Regulatory experience in applying a radiological environmental protection framework for existing and planned nuclear facilities.

PubMed

Mihok, S; Thompson, P

2012-01-01

Frameworks and methods for the radiological protection of non-human biota have been evolving rapidly at the International Commission on Radiological Protection and through various European initiatives. The International Atomic Energy Agency has incorporated a requirement for environmental protection in the latest revision of its Basic Safety Standards. In Canada, the Canadian Nuclear Safety Commission has been legally obligated to prevent unreasonable risk to the environment since 2000. Licensees have therefore been meeting generic legal requirements to demonstrate adequate control of releases of radioactive substances for the protection of both people and biota for many years. In the USA, in addition to the generic requirements of the Environmental Protection Agency and the Nuclear Regulatory Commission, Department of Energy facilities have also had to comply with specific dose limits after a standard assessment methodology was finalised in 2002. Canadian regulators developed a similar framework for biota dose assessment through a regulatory assessment under the Canadian Environmental Protection Act in the late 1990s. Since then, this framework has been applied extensively to satisfy legal requirements under the Canadian Environmental Assessment Act and the Nuclear Safety and Control Act. After approximately a decade of experience in applying these methods, it is clear that simple methods are fit for purpose, and can be used for making regulatory decisions for existing and planned nuclear facilities. Copyright © 2012. Published by Elsevier Ltd.

An Assessment of Levels of Safety in Psychiatric Units.

PubMed

Bayramzadeh, Sara

2017-01-01

This article aims to understand the incident patterns in relation to different types of spaces within a psychiatric unit, which are discussed using the five levels of safety framework. Implementing measures to improve patient safety is essential particularly in a psychiatric hospital, where limited research has been conducted on inpatient safety. Therefore, this article aims to understand the incident patterns from the lens of the five levels of safety framework, which categorizes spaces according to the level of patient supervision in psychiatric facilities, as follows: service areas, corridors, dayrooms, patient rooms and bathrooms, seclusions and admissions. In an 81-bed psychiatric hospital, this mixed-method study drew 7 years of incident reports and caregivers' perceptions gathered through focus groups. Incident reports on physical safety were analyzed based on the five levels of safety framework ( N = 1,316). Focus groups ( n = 9) explored the caregivers' viewpoints on patient safety and five categories of spaces. Overall findings support the five levels of safety pattern, confirming that most incidents occurred in patient rooms and bathrooms; moreover, relatively fewer incidents happened in dayrooms and corridors. Elopements are higher in hallways and dayrooms. Suicide is most common in patient rooms and bathrooms, and violence is more frequent in dayrooms. Focus groups results yielded insightful recommendations. Levels of safety framework can be adapted to seven categories where seclusion room and admission area would be two of the spaces with least incidents.

Financial Responsibility for Reentry Vehicle Operations

DOT National Transportation Integrated Search

1995-05-01

The Department of Transportation's Office of Commercial Space Transportation is : in the process of assessing the safety of a reentry vehicle and its operation : and is developing an associated regulatory framework for ensuring public safety : while ...

Advanced Small Modular Reactor (SMR) Probabilistic Risk Assessment (PRA) Technical Exchange Meeting

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

Smith, Curtis

2013-09-01

During FY13, the INL developed an advanced SMR PRA framework which has been described in the report Small Modular Reactor (SMR) Probabilistic Risk Assessment (PRA) Detailed Technical Framework Specification, INL/EXT-13-28974 (April 2013). In this framework, the various areas are considered: Probabilistic models to provide information specific to advanced SMRs Representation of specific SMR design issues such as having co-located modules and passive safety features Use of modern open-source and readily available analysis methods Internal and external events resulting in impacts to safety All-hazards considerations Methods to support the identification of design vulnerabilities Mechanistic and probabilistic data needs to support modelingmore » and tools In order to describe this framework more fully and obtain feedback on the proposed approaches, the INL hosted a technical exchange meeting during August 2013. This report describes the outcomes of that meeting.« less

Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

PubMed

Singh, Hardeep; Sittig, Dean F

2016-04-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Advancing the framework for considering the effects of climate change on worker safety and health.

PubMed

Schulte, P A; Bhattacharya, A; Butler, C R; Chun, H K; Jacklitsch, B; Jacobs, T; Kiefer, M; Lincoln, J; Pendergrass, S; Shire, J; Watson, J; Wagner, G R

2016-11-01

In 2009, a preliminary framework for how climate change could affect worker safety and health was described. That framework was based on a literature search from 1988-2008 that supported seven categories of climate-related occupational hazards: (1) increased ambient temperature; (2) air pollution; (3) ultraviolet radiation exposure; (4) extreme weather; (5) vector-borne diseases and expanded habitats; (6) industrial transitions and emerging industries; and (7) changes in the built environment. This article reviews the published literature from 2008-2014 in each of the seven categories. Additionally, three new topics related to occupational safety and health are considered: mental health effects, economic burden, and potential worker safety and health impacts associated with the nascent field of climate intervention (geoengineering). Beyond updating the literature, this article also identifies key priorities for action to better characterize and understand how occupational safety and health may be associated with climate change events and ensure that worker health and safety issues are anticipated, recognized, evaluated, and mitigated. These key priorities include research, surveillance, risk assessment, risk management, and policy development. Strong evidence indicates that climate change will continue to present occupational safety and health hazards, and this framework may be a useful tool for preventing adverse effects to workers.

Advancing the framework for considering the effects of climate change on worker safety and health

PubMed Central

Schulte, P.A.; Bhattacharya, A.; Butler, C.R.; Chun, H.K.; Jacklitsch, B.; Jacobs, T.; Kiefer, M.; Lincoln, J.; Pendergrass, S.; Shire, J.; Watson, J.; Wagner, G.R.

2016-01-01

ABSTRACT In 2009, a preliminary framework for how climate change could affect worker safety and health was described. That framework was based on a literature search from 1988–2008 that supported seven categories of climate-related occupational hazards: (1) increased ambient temperature; (2) air pollution; (3) ultraviolet radiation exposure; (4) extreme weather; (5) vector-borne diseases and expanded habitats; (6) industrial transitions and emerging industries; and (7) changes in the built environment. This article reviews the published literature from 2008–2014 in each of the seven categories. Additionally, three new topics related to occupational safety and health are considered: mental health effects, economic burden, and potential worker safety and health impacts associated with the nascent field of climate intervention (geoengineering). Beyond updating the literature, this article also identifies key priorities for action to better characterize and understand how occupational safety and health may be associated with climate change events and ensure that worker health and safety issues are anticipated, recognized, evaluated, and mitigated. These key priorities include research, surveillance, risk assessment, risk management, and policy development. Strong evidence indicates that climate change will continue to present occupational safety and health hazards, and this framework may be a useful tool for preventing adverse effects to workers. PMID:27115294

Adverse Outcome Pathways can drive non-animal approaches for safety assessment

PubMed Central

Burden, Natalie; Sewell, Fiona; Andersen, Melvin E; Boobis, Alan; Chipman, J Kevin; Cronin, Mark T D; Hutchinson, Thomas H; Kimber, Ian; Whelan, Maurice

2015-01-01

Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs and other chemicals, and may ultimately play an important role in regulatory decision making. Not only can the development and application of AOPs pave the way for the development of improved evidence-based approaches for hazard and risk assessment, there is also the promise of a significant impact on animal welfare, with a reduced reliance on animal-based methods. The establishment of a useable and coherent knowledge framework under which AOPs will be developed and applied has been a first critical step towards realizing this opportunity. This article explores how the development of AOPs under this framework, and their application in practice, could benefit the science and practice of safety assessment, while in parallel stimulating a move away from traditional methods towards an increased acceptance of non-animal approaches. We discuss here the key areas where current, and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. This article explores how the development and application of Adverse Outcome Pathways (AOPs) could benefit the science and practice of chemical safety assessment, with a particular focus on how their use in practice could reduce reliance on traditional animal toxicity tests. This includes discussion of the key areas where current and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. PMID:25943792

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

PubMed

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

2017-08-01

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

Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

PubMed

Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

2008-11-01

Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. 2008 FRAME.

INTEGRATED RISK ASSESSMENT - RESULTS FROM AN INTERNATIONAL WORKSHOP

EPA Science Inventory

The WHO International Programme on Chemical Safety and international partners have developed a framework for integrated assessment of human health and ecological risks and four case studies. An international workshop was convened to consider how ecological and health risk assess...

FRAMEWORK FOR EVALUATION OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR USE IN SAFETY OR RISK ASSESSMENT

EPA Science Inventory

ABSTRACT

Proposed applications of increasingly sophisticated biologically-based computational models, such as physiologically-based pharmacokinetic (PBPK) models, raise the issue of how to evaluate whether the models are adequate for proposed uses including safety or risk ...

CONTEXTUALIZED ASSESSMENT WITH BATTERED WOMEN: STRATEGIC SAFETY PLANNING TO COPE WITH MULTIPLE HARMS

PubMed Central

Lindhorst, Taryn; Nurius, Paula; Macy, Rebecca J.

2007-01-01

Given the prevalence of domestic violence and the likelihood that many victims will not receive services from specialized domestic violence providers, this article provides a framework for contextualized assessment that can be used by generalist practitioners. Drawing from stress and coping theory, the authors discuss the relevance of assessing appraisals and emotional responses within the context of environmental and individual risk and protective factors. Through an illustrative case assessment, the authors describe the contextualized assessment process and its ramifications for strategic safety planning. PMID:18167523

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

NASA Technical Reports Server (NTRS)

Guarro, Sergio B.

2010-01-01

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

Research product transfer for local calibration factors of the Highway Safety Manual (HSM) and integrated surrogate safety assessment framework : final report.

DOT National Transportation Integrated Search

2015-12-01

This technology transfer workshop presented transportation planners in the public and private sectors with two successful and closely related studies, conducted respectively by Morgan State University and the University of Virginia. The first module ...

Video Gambling in Foreign Air Transportation: Safety Effects, Competitive Consequences, Bilateral Issues & Legal Framework

DOT National Transportation Integrated Search

1996-03-01

In accordance with the Congress' directive, this study assesses: : 1)The effects of electronic entertainment systems and video gambling on air travel safety from both a technical standpoint and a behavioral standpoint, 2)the impact of the current U.S...

Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

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

Astuto-Gribble, Lisa M; Caskey, Susan Adele

2014-07-01

The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

Engaging policy makers in road safety research in Malaysia: a theoretical and contextual analysis.

PubMed

Tran, Nhan T; Hyder, Adnan A; Kulanthayan, Subramaniam; Singh, Suret; Umar, R S Radin

2009-04-01

Road traffic injuries (RTIs) are a growing public health problem that must be addressed through evidence-based interventions including policy-level changes such as the enactment of legislation to mandate specific behaviors and practices. Policy makers need to be engaged in road safety research to ensure that road safety policies are grounded in scientific evidence. This paper examines the strategies used to engage policy makers and other stakeholder groups and discusses the challenges that result from a multi-disciplinary, inter-sectoral collaboration. A framework for engaging policy makers in research was developed and applied to describe an example of collective road safety research in Malaysia. Key components of this framework include readiness, assessment, planning, implementation/evaluation, and policy development/sustainability. The case study of a collaborative intervention trial for the prevention of motorcycle crashes and deaths in Malaysia serves as a model for policy engagement by road safety and injury researchers. The analytic description of this research process in Malaysia demonstrates that the framework, through its five stages, can be used as a tool to guide the integration of needed research evidence into policy for road safety and injury prevention.

FRAMEWORK FOR THE INTEGRATION OF HEALTH AND ECOLOIGCAL RISK ASSESSMENT

EPA Science Inventory

The World Health Organization's International Programme on Chemical Safety (IPCS), the Organization for Economic Cooperation and Development (OECD), and the U.S. Environmental Protection Agency have developed a collaborative partnership to foster integration; of assessment approa...

CSHM: Web-based safety and health monitoring system for construction management.

PubMed

Cheung, Sai On; Cheung, Kevin K W; Suen, Henry C H

2004-01-01

This paper describes a web-based system for monitoring and assessing construction safety and health performance, entitled the Construction Safety and Health Monitoring (CSHM) system. The design and development of CSHM is an integration of internet and database systems, with the intent to create a total automated safety and health management tool. A list of safety and health performance parameters was devised for the management of safety and health in construction. A conceptual framework of the four key components of CSHM is presented: (a) Web-based Interface (templates); (b) Knowledge Base; (c) Output Data; and (d) Benchmark Group. The combined effect of these components results in a system that enables speedy performance assessment of safety and health activities on construction sites. With the CSHM's built-in functions, important management decisions can theoretically be made and corrective actions can be taken before potential hazards turn into fatal or injurious occupational accidents. As such, the CSHM system will accelerate the monitoring and assessing of performance safety and health management tasks.

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

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

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safetymore » assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.« less

Constantly evolving safety assessment protocols for GM foods.

PubMed

Sesikeran, B; Vasanthi, Siruguri

2008-01-01

he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.

Striving for safety: communicating and deciding in sociotechnical systems

PubMed Central

Flach, John M.; Carroll, John S.; Dainoff, Marvin J.; Hamilton, W. Ian

2015-01-01

How do communications and decisions impact the safety of sociotechnical systems? This paper frames this question in the context of a dynamic system of nested sub-systems. Communications are related to the construct of observability (i.e. how components integrate information to assess the state with respect to local and global constraints). Decisions are related to the construct of controllability (i.e. how component sub-systems act to meet local and global safety goals). The safety dynamics of sociotechnical systems are evaluated as a function of the coupling between observability and controllability across multiple closed-loop components. Two very different domains (nuclear power and the limited service food industry) provide examples to illustrate how this framework might be applied. While the dynamical systems framework does not offer simple prescriptions for achieving safety, it does provide guides for exploring specific systems to consider the potential fit between organisational structures and work demands, and for generalising across different systems regarding how safety can be managed. Practitioner Summary: While offering no simple prescriptions about how to achieve safety in sociotechnical systems, this paper develops a theoretical framework based on dynamical systems theory as a practical guide for generalising from basic research to work domains and for generalising across alternative work domains to better understand how patterns of communication and decision-making impact system safety. PMID:25761155

A Model-based Framework for Risk Assessment in Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems. This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions. Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

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

PubMed

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

2013-01-01

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

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

mHealth and Mobile Medical Apps: A Framework to Assess Risk and Promote Safer Use

PubMed Central

2014-01-01

The use of mobile medical apps by clinicians and others has grown considerably since the introduction of mobile phones. Medical apps offer clinicians the ability to access medical knowledge and patient data at the point of care, but several studies have highlighted apps that could compromise patient safety and are potentially dangerous. This article identifies a range of different kinds of risks that medical apps can contribute to and important contextual variables that can modify these risks. We have also developed a simple generic risk framework that app users, developers, and other stakeholders can use to assess the likely risks posed by a specific app in a specific context. This should help app commissioners, developers, and users to manage risks and improve patient safety. PMID:25223398

mHealth and mobile medical Apps: a framework to assess risk and promote safer use.

PubMed

Lewis, Thomas Lorchan; Wyatt, Jeremy C

2014-09-15

The use of mobile medical apps by clinicians and others has grown considerably since the introduction of mobile phones. Medical apps offer clinicians the ability to access medical knowledge and patient data at the point of care, but several studies have highlighted apps that could compromise patient safety and are potentially dangerous. This article identifies a range of different kinds of risks that medical apps can contribute to and important contextual variables that can modify these risks. We have also developed a simple generic risk framework that app users, developers, and other stakeholders can use to assess the likely risks posed by a specific app in a specific context. This should help app commissioners, developers, and users to manage risks and improve patient safety.

Propensity scores-potential outcomes framework to incorporate severity probabilities in the highway safety manual crash prediction algorithm.

PubMed

Sasidharan, Lekshmi; Donnell, Eric T

2014-10-01

Accurate estimation of the expected number of crashes at different severity levels for entities with and without countermeasures plays a vital role in selecting countermeasures in the framework of the safety management process. The current practice is to use the American Association of State Highway and Transportation Officials' Highway Safety Manual crash prediction algorithms, which combine safety performance functions and crash modification factors, to estimate the effects of safety countermeasures on different highway and street facility types. Many of these crash prediction algorithms are based solely on crash frequency, or assume that severity outcomes are unchanged when planning for, or implementing, safety countermeasures. Failing to account for the uncertainty associated with crash severity outcomes, and assuming crash severity distributions remain unchanged in safety performance evaluations, limits the utility of the Highway Safety Manual crash prediction algorithms in assessing the effect of safety countermeasures on crash severity. This study demonstrates the application of a propensity scores-potential outcomes framework to estimate the probability distribution for the occurrence of different crash severity levels by accounting for the uncertainties associated with them. The probability of fatal and severe injury crash occurrence at lighted and unlighted intersections is estimated in this paper using data from Minnesota. The results show that the expected probability of occurrence of fatal and severe injury crashes at a lighted intersection was 1 in 35 crashes and the estimated risk ratio indicates that the respective probabilities at an unlighted intersection was 1.14 times higher compared to lighted intersections. The results from the potential outcomes-propensity scores framework are compared to results obtained from traditional binary logit models, without application of propensity scores matching. Traditional binary logit analysis suggests that the probability of occurrence of severe injury crashes is higher at lighted intersections compared to unlighted intersections, which contradicts the findings obtained from the propensity scores-potential outcomes framework. This finding underscores the importance of having comparable treated and untreated entities in traffic safety countermeasure evaluations. Copyright © 2014 Elsevier Ltd. All rights reserved.

Getting the foundations right for the measurement of medication safety: the need for a meaningful conceptual frame.

PubMed

Ng, Jerome; Scahill, Shane; Harrison, Jeff

2017-03-24

A number of initiatives aimed at improving medication safety in and across New Zealand public hospitals have been introduced over recent years. Clinicians, policymakers and patients now want to know whether patients are safer today from medicine use than they have been in the past. The challenge has been determining exactly what should be measured. In this viewpoint, we critically examine the suitability of adverse drug events (ADE) as a primary metric for assessing the progress of medication safety improvement. We provide an overview of contemporary dialogue on medication safety measurement and highlight the emergent challenges. Finally, we reflect on how New Zealand has approached medication safety measurement so far and argue the need for a multi-stakeholder informed conceptual framework with a view to further enhancing meaningful assessment of medication safety.

Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis. Volume 1

NASA Technical Reports Server (NTRS)

Murri, Daniel G.

2010-01-01

The NASA Engineering and Safety Center (NESC) was requested to establish the Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis assessment, which involved development of an enhanced simulation architecture using the Program to Optimize Simulated Trajectories II (POST2) simulation tool. The assessment was requested to enhance the capability of the Agency to provide rapid evaluation of EDL characteristics in systems analysis studies, preliminary design, mission development and execution, and time-critical assessments. Many of the new simulation framework capabilities were developed to support the Agency EDL Systems Analysis (EDL-SA) team, that is conducting studies of the technologies and architectures that are required to enable higher mass robotic and human mission to Mars. The findings of the assessment are contained in this report.

Opportunities to Apply the 3Rs in Safety Assessment Programs

PubMed Central

Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

2016-01-01

Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

PubMed

Goh, Yang Miang; Askar Ali, Mohamed Jawad

2016-08-01

One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Public Health Framework of Legalized Marijuana in Colorado.

PubMed

Ghosh, Tista; Van Dyke, Mike; Maffey, Ali; Whitley, Elizabeth; Gillim-Ross, Laura; Wolk, Larry

2016-01-01

On January 1, 2014, Colorado became the first state in the nation to sell legal recreational marijuana for adult use. As a result, Colorado has had to carefully examine potential population health and safety impacts as well as the role of public health in response to legalization. We have discussed an emerging public health framework for legalized recreational marijuana. We have outlined this framework according to the core public health functions of assessment, policy development, and assurance. In addition, we have discussed challenges to implementing this framework that other states considering legalization may face.

An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

PubMed

Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

2016-01-01

As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

Environment, Safety and Health Self-Assessment Report Fiscal Year 2010

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

Robinson, Scott

2011-03-23

The Lawrence Berkeley National Laboratory (LBNL) Environment, Safety, and Health (ES&H) Self-Assessment Program was established to ensure that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The ES&H Self-Assessment Program, managed by the Office of Contractor Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The primary objective of the program is to ensure that work is conducted safely and with minimal negative impact to workers, the public, and the environment. Self-assessment follows the five core functions and guiding principles of ISM. Self-assessment is the mechanism used to promote the continuousmore » improvement of the Laboratory's ES&H programs. The process is described in the Environment, Safety, and Health Assurance Plan (PUB-5344) and is composed of three types of self-assessments: Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review. The Division ES&H Self-Assessment Manual (PUB-3105) provides the framework by which divisions conduct formal ES&H self-assessments to systematically identify program deficiencies. Issue-specific assessments are designed and implemented by the divisions and focus on areas of interest to division management. They may be conducted by teams and involve advance planning to ensure that appropriate resources are available. The ES&H Technical Assurance Program Manual (PUB-913E) provides the framework for systematic reviews of ES&H programs and processes. The ES&H Technical Assurance Program Assessment is designed to evaluate whether ES&H programs and processes are compliant with guiding regulations, are effective, and are properly implemented by LBNL divisions. The Division ES&H Peer Review Manual provides the framework by which division ISM systems are evaluated and improved. Peer Reviews are conducted by teams under the direction of senior division management and focus on higher-level management issues. Peer Review teams are selected on the basis of members knowledge and experience in the issues of interest to the division director. LBNL periodically requests in-depth independent assessments of selected ES&H programs. Such assessments augment LBNL's established assessment processes and provide an objective view of ES&H program effectiveness. Institutional Findings, Observations, and Noteworthy Practices identified during independent assessments are specifically intended to help LBNL identify opportunities for program improvement. This report includes the results of the Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review, respectively.« less

A Framework for School Safety and Risk Management: Results from a Study of 18 Targeted School Shooters

ERIC Educational Resources Information Center

Lenhardt, Ann Marie C.; Graham, Lemuel W.; Farrell, Melissa L.

2018-01-01

Targeted violence continues to pose a threat to school safety. Reported here are the results of a study of 18 cases of school shooters from 1996 to 2012. Variables examined are individual factors and behaviors, family dynamics, and triggering events. Results indicate the need for expanded school-based mental health services, threat assessment, and…

Use of botanicals in food supplements. Regulatory scope, scientific risk assessment and claim substantiation. 2005.

PubMed

Coppens, P; Delmulle, L; Gulati, O; Richardson, D; Ruthsatz, M; Sievers, H; Sidani, S

2006-01-01

In the European Union, an elaborate legal framework regulates botanical products both under food and medicinal law. The decision as to which legal framework applies to an individual product may differ between the Member States. In the case of botanical food supplements, all food law provisions apply to their manufacturing, composition and marketing, including the new claims legislation. Elements from EU and national law, scientific and other publications are brought together to investigate how to clarify the differentiation between the use of botanicals for medicinal and health-promoting purposes on a scientific basis. Guidance on the safety assessment and quality evaluation of botanicals is proposed in light of the different approaches described in the scientific literature with particular attention to the concept of long-term use as an integral part of safety evaluation. Guidance on claims substantiation is also included, taking into consideration the proposed legislation, the concept of long-term experience and grading of evidence. A model for safety and efficacy assessment of botanical food supplements in the EU is proposed, and should be taken into consideration in the development of legislation and scientific research on botanicals. Copyright 2006 S. Karger AG, Basel.

The AOP framework and causality: Meeting chemical risk assessment challenges in the 21st century

EPA Science Inventory

Chemical safety assessments are expanding from a focus on a few chemicals (or chemical mixtures) to the broader “universe” of thousands, if not hundreds of thousands of substances that potentially could impact humans or the environment. This is exemplified in ...

A Risk Assessment Model for Reduced Aircraft Separation: A Quantitative Method to Evaluate the Safety of Free Flight

NASA Technical Reports Server (NTRS)

Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)

1996-01-01

As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in-trail approaches. This research was performed under contract to NASA and in cooperation with the FAA's Safety Division (ASY).

Cleaning and asthma: A systematic review and approach for effective safety assessment.

PubMed

Vincent, Melissa J; Parker, Ann; Maier, Andrew

2017-11-01

Research indicates a correlative relationship between asthma and use of consumer cleaning products. We conduct a systematic review of epidemiological literature on persons who use or are exposed to cleaning products, both in occupational and domestic settings, and risk of asthma or asthma-like symptoms to improve understanding of the causal relationship between exposure and asthma. A scoring method for assessing study reliability is presented. Although research indicates an association between asthma and the use of cleaning products, no study robustly investigates exposure to cleaning products or ingredients along with asthma risk. This limits determination of causal relationships between asthma and specific products or ingredients in chemical safety assessment. These limitations, and a lack of robust animal models for toxicological assessment of asthma, create the need for a weight-of-evidence (WoE) approach to examine an ingredient or product's asthmatic potential. This proposed WoE method organizes diverse lines of data (i.e., asthma, sensitization, and irritation information) through a systematic, hierarchical framework that provides qualitatively categorized conclusions using hazard bands to predict a specific product or ingredient's potential for asthma induction. This work provides a method for prioritizing chemicals as a first step for quantitative and scenario-specific safety assessments based on their potential for inducing asthmatic effects. Acetic acid is used as a case study to test this framework. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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.

Safety of Pseudomonas chlororaphis as a gene source for genetically modified crops.

PubMed

Anderson, Jennifer A; Staley, Jamie; Challender, Mary; Heuton, Jamie

2018-02-01

Genetically modified crops undergo extensive evaluation to characterize their food, feed and environmental safety prior to commercial introduction, using a well-established, science-based assessment framework. One component of the safety assessment includes an evaluation of each introduced trait, including its source organism, for potential adverse pathogenic, toxic and allergenic effects. Several Pseudomonas species have a history of safe use in agriculture and certain species represent a source of genes with insecticidal properties. The ipd072Aa gene from P. chlororaphis encodes the IPD072Aa protein, which confers protection against certain coleopteran pests when expressed in maize plants. P. chlororaphis is ubiquitous in the environment, lacks known toxic or allergenic properties, and has a history of safe use in agriculture and in food and feed crops. This information supports, in part, the safety assessment of potential traits, such as IPD072Aa, that are derived from this source organism.

Application of an Informatics-Based Decision-Making Framework and Process to the Assessment of Radiation Safety in Nanotechnology

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

Hoover, Mark D.; Myers, David S.; Cash, Leigh J.

The National Council on Radiation Protection and Measurements (NCRP) has established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. While the full report is in preparation, this article presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are alreadymore » present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.« less

Application of an informatics-based decision-making framework and process to the assessment of radiation safety in nanotechnology.

PubMed

Hoover, Mark D; Myers, David S; Cash, Leigh J; Guilmette, Raymond A; Kreyling, Wolfgang G; Oberdörster, Günter; Smith, Rachel; Cassata, James R; Boecker, Bruce B; Grissom, Michael P

2015-02-01

The National Council on Radiation Protection and Measurements (NCRP) established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between ∼1 and 100 nm, where unique phenomena enable novel applications. While the full report is in preparation, this paper presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are already present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.

Application of an Informatics-Based Decision-Making Framework and Process to the Assessment of Radiation Safety in Nanotechnology

DOE PAGES

Hoover, Mark D.; Myers, David S.; Cash, Leigh J.; ...

2015-01-01

The National Council on Radiation Protection and Measurements (NCRP) has established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. While the full report is in preparation, this article presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are alreadymore » present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.« less

Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis. Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Murri, Daniel G.

2010-01-01

The NASA Engineering and Safety Center (NESC) was requested to establish the Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis assessment, which involved development of an enhanced simulation architecture using the Program to Optimize Simulated Trajectories II (POST2) simulation tool. The assessment was requested to enhance the capability of the Agency to provide rapid evaluation of EDL characteristics in systems analysis studies, preliminary design, mission development and execution, and time-critical assessments. Many of the new simulation framework capabilities were developed to support the Agency EDL Systems Analysis (EDL-SA) team, that is conducting studies of the technologies and architectures that are required to enable higher mass robotic and human mission to Mars. The appendices to the original report are contained in this document.

Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis, Phase 2 Results

NASA Technical Reports Server (NTRS)

Murri, Daniel G.

2011-01-01

The NASA Engineering and Safety Center (NESC) was requested to establish the Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis assessment, which involved development of an enhanced simulation architecture using the Program to Optimize Simulated Trajectories II simulation tool. The assessment was requested to enhance the capability of the Agency to provide rapid evaluation of EDL characteristics in systems analysis studies, preliminary design, mission development and execution, and time-critical assessments. Many of the new simulation framework capabilities were developed to support the Agency EDL-Systems Analysis (SA) team that is conducting studies of the technologies and architectures that are required to enable human and higher mass robotic missions to Mars. The findings, observations, and recommendations from the NESC are provided in this report.

How to systematically assess serious games applied to health care.

PubMed

Graafland, Maurits; Dankbaar, Mary; Mert, Agali; Lagro, Joep; De Wit-Zuurendonk, Laura; Schuit, Stephanie; Schaafstal, Alma; Schijven, Marlies

2014-11-11

The usefulness and effectiveness of specific serious games in the medical domain is often unclear. This is caused by a lack of supporting evidence on validity of individual games, as well as a lack of publicly available information. Moreover, insufficient understanding of design principles among the individuals and institutions that develop or apply a medical serious game compromises their use. This article provides the first consensus-based framework for the assessment of specific medical serious games. The framework provides 62 items in 5 main themes, aimed at assessing a serious game's rationale, functionality, validity, and data safety. This will allow caregivers and educators to make balanced choices when applying a serious game for healthcare purposes. Furthermore, the framework provides game manufacturers with standards for the development of new, valid serious games.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-09-01

There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-01-01

ABSTRACT Background: There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. Objective: To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Methods: Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. Results: The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Conclusion: Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care. PMID:26339832

The Public Health Framework of Legalized Marijuana in Colorado

PubMed Central

Van Dyke, Mike; Maffey, Ali; Whitley, Elizabeth; Gillim-Ross, Laura; Wolk, Larry

2016-01-01

On January 1, 2014, Colorado became the first state in the nation to sell legal recreational marijuana for adult use. As a result, Colorado has had to carefully examine potential population health and safety impacts as well as the role of public health in response to legalization. We have discussed an emerging public health framework for legalized recreational marijuana. We have outlined this framework according to the core public health functions of assessment, policy development, and assurance. In addition, we have discussed challenges to implementing this framework that other states considering legalization may face. PMID:26562117

Promoting the 3Rs to enhance the OECD fish toxicity testing framework.

PubMed

Hutchinson, Thomas H; Wheeler, James R; Gourmelon, Anne; Burden, Natalie

2016-04-01

Fish toxicity testing has been conducted since the 1860's in order to help define safe levels of chemical contaminants in lakes, rivers and coastal waters. The historical emphasis on acute lethality testing of chemicals has more recently focussed on long term sublethal effects of chemicals on fish and their prey species. Fish toxicity testing is now embedded in much environment legislation on chemical safety while it is recognized that animal use should be Replaced, Reduced and Refined (the 3Rs) where possible. The OECD Fish Toxicity Testing Framework provides a useful structure with which to address the needs of environmental safety assessment whilst implementing the 3Rs. This commentary aims to promote the implementation of the recommendations of the OECD Fish Toxicity Testing Framework. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety Metrics for Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Leveson, Nancy G; Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems.This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

Highly stable aluminum-based metal-organic frameworks as biosensing platforms for assessment of food safety.

