of disadvantaged groups to resources and services. We examined how community development in primary healthcare services may improve patient safety by involving people in activities that lead to their enhanced use of services. Audits of service activity and 68 in-depth interviews at six primary healthcare services in South Australia and the Northern Territory. Managers, practitioners and administration staff, plus regional health service executives and departmental funders participated in the interviews. Each of the services undertook some community development. Reported benefits included engaging people in health promoting activity, providing people with social contacts and, crucially, encouraging people to use health services. Community development is a means of engaging people who, for a range of reasons, are reluctant to use services and therefore can increase patient safety.

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

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

Development, implementation and evaluation of a pedestrian safety zone for elderly pedestrians

DOT National Transportation Integrated Search

1998-02-01

The objectives of this study were to develop and apply procedures for defining pedestrian safety zones for the older (age 65+) adult and to develop, implement and evaluate a countermeasure program in the defined zones. Zone definition procedures were...

Developing a model for hospital inherent safety assessment: Conceptualization and validation.

PubMed

Yari, Saeed; Akbari, Hesam; Gholami Fesharaki, Mohammad; Khosravizadeh, Omid; Ghasemi, Mohammad; Barsam, Yalda; Akbari, Hamed

2018-01-01

Paying attention to the safety of hospitals, as the most crucial institute for providing medical and health services wherein a bundle of facilities, equipment, and human resource exist, is of significant importance. The present research aims at developing a model for assessing hospitals' safety based on principles of inherent safety design. Face validity (30 experts), content validity (20 experts), construct validity (268 examples), convergent validity, and divergent validity have been employed to validate the prepared questionnaire; and the items analysis, the Cronbach's alpha test, ICC test (to measure reliability of the test), composite reliability coefficient have been used to measure primary reliability. The relationship between variables and factors has been confirmed at 0.05 significance level by conducting confirmatory factor analysis (CFA) and structural equations modeling (SEM) technique with the use of Smart-PLS. R-square and load factors values, which were higher than 0.67 and 0.300 respectively, indicated the strong fit. Moderation (0.970), simplification (0.959), substitution (0.943), and minimization (0.5008) have had the most weights in determining the inherent safety of hospital respectively. Moderation, simplification, and substitution, among the other dimensions, have more weight on the inherent safety, while minimization has the less weight, which could be due do its definition as to minimize the risk.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

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

2017-01-01

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

You can't improve what you don't measure: Safety climate measures available in the German-speaking countries to support safety culture development in healthcare.

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

Safety climate measurement is a key input into safety culture development. The aim of this review is to provide an overview of the safety climate measures that have been evaluated for their psychometric properties in a German-speaking country and to make recommendations on how to use them in quality and patient safety improvement. A systematic search strategy was implemented to obtain relevant articles. PubMed and Web of Science databases were searched, and 128 abstracts were identified. After application of limits, 33 full texts were retrieved for subsequent evaluation. Studies were included on the basis of predetermined inclusion criteria and independent assessment by two reviewers. Publications were reviewed concerning healthcare setting, target group, safety culture dimensions covered and results of their psychometric evaluation. This review identified 11 instruments for safety climate assessment in different healthcare settings (i. e. hospitals, nursing homes, primary care, dental care and community pharmacy) for which acceptable to good internal consistency was reported. We observed wide variability concerning the number of dimensions (1 to 14; in some cases including outcome dimensions) and items (9 to 128) that the instruments were comprised of. Nevertheless, consistency with regard to the thematic areas covered was rather high. While there is clear evidence that we can assess safety climate in healthcare, the application of safety climate measures by quality and patient safety practitioners has so far been rather limited. This review bridges this gap between research and improvement practice by highlighting the central role of safety climate assessment in a mixed methods approach to inform safety culture development. Copyright © 2016. Published by Elsevier GmbH.

The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

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

Hughes, P. J.; Westwood, R.N; Mark, R. T.

2006-07-01

The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety casesmore » for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)« less

The development and test of urban and rural pedestrian safety messages

DOT National Transportation Integrated Search

1985-01-01

The objective of this project was to identify, develop and produce public education messages for pedestrian safety. Pedestrian accident types and situations which had not been previously addressed through public education were selected. These include...

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.

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

PubMed

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

[Safety culture in the context of work intensification--development in Germany over the last 10 years].

PubMed

Lauterberg, Jörg

2009-01-01

This article tries to review the development of patient safety culture in the German healthcare system over the last decade. Since the use of standardized questionnaires and other instruments to measure safety culture in Germany has only just begun there are no representative and longitudinal data. Therefore a set of indicators and clues is chosen to characterise the safety culture development on the micro-, meso- and macro-level of the healthcare system in four areas. Is patient safety an issue of the healthcare debates and especially of research? Have dedicated structures and processes been implemented to support clinical risk management? What are the objective outcomes of healthcare and treatment in regard to patient safety? In summary, there are a lot of signs that patient safety issues in Germany are gaining more and more importance on all levels of the healthcare system. To date there have been single evidence-based studies only indicating a causal or close temporal relationship between patient safety outcomes and the increasing efforts of hospitals, outpatient and long-term care facilities.

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.

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.

Methods for identifying high collision concentrations for identifying potential safety improvements : development of advanced type 2 safety performance functions.

DOT National Transportation Integrated Search

2016-06-30

This research developed advanced type 2 safety performance functions (SPF) for roadway segments, intersections and ramps on the entire Caltrans network. The advanced type 2 SPFs included geometrics, traffic volume and hierarchical random effects, whi...

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.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive

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

Occupational safety and health criteria for responsible development of nanotechnology

NASA Astrophysics Data System (ADS)

Schulte, P. A.; Geraci, C. L.; Murashov, V.; Kuempel, E. D.; Zumwalde, R. D.; Castranova, V.; Hoover, M. D.; Hodson, L.; Martinez, K. F.

2014-01-01

Organizations around the world have called for the responsible development of nanotechnology. The goals of this approach are to emphasize the importance of considering and controlling the potential adverse impacts of nanotechnology in order to develop its capabilities and benefits. A primary area of concern is the potential adverse impact on workers, since they are the first people in society who are exposed to the potential hazards of nanotechnology. Occupational safety and health criteria for defining what constitutes responsible development of nanotechnology are needed. This article presents five criterion actions that should be practiced by decision-makers at the business and societal levels—if nanotechnology is to be developed responsibly. These include (1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers' exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits. All these criteria are necessary for responsible development to occur. Since it is early in the commercialization of nanotechnology, there are still many unknowns and concerns about nanomaterials. Therefore, it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments. In this emergent period, it is necessary to be clear about the extent of uncertainty and the need for prudent actions.

SafetyAnalyst

DOT National Transportation Integrated Search

2009-01-01

This booklet provides an overview of SafetyAnalyst. SafetyAnalyst is a set of software tools under development to help State and local highway agencies advance their programming of site-specific safety improvements. SafetyAnalyst will incorporate sta...

Engineering and Development Program Plan, Aircraft Cabin Fire Safety.

DTIC Science & Technology

1980-06-01

relative to a postcrash fuel fire, or whether advanced materials provide a significant safety benefit in comparison to inservice materials. if either...have always been controlled by early detection and prompt extinguishment action by effectively trained crew members. In addition, the fire resistant...occupants. g. Develop a computer fire test data bank with broad user availability for inservice and candidate cabin interior materials. h. Identify

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

In spite of a very compressed schedule, Project Orion's AFT safety team was able to pull together a comprehensive set of ground safety requirements using existing requirements and subject matter experts. These requirements will serve as the basis for the design of GSE and ground operations. Using the above lessons as a roadmap, new Projects can produce the same results. A rigorous set of ground safety requirements is required to assure ground support equipment (GSE) and associated flight hardware ground operations are conducted safety

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

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

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

PubMed

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

2015-07-10

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

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

Development and application of a safety assessment methodology for waste disposals

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

Little, R.H.; Torres, C.; Schaller, K.H.

1996-12-31

As part of a European Commission funded research programme, QuantiSci (formerly the Environmental Division of Intera Information Technologies) and Instituto de Medio Ambiente of the Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (IMA/CIEMAT) have developed and applied a comprehensive, yet practicable, assessment methodology for post-disposal safety assessment of land-based disposal facilities. This Safety Assessment Comparison (SACO) Methodology employs a systematic approach to the collection, evaluation and use of waste and disposal system data. It can be used to assess engineered barrier performance, the attenuating properties of host geological formations, and the long term impacts of a facility on the environmentmore » and human health, as well as allowing the comparison of different disposal options for radioactive, mixed and non-radioactive wastes. This paper describes the development of the methodology and illustrates its use.« less

Is Model-Based Development a Favorable Approach for Complex and Safety-Critical Computer Systems on Commercial Aircraft?