PubMed

Liu, Chun-Sen; Sun, Chun-Xiao; Tian, Jia-Yue; Wang, Zhuo-Wei; Ji, Hong-Fei; Song, Ying-Pan; Zhang, Shuai; Zhang, Zhi-Hong; He, Ling-Hao; Du, Miao

2017-05-15

Two unique immunosensors made of aluminum-based metal-organic frameworks (MOFs), namely, 515- and 516-MOFs, with 4,4',4''-nitrilotribenzoic acid (H 3 NTB) were successfully obtained to efficiently assess food safety. The as-prepared 515- and 516-MOFs exhibited superior thermal and physicochemical stability, high electrochemical activity, and good biocompatibility. Among these immunosensors, 516-MOF showed a preferable biosensing ability toward analytes determined by electrochemical techniques. The developed 516-MOF-based electrochemical biosensor not only demonstrated high sensitivity with low detection limits of 0.70 and 0.40pgmL -1 toward vomitoxin and salbutamol, respectively, but also showed good selectivity in the presence of other interferences. Therefore, with the advantages of high sensitivity, good selectivity, and simple operation, this new strategy is believed to exhibit great potential for simple and convenient detection of poisonous and harmful residues in food. Copyright © 2017 Elsevier B.V. All rights reserved.

Incorporating organisational safety culture within ergonomics practice.

PubMed

Bentley, Tim; Tappin, David

2010-10-01

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

Work-related stress risk assessment in Italy: a methodological proposal adapted to regulatory guidelines.

PubMed

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-06-01

Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

PubMed Central

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-01-01

Background Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons. PMID:23961332

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

Development of indicators for measuring outcomes of water safety plans

PubMed Central

Lockhart, Gabriella; Oswald, William E.; Hubbard, Brian; Medlin, Elizabeth; Gelting, Richard J.

2015-01-01

Water safety plans (WSPs) are endorsed by the World Health Organization as the most effective method of protecting a water supply. With the increase in WSPs worldwide, several valuable resources have been developed to assist practitioners in the implementation of WSPs, yet there is still a need for a practical and standardized method of evaluating WSP effectiveness. In 2012, the Centers for Disease Control and Prevention (CDC) published a conceptual framework for the evaluation of WSPs, presenting four key outcomes of the WSP process: institutional, operational, financial and policy change. In this paper, we seek to operationalize this conceptual framework by providing a set of simple and practical indicators for assessing WSP outcomes. Using CDC’s WSP framework as a foundation and incorporating various existing performance monitoring indicators for water utilities, we developed a set of approximately 25 indicators of institutional, operational, financial and policy change within the WSP context. These outcome indicators hold great potential for the continued implementation and expansion of WSPs worldwide. Having a defined framework for evaluating a WSP’s effectiveness, along with a set of measurable indicators by which to carry out that evaluation, will help implementers assess key WSP outcomes internally, as well as benchmark their progress against other WSPs in their region and globally. PMID:26361540

How to Systematically Assess Serious Games Applied to Health Care

PubMed Central

Graafland, Maurits; Dankbaar, Mary; Mert, Agali; Lagro, Joep; De Wit-Zuurendonk, Laura; Schuit, Stephanie; Schaafstal, Alma

2014-01-01

The usefulness and effectiveness of specific serious games in the medical domain is often unclear. This is caused by a lack of supporting evidence on validity of individual games, as well as a lack of publicly available information. Moreover, insufficient understanding of design principles among the individuals and institutions that develop or apply a medical serious game compromises their use. This article provides the first consensus-based framework for the assessment of specific medical serious games. The framework provides 62 items in 5 main themes, aimed at assessing a serious game’s rationale, functionality, validity, and data safety. This will allow caregivers and educators to make balanced choices when applying a serious game for healthcare purposes. Furthermore, the framework provides game manufacturers with standards for the development of new, valid serious games. PMID:25654163

Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

PubMed

Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

2017-10-05

As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu

2017-04-01

To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.

Tracing the foundations of a conceptual framework for a patient safety ontology.

PubMed

Runciman, William B; Baker, G Ross; Michel, Philippe; Dovey, Susan; Lilford, Richard J; Jensen, Natasja; Flin, Rhona; Weeks, William B; Lewalle, Pierre; Larizgoitia, Itziar; Bates, David

2010-12-01

In work for the World Alliance for Patient Safety on research methods and measures and on defining key concepts for an International Patient Safety Classification (ICPS), it became apparent that there was a need to try to understand how the meaning of patient safety and underlying concepts relate to the existing safety and quality frameworks commonly used in healthcare. To unfold the concept of patient safety and how it relates to safety and quality frameworks commonly used in healthcare and to trace the evolution of the ICPS framework as a basis of the electronic capture of the component elements of patient safety. The ICPS conceptual framework for patient safety has its origins in existing frameworks and an international consultation process. Although its 10 classes and their semantic relationships may be used as a reference model for different disciplines, it must remain dynamic in the ever-changing world of healthcare. By expanding the ICPS by examining data from all available sources, and ensuring rigorous compliance with the latest principles of informatics, a deeper interdisciplinary approach will progressively be developed to address the complex, refractory problem of reducing healthcare-associated harm.

Measuring hospital-wide activity volume for patient safety and infection control: a multi-centre study in Japan.

PubMed

Hayashida, Kenshi; Imanaka, Yuichi; Fukuda, Haruhisa

2007-09-03

In Japan, as in many other countries, several quality and safety assurance measures have been implemented since the 1990's. This has occurred in spite of cost containment efforts. Although government and hospital decision-makers demand comprehensive analysis of these activities at the hospital-wide level, there have been few studies that actually quantify them. Therefore, the aims of this study were to measure hospital-wide activities for patient safety and infection control through a systematic framework, and to identify the incremental volume of these activities implemented over the last five years. Using the conceptual framework of incremental activity corresponding to incremental cost, we defined the scope of patient safety and infection control activities. We then drafted a questionnaire to analyze these realms. After implementing the questionnaire, we conducted several in-person interviews with managers and other staff in charge of patient safety and infection control in seven acute care teaching hospitals in Japan. At most hospitals, nurses and clerical employees acted as the main figures in patient safety practices. The annual amount of activity ranged from 14,557 to 72,996 person-hours (per 100 beds: 6,240; per 100 staff: 3,323) across participant hospitals. Pharmacists performed more incremental activities than their proportional share. With respect to infection control activities, the annual volume ranged from 3,015 to 12,196 person-hours (per 100 beds: 1,141; per 100 staff: 613). For infection control, medical doctors and nurses tended to perform somewhat more of the duties relative to their share. We developed a systematic framework to quantify hospital-wide activities for patient safety and infection control. We also assessed the incremental volume of these activities in Japanese hospitals under the reimbursement containment policy. Government and hospital decision makers can benefit from this type of analytic framework and its empirical findings.

Collaboratively planning for medicines administration competency: a survey evaluation.

PubMed

Hemingway, Steve; Baxter, Hazel; Smith, George; Burgess-Dawson, Rebecca; Dewhirst, Kate

2011-04-01

This survey evaluated the experiences of mental health nurses who had undergone assessment of their competence in the administration of medicines using established assessment frameworks. Medicines management activities have at times been widely criticized. Joint collaborations between Higher Education Authorities and the National Health Service in education and training can start to address some of these criticisms. A questionnaire using 22 closed and open response questions was distributed to 827 practising mental health nurses and 44 graduate mental health nurses. A total of 70 registered and 41 graduate mental health nurses who had completed the assessment of administration competency frameworks responded to the survey. Response rates were 24 and 96%, respectively. The assessment frameworks were received positively. Environmental factors were perceived as the main barrier to medicines safety; however, this was not reflected in how this aspect of the competency framework was perceived. The administration of medicines is an area of mental health and all fields of nursing practice that needs attention. The use of competency frameworks as outlined in the 'Medicine with Respect Project' is one strategy to achieve the improvement in this essential clinical skill. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

Occupational safety and health in Europe: lessons from the past, challenges and opportunities for the future.

PubMed

Gagliardi, Diana; Marinaccio, Alessandro; Valenti, Antonio; Iavicoli, Sergio

2012-01-01

Europe has always played a key role in the field of Occupational Health and Safety (OHS) and can be considered the cradle of Occupational Health. The European policy framework has been set since the establishment of the European Union, but its strength lies in the enactment of the Framework Directive on Occupational Health and Safety (89/391/EC), which has had a strong positive impact on the assessment and management of occupational risk factors and has promoted the quick diffusion of common standards across Europe. Yet, some implementation issues still remain to be addressed, due to changes in the world of work, fragmentation, economic crisis and, more generally, to the impact of globalization. Therefore, actions need to be reviewed with respect to research plans and policy implementation so as to support the OHS social dimension fostering a broader concept of wellbeing at work.

[Expert investigation on food safety standard system framework construction in China].

PubMed

He, Xiang; Yan, Weixing; Fan, Yongxiang; Zeng, Biao; Peng, Zhen; Sun, Zhenqiu

2013-09-01

Through investigating food safety standard framework among food safety experts, to summarize the basic elements and principles of food safety standard system, and provide policy advices for food safety standards framework. A survey was carried out among 415 experts from government, professional institutions and the food industry/enterprises using the National Food Safety Standard System Construction Consultation Questionnaire designed in the name of the Secretariat of National Food Safety Standard Committee. Experts have different advices in each group about the principles of food product standards, food additive product standards, food related product standards, hygienic practice, test methods. According to the results, the best solution not only may reflect experts awareness of the work of food safety standards situation, but also provide advices for setting and revision of food safety standards for the next. Through experts investigation, the framework and guiding principles of food safety standard had been built.

Workplace Bullying, Job Stress, Intent to Leave, and Nurses' Perceptions of Patient Safety in South Korean Hospitals.

PubMed

Oh, Hyunjin; Uhm, Dong-Choon; Yoon, Young Joo

2016-01-01

Negative work environments influence the ability of nurses to provide optimal patient care in a safe environment. The purpose of the study was to test a model linking workplace bullying (WPB) and lateral violence (LV) with job stress, intent to leave, and, subsequently, nurse-assessed patient adverse outcomes (safety issues). This descriptive-correlational study examined the relationships between study variables and used a structural equation model to test the validity of the proposed theoretical framework. A convenience sample of 508 clinical nurses working in eight general hospitals in Daejeon, South Korea, completed a questionnaire on measures of WPB, LV, job stress, intent to leave, and nurse-assessed patient safety. Analysis of moment structures was used to estimate a set of three models with competing measurement structures for WPB and LV and the same structural model. Akaike Information Criterion was used for model selection. Among the three proposed models, the model with complex factor loadings was selected (WPB and LV were both associated with verbal abuse and physical threat). WPB directly and indirectly influenced nurse-assessed patient safety. Job stress directly influenced intent to leave, and intent to leave directly influenced nurse-assessed patient safety. The results of the study support the proposition that WPB, job stress, and intent to leave may be associated with nurse-perceived adverse outcomes (patient safety issues) in hospitals. Nurse perceptions of WPB were associated with nurse-assessed patient safety outcomes (adverse events) directly and through mediating job stress and intent to leave. LV was not associated with the mediators or nurse-assessed adverse outcomes (safety).

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Schools and Disasters: Safety and Mental Health Assessment and Interventions for Children.

PubMed

Lai, Betty S; Esnard, Ann-Margaret; Lowe, Sarah R; Peek, Lori

2016-12-01

This article draws on experiences and lessons from global disasters and utilizes the United Nations Comprehensive School Safety Framework to highlight the necessary role of safe schools in protecting children, as well as adult staff, from the immediate threats and long-term implications of disasters. Specifically, we focus on three well-established pillars of school safety: Pillar I: Safe Learning Facilities; Pillar II: Disaster Management; and Pillar III: Risk Reduction and Resilience Education. In addition, we propose a potential fourth pillar, which underscores the function of schools in postdisaster mental health assessment and intervention for children. We argue that schools offer a central location and trusted institutional space for mental health assessment and intervention after disasters. We also examine the important linkages between schools, child mental health, and household and family recovery. We conclude with recommendations for filling gaps in research and practice related to ensuring the safety of schools and the associated health and well-being of children in the face of future disasters.

Assessing safety of herbal products for menopausal complaints: an international perspective.

PubMed

Dog, Tieraona Low; Marles, Robin; Mahady, Gail; Gardiner, Paula; Ko, Richard; Barnes, Jo; Chavez, Mary L; Griffiths, James; Giancaspro, Gabriel; Sarma, Nandakumara D

2010-08-01

Future research of herbal products for menopausal women should include long-term safety assessments because women may use these products for prolonged periods of time. Growing numbers of women take prescription medications and concurrently use herbal products for alleviation of menopausal symptoms. Because of possible herb-drug interactions, both drug and supplement manufacturers should provide basic pharmacokinetic data to reduce the risk of adverse interactions. In addition, herbal products produced to high quality standards are essential for ensuring consumer safety. Regulatory frameworks must be in place to ensure that herbal ingredients' identities have been verified, that they have been properly quantified per unit dose, that the product is within tolerance limits for contaminants, that the product's safety and effectiveness under the recommended conditions of use have been assessed before sale to the public, and that a system is in place to detect and deal with adverse reactions when they arise. This article explores these and related concerns. Copyright 2010. Published by Elsevier Ireland Ltd.

System modeling with the DISC framework: evidence from safety-critical domains.

PubMed

Reiman, Teemu; Pietikäinen, Elina; Oedewald, Pia; Gotcheva, Nadezhda

2012-01-01

The objective of this paper is to illustrate the development and application of the Design for Integrated Safety Culture (DISC) framework for system modeling by evaluating organizational potential for safety in nuclear and healthcare domains. The DISC framework includes criteria for good safety culture and a description of functions that the organization needs to implement in order to orient the organization toward the criteria. Three case studies will be used to illustrate the utilization of the DISC framework in practice.

Multi-criteria framework as an innovative tradeoff approach to determine the shelf-life of high pressure-treated poultry.

PubMed

Guillou, S; Lerasle, M; Simonin, H; Anthoine, V; Chéret, R; Federighi, M; Membré, J-M

2016-09-16

A multi-criteria framework combining safety, hygiene and sensorial quality was developed to investigate the possibility of extending the shelf-life and/or removing lactate by applying High Hydrostatic Pressure (HHP) in a ready-to-cook (RTC) poultry product. For this purpose, Salmonella and Listeria monocytogenes were considered as safety indicators and Escherichia coli as hygienic indicator. Predictive modeling was used to determine the influence of HHP and lactate concentration on microbial growth and survival of these indicators. To that end, probabilistic assessment exposure models developed in a previous study (Lerasle, M., Guillou, S., Simonin, H., Anthoine, V., Chéret, R., Federighi, M., Membré, J.M. 2014. Assessment of Salmonella and L. monocytogenes level in ready-to-cook poultry meat: Effect of various high pressure treatments and potassium lactate concentrations. International Journal of Food Microbiology 186, 74-83) were used for L. monocytogenes and Salmonella. Besides, for E. coli, an exposure assessment model was built by modeling data from challenge-test experiments. Finally, sensory tests and color measurements were performed to evaluate the effect of HHP on the organoleptic quality of an RTC product. Quantitative rules of decision based on safety, hygienic and organoleptic criteria were set. Hygienic and safety criteria were associated with probability to exceed maximum contamination levels of L. monocytogenes, Salmonella and E. coli at the end of the shelf-life whereas organoleptic criteria corresponded to absence of statistical difference between pressurized and unpressurized products. A tradeoff between safety and hygienic risk, color and taste, was then applied to define process and formulation enabling shelf-life extension. In the resulting operating window, one condition was experimentally assayed on naturally contaminated RTC products to validate the multi-criteria approach. As a conclusion, the framework was validated; it was possible to extend the shelf-life of an RTC poultry product containing 1.8% (w/w) lactate by one week, despite slight color alteration. This approach could be profitably implemented by food processors as a decision support tool for shelf-life determination. Copyright © 2016 Elsevier B.V. All rights reserved.

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

NASA Astrophysics Data System (ADS)

Summerer, Leopold

2014-08-01

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

Comparison of two drug safety signals in a pharmacovigilance data mining framework.

PubMed

Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

2016-04-01

Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database. © The Author(s) 2012.

Advancing the Adverse Outcome Pathway Framework - an International Horizon Scanning Approach

EPA Science Inventory

The ability of scientists to conduct whole organism toxicity tests to understand chemical safety has been significantly outpaced by the rapid synthesis of new chemicals. Therefore, to increase efficiencies in chemical risk assessment, scientists are turning to mechanistic-based ...

Developing a Defense Sector Assessment Rating Tool

DTIC Science & Technology

2010-01-01

JUSTICE EDUCATION ENERGY AND ENVIRONMENT HEALTH AND HEALTH CARE INTERNATIONAL AFFAIRS NATIONAL SECURITY POPULATION AND AGING PUBLIC SAFETY SCIENCE AND...Cathryn Quantic Thurston, and Gregory F. Treverton (MG-863-OSD). • Making Liberia Safe: Transformation of the National Security Sector, by David C...Cathryn Quantic Thurston, and Gregory F. Treverton, A Framework to Assess Programs for Building Partnerships, Santa Monica, Calif.: RAND Corporation

The Victim-Offender Overlap and Fear of In-School Victimization: A Longitudinal Examination of Risk Assessment Models

ERIC Educational Resources Information Center

Melde, Chris; Esbensen, Finn-Aage

2009-01-01

Reports of serious violence in schools have raised general awareness and concern about safety in America's schools. In this article, the authors examine the extent to which in-school victimization is associated with students' perceived risk and fear of victimization. By expanding on Ferraro's risk assessment framework, the current study explores…

ASSIP Study of Real-Time Safety-Critical Embedded Software-Intensive System Engineering Practices

DTIC Science & Technology

2008-02-01

and assessment 2. product engineering processes 3. tooling processes 6 | CMU/SEI-2008-SR-001 Slide 1 Process Standards IEC/ ISO 12207 Software...and technical effort to align with 12207 IEC/ ISO 15026 System & Software Integrity Levels Generic Safety SAE ARP 4754 Certification Considerations...Process Frameworks in revision – ISO 9001, ISO 9004 – ISO 15288/ ISO 12207 harmonization – RTCA DO-178B, MOD Standard UK 00-56/3, … • Methods & Tools

Assessing school disaster preparedness by applying a comprehensive school safety framework: A case of elementary schools in Banda Aceh City

NASA Astrophysics Data System (ADS)

Sakurai, A.; Bisri, M. B. F.; Oda, T.; Oktari, R. S.; Murayama, Y.

2017-02-01

The study assessed the depth of school disaster safety at public elementary schools in Banda Aceh City, Indonesia in terms of comprehensive school safety, especially school location, disaster management and disaster education. The findings indicate that 56% of public elementary schools in Banda Aceh City are exposed to high tsunami risk, and most externally driven school disaster preparedness activities were not continued by the schools due to lack of ownership and funding. To realize comprehensive school safety, disaster preparedness programs should neither be brought in by external donors, nor be in a patchwork. Rather, it should be conducted jointly and sustainably by the local school and the community and supported by multi-sectoral support in the city. Comprehensive school safety of public elementary schools in Banda Aceh City could be realized by reviewing, updating and localizing school disaster preparedness programs by all the education partners in the city with strong political will and commitment.

Specialty Care Access in the Safety Net-the Role of Public Hospitals and Health Systems.

PubMed

Makaroun, Lena K; Bowman, Chelsea; Duan, Kevin; Handley, Nathan; Wheeler, Daniel J; Pierluissi, Edgar; Chen, Alice Hm

2017-01-01

Access to specialty care in the United States safety net, already strained, is fac-ing increasing pressure with an influx of patients following the passage of the Affordable Care Act (ACA). We surveyed 18 public hospitals and health systems across the country to describe the current state of specialty care delivery in safety-net systems. We elicited information regarding challenges, provider models, metrics of access and productivity, and strategies for improving access. Based on our findings, we propose a framework for assessing and improving specialty care access with a focus on population health planning.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

How Adverse Outcome Pathways Can Aid the Development and Use of Computational Prediction Models for Regulatory Toxicology

PubMed Central

Aladjov, Hristo; Ankley, Gerald; Byrne, Hugh J.; de Knecht, Joop; Heinzle, Elmar; Klambauer, Günter; Landesmann, Brigitte; Luijten, Mirjam; MacKay, Cameron; Maxwell, Gavin; Meek, M. E. (Bette); Paini, Alicia; Perkins, Edward; Sobanski, Tomasz; Villeneuve, Dan; Waters, Katrina M.; Whelan, Maurice

2017-01-01

Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework provides a systematic approach for organizing knowledge that may support such inference. Likewise, computational models of biological systems at various scales provide another means and platform to integrate current biological understanding to facilitate inference and extrapolation. We argue that the systematic organization of knowledge into AOP frameworks can inform and help direct the design and development of computational prediction models that can further enhance the utility of mechanistic and in silico data for chemical safety assessment. This concept was explored as part of a workshop on AOP-Informed Predictive Modeling Approaches for Regulatory Toxicology held September 24–25, 2015. Examples of AOP-informed model development and its application to the assessment of chemicals for skin sensitization and multiple modes of endocrine disruption are provided. The role of problem formulation, not only as a critical phase of risk assessment, but also as guide for both AOP and complementary model development is described. Finally, a proposal for actively engaging the modeling community in AOP-informed computational model development is made. The contents serve as a vision for how AOPs can be leveraged to facilitate development of computational prediction models needed to support the next generation of chemical safety assessment. PMID:27994170

Real-Time Risk Assessment Framework for Unmanned Aircraft System (UAS) Traffic Management (UTM)

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Capristan, Francisco M.; Foster, John V.; Condotta, Ryan

2017-01-01

The new Federal Aviation Administration (FAA) Small Unmanned Aircraft rule (Part 107) marks the first national regulations for commercial operation of small unmanned aircraft systems (sUAS) under 55 pounds within the National Airspace System (NAS). Although sUAS flights may not be performed beyond visual line-of-sight or over non- participant structures and people, safety of sUAS operations must still be maintained and tracked at all times. Moreover, future safety-critical operation of sUAS (e.g., for package delivery) are already being conceived and tested. NASA's Unmanned Aircraft System Trac Management (UTM) concept aims to facilitate the safe use of low-altitude airspace for sUAS operations. This paper introduces the UTM Risk Assessment Framework (URAF) which was developed to provide real-time safety evaluation and tracking capability within the UTM concept. The URAF uses Bayesian Belief Networks (BBNs) to propagate off -nominal condition probabilities based on real-time component failure indicators. This information is then used to assess the risk to people on the ground by calculating the potential impact area and the effects of the impact. The visual representation of the expected area of impact and the nominal risk level can assist operators and controllers with dynamic trajectory planning and execution. The URAF was applied to a case study to illustrate the concept.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Managing health and safety risks: Implications for tailoring health and safety management system practices.

PubMed

Willmer, D R; Haas, E J

2016-01-01

As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.

Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

PubMed

Hong, Bonnie; Du, Yingzhou; Mukerji, Pushkor; Roper, Jason M; Appenzeller, Laura M

2017-07-12

Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

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.

Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

PubMed Central

Farley, Donna O; Damberg, Cheryl L

2009-01-01

Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

A study of patient safety management in the framework of clinical governance according to the nurses working in the ICU of the hospitals in the East of Tehran.

PubMed

Sahebalzamani, Mohammad; Mohammady, Mohsen

2014-05-01

The improvement of patient safety conditions in the framework of clinical service governance is one of the most important concerns worldwide. The importance of this issue and its effects on the health of patients encouraged the researcher to conduct this study to evaluate patient safety management in the framework of clinical governance according to the nurses working in the intensive care units (ICUs) of the hospitals of the east of Tehran, Iran in 2012. This descriptive study, which was based on census method, was conducted on 250 nurses sampled from the hospitals located in the east of Tehran. For the collection of data, a researcher-made questionnaire in five categories, including culture, leadership, training, environment, and technology, as well as on safety items was used. To test the validity of the questionnaire, content validity test was conducted, and the reliability of the questionnaire was assessed by retest method, in which the value of alpha was equal to 91%. The results showed that safety culture was at a high level in 55% of cases, safety leadership was at a high level in 40% cases and at a low level in 2.04% cases, safety training was at a high level in 64.8% cases and at a low level in 4% cases, safety of environment and technology was at a high level in 56.8% cases and at a low level in 1.6% cases, and safety items of the patients in their reports were at a high level in approximately 44% cases and at a low level in 6.5% cases. The results of Student's t-test (P < 0.001) showed that the average score of all safety categories of the patients was significantly higher than the average points. Diligence of the management and personnel of the hospital is necessary for the improvement of safety management. For this purpose, the management of hospitals can show interest in safety, develop an events reporting system, enhance teamwork, and implement clinical governance plans.

Evaluating the Safety In Numbers effect for pedestrians at urban intersections.

PubMed

Murphy, Brendan; Levinson, David M; Owen, Andrew

2017-09-01

Assessment of collision risk between pedestrians and automobiles offers a powerful and informative tool in urban planning applications, and can be leveraged to inform proper placement of improvements and treatment projects to improve pedestrian safety. Such assessment can be performed using existing datasets of crashes, pedestrian counts, and automobile traffic flows to identify intersections or corridors characterized by elevated collision risks to pedestrians. The Safety In Numbers phenomenon, which refers to the observable effect that pedestrian safety is positively correlated with increased pedestrian traffic in a given area (i.e. that the individual per-pedestrian risk of a collision decreases with additional pedestrians), is a readily observed phenomenon that has been studied previously, though its directional causality is not yet known. A sample of 488 intersections in Minneapolis were analyzed, and statistically-significant log-linear relationships between pedestrian traffic flows and the per-pedestrian crash risk were found, indicating the Safety In Numbers effect. Potential planning applications of this analysis framework towards improving pedestrian safety in urban environments are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ensuring long-term utility of the AOP framework and knowledge for multiple stakeholders

EPA Science Inventory

1.Introduction There is a need to increase the development and implementation of predictive approaches to support chemical safety assessment. These predictive approaches feature generation of data from tools such as computational models, pathway-based in vitro assays, and short-t...

Mode of Action Profiles for Pesticide Compounds with Rodent Liver Tumor Outcomes

EPA Science Inventory

Mode of action (MOA) provides a central framework for assessing human relevance of adverse health outcomes observed in nonclinical safety studies. The goal of this study was to characterize MOA profiles for known rodent liver tumorigens identified from a database of pesticides as...

TYPES OF INTEGRATION IN RISK ASSESSMENT AND MANAGEMENT, AND WHY THEY ARE NEEDED

EPA Science Inventory

Risk-based decision making requires that the decision makers and stakeholders are informed of all risks that are potentially significant and relevant to the decision. The International Programme on Chemical Safety of the World Health Organization has developed a framework for int...

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Methodology Development for Passive Component Reliability Modeling in a Multi-Physics Simulation Environment

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

Aldemir, Tunc; Denning, Richard; Catalyurek, Umit

Reduction in safety margin can be expected as passive structures and components undergo degradation with time. Limitations in the traditional probabilistic risk assessment (PRA) methodology constrain its value as an effective tool to address the impact of aging effects on risk and for quantifying the impact of aging management strategies in maintaining safety margins. A methodology has been developed to address multiple aging mechanisms involving large numbers of components (with possibly statistically dependent failures) within the PRA framework in a computationally feasible manner when the sequencing of events is conditioned on the physical conditions predicted in a simulation environment, suchmore » as the New Generation System Code (NGSC) concept. Both epistemic and aleatory uncertainties can be accounted for within the same phenomenological framework and maintenance can be accounted for in a coherent fashion. The framework accommodates the prospective impacts of various intervention strategies such as testing, maintenance, and refurbishment. The methodology is illustrated with several examples.« less

Towards a conceptual framework of OSH risk management in smart working environments based on smart PPE, ambient intelligence and the Internet of Things technologies.

PubMed

Podgórski, Daniel; Majchrzycka, Katarzyna; Dąbrowska, Anna; Gralewicz, Grzegorz; Okrasa, Małgorzata

2017-03-01

Recent developments in domains of ambient intelligence (AmI), Internet of Things, cyber-physical systems (CPS), ubiquitous/pervasive computing, etc., have led to numerous attempts to apply ICT solutions in the occupational safety and health (OSH) area. A literature review reveals a wide range of examples of smart materials, smart personal protective equipment and other AmI applications that have been developed to improve workers' safety and health. Because the use of these solutions modifies work methods, increases complexity of production processes and introduces high dynamism into thus created smart working environments (SWE), a new conceptual framework for dynamic OSH management in SWE is called for. A proposed framework is based on a new paradigm of OSH risk management consisting of real-time risk assessment and the capacity to monitor the risk level of each worker individually. A rationale for context-based reasoning in SWE and a respective model of the SWE-dedicated CPS are also proposed.

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

PubMed

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Application of Non-Human Biota Assessment Methodologies to the Assessment of Potential Impacts from a Nuclear Waste Repository

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

Smith, K.L.; Robinson, C.A.; Ikonen, A.T.K.

2007-07-01

The protection of the environment from the effects of ionising radiation has become increasingly more topical over the last few years as the intentions enshrined in international principles and agreements have become more binding through national and international law. For example, the Directive on impact of certain projects on the environment (EIA Directive 85/337/EEC) [CEC, 1985], amended in 1997 [CEC, 1997], places a mandatory requirement on all EU Member States to conduct environmental impact assessments for a range of project having potential impact on the environment, including radioactive waste disposal. Such assessments must consider humans, fauna and flora, the abioticmore » environment (soil, water, air), material assets and cultural heritage as well as the interactions between these factors. In Finland, Posiva Oy are responsible for the overall repository programme for spent nuclear fuel and, as such, are conducting the Safety Case Assessment for a proposed geological repository for nuclear waste. Within the European legislation framework, the Finnish regulatory body requires that the repository safety case assessment should include not only human radiological safety, but also an assessment of the potential impact upon populations of non-human biota. Specifically, the Safety Case should demonstrate that there will be: - no decline in the biodiversity of currently living populations; - no significant detriment to populations of fauna and flora; and, - no detrimental effects on individuals of domestic animals and rare plants and animals. At present, there are no internationally agreed criteria that explicitly address protection of the environment from ionising radiation. However, over recent years a number of assessment methodologies have been developed including, at a European level, the Framework for the Assessment of Environmental impact (FASSET) and Environmental Risks from Ionising Contaminants (ERICA). The International Committee on Radiation Protection (ICRP) have also proposed an approach to allow for assessments of potential impacts on non-human species, in its report in 2003. This approach is based on the development and use of a small set of reference animals and plants, with their associated dose models and data sets. Such approaches are broadly applicable to the Posiva Safety Case. However, the specific biota of concern and the current climatic conditions within Finland present an additional challenge to the assessment. The assessment methods most applicable to the Posiva Safety Case have therefore been reviewed in consideration of the regulatory requirements for the assessment and recommendations made on a suitable assessment approach. This has been applied within a test case and adaptations to the overall assessment method have been made to enable both population and individual impacts to be assessed where necessary. The test case has been undertaken to demonstrate the application of the recommended methodology, but also to identify data gaps, uncertainties and other specific issues associated with the application of an assessment method within the regulatory context. (authors)« less

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

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-03-24

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

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

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-01-01

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

Integrated Framework for Patient Safety and Energy Efficiency in Healthcare Facilities Retrofit Projects.

PubMed

Mohammadpour, Atefeh; Anumba, Chimay J; Messner, John I

2016-07-01

There is a growing focus on enhancing energy efficiency in healthcare facilities, many of which are decades old. Since replacement of all aging healthcare facilities is not economically feasible, the retrofitting of these facilities is an appropriate path, which also provides an opportunity to incorporate energy efficiency measures. In undertaking energy efficiency retrofits, it is vital that the safety of the patients in these facilities is maintained or enhanced. However, the interactions between patient safety and energy efficiency have not been adequately addressed to realize the full benefits of retrofitting healthcare facilities. To address this, an innovative integrated framework, the Patient Safety and Energy Efficiency (PATSiE) framework, was developed to simultaneously enhance patient safety and energy efficiency. The framework includes a step -: by -: step procedure for enhancing both patient safety and energy efficiency. It provides a structured overview of the different stages involved in retrofitting healthcare facilities and improves understanding of the intricacies associated with integrating patient safety improvements with energy efficiency enhancements. Evaluation of the PATSiE framework was conducted through focus groups with the key stakeholders in two case study healthcare facilities. The feedback from these stakeholders was generally positive, as they considered the framework useful and applicable to retrofit projects in the healthcare industry. © The Author(s) 2016.

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

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

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

Improving health, safety and energy efficiency in New Zealand through measuring and applying basic housing standards.

PubMed

Gillespie-Bennett, Julie; Keall, Michael; Howden-Chapman, Philippa; Baker, Michael G

2013-08-02

Substandard housing is a problem in New Zealand. Historically there has been little recognition of the important aspects of housing quality that affect people's health and safety. In this viewpoint article we outline the importance of assessing these factors as an essential step to improving the health and safety of New Zealanders and household energy efficiency. A practical risk assessment tool adapted to New Zealand conditions, the Healthy Housing Index (HHI), measures the physical characteristics of houses that affect the health and safety of the occupants. This instrument is also the only tool that has been validated against health and safety outcomes and reported in the international peer-reviewed literature. The HHI provides a framework on which a housing warrant of fitness (WOF) can be based. The HHI inspection takes about one hour to conduct and is performed by a trained building inspector. To maximise the effectiveness of this housing quality assessment we envisage the output having two parts. The first would be a pass/fail WOF assessment showing whether or not the house meets basic health, safety and energy efficiency standards. The second component would rate each main assessment area (health, safety and energy efficiency), potentially on a five-point scale. This WOF system would establish a good minimum standard for rental accommodation as well encouraging improved housing performance over time. In this article we argue that the HHI is an important, validated, housing assessment tool that will improve housing quality, leading to better health of the occupants, reduced home injuries, and greater energy efficiency. If required, this tool could be extended to also cover resilience to natural hazards, broader aspects of sustainability, and the suitability of the dwelling for occupants with particular needs.

Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials.

PubMed

Veyrand, Julien; Marin-Kuan, Maricel; Bezencon, Claudine; Frank, Nancy; Guérin, Violaine; Koster, Sander; Latado, Hélia; Mollergues, Julie; Patin, Amaury; Piguet, Dominique; Serrant, Patrick; Varela, Jesus; Schilter, Benoît

2017-10-01

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

Qualichem In Vivo: A Tool for Assessing the Quality of In Vivo Studies and Its Application for Bisphenol A

PubMed Central

Maxim, Laura; van der Sluijs, Jeroen P.

2014-01-01

In regulatory toxicology, quality assessment of in vivo studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called “Qualichem in vivo” that is designed to systematically and transparently assess the quality of in vivo studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views—an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of in vivo studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines. PMID:24489958

Systematic evaluation of non-animal test methods for skin sensitisation safety assessment.

PubMed

Reisinger, Kerstin; Hoffmann, Sebastian; Alépée, Nathalie; Ashikaga, Takao; Barroso, Joao; Elcombe, Cliff; Gellatly, Nicola; Galbiati, Valentina; Gibbs, Susan; Groux, Hervé; Hibatallah, Jalila; Keller, Donald; Kern, Petra; Klaric, Martina; Kolle, Susanne; Kuehnl, Jochen; Lambrechts, Nathalie; Lindstedt, Malin; Millet, Marion; Martinozzi-Teissier, Silvia; Natsch, Andreas; Petersohn, Dirk; Pike, Ian; Sakaguchi, Hitoshi; Schepky, Andreas; Tailhardat, Magalie; Templier, Marie; van Vliet, Erwin; Maxwell, Gavin

2015-02-01

The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitization potency prediction. The results of the first phase – systematic evaluation of 16 test methods – are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data,potential for throughput, transferability and accessibility in cooperation with the test method developers.A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy – combined with bioavailability and skin metabolism data and exposure consideration – is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients.

Transoral endoscopic thyroidectomy vestibular approach: a preliminary framework for assessment and safety.

PubMed

Russell, Jonathon; Anuwong, Angkoon; Dionigi, Gianlorenzo; Inabnet, William B; Kim, Hoon Yub; Randolph, Gregory W; Richmon, Jeremy D; Tufano, Ralph P

2018-05-23

Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a new approach to the central neck that avoids an anterior cervical incision. This approach can be performed with endoscopic or robotic assistance and offers access to the bilateral central neck. It has been completed safely in both North American and, even more extensively, international populations. With any new technology or approach, complications during the learning curve, expense, instrument limitations, and overall safety may affect its ultimate adoption and utility. To ensure patient safety, it is imperative to define steps that should be considered by any surgeon or group before adoption of this new approach.

Check-Cases for Verification of 6-Degree-of-Freedom Flight Vehicle Simulations. Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Murri, Daniel G.; Jackson, E. Bruce; Shelton, Robert O.

2015-01-01

This NASA Engineering and Safety Center (NESC) assessment was established to develop a set of time histories for the flight behavior of increasingly complex example aerospacecraft that could be used to partially validate various simulation frameworks. The assessment was conducted by representatives from several NASA Centers and an open-source simulation project. This document contains details on models, implementation, and results.

Determining the causal relationships among balanced scorecard perspectives on school safety performance: case of Saudi Arabia.

PubMed

Alolah, Turki; Stewart, Rodney A; Panuwatwanich, Kriengsak; Mohamed, Sherif

2014-07-01

In the public schools of many developing countries, numerous accidents and incidents occur because of poor safety regulations and management systems. To improve the educational environment in Saudi Arabia, the Ministry of Education seeks novel approaches to measure school safety performance in order to decrease incidents and accidents. The main objective of this research was to develop a systematic approach for measuring Saudi school safety performance using the balanced scorecard framework philosophy. The evolved third generation balanced scorecard framework is considered to be a suitable and robust framework that captures the system-wide leading and lagging indicators of business performance. The balanced scorecard architecture is ideal for adaptation to complex areas such as safety management where a holistic system evaluation is more effective than traditional compartmentalised approaches. In developing the safety performance balanced scorecard for Saudi schools, the conceptual framework was first developed and peer-reviewed by eighteen Saudi education experts. Next, 200 participants, including teachers, school executives, and Ministry of Education officers, were recruited to rate both the importance and the performance of 79 measurement items used in the framework. Exploratory factor analysis, followed by the confirmatory partial least squares method, was then conducted in order to operationalise the safety performance balanced scorecard, which encapsulates the following five salient perspectives: safety management and leadership; safety learning and training; safety policy, procedures and processes; workforce safety culture; and safety performance. Partial least squares based structural equation modelling was then conducted to reveal five significant relationships between perspectives, namely, safety management and leadership had a significant effect on safety learning and training and safety policy, procedures and processes, both safety learning and training and safety policy, procedures and processes had significant effects on workforce safety culture, and workforce safety culture had a significant effect on safety performance. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-01-01

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

Applicability of risk-based management and the need for risk-based economic decision analysis at hazardous waste contaminated sites.

PubMed

Khadam, Ibrahim; Kaluarachchi, Jagath J

2003-07-01

Decision analysis in subsurface contamination management is generally carried out through a traditional engineering economic viewpoint. However, new advances in human health risk assessment, namely, the probabilistic risk assessment, and the growing awareness of the importance of soft data in the decision-making process, require decision analysis methodologies that are capable of accommodating non-technical and politically biased qualitative information. In this work, we discuss the major limitations of the currently practiced decision analysis framework, which evolves around the definition of risk and cost of risk, and its poor ability to communicate risk-related information. A demonstration using a numerical example was conducted to provide insight on these limitations of the current decision analysis framework. The results from this simple ground water contamination and remediation scenario were identical to those obtained from studies carried out on existing Superfund sites, which suggests serious flaws in the current risk management framework. In order to provide a perspective on how these limitations may be avoided in future formulation of the management framework, more matured and well-accepted approaches to decision analysis in dam safety and the utility industry, where public health and public investment are of great concern, are presented and their applicability in subsurface remediation management is discussed. Finally, in light of the success of the application of risk-based decision analysis in dam safety and the utility industry, potential options for decision analysis in subsurface contamination management are discussed.

Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data.

PubMed

Nyeland, Martin Erik; Laursen, Mona Vestergaard; Callréus, Torbjörn

2017-06-01

For both marketing authorization holders and regulatory authorities, evaluating the effectiveness of risk minimization measures is now an integral part of pharmacovigilance in the European Union. The overall aim of activities in this area is to assess the performance of risk minimization measures implemented in order to ensure a positive benefit-risk balance in patients treated with a medicinal product. Following a review of the relevant literature, we developed a conceptual framework consisting of four domains (data, knowledge, behaviour and outcomes) intended for the evaluation of risk minimization measures put into practice in the Danish health-care system. For the implementation of the framework, four classes of monitoring variables can be named and defined: patient descriptors, performance-related indicators of knowledge, behaviour and outcomes. We reviewed the features of the framework when applied to historical, real-world data following the introduction of dabigatran in Denmark for the prophylactic treatment of patients with non-valvular atrial fibrillation. The application of the framework provided useful graphical displays and an opportunity for a statistical evaluation (interrupted time series analysis) of a regulatory intervention. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.

Microbiological risk assessment for personal care products.

PubMed

Stewart, S E; Parker, M D; Amézquita, A; Pitt, T L

2016-12-01

Regulatory decisions regarding microbiological safety of cosmetics and personal care products are primarily hazard-based, where the presence of a potential pathogen determines decision-making. This contrasts with the Food industry where it is a commonplace to use a risk-based approach for ensuring microbiological safety. A risk-based approach allows consideration of the degree of exposure to assess unacceptable health risks. As there can be a number of advantages in using a risk-based approach to safety, this study explores the Codex Alimentarius (Codex) four-step Microbiological Risk Assessment (MRA) framework frequently used in the Food industry and examines how it can be applied to the safety assessment of personal care products. The hazard identification and hazard characterization steps (one and two) of the Codex MRA framework consider the main microorganisms of concern. These are addressed by reviewing the current industry guidelines for objectionable organisms and analysing reports of contaminated products notified by government agencies over a recent 5-year period, together with examples of reported outbreaks. Data related to estimation of exposure (step three) are discussed, and examples of possible calculations and references are included. The fourth step, performed by the risk assessor (risk characterization), is specific to each assessment and brings together the information from the first three steps to assess the risk. Although there are very few documented uses of the MRA approach for personal care products, this study illustrates that it is a practicable and sound approach for producing products that are safe by design. It can be helpful in the context of designing products and processes going to market and with setting of microbiological specifications. Additionally, it can be applied reactively to facilitate decision-making when contaminated products are released on to the marketplace. Currently, the knowledge available may only allow a qualitative or semi-quantitative rather than fully quantitative risk assessment, but an added benefit is that the disciplined structuring of available knowledge enables clear identification of gaps to target resources and if appropriate, instigate data generation. © 2016 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

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

How Adverse Outcome Pathways Can Aid the Development and Use of Computational Prediction Models for Regulatory Toxicology.

PubMed

Wittwehr, Clemens; Aladjov, Hristo; Ankley, Gerald; Byrne, Hugh J; de Knecht, Joop; Heinzle, Elmar; Klambauer, Günter; Landesmann, Brigitte; Luijten, Mirjam; MacKay, Cameron; Maxwell, Gavin; Meek, M E Bette; Paini, Alicia; Perkins, Edward; Sobanski, Tomasz; Villeneuve, Dan; Waters, Katrina M; Whelan, Maurice

2017-02-01

Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework provides a systematic approach for organizing knowledge that may support such inference. Likewise, computational models of biological systems at various scales provide another means and platform to integrate current biological understanding to facilitate inference and extrapolation. We argue that the systematic organization of knowledge into AOP frameworks can inform and help direct the design and development of computational prediction models that can further enhance the utility of mechanistic and in silico data for chemical safety assessment. This concept was explored as part of a workshop on AOP-Informed Predictive Modeling Approaches for Regulatory Toxicology held September 24-25, 2015. Examples of AOP-informed model development and its application to the assessment of chemicals for skin sensitization and multiple modes of endocrine disruption are provided. The role of problem formulation, not only as a critical phase of risk assessment, but also as guide for both AOP and complementary model development is described. Finally, a proposal for actively engaging the modeling community in AOP-informed computational model development is made. The contents serve as a vision for how AOPs can be leveraged to facilitate development of computational prediction models needed to support the next generation of chemical safety assessment. © The Author 2016. Published by Oxford University Press on behalf of the Society of Toxicology.

"No-Go Considerations" for In Situ Simulation Safety.

PubMed

Bajaj, Komal; Minors, Anjoinette; Walker, Katie; Meguerdichian, Michael; Patterson, Mary

2018-06-01

In situ simulation is the practice of simulation in the actual clinical environment and has demonstrated utility in the assessment of system processes, identification of latent safety threats, and improvement in teamwork and communication. Nonetheless, performing simulated events in a real patient care setting poses potential risks to patient and staff safety. One integral aspect of a comprehensive approach to ensure the safety of in situ simulation includes the identification and establishment of "no-go considerations," that is, key decision-making considerations under which in situ simulations should be canceled, postponed, moved to another area, or rescheduled. These considerations should be modified and adjusted to specific clinical units. This article provides a framework of key essentials in developing no-go considerations.

System Theoretic Frameworks for Mitigating Risk Complexity in the Nuclear Fuel Cycle

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

Williams, Adam David; Mohagheghi, Amir H.; Cohn, Brian

In response to the expansion of nuclear fuel cycle (NFC) activities -- and the associated suite of risks -- around the world, this project evaluated systems-based solutions for managing such risk complexity in multimodal and multi-jurisdictional international spent nuclear fuel (SNF) transportation. By better understanding systemic risks in SNF transportation, developing SNF transportation risk assessment frameworks, and evaluating these systems-based risk assessment frameworks, this research illustrated interdependency between safety, security, and safeguards risks is inherent in NFC activities and can go unidentified when each "S" is independently evaluated. Two novel system-theoretic analysis techniques -- dynamic probabilistic risk assessment (DPRA) andmore » system-theoretic process analysis (STPA) -- provide integrated "3S" analysis to address these interdependencies and the research results suggest a need -- and provide a way -- to reprioritize United States engagement efforts to reduce global nuclear risks. Lastly, this research identifies areas where Sandia National Laboratories can spearhead technical advances to reduce global nuclear dangers.« less

Engineered nanomaterials: exposures, hazards, and risk prevention

PubMed Central

2011-01-01

Nanotechnology presents the possibility of revolutionizing many aspects of our lives. People in many settings (academic, small and large industrial, and the general public in industrialized nations) are either developing or using engineered nanomaterials (ENMs) or ENM-containing products. However, our understanding of the occupational, health and safety aspects of ENMs is still in its formative stage. A survey of the literature indicates the available information is incomplete, many of the early findings have not been independently verified, and some may have been over-interpreted. This review describes ENMs briefly, their application, the ENM workforce, the major routes of human exposure, some examples of uptake and adverse effects, what little has been reported on occupational exposure assessment, and approaches to minimize exposure and health hazards. These latter approaches include engineering controls such as fume hoods and personal protective equipment. Results showing the effectiveness - or lack thereof - of some of these controls are also included. This review is presented in the context of the Risk Assessment/Risk Management framework, as a paradigm to systematically work through issues regarding human health hazards of ENMs. Examples are discussed of current knowledge of nanoscale materials for each component of the Risk Assessment/Risk Management framework. Given the notable lack of information, current recommendations to minimize exposure and hazards are largely based on common sense, knowledge by analogy to ultrafine material toxicity, and general health and safety recommendations. This review may serve as an overview for health and safety personnel, management, and ENM workers to establish and maintain a safe work environment. Small start-up companies and research institutions with limited personnel or expertise in nanotechnology health and safety issues may find this review particularly useful. PMID:21418643

Calculation of the Phenix end-of-life test 'Control Rod Withdrawal' with the ERANOS code

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

Tiberi, V.

2012-07-01

The Inst. of Radiological Protection and Nuclear Safety (IRSN) acts as technical support to French public authorities. As such, IRSN is in charge of safety assessment of operating and under construction reactors, as well as future projects. In this framework, one current objective of IRSN is to evaluate the ability and accuracy of numerical tools to foresee consequences of accidents. Neutronic studies step in the safety assessment from different points of view among which the core design and its protection system. They are necessary to evaluate the core behavior in case of accident in order to assess the integrity ofmore » the first barrier and the absence of a prompt criticality risk. To reach this objective one main physical quantity has to be evaluated accurately: the neutronic power distribution in core during whole reactor lifetime. Phenix end of life tests, carried out in 2009, aim at increasing the experience feedback on sodium cooled fast reactors. These experiments have been done in the framework of the development of the 4. generation of nuclear reactors. Ten tests have been carried out: 6 on neutronic and fuel aspects, 2 on thermal hydraulics and 2 for the emergency shutdown. Two of them have been chosen for an international exercise on thermal hydraulics and neutronics in the frame of an IAEA Coordinated Research Project. Concerning neutronics, the Control Rod Withdrawal test is relevant for safety because it allows evaluating the capability of calculation tools to compute the radial power distribution on fast reactors core configurations in which the flux field is very deformed. IRSN participated to this benchmark with the ERANOS code developed by CEA for fast reactors studies. This paper presents the results obtained in the framework of the benchmark activity. A relatively good agreement was found with available measures considering the approximations done in the modeling. The work underlines the importance of burn-up calculations in order to have a fine core concentrations mesh for the calculation of the power distribution. (authors)« less

Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

PubMed

Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

2017-02-01

Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

Sustainable development and next generation's health: a long-term perspective about the consequences of today's activities for food safety.

PubMed

Frazzoli, Chiara; Petrini, Carlo; Mantovani, Alberto

2009-01-01

Development is defined sustainable when it meets the needs of the present without compromising the ability of future generations to meet their own needs. Pivoting on social, environmental and economic aspects of food chain sustainability, this paper presents the concept of sustainable food safety based on the prevention of risks and burden of poor health for generations to come. Under this respect, the assessment of long-term, transgenerational risks is still hampered by serious scientific uncertainties. Critical issues to the development of a sustainable food safety framework may include: endocrine disrupters as emerging contaminants that specifically target developing organisms; toxicological risks assessment in Countries at the turning point of development; translating knowledge into toxicity indexes to support risk management approaches, such as hazard analysis and critical control points (HACCP); the interplay between chemical hazards and social determinants. Efforts towards the comprehensive knowledge and management of key factors of sustainable food safety appear critical to the effectiveness of the overall sustainability policies.

Object-Oriented Bayesian Networks (OOBN) for Aviation Accident Modeling and Technology Portfolio Impact Assessment

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon M.

2012-01-01

The concern for reducing aviation safety risk is rising as the National Airspace System in the United States transforms to the Next Generation Air Transportation System (NextGen). The NASA Aviation Safety Program is committed to developing an effective aviation safety technology portfolio to meet the challenges of this transformation and to mitigate relevant safety risks. The paper focuses on the reasoning of selecting Object-Oriented Bayesian Networks (OOBN) as the technique and commercial software for the accident modeling and portfolio assessment. To illustrate the benefits of OOBN in a large and complex aviation accident model, the in-flight Loss-of-Control Accident Framework (LOCAF) constructed as an influence diagram is presented. An OOBN approach not only simplifies construction and maintenance of complex causal networks for the modelers, but also offers a well-organized hierarchical network that is easier for decision makers to exploit the model examining the effectiveness of risk mitigation strategies through technology insertions.

Application of Framework for Integrating Safety, Security and Safeguards (3Ss) into the Design Of Used Nuclear Fuel Storage Facility

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

Badwan, Faris M.; Demuth, Scott F

Department of Energy’s Office of Nuclear Energy, Fuel Cycle Research and Development develops options to the current commercial fuel cycle management strategy to enable the safe, secure, economic, and sustainable expansion of nuclear energy while minimizing proliferation risks by conducting research and development focused on used nuclear fuel recycling and waste management to meet U.S. needs. Used nuclear fuel is currently stored onsite in either wet pools or in dry storage systems, with disposal envisioned in interim storage facility and, ultimately, in a deep-mined geologic repository. The safe management and disposition of used nuclear fuel and/or nuclear waste is amore » fundamental aspect of any nuclear fuel cycle. Integrating safety, security, and safeguards (3Ss) fully in the early stages of the design process for a new nuclear facility has the potential to effectively minimize safety, proliferation, and security risks. The 3Ss integration framework could become the new national and international norm and the standard process for designing future nuclear facilities. The purpose of this report is to develop a framework for integrating the safety, security and safeguards concept into the design of Used Nuclear Fuel Storage Facility (UNFSF). The primary focus is on integration of safeguards and security into the UNFSF based on the existing Nuclear Regulatory Commission (NRC) approach to addressing the safety/security interface (10 CFR 73.58 and Regulatory Guide 5.73) for nuclear power plants. The methodology used for adaptation of the NRC safety/security interface will be used as the basis for development of the safeguards /security interface and later will be used as the basis for development of safety and safeguards interface. Then this will complete the integration cycle of safety, security, and safeguards. The overall methodology for integration of 3Ss will be proposed, but only the integration of safeguards and security will be applied to the design of the UNFSF. The framework for integration of safeguards and security into the UNFSF will include 1) identification of applicable regulatory requirements, 2) selection of a common system that share dual safeguard and security functions, 3) development of functional design criteria and design requirements for the selected system, 4) identification and integration of the dual safeguards and security design requirements, and 5) assessment of the integration and potential benefit.« less

Towards an International Classification for Patient Safety: the conceptual framework.

PubMed

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-02-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose.

Towards an International Classification for Patient Safety: the conceptual framework

PubMed Central

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-01-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose. PMID:19147595

Advancing the Adverse Outcome Pathway Framework - an ...

EPA Pesticide Factsheets

The ability of scientists to conduct whole organism toxicity tests to understand chemical safety has been significantly outpaced by the rapid synthesis of new chemicals. Therefore, to increase efficiencies in chemical risk assessment, scientists are turning to mechanistic-based studies, making greater use of in vitro and in silico methods, to screen for potential environmental and human health hazards. A framework that has gained traction for capturing available knowledge describing the linkage between mechanistic data and apical toxicity endpoints, required for regulatory assessments, is the adverse outcome pathway (AOP). A number of international activities have focused on AOP development and plausible applications to regulatory decision-making. These interactions have prompted dialog between research scientists and regulatory communities to consider how best to use the AOP framework in risk assessment. While expert-facilitated discussions have been instrumental in moving the science of AOPs forward, it was recognized that a survey of the broader scientific community would aid in identifying shortcomings and guiding future initiatives for the AOP framework. To that end, a ?‘Horizon Scanning’ exercise was conducted to solicit questions from the global scientific and regulatory communities concerning the challenges or limitations that must be addressed to realize the full potential of the AOP framework in research and regulatory decision making. The m

A case study using the PrOACT-URL and BRAT frameworks for structured benefit risk assessment.

PubMed

Nixon, Richard; Dierig, Christoph; Mt-Isa, Shahrul; Stöckert, Isabelle; Tong, Thaison; Kuhls, Silvia; Hodgson, Gemma; Pears, John; Waddingham, Ed; Hockley, Kimberley; Thomson, Andrew

2016-01-01

While benefit-risk assessment is a key component of the drug development and maintenance process, it is often described in a narrative. In contrast, structured benefit-risk assessment builds on established ideas from decision analysis and comprises a qualitative framework and quantitative methodology. We compare two such frameworks, applying multi-criteria decision-analysis (MCDA) within the PrOACT-URL framework and weighted net clinical benefit (wNCB), within the BRAT framework. These are applied to a case study of natalizumab for the treatment of relapsing remitting multiple sclerosis. We focus on the practical considerations of applying these methods and give recommendations for visual presentation of results. In the case study, we found structured benefit-risk analysis to be a useful tool for structuring, quantifying, and communicating the relative benefit and safety profiles of drugs in a transparent, rational and consistent way. The two frameworks were similar. MCDA is a generic and flexible methodology that can be used to perform a structured benefit-risk in any common context. wNCB is a special case of MCDA and is shown to be equivalent to an extension of the number needed to treat (NNT) principle. It is simpler to apply and understand than MCDA and can be applied when all outcomes are measured on a binary scale. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Building a Foundation to Study Distributed Information Behaviour

ERIC Educational Resources Information Center

von Thaden, Terry L.

2007-01-01

Introduction: The purpose of this research is to assess information behaviour as it pertains to operational teams in dynamic safety critical operations. Method: In this paper, I describe some of the problems faced by crews on modern flight decks and suggest a framework modelled on Information Science, Human Factors, and Activity Theory research to…

A Night in Tijuana: Female Victimization in a High-Risk Environment

ERIC Educational Resources Information Center

Kelley-Baker, Tara; Mumford, Elizabeth A.; Vishnuvajjala, Radha; Voas, Robert B.; Romano, Eduardo; Johnson, Mark

2008-01-01

We examine the epidemiology of victimization among females crossing the U.S. border to drink in Tijuana, Mexico, with the purpose of creating a framework for an intervention to improve safety among female youth in drinking settings. Drinking history, history of victimization, evening drinking experience, and environmental factors are assessed.…

How Successful are U.S. Efforts to Build Capacity in Developing Countries? A Framework to Assess the Global Train and Equip 1206 Program

DTIC Science & Technology

2011-01-01

CARE INFRASTRUCTURE AND TRANSPORTATION INTERNATIONAL AFFAIRS LAW AND BUSINESS NATIONAL SECURITY POPULATION AND AGING PUBLIC SAFETY SCIENCE AND...Prevention—International cooperation—Evaluation. 5. Combined operations (Military science )—Evaluation. 6. United States—Military relations—Foreign...as well as to elicit informa- tion regarding assessment guidance and skills. 7 See Jennifer D. P. Moroney, Jefferson P. Marquis, Cathryn Quantic

Supporting and activating clinical governance development in Ireland: sharing our learning.

PubMed

Flynn, Maureen A; Burgess, Thora; Crowley, Philip

2015-01-01

The purpose of this paper is to present a description of the Irish national clinical governance development initiative and an evaluation of the initiative with the purpose of sharing the learning and proposing actions to activate structures and processes for quality and safety. The Quality and Patient Safety Division of the Health Service Executive established the initiative to counterbalance a possible focus on finances during the economic crisis in Ireland and bring attention to the quality of clinical care. A clinical governance framework for quality in healthcare in Ireland was developed to clearly articulate the fundamentals of clinical governance. The project plan involved three overlapping phases. The first was designing resources for practice; the second testing the implementation of the national resources in practice; and the third phase focused on gathering feedback and learning. Staff responded positively to the clinical governance framework. At a time when there are a lot of demands (measurement and scrutiny) the health services leads and responds well to focused support as they improve the quality and safety of services. Promoting the use of the term "governance for quality and safety" assisted in gaining an understanding of the more traditional term "clinical governance". The experience and outcome of the initiative informed the identification of 12 key learning points and a series of recommendations The initial evaluation was conducted at 24 months so at this stage it is not possible to assess the broader impact of the clinical governance framework beyond the action project hospitals. The single most important obligation for any health system is patient safety and improving the quality of care. The easily accessible, practical resources assisted project teams to lead changes in structures and processes within their services. This paper describes the fundamentals of the clinical governance framework which might serve as a guide for more integrative research endeavours on governance for quality and safety. Experience was gained in both the development of national guidance and their practical use in targeted action projects activating structures and processes that are a prerequisite to delivering safe quality services.

Results of a community-based survey of construction safety climate for Hispanic workers.

PubMed

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. While contractors and construction supervisors' (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30·6 vs 46·5%, P<0·05). Safety climate scores were not associated with English language ability or years lived in the United States. We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements.

Results of a community-based survey of construction safety climate for Hispanic workers

PubMed Central

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Background: Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. Objectives: To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. Methods: We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. Results: While contractors and construction supervisors’ (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30.6 vs 46.5%, P<0.05). Safety climate scores were not associated with English language ability or years lived in the United States. Conclusions: We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements. PMID:26145454

Prediction based active ramp metering control strategy with mobility and safety assessment

NASA Astrophysics Data System (ADS)

Fang, Jie; Tu, Lili

2018-04-01

Ramp metering is one of the most direct and efficient motorway traffic flow management measures so as to improve traffic conditions. However, owing to short of traffic conditions prediction, in earlier studies, the impact on traffic flow dynamics of the applied RM control was not quantitatively evaluated. In this study, a RM control algorithm adopting Model Predictive Control (MPC) framework to predict and assess future traffic conditions, which taking both the current traffic conditions and the RM-controlled future traffic states into consideration, was presented. The designed RM control algorithm targets at optimizing the network mobility and safety performance. The designed algorithm is evaluated in a field-data-based simulation. Through comparing the presented algorithm controlled scenario with the uncontrolled scenario, it was proved that the proposed RM control algorithm can effectively relieve the congestion of traffic network with no significant compromises in safety aspect.

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

NASA Astrophysics Data System (ADS)

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

2015-06-01

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

The importance of data collection for timely and accurate risk assessment

NASA Astrophysics Data System (ADS)

Gilsenan, MB

2017-09-01

The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Formalizing Probabilistic Safety Claims

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

2011-01-01

A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

An implementation evaluation of a qualitative culture assessment tool.

PubMed

Tappin, D C; Bentley, T A; Ashby, L E

2015-03-01

Safety culture has been identified as a critical element of healthy and safe workplaces and as such warrants the attention of ergonomists involved in occupational health and safety (OHS). This study sought to evaluate a tool for assessing organisational safety culture as it impacts a common OHS problem: musculoskeletal disorders (MSD). The level of advancement across nine cultural aspects was assessed in two implementation site organisations. These organisations, in residential healthcare and timber processing, enabled evaluation of the tool in contrasting settings, with reported MSD rates also high in both sectors. Interviews were conducted with 39 managers and workers across the two organisations. Interview responses and company documentation were compared by two researchers to the descriptor items for each MSD culture aspect. An assignment of the level of advancement, using a five stage framework, was made for each aspect. The tool was readily adapted to each implementation site context and provided sufficient evidence to assess their levels of advancement. Assessments for most MSD culture aspects were in the mid to upper levels of advancement, although the levels differed within each organisation, indicating that different aspects of MSD culture, as with safety culture, develop at a different pace within organisations. Areas for MSD culture improvement were identified for each organisation. Reflections are made on the use and merits of the tool by ergonomists for addressing MSD risk. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Implementation of team training in medical education in Denmark

PubMed Central

Ostergaard, H; Ostergaard, D; Lippert, A

2004-01-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed. PMID:15465962

Implementation of team training in medical education in Denmark.