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

A system is safety-critical if its failure can endanger human life or cause significant damage to property or the environment. State-of-the-art computer systems on commercial aircraft are highly complex, software-intensive, functionally integrated, and network-centric systems of systems. Ensuring that such systems are safe and comply with existing safety regulations is costly and time-consuming as the level of rigor in the development process, especially the validation and verification activities, is determined by considerations of system complexity and safety criticality. A significant degree of care and deep insight into the operational principles of these systems is required to ensure adequate coverage of all design implications relevant to system safety. Model-based development methodologies, methods, tools, and techniques facilitate collaboration and enable the use of common design artifacts among groups dealing with different aspects of the development of a system. This paper examines the application of model-based development to complex and safety-critical aircraft computer systems. Benefits and detriments are identified and an overall assessment of the approach is given.

ASAS Centennial Paper: Developments and future outlook for preharvest food safety.

PubMed

Oliver, S P; Patel, D A; Callaway, T R; Torrence, M E

2009-01-01

The last century of food animal agriculture is a remarkable triumph of scientific research. Knowledge derived through research has resulted in the development and use of new technologies that have increased the efficiency of food production and created a huge animal production and food manufacturing industry capable of feeding the US population while also providing significant quantities of high-quality food for export to other countries. Although the US food supply is among the safest in the world, the US Center for Disease Prevention and Control estimates that 76 million people get sick, more than 300,000 are hospitalized, and 5,000 die each year from foodborne illness. Consequently, preventing foodborne illness and death remains a major public health concern. Challenges to providing a safe, abundant, and nutritious food supply are complex because all aspects of food production, from farm to fork, must be considered. Given the national and international demand and expectations for food safety as well as the formidable challenges of producing and maintaining a safe food supply, food safety research and educational programs have taken on a new urgency. Remarkable progress has been made during the last century. Wisdom from a century of animal agriculture research now includes the realization that on-farm pathogens are intricately associated with animal health and well-being, the production of high-quality food, and profitability. In this review, some of the developments that have occurred over the last few decades are summarized, including types, sources, and concentrations of disease-causing pathogens encountered in food-producing animal environments and their association with food safety; current and future methods to control or reduce foodborne pathogens on the farm; and present and future preharvest food safety research directions. Future scientific breakthroughs will no doubt have a profound impact on animal agriculture and the production of high-quality food

Development of a highway safety fundamental course.

DOT National Transportation Integrated Search

2015-05-01

Although the need for road safety education was first recognized in the 1960s, it has become an increasingly urgent issue : in recent years. To fulfill the hefty goal set up by the AASHTO Highway Safety Strategy and by state DOTS, it is critical : to...

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

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.

MRI Evaluation and Safety in the Developing Brain

PubMed Central

Tocchio, Shannon; Kline-Fath, Beth; Kanal, Emanuel; Schmithorst, Vincent J.; Panigrahy, Ashok

2015-01-01

Magnetic resonance imaging (MRI) evaluation of the developing brain has dramatically increased over the last decade. Faster acquisitions and the development of advanced MRI sequences such as magnetic resonance spectroscopy (MRS), diffusion tensor imaging (DTI), perfusion imaging, functional MR imaging (fMRI), and susceptibility weighted imaging (SWI), as well as the use of higher magnetic field strengths has made MRI an invaluable tool for detailed evaluation of the developing brain. This article will provide an overview of the use and challenges associated with 1.5T and 3T static magnetic fields for evaluation of the developing brain. This review will also summarize the advantages, clinical challenges and safety concerns specifically related to MRI in the fetus and newborn, including the implications of increased magnetic field strength, logistics related to transporting and monitoring of neonates during scanning, sedation considerations and a discussion of current technologies such as MRI-conditional neonatal incubators and dedicated small-foot print neonatal intensive care unit (NICU) scanners. PMID:25743582

76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...] Draft Guidance for Industry on ``Target Animal Safety and Effectiveness Protocol Development and...) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of... Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to...

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

PubMed

Wu, Tsung-Chih

2011-10-01

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

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.

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.

Recent Developments in Hyperspectral Imaging for Assessment of Food Quality and Safety

PubMed Central

Huang, Hui; Liu, Li; Ngadi, Michael O.

2014-01-01

Hyperspectral imaging which combines imaging and spectroscopic technology is rapidly gaining ground as a non-destructive, real-time detection tool for food quality and safety assessment. Hyperspectral imaging could be used to simultaneously obtain large amounts of spatial and spectral information on the objects being studied. This paper provides a comprehensive review on the recent development of hyperspectral imaging applications in food and food products. The potential and future work of hyperspectral imaging for food quality and safety control is also discussed. PMID:24759119

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…

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.

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.

Development and implementation of participant safety plans for international research with stigmatised populations.

PubMed

Sugarman, Jeremy; Barnes, Mark; Rose, Scott; Dumchev, Kostyantyn; Sarasvita, Riza; Viet, Ha Tran; Zeziulin, Oleksandr; Susami, Hepa; Go, Vivian; Hoffman, Irving; Miller, William C

2018-06-22

People who inject drugs with high-risk sharing practices have high rates of HIV transmission and face barriers to HIV care. Interventions to overcome these barriers are needed; however, stigmatisation of drug use and HIV infection leads to safety concerns during the planning and conduct of research on such interventions. In preparing to address concerns about safety and wellbeing of participants in an international research study, HIV Prevention Trials Network 074, we developed participant safety plans (PSPs) at each site to supplement local research ethics committee oversight, community engagement, and usual clinical trial procedures. The PSPs were informed by systematic local legal and policy assessments, and interviews with key stakeholders. After PSP refinement and implementation, we assessed social impacts at each study visit to ensure continued safety. Throughout the study, five participants reported a negative social impact, with three resulting from study participation. Future research with stigmatised populations should consider using and assessing this approach to enhance safety and welfare. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

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.

Development of an economic skill building intervention to promote women's safety and child development in Karachi, Pakistan.

PubMed

Hirani, Saima Shams; Karmaliani, Rozina; McFarlane, Judith; Asad, Nargis; Madhani, Farhana; Shehzad, Shireen; Ali, Nazbano Ahmed

2010-02-01

Violence against women is a global epidemic phenomenon that can result in major mental health problems. Not only are women affected but also the health and well-being of their children are in jeopardy. To prevent violence and promote women's safety, several strategies have been tested in various cultural contexts. This article describes the process of developing and validating an economic skill building intervention for women of an urban slum area of Karachi, Pakistan. The purpose of the intervention is to increase women's economic independence, promote women's safety, and improve the behavioral functioning of their children.

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

PubMed

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

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

PubMed Central

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

2011-01-01

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

Establishment of minimal positive-control conditions to ensure brain safety during rapid development of emergency vaccines.

PubMed

Baek, Hyekyung; Kim, Kwang Ho; Park, Min Young; Kim, Kyeongryun; Ko, Bokyeong; Seo, Hyung Seok; Kim, Byoung Soo; Hahn, Tae-Wook; Yi, Sun Shin

2017-08-31

With the increase in international human and material exchanges, contagious and infectious epidemics are occurring. One of the effective methods of epidemic inhibition is the rapid development and supply of vaccines. Considering the safety of the brain during vaccine development is very important. However, manuals for brain safety assays for new vaccines are not uniform or effective globally. Therefore, the aim of this study is to establish a positive-control protocol for an effective brain safety test to enhance rapid vaccine development. The blood-brain barrier's tight junctions provide selective defense of the brain; however, it is possible to destroy these important microstructures by administering lipopolysaccharides (LPSs), thereby artificially increasing the permeability of brain parenchyma. In this study, test conditions are established so that the degree of brain penetration or brain destruction of newly developed vaccines can be quantitatively identified. The most effective conditions were suggested by measuring time-dependent expressions of tight junction biomarkers (zonula occludens-1 [ZO-1] and occludin) in two types of mice (C57BL/6 and ICR) following exposure to two types of LPS ( Salmonella and Escherichia ). In the future, we hope that use of the developed positive-control protocol will help speed up the determination of brain safety of novel vaccines.

Risky Play and Children’s Safety: Balancing Priorities for Optimal Child Development

PubMed Central

Brussoni, Mariana; Olsen, Lise L.; Pike, Ian; Sleet, David A.

2012-01-01

Injury prevention plays a key role in keeping children safe, but emerging research suggests that imposing too many restrictions on children’s outdoor risky play hinders their development. We explore the relationship between child development, play, and conceptions of risk taking with the aim of informing child injury prevention. Generational trends indicate children’s diminishing engagement in outdoor play is influenced by parental and societal concerns. We outline the importance of play as a necessary ingredient for healthy child development and review the evidence for arguments supporting the need for outdoor risky play, including: (1) children have a natural propensity towards risky play; and, (2) keeping children safe involves letting them take and manage risks. Literature from many disciplines supports the notion that safety efforts should be balanced with opportunities for child development through outdoor risky play. New avenues for investigation and action are emerging seeking optimal strategies for keeping children “as safe as necessary,” not “as safe as possible.” This paradigm shift represents a potential for epistemological growth as well as cross-disciplinary collaboration to foster optimal child development while preserving children’s safety. PMID:23202675

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).

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

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

PubMed

McKenney, James; Bays, Harold; Gleim, Gilbert; Mitchel, Yale; Kuznetsova, Olga; Sapre, Aditi; Sirah, Waheeda; Maccubbin, Darbie

2015-01-01

The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets. We examined the safety profile of ERN-LRPT vs the comparators ERN alone and statins in the ERN-LRPT development program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to ERN or LRPT. Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) ERN-LRPT; (2) ERN-NSP (ERN, Merck & Co, Inc or Niaspan [NSP], Abbott Laboratories); and (3) statin-PBO (statin or PBO). The safety profiles of ERN-LRPT and ERN-NSP were similar, except for less flushing with ERN-LRPT. Nonflushing AEs reported more frequently with ERN-LRPT or ERN-NSP than with statin-PBO were mostly nonserious and typical of niacin (nausea, diarrhea, and increased blood glucose). There was no evidence for an increased risk of serious AEs related to diabetes, muscle, infection, or bleeding. Pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of ERN-LRPT was similar to that of ERN-NSP; LRPT did not appear to adversely affect the side-effect profile of ERN. The inability to replicate the unexpected AE findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Developing effective worker health and safety training materials: hazard awareness, identification, recognition, and control for the salon industry.

PubMed

Mayer, Annyce S; Brazile, William J; Erb, Samantha; Autenrieth, Daniel A; Serrano, Katherine; Van Dyke, Michael V

2015-05-01

In addition to formaldehyde, workers in salons can be exposed to other chemical irritants, sensitizers, carcinogens, reproductive hazards, infectious agents, ergonomic, and other physical hazards. Worker health and safety training is challenging because of current product labeling practices and the myriad of hazards portending risk for a wide variety of health effects. Through a Susan B. Harwood Targeted Topic Training grant from the Occupational Safety and Health Administration and assistance from salon development and training partners, we developed, delivered, and validated a health and safety training program using an iterative five-pronged approach. The training was well received and resulted in knowledge gain, improved workplace safety practices, and increased communication about health and safety. These training materials are available for download from the Occupational Safety and Health Administration's Susan B. Harwood Training Grant Program Web site.

MRI evaluation and safety in the developing brain.

PubMed

Tocchio, Shannon; Kline-Fath, Beth; Kanal, Emanuel; Schmithorst, Vincent J; Panigrahy, Ashok

2015-03-01

Magnetic resonance imaging (MRI) evaluation of the developing brain has dramatically increased over the last decade. Faster acquisitions and the development of advanced MRI sequences, such as magnetic resonance spectroscopy (MRS), diffusion tensor imaging (DTI), perfusion imaging, functional MR imaging (fMRI), and susceptibility-weighted imaging (SWI), as well as the use of higher magnetic field strengths has made MRI an invaluable tool for detailed evaluation of the developing brain. This article will provide an overview of the use and challenges associated with 1.5-T and 3-T static magnetic fields for evaluation of the developing brain. This review will also summarize the advantages, clinical challenges, and safety concerns specifically related to MRI in the fetus and newborn, including the implications of increased magnetic field strength, logistics related to transporting and monitoring of neonates during scanning, and sedation considerations, and a discussion of current technologies such as MRI conditional neonatal incubators and dedicated small-foot print neonatal intensive care unit (NICU) scanners. Copyright © 2015 Elsevier Inc. All rights reserved.

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 ...

Occupational health and safety in the least developed countries--a simple case of neglect.

PubMed

Ahasan, M R; Partanen, T

2001-03-01

In many of the least developed countries, working people are significantly exposed to a number of occupational problems that may result in a deterioration of their health, safety and well being. These work-related problems are untenable, not only because of the occupational problems itself but also because of the simultaneous exposure to heat, dusts, noise, organo-chemicals, and biological and environmental pollution. This situation has existed for a long time due to various socio economic,geographical, cultural and local factors. The deteriorating situation of health and safety in the workplace may perhaps exist due to the inadequate resource facilities, economic constraints and lack of opportunity to conduct research and studies on the assessment of exposure-diseases associations. Officials, who are employed by the state, are not able to implement work regulations and labour legislation easily. Generally, they are not professionally trained and expert in the occupational health, industrial hygiene and/or safety fields, and thus, successful application and implementation of control measures are lacking. Steps to control work exposure limits have been ineffective, since national policies have been rare, owing to the multiple obstacles in preventing occupational problems. However, the major focus is on practical solutions to differing workers' needs, consideration of which is very important, depending on the what the industrial entrepreneurs could reasonably to be expected to afford. Why there is a lack of motivation and effort regarding the development of health and safety-this paper explores some important issues, aiming to focus public attention on the legacy of national and international efforts. Examples are likewise given to show the real situation of health and safety in the least developed countries.

Connected commercial vehicles — retrofit safety device kit project : safety applications and development plan.

DOT National Transportation Integrated Search

2014-03-01

Connected vehicle wireless data communications can enable safety applications that may reduce injuries and fatalities. Cooperative vehicle-to-vehicle (V2V) safety applications will be effective only if a high fraction of vehicles are equipped. Deploy...

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

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

Determination of Waste Groupings for Safety Analyses

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

BARKER, S.A.

2000-04-27

Two workshops were held in May and July 1999 to review data analysis methodologies associated with the analysis of flammable gas behavior. The workshop participants decided that missing data could he estimated by using a distribution of values that encompassed tanks with wastes that behaved in a similar fashion. It was also determined that because of the limited amount of tank data pertaining to flammable gas generation and retention, it was not justified to divide the tanks into many small waste groupings. The purpose for grouping tanks is so that limited gas retention and release data, which may be availablemore » for some tanks within a group, can be applied to other tanks containing the same waste form. This is necessary when estimating waste properties for tanks with missing or incomplete information. Following the workshop, a preliminary tank grouping was prepared based on content of solids, liquids, sludge, saltcake, or salt slurry The saltcake and salt slurry were then grouped together and referred to as saltcake/salt slurry. Initial tank classifications were based on waste forms from the Rest Basis Inventory, the Hanford Defined Waste (HDW) (''Agnew'') Model, or the Waste Tank Summary (''Hanlon'') Report The results of this grouping arc presented in ''Flamable Gas Safety Analysis Data Review'', SNL-000 198 (Barker, et al., 1999). At the time of the release of SNL-000198, tank waste inventories were not consistent between published sources, such as the ''Best Basis Inventory'' and the ''Waste Tank Summary Report for Month Ending August 31, 1999'' (Hanlon l999). This calculation note documents the process and basis used when revising the waste groupings following the release of SNL-000198. The waste layer volume information is compared between the various databases, including information obtained from process measurements. Differences are then resolved based on tank characterization information and waste behavior.« less

Predictive models of safety based on audit findings: Part 1: Model development and reliability.

PubMed

Hsiao, Yu-Lin; Drury, Colin; Wu, Changxu; Paquet, Victor

2013-03-01

This consecutive study was aimed at the quantitative validation of safety audit tools as predictors of safety performance, as we were unable to find prior studies that tested audit validity against safety outcomes. An aviation maintenance domain was chosen for this work as both audits and safety outcomes are currently prescribed and regulated. In Part 1, we developed a Human Factors/Ergonomics classification framework based on HFACS model (Shappell and Wiegmann, 2001a,b), for the human errors detected by audits, because merely counting audit findings did not predict future safety. The framework was tested for measurement reliability using four participants, two of whom classified errors on 1238 audit reports. Kappa values leveled out after about 200 audits at between 0.5 and 0.8 for different tiers of errors categories. This showed sufficient reliability to proceed with prediction validity testing in Part 2. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

[Development and validation of the Korean patient safety culture scale for nursing homes].

PubMed

Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

2013-06-01

The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

Developing a disaster education program for community safety and resilience: The preliminary phase

NASA Astrophysics Data System (ADS)

Nifa, Faizatul Akmar Abdul; Abbas, Sharima Ruwaida; Lin, Chong Khai; Othman, Siti Norezam

2017-10-01

Resilience encompasses both the principles of preparedness and reaction within the dynamic systems and focuses responses on bridging the gap between pre-disaster activities and post-disaster intervention and among structural/non-structural mitigation. Central to this concept is the ability of the affected communities to recover their livelihood and inculcating necessary safety practices during the disaster and after the disaster strikes. While these ability and practices are important to improve the community safety and resilience, such factors will not be effective unless the awareness is present among the community. There have been studies conducted highlighting the role of education in providing awareness for disaster safety and resilience from a very young age. However for Malaysia, these area of research has not been fully explored and developed based on the specific situational and geographical factors of high-risk flood disaster locations. This paper explores the importance of disaster education program in Malaysia and develops into preliminary research project which primary aim is to design a flood disaster education pilot program in Kampung Karangan Primary School, Kelantan, Malaysia.