PubMed

Østergaard, H T; Østergaard, D; Lippert, A

2004-10-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed.

Implementation of team training in medical education in Denmark.

PubMed

Østergaard, H T; Østergaard, D; Lippert, A

2008-10-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed.

Helping Birmingham Families Early: The "Signs of Safety and Well-Being" Practice Framework

ERIC Educational Resources Information Center

Stanley, Tony; Keenan, Karol; Roberts, Dawn; Moore, Richard

2018-01-01

Rising demand for early help services is currently taking place against a backdrop of closing or reduced services and shrinking public authority budgets across England. Complicating matters is the wide variety of service orientations and differences in assessments offered to vulnerable families. This can be confusing for them. Moreover, this is an…

Development of hospital disaster resilience: conceptual framework and potential measurement.

PubMed

Zhong, Shuang; Clark, Michele; Hou, Xiang-Yu; Zang, Yu-Li; Fitzgerald, Gerard

2014-11-01

Despite 'hospital resilience' gaining prominence in recent years, it remains poorly defined. This article aims to define hospital resilience, build a preliminary conceptual framework and highlight possible approaches to measurement. Searches were conducted of the commonly used health databases to identify relevant literature and reports. Search terms included 'resilience and framework or model' or 'evaluation or assess or measure and hospital and disaster or emergency or mass casualty and resilience or capacity or preparedness or response or safety'. Articles were retrieved that focussed on disaster resilience frameworks and the evaluation of various hospital capacities. A total of 1480 potentially eligible publications were retrieved initially but the final analysis was conducted on 47 articles, which appeared to contribute to the study objectives. Four disaster resilience frameworks and 11 evaluation instruments of hospital disaster capacity were included. Hospital resilience is a comprehensive concept derived from existing disaster resilience frameworks. It has four key domains: hospital safety; disaster preparedness and resources; continuity of essential medical services; recovery and adaptation. These domains were categorised according to four criteria, namely, robustness, redundancy, resourcefulness and rapidity. A conceptual understanding of hospital resilience is essential for an intellectual basis for an integrated approach to system development. This article (1) defines hospital resilience; (2) constructs conceptual framework (including key domains); (3) proposes comprehensive measures for possible inclusion in an evaluation instrument; and (4) develops a matrix of critical issues to enhance hospital resilience to cope with future disasters. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

PubMed

Robinson, Susan N; Neyens, David M; Diller, Thomas

Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

A framework for the implementation of new radiation therapy technologies and treatment techniques in low-income countries.

PubMed

Brown, Derek W; Shulman, Adam; Hudson, Alana; Smith, Wendy; Fisher, Brandon; Hollon, Jon; Pipman, Yakov; Van Dyk, Jacob; Einck, John

2014-11-01

We present a practical, generic, easy-to-use framework for the implementation of new radiation therapy technologies and treatment techniques in low-income countries. The framework is intended to standardize the implementation process, reduce the effort involved in generating an implementation strategy, and provide improved patient safety by reducing the likelihood that steps are missed during the implementation process. The 10 steps in the framework provide a practical approach to implementation. The steps are, 1) Site and resource assessment, 2) Evaluation of equipment and funding, 3) Establishing timelines, 4) Defining the treatment process, 5) Equipment commissioning, 6) Training and competency assessment, 7) Prospective risk analysis, 8) System testing, 9) External dosimetric audit and incident learning, and 10) Support and follow-up. For each step, practical advice for completing the step is provided, as well as links to helpful supplementary material. An associated checklist is provided that can be used to track progress through the steps in the framework. While the emphasis of this paper is on addressing the needs of low-income countries, the concepts also apply in high-income countries. Copyright © 2014 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Frameworks for Assessing the Quality of Modeling and Simulation Capabilities

NASA Astrophysics Data System (ADS)

Rider, W. J.

2012-12-01

The importance of assuring quality in modeling and simulation has spawned several frameworks for structuring the examination of quality. The format and content of these frameworks provides an emphasis, completeness and flow to assessment activities. I will examine four frameworks that have been developed and describe how they can be improved and applied to a broader set of high consequence applications. Perhaps the first of these frameworks was known as CSAU [Boyack] (code scaling, applicability and uncertainty) used for nuclear reactor safety and endorsed the United States' Nuclear Regulatory Commission (USNRC). This framework was shaped by nuclear safety practice, and the practical structure needed after the Three Mile Island accident. It incorporated the dominant experimental program, the dominant analysis approach, and concerns about the quality of modeling. The USNRC gave it the force of law that made the nuclear industry take it seriously. After the cessation of nuclear weapons' testing the United States began a program of examining the reliability of these weapons without testing. This program utilizes science including theory, modeling, simulation and experimentation to replace the underground testing. The emphasis on modeling and simulation necessitated attention on the quality of these simulations. Sandia developed the PCMM (predictive capability maturity model) to structure this attention [Oberkampf]. PCMM divides simulation into six core activities to be examined and graded relative to the needs of the modeling activity. NASA [NASA] has built yet another framework in response to the tragedy of the space shuttle accidents. Finally, Ben-Haim and Hemez focus upon modeling robustness and predictive fidelity in another approach. These frameworks are similar, and applied in a similar fashion. The adoption of these frameworks at Sandia and NASA has been slow and arduous because the force of law has not assisted acceptance. All existing frameworks are incomplete and need to be extended incorporating elements from the other as well as new elements related to how models are solved, and how the model will be applied. I will describe this merger of approach and how it should be applied. The problems in adoption are related to basic human nature in that no one likes to be graded, or told they are not sufficiently quality oriented. Rather than engage in an adversarial role, I suggest that the frameworks be viewed as a collaborative tool. Instead these frameworks should be used to structure collaborations that can be used to assist the modeling and simulation efforts to be high quality. The framework provides a comprehensive setting of modeling and simulation themes that should be explored in providing high quality. W. Oberkampf, M. Pilch, and T. Trucano, Predictive Capability Maturity Model for Computational Modeling and Simulation, SAND2007-5948, 2007. B. Boyack, Quantifying Reactor Safety Margins Part 1: An Overview of the Code Scaling, Applicability, and Uncertainty Evaluation Methodology, Nuc. Eng. Design, 119, pp. 1-15, 1990. National Aeronautics and Space Administration, STANDARD FOR MODELS AND SIMULATIONS, NASA-STD-7009, 2008. Y. Ben-Haim and F. Hemez, Robustness, fidelity and prediction-looseness of models, Proc. R. Soc. A (2012) 468, 227-244.

A strategic framework for the development and enhancement of safety culture in the artificial tanning sector in Greece.

PubMed

Petri, Aspasia; Karabetsos, Efthymios

2018-06-08

Herein, the strategic framework for the development and enhancement of safety culture in the artificial tanning sector in Greece is presented. This framework has been designed and promoted by the competent national regulatory authority, which is the Greek Atomic Energy Commission (EEAE). The aim is to ensure a common understanding regarding ultraviolet radiation (UVR) and artificial tanning among the artificial tanning professionals, the stakeholders and the general public. The strategic framework is founded on the international organizations' recommendations, the EU requirements and the relevant technical standards. It is comprised of three autonomous but interconnected components: A) A sunbed operators' e-training course and certification process, B) A code of practice addressed individually to the business owners, the sunbeds operators and the sunbeds users, C) Communication strategies aiming to raise awareness regarding UVR and artificial tanning to all the interested parties. The artificial tanning safety culture framework presented here is the policy option that EEAE undertook and it is embedded in the upcoming legislation and regulations for the provision of artificial tanning services in Greece. EEAE considers that the structure of the artificial tanning safety culture strategic framework will serve as the guide for the development and promotion of relevant safety culture strategic frameworks for the provision of aesthetic/wellness services that utilize other non-ionizing radiation sources, which currently don't exist. © 2018 IOP Publishing Ltd.

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

PubMed

Welp, Annalena; Manser, Tanja

2016-07-19

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

A 3S Risk ?3SR? Assessment Approach for Nuclear Power: Safety Security and Safeguards.

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

Forrest, Robert; Reinhardt, Jason Christian; Wheeler, Timothy A.

Safety-focused risk analysis and assessment approaches struggle to adequately include malicious, deliberate acts against the nuclear power industry's fissile and waste material, infrastructure, and facilities. Further, existing methods do not adequately address non- proliferation issues. Treating safety, security, and safeguards concerns independently is inefficient because, at best, it may not take explicit advantage of measures that provide benefits against multiple risk domains, and, at worst, it may lead to implementations that increase overall risk due to incompatibilities. What is needed is an integrated safety, security and safeguards risk (or "3SR") framework for describing and assessing nuclear power risks that canmore » enable direct trade-offs and interactions in order to inform risk management processes -- a potential paradigm shift in risk analysis and management. These proceedings of the Sandia ePRA Workshop (held August 22-23, 2017) are an attempt to begin the discussions and deliberations to extend and augment safety focused risk assessment approaches to include security concerns and begin moving towards a 3S Risk approach. Safeguards concerns were not included in this initial workshop and are left to future efforts. This workshop focused on four themes in order to begin building out a the safety and security portions of the 3S Risk toolkit: 1. Historical Approaches and Tools 2. Current Challenges 3. Modern Approaches 4. Paths Forward and Next Steps This report is organized along the four areas described above, and concludes with a summary of key points. 2 Contact: rforres@sandia.gov; +1 (925) 294-2728« less

Implications of applying cumulative risk assessment to the workplace.

PubMed

Fox, Mary A; Spicer, Kristen; Chosewood, L Casey; Susi, Pam; Johns, Douglas O; Dotson, G Scott

2018-06-01

Multiple changes are influencing work, workplaces and workers in the US including shifts in the main types of work and the rise of the 'gig' economy. Work and workplace changes have coincided with a decline in unions and associated advocacy for improved safety and health conditions. Risk assessment has been the primary method to inform occupational and environmental health policy and management for many types of hazards. Although often focused on one hazard at a time, risk assessment frameworks and methods have advanced toward cumulative risk assessment recognizing that exposure to a single chemical or non-chemical stressor rarely occurs in isolation. We explore how applying cumulative risk approaches may change the roles of workers and employers as they pursue improved health and safety and elucidate some of the challenges and opportunities that might arise. Application of cumulative risk assessment should result in better understanding of complex exposures and health risks with the potential to inform more effective controls and improved safety and health risk management overall. Roles and responsibilities of both employers and workers are anticipated to change with potential for a greater burden of responsibility on workers to address risk factors both inside and outside the workplace that affect health at work. A range of policies, guidance and training have helped develop cumulative risk assessment for the environmental health field and similar approaches are available to foster the practice in occupational safety and health. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Role of Interpersonal Relations in Healthcare Team Communication and Patient Safety: A Proposed Model of Interpersonal Process in Teamwork.

PubMed

Lee, Charlotte Tsz-Sum; Doran, Diane Marie

2017-06-01

Patient safety is compromised by medical errors and adverse events related to miscommunications among healthcare providers. Communication among healthcare providers is affected by human factors, such as interpersonal relations. Yet, discussions of interpersonal relations and communication are lacking in healthcare team literature. This paper proposes a theoretical framework that explains how interpersonal relations among healthcare team members affect communication and team performance, such as patient safety. We synthesized studies from health and social science disciplines to construct a theoretical framework that explicates the links among these constructs. From our synthesis, we identified two relevant theories: framework on interpersonal processes based on social relation model and the theory of relational coordination. The former involves three steps: perception, evaluation, and feedback; and the latter captures relational communicative behavior. We propose that manifestations of provider relations are embedded in the third step of the framework on interpersonal processes: feedback. Thus, varying team-member relationships lead to varying collaborative behavior, which affects patient-safety outcomes via a change in team communication. The proposed framework offers new perspectives for understanding how workplace relations affect healthcare team performance. The framework can be used by nurses, administrators, and educators to improve patient safety, team communication, or to resolve conflicts.

Safety assessment on pedestrian crossing environments using MLS data.

PubMed

Soilán, Mario; Riveiro, Belén; Sánchez-Rodríguez, Ana; Arias, Pedro

2018-02-01

In the framework of infrastructure analysis and maintenance in an urban environment, it is important to address the safety of every road user. This paper presents a methodology for the evaluation of several safety indicators on pedestrian crossing environments using geometric and radiometric information extracted from 3D point clouds collected by a Mobile Mapping System (MMS). The methodology is divided in four main modules which analyze the accessibility of the crossing area, the presence of traffic lights and traffic signs, and the visibility between a driver and a pedestrian on the proximities of a pedestrian crossing. The outputs of the analysis are exported to a Geographic Information System (GIS) where they are visualized and can be further processed in the context of city management. The methodology has been tested on approximately 30 pedestrian crossings in cluttered urban environments of two different cities. Results show that MMS are a valid mean to assess the safety of a specific urban environment, regarding its geometric conditions. Remarkable results are presented on traffic light classification, with a global F-score close to 95%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Risk management for the Space Exploration Initiative

NASA Technical Reports Server (NTRS)

Buchbinder, Ben

1993-01-01

Probabilistic Risk Assessment (PRA) is a quantitative engineering process that provides the analytic structure and decision-making framework for total programmatic risk management. Ideally, it is initiated in the conceptual design phase and used throughout the program life cycle. Although PRA was developed for assessment of safety, reliability, and availability risk, it has far greater application. Throughout the design phase, PRA can guide trade-off studies among system performance, safety, reliability, cost, and schedule. These studies are based on the assessment of the risk of meeting each parameter goal, with full consideration of the uncertainties. Quantitative trade-off studies are essential, but without full identification, propagation, and display of uncertainties, poor decisions may result. PRA also can focus attention on risk drivers in situations where risk is too high. For example, if safety risk is unacceptable, the PRA prioritizes the risk contributors to guide the use of resources for risk mitigation. PRA is used in the Space Exploration Initiative (SEI) Program. To meet the stringent requirements of the SEI mission, within strict budgetary constraints, the PRA structure supports informed and traceable decision-making. This paper briefly describes the SEI PRA process.

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

PubMed

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

2017-02-01

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

A modular Human Exposure Model (HEM) framework to ...

EPA Pesticide Factsheets

Life Cycle Impact Analysis (LCIA) has proven to be a valuable tool for systematically comparing processes and products, and has been proposed for use in Chemical Alternatives Analysis (CAA). The exposure assessment portion of the human health impact scores of LCIA has historically focused on far-field sources (environmentally mediated exposures) while research has shown that use related exposures, (near-field exposures) typically dominate population exposure. Characterizing the human health impacts of chemicals in consumer products over the life cycle of these products requires an evaluation of both near-field as well far-field sources. Assessing the impacts of the near-field exposures requires bridging the scientific and technical gaps that currently prevent the harmonious use of the best available methods and tools from the fields of LCIA and human health exposure and risk assessment. The U.S. EPA’s Chemical Safety and Sustainability LC-HEM project is developing the Human Exposure Model (HEM) to assess near-field exposures to chemicals that occur to various populations over the life cycle of a commercial product. The HEM will be a publically available, web-based, modular system which will allow for the evaluation of chemical/product impacts in a LCIA framework to support CAA. We present here an overview of the framework for the modular HEM system. The framework includes a data flow diagram of in-progress and future planned modules, the definition of each mod

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

NASA Astrophysics Data System (ADS)

Klicker, M.; Putzer, H.

2012-01-01

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

Comparing models for quantitative risk assessment: an application to the European Registry of foreign body injuries in children.

PubMed

Berchialla, Paola; Scarinzi, Cecilia; Snidero, Silvia; Gregori, Dario

2016-08-01

Risk Assessment is the systematic study of decisions subject to uncertain consequences. An increasing interest has been focused on modeling techniques like Bayesian Networks since their capability of (1) combining in the probabilistic framework different type of evidence including both expert judgments and objective data; (2) overturning previous beliefs in the light of the new information being received and (3) making predictions even with incomplete data. In this work, we proposed a comparison among Bayesian Networks and other classical Quantitative Risk Assessment techniques such as Neural Networks, Classification Trees, Random Forests and Logistic Regression models. Hybrid approaches, combining both Classification Trees and Bayesian Networks, were also considered. Among Bayesian Networks, a clear distinction between purely data-driven approach and combination of expert knowledge with objective data is made. The aim of this paper consists in evaluating among this models which best can be applied, in the framework of Quantitative Risk Assessment, to assess the safety of children who are exposed to the risk of inhalation/insertion/aspiration of consumer products. The issue of preventing injuries in children is of paramount importance, in particular where product design is involved: quantifying the risk associated to product characteristics can be of great usefulness in addressing the product safety design regulation. Data of the European Registry of Foreign Bodies Injuries formed the starting evidence for risk assessment. Results showed that Bayesian Networks appeared to have both the ease of interpretability and accuracy in making prediction, even if simpler models like logistic regression still performed well. © The Author(s) 2013.

Visualizing variations in organizational safety culture across an inter-hospital multifaceted workforce.

PubMed

Kobuse, Hiroe; Morishima, Toshitaka; Tanaka, Masayuki; Murakami, Genki; Hirose, Masahiro; Imanaka, Yuichi

2014-06-01

To develop a reliable and valid questionnaire that can distinguish features of organizational culture for patient safety across subgroups such as hospitals, professions, management/non-management positions and units/wards. We developed a Hospital Organizational Culture Questionnaire based on a conceptual framework incorporating items from a review of existing literature. The questionnaire was administered to hospital staff including doctors, nurses, allied health personnel, and administrative staff at six public hospitals in Japan. Reliability and validity were assessed through exploratory factor analysis, multitrait scaling analysis, Cronbach's alpha coefficient and multiple regression analysis using staff-perceived achievement of safety as the response variable. Discriminative power across subgroups was assessed with radar chart profiling. Of the 3304 hospital staff surveyed, 2924 (88.5%) responded. After exploratory factor analysis and multitrait analysis, the finalized questionnaire was composed of 24 items in the following eight dimensions: improvement orientation, passion for mission, professional growth, resource allocation prioritization, inter-sectional collaboration, responsibility and authority, teamwork, and information sharing. Construct validity and internal consistency of dimensions were confirmed with multitrait analysis and Cronbach's alpha coefficients, respectively. Multiple regression analysis showed that improvement orientation, passion for mission, resource allocation prioritization and information sharing were significantly associated with higher achievement in safety practices. Our questionnaire tool was able to distinguish features of safety culture among different subgroups. Our questionnaire demonstrated excellent validity and reliability, and revealed distinct cultural patterns among different subgroups. Quantitative assessment of organizational safety culture with this tool may further the understanding of associated characteristics of each subgroup and provide insight into organizational readiness for patient safety improvement. © 2014 John Wiley & Sons, Ltd.

A strategic approach for Water Safety Plans implementation in Portugal.

PubMed

Vieira, Jose M P

2011-03-01

Effective risk assessment and risk management approaches in public drinking water systems can benefit from a systematic process for hazards identification and effective management control based on the Water Safety Plan (WSP) concept. Good results from WSP development and implementation in a small number of Portuguese water utilities have shown that a more ambitious nationwide strategic approach to disseminate this methodology is needed. However, the establishment of strategic frameworks for systematic and organic scaling-up of WSP implementation at a national level requires major constraints to be overcome: lack of legislation and policies and the need for appropriate monitoring tools. This study presents a framework to inform future policy making by understanding the key constraints and needs related to institutional, organizational and research issues for WSP development and implementation in Portugal. This methodological contribution for WSP implementation can be replicated at a global scale. National health authorities and the Regulator may promote changes in legislation and policies. Independent global monitoring and benchmarking are adequate tools for measuring the progress over time and for comparing the performance of water utilities. Water utilities self-assessment must include performance improvement, operational monitoring and verification. Research and education and resources dissemination ensure knowledge acquisition and transfer.

Advancing the adverse outcome pathway framework and its ...

EPA Pesticide Factsheets

Regulatory agencies worldwide are confronted with the challenging task of assessing the risks of thousands of chemicals to protect both human health and the environment. Traditional toxicity testing largely relies on apical endpoints from whole animal studies, which, in addition to ethical concerns, is costly and time prohibitive. As a result, the utility of mechanism-based in silico, in vitro, and in vivo approaches to support chemical safety evaluations have increasingly been explored. An approach that has gained traction for capturing available knowledge describing the linkage between mechanistic data and apical toxicity endpoints, required for regulatory assessments, is the adverse outcome pathway (AOP) framework. A number of international workshops and expert meetings have been held over the past years focusing on the AOP framework and its applications to chemical risk assessment. Although, these interactions have illustrated the necessity of expert guidance in moving the science of AOPs and their applications forward, there is also the recognition that a broader survey of the scientific community could be useful in guiding future initiatives in the AOP arena. To that end, a Horizon Scanning exercise was conducted to solicit questions from the global scientific community concerning the challenges or limitations that must be addressed in order to realize the full potential of the AOP framework in research and regulatory decision making. Over a 4 month ques

Implementation guide for monitoring work zone safety and mobility impacts

DOT National Transportation Integrated Search

2009-01-01

This implementation guide describes the conceptual framework, data requirements, and computational procedures for determining the safety and mobility impacts of work zones in Texas. Researchers designed the framework and procedures to assist district...

A conceptual framework for road safety and mobility applied to cycling safety.

PubMed

Schepers, Paul; Hagenzieker, Marjan; Methorst, Rob; van Wee, Bert; Wegman, Fred

2014-01-01

Scientific literature lacks a model which combines exposure to risk, risk, and the relationship between them. This paper presents a conceptual road safety framework comprising mutually interacting factors for exposure to risk resulting from travel behaviour (volumes, modal split, and distribution of traffic over time and space) and for risk (crash and injury risk). The framework's three determinants for travel behaviour are locations of activities; resistances (generalized transport costs); needs, opportunities, and abilities. Crash and injury risks are modelled by the three 'safety pillars': infrastructure, road users and the vehicles they use. Creating a link in the framework between risk and exposure is important because of the 'non-linear relationship' between them, i.e. risk tends to decrease as exposure increases. Furthermore, 'perceived' risk (a type of travel resistance) plays a role in mode choice, i.e. the perception that a certain type of vehicle is unsafe can be a deterrent to its use. This paper uses theories to explain how the elements in the model interact. Cycling is an area where governments typically have goals for both mobility and safety. To exemplify application of the model, the paper uses the framework to link research on cycling (safety) to land use and infrastructure. The model's value lies in its ability to identify potential consequences of measures and policies for both exposure and risk. This is important from a scientific perspective and for policy makers who often have objectives for both mobility and safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

'Governance of' and 'Governance by': implementing a clinical governance framework in an area mental health service.

PubMed

O'Connor, Nick; Paton, Michael

2008-04-01

A framework developed to promote the understanding and application of clinical governance principles in an area mental health service is described. The framework is operationalized through systems, processes, roles and responsibilities. The development of an explicit and operationalizable framework for clinical governance arose from the authors' experiences in leading and managing mental health services. There is a particular emphasis on improvement of quality of care and patient safety. The framework is informed by recent developments in thinking about clinical governance, including key documents from Australia and the United Kingdom. The operational nature of the framework allows for key components of clinical governance to be described explicitly, communicated effectively, and continually tested and improved. Further consideration and assessment of the value of differing approaches to this task are required. For example, a general, illustrative approach to raise clinician awareness can be contrasted with prescriptive and specified approaches which progressively encompass the many functions and processes of a mental health service. Mental health clinicians and managers can be guided by a framework that will ensure safe, high quality and continually improving processes of care.

Consumer confidence in the safety of food and newspaper coverage of food safety issues: a longitudinal perspective.

PubMed

de Jonge, Janneke; Van Trijp, Hans; Renes, Reint Jan; Frewer, Lynn J

2010-01-01

This study develops a longitudinal perspective on consumer confidence in the safety of food to explore if, how, and why consumer confidence changes over time. In the first study, a theory-based monitoring instrument for consumer confidence in the safety of food was developed and validated. The monitoring instrument assesses consumer confidence together with its determinants. Model and measurement invariance were validated rigorously before developments in consumer confidence in the safety of food and its determinants were investigated over time. The results from the longitudinal analysis show that across four waves of annual data collection (2003-2006), the framework was stable and that the relative importance of the determinants of confidence was, generally, constant over time. Some changes were observed regarding the mean ratings on the latent constructs. The second study explored how newspaper coverage of food safety related issues affects consumer confidence in the safety of food through subjective consumer recall of food safety incidents. The results show that the newspaper coverage on food safety issues is positively associated with consumer recall of food safety incidents, both in terms of intensity and recency of media coverage.

A multi-agent safety response model in the construction industry.

PubMed

Meliá, José L

2015-01-01

The construction industry is one of the sectors with the highest accident rates and the most serious accidents. A multi-agent safety response approach allows a useful diagnostic tool in order to understand factors affecting risk and accidents. The special features of the construction sector can influence the relationships among safety responses along the model of safety influences. The purpose of this paper is to test a model explaining risk and work-related accidents in the construction industry as a result of the safety responses of the organization, the supervisors, the co-workers and the worker. 374 construction employees belonging to 64 small Spanish construction companies working for two main companies participated in the study. Safety responses were measured using a 45-item Likert-type questionnaire. The structure of the measure was analyzed using factor analysis and the model of effects was tested using a structural equation model. Factor analysis clearly identifies the multi-agent safety dimensions hypothesized. The proposed safety response model of work-related accidents, involving construction specific results, showed a good fit. The multi-agent safety response approach to safety climate is a useful framework for the assessment of organizational and behavioral risks in construction.

How Adverse Outcome Pathways Can Aid the Development and Use of Computational Prediction Models for Regulatory Toxicology

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

Wittwehr, Clemens; Aladjov, Hristo; Ankley, Gerald

Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework has emerged as a systematic approach for organizing knowledge that supports such inference. We argue that this systematic organization of knowledge can inform and help direct the design and development of computational prediction models that can further enhance the utility of mechanistic and in silico data for chemical safety assessment.more » Examples of AOP-informed model development and its application to the assessment of chemicals for skin sensitization and multiple modes of endocrine disruption are provided. The role of problem formulation, not only as a critical phase of risk assessment, but also as guide for both AOP and complementary model development described. Finally, a proposal for actively engaging the modeling community in AOP-informed computational model development is made. The contents serve as a vision for how AOPs can be leveraged to facilitate development of computational prediction models needed to support the next generation of chemical safety assessment.« less

How adverse outcome pathways can aid the development and ...

EPA Pesticide Factsheets

Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework has emerged as a systematic approach for organizing knowledge that supports such inference. We argue that this systematic organization of knowledge can inform and help direct the design and development of computational prediction models that can further enhance the utility of mechanistic and in silico data for chemical safety assessment. Examples of AOP-informed model development and its application to the assessment of chemicals for skin sensitization and multiple modes of endocrine disruption are provided. The role of problem formulation, not only as a critical phase of risk assessment, but also as guide for both AOP and complementary model development described. Finally, a proposal for actively engaging the modeling community in AOP-informed computational model development is made. The contents serve as a vision for how AOPs can be leveraged to facilitate development of computational prediction models needed to support the next generation of chemical safety assessment. The present manuscript reports on expert opinion and case studies that came out of a European Commission, Joint Research Centre-sponsored work

To what extent can theory account for the findings of road safety evaluation studies?

PubMed

Elvik, Rune

2004-09-01

This paper proposes a conceptual framework that can be used to assess to what extent the findings of road safety evaluation research make sense from a theoretical point of view. The effects of road safety measures are modelled as passing through two causal chains. One of these, termed the engineering effect, refers to the intended effects of a road safety measure on a set of risk factors related to accident occurrence or injury severity. The engineering effect of road safety measures is modelled in terms of nine basic risk factors, one or more of which any road safety measure needs to influence in order to have the intended effect on accidents or injuries. The other causal chain producing the effects of road safety measures is termed the behavioural effect, and refers to road user behavioural adaptations to road safety measures. The behavioural effect is related to the engineering effect, in the sense that certain properties of the engineering effect of a road safety measure influence the likelihood that behavioural adaptation will occur. The behavioural effect of a road safety measure is modelled in terms of six factors that influence the likelihood that behavioural adaptation will occur. The nine basic risk factors representing the engineering effect of a road safety measure, and the six factors influencing the likelihood of behavioural adaptation can be used as checklists in assessing whether or not the findings of road safety evaluation studies make sense from a theoretical point of view. At the current state of knowledge, a more stringent evaluation of the extent to which theory can explain the findings of road safety evaluation studies is, in most cases, not possible. Copyright 2003 Elsevier Ltd.

Incorporating New Technologies Into Toxicity Testing and Risk Assessment: Moving From 21st Century Vision to a Data-Driven Framework

PubMed Central

Thomas, Russell S.

2013-01-01

Based on existing data and previous work, a series of studies is proposed as a basis toward a pragmatic early step in transforming toxicity testing. These studies were assembled into a data-driven framework that invokes successive tiers of testing with margin of exposure (MOE) as the primary metric. The first tier of the framework integrates data from high-throughput in vitro assays, in vitro-to-in vivo extrapolation (IVIVE) pharmacokinetic modeling, and exposure modeling. The in vitro assays are used to separate chemicals based on their relative selectivity in interacting with biological targets and identify the concentration at which these interactions occur. The IVIVE modeling converts in vitro concentrations into external dose for calculation of the point of departure (POD) and comparisons to human exposure estimates to yield a MOE. The second tier involves short-term in vivo studies, expanded pharmacokinetic evaluations, and refined human exposure estimates. The results from the second tier studies provide more accurate estimates of the POD and the MOE. The third tier contains the traditional animal studies currently used to assess chemical safety. In each tier, the POD for selective chemicals is based primarily on endpoints associated with a proposed mode of action, whereas the POD for nonselective chemicals is based on potential biological perturbation. Based on the MOE, a significant percentage of chemicals evaluated in the first 2 tiers could be eliminated from further testing. The framework provides a risk-based and animal-sparing approach to evaluate chemical safety, drawing broadly from previous experience but incorporating technological advances to increase efficiency. PMID:23958734

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

PubMed

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

Development and delivery of clinical pharmacology in regulatory agencies

PubMed Central

Breckenridge, Alasdair

2012-01-01

Medicines regulation is based on a foundation of science, policy and judgement. It operates within several frameworks (scientific, legal and public health), which are interdependent. While safety, quality and efficacy remain the criteria by which medicines are assessed, the benefit-to-harm balance for any medicine or medical device is of paramount importance. While the regulator was hitherto the gatekeeper who allowed a medicine on to the market, payers now require, in addition, assessment of cost and clinical effectiveness before use. As regulatory frameworks develop, several changes will occur, as follows: (i) formal benefit–harm assessment will become an integral part of submission for marketing authorizations; (ii) there will be greater use of surveillance for adverse reactions to new medicines using methods other than voluntary reporting; (iii) risk management plans will become benefit–risk management plans; (iv) life-saving medicines will be approved earlier; and (v) regulation and health technology assessment will take place simultaneously. Clinical pharmacologists will play important roles in these developments. PMID:22360651

Payload Safety: Risk and Characteristic-Based Control of Engineered Nanomaterials

NASA Astrophysics Data System (ADS)

Abou, Seraphin Chally; Saad, Maarouf

2013-09-01

In the last decade progress has been made to assist organizations that are developing payloads intended for flight on the International Space Station (ISS) and/or Space Shuttle. Collaboration programs for comprehensive risk assessment have been initiated between the U.S. and the European Union to generate requirements and data needed to comply with payloads safety and to perform risk assessment and controls guidance. Yet, substantial research gaps remain, as do challenges in the translation of these research findings to control for exposure to nanoscale material payloads, and the health effects. Since nanomaterial structures are different from traditional molecules, some standard material properties can change at size of 50nm or less. Changes in material properties at this scale challenge our understanding of hazards posed by nanomaterial payloads in the ISS realistic exposure conditions, and our ability to anticipate, evaluate, and control potential health issues, and safety. The research question addressed in this framework is: what kind of descriptors can be developed for nanomaterial payloads risks assessment? Methods proposed incorporate elements of characteristic- based risk an alysis: (1) to enable characterization of anthropogenic nanomaterials which can result in incidental from natural nanoparticles; and (2) to better understand safety attributes in terms of human health impacts from exposure to varying types of engineered nanomaterials.