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.

Developing a Practical and Sustainable Faculty Development Program With a Focus on Teaching Quality Improvement and Patient Safety: An Alliance for Independent Academic Medical Centers National Initiative III Project.

PubMed

Rodrigue, Christopher; Seoane, Leonardo; Gala, Rajiv B; Piazza, Janice; Amedee, Ronald G

2012-01-01

Teaching the next generation of physicians requires more than traditional teaching models. The Accreditation Council for Graduate Medical Education's Next Accreditation System places considerable emphasis on developing a learning environment that fosters resident education in quality improvement and patient safety. The goal of this project was to develop a comprehensive and sustainable faculty development program with a focus on teaching quality improvement and patient safety. A multidisciplinary team representing all stakeholders in graduate medical education developed a validated survey to assess faculty and house officer baseline perceptions of their experience with faculty development opportunities, quality improvement tools and training, and resident participation in quality improvement and patient safety programs at our institution. We then developed a curriculum to address these 3 areas. Our pilot survey revealed a need for a comprehensive program to teach faculty and residents the art of teaching. Two other areas of need are (1) regular resident participation in quality improvement and patient safety efforts and (2) effective tools for developing skills and habits to analyze practices using quality improvement methods. Resident and faculty pairs in 17 Ochsner training programs developed and began quality improvement projects while completing the first learning module. Resident and faculty teams also have been working on the patient safety modules and incorporating aspects of patient safety into their individual work environments. Our team's goal is to develop a sustainable and manageable faculty development program that includes modules addressing quality improvement and patient safety in accordance with Accreditation Council for Graduate Medical Education accreditation requirements.

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

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...

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 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...

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.

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

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

Development and Validation of a Short-Form Safety Net Medical Home Scale.

PubMed

Nocon, Robert S; Gunter, Kathryn E; Gao, Yue; Lee, Sang Mee; Chin, Marshall H

2017-12-01

To develop a short-form Safety Net Medical Home Scale (SNMHS) for assessing patient-centered medical home (PCMH) capability in safety net clinics. National surveys of federally qualified health centers (FQHCs). Interviews with FQHC directors. We constructed three short-form SNMHS versions and examined correlations with full SNMHS and related primary care assessments. We tested usability with FQHC directors and reviewed scale development with an advisory group. Federally qualified health center surveys were administered in 2009 and 2013, by mail and online. Usability testing was conducted through telephone interviews with FQHC directors in 2013. Six-, 12-, and 18-question short-form SNMHS versions had Pearson correlations with full scale of 0.84, 0.92, and 0.96, respectively. All versions showed a level of convergent validity with other primary care assessment scales comparable to the full SNMHS. User testers found short forms to be low-burden, though missing some PCMH concepts. Advisory group members expressed caution over missing concepts and appropriate use of short-form self-assessments. Short-form versions of SNMHS showed strong correlations with full scale and may be useful for brief assessment of safety net PCMH capability. Each short-form SNMHS version may be appropriate for different research, quality improvement, and assessment purposes. © Health Research and Educational Trust.

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

Safety sans Frontières: An International Safety Culture Model.

PubMed

Reader, Tom W; Noort, Mark C; Shorrock, Steven; Kirwan, Barry

2015-05-01

The management of safety culture in international and culturally diverse organizations is a concern for many high-risk industries. Yet, research has primarily developed models of safety culture within Western countries, and there is a need to extend investigations of safety culture to global environments. We examined (i) whether safety culture can be reliably measured within a single industry operating across different cultural environments, and (ii) if there is an association between safety culture and national culture. The psychometric properties of a safety culture model developed for the air traffic management (ATM) industry were examined in 17 European countries from four culturally distinct regions of Europe (North, East, South, West). Participants were ATM operational staff (n = 5,176) and management staff (n = 1,230). Through employing multigroup confirmatory factor analysis, good psychometric properties of the model were established. This demonstrates, for the first time, that when safety culture models are tailored to a specific industry, they can operate consistently across national boundaries and occupational groups. Additionally, safety culture scores at both regional and national levels were associated with country-level data on Hofstede's five national culture dimensions (collectivism, power distance, uncertainty avoidance, masculinity, and long-term orientation). MANOVAs indicated safety culture to be most positive in Northern Europe, less so in Western and Eastern Europe, and least positive in Southern Europe. This indicates that national cultural traits may influence the development of organizational safety culture, with significant implications for safety culture theory and practice. © 2015 Society for Risk Analysis.

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.

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.

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

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

Kessler, S

2009-04-21

With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007

Improving Patient Safety in Public Hospitals: Developing Standard Measures to Track Medical Errors and Process Breakdowns.

PubMed

Ackerman, Sara L; Gourley, Gato; Le, Gem; Williams, Pamela; Yazdany, Jinoos; Sarkar, Urmimala

2018-03-14

The aim of the study was to develop standards for tracking patient safety gaps in ambulatory care in safety net health systems. Leaders from five California safety net health systems were invited to participate in a modified Delphi process sponsored by the Safety Promotion Action Research and Knowledge Network (SPARKNet) and the California Safety Net Institute in 2016. During each of the three Delphi rounds, the feasibility and validity of 13 proposed patient safety measures were discussed and prioritized. Surveys and transcripts from the meetings were analyzed to understand the decision-making process. The Delphi process included eight panelists. Consensus was reached to adopt 9 of 13 proposed measures. All 9 measures were unanimously considered valid, but concern was expressed about the feasibility of implementing several of the measures. Although safety net health systems face high barriers to standardized measurement, our study demonstrates that consensus can be reached on acceptable and feasible methods for tracking patient safety gaps in safety net health systems. If accompanied by the active participation key stakeholder groups, including patients, clinicians, staff, data system professionals, and health system leaders, the consensus measures reported here represent one step toward improving ambulatory patient safety in safety net health systems.

Supervisor Involvement and Professional Development Needs Associated with SAE Programming and Safety

ERIC Educational Resources Information Center

Lawver, Rebecca G.; Pate, Michael L.; Sorensen, Tyson J.

2016-01-01

This descriptive survey research study sought to gather evidence of school-based agriculture teachers' perceptions of community supervisor involvement with supervision and planning of students' Supervised Agricultural Experience (SAE) work activities and safety training professional development needs. Responding teachers indicated they agreed to…

Development of Guidance for States Transitioning to New Safety Analysis Tools

ERIC Educational Resources Information Center

Alluri, Priyanka

2010-01-01

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act--A Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway…

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

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

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

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

Safety belt laws and disparities in safety belt use among US high-school drivers.

PubMed

García-España, J Felipe; Winston, Flaura K; Durbin, Dennis R

2012-06-01

We compared reported safety belt use, for both drivers and passengers, among teenagers with learner's permits, provisional licenses, and unrestricted licenses in states with primary or secondary enforcement of safety belt laws. Our data source was the 2006 National Young Driver Survey, which included a national representative sample of 3126 high-school drivers. We used multivariate, log-linear regression analyses to assess associations between safety belt laws and belt use. Teenaged drivers were 12% less likely to wear a safety belt as drivers and 15% less likely to wear one as passengers in states with a secondary safety belt law than in states with a primary law. The apparent reduction in belt use among teenagers as they progressed from learner to unrestricted license holder occurred in only secondary enforcement states. Groups reporting particularly low use included African American drivers, rural residents, academically challenged students, and those driving pickup trucks. The results provided further evidence for enactment of primary enforcement provisions in safety belt laws because primary laws are associated with higher safety belt use rates and lower crash-related injuries and mortality.

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.

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.

Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care.

PubMed

Esmail, Aneez; Valderas, Jose M; Verstappen, Wim; Godycki-Cwirko, Maciek; Wensing, Michel

2015-09-01

This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009-2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement.

Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Esmail, Aneez; Valderas, Jose M.; Verstappen, Wim; Godycki-Cwirko, Maciek; Wensing, Michel

2015-01-01

ABSTRACT This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009–2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement. PMID:26339828

[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.

Sanitation and Safety for School Food Service: Program Development. Bulletin No. 92408.

ERIC Educational Resources Information Center

Bass, Kathleen S.

This resource manual contains criteria, prototype policies, procedure, and forms for establishing a comprehensive sanitation and safety program in Wisconsin public schools. The introduction contains a mission statement and a description of responsibilities for various state employees. The section on policy and procedure development outlines…

Mathematical modelling of active safety system functions as tools for development of driverless vehicles

NASA Astrophysics Data System (ADS)

Ryazantsev, V.; Mezentsev, N.; Zakharov, A.

2018-02-01

This paper is dedicated to a solution of the issue of synthesis of the vehicle longitudinal dynamics control functions (acceleration and deceleration control) based on the element base of the vehicle active safety system (ESP) - driverless vehicle development tool. This strategy helps to reduce time and complexity of integration of autonomous motion control systems (AMCS) into the vehicle architecture and allows direct control of actuators ensuring the longitudinal dynamics control, as well as reduction of time for calibration works. The “vehicle+wheel+road” longitudinal dynamics control is complicated due to the absence of the required prior information about the control object. Therefore, the control loop becomes an adaptive system, i.e. a self-adjusting monitoring system. Another difficulty is the driver’s perception of the longitudinal dynamics control process in terms of comfort. Traditionally, one doesn’t pay a lot of attention to this issue within active safety systems, and retention of vehicle steerability, controllability and stability in emergency situations are considered to be the quality criteria. This is mainly connected to its operational limits, since it is activated only in critical situations. However, implementation of the longitudinal dynamics control in the AMCS poses another challenge for the developers - providing the driver with comfortable vehicle movement during acceleration and deceleration - while the possible highest safety level in terms of the road grip is provided by the active safety system (ESP). The results of this research are: universal active safety system - AMCS interaction interface; block diagram for the vehicle longitudinal acceleration and deceleration control as one of the active safety system’s integrated functions; ideology of adaptive longitudinal dynamics control, which enables to realize the deceleration and acceleration requested by the AMCS; algorithms synthesised; analytical experiments proving the

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

This Volume 3 of the NASA Safety Manual sets forth the basic elements and techniques for managing a system safety program and the technical methods recommended for use in developing a risk evaluation program that is oriented to the identification of hazards in aerospace hardware systems and the development of residual risk management information for the program manager that is based on the hazards identified. The methods and techniques described in this volume are in consonance with the requirements set forth in NHB 1700.1 (VI), Chapter 3. This volume and future volumes of the NASA Safety Manual shall not be rewritten, reprinted, or reproduced in any manner. Installation implementing procedures, if necessary, shall be inserted as page supplements in accordance with the provisions of Appendix A. No portion of this volume or future volumes of the NASA Safety Manual shall be invoked in contracts.

Development, Dissemination, and Assessment of a Food Safety Systems Management Curriculum for Agribusiness Students in Armenia

ERIC Educational Resources Information Center

Pokharel, Siroj; Marcy, Joseph E.; Neilan, Angela M.; Cutter, Catherine N.

2017-01-01

This study addresses the development, dissemination, and assessment of a Food Safety System Management (FSSM) curriculum offered to college-aged, agribusiness students in Yerevan, Armenia. Prior to beginning the program, demographic data were collected and a paper-based pretest was administered to access the food safety knowledge, behavior, and…

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.

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.

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.

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.

Fire safety applications for spacecraft

NASA Technical Reports Server (NTRS)

Friedman, Robert; Olson, Sandra L.

1989-01-01

Fire safety for spacecraft is reviewed by first describing current practices, many of which are adapted directly from aircraft. Then, current analyses and experimental knowledge in low-gravity combustion, with implications for fire safety are discussed. In orbiting spacecraft, the detection and suppression of flames are strongly affected by the large reduction in buoyant flows under low gravity. Generally, combustion intensity is reduced in low gravity. There are some notable exceptions, however, one example being the strong enhancement of flames by low-velocity ventilation flows in space. Finally, the future requirements in fire safety, particularly the needs of long-duration space stations in fire prevention, detection, extinguishment, and atmospheric control are examined. The goal of spacecraft fire-safety investigations is the establishment of trade-offs that promote maximum safety without hampering the useful human and scientific activities in space.

Car manufacturers and global road safety: a word frequency analysis of road safety documents.

PubMed

Roberts, I; Wentz, R; Edwards, P

2006-10-01

The World Bank believes that the car manufacturers can make a valuable contribution to road safety in poor countries and has established the Global Road Safety Partnership (GRSP) for this purpose. However, some commentators are sceptical. The authors examined road safety policy documents to assess the extent of any bias. Word frequency analyses of road safety policy documents from the World Health Organization (WHO) and the GRSP. The relative occurrence of key road safety terms was quantified by calculating a word prevalence ratio with 95% confidence intervals. Terms for which there was a fourfold difference in prevalence between the documents were tabulated. Compared to WHO's World report on road traffic injury prevention, the GRSP road safety documents were substantially less likely to use the words speed, speed limits, child restraint, pedestrian, public transport, walking, and cycling, but substantially more likely to use the words school, campaign, driver training, and billboard. There are important differences in emphasis in road safety policy documents prepared by WHO and the GRSP. Vigilance is needed to ensure that the road safety interventions that the car industry supports are based on sound evidence of effectiveness.

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...

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Staying silent about safety issues: Conceptualizing and measuring safety silence motives.

PubMed

Manapragada, Archana; Bruk-Lee, Valentina

2016-06-01

Communication between employees and supervisors about safety-related issues is an important component of a safe workplace. When supervisors receive information from employees about safety issues, they may gain otherwise-missed opportunities to correct these issues and/or prevent negative safety outcomes. A series of three studies were conducted to identify various safety silence motives, which describe the reasons that employees do not speak up to supervisors about safety-related issues witnessed in the workplace, and to develop a tool to assess these motives. Results suggest that employees stay silent about safety issues based on perceptions of altering relationships with others (relationship-based), perceptions of the organizational climate (climate-based), the assessment of the safety issue (issue-based), or characteristics of the job (job-based). We developed a 17-item measure to assess these four motives, and initial evidence was found for the construct and incremental validity of the safety silence motives measure in a sample of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

Communicating vaccine safety during the development and introduction of vaccines.

PubMed

Kochhar, Sonali

2015-01-01

Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

Combustion Stability Analyses for J-2X Gas Generator Development

NASA Technical Reports Server (NTRS)

Hulka, J. R.; Protz, C. S.; Casiano, M. J.; Kenny, R. J.

2010-01-01

The National Aeronautics and Space Administration (NASA) is developing a liquid oxygen/liquid hydrogen rocket engine for upper stage and trans-lunar applications of the Ares vehicles for the Constellation program. This engine, designated the J-2X, is a higher pressure, higher thrust variant of the Apollo-era J-2 engine. Development was contracted to Pratt & Whitney Rocketdyne in 2006. Over the past several years, development of the gas generator for the J-2X engine has progressed through a variety of workhorse injector, chamber, and feed system configurations. Several of these configurations have resulted in injection-coupled combustion instability of the gas generator assembly at the first longitudinal mode of the combustion chamber. In this paper, the longitudinal mode combustion instabilities observed on the workhorse test stand are discussed in detail. Aspects of this combustion instability have been modeled at the NASA Marshall Space Flight Center with several codes, including the Rocket Combustor Interaction Design and Analysis (ROCCID) code and a new lumped-parameter MatLab model. To accurately predict the instability characteristics of all the chamber and injector geometries and test conditions, several features of the submodels in the ROCCID suite of calculations required modification. Finite-element analyses were conducted of several complicated combustion chamber geometries to determine how to model and anchor the chamber response in ROCCID. A large suite of sensitivity calculations were conducted to determine how to model and anchor the injector response in ROCCID. These modifications and their ramification for future stability analyses of this type are discussed in detail. The lumped-parameter MatLab model of the gas generator assembly was created as an alternative calculation to the ROCCID methodology. This paper also describes this model and the stability calculations.

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...

NASA Software Safety Standard

NASA Technical Reports Server (NTRS)

Rosenberg, Linda

1997-01-01

If software is a critical element in a safety critical system, it is imperative to implement a systematic approach to software safety as an integral part of the overall system safety programs. The NASA-STD-8719.13A, "NASA Software Safety Standard", describes the activities necessary to ensure that safety is designed into software that is acquired or developed by NASA, and that safety is maintained throughout the software life cycle. A PDF version, is available on the WWW from Lewis. A Guidebook that will assist in the implementation of the requirements in the Safety Standard is under development at the Lewis Research Center (LeRC). After completion, it will also be available on the WWW from Lewis.

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.

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.

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

The potential for further development of passive safety.