Validation of a Framework for Measuring Hospital Disaster Resilience Using Factor Analysis

PubMed Central

Zhong, Shuang; Clark, Michele; Hou, Xiang-Yu; Zang, Yuli; FitzGerald, Gerard

2014-01-01

Hospital disaster resilience can be defined as “the ability of hospitals to resist, absorb, and respond to the shock of disasters while maintaining and surging essential health services, and then to recover to its original state or adapt to a new one.” This article aims to provide a framework which can be used to comprehensively measure hospital disaster resilience. An evaluation framework for assessing hospital resilience was initially proposed through a systematic literature review and Modified-Delphi consultation. Eight key domains were identified: hospital safety, command, communication and cooperation system, disaster plan, resource stockpile, staff capability, disaster training and drills, emergency services and surge capability, and recovery and adaptation. The data for this study were collected from 41 tertiary hospitals in Shandong Province in China, using a specially designed questionnaire. Factor analysis was conducted to determine the underpinning structure of the framework. It identified a four-factor structure of hospital resilience, namely, emergency medical response capability (F1), disaster management mechanisms (F2), hospital infrastructural safety (F3), and disaster resources (F4). These factors displayed good internal consistency. The overall level of hospital disaster resilience (F) was calculated using the scoring model: F = 0.615F1 + 0.202F2 + 0.103F3 + 0.080F4. This validated framework provides a new way to operationalise the concept of hospital resilience, and it is also a foundation for the further development of the measurement instrument in future studies. PMID:24945190

Assessing Drinking Water Quality and Water Safety Management in Sub-Saharan Africa Using Regulated Monitoring Data.

PubMed

Kumpel, Emily; Peletz, Rachel; Bonham, Mateyo; Khush, Ranjiv

2016-10-18

Universal access to safe drinking water is prioritized in the post-2015 Sustainable Development Goals. Collecting reliable and actionable water quality information in low-resource settings, however, is challenging, and little is known about the correspondence between water quality data collected by local monitoring agencies and global frameworks for water safety. Using 42 926 microbial water quality test results from 32 surveillance agencies and water suppliers in seven sub-Saharan African countries, we determined the degree to which water sources were monitored, how water quality varied by source type, and institutional responses to results. Sixty-four percent of the water samples were collected from piped supplies, although the majority of Africans rely on nonpiped sources. Piped supplies had the lowest levels of fecal indicator bacteria (FIB) compared to any other source type: only 4% of samples of water piped to plots and 2% of samples from water piped to public taps/standpipes were positive for FIB (n = 14 948 and n = 12 278, respectively). Among other types of improved sources, samples from harvested rainwater and boreholes were less often positive for FIB (22%, n = 167 and 31%, n = 3329, respectively) than protected springs or protected dug wells (39%, n = 472 and 65%, n = 505). When data from different settings were aggregated, the FIB levels in different source types broadly reflected the source-type water safety framework used by the Joint Monitoring Programme. However, the insufficient testing of nonpiped sources relative to their use indicates important gaps in current assessments. Our results emphasize the importance of local data collection for water safety management and measurement of progress toward universal safe drinking water access.

The Euratom Seventh Framework Programme FP7 (2007-2011)

NASA Astrophysics Data System (ADS)

Garbil, R.

2010-10-01

The objective of the Seventh Euratom Framework Program in the area of nuclear fission and radiation protection is to establish a sound scientific and technical basis to accelerate practical developments of nuclear energy related to resource efficiency, enhancing safety performance, cost-effectiveness and safer management of long-lived radioactive waste. Key cross-cutting topics such as the nuclear fuel cycle, actinide chemistry, risk analysis, safety assessment, even societal and governance issues are linked to the individual technical areas. Research need to explore new scientific and techno- logical opportunities and to respond in a flexible way to new policy needs that arise. The following activities are to be pursued. (a) Management of radioactive waste, research on partitioning and transmutation and/or other concepts aimed at reducing the amount and/or hazard of the waste for disposal; (b) Reactor systems research to underpin the con- tinued safe operation of all relevant types of existing reactor systems (including fuel cycle facilities), life-time extension, development of new advanced safety assessment methodologies and waste-management aspects of future reactor systems; (c) Radiation protection research in particular on the risks from low doses on medical uses and on the management of accidents; (d) Infrastructures and support given to the availability of, and cooperation between, research infrastructures necessary to maintain high standards of technical achievement, innovation and safety in the European nuclear sector and Research Area. (e) Human resources, mobility and training support to be provided for the retention and further development of scientific competence, human capacity through joint training activities in order to guarantee the availability of suitably qualified researchers, engineers and employees in the nuclear sector over the longer term.

Seismic assessment of Technical Area V (TA-V).

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

Medrano, Carlos S.

The Technical Area V (TA-V) Seismic Assessment Report was commissioned as part of Sandia National Laboratories (SNL) Self Assessment Requirement per DOE O 414.1, Quality Assurance, for seismic impact on existing facilities at Technical Area-V (TA-V). SNL TA-V facilities are located on an existing Uniform Building Code (UBC) Seismic Zone IIB Site within the physical boundary of the Kirtland Air Force Base (KAFB). The document delineates a summary of the existing facilities with their safety-significant structure, system and components, identifies DOE Guidance, conceptual framework, past assessments and the present Geological and Seismic conditions. Building upon the past information and themore » evolution of the new seismic design criteria, the document discusses the potential impact of the new standards and provides recommendations based upon the current International Building Code (IBC) per DOE O 420.1B, Facility Safety and DOE G 420.1-2, Guide for the Mitigation of Natural Phenomena Hazards for DOE Nuclear Facilities and Non-Nuclear Facilities.« less

Spatial modeling of personalized exposure dynamics: the case of pesticide use in small-scale agricultural production landscapes of the developing world.

PubMed

Leyk, Stefan; Binder, Claudia R; Nuckols, John R

2009-03-30

Pesticide poisoning is a global health issue with the largest impacts in the developing countries where residential and small-scale agricultural areas are often integrated and pesticides sprayed manually. To reduce health risks from pesticide exposure approaches for personalized exposure assessment (PEA) are needed. We present a conceptual framework to develop a spatial individual-based model (IBM) prototype for assessing potential exposure of farm-workers conducting small-scale agricultural production, which accounts for a considerable portion of global food crop production. Our approach accounts for dynamics in the contaminant distributions in the environment, as well as patterns of movement and activities performed on an individual level under different safety scenarios. We demonstrate a first prototype using data from a study area in a rural part of Colombia, South America. Different safety scenarios of PEA were run by including weighting schemes for activities performed under different safety conditions. We examined the sensitivity of individual exposure estimates to varying patterns of pesticide application and varying individual patterns of movement. This resulted in a considerable variation in estimates of magnitude, frequency and duration of exposure over the model runs for each individual as well as between individuals. These findings indicate the influence of patterns of pesticide application, individual spatial patterns of movement as well as safety conditions on personalized exposure in the agricultural production landscape that is the focus of our research. This approach represents a conceptual framework for developing individual based models to carry out PEA in small-scale agricultural settings in the developing world based on individual patterns of movement, safety conditions, and dynamic contaminant distributions. The results of our analysis indicate our prototype model is sufficiently sensitive to differentiate and quantify the influence of individual patterns of movement and decision-based pesticide management activities on potential exposure. This approach represents a framework for further understanding the contribution of agricultural pesticide use to exposure in the small-scale agricultural production landscape of many developing countries, and could be useful to evaluate public health intervention strategies to reduce risks to farm-workers and their families. Further research is needed to fully develop an operational version of the model.

Pharmaceuticals in tap water: human health risk assessment and proposed monitoring framework in China.

PubMed

Leung, Ho Wing; Jin, Ling; Wei, Si; Tsui, Mirabelle Mei Po; Zhou, Bingsheng; Jiao, Liping; Cheung, Pak Chuen; Chun, Yiu Kan; Murphy, Margaret Burkhardt; Lam, Paul Kwan Sing

2013-07-01

Pharmaceuticals are known to contaminate tap water worldwide, but the relevant human health risks have not been assessed in China. We monitored 32 pharmaceuticals in Chinese tap water and evaluated the life-long human health risks of exposure in order to provide information for future prioritization and risk management. We analyzed samples (n = 113) from 13 cities and compared detected concentrations with existing or newly-derived safety levels for assessing risk quotients (RQs) at different life stages, excluding the prenatal stage. We detected 17 pharmaceuticals in 89% of samples, with most detectable concentrations (92%) at < 50 ng/L. Caffeine (median-maximum, nanograms per liter: 24.4-564), metronidazole (1.8-19.3), salicylic acid (16.6-41.2), clofibric acid (1.2-3.3), carbamazepine (1.3-6.7), and dimetridazole (6.9-14.7) were found in ≥ 20% of samples. Cities within the Yangtze River region and Guangzhou were regarded as contamination hot spots because of elevated levels and frequent positive detections. Of the 17 pharmaceuticals detected, 13 showed very low risk levels, but 4 (i.e., dimetridazole, thiamphenicol, sulfamethazine, and clarithromycin) were found to have at least one life-stage RQ ≥ 0.01, especially for the infant and child life stages, and should be considered of high priority for management. We propose an indicator-based monitoring framework for providing information for source identification, water treatment effectiveness, and water safety management in China. Chinese tap water is an additional route of human exposure to pharmaceuticals, particularly for dimetridazole, although the risk to human health is low based on current toxicity data. Pharmaceutical detection and application of the proposed monitoring framework can be used for water source protection and risk management in China and elsewhere.

[Topical issues of biological safety under current conditions. Part 2. Conceptual, terminological, and definitive framework of biological safety].

PubMed

Onishchenko, G G; Smolenskiĭ, V Iu; Ezhlova, E B; Demina, Iu V; Toporkov, V P; Toporkov, A V; Liapin, M N; Kutyrev, V V

2013-01-01

In accordance with the established conceptual base for the up-to-date broad interpretation of biological safety, and IHR (2005), developed is the notional, terminological, and definitive framework, comprising 33 elements. Key item of the nomenclature is the biological safety that is identified as population safety (individual, social, national) from direct and (or) human environment mediated (occupational, socio-economic, geopolitical infrastructures, ecological system) exposures to hazardous biological factors. Ultimate objective of the biological safety provision is to prevent and liquidate aftermaths of emergency situations of biological character either of natural or human origin (anthropogenic) arising from direct and indirect impact of the biological threats to the public health compatible with national and international security hazard. Elaborated terminological framework allows for the construction of self-sufficient semantic content for biological safety provision, subject to formalization in legislative, normative and methodological respects and indicative of improvement as regards organizational and structural-functional groundwork of the Russian Federation National chemical and biological safety system, which is to become topical issue of Part 3.

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

PubMed

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

2011-10-01

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

Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

PubMed

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

Review of the regulation and safety assessment of food substances in various countries and jurisdictions

PubMed Central

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

The role of simulation in mixed-methods research: a framework & application to patient safety.

PubMed

Guise, Jeanne-Marie; Hansen, Matthew; Lambert, William; O'Brien, Kerth

2017-05-04

Research in patient safety is an important area of health services research and is a national priority. It is challenging to investigate rare occurrences, explore potential causes, and account for the complex, dynamic context of healthcare - yet all are required in patient safety research. Simulation technologies have become widely accepted as education and clinical tools, but have yet to become a standard tool for research. We developed a framework for research that integrates accepted patient safety models with mixed-methods research approaches and describe the performance of the framework in a working example of a large National Institutes of Health (NIH)-funded R01 investigation. This worked example of a framework in action, identifies the strengths and limitations of qualitative and quantitative research approaches commonly used in health services research. Each approach builds essential layers of knowledge. We describe how the use of simulation ties these layers of knowledge together and adds new and unique dimensions of knowledge. A mixed-methods research approach that includes simulation provides a broad multi-dimensional approach to health services and patient safety research.

Using the Framework for Health Promotion Action to address staff perceptions of occupational health and safety at a fly-in/fly-out mine in north-west Queensland.

PubMed

Devine, Susan G; Muller, Reinhold; Carter, Anthony

2008-12-01

An exploratory descriptive study was undertaken to identify staff perceptions of the types and sources of occupational health and safety hazards at a remote fly-in-fly-out minerals extraction and processing plant in northwest Queensland. Ongoing focus groups with all sectors of the operation were conducted concurrently with quantitative research studies from 2001 to 2005. Action research processes were used with management and staff to develop responses to identified issues. Staff identified and generated solutions to the core themes of: health and safety policies and procedures; chemical exposures; hydration and fatigue. The Framework for Health Promotion Action was applied to ensure a comprehensive and holistic response to identified issues. Participatory processes using an action research framework enabled a deep understanding of staff perceptions of occupational health and safety hazards in this setting. The Framework for Health Promotion provided a relevant and useful tool to engage with staff and develop solutions to perceived occupational health and safety issues in the workplace.

Understanding Country Planning: A Guide for Air Force Component Planners

DTIC Science & Technology

2012-01-01

TRANSPORTATION INTERNATIONAL AFFAIRS LAW AND BUSINESS NATIONAL SECURITY POPULATION AND AGING PUBLIC SAFETY SCIENCE AND TECHNOLOGY TERRORISM AND...example, Jefferson P. Marquis, Richard E. Darilek, Jasen J. Castillo, Cathryn Quantic Thurston, Anny Wong, Cynthia Huger, Andrea Mejia, Jennifer D. P...2006; Jennifer D. P. Moroney, Jefferson P. Marquis, Cathryn Quantic Thurston, and Gregory F. Treverton, A Framework to Assess Programs for Building

Assessing Irregular Warfare: A Framework for Intelligence Analysis

DTIC Science & Technology

2008-01-01

AND HEALTH CARE INTERNATIONAL AFFAIRS NATIONAL SECURITY POPULATION AND AGING PUBLIC SAFETY SCIENCE AND TECHNOLOGY SUBSTANCE ABUSE TERRORISM AND...Interim FSTC Foreign Science and Technology Center GMI general military intelligence IED improvised explosive device INSCOM Intelligence and Security...ground forces intelligence in the Department of Defense (DoD).1 NGIC was created in March 1995, when the U.S. Army Foreign Science and Technology

Total safety management: An approach to improving safety culture

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

Blush, S.M.

A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobylmore » nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair.« less

High-Reliability Health Care: Getting There from Here

PubMed Central

Chassin, Mark R; Loeb, Jerod M

2013-01-01

Context Despite serious and widespread efforts to improve the quality of health care, many patients still suffer preventable harm every day. Hospitals find improvement difficult to sustain, and they suffer “project fatigue” because so many problems need attention. No hospitals or health systems have achieved consistent excellence throughout their institutions. High-reliability science is the study of organizations in industries like commercial aviation and nuclear power that operate under hazardous conditions while maintaining safety levels that are far better than those of health care. Adapting and applying the lessons of this science to health care offer the promise of enabling hospitals to reach levels of quality and safety that are comparable to those of the best high-reliability organizations. Methods We combined the Joint Commission's knowledge of health care organizations with knowledge from the published literature and from experts in high-reliability industries and leading safety scholars outside health care. We developed a conceptual and practical framework for assessing hospitals’ readiness for and progress toward high reliability. By iterative testing with hospital leaders, we refined the framework and, for each of its fourteen components, defined stages of maturity through which we believe hospitals must pass to reach high reliability. Findings We discovered that the ways that high-reliability organizations generate and maintain high levels of safety cannot be directly applied to today's hospitals. We defined a series of incremental changes that hospitals should undertake to progress toward high reliability. These changes involve the leadership's commitment to achieving zero patient harm, a fully functional culture of safety throughout the organization, and the widespread deployment of highly effective process improvement tools. Conclusions Hospitals can make substantial progress toward high reliability by undertaking several specific organizational change initiatives. Further research and practical experience will be necessary to determine the validity and effectiveness of this framework for high-reliability health care. PMID:24028696

High-reliability health care: getting there from here.

PubMed

Chassin, Mark R; Loeb, Jerod M

2013-09-01

Despite serious and widespread efforts to improve the quality of health care, many patients still suffer preventable harm every day. Hospitals find improvement difficult to sustain, and they suffer "project fatigue" because so many problems need attention. No hospitals or health systems have achieved consistent excellence throughout their institutions. High-reliability science is the study of organizations in industries like commercial aviation and nuclear power that operate under hazardous conditions while maintaining safety levels that are far better than those of health care. Adapting and applying the lessons of this science to health care offer the promise of enabling hospitals to reach levels of quality and safety that are comparable to those of the best high-reliability organizations. We combined the Joint Commission's knowledge of health care organizations with knowledge from the published literature and from experts in high-reliability industries and leading safety scholars outside health care. We developed a conceptual and practical framework for assessing hospitals' readiness for and progress toward high reliability. By iterative testing with hospital leaders, we refined the framework and, for each of its fourteen components, defined stages of maturity through which we believe hospitals must pass to reach high reliability. We discovered that the ways that high-reliability organizations generate and maintain high levels of safety cannot be directly applied to today's hospitals. We defined a series of incremental changes that hospitals should undertake to progress toward high reliability. These changes involve the leadership's commitment to achieving zero patient harm, a fully functional culture of safety throughout the organization, and the widespread deployment of highly effective process improvement tools. Hospitals can make substantial progress toward high reliability by undertaking several specific organizational change initiatives. Further research and practical experience will be necessary to determine the validity and effectiveness of this framework for high-reliability health care. © 2013 The Authors. The Milbank Quarterly published by Wiley Periodicals Inc. on behalf of Milbank Memorial Fund.

A framework for cumulative risk assessment in the 21st century.

PubMed

Moretto, Angelo; Bachman, Ammie; Boobis, Alan; Solomon, Keith R; Pastoor, Timothy P; Wilks, Martin F; Embry, Michelle R

2017-02-01

The ILSI Health and Environmental Sciences Institute (HESI) has developed a framework to support a transition in the way in which information for chemical risk assessment is obtained and used (RISK21). The approach is based on detailed problem formulation, where exposure drives the data acquisition process in order to enable informed decision-making on human health safety as soon as sufficient evidence is available. Information is evaluated in a transparent and consistent way with the aim of optimizing available resources. In the context of risk assessment, cumulative risk assessment (CRA) poses additional problems and questions that can be addressed using the RISK21 approach. The focus in CRA to date has generally been on chemicals that have common mechanisms of action. Recently, concern has also been expressed about chemicals acting on multiple pathways that lead to a common health outcome, and non-chemical other conditions (non-chemical stressors) that can lead to or modify a common outcome. Acknowledging that CRAs, as described above, are more conceptually, methodologically and computationally complex than traditional single-stressor risk assessments, RISK21 further developed the framework for implementation of workable processes and procedures for conducting assessments of combined effects from exposure to multiple chemicals and non-chemical stressors. As part of the problem formulation process, this evidence-based framework allows the identification of the circumstances in which it is appropriate to conduct a CRA for a group of compounds. A tiered approach is then proposed, where additional chemical stressors and/or non-chemical modulating factors (ModFs) are considered sequentially. Criteria are provided to facilitate the decision on whether or not to include ModFs in the formal quantitative assessment, with the intention to help focus the use of available resources to have the greatest potential to protect public health.

The Use of Crow-AMSAA Plots to Assess Mishap Trends

NASA Technical Reports Server (NTRS)

Dawson, Jeffrey W.

2011-01-01

Crow-AMSAA (CA) plots are used to model reliability growth. Use of CA plots has expanded into other areas, such as tracking events of interest to management, maintenance problems, and safety mishaps. Safety mishaps can often be successfully modeled using a Poisson probability distribution. CA plots show a Poisson process in log-log space. If the safety mishaps are a stable homogenous Poisson process, a linear fit to the points in a CA plot will have a slope of one. Slopes of greater than one indicate a nonhomogenous Poisson process, with increasing occurrence. Slopes of less than one indicate a nonhomogenous Poisson process, with decreasing occurrence. Changes in slope, known as "cusps," indicate a change in process, which could be an improvement or a degradation. After presenting the CA conceptual framework, examples are given of trending slips, trips and falls, and ergonomic incidents at NASA (from Agency-level data). Crow-AMSAA plotting is a robust tool for trending safety mishaps that can provide insight into safety performance over time.

A framework for evaluating the appropriateness of clinical decision support alerts and responses

PubMed Central

Waitman, Lemuel R; Lewis, Julia B; Wright, Julie A; Choma, David P; Miller, Randolph A; Peterson, Josh F

2011-01-01

Objective Alerting systems, a type of clinical decision support, are increasingly prevalent in healthcare, yet few studies have concurrently measured the appropriateness of alerts with provider responses to alerts. Recent reports of suboptimal alert system design and implementation highlight the need for better evaluation to inform future designs. The authors present a comprehensive framework for evaluating the clinical appropriateness of synchronous, interruptive medication safety alerts. Methods Through literature review and iterative testing, metrics were developed that describe successes, justifiable overrides, provider non-adherence, and unintended adverse consequences of clinical decision support alerts. The framework was validated by applying it to a medication alerting system for patients with acute kidney injury (AKI). Results Through expert review, the framework assesses each alert episode for appropriateness of the alert display and the necessity and urgency of a clinical response. Primary outcomes of the framework include the false positive alert rate, alert override rate, provider non-adherence rate, and rate of provider response appropriateness. Application of the framework to evaluate an existing AKI medication alerting system provided a more complete understanding of the process outcomes measured in the AKI medication alerting system. The authors confirmed that previous alerts and provider responses were most often appropriate. Conclusion The new evaluation model offers a potentially effective method for assessing the clinical appropriateness of synchronous interruptive medication alerts prior to evaluating patient outcomes in a comparative trial. More work can determine the generalizability of the framework for use in other settings and other alert types. PMID:21849334

Beyond safety outcomes: An investigation of the impact of safety climate on job satisfaction, employee engagement and turnover using social exchange theory as the theoretical framework.

PubMed

Huang, Yueng-Hsiang; Lee, Jin; McFadden, Anna C; Murphy, Lauren A; Robertson, Michelle M; Cheung, Janelle H; Zohar, Dov

2016-07-01

Safety climate, a measure of the degree to which safety is perceived by employees to be a priority in their company, is often implicated as a key factor in the promotion of injury-reducing behavior and safe work environments. Using social exchange theory as a theoretical basis, this study hypothesized that safety climate would be related to employees' job satisfaction, engagement, and turnover rate, highlighting the beneficial effects of safety climate beyond typical safety outcomes. Survey data were collected from 6207 truck drivers from two U.S. trucking companies. The objective turnover rate was collected one year after the survey data collection. Results showed that employees' safety climate perceptions were linked to employees' level of job satisfaction, engagement, and objective turnover rate, thus supporting the application of social exchange theory. Job satisfaction was also a significant mediator between safety climate and the two human resource outcomes (i.e., employee engagement and turnover rate). This study is among the first to assess the impact of safety climate beyond safety outcomes among lone workers (using truck drivers as an exemplar). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Modeling patient safety incidents knowledge with the Categorial Structure method.

PubMed

Souvignet, Julien; Bousquet, Cédric; Lewalle, Pierre; Trombert-Paviot, Béatrice; Rodrigues, Jean Marie

2011-01-01

Following the WHO initiative named World Alliance for Patient Safety (PS) launched in 2004 a conceptual framework developed by PS national reporting experts has summarized the knowledge available. As a second step, the Department of Public Health of the University of Saint Etienne team elaborated a Categorial Structure (a semi formal structure not related to an upper level ontology) identifying the elements of the semantic structure underpinning the broad concepts contained in the framework for patient safety. This knowledge engineering method has been developed to enable modeling patient safety information as a prerequisite for subsequent full ontology development. The present article describes the semantic dissection of the concepts, the elicitation of the ontology requirements and the domain constraints of the conceptual framework. This ontology includes 134 concepts and 25 distinct relations and will serve as basis for an Information Model for Patient Safety.

Human factors paradigm and customer care perceptions.

PubMed

Clarke, Colin; Eales-Reynolds, Lesley-Jane

2015-01-01

The purpose of this paper is to examine if customer care (CC) can be directly linked to patient safety through a human factors (HF) framework. Data from an online questionnaire, completed by a convenience healthcare worker sample (n=373), was interrogated using thematic analysis within Vincent et al.'s (1998) HF theoretical framework. This proposes seven areas affecting patient safety: institutional context, organisation and management, work environment, team factors, individual, task and patient. Analysis identified responses addressing all framework areas. Responses (597) principally focused on work environment 40.7 per cent (n=243), organisation and management 28.8 per cent (n=172). Nevertheless, reference to other framework areas were clearly visible within the data: teams 10.2 per cent (n=61), individual 6.7 per cent (n=40), patients 6.0 per cent (n=36), tasks 4.2 per cent (n=24) and institution 3.5 per cent (n=21). Findings demonstrate congruence between CC perceptions and patient safety within a HF framework. The questionnaire requested participants to identify barriers to rather than CC enablers. Although this was at a single site complex organisation, it was similar to those throughout the NHS and other international health systems. CC can be viewed as consonant with patient safety rather than the potentially dangerous consumerisation stance, which could ultimately compromise patient safety. This work provides an original perspective on the link between CC and patient safety and has the potential to re-focus healthcare perceptions.

Feasibility of Genome-Wide Screening for Biosafety Assessment of Probiotics: A Case Study of Lactobacillus helveticus MTCC 5463.

PubMed

Senan, S; Prajapati, J B; Joshi, C G

2015-12-01

Recent years have witnessed an explosion in genome sequencing of probiotic strains for accurate identification and characterization. Regulatory bodies are emphasizing on the need for performing phase I safety studies for probiotics. The main hypothesis of this study was to explore the feasibility of using genome databases for safety screening of strains. In this study, we attempted to develop a framework for the safety assessment of a potential probiotic strain, Lactobacillus helveticus MTCC 5463 based on genome mining for genes associated with antibiotic resistance, production of harmful metabolites, and virulence. The sequencing of MTCC 5463 was performed using GS-FLX Titanium reagents. Genes coding for antibiotic resistance and virulence were identified using Antibiotic Resistance Genes Database and Virulence Factors Database. Results indicated that MTCC 5463 carried antibiotic resistance genes associated with beta-lactam and fluoroquinolone. There is no threat of transfer of these genes to host gut commensals because the genes are not plasmid encoded. The presence of genes for adhesion, biofilm, surface proteins, and stress-related proteins provides robustness to the strain. The presence of hemolysin gene in the genome revealed a theoretical risk of virulence. The results of in silico analysis complemented the in vitro studies and human clinical trials, confirming the safety of the probiotic strain. We propose that the safety assessment of probiotic strains administered live at high doses using a genome-wide screening could be an effective and time-saving tool for identifying prognostic biomarkers of biosafety.

[Strategy for implementing and assessing a health care risk management unit in a primary care area].

PubMed

Mena Mateo, José María; de la Fuente, Angel Sanz-Vírseda; Cañada Dorado, Asunción; Villamor Borrego, Manuela

2009-06-01

To describe the setting up of a clinical risk management unit (CRMU) within primary care management, as well as the aims of the project, its implementation phases and the assessment of the results after one year of experience. A safety plan was prepared, based on the European Excellence Model (EFQM), to establish a strategic working framework. The plan included 38 proposed actions, associated with criteria elements and 26 indicators to evaluate the selected criteria. A total of 82% of the anticipated actions were implemented in 2007, which included, actions related to teaching and training (15 activities with 237 trainees), spreading of information associated with patient safety, incident analysis (14) and the introduction of specific safe practices (12). Four of those were considered as "generalisable" safe practices and were spread to the rest of the CRMUs in the Autonomous Region of Madrid. The CRMUs have introduced and monitored three processes related to patient safety, participated in a formal programme on the polymedicated elderly, with good results in cover and quality of the indicators. A primary care team (PCT) from the area took part in the first study carried out in Spain on adverse effects in primary care (APEAS Study). The CRMU can give impetus to strategic lines of safety. The preparation of a strategy defining specific aims has helped in the introduction of patient safety activities and along with the proposed indicators enables the impact of the intervention to be assessed.

Sensemaking of patient safety risks and hazards.

PubMed

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-08-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced.

Sensemaking of Patient Safety Risks and Hazards

PubMed Central

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-01-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced. PMID:16898979

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

NASA System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon

2012-01-01

This report has been developed by the National Aeronautics and Space Administration (NASA) Human Exploration and Operations Mission Directorate (HEOMD) Risk Management team knowledge capture forums.. This document provides a point-in-time, cumulative, summary of actionable key lessons learned in safety framework and concepts.

A baseline assessment of emergency planning and preparedness in Italian universities.

PubMed

Marincioni, Fausto; Fraboni, Rita

2012-04-01

Besides offering teaching and research services, schools and universities also must provide for the safety and security of their employees, students, and visitors. This paper describes emergency preparedness in a sample of Italian universities. In particular it examines risk perception within a specific professional category (university safety and security officers) in a specific cultural context (Italy). In addition, it discusses the transposition and implementation in a European Union (EU) member state of EU Council Directive 89/391/EEC of 12 June 1989, on the introduction of measures to encourage improvements in the safety and health of workers. The findings highlight heterogeneous and fragmented emergency management models within the Italian university system, underlining the need for a stricter framework of standardised safety protocols and emergency management guidelines. The study also points out that enhancing emergency planning and preparedness in Italian universities entails increasing safety leadership, employee engagement and individual responsibility for safety and security; essentially, it necessitates improving the culture of risk prevention. © 2012 The Author(s). Disasters © Overseas Development Institute, 2012.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk.

PubMed

Eyles, John; Heddle, Nancy; Webert, Kathryn; Arnold, Emmy; McCurdy, Bronwen

2011-08-24

Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk

PubMed Central

2011-01-01

Background Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Methods Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. Results While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Conclusions Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches. PMID:21864330

The regulatory framework for safe decommissioning of nuclear power plants in Korea

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

Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

PubMed

Kristensen, Finn Børlum; Lampe, Kristian; Wild, Claudia; Cerbo, Marina; Goettsch, Wim; Becla, Lidia

2017-02-01

The HTA Core Model ® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. The HTA Core Model is now available for everyone around the world as a framework for assessing value. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Integration of Federal Bureau of Investigation and United States Secret Service/Department of Education Threat Assessment Models into a Conceptual Framework for Prevention of School Violence

ERIC Educational Resources Information Center

Augustyniak, Kristine M.

2005-01-01

Professionals entered the 21st century with a heightened call to address school safety. Though notable contributions have been made to insure peaceful school communities through a wide range of primary and secondary prevention programs, research suggests that these programs are often an insufficient response to students who are at increased risk…

Incident reporting to BfArM - regulatory framework, results and challenges.

PubMed

Seidel, Robin; Stößlein, Ekkehard; Lauer, Wolfgang

2016-04-01

Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

Radiation Safety Culture in the UK Medical Sector: A Top to Bottom Strategy.