PubMed

Frampton, Richard; Lenard, James

2009-10-01

In Europe, emphasis is being transferred from injury prevention to accident prevention to reduce road casualties. This study attempted to identify the current potential for serious casualty reduction using passive safety by examining the crash performance of new cars with seriously injured occupants. The Co-operative Crash Injury Study conducts in-depth investigations of around 1200 vehicles per year from seven sample regions around England. Attention was focussed on passenger cars manufactured from 2004 to 2008 with at least one occupant injured to AIS level 3 or more. 28% of MAIS 3+ occupants were unbelted and 40% were belted but involved in crashes with limited potential for passive protection. A further 32% of occupants were belted and involved in crashes with potential for improved crashworthiness design. For these occupants, five major functional requirements were identified for crashworthiness improvement: a reduction of seatbelt loads on the chest and abdomen in frontal crashes, particularly for seniors; reduction in femur and tibia loads in frontal crashes; provision of head and chest protection in near-side crashes; and reduction of occupant lateral excursion in far-side impacts. Together these functions accounted for 70% of the identified requirements. Other smaller requirements were identified, each contributing up to 5% of total. Overall, the case supporting further developments in passive safety still appears significant.

The Potential for Further Development of Passive Safety

PubMed Central

Frampton, Richard; Lenard, James

2009-01-01

In Europe, emphasis is being transferred from injury prevention to accident prevention to reduce road casualties. This study attempted to identify the current potential for serious casualty reduction using passive safety by examining the crash performance of new cars with seriously injured occupants. The Co-operative Crash Injury Study conducts in-depth investigations of around 1200 vehicles per year from seven sample regions around England. Attention was focussed on passenger cars manufactured from 2004 to 2008 with at least one occupant injured to AIS level 3 or more. 28% of MAIS 3+ occupants were unbelted and 40% were belted but involved in crashes with limited potential for passive protection. A further 32% of occupants were belted and involved in crashes with potential for improved crashworthiness design. For these occupants, five major functional requirements were identified for crashworthiness improvement: a reduction of seatbelt loads on the chest and abdomen in frontal crashes, particularly for seniors; reduction in femur and tibia loads in frontal crashes; provision of head and chest protection in near-side crashes; and reduction of occupant lateral excursion in far-side impacts. Together these functions accounted for 70% of the identified requirements. Other smaller requirements were identified, each contributing up to 5% of total. Overall, the case supporting further developments in passive safety still appears significant. PMID:20184832

Developing Expert Teams with a Strong Safety Culture

NASA Technical Reports Server (NTRS)

Rogers, David G.

2010-01-01

Would you like to lead a world renowned team that draws out all the talents and expertise of its members and consistently out performs all others in the industry? Ever wonder why so many organizations fail to truly learn from past mistakes only to repeat the same ones at a later date? Are you a program/project manager or team member in a high-risk organization where the decisions made often carry the highest of consequences? Leadership, communication, team building, critical decision-making and continuous team improvement skills and behaviors are mere talking points without the attitudes, commitment and strategies necessary to make them the very fabric of a team. Developing Expert Teams with a Strong Safety Culture, will provide you with proven knowledge and strategies to take your team soaring to heights you may have not thought possible. A myriad of teams have applied these strategies and techniques within their organization team environments: military and commercial aviation, astronaut flight crews, Shuttle flight controllers, members of the Space Shuttle Program Mission Management Team, air traffic controllers, nuclear power control teams, surgical teams, and the fire service report having spectacular success. Many industry leaders are beginning to realize that although the circumstances and environments of these teams may differ greatly to their own, the core elements, governing principles and dynamics involved in managing and building a stellar safety conscious team remain identical.

Development of Flight Safety Prediction Methodology for U. S. Naval Safety Center. Revision 1

DTIC Science & Technology

1970-02-01

Safety Center. The methodology develoned encompassed functional analysis of the F-4J aircraft, assessment of the importance of safety- sensitive ... Sensitivity ... ....... . 4-8 V 4.5 Model Implementation ........ ......... . 4-10 4.5.1 Functional Analysis ..... ........... . 4-11 4. 5. 2 Major...Function Sensitivity Assignment ........ ... 4-13 i 4.5.3 Link Dependency Assignment ... ......... . 4-14 4.5.4 Computer Program for Sensitivity

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.

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.

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.

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

-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

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.

Development of a Universal Safety Behavior Management System for Coal Mine Workers

PubMed Central

LI, Jizu; LI, Yuejiao; LIU, Xiaoguang

2015-01-01

Background: In China, over 80% of all work-related deaths in the mining industry occur in coal mines and human factors constitute 85% of the direct causes of coal mine accidents, which indicates that significant shortcomings currently exist in the safety behavior management of Chinese coal mine workers. We aimed to verify the impact of human psychological behavior in coal mine accidents systematically through experimental study, theoretical analysis and management application. Methods: Four test instruments (Sensory and cognitive capacity test, Sixteen-Personal Factor Questionnaire, Symptom Checklist 90 Questionnaire and the supervisors’ evaluation) were employed from November 2013 to June 2014 to identify unsafe behavior factors, the self-established Questionnaire of Safety Behavior Norms (QSBN) was also used to propose the safety behavior countermeasures of coal mine employees. Results: The mental health of most coal mine workers’ is relatively poor. The sensory and cognitive capacity of those in different work posts varies greatly, as does the sense of responsibility. Workers are susceptible to external influences, and score low in site management. When the 16-PF and SCL-90 sensory and cognitive assessments were combined, the psychological index predictive power was greatest for estimating sense of efficiency and degree of satisfaction in internal evaluations, while at the same time lowest for estimating control of introversion-extroversion and stress character. Conclusion: The psychological indicators can predict part of employee safety behavior, and assist a coal mine enterprise to recruit staff, develop occupational safety norms and improve the working environment. PMID:26258088

Design Development Analyses in Support of a Heatpipe-Brayton Cycle Heat Exchanger

NASA Technical Reports Server (NTRS)

Steeve, Brian; VanDyke, Melissa; Majumdar, Alok; Nguyen, Dalton; Corley, Melissa; Guffee, Ray M.; Kapernick, Richard J.

2003-01-01

One of the power systems under consideration for nuclear electric propulsion or as a planetary surface power source is a heatpipe-cooled reactor coupled to a Brayton cycle. In this system, power is transferred from the heatpipes to the Brayton gas via a heat exchanger attached to the heatpipes. This paper discusses the fluid, thermal and structural analyses that were performed in support of the design of the heat exchanger to be tested in the SAFE-100 experimental program at Marshall Space Flight Center. A companion paper, "Mechanical Design and Fabrication of a SAFE-100 Heat Exchanger for use in NASA s Advanced Propulsion Thermal-hydraulic Simulator", presents the fabrication issues and prototyping studies that, together with these analyses, led to the development of this heat exchanger. An important consideration throughout the design development of the heat exchanger was its capability to be utilized for higher power and temperature applications. This paper also discusses this aspect of the design and presents designs for specific applications that are under consideration.

Definition of run-off-road crash clusters-For safety benefit estimation and driver assistance development.

PubMed

Nilsson, Daniel; Lindman, Magdalena; Victor, Trent; Dozza, Marco

2018-04-01

Single-vehicle run-off-road crashes are a major traffic safety concern, as they are associated with a high proportion of fatal outcomes. In addressing run-off-road crashes, the development and evaluation of advanced driver assistance systems requires test scenarios that are representative of the variability found in real-world crashes. We apply hierarchical agglomerative cluster analysis to define similarities in a set of crash data variables, these clusters can then be used as the basis in test scenario development. Out of 13 clusters, nine test scenarios are derived, corresponding to crashes characterised by: drivers drifting off the road in daytime and night-time, high speed departures, high-angle departures on narrow roads, highways, snowy roads, loss-of-control on wet roadways, sharp curves, and high speeds on roads with severe road surface conditions. In addition, each cluster was analysed with respect to crash variables related to the crash cause and reason for the unintended lane departure. The study shows that cluster analysis of representative data provides a statistically based method to identify relevant properties for run-off-road test scenarios. This was done to support development of vehicle-based run-off-road countermeasures and driver behaviour models used in virtual testing. Future studies should use driver behaviour from naturalistic driving data to further define how test-scenarios and behavioural causation mechanisms should be included. Copyright © 2018 Elsevier Ltd. All rights reserved.

Developing effective health and safety training materials for workers in beryllium-using industries.

PubMed

Mayer, A S; Brazile, W J; Erb, S A; Barker, E A; Miller, C M; Mroz, M M; Maier, L A; Van Dyke, M V

2013-07-01

Despite reduced workplace exposures, beryllium sensitization and chronic beryllium disease still occur. Effective health and safety training is needed. Through an Occupational Safety and Health Administration (OSHA) Targeted Topic Training grant and company partners, we developed a training program. Evaluation and validation included knowledge and training reaction assessments and training impact survey. We describe herein the iterative, five-pronged approach: (1) needs assessment; (2) materials development; (3) pilot-testing, evaluation, and material revisions; (4) worker training; and (5) evaluation and validation. Mean posttraining test score increased 14% (82% to 96%; P < 0.005) and were unchanged at 90-day follow-up (94%; P = 0.744). In addition, 49% reported making changes in work practices. The use of a five-pronged training program was effective and well received and resulted in improved work practices. These materials are available on the OSHA Web site.