PubMed

Chapple, Claire-Louise; Bradley, Andy; Murray, Maria; Orr, Phil; Reay, Jill; Riley, Peter; Rogers, Andy; Sandhu, Navneet; Thurston, Jim

2017-04-01

UK professional bodies have established a number of sectorial working parties to provide guidance on the improvement of radiation safety (RS) culture in the workplace. The medical sector provides unique challenges in this regard, and the remit of the medical group was to review the current state of RS culture and to develop a framework for improvement. The review of current RS culture was based on measurable indicators, including data from regulatory inspections, personal monitoring data and incident data. An online survey to capture the RS-related views and experience of hospital staff at all levels was carried out, and the responses provided a wealth of information on RS awareness and implementation across the country. The framework for improving RS culture includes both 'top-down' initiatives to engage management and regulators, and 'bottom-up' initiatives relating to engagement and training of different staff groups. A 'Ten-point Assessment' on what constitutes a good approach to medical RS culture has been proposed, which provides a tool for management to assess RS culture in the workplace and has potential use in regulatory inspections in the UK. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Framework to Define Structure and Boundaries of Complex Health Intervention Systems: The ALERT Project

PubMed Central

Boriani, Elena; Esposito, Roberto; Frazzoli, Chiara; Fantke, Peter; Hald, Tine; Rüegg, Simon R.

2017-01-01

Health intervention systems are complex and subject to multiple variables in different phases of implementation. This constitutes a concrete challenge for the application of translational science in real life. Complex systems as health-oriented interventions call for interdisciplinary approaches with carefully defined system boundaries. Exploring individual components of such systems from different viewpoints gives a wide overview and helps to understand the elements and the relationships that drive actions and consequences within the system. In this study, we present an application and assessment of a framework with focus on systems and system boundaries of interdisciplinary projects. As an example on how to apply our framework, we analyzed ALERT [an integrated sensors and biosensors’ system (BEST) aimed at monitoring the quality, health, and traceability of the chain of the bovine milk], a multidisciplinary and interdisciplinary project based on the application of measurable biomarkers at strategic points of the milk chain for improved food security (including safety), human, and ecosystem health (1). In fact, the European food safety framework calls for science-based support to the primary producers’ mandate for legal, scientific, and ethical responsibility in food supply. Because of its multidisciplinary and interdisciplinary approach involving human, animal, and ecosystem health, ALERT can be considered as a One Health project. Within the ALERT context, we identified the need to take into account the main actors, interactions, and relationships of stakeholders to depict a simplified skeleton of the system. The framework can provide elements to highlight how and where to improve the project development when project evaluations are required. PMID:28804707

Framework to Define Structure and Boundaries of Complex Health Intervention Systems: The ALERT Project.

PubMed

Boriani, Elena; Esposito, Roberto; Frazzoli, Chiara; Fantke, Peter; Hald, Tine; Rüegg, Simon R

2017-01-01

Health intervention systems are complex and subject to multiple variables in different phases of implementation. This constitutes a concrete challenge for the application of translational science in real life. Complex systems as health-oriented interventions call for interdisciplinary approaches with carefully defined system boundaries. Exploring individual components of such systems from different viewpoints gives a wide overview and helps to understand the elements and the relationships that drive actions and consequences within the system. In this study, we present an application and assessment of a framework with focus on systems and system boundaries of interdisciplinary projects. As an example on how to apply our framework, we analyzed ALERT [an integrated sensors and biosensors' system (BEST) aimed at monitoring the quality, health, and traceability of the chain of the bovine milk], a multidisciplinary and interdisciplinary project based on the application of measurable biomarkers at strategic points of the milk chain for improved food security (including safety), human, and ecosystem health (1). In fact, the European food safety framework calls for science-based support to the primary producers' mandate for legal, scientific, and ethical responsibility in food supply. Because of its multidisciplinary and interdisciplinary approach involving human, animal, and ecosystem health, ALERT can be considered as a One Health project. Within the ALERT context, we identified the need to take into account the main actors, interactions, and relationships of stakeholders to depict a simplified skeleton of the system. The framework can provide elements to highlight how and where to improve the project development when project evaluations are required.

Gender-affirming Surgeries in the Era of Insurance Coverage: Developing a Framework for Psychosocial Support and Care Navigation in the Perioperative Period.

PubMed

Deutsch, Madeline B

2016-01-01

Transgender people have a gender identity different from their birth-assigned sex. Transgender people may seek gender-affirming surgeries to align their body with their identified gender. With increasing visibility of transgender identities, and recognition of the importance of gender-affirming care, has come a policy shift toward mandated coverage or provision of blanket exclusions of these procedures by insurance companies and Medicaid. The World Professional Association for Transgender Health provides guidance to mental health professionals evaluating patients for gender-affirming surgeries, including making a diagnosis and assessing for capacity to consent. However the expansion of covered gender-affirming surgeries to safety-net populations has highlighted the need for an expanded presurgical process which includes a psychosocial assessment and care navigation. The proposed framework expands the preoperative assessment to include these components, and can be used to guide both health systems and insurance providers in the development of transgender medicine programs.

Fuzzy-logic-based network for complex systems risk assessment: application to ship performance analysis.

PubMed

Abou, Seraphin C

2012-03-01

In this paper, a new interpretation of intuitionistic fuzzy sets in the advanced framework of the Dempster-Shafer theory of evidence is extended to monitor safety-critical systems' performance. Not only is the proposed approach more effective, but it also takes into account the fuzzy rules that deal with imperfect knowledge/information and, therefore, is different from the classical Takagi-Sugeno fuzzy system, which assumes that the rule (the knowledge) is perfect. We provide an analytical solution to the practical and important problem of the conceptual probabilistic approach for formal ship safety assessment using the fuzzy set theory that involves uncertainties associated with the reliability input data. Thus, the overall safety of the ship engine is investigated as an object of risk analysis using the fuzzy mapping structure, which considers uncertainty and partial truth in the input-output mapping. The proposed method integrates direct evidence of the frame of discernment and is demonstrated through references to examples where fuzzy set models are informative. These simple applications illustrate how to assess the conflict of sensor information fusion for a sufficient cooling power system of vessels under extreme operation conditions. It was found that propulsion engine safety systems are not only a function of many environmental and operation profiles but are also dynamic and complex. Copyright © 2011 Elsevier Ltd. All rights reserved.

Using SAFRAN Software to Assess Radiological Hazards from Dismantling of Tammuz-2 Reactor Core at Al-tuwaitha Nuclear Site

NASA Astrophysics Data System (ADS)

Abed Gatea, Mezher; Ahmed, Anwar A.; jundee kadhum, Saad; Ali, Hasan Mohammed; Hussein Muheisn, Abbas

2018-05-01

The Safety Assessment Framework (SAFRAN) software has implemented here for radiological safety analysis; to verify that the dose acceptance criteria and safety goals are met with a high degree of confidence for dismantling of Tammuz-2 reactor core at Al-tuwaitha nuclear site. The activities characterizing, dismantling and packaging were practiced to manage the generated radioactive waste. Dose to the worker was considered an endpoint-scenario while dose to the public has neglected due to that Tammuz-2 facility is located in a restricted zone and 30m berm surrounded Al-tuwaitha site. Safety assessment for dismantling worker endpoint-scenario based on maximum external dose at component position level in the reactor pool and internal dose via airborne activity while, for characterizing and packaging worker endpoints scenarios have been done via external dose only because no evidence for airborne radioactivity hazards outside the reactor pool. The in-situ measurements approved that reactor core components are radiologically activated by Co-60 radioisotope. SAFRAN results showed that the maximum received dose for workers are (1.85, 0.64 and 1.3mSv/y) for activities dismantling, characterizing and packaging of reactor core components respectively. Hence, the radiological hazards remain below the low level hazard and within the acceptable annual dose for workers in radiation field

Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

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

Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978 and 1988. All of the reports reviewed were the regulator’s assessment of the PSR findings rather than the original PSR report, and all but one were English translations from the original language. In these reviews, it was found that most of the countries base their regulatory guidance to some extent (and often to a large extent) on U.S. design codes and standards, NRC regulatory guidance, and U.S. industry guidance. In addition, many of the observed operational technical issues and OpE events reported for U.S. reactors are also cited in the PSR reports. The PSR reports also identified a number of potential technical material/component performance issues and OpE events that are not commonly reported for U.S. plants.« less

Non-targeted multi-component analytical surveillance of plastic food contact materials: Identification of substances not included in EU positive lists and their risk assessment.

PubMed

Skjevrak, Ingun; Brede, Cato; Steffensen, Inger-Lise; Mikalsen, Arne; Alexander, Jan; Fjeldal, Per; Herikstad, Hallgeir

2005-10-01

A procedure used by the Norwegian Food Safety Authority for surveillance of contaminants from plastic food contact materials (polyolefin drinking bottles, water boilers, polyamide cooking utensils and plastic multi-layer materials) is described. It is based on gas chromatographic-mass spectrometric (GC/MS) analysis of food simulants exposed to plastic materials. Most migrants were substances not-intentionally added to the plastic (degradation products, impurities) or originated from non-plastic components, such as printing inks, adhesives, not-listed additives, solvents and coatings. Hence, the majority of the identified migrants were regulated by the general statements in the EU Framework Regulation, which neither specify limits nor requirements regarding risk assessment, rather than by specific migration controls. Risk assessment has been carried out for selected non-authorized substances. The analysis and the management of these substances and materials with respect to safety represents a challenge to the food authorities.

10 CFR Appendix B to Part 851 - General Statement of Enforcement Policy

Code of Federal Regulations, 2013 CFR

2013-01-01

... the general framework through which the U.S. Department of Energy (DOE) will seek to ensure compliance... Administrator acts after consideration of the Director's recommendation. V. Procedural Framework (a) Title 10... varying degrees of safety and health significance. Therefore, the relative safety and health risk of each...

10 CFR Appendix B to Part 851 - General Statement of Enforcement Policy

Code of Federal Regulations, 2014 CFR

2014-01-01

... the general framework through which the U.S. Department of Energy (DOE) will seek to ensure compliance... Administrator acts after consideration of the Director's recommendation. V. Procedural Framework (a) Title 10... varying degrees of safety and health significance. Therefore, the relative safety and health risk of each...

Using systematic review in occupational safety and health.

PubMed

Howard, John; Piacentino, John; MacMahon, Kathleen; Schulte, Paul

2017-11-01

Evaluation of scientific evidence is critical in developing recommendations to reduce risk. Healthcare was the first scientific field to employ a systematic review approach for synthesizing research findings to support evidence-based decision-making and it is still the largest producer and consumer of systematic reviews. Systematic reviews in the field of occupational safety and health are being conducted, but more widespread use and adoption would strengthen assessments. In 2016, NIOSH asked RAND to develop a framework for applying the traditional systematic review elements to the field of occupational safety and health. This paper describes how essential systematic review elements can be adapted for use in occupational systematic reviews to enhance their scientific quality, objectivity, transparency, reliability, utility, and acceptability. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Development and delivery of clinical pharmacology in regulatory agencies.

PubMed

Breckenridge, Alasdair

2012-06-01

Medicines regulation is based on a foundation of science, policy and judgement. It operates within several frameworks (scientific, legal and public health), which are interdependent. While safety, quality and efficacy remain the criteria by which medicines are assessed, the benefit-to-harm balance for any medicine or medical device is of paramount importance. While the regulator was hitherto the gatekeeper who allowed a medicine on to the market, payers now require, in addition, assessment of cost and clinical effectiveness before use. As regulatory frameworks develop, several changes will occur, as follows: (i) formal benefit-harm assessment will become an integral part of submission for marketing authorizations; (ii) there will be greater use of surveillance for adverse reactions to new medicines using methods other than voluntary reporting; (iii) risk management plans will become benefit-risk management plans; (iv) life-saving medicines will be approved earlier; and (v) regulation and health technology assessment will take place simultaneously. Clinical pharmacologists will play important roles in these developments. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.

Human Error Assessment and Reduction Technique (HEART) and Human Factor Analysis and Classification System (HFACS)

NASA Technical Reports Server (NTRS)

Alexander, Tiffaney Miller

2017-01-01

Research results have shown that more than half of aviation, aerospace and aeronautics mishaps incidents are attributed to human error. As a part of Safety within space exploration ground processing operations, the identification and/or classification of underlying contributors and causes of human error must be identified, in order to manage human error. This research provides a framework and methodology using the Human Error Assessment and Reduction Technique (HEART) and Human Factor Analysis and Classification System (HFACS), as an analysis tool to identify contributing factors, their impact on human error events, and predict the Human Error probabilities (HEPs) of future occurrences. This research methodology was applied (retrospectively) to six (6) NASA ground processing operations scenarios and thirty (30) years of Launch Vehicle related mishap data. This modifiable framework can be used and followed by other space and similar complex operations.

Human Error Assessment and Reduction Technique (HEART) and Human Factor Analysis and Classification System (HFACS)

NASA Technical Reports Server (NTRS)

Alexander, Tiffaney Miller

2017-01-01

Research results have shown that more than half of aviation, aerospace and aeronautics mishaps/incidents are attributed to human error. As a part of Safety within space exploration ground processing operations, the identification and/or classification of underlying contributors and causes of human error must be identified, in order to manage human error. This research provides a framework and methodology using the Human Error Assessment and Reduction Technique (HEART) and Human Factor Analysis and Classification System (HFACS), as an analysis tool to identify contributing factors, their impact on human error events, and predict the Human Error probabilities (HEPs) of future occurrences. This research methodology was applied (retrospectively) to six (6) NASA ground processing operations scenarios and thirty (30) years of Launch Vehicle related mishap data. This modifiable framework can be used and followed by other space and similar complex operations.

Barriers to, and facilitators of, the prevention of unintentional injury in children in the home: a systematic review and synthesis of qualitative research.

PubMed

Smithson, Janet; Garside, Ruth; Pearson, Mark

2011-04-01

This review considers barriers to, and facilitators of, success for interventions to reduce unintentional injury to children in the home through supply and/or installation of home safety equipment, and looks at risk assessments. A systematic review of qualitative research. Bibliographic databases were searched for studies on interventions to reduce unintentional child injury in the home, or on related attitudes and behaviours. Studies were quality appraised, findings extracted, and a conceptual framework was developed to assess factors affecting the success of interventions. Nine peer-reviewed journal articles were included. Barriers and facilitators were highlighted at organisational, environmental and personal levels. Effective provision of safety equipment involves ongoing support with installation and maintenance. Take up and success of interventions depends on adjusting interventions according to practical limitations and parents' cultural expectations. A particular barrier was parents' inability to modify rented or shared accommodation. The review highlights ways in which health inequalities affect the take up and success of home safety interventions, and how health workers can use this knowledge to facilitate future interventions.

The Toxic Truth About Carbon Nanotubes in Water Purification: a Perspective View.

PubMed

Das, Rasel; Leo, Bey Fen; Murphy, Finbarr

2018-06-18

Without nanosafety guidelines, the long-term sustainability of carbon nanotubes (CNTs) for water purifications is questionable. Current risk measurements of CNTs are overshadowed by uncertainties. New risks associated with CNTs are evolving through different waste water purification routes, and there are knowledge gaps in the risk assessment of CNTs based on their physical properties. Although scientific efforts to design risk estimates are evolving, there remains a paucity of knowledge on the unknown health risks of CNTs. The absence of universal CNT safety guidelines is a specific hindrance. In this paper, we close these gaps and suggested several new risk analysis roots and framework extrapolations from CNT-based water purification technologies. We propose a CNT safety clock that will help assess risk appraisal and management. We suggest that this could form the basis of an acceptable CNT safety guideline. We pay particular emphasis on measuring risks based on CNT physico-chemical properties such as diameter, length, aspect ratio, type, charge, hydrophobicity, functionalities and so on which determine CNT behaviour in waste water treatment plants and subsequent release into the environment.

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion

PubMed Central

Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J.; Tamargo, Juan; Bakris, George L.; Borer, Jeffrey S.; Alonso García, Maria de los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A.; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J.; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B.; Calvo, Gonzalo

2016-01-01

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. PMID:27418973

Multiple Criteria Decision Analysis (MCDA) for evaluating new medicines in Health Technology Assessment and beyond: The Advance Value Framework.

PubMed

Angelis, Aris; Kanavos, Panos

2017-09-01

Escalating drug prices have catalysed the generation of numerous "value frameworks" with the aim of informing payers, clinicians and patients on the assessment and appraisal process of new medicines for the purpose of coverage and treatment selection decisions. Although this is an important step towards a more inclusive Value Based Assessment (VBA) approach, aspects of these frameworks are based on weak methodologies and could potentially result in misleading recommendations or decisions. In this paper, a Multiple Criteria Decision Analysis (MCDA) methodological process, based on Multi Attribute Value Theory (MAVT), is adopted for building a multi-criteria evaluation model. A five-stage model-building process is followed, using a top-down "value-focused thinking" approach, involving literature reviews and expert consultations. A generic value tree is structured capturing decision-makers' concerns for assessing the value of new medicines in the context of Health Technology Assessment (HTA) and in alignment with decision theory. The resulting value tree (Advance Value Tree) consists of three levels of criteria (top level criteria clusters, mid-level criteria, bottom level sub-criteria or attributes) relating to five key domains that can be explicitly measured and assessed: (a) burden of disease, (b) therapeutic impact, (c) safety profile (d) innovation level and (e) socioeconomic impact. A number of MAVT modelling techniques are introduced for operationalising (i.e. estimating) the model, for scoring the alternative treatment options, assigning relative weights of importance to the criteria, and combining scores and weights. Overall, the combination of these MCDA modelling techniques for the elicitation and construction of value preferences across the generic value tree provides a new value framework (Advance Value Framework) enabling the comprehensive measurement of value in a structured and transparent way. Given its flexibility to meet diverse requirements and become readily adaptable across different settings, the Advance Value Framework could be offered as a decision-support tool for evaluators and payers to aid coverage and reimbursement of new medicines. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The determinants of employee participation in occupational health and safety management.

PubMed

Masso, Märt

2015-01-01

This article focuses on employee direct participation in occupational health and safety (OHS) management. The article explains what determines employee opportunities to participate in OHS management. The explanatory framework focuses on safety culture and safety management at workplaces. The framework is empirically tested using Estonian cross-sectional, multilevel data of organizations and their employees. The analysis indicates that differences in employee participation in OHS management in the Estonian case could be explained by differences in OHS management practices rather than differences in safety culture. This indicates that throughout the institutional change and shift to the European model of employment relations system, change in management practices has preceded changes in safety culture which according to theoretical argument is supposed to follow culture change.

Securing Safety - Spaceflight Standards for the Mass Market

NASA Astrophysics Data System (ADS)

Goh, G.

The projected total revenue of the space tourism industry is expected to exceed USD $1 billion by 2021. The vast economic potential of space tourism has fuelled ambitious plans for commercial orbital and suborbital flights, in addition to longer- duration spaceflights on board the International Space Station (ISS) and other planned orbiting habitats. International and national legal frameworks are challenged to provide regulations to ensure minimum standards of spaceflight safety for a high risk activity that aims to enter the mainstream tourism market. Thrown into the mix are various considerations of the number of spaceflight participants per flight, the economic viability of stringent safety standards, the plethora of possible flight vehicles and the compensation mechanism in case of violations of safety regulations. This paper surveys the legal challenges in the regulation of safety in commercial manned spaceflight, including issues of jurisdiction, authorization, licensing and liability. Drawing on analogous developments in other fields of law related to international carriage, a safety regulation framework with minimum international standards is proposed. This proposed framework considers both accident avoidance and emergency response in light of international legal, policy and economic perspectives.

Using a High-Resolution Ensemble Modeling Method to Inform Risk-Based Decision-Making at Taylor Park Dam, Colorado

NASA Astrophysics Data System (ADS)

Mueller, M.; Mahoney, K. M.; Holman, K. D.

2015-12-01

The Bureau of Reclamation (Reclamation) is responsible for the safety of Taylor Park Dam, located in central Colorado at an elevation of 9300 feet. A key aspect of dam safety is anticipating extreme precipitation, runoff and the associated inflow of water to the reservoir within a probabilistic framework for risk analyses. The Cooperative Institute for Research in Environmental Sciences (CIRES) has partnered with Reclamation to improve understanding and estimation of precipitation in the western United States, including the Taylor Park watershed. A significant challenge is that Taylor Park Dam is located in a relatively data-sparse region, surrounded by mountains exceeding 12,000 feet. To better estimate heavy precipitation events in this basin, a high-resolution modeling approach is used. The Weather Research and Forecasting (WRF) model is employed to simulate events that have produced observed peaks in streamflow at the location of interest. Importantly, an ensemble of model simulations are run on each event so that uncertainty bounds (i.e., forecast error) may be provided such that the model outputs may be more effectively used in Reclamation's risk assessment framework. Model estimates of precipitation (and the uncertainty thereof) are then used in rainfall runoff models to determine the probability of inflows to the reservoir for use in Reclamation's dam safety risk analyses.

Modeling Increased Complexity and the Reliance on Automation: FLightdeck Automation Problems (FLAP) Model

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

This paper highlights the development of a model that is focused on the safety issue of increasing complexity and reliance on automation systems in transport category aircraft. Recent statistics show an increase in mishaps related to manual handling and automation errors due to pilot complacency and over-reliance on automation, loss of situational awareness, automation system failures and/or pilot deficiencies. Consequently, the aircraft can enter a state outside the flight envelope and/or air traffic safety margins which potentially can lead to loss-of-control (LOC), controlled-flight-into-terrain (CFIT), or runway excursion/confusion accidents, etc. The goal of this modeling effort is to provide NASA's Aviation Safety Program (AvSP) with a platform capable of assessing the impacts of AvSP technologies and products towards reducing the relative risk of automation related accidents and incidents. In order to do so, a generic framework, capable of mapping both latent and active causal factors leading to automation errors, is developed. Next, the framework is converted into a Bayesian Belief Network model and populated with data gathered from Subject Matter Experts (SMEs). With the insertion of technologies and products, the model provides individual and collective risk reduction acquired by technologies and methodologies developed within AvSP.

Hazard analysis and critical control point systems in the United States Department of Agriculture regulatory policy.

PubMed

Billy, T J; Wachsmuth, I K

1997-08-01

Recent outbreaks of foodborne illness and studies by expert groups have established the need for fundamental change in the United States meat and poultry inspection programme to reduce the risk of foodborne illness. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) has embarked on a broad effort to bring about such change, with particular emphasis on the reduction of pathogenic micro-organisms in raw meat and poultry products. The publication on 25 July 1996 of the Final Rule on pathogen reduction and hazard analysis and critical control point (HACCP) systems was a major milestone in the FSIS strategy for change. The Final Rule provides a framework for change and clarifies the respective roles of industry and government in ensuring the safety of meat and poultry products. With the implementation of this Final Rule underway, the FSIS has been exploring ways in which slaughter inspection carried out under an HACCP-based system can be changed so that food safety risks are addressed more adequately and the allocation of inspection resources is improved further. In addition, the FSIS is broadening the focus of food safety activities to extend beyond slaughter and processing plants by working with industry, academia and other government agencies. Such co-operation should lead to the development of measures to improve food safety before animals reach the slaughter plant and after products leave the inspected establishment for distribution to the retail level. For the future, the FSIS believes that quantitative risk assessments will be at the core of food safety activities. Risk assessments provide the most effective means of identifying how specific pathogens and other hazards may be encountered throughout the farm-to-table chain and of measuring the potential impact of various interventions. In addition, these assessments will be used in the development and evaluation of HACCP systems. The FSIS is currently conducting a quantitative risk assessment for eggs, and several surveys and studies are being performed to supply data needed to conduct other risk assessments. The FSIS has established a food safety research agenda which will fill data gaps.

A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

PubMed

Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

2017-01-01

Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous improvement of sustainability with regard to ecotoxicity is to focus efforts on instances where the safety margins for ingredients as used in specific products are narrow. This necessitates a risk-based approach. Integr Environ Assess Manag 2017;13:127-138. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of SETAC. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of SETAC.

A Simplified Approach to Risk Assessment Based on System Dynamics: An Industrial Case Study.

PubMed

Garbolino, Emmanuel; Chery, Jean-Pierre; Guarnieri, Franck

2016-01-01

Seveso plants are complex sociotechnical systems, which makes it appropriate to support any risk assessment with a model of the system. However, more often than not, this step is only partially addressed, simplified, or avoided in safety reports. At the same time, investigations have shown that the complexity of industrial systems is frequently a factor in accidents, due to interactions between their technical, human, and organizational dimensions. In order to handle both this complexity and changes in the system over time, this article proposes an original and simplified qualitative risk evaluation method based on the system dynamics theory developed by Forrester in the early 1960s. The methodology supports the development of a dynamic risk assessment framework dedicated to industrial activities. It consists of 10 complementary steps grouped into two main activities: system dynamics modeling of the sociotechnical system and risk analysis. This system dynamics risk analysis is applied to a case study of a chemical plant and provides a way to assess the technological and organizational components of safety. © 2016 Society for Risk Analysis.

[Implementation and validation in the Italian context of the HSE management standards: a contribution to provide a practical model for the assessment of work-related stress].

PubMed

Iavicoli, S; Natali, E; Rondinone, B M; Castaldi, T; Persechino, B

2010-01-01

Over the last years, stress has been recognized as a potential work-related risk factor. Unfortunately, work-related stress is a very delicate subject, especially because it is difficult to assess it objectively and in broadly acceptable terms. In fact, work-related stress is a subjective personal response to a specific work environment, ad is of a multifactorial origin. In order to provide a practical tool for the assessment of work-related stress, the authors carried out a thorough benchmarking analysis of the various models to manage work stress problems adopted by EU countries. As a result, the authors have chosen to apply and implement the Health and Safety Executive (HSE) Management Standards approach in the Italian context. In compliance with the European Framework Agreement signed on October 8, 2004, HSE Management Standards ask for the coordinated and integrated involvement of workers and safety personnel and represent a valid assessment approach based on principles widely acknowledged in the scientific literature.

Findings From the National Machine Guarding Program: A Small Business Intervention: Lockout/Tagout.

PubMed

Parker, David L; Yamin, Samuel C; Xi, Min; Brosseau, Lisa M; Gordon, Robert; Most, Ivan G; Stanley, Rodney

2016-01-01

Failure to implement lockout/tagout (LOTO) procedures adversely affects the rate of work-related fatalities and serious traumatic injury and is one of the most frequently cited Occupational Safety and Health Administration standards. This study assesses the impact of a nationwide intervention to improve LOTO in small metal fabrication businesses. Insurance safety consultants conducted a standardized and validated evaluation of LOTO programs and procedures. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. The intervention was completed by 160 businesses. The mean LOTO procedure score improved from 8% to 33% (P < 0.0001), the mean program score went from 55% to 76% (P < 0.0001), and the presence of lockable disconnects went from 88% to 92% (P < 0.0001). This nationwide intervention showed substantial improvements in LOTO. It provides a framework for assessing and improving LOTO.

RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of a new integrated local trajectory planning and tracking control framework for autonomous ground vehicles

NASA Astrophysics Data System (ADS)

Li, Xiaohui; Sun, Zhenping; Cao, Dongpu; Liu, Daxue; He, Hangen

2017-03-01

This study proposes a novel integrated local trajectory planning and tracking control (ILTPTC) framework for autonomous vehicles driving along a reference path with obstacles avoidance. For this ILTPTC framework, an efficient state-space sampling-based trajectory planning scheme is employed to smoothly follow the reference path. A model-based predictive path generation algorithm is applied to produce a set of smooth and kinematically-feasible paths connecting the initial state with the sampling terminal states. A velocity control law is then designed to assign a speed value at each of the points along the generated paths. An objective function considering both safety and comfort performance is carefully formulated for assessing the generated trajectories and selecting the optimal one. For accurately tracking the optimal trajectory while overcoming external disturbances and model uncertainties, a combined feedforward and feedback controller is developed. Both simulation analyses and vehicle testing are performed to verify the effectiveness of the proposed ILTPTC framework, and future research is also briefly discussed.

Data protection and the patient's right to safety.

PubMed

Herveg, Jean

2014-06-01

The article investigates the issue of knowing whether or not the proposal for a general data protection regulation could improve the patient's safety. This has been analyzed through the four main contributions that should be expected at least from data protection to the patient's safety. In our view, data protection should help supporting efficient information systems in healthcare, increasing data quality, strengthening the patient's rights and drawing the legal framework for performing quality control procedures. Compared to the current legal framework, it is not sure that the proposal might improve any of these contributions to the patient's safety.

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.

Using Principles of Quality and Safety Education for Nurses in School Nurse Continuing Education

ERIC Educational Resources Information Center

Rosenblum, Ruth K.; Sprague-McRae, Julie

2014-01-01

School nurses require ongoing continuing education in a number of areas. The Quality and Safety Education for Nurses (QSEN) framework can be utilized in considering school nurses' roles and developing continuing education. Focusing on neurology continuing education, the QSEN framework is illustrated with the example of concussion management…

A multidimensional framework for assessing patient room configurations.

PubMed

Pati, Debajyoti; Harvey, Thomas E; Reyers, Evelyn; Evans, Jennie; Waggener, Laurie; Serrano, Marjorie; Saucier, Rachel; Nagle, Tina

2009-01-01

A framework for multidimensional assessment of patient room configurations is presented. Twenty-three issues are considered and categorized under six domains of assessment: (1) patient safety, (2) staff efficiency, (3) circulation, (4) infection control, (5) patient considerations, and (6) family amenities. Use of the framework to rank issues by importance and assess six alternative patient room configurations by a diverse group of experts in a symposium is described. One of the key questions posed during inpatient room design is the location of the bathroom. What issues are affected by the variations in room configuration that arise from bathroom location? A complete articulation of the issues that potentially are affected by room configuration is not available in the literature. The list of issues was developed by the authors in preparation for a symposium. The symposium was organized in May 2007 and attended by 14 experts from four institutions. Six alternative room configurations were used. Variations in the configurations included: (1) three same-handed and three mirror-image rooms; (2) three outboard, two inboard, and one nested bathroom; and (3) three rooms with footwall bathrooms and three with headwall bathrooms. In a four-step process, the attendees ranked the issues, discussed them in detail, rated each room configuration against each issue on a seven-point suitability scale, and conducted an overall assessment of the six configurations. Based on the ratings and rankings provided by the symposium participants, outboard bathroom locations were found to be most suitable, followed by nested and inboard configurations. Furthermore, configurations with patient bathrooms located on the footwall were rated as more suitable than headwall locations. The authors recommend, however, that the framework be used to determine a suitable room configuration in a specific context, rather than to identify configurations that will perform well universally.

Development of a First-of-a-Kind Deterministic Decision-Making Tool for Supervisory Control System

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

Cetiner, Sacit M; Kisner, Roger A; Muhlheim, Michael David

2015-07-01

Decision-making is the process of identifying and choosing alternatives where each alternative offers a different approach or path to move from a given state or condition to a desired state or condition. The generation of consistent decisions requires that a structured, coherent process be defined, immediately leading to a decision-making framework. The overall objective of the generalized framework is for it to be adopted into an autonomous decision-making framework and tailored to specific requirements for various applications. In this context, automation is the use of computing resources to make decisions and implement a structured decision-making process with limited or nomore » human intervention. The overriding goal of automation is to replace or supplement human decision makers with reconfigurable decision- making modules that can perform a given set of tasks reliably. Risk-informed decision making requires a probabilistic assessment of the likelihood of success given the status of the plant/systems and component health, and a deterministic assessment between plant operating parameters and reactor protection parameters to prevent unnecessary trips and challenges to plant safety systems. The implementation of the probabilistic portion of the decision-making engine of the proposed supervisory control system was detailed in previous milestone reports. Once the control options are identified and ranked based on the likelihood of success, the supervisory control system transmits the options to the deterministic portion of the platform. The deterministic multi-attribute decision-making framework uses variable sensor data (e.g., outlet temperature) and calculates where it is within the challenge state, its trajectory, and margin within the controllable domain using utility functions to evaluate current and projected plant state space for different control decisions. Metrics to be evaluated include stability, cost, time to complete (action), power level, etc. The integration of deterministic calculations using multi-physics analyses (i.e., neutronics, thermal, and thermal-hydraulics) and probabilistic safety calculations allows for the examination and quantification of margin recovery strategies. This also provides validation of the control options identified from the probabilistic assessment. Thus, the thermal-hydraulics analyses are used to validate the control options identified from the probabilistic assessment. Future work includes evaluating other possible metrics and computational efficiencies.« less

OPPE, FPPE, QPS, and why the alphabet soup of physician assessment is essential for safer patient care.

PubMed

Loftus, Michael L

Creating a successful quality and patient safety program requires a multifaceted approach that systematically reviews overall systems and processes, but also creates a standardized framework for evaluating individual practitioner performance on a routine basis. There are two required elements of competency assessment that are typically tied to the hospital credentialing process: ongoing professional practice evaluation (OPPE) and focused professional practice evaluation (FPPE). Each of these processes are mandated by the Joint Commission, and form an important cornerstone for ensuring adequate physician performance and knowledge base. Copyright © 2017. Published by Elsevier Inc.

Advancing patient safety: a framework for accountability and practical action.

PubMed

Wilson, N J; Hatlie, M J

2001-01-01

This article traces the development of the patient safety movement in healthcare from 1997 to the present. It reviews the findings and recommendations in the Institute of Medicine report on medical errors, which issued a call to action. Moving beyond the call to action requires aligning incentives, in both public and private sectors, consistent with complexity theory and the tenets of a systems approach to the reliable delivery of service in dynamic environments in which failure produces severe consequences. Because safety is a fundamental value of healthcare and has money-saving potential, it can be a powerful pathway forcultural change. Thisarticle explains a simple framework that requires alignment among stakeholder groups and communities. It recommends a practical problem-solving approach and explores the roles and responsibilities of each segment within the framework. Finally, it describes a VHA Inc. leadership initiative, based on the framework, to promote change within healthcare systems.

The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

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

Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

Applying the WHO conceptual framework for the International Classification for Patient Safety to a surgical population

PubMed Central

McElroy, L. M.; Woods, D. M.; Yanes, A. F.; Skaro, A. I.; Daud, A.; Curtis, T.; Wymore, E.; Holl, J. L.; Abecassis, M. M.; Ladner, D. P.

2016-01-01

Objective Efforts to improve patient safety are challenged by the lack of universally agreed upon terms. The International Classification for Patient Safety (ICPS) was developed by the World Health Organization for this purpose. This study aimed to test the applicability of the ICPS to a surgical population. Design A web-based safety debriefing was sent to clinicians involved in surgical care of abdominal organ transplant patients. A multidisciplinary team of patient safety experts, surgeons and researchers used the data to develop a system of classification based on the ICPS. Disagreements were reconciled via consensus, and a codebook was developed for future use by researchers. Results A total of 320 debriefing responses were used for the initial review and codebook development. In total, the 320 debriefing responses contained 227 patient safety incidents (range: 0–7 per debriefing) and 156 contributing factors/hazards (0–5 per response). The most common severity classification was ‘reportable circumstance,’ followed by ‘near miss.’ The most common incident types were ‘resources/organizational management,’ followed by ‘medical device/equipment.’ Several aspects of surgical care were encompassed by more than one classification, including operating room scheduling, delays in care, trainee-related incidents, interruptions and handoffs. Conclusions This study demonstrates that a framework for patient safety can be applied to facilitate the organization and analysis of surgical safety data. Several unique aspects of surgical care require consideration, and by using a standardized framework for describing concepts, research findings can be compared and disseminated across surgical specialties. The codebook is intended for use as a framework for other specialties and institutions. PMID:26803539

Intelligent cooperation: A framework of pedagogic practice in the operating room.

PubMed

Sutkin, Gary; Littleton, Eliza B; Kanter, Steven L

2018-04-01

Surgeons who work with trainees must address their learning needs without compromising patient safety. We used a constructivist grounded theory approach to examine videos of five teaching surgeries. Attending surgeons were interviewed afterward while watching cued videos of their cases. Codes were iteratively refined into major themes, and then constructed into a larger framework. We present a novel framework, Intelligent Cooperation, which accounts for the highly adaptive, iterative features of surgical teaching in the operating room. Specifically, we define Intelligent Cooperation as a sequence of coordinated exchanges between attending and trainee that accomplishes small surgical steps while simultaneously uncovering the trainee's learning needs. Intelligent Cooperation requires the attending to accurately determine learning needs, perform real-time needs assessment, provide critical scaffolding, and work with the learner to accomplish the next step in the surgery. This is achieved through intense, coordinated verbal and physical cooperation. Copyright © 2017 Elsevier Inc. All rights reserved.

New perspectives on understanding cultural diversity in nurse–patient communication.

PubMed

Crawford, Tonia; Candlin, Sally; Roger, Peter

Effective communication is essential in developing rapport with patients, and many nursing roles such as patient assessment, education, and counselling consist only of dialogue. With increasing cultural diversity among nurses and patients in Australia, there are growing concerns relating to the potential for miscommunication, as differences in language and culture can cause misunderstandings which can have serious impacts on health outcomes and patient safety (Hamilton & Woodward-Kron, 2010). According to Grant and Luxford (2011)) there is little research into the way health professionals approach working with cultural difference or how this impacts on their everyday practice. Furthermore, there has been minimal examination of intercultural nurse–patient communication from a linguistic perspective. Applying linguistic frameworks to nursing practice can help nurses understand what is happening in their communication with patients, particularly where people from different cultures are interacting. This paper discusses intercultural nurse–patient communication and refers to theoretical frameworks from applied linguistics to explain how miscommunication may occur. It illustrates how such approaches will help to raise awareness of underlying causes and potentially lead to more effective communication skills, therapeutic relationships and therefore patient satisfaction and safety.

Regulation of naturally occurring radioactive materials in Australia.

PubMed

Jeffries, Cameron; Akber, Riaz; Johnston, Andrew; Cassels, Brad

2011-07-01

In order to promote uniformity between jurisdictions, the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) has developed the National Directory for Radiation Protection, which is a regulatory framework that all Australian governments have agreed to adopt. There is a large and diverse range of industries involved in mining or mineral processing, and the production of fossil fuels in Australia. Enhanced levels of naturally occurring radionuclides can be associated with mineral extraction and processing, other industries (e.g. metal recycling) and some products (e.g. plasterboard). ARPANSA, in conjunction with industry and State regulators, has undertaken a review and assessment of naturally occurring radioactive material (NORM) management in Australian industries. This review has resulted in guidance on the management of NORM that will be included in the National Directory for Radiation Protection. The first NORM safety guide provides the framework for NORM management and addresses specific NORM issues in oil and gas production, bauxite, aluminium and phosphate industries. Over time further guidance material for other NORM-related industries will be developed. This presentation will provide an overview of the regulatory approach to managing NORM industries in Australia.

IVHM Framework for Intelligent Integration for Vehicle Health Management

NASA Technical Reports Server (NTRS)

Paris, Deidre; Trevino, Luis C.; Watson, Michael D.

2005-01-01

Integrated Vehicle Health Management (IVHM) systems for aerospace vehicles, is the process of assessing, preserving, and restoring system functionality across flight and techniques with sensor and communication technologies for spacecraft that can generate responses through detection, diagnosis, reasoning, and adapt to system faults in support of Integrated Intelligent Vehicle Management (IIVM). These real-time responses allow the IIVM to modify the affected vehicle subsystem(s) prior to a catastrophic event. Furthermore, this framework integrates technologies which can provide a continuous, intelligent, and adaptive health state of a vehicle and use this information to improve safety and reduce costs of operations. Recent investments in avionics, health management, and controls have been directed towards IIVM. As this concept has matured, it has become clear that IIVM requires the same sensors and processing capabilities as the real-time avionics functions to support diagnosis of subsystem problems. New sensors have been proposed, in addition to augment the avionics sensors to support better system monitoring and diagnostics. As the designs have been considered, a synergy has been realized where the real-time avionics can utilize sensors proposed for diagnostics and prognostics to make better real-time decisions in response to detected failures. IIVM provides for a single system allowing modularity of functions and hardware across the vehicle. The framework that supports IIVM consists of 11 major on-board functions necessary to fully manage a space vehicle maintaining crew safety and mission objectives. These systems include the following: Guidance and Navigation; Communications and Tracking; Vehicle Monitoring; Information Transport and Integration; Vehicle Diagnostics; Vehicle Prognostics; Vehicle Mission Planning, Automated Repair and Replacement; Vehicle Control; Human Computer Interface; and Onboard Verification and Validation. Furthermore, the presented framework provides complete vehicle management which not only allows for increased crew safety and mission success through new intelligence capabilities, but also yields a mechanism for more efficient vehicle operations.

Bioactive nutrients - Time for tolerable upper intake levels to address safety.

PubMed

Yates, Allison A; Erdman, John W; Shao, Andrew; Dolan, Laurie C; Griffiths, James C

2017-03-01

There is increasing interest by consumers, researchers, and regulators into the roles that certain bioactive compounds, derived from plants and other natural sources, can play in health maintenance and promotion, and even prolonging a productive quality of life. Research has rapidly emerged suggesting that a wide range of compounds and mixtures in and from plants (such as fruits and vegetables, tea and cocoa) and animals (such as fish and probiotics) may exert substantial health benefits. There is interest in exploring the possibility of establishing recommended intakes or dietary guidance for certain bioactive substances to help educate consumers. A key aspect of establishing dietary guidance is the assessment of safety/toxicity of these substances. Toxicologists need to be involved in both the development of the safety framework and in the evaluation of the science to establish maximum intake/upper limits. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Hospital Nurses' Work Environment Characteristics and Patient Safety Outcomes: A Literature Review.

PubMed

Lee, Seung Eun; Scott, Linda D

2018-01-01

This integrative literature review assesses the relationship between hospital nurses' work environment characteristics and patient safety outcomes and recommends directions for future research based on examination of the literature. Using an electronic search of five databases, 18 studies published in English between 1999 and 2016 were identified for review. All but one study used a cross-sectional design, and only four used a conceptual/theoretical framework to guide the research. No definition of work environment was provided in most studies. Differing variables and instruments were used to measure patient outcomes, and findings regarding the effects of work environment on patient outcomes were inconsistent. To clarify the relationship between nurses' work environment characteristics and patient safety outcomes, researchers should consider using a longitudinal study design, using a theoretical foundation, and providing clear operational definitions of concepts. Moreover, given the inconsistent findings of previous studies, they should choose their measurement methodologies with care.

A new approach to managing work-related road traffic injury: The development of a health investment framework.

PubMed

Warmerdam, Amanda; Newnam, Sharon; Sheppard, Dianne; Griffin, Mark; Stevenson, Mark

2017-08-18

Statistics indicate that employees commuting or traveling as part of their work are overrepresented in workplace injury and death. Despite this, many organizations are unaware of the factors within their organizations that are likely to influence potential reductions in work-related road traffic injury. This article presents a multilevel conceptual framework that identifies health investment as the central feature in reducing work-related road traffic injury. Within this framework, we explore factors operating at the individual driver, workgroup supervisor, and organizational senior management levels that create a mutually reinforcing system of safety. The health investment framework identifies key factors at the senior manager, supervisor, and driver levels to cultivating a safe working environment. These factors are high-performance workplace systems, leader-member exchange and autonomy, trust and empowerment, respectively. The framework demonstrates the important interactions between these factors and how they create a self-sustaining organizational safety system. The framework aims to provide insight into the future development of interventions that are strategically aligned with the organization and target elements that facilitate and enhance driver safety and ultimately reduce work-related road traffic injury and death.

Pharmaceuticals in Tap Water: Human Health Risk Assessment and Proposed Monitoring Framework in China

PubMed Central

Leung, Ho Wing; Jin, Ling; Wei, Si; Tsui, Mirabelle Mei Po; Zhou, Bingsheng; Jiao, Liping; Cheung, Pak Chuen; Chun, Yiu Kan

2013-01-01

Background: Pharmaceuticals are known to contaminate tap water worldwide, but the relevant human health risks have not been assessed in China. Objectives: We monitored 32 pharmaceuticals in Chinese tap water and evaluated the life-long human health risks of exposure in order to provide information for future prioritization and risk management. Methods: We analyzed samples (n = 113) from 13 cities and compared detected concentrations with existing or newly-derived safety levels for assessing risk quotients (RQs) at different life stages, excluding the prenatal stage. Results: We detected 17 pharmaceuticals in 89% of samples, with most detectable concentrations (92%) at < 50 ng/L. Caffeine (median–maximum, nanograms per liter: 24.4–564), metronidazole (1.8–19.3), salicylic acid (16.6–41.2), clofibric acid (1.2–3.3), carbamazepine (1.3–6.7), and dimetridazole (6.9–14.7) were found in ≥ 20% of samples. Cities within the Yangtze River region and Guangzhou were regarded as contamination hot spots because of elevated levels and frequent positive detections. Of the 17 pharmaceuticals detected, 13 showed very low risk levels, but 4 (i.e., dimetridazole, thiamphenicol, sulfamethazine, and clarithromycin) were found to have at least one life-stage RQ ≥ 0.01, especially for the infant and child life stages, and should be considered of high priority for management. We propose an indicator-based monitoring framework for providing information for source identification, water treatment effectiveness, and water safety management in China. Conclusion: Chinese tap water is an additional route of human exposure to pharmaceuticals, particularly for dimetridazole, although the risk to human health is low based on current toxicity data. Pharmaceutical detection and application of the proposed monitoring framework can be used for water source protection and risk management in China and elsewhere. PMID:23665928

Assessing the safety culture of care homes: a multimethod evaluation of the adaptation, face validity and feasibility of the Manchester Patient Safety Framework.

PubMed

Marshall, Martin; Cruickshank, Lesley; Shand, Jenny; Perry, Sarah; Anderson, James; Wei, Li; Parker, Dianne; de Silva, Debra

2017-09-01

Understanding the cultural characteristics of healthcare organisations is widely recognised to be an important component of patient safety. A growing number of vulnerable older people are living in care homes but little attention has been paid to safety culture in this sector. In this study, we aimed to adapt the Manchester Patient Safety Framework (MaPSaF), a commonly used tool in the health sector, for use in care homes and then to test its face validity and preliminary feasibility as a tool for developing a better understanding of safety culture in the sector. As part of a wider improvement programme to reduce the prevalence of common safety incidents among residents in 90 care homes in England, we adapted MaPSaF and carried out a multimethod participatory evaluation of its face validity and feasibility for care home staff. Data were collected using participant observation, interviews, documentary analysis and a survey, and were analysed thematically. MaPSaF required considerable adaptation in terms of its length, language and content in order for it to be perceived to be acceptable and useful to care home staff. The changes made reflected differences between the health and care home sectors in terms of the local context and wider policy environment, and the expectations, capacity and capabilities of the staff. Based on this preliminary study, the adapted tool, renamed 'Culture is Key', appears to have reasonable face validity and, with adequate facilitation, it is usable by front-line staff and useful in raising their awareness about safety issues. 'Culture is Key' is a new tool which appears to have acceptable face validity and feasibility to be used by care home staff to deepen their understanding of the safety culture of their organisations and therefore has potential to contribute to improving care for vulnerable older people. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

PubMed

Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

2006-04-03

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including functional foods and nutraceuticals is 'safety'. Decisions on the safety-basis of legislation are based on risk analysis, in which scientific risk assessment is performed by the European Food Safety Authority and risk management is performed by the European Commission, the Member States, and in case of legislation, together with the European Parliament. In the risk management phase, both the precautionary principle and other legitimate factors may be considered in choosing the best way of dealing with an issue. Due to the numerous pieces of legislation applying and to the different procedures to be followed, the process of having 'functional foods' ready for the market is certainly a costly and time-consuming task. However, it may also be clearly worth it in terms of market success and improved consumer health.

Promoting Adoption of the 3Rs through Regulatory Qualification.

PubMed

Walker, Elizabeth Gribble; Baker, Amanda F; Sauer, John-Michael

2016-12-01

One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting. When accumulating the data to support a particular "context-of-use," the concept of "fit-for-purpose" often guides assay validation, as well as the type and amount of data or evidence required to evaluate the tool. This paper will review pathways for regulatory acceptance of novel DDTs and discuss examples of safety projects considered for regulatory qualification. Key concepts to be considered when defining the evidence required to formally adopt and potentially replace animal-intensive traditional safety assessment methods using qualified DDTs are proposed. Presently, the use of qualified translational kidney safety biomarkers can refine and reduce the total numbers of animals used in drug development. We propose that the same conceptual regulatory framework will be appropriate to assess readiness of new technologies that may eventually replace whole animal models. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

An evaluation of a new instrument to measure organisational safety culture values and practices.

PubMed

Díaz-Cabrera, D; Hernández-Fernaud, E; Isla-Díaz, R

2007-11-01

The main aim of this research is to evaluate a safety culture measuring instrument centred upon relevant organisational values and practices related to the safety management system. Seven dimensions that reflect underlying safety meanings are proposed. A second objective is to explore the four cultural orientations in the field of safety arising from the competing values framework. The study sample consisted of 299 participants from five companies in different sectors. The results show six dimensions of organisational values and practices and different company profiles in the organisations studied. The four cultural orientations proposed by the competing values framework are not confirmed. Nevertheless, a coexistence of diverse cultural orientations or paradoxes in the companies is observed.

The role of the ward manager in promoting patient safety.

PubMed

Pinnock, David

In this article the role of the ward manager in promoting patient safety is explored. The background to the development of the patient safety agenda is briefly discussed and the relationship between quality and safety is illustrated. The pivotal importance of the role of the ward manager in delivering services to patients is underlined and literature on patient safety is examined to identify what a ward manager can do to make care safer. Possible actions of the ward manager to improve safety discussed in the literature are structured around the Leadership Framework. This framework identifies seven domains for the leadership of service delivery. Ward managers use their personal qualities, and network and work within teams, while managing performance and facilitating innovation, change and measurement for improvement. The challenge of promoting patient safety for ward managers is briefly explored and recommendations for further research are made.

Health Effects of Environmental Exposures, Occupational Hazards and Climate Change in Ethiopia: Synthesis of Situational Analysis, Needs Assessment and the Way Forward.

PubMed

Berhane, Kiros; Kumie, Abera; Samet, Jonathan

2016-01-01

The burden of diseases caused by environmental and occupational health hazards and the effects of global climate change are of growing concerns in Ethiopia. However, no adequate information seems to be available on the current situation. This means there is a critical gap in research, policy framework and implementation in the country. The purpose of this paper was to synthesize evidence from a systematic situational analysis and needs assessment to help establish a hub for research and training on three major themes and their related policy frameworks: air pollution and health, occupational health and safety and climate change and health. The methods used in this work include a systematic review of secondary data from peer-reviewed literature, thesis reports from academia, government and national statistical reports. Limited primary data based on key informant interviews held with major stakeholders were also used as sources of data. Exposures to high levels of indoor and outdoor air pollutants were found to be major sources of public health challenges. Lack of occupational safety and health due to agricultural activities and exposure to industries was found to be substantial. Worse is the growing fear that climate change will pose increasingly significant multidimensional challenges to the environment and public health. Across all three areas of focus, there was a paucity of information on local scientific evidence. There is also very limited trained skilled manpower and physical infrastructure to monitor the environment and enforce regulatory guidelines. Research, policy frameworks and regulatory mechanisms were among the cross-cutting issues that needed urgent attention. Critical gaps were observed in research and training across the three themes. Also, there is a limitation in implementing the link between policy and related regulations in the environment and health.

Risk analysis for veterinary biologicals released into the environment.

PubMed

Silva, S V; Samagh, B S; Morley, R S

1995-12-01

All veterinary biologicals licensed in Canada must be shown to be pure, potent, safe and effective. A risk-based approach is used to evaluate the safety of all biologicals, whether produced by conventional methods or by molecular biological techniques. Traditionally, qualitative risk assessment methods have been used for this purpose. More recently, quantitative risk assessment has become available for complex issues. The quantitative risk assessment method uses "scenario tree analysis' to predict the likelihood of various outcomes and their respective impacts. The authors describe the quantitative risk assessment approach which is used within the broader context of risk analysis (i.e. risk assessment, risk management and risk communication) to develop recommendations for the field release of veterinary biologicals. The general regulatory framework for the licensing of veterinary biologicals in Canada is also presented.

A framework for conducting mechanistic based reliability assessments of components operating in complex systems

NASA Astrophysics Data System (ADS)

Wallace, Jon Michael

2003-10-01

Reliability prediction of components operating in complex systems has historically been conducted in a statistically isolated manner. Current physics-based, i.e. mechanistic, component reliability approaches focus more on component-specific attributes and mathematical algorithms and not enough on the influence of the system. The result is that significant error can be introduced into the component reliability assessment process. The objective of this study is the development of a framework that infuses the needs and influence of the system into the process of conducting mechanistic-based component reliability assessments. The formulated framework consists of six primary steps. The first three steps, identification, decomposition, and synthesis, are primarily qualitative in nature and employ system reliability and safety engineering principles to construct an appropriate starting point for the component reliability assessment. The following two steps are the most unique. They involve a step to efficiently characterize and quantify the system-driven local parameter space and a subsequent step using this information to guide the reduction of the component parameter space. The local statistical space quantification step is accomplished using two proposed multivariate probability models: Multi-Response First Order Second Moment and Taylor-Based Inverse Transformation. Where existing joint probability models require preliminary distribution and correlation information of the responses, these models combine statistical information of the input parameters with an efficient sampling of the response analyses to produce the multi-response joint probability distribution. Parameter space reduction is accomplished using Approximate Canonical Correlation Analysis (ACCA) employed as a multi-response screening technique. The novelty of this approach is that each individual local parameter and even subsets of parameters representing entire contributing analyses can now be rank ordered with respect to their contribution to not just one response, but the entire vector of component responses simultaneously. The final step of the framework is the actual probabilistic assessment of the component. Although the same multivariate probability tools employed in the characterization step can be used for the component probability assessment, variations of this final step are given to allow for the utilization of existing probabilistic methods such as response surface Monte Carlo and Fast Probability Integration. The overall framework developed in this study is implemented to assess the finite-element based reliability prediction of a gas turbine airfoil involving several failure responses. Results of this implementation are compared to results generated using the conventional 'isolated' approach as well as a validation approach conducted through large sample Monte Carlo simulations. The framework resulted in a considerable improvement to the accuracy of the part reliability assessment and an improved understanding of the component failure behavior. Considerable statistical complexity in the form of joint non-normal behavior was found and accounted for using the framework. Future applications of the framework elements are discussed.

Small-Scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons

DTIC Science & Technology

2004-06-23

Vibrio cholerae ) + — — — + Unknown Salmonella Typhimurium + — + — — Unknown Typhoid fever (Salmonella Typhi) + O — — — Unknown Source: This...disseminated by contamination of food or drink. Cholera bb ( Vibrio cholerae ) Cholera occurs in many of the developing countries of Africa and Asia...diseaseinfo/cholera_g.htm]; the Health Canada Material Safety Data Sheet - Infectious Substances for Vibrio cholerae , found online at [http://www.hc-sc.gc.ca

A benefit/risk approach towards selecting appropriate pharmaceutical dosage forms - an application for paediatric dosage form selection.

PubMed

Sam, Tom; Ernest, Terry B; Walsh, Jennifer; Williams, Julie L

2012-10-05

The design and selection of new pharmaceutical dosage forms involves the careful consideration and balancing of a quality target product profile against technical challenges and development feasibility. Paediatric dosage forms present particular complexity due to the diverse patient population, patient compliance challenges and safety considerations of this vulnerable population. This paper presents a structured framework for assessing the comparative benefits and risks of different pharmaceutical design options against pre-determined criteria relating to (1) efficacy, (2) safety and (3) patient access. This benefit/risk framework has then been applied to three hypothetical, but realistic, scenarios for paediatric dosage forms in order to explore its utility in guiding dosage form design and formulation selection. The approach allows a rigorous, systematic and qualitative assessment of the merits and disadvantages of each dosage form option and helps identify mitigating strategies to modify risk. The application of a weighting and scoring system to the criteria depending on the specific case could further refine the analysis and aid decision-making. In this paper, one case study is scored for illustrative purposes. However, it is acknowledged that in real development scenarios, the generation of actual data considering the very specific situation for the patient/product/developer would come into play to drive decisions on the most appropriate dosage form strategy. Copyright © 2012 Elsevier B.V. All rights reserved.

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

NASA Astrophysics Data System (ADS)

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

2015-04-01

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

Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority.

PubMed

Rortais, Agnès; Arnold, Gérard; Dorne, Jean-Lou; More, Simon J; Sperandio, Giorgio; Streissl, Franz; Szentes, Csaba; Verdonck, Frank

2017-06-01

Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In conclusion, EFSA calls for collaborative action at the EU level to establish a common and open access database to serve multiple purposes and different stakeholders. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The Power to drive change: Working together for excellence. Creating a continuously improving consumer engagement framework for excellence in patient-centered care.

PubMed

Ryan, Catherine

2016-01-01

The World Health Organization has acknowledged Patient Safety while receiving hospital care as a serious global public health issue, with patient empowerment and community engagement key to continuously improving safety and quality of care for the best possible clinical and patient outcomes. In Australia, the introduction of ten mandatory National Safety and Quality Health Service Standards in 2011 provided the catalyst for all Australian health facilities to review their systems. Standard 2: Partnering with Consumers required health facilities across Australia to assess commitment to, and capacity for consumer and community engagement and participation. At this time, the Royal Brisbane and Women's Hospital did not have a strategic perspective and understanding, or an organizational structure for engaging with consumers (patients, families, care givers and community members). The concept required a new model to replace the clinician-led model of healthcare historically featured in Australia, with a change in culture and core business. processes to partner with consumers at all levels of the system, from individual patient care through to participating in policy development, health service planning and delivery, and evaluation and measurement processes. The challenge for the hospital was to build a sustainable framework of engagement for a genuine patient-centered model of care informed by best practice, and provide leadership and commitment to developing as an area of excellence in patient engagement and experience. A successful and sustainable framework for consumer and community engagement has been embedded in the hospital, with resultant culture change, achieving accreditation across all core and developmental criteria for the partnering with consumer standards including several Met with Merit ratings.

Resilient Practices in Maintaining Safety of Health Information Technologies

PubMed Central

Ash, Joan S.; Sittig, Dean F.; Singh, Hardeep

2014-01-01

Electronic health record systems (EHRs) can improve safety and reliability of health care, but they can also introduce new vulnerabilities by failing to accommodate changes within a dynamic EHR-enabled health care system. Continuous assessment and improvement is thus essential for achieving resilience in EHR-enabled health care systems. Given the rapid adoption of EHRs by many organizations that are still early in their experiences with EHR safety, it is important to understand practices for maintaining resilience used by organizations with a track record of success in EHR use. We conducted interviews about safety practices with 56 key informants (including information technology managers, chief medical information officers, physicians, and patient safety officers) at two large health care systems recognized as leaders in EHR use. We identified 156 references to resilience-related practices from 41 informants. Framework analysis generated five categories of resilient practices: (a) sensitivity to dynamics and interdependencies affecting risks, (b) basic monitoring and responding practices, (c) management of practices and resources for monitoring and responding, (d) sensitivity to risks beyond the horizon, and (e) reflecting on risks with the safety and quality control process itself. The categories reflect three functions that facilitate resilience: reflection, transcending boundaries, and involving sharp-end practitioners in safety management. PMID:25866492

RIFM fragrance ingredient safety assessment, benzyl butyrate, CAS Registry Number 103-37-7.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog benzyl acetate (CAS # 140-11-4) show that this material is not genotoxic nor does it have skin sensitization potential and also provided a MOE > 100 for the repeated dose, developmental and reproductive, and local respiratory toxicity endpoints. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

RIFM fragrance ingredient safety assessment, isobornyl isovalerate, CAS registry number 7779-73-9.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lapczynski, A; Liebler, D C; O'Brien, D; Parakhia, R; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2017-12-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization potential, as well as, environmental safety. Data from the suitable read across analog isobornyl acetate (CAS # 125-12-2) show that this material is not genotoxic, provided a MOE > 100 for the repeated dose, developmental and reproductive endpoints, and does not have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (threshold of Toxicological Concern) for a Cramer Class II material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

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

Chernowski, John

2009-02-27

Lawrence Berkeley National Laboratory's Environment, Safety, and Health (ES&H) Self-Assessment Program ensures that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The Self-Assessment Program, managed by the Office of Contract Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The functions of the program are to ensure that work is conducted safely, and with minimal negative impact to workers, the public, and the environment. The Self-Assessment Program is also the mechanism used to institute continuous improvements to the Laboratory's ES&H programs. The program is described in LBNL/PUB 5344, Environment, Safety, andmore » Health Self-Assessment Program and is composed of four distinct assessments: the Division Self-Assessment, the Management of Environment, Safety, and Health (MESH) review, ES&H Technical Assurance, and the Appendix B Self-Assessment. The Division Self-Assessment uses the five core functions and seven guiding principles of ISM as the basis of evaluation. Metrics are created to measure performance in fulfilling ISM core functions and guiding principles, as well as promoting compliance with applicable regulations. The five core functions of ISM are as follows: (1) Define the Scope of Work; (2) Identify and Analyze Hazards; (3) Control the Hazards; (4) Perform the Work; and (5) Feedback and Improvement. The seven guiding principles of ISM are as follows: (1) Line Management Responsibility for ES&H; (2) Clear Roles and Responsibilities; (3) Competence Commensurate with Responsibilities; (4) Balanced Priorities; (5) Identification of ES&H Standards and Requirements; (6) Hazard Controls Tailored to the Work Performed; and (7) Operations Authorization. Performance indicators are developed by consensus with OCA, representatives from each division, and Environment, Health, and Safety (EH&S) Division program managers. Line management of each division performs the Division Self-Assessment annually. The primary focus of the review is workplace safety. The MESH review is an evaluation of division management of ES&H in its research and operations, focusing on implementation and effectiveness of the division's ISM plan. It is a peer review performed by members of the LBNL Safety Review Committee (SRC), with staff support from OCA. Each division receives a MESH review every two to four years, depending on the results of the previous review. The ES&H Technical Assurance Program (TAP) provides the framework for systematic reviews of ES&H programs and processes. The intent of ES&H Technical Assurance assessments is to provide assurance that ES&H programs and processes comply with their guiding regulations, are effective, and are properly implemented by LBNL divisions. The Appendix B Performance Evaluation and Measurement Plan (PEMP) requires that LBNL sustain and enhance the effectiveness of integrated safety, health, and environmental protection through a strong and well-deployed system. Information required for Appendix B is provided by EH&S Division functional managers. The annual Appendix B report is submitted at the close of the fiscal year. This assessment is the Department of Energy's (DOE) primary mechanism for evaluating LBNL's contract performance in ISM.« less

Factors Influencing Implementation of OHSAS 18001 in Indian Construction Organizations: Interpretive Structural Modeling Approach

PubMed Central

Rajaprasad, Sunku Venkata Siva; Chalapathi, Pasupulati Venkata

2015-01-01

Background Construction activity has made considerable breakthroughs in the past two decades on the back of increases in development activities, government policies, and public demand. At the same time, occupational health and safety issues have become a major concern to construction organizations. The unsatisfactory safety performance of the construction industry has always been highlighted since the safety management system is neglected area and not implemented systematically in Indian construction organizations. Due to a lack of enforcement of the applicable legislation, most of the construction organizations are forced to opt for the implementation of Occupational Health Safety Assessment Series (OHSAS) 18001 to improve safety performance. Methods In order to better understand factors influencing the implementation of OHSAS 18001, an interpretive structural modeling approach has been applied and the factors have been classified using matrice d'impacts croises-multiplication appliqué a un classement (MICMAC) analysis. The study proposes the underlying theoretical framework to identify factors and to help management of Indian construction organizations to understand the interaction among factors influencing in implementation of OHSAS 18001. Results Safety culture, continual improvement, morale of employees, and safety training have been identified as dependent variables. Safety performance, sustainable construction, and conducive working environment have been identified as linkage variables. Management commitment and safety policy have been identified as the driver variables. Conclusion Management commitment has the maximum driving power and the most influential factor is safety policy, which states clearly the commitment of top management towards occupational safety and health. PMID:26929828

75 FR 68224 - Safety Management Systems for Part 121 Certificate Holders

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... the general framework for an organization-wide safety management approach to air carrier operations... System? An SMS is an organization-wide approach to managing safety risk and assuring the effectiveness of... under 14 CFR part 121 to develop and implement a safety management system (SMS) to improve the safety of...