Occupational safety and health in nanotechnology and Organisation for Economic Cooperation and Development

NASA Astrophysics Data System (ADS)

Murashov, Vladimir; Engel, Stefan; Savolainen, Kai; Fullam, Brian; Lee, Michelle; Kearns, Peter

2009-10-01

The Organization for Economic Cooperation and Development (OECD), an intergovernmental organization, is playing a critical global role in ensuring that emerging technologies, such as nanotechnology, are developed responsibly. This article describes OECD activities around occupational safety and health of nanotechnology and provides state-of-the-science overview resulting from an OECD workshop on exposure assessment and mitigation for nanotechnology workplace.

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

Development and Piloting of a Food Safety Audit Tool for the Domestic Environment.

PubMed

Borrusso, Patricia; Quinlan, Jennifer J

2013-12-04

Research suggests that consumers often mishandle food in the home based on survey and observation studies. There is a need for a standardized tool for researchers to objectively evaluate the prevalence and identify the nature of food safety risks in the domestic environment. An audit tool was developed to measure compliance with recommended sanitation, refrigeration and food storage conditions in the domestic kitchen. The tool was piloted by four researchers who independently completed the inspection in 22 homes. Audit tool questions were evaluated for reliability using the κ statistic. Questions that were not sufficiently reliable (κ < 0.5) or did not provide direct evidence of risk were revised or eliminated from the final tool. Piloting the audit tool found good reliability among 18 questions, 6 questions were revised and 28 eliminated, resulting in a final 24 question tool. The audit tool was able to identify potential food safety risks, including evidence of pest infestation (27%), incorrect refrigeration temperature (73%), and lack of hot water (>43 °C, 32%). The audit tool developed here provides an objective measure for researchers to observe and record the most prevalent food safety risks in consumer's kitchens and potentially compare risks among consumers of different demographics.

Development and Piloting of a Food Safety Audit Tool for the Domestic Environment

PubMed Central

Borrusso, Patricia; Quinlan, Jennifer J.

2013-01-01

Research suggests that consumers often mishandle food in the home based on survey and observation studies. There is a need for a standardized tool for researchers to objectively evaluate the prevalence and identify the nature of food safety risks in the domestic environment. An audit tool was developed to measure compliance with recommended sanitation, refrigeration and food storage conditions in the domestic kitchen. The tool was piloted by four researchers who independently completed the inspection in 22 homes. Audit tool questions were evaluated for reliability using the κ statistic. Questions that were not sufficiently reliable (κ < 0.5) or did not provide direct evidence of risk were revised or eliminated from the final tool. Piloting the audit tool found good reliability among 18 questions, 6 questions were revised and 28 eliminated, resulting in a final 24 question tool. The audit tool was able to identify potential food safety risks, including evidence of pest infestation (27%), incorrect refrigeration temperature (73%), and lack of hot water (>43 °C, 32%). The audit tool developed here provides an objective measure for researchers to observe and record the most prevalent food safety risks in consumer’s kitchens and potentially compare risks among consumers of different demographics. PMID:28239139

Track train dynamics analysis and test program: Methodology development for the derailment safety analysis of six-axle locomotives

NASA Technical Reports Server (NTRS)

Marcotte, P. P.; Mathewson, K. J. R.

1982-01-01

The operational safety of six axle locomotives is analyzed. A locomotive model with corresponding data on suspension characteristics, a method of track defect characterization, and a method of characterizing operational safety are used. A user oriented software package was developed as part of the methodology and was used to study the effect (on operational safety) of various locomotive parameters and operational conditions such as speed, tractive effort, and track curvature. The operational safety of three different locomotive designs was investigated.

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

Safety Belt Laws and Disparities in Safety Belt Use Among US High-School Drivers

PubMed Central

Winston, Flaura K.; Durbin, Dennis R.

2012-01-01

Objectives. We compared reported safety belt use, for both drivers and passengers, among teenagers with learner’s permits, provisional licenses, and unrestricted licenses in states with primary or secondary enforcement of safety belt laws. Methods. Our data source was the 2006 National Young Driver Survey, which included a national representative sample of 3126 high-school drivers. We used multivariate, log-linear regression analyses to assess associations between safety belt laws and belt use. Results. Teenaged drivers were 12% less likely to wear a safety belt as drivers and 15% less likely to wear one as passengers in states with a secondary safety belt law than in states with a primary law. The apparent reduction in belt use among teenagers as they progressed from learner to unrestricted license holder occurred in only secondary enforcement states. Groups reporting particularly low use included African American drivers, rural residents, academically challenged students, and those driving pickup trucks. Conclusions. The results provided further evidence for enactment of primary enforcement provisions in safety belt laws because primary laws are associated with higher safety belt use rates and lower crash-related injuries and mortality. PMID:22515851

[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.

Normal development of the tomato clownfish Amphiprion frenatus: live imaging and in situ hybridization analyses of mesodermal and neurectodermal development.

PubMed

Ghosh, J; Wilson, R W; Kudoh, T

2009-12-01

The normal embryonic development of the tomato clownfish Amphiprion frenatus was analysed using live imaging and by in situ hybridization for detection of mesodermal and neurectodermal development. Both morphology of live embryos and tissue-specific staining revealed significant differences in the gross developmental programme of A. frenatus compared with better-known teleost fish models, in particular, initiation of somitogenesis before complete epiboly, initiation of narrowing of the neurectoderm (neurulation) before somitogenesis, relatively early pigmentation of melanophores at the 10-15 somite stage and a distinctive pattern of melanophore distribution. These results suggest evolutionary adaptability of the teleost developmental programme. The ease of obtaining eggs, in vitro culture of the embryo, in situ staining analyses and these reported characteristics make A. frenatus a potentially important model marine fish species for studying embryonic development, physiology, ecology and evolution.

Safety leadership: application in construction site.

PubMed

Cooper, Dominic

2010-01-01

The extant safety literature suggests that managerial Safety Leadership is vital to the success and maintenance of a behavioral safety process. The current paper explores the role of Managerial Safety Leadership behaviors in the success of a behavioral safety intervention in the Middle-East with 47,000 workers from multiple nationalities employed by fourteen sub-contractors and one main contractor. A quasi-experimental repeating ABABAB, within groups design was used. Measurement focused on managerial Safety Leadership and employee safety behaviors as well as Corrective Actions. Data was collected over 104 weeks. During this time, results show safety behavior improved by 30 percentage points from an average of 65% during baseline to an average of 95%. The site achieved 121 million man-hours free of lost-time injuries on the longest run. Stepwise multiple regression analyses indicated 86% of the variation in employee safety behavior was associated with senior, middle and front-line manager's Safety Leadership behaviors and the Corrective Action Rate. Approximately 38% of the variation in the Total Recordable Incident Rate (TRIR) was associated with the Observation rate, Corrective Action Rate and Observers Records of managerial safety leaders (Visible Ongoing Support). The results strongly suggest manager's Safety Leadership influences the success of Behavioral Safety processes.

Development and applicability of Hospital Survey on Patient Safety Culture (HSOPS) in Japan.

PubMed

Ito, Shinya; Seto, Kanako; Kigawa, Mika; Fujita, Shigeru; Hasegawa, Toshihiko; Hasegawa, Tomonori

2011-02-07

Patient safety culture at healthcare organizations plays an important role in guaranteeing, improving and promoting overall patient safety. Although several conceptual frameworks have been proposed in the past, no standard measurement tool has yet been developed for Japan. In order to examine possibilities to introduce the Hospital Survey on Patient Safety Culture (HSOPS) in Japan, the authors of this study translated the HSOPS into Japanese, and evaluated its factor structure, internal consistency, and construct validity. Healthcare workers (n = 6,395) from 13 acute care general hospitals in Japan participated in this survey. Confirmatory factor analysis indicated that the Japanese HSOPS' 12-factor model was selected as the most pertinent, and showed a sufficiently high standard partial regression coefficient. The internal reliability of the subscale scores was 0.46-0.88. The construct validity of each safety culture sub-dimension was confirmed by polychoric correlation, and by an ordered probit analysis. The results of the present study indicate that the factor structures of the Japanese and the American HSOPS are almost identical, and that the Japanese HSOPS has acceptable levels of internal reliability and construct validity. This shows that the HSOPS can be introduced in Japan.

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.

Arizona Traffic Safety Education, K-3. Pedestrian Safety, Grade 3.

ERIC Educational Resources Information Center

Mesa Public Schools, AZ.

One in a series designed to assist Arizona elementary and junior high school teachers in developing children's traffic safety skills, this curriculum guide contains nine lessons on pedestrian safety for use in grade 3. Introductory information provided for the teacher includes basic highway safety concepts, stressing communication methods for…

Safety Teams: An Approach to Engage Students in Laboratory Safety

ERIC Educational Resources Information Center

Alaimo, Peter J.; Langenhan, Joseph M.; Tanner, Martha J.; Ferrenberg, Scott M.

2010-01-01

We developed and implemented a yearlong safety program into our organic chemistry lab courses that aims to enhance student attitudes toward safety and to ensure students learn to recognize, demonstrate, and assess safe laboratory practices. This active, collaborative program involves the use of student "safety teams" and includes…

Arizona Traffic Safety Education, K-8. Pedestrian Safety, Grade 2.

ERIC Educational Resources Information Center

Mesa Public Schools, AZ.

One in a series designed to assist Arizona elementary and junior high school teachers in developing children's traffic safety skills, this curriculum guide contains eight lessons on pedestrian safety for use in grade 2. Introductory information provided for the teacher includes basic highway safety concepts, stressing communication methods for…

Note on evaluating safety performance of road infrastructure to motivate safety competition.

PubMed

Han, Sangjin

2016-01-01

Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

PubMed

Groves, Patricia S; Bunch, Jacinda L

2018-05-18

The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

The mediating role of integration of safety by activity versus operator between organizational culture and safety climate.

PubMed

Auzoult, Laurent; Gangloff, Bernard

2018-04-20

In this study, we analyse the impact of the organizational culture and introduce a new variable, the integration of safety, which relates to the modalities for the implementation and adoption of safety in the work process, either through the activity or by the operator. One hundred and eighty employees replied to a questionnaire measuring the organizational climate, the safety climate and the integration of safety. We expected that implementation centred on the activity or on the operator would mediate the relationship between the organizational culture and the safety climate. The results support our assumptions. A regression analysis highlights the positive impact on the safety climate of organizational values of the 'rule' and 'support' type, as well as of integration by the operator and activity. Moreover, integration mediates the relation between these variables. The results suggest to take into account organizational culture and to introduce different implementation modalities to improve the safety climate.

Injury Prevention and Safety

MedlinePlus

... The percentage of states that provided funding for staff development or offered staff development on injury prevention and safety to those ... classes or courses with a teacher who received staff development on injury prevention and safety increased from ...

HSE's safety assessment principles for criticality safety.

PubMed

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

2008-06-01

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

The Feasibility of Establishing Highway Safety Manpower Development and Research Centers at University-Level Institutions. Final Report, Volume I: Study Report.

ERIC Educational Resources Information Center

Chorness, Maury H.; And Others

To examine the feasibility of establishing Highway Safety Manpower Development and Research (HSMDR) Centers at university-level institutions which would produce three types of manpower--safety specialists, safety professionals, and research manpower, previous National Highway Safety Bureau research studies and approximately 50 federally funded…

Development of a multilevel health and safety climate survey tool within a mining setting.

PubMed

Parker, Anthony W; Tones, Megan J; Ritchie, Gabrielle E

2017-09-01

This study aimed to design, implement and evaluate the reliability and validity of a multifactorial and multilevel health and safety climate survey (HSCS) tool with utility in the Australian mining setting. An 84-item questionnaire was developed and pilot tested on a sample of 302 Australian miners across two open cut sites. A 67-item, 10 factor solution was obtained via exploratory factor analysis (EFA) representing prioritization and attitudes to health and safety across multiple domains and organizational levels. Each factor demonstrated a high level of internal reliability, and a series of ANOVAs determined a high level of consistency in responses across the workforce, and generally irrespective of age, experience or job category. Participants tended to hold favorable views of occupational health and safety (OH&S) climate at the management, supervisor, workgroup and individual level. The survey tool demonstrated reliability and validity for use within an open cut Australian mining setting and supports a multilevel, industry specific approach to OH&S climate. Findings suggested a need for mining companies to maintain high OH&S standards to minimize risks to employee health and safety. Future research is required to determine the ability of this measure to predict OH&S outcomes and its utility within other mine settings. As this tool integrates health and safety, it may have benefits for assessment, monitoring and evaluation in the industry, and improving the understanding of how health and safety climate interact at multiple levels to influence OH&S outcomes. Copyright © 2017 National Safety Council and 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.

Arizona Traffic Safety Education, K-8. Passenger Safety, Grade 3.

ERIC Educational Resources Information Center

Mesa Public Schools, AZ.

One in a series designed to assist Arizona elementary and junior high school teachers in developing children's traffic safety skills, this curriculum guide contains four lessons and an appendix of school bus safety tips for use in grade 3. Introductory information provided for the teacher includes basic highway safety concepts, stressing…

National Institute of Occupational Safety and Health (NIOSH) Partnered Development of Cryogenic Life Support Technologies

NASA Technical Reports Server (NTRS)

Bush, David R.

2014-01-01

Partnering with National Institute of Occupational Safety and Health (NIOSH) to develop several cyrogenically based life support technologies to be used in mine escape and rescue scenarios. Technologies developed for mine rescue directly benefit future NASA rescue and ground operation missions.

Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.

PubMed

Nathan, Steven D; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; Glaspole, Ian; Glassberg, Marilyn K; Kardatzke, David R; Daigl, Monica; Kirchgaessler, Klaus-Uwe; Lancaster, Lisa H; Lederer, David J; Pereira, Carlos A; Swigris, Jeffrey J; Valeyre, Dominique; Noble, Paul W

2017-01-01

In clinical trials of idiopathic pulmonary fibrosis, rates of all-cause mortality are low. Thus prospective mortality trials are logistically very challenging, justifying the use of pooled analyses or meta-analyses. We did pooled analyses and meta-analyses of clinical trials of pirfenidone versus placebo to determine the effect of pirfenidone on mortality outcomes over 120 weeks. We did a pooled analysis of the combined patient populations of the three global randomised phase 3 trials of pirfenidone versus placebo-Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY 004 and 006; trial durations 72-120 weeks) and Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND 016; 52 weeks)-for all-cause mortality, treatment-emergent all-cause mortality, idiopathic-pulmonary-fibrosis-related mortality, and treatment-emergent idiopathic-pulmonary-fibrosis-related mortality at weeks 52, 72, and 120. We also did meta-analyses of these data and data from two Japanese trials of pirfenidone versus placebo-Shionogi Phase 2 (SP2) and Shionogi Phase 3 (SP3; trial durations 36-52 weeks). At week 52, the relative risk of death for all four mortality outcomes was significantly lower in the pirfenidone group than in the placebo group in the pooled population (all-cause mortality hazard ratio [HR] 0·52 [95% CI 0·31-0·87; p=0·0107]; treatment-emergent all-cause mortality 0·45 [0·24-0·83; 0·0094]; idiopathic-pulmonary-fibrosis-related mortality 0·35 [0·17-0·72; 0·0029]; treatment-emergent idiopathic-pulmonary-fibrosis-related mortality 0·32 [0·14-0·76; 0·0061]). Consistent with the pooled analysis, meta-analyses for all-cause mortality at week 52 also showed a clinically relevant and significant risk reduction in the pirfenidone group compared with the placebo group. Over 120 weeks, we noted significant differences in the pooled analysis favouring pirfenidone

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.

Genomic Analyses Reveal the Influence of Geographic Origin, Migration, and Hybridization on Modern Dog Breed Development.

PubMed

Parker, Heidi G; Dreger, Dayna L; Rimbault, Maud; Davis, Brian W; Mullen, Alexandra B; Carpintero-Ramirez, Gretchen; Ostrander, Elaine A

2017-04-25

There are nearly 400 modern domestic dog breeds with a unique histories and genetic profiles. To track the genetic signatures of breed development, we have assembled the most diverse dataset of dog breeds, reflecting their extensive phenotypic variation and heritage. Combining genetic distance, migration, and genome-wide haplotype sharing analyses, we uncover geographic patterns of development and independent origins of common traits. Our analyses reveal the hybrid history of breeds and elucidate the effects of immigration, revealing for the first time a suggestion of New World dog within some modern breeds. Finally, we used cladistics and haplotype sharing to show that some common traits have arisen more than once in the history of the dog. These analyses characterize the complexities of breed development, resolving longstanding questions regarding individual breed origination, the effect of migration on geographically distinct breeds, and, by inference, transfer of trait and disease alleles among dog breeds. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

ERIC Educational Resources Information Center

Bresler, B.; And Others

This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

Developing safety risk index for truck preferred arterial corridor.