Framework for Considering Productive Aging and Work.

PubMed

Schulte, Paul A; Grosch, James; Scholl, Juliann C; Tamers, Sara L

2018-05-01

The U.S. population is experiencing a demographic transition resulting in an aging workforce. The objective of this article is to elucidate and expand an approach to keep that workforce safe, healthy, and productive. This article elucidates the framework for the National Center for Productive Aging at Work of the National Institute for Occupational Safety and Health. Subject matter experts used a snowball method to review published literature to substantiate elements in the framework. Evidence-based literature supports a productive aging framework for the workforce involving the following elements: 1) life span perspective; 2) comprehensive and integrated approaches to occupational safety and health; 3) emphasis on positive outcomes for both workers and organizations; and 4) supportive work culture for multigenerational issues. The productive aging framework provides a foundational and comprehensive approach for addressing the aging workforce.

Reprint of "Safe places for pedestrians: using cognitive work analysis to consider the relationships between the engineering and urban design of footpaths".

PubMed

Stevens, Nicholas; Salmon, Paul

2015-01-01

Footpaths provide an integral component of our urban environments and have the potential to act as safe places for people and the focus for community life. Despite this, the approach to designing footpaths that are safe while providing this sense of place often occurs in silos. There is often very little consideration given to how designing for sense of place impacts safety and vice versa. The aim of this study was to use a systems analysis and design framework to develop a design template for an 'ideal' footpath system that embodies both safety and sense of place. This was achieved through using the first phase of the Cognitive Work Analysis framework, Work Domain Analysis, to specify a model of footpaths as safe places for pedestrians. This model was subsequently used to assess two existing footpath environments to determine the extent to which they meet the design requirements specified. The findings show instances where the existing footpaths both meet and fail to meet the design requirements specified. Through utilising a systems approach for footpaths, this paper has provided a novel design template that can inform new footpath design efforts or be used to evaluate the extent to which existing footpaths achieve their safety and sense of place requirements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safe places for pedestrians: using cognitive work analysis to consider the relationships between the engineering and urban design of footpaths.

PubMed

Stevens, Nicholas; Salmon, Paul

2014-11-01

Footpaths provide an integral component of our urban environments and have the potential to act as safe places for people and the focus for community life. Despite this, the approach to designing footpaths that are safe while providing this sense of place often occurs in silos. There is often very little consideration given to how designing for sense of place impacts safety and vice versa. The aim of this study was to use a systems analysis and design framework to develop a design template for an 'ideal' footpath system that embodies both safety and sense of place. This was achieved through using the first phase of the Cognitive Work Analysis framework, Work Domain Analysis, to specify a model of footpaths as safe places for pedestrians. This model was subsequently used to assess two existing footpath environments to determine the extent to which they meet the design requirements specified. The findings show instances where the existing footpaths both meet and fail to meet the design requirements specified. Through utilising a systems approach for footpaths, this paper has provided a novel design template that can inform new footpath design efforts or be used to evaluate the extent to which existing footpaths achieve their safety and sense of place requirements. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Topical issues of biological safety under current conditions. Part 3. Scientific provision for the national regulation of the biological safety framework in its broad interpretation].

PubMed

Onishchenko, G G; Smolensky, V Yu; Ezhlova, E B; Demina, Yu V; Toporkov, V P; Toporkov, A V; Lyapin, M N; Kutyrev, V V

2014-01-01

Consequent of investigation concerned with biological safety (BS) framework development in its broad interpretation, reflected in the Russian Federation State Acts, identified have been conceptual entity parameters of the up-to-date broad interpretation of BS, which have formed a part of the developed by the authors system for surveillance (prophylaxis, localization, indication, identification, and diagnostics) and control (prophylaxis, localization, and response/elimination) over the emergency situations of biological (sanitary-epidemiological) character. The System functionality is activated through supplying the content with information data which are concerned with monitoring and control of specific internal and external threats in the sphere of BS provision fixed in the Supplement 2 of the International Health Regulations (IHR, 2005), and with the previously characterized nomenclature of hazardous biological factors. The system is designed as a network-based research-and-practice tool for evaluation of the situation in the sphere of BS provision, as well as assessment of efficacy of management decision making as regards BS control and proper State policy implementation. Most of the system elements either directly or indirectly relate to the scope of activities conducted by Federal Service for Surveillance in the Sphere of Consumers Rights Protection and Human Welfare, being substantial argument for allocating coordination functions in the sphere of BS provision to this government agency and consistent with its function as the State Coordinator on IHR (2005). The data collected serve as materials to Draft Federal Law "Concerning biological safety provision of the population".

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo

2016-07-01

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

The elements of a commercial human spaceflight safety reporting system

NASA Astrophysics Data System (ADS)

Christensen, Ian

2017-10-01

In its report on the SpaceShipTwo accident the National Transportation Safety Board (NTSB) included in its recommendations that the Federal Aviation Administration (FAA) ;in collaboration with the commercial spaceflight industry, continue work to implement a database of lessons learned from commercial space mishap investigations and encourage commercial space industry members to voluntarily submit lessons learned.; In its official response to the NTSB the FAA supported this recommendation and indicated it has initiated an iterative process to put into place a framework for a cooperative safety data sharing process including the sharing of lessons learned, and trends analysis. Such a framework is an important element of an overall commercial human spaceflight safety system.

Development of Uniform Protocol for Alopecia Areata Clinical Trials.

PubMed

Solomon, James A

2015-11-01

Developing a successful treatment for alopecia areata (AA), clearly has not been at the forefront of the agenda for new drug/device development among the pharmaceutical and medical device industry. The National Alopecia Areata Foundation (NAAF), a patient advocacy group, initiated a plan to facilitate and drive clinical research toward finding safe and efficacious treatments for AA. As such, Alopecia Areata Uniform Protocols for clinical trials to test new treatments for AA were developed. The design of the uniform protocol is to accomplish the development of a plug-and-play template as well as to provide a framework wherein data from studies utilizing the uniform protocol can be compared through consistency of inclusions/exclusions, safety, and outcome assessment measures. A core uniform protocol for use by pharmaceutical companies in testing proof of concept for investigational products to treat AA. The core protocol includes standardized title, informed consent, inclusion/exclusion criteria, disease outcome assessments, and safety assessments. The statistical methodology to assess successful outcomes will also be standardized. The protocol as well as the informed consent form has been approved in concept by Liberty IRB and is ready to present to pharmaceutical companies.

The landscape of fear conceptual framework: definition and review of current applications and misuses.

PubMed

Bleicher, Sonny S

2017-01-01

Landscapes of Fear (LOF), the spatially explicit distribution of perceived predation risk as seen by a population, is increasingly cited in ecological literature and has become a frequently used "buzz-word". With the increase in popularity, it became necessary to clarify the definition for the term, suggest boundaries and propose a common framework for its use. The LOF, as a progeny of the "ecology of fear" conceptual framework, defines fear as the strategic manifestation of the cost-benefit analysis of food and safety tradeoffs. In addition to direct predation risk, the LOF is affected by individuals' energetic-state, inter- and intra-specific competition and is constrained by the evolutionary history of each species. Herein, based on current applications of the LOF conceptual framework, I suggest the future research in this framework will be directed towards: (1) finding applied management uses as a trait defining a population's habitat-use and habitat-suitability; (2) studying multi-dimensional distribution of risk-assessment through time and space; (3) studying variability between individuals within a population; (4) measuring eco-neurological implications of risk as a feature of environmental heterogeneity and (5) expanding temporal and spatial scales of empirical studies.

The landscape of fear conceptual framework: definition and review of current applications and misuses

PubMed Central

2017-01-01

Landscapes of Fear (LOF), the spatially explicit distribution of perceived predation risk as seen by a population, is increasingly cited in ecological literature and has become a frequently used “buzz-word”. With the increase in popularity, it became necessary to clarify the definition for the term, suggest boundaries and propose a common framework for its use. The LOF, as a progeny of the “ecology of fear” conceptual framework, defines fear as the strategic manifestation of the cost-benefit analysis of food and safety tradeoffs. In addition to direct predation risk, the LOF is affected by individuals’ energetic-state, inter- and intra-specific competition and is constrained by the evolutionary history of each species. Herein, based on current applications of the LOF conceptual framework, I suggest the future research in this framework will be directed towards: (1) finding applied management uses as a trait defining a population’s habitat-use and habitat-suitability; (2) studying multi-dimensional distribution of risk-assessment through time and space; (3) studying variability between individuals within a population; (4) measuring eco-neurological implications of risk as a feature of environmental heterogeneity and (5) expanding temporal and spatial scales of empirical studies. PMID:28929015

One Health in food safety and security education: Subject matter outline for a curricular framework.

PubMed

Angelos, John A; Arens, Amanda L; Johnson, Heather A; Cadriel, Jessica L; Osburn, Bennie I

2017-06-01

Educating students in the range of subjects encompassing food safety and security as approached from a One Health perspective requires consideration of a variety of different disciplines and the interrelationships among disciplines. The Western Institute for Food Safety and Security developed a subject matter outline to accompany a previously published One Health in food safety and security curricular framework. The subject matter covered in this outline encompasses a variety of topics and disciplines related to food safety and security including effects of food production on the environment. This subject matter outline should help guide curriculum development and education in One Health in food safety and security and provides useful information for educators, researchers, students, and public policy-makers facing the inherent challenges of maintaining and/or developing safe and secure food supplies without destroying Earth's natural resources.

Safety measurement and monitoring in healthcare: a framework to guide clinical teams and healthcare organisations in maintaining safety

PubMed Central

Vincent, Charles; Burnett, Susan; Carthey, Jane

2014-01-01

Patients, clinicians and managers all want to be reassured that their healthcare organisation is safe. But there is no consensus about what we mean when we ask whether a healthcare organisation is safe or how this is achieved. In the UK, the measurement of harm, so important in the evolution of patient safety, has been neglected in favour of incident reporting. The use of softer intelligence for monitoring and anticipation of problems receives little mention in official policy. The Francis Inquiry report into patient treatment at the Mid Staffordshire NHS Foundation Trust set out 29 recommendations on measurement, more than on any other topic, and set the measurement of safety an absolute priority for healthcare organisations. The Berwick review found that most healthcare organisations at present have very little capacity to analyse, monitor or learn from safety and quality information. This paper summarises the findings of a more extensive report and proposes a framework which can guide clinical teams and healthcare organisations in the measurement and monitoring of safety and in reviewing progress against safety objectives. The framework has been used so far to promote self-reflection at both board and clinical team level, to stimulate an organisational check or analysis in the gaps of information and to promote discussion of ‘what could we do differently’. PMID:24764136

Discounting the value of safety: effects of perceived risk and effort.

PubMed

Sigurdsson, Sigurdur O; Taylor, Matthew A; Wirth, Oliver

2013-09-01

Although falls from heights remain the most prevalent cause of fatalities in the construction industry, factors impacting safety-related choices associated with work at heights are not completely understood. Better tools are needed to identify and study the factors influencing safety-related choices and decision making. Using a computer-based task within a behavioral economics paradigm, college students were presented a choice between two hypothetical scenarios that differed in working height and effort associated with retrieving and donning a safety harness. Participants were instructed to choose the scenario in which they were more likely to wear the safety harness. Based on choice patterns, switch points were identified, indicating when the perceived risk in both scenarios was equivalent. Switch points were a systematic function of working height and effort, and the quantified relation between perceived risk and effort was described well by a hyperbolic equation. Choice patterns revealed that the perceived risk of working at heights decreased as the effort to retrieve and don a safety harness increased. Results contribute to the development of computer-based procedure for assessing risk discounting within a behavioral economics framework. Such a procedure can be used as a research tool to study factors that influence safety-related decision making with a goal of informing more effective prevention and intervention strategies. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

The Development And Implementation Of A Concept To Permanent Reduction Of Noise Pollution In Production Taking Into Account The Legal And Economic Framework Conditions

NASA Astrophysics Data System (ADS)

Zaušková, Lucia; Czán, Andrej; Babík, Ondrej; Piešová, Marianna

2015-12-01

Article deals with the issue of reducing noise impact in real conditions of industrial production. The solution includes measurements and calculations of noise level the person is exposed to and developing proposals for effective reduction of noise levels at the specific workplace. When assessing noise levels and design to reduce it to an acceptable level we will consider the legal, safety and economic conditions.

Small-Scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons

DTIC Science & Technology

2004-05-20

Unknown Cholera ( Vibrio cholerae ) + — — — + Unknown Salmonella Typhimurium + — + — — Unknown Typhoid fever (Salmonella Typhi) + O — — — Unknown... Cholera bb ( Vibrio cholerae ) Cholera occurs in many of the developing countries of Africa and Asia, especially where sanitary conditions are not optimal...Safety Data Sheet - Infectious Substances for Vibrio cholerae , found online at [http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/msds164e.html]; D. Hank

Challenges Ahead for Nuclear Facility Site-Specific Seismic Hazard Assessment in France: The Alternative Energies and the Atomic Energy Commission (CEA) Vision

NASA Astrophysics Data System (ADS)

Berge-Thierry, C.; Hollender, F.; Guyonnet-Benaize, C.; Baumont, D.; Ameri, G.; Bollinger, L.

2017-09-01

Seismic analysis in the context of nuclear safety in France is currently guided by a pure deterministic approach based on Basic Safety Rule ( Règle Fondamentale de Sûreté) RFS 2001-01 for seismic hazard assessment, and on the ASN/2/01 Guide that provides design rules for nuclear civil engineering structures. After the 2011 Tohohu earthquake, nuclear operators worldwide were asked to estimate the ability of their facilities to sustain extreme seismic loads. The French licensees then defined the `hard core seismic levels', which are higher than those considered for design or re-assessment of the safety of a facility. These were initially established on a deterministic basis, and they have been finally justified through state-of-the-art probabilistic seismic hazard assessments. The appreciation and propagation of uncertainties when assessing seismic hazard in France have changed considerably over the past 15 years. This evolution provided the motivation for the present article, the objectives of which are threefold: (1) to provide a description of the current practices in France to assess seismic hazard in terms of nuclear safety; (2) to discuss and highlight the sources of uncertainties and their treatment; and (3) to use a specific case study to illustrate how extended source modeling can help to constrain the key assumptions or parameters that impact upon seismic hazard assessment. This article discusses in particular seismic source characterization, strong ground motion prediction, and maximal magnitude constraints, according to the practice of the French Atomic Energy Commission. Due to increases in strong motion databases in terms of the number and quality of the records in their metadata and the uncertainty characterization, several recently published empirical ground motion prediction models are eligible for seismic hazard assessment in France. We show that propagation of epistemic and aleatory uncertainties is feasible in a deterministic approach, as in a probabilistic way. Assessment of seismic hazard in France in the framework of the safety of nuclear facilities should consider these recent advances. In this sense, the opening of discussions with all of the stakeholders in France to update the reference documents (i.e., RFS 2001-01; ASN/2/01 Guide) appears appropriate in the short term.

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

ERIC Educational Resources Information Center

Steighner, Tammy Rose

2017-01-01

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

Dynamic Safety Cases for Through-Life Safety Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

2015-01-01

We describe dynamic safety cases, a novel operationalization of the concept of through-life safety assurance, whose goal is to enable proactive safety management. Using an example from the aviation systems domain, we motivate our approach, its underlying principles, and a lifecycle. We then identify the key elements required to move towards a formalization of the associated framework.

I-81 ITS program evaluation framework

DOT National Transportation Integrated Search

2003-07-01

This document presents the evaluation framework for the I-81 ITS Model Safety Corridor Program. The objectives of the framework are threefold: 1) serve as input into the development of infrastructure in the I-81 Corridor to generate baseline data for...

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

PubMed

Pignatti, Francesco; Ehmann, Falk; Hemmings, Robert; Jonsson, Bertil; Nuebling, Micha; Papaluca-Amati, Marisa; Posch, Martin; Rasi, Guido

2014-03-15

The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Health system frameworks and performance indicators in eight countries: A comparative international analysis

PubMed Central

Braithwaite, Jeffrey; Hibbert, Peter; Blakely, Brette; Plumb, Jennifer; Hannaford, Natalie; Long, Janet Cameron; Marks, Danielle

2017-01-01

Objectives: Performance indicators are a popular mechanism for measuring the quality of healthcare to facilitate both quality improvement and systems management. Few studies make comparative assessments of different countries’ performance indicator frameworks. This study identifies and compares frameworks and performance indicators used in selected Organisation for Economic Co-operation and Development health systems to measure and report on the performance of healthcare organisations and local health systems. Countries involved are Australia, Canada, Denmark, England, the Netherlands, New Zealand, Scotland and the United States. Methods: Identification of comparable international indicators and analyses of their characteristics and of their broader national frameworks and contexts were undertaken. Two dimensions of indicators – that they are nationally consistent (used across the country rather than just regionally) and locally relevant (measured and reported publicly at a local level, for example, a health service) – were deemed important. Results: The most commonly used domains in performance frameworks were safety, effectiveness and access. The search found 401 indicators that fulfilled the ‘nationally consistent and locally relevant’ criteria. Of these, 45 indicators are reported in more than one country. Cardiovascular, surgery and mental health were the most frequently reported disease groups. Conclusion: These comparative data inform researchers and policymakers internationally when designing health performance frameworks and indicator sets. PMID:28228948

Frameworks and tools for risk assessment of manufactured nanomaterials.

PubMed

Hristozov, Danail; Gottardo, Stefania; Semenzin, Elena; Oomen, Agnes; Bos, Peter; Peijnenburg, Willie; van Tongeren, Martie; Nowack, Bernd; Hunt, Neil; Brunelli, Andrea; Scott-Fordsmand, Janeck J; Tran, Lang; Marcomini, Antonio

2016-10-01

Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screening-level assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

PubMed

Smith, Meredith Y; Benattia, Isma

2016-09-01

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and processes they implement to achieve this end effectively and efficiently, promise to become distinguishing factors in the highly competitive biopharmaceutical industry landscape.

Framework for selection and evaluation of bicycle and pedestrian safety projects in Virginia.

DOT National Transportation Integrated Search

2008-01-01

The Virginia Department of Transportation's (VDOT) Bicycle and Pedestrian Safety (BPS) Program provides funds for implementing short-term, low-cost bicycle and pedestrian safety projects in Virginia. This initiative is administered by evaluating each...

Modification of the SAS4A Safety Analysis Code for Integration with the ADAPT Discrete Dynamic Event Tree Framework.

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

Jankovsky, Zachary Kyle; Denman, Matthew R.

It is difficult to assess the consequences of a transient in a sodium-cooled fast reactor (SFR) using traditional probabilistic risk assessment (PRA) methods, as numerous safety-related sys- tems have passive characteristics. Often there is significant dependence on the value of con- tinuous stochastic parameters rather than binary success/failure determinations. One form of dynamic PRA uses a system simulator to represent the progression of a transient, tracking events through time in a discrete dynamic event tree (DDET). In order to function in a DDET environment, a simulator must have characteristics that make it amenable to changing physical parameters midway through themore » analysis. The SAS4A SFR system analysis code did not have these characteristics as received. This report describes the code modifications made to allow dynamic operation as well as the linking to a Sandia DDET driver code. A test case is briefly described to demonstrate the utility of the changes.« less

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

Ramuhalli, Pradeep; Hirt, Evelyn H.; Veeramany, Arun

This research report summaries the development and evaluation of a prototypic enhanced risk monitor (ERM) methodology (framework) that includes alternative risk metrics and uncertainty analysis. This updated ERM methodology accounts for uncertainty in the equipment condition assessment (ECA), the prognostic result, and the probabilistic risk assessment (PRA) model. It is anticipated that the ability to characterize uncertainty in the estimated risk and update the risk estimates in real time based on equipment condition assessment (ECA) will provide a mechanism for optimizing plant performance while staying within specified safety margins. These results (based on impacting active component O&M using real-time equipmentmore » condition information) are a step towards ERMs that, if integrated with AR supervisory plant control systems, can help control O&M costs and improve affordability of advanced reactors.« less

A Biological Signal-Based Stress Monitoring Framework for Children Using Wearable Devices.

PubMed

Choi, Yerim; Jeon, Yu-Mi; Wang, Lin; Kim, Kwanho

2017-08-23

The safety of children has always been an important issue, and several studies have been conducted to determine the stress state of a child to ensure the safety. Audio signals and biological signals including heart rate are known to be effective for stress state detection. However, collecting those data requires specialized equipment, which is not appropriate for the constant monitoring of children, and advanced data analysis is required for accurate detection. In this regard, we propose a stress state detection framework which utilizes both audio signal and heart rate collected from wearable devices, and adopted machine learning methods for the detection. Experiments using real-world data were conducted to compare detection performances across various machine learning methods and noise levels of audio signal. Adopting the proposed framework in the real-world will contribute to the enhancement of child safety.

Consensus achievement of leadership, organisational and individual factors that influence safety climate: Implications for nursing management.

PubMed

Fischer, Shelly A; Jones, Jacqueline; Verran, Joyce A

2018-01-01

To validate a framework of factors that influence the relationship of transformational leadership and safety climate, and to enable testing of safety chain factors by generating hypotheses regarding their mediating and moderating effects. Understanding the patient safety chain and mechanisms by which leaders affect a strong climate of safety is essential to transformational leadership practice, education, and research. A systematic review of leadership and safety literature was used to develop an organising framework of factors proposed to influence the climate of safety. A panel of 25 international experts in leadership and safety engaged a three-round modified Delphi study with Likert-scored surveys. Eighty per cent of participating experts from six countries were retained to the final survey round. Consensus (>66% agreement) was achieved on 40 factors believed to influence safety climate in the acute care setting. Consensus regarding specific factors that play important roles in an organisation's climate of safety can be reached. Generally, the demonstration of leadership commitment to safety is key to cultivating a culture of patient safety. Transformational nurse leaders should consider and employ all three categories of factors in daily leadership activities and decision-making to drive a strong climate of patient safety. © 2017 John Wiley & Sons Ltd.

Validation of Safety-Critical Systems for Aircraft Loss-of-Control Prevention and Recovery

NASA Technical Reports Server (NTRS)

Belcastro, Christine M.

2012-01-01

Validation of technologies developed for loss of control (LOC) prevention and recovery poses significant challenges. Aircraft LOC can result from a wide spectrum of hazards, often occurring in combination, which cannot be fully replicated during evaluation. Technologies developed for LOC prevention and recovery must therefore be effective under a wide variety of hazardous and uncertain conditions, and the validation framework must provide some measure of assurance that the new vehicle safety technologies do no harm (i.e., that they themselves do not introduce new safety risks). This paper summarizes a proposed validation framework for safety-critical systems, provides an overview of validation methods and tools developed by NASA to date within the Vehicle Systems Safety Project, and develops a preliminary set of test scenarios for the validation of technologies for LOC prevention and recovery

The safety net medical home initiative: transforming care for vulnerable populations.

PubMed

Sugarman, Jonathan R; Phillips, Kathryn E; Wagner, Edward H; Coleman, Katie; Abrams, Melinda K

2014-11-01

Despite findings that medical homes may reduce or eliminate health care disparities among underserved and minority populations, most previous medical home pilot and demonstration projects have focused on health care delivery systems serving commercially insured patients and Medicare beneficiaries. To develop a replicable approach to support medical home transformation among diverse practices serving vulnerable and underserved populations. Facilitated by a national program team, convening organizations in 5 states provided coaching and learning community support to safety net practices over a 4-year period. To guide transformation, we developed a framework of change concepts aligned with supporting tools including implementation guides, activity checklists, and measurement instruments. Sixty-five health centers, homeless clinics, private practices, residency training centers, and other safety net practices in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania. We evaluated implementation of the change concepts using the Patient-Centered Medical Home-Assessment, and conducted a survey of participating practices to assess perceptions of the impact of the technical assistance. All practices implemented key features of the medical home model, and nearly half (47.6%) implemented the 33 identified key changes to a substantial degree as evidenced by level A Patient-Centered Medical Home-Assessment scores. Two thirds of practices that achieved substantial implementation did so only after participating in the initiative for >2 years. By the end of the initiative, 83.1% of sites achieved external recognition as medical homes. Despite resource constraints and high-need populations, safety net clinics made considerable progress toward medical home implementation when provided robust, multimodal support over a 4-year period.

Global harmonization of safety regulations for the use of industrial robots-permission of collaborative operation and a related study by JNIOSH.

PubMed

Saito, Tsuyoshi; Hoshi, Toshiro; Ikeda, Hiroyasu; Okabe, Kohei

2015-01-01

In December 2013, the Japanese Ministry of Health, Labour and Welfare (MHLW) partially amended the safety regulations for use of industrial robots so that "collaborative operation" could be performed at Japanese worksites as allowed in the ISO standard for industrial robots. In order to show global harmonization of Japanese legislation on machinery safety and problems with applying ISO safety standards to Japanese worksites, this paper reports the progress of a research study which have been conducted in National Institute of Occupational Safety and Health, Japan from 2011 to the present at the request of MHLW to examine the necessity and effect of the amendment. In the first phase of this study, a questionnaire survey was conducted among domestic robot manufacturers and users. The obtained results revealed their potential demand for the collaborative operation and problems concerning their risk assessment and rule-based risk reduction. To solve the problems, we propose a method based on an investigation result of the regulatory framework for safety of machinery in the European Union. Furthermore, a model of robot system capable of demonstrating the collaborative operation and risk reduction measures which is being developed to support appropriate implementation of the amendment is also described.

Value: A Framework for Radiation Oncology

PubMed Central

Teckie, Sewit; McCloskey, Susan A.; Steinberg, Michael L.

2014-01-01

In the current health care system, high costs without proportional improvements in quality or outcome have prompted widespread calls for change in how we deliver and pay for care. Value-based health care delivery models have been proposed. Multiple impediments exist to achieving value, including misaligned patient and provider incentives, information asymmetries, convoluted and opaque cost structures, and cultural attitudes toward cancer treatment. Radiation oncology as a specialty has recently become a focus of the value discussion. Escalating costs secondary to rapidly evolving technologies, safety breaches, and variable, nonstandardized structures and processes of delivering care have garnered attention. In response, we present a framework for the value discussion in radiation oncology and identify approaches for attaining value, including economic and structural models, process improvements, outcome measurement, and cost assessment. PMID:25113759

Bridging the Gap: A Framework and Strategies for Integrating the Quality and Safety Mission of Teaching Hospitals and Graduate Medical Education.

PubMed

Tess, Anjala; Vidyarthi, Arpana; Yang, Julius; Myers, Jennifer S

2015-09-01

Integrating the quality and safety mission of teaching hospitals and graduate medical education (GME) is a necessary step to provide the next generation of physicians with the knowledge, skills, and attitudes they need to participate in health system improvement. Although many teaching hospital and health system leaders have made substantial efforts to improve the quality of patient care, few have fully included residents and fellows, who deliver a large portion of that care, in their efforts. Despite expectations related to the engagement of these trainees in health care quality improvement and patient safety outlined by the Accreditation Council for Graduate Medical Education in the Clinical Learning Environment Review program, a structure for approaching this integration has not been described.In this article, the authors present a framework that they hope will assist teaching hospitals in integrating residents and fellows into their quality and safety efforts and in fostering a positive clinical learning environment for education and patient care. The authors define the six essential elements of this framework-organizational culture, teaching hospital-GME alignment, infrastructure, curricular resources, faculty development, and interprofessional collaboration. They then describe the organizational characteristics required for each element and offer concrete strategies to achieve integration. This framework is meant to be a starting point for the development of robust national models of infrastructure, alignment, and collaboration between GME and health care quality and safety leaders at teaching hospitals.

New developments in the evolution and application of the WHO/IPCS framework on mode of action/species concordance analysis.

PubMed

Meek, M E; Boobis, A; Cote, I; Dellarco, V; Fotakis, G; Munn, S; Seed, J; Vickers, C

2014-01-01

The World Health Organization/International Programme on Chemical Safety mode of action/human relevance framework has been updated to reflect the experience acquired in its application and extend its utility to emerging areas in toxicity testing and non-testing methods. The underlying principles have not changed, but the framework's scope has been extended to enable integration of information at different levels of biological organization and reflect evolving experience in a much broader range of potential applications. Mode of action/species concordance analysis can also inform hypothesis-based data generation and research priorities in support of risk assessment. The modified framework is incorporated within a roadmap, with feedback loops encouraging continuous refinement of fit-for-purpose testing strategies and risk assessment. Important in this construct is consideration of dose-response relationships and species concordance analysis in weight of evidence. The modified Bradford Hill considerations have been updated and additionally articulated to reflect increasing experience in application for cases where the toxicological outcome of chemical exposure is known. The modified framework can be used as originally intended, where the toxicological effects of chemical exposure are known, or in hypothesizing effects resulting from chemical exposure, using information on putative key events in established modes of action from appropriate in vitro or in silico systems and other lines of evidence. This modified mode of action framework and accompanying roadmap and case examples are expected to contribute to improving transparency in explicitly addressing weight of evidence considerations in mode of action/species concordance analysis based on both conventional data sources and evolving methods. Copyright © 2013 John Wiley & Sons, Ltd. The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.

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

PubMed

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

2015-07-10

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

76 FR 10295 - Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... Docket 07-100; FCC 11-6] Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the... framework for the nationwide public safety broadband network. This document considers and proposes... broadband networks operating in the 700 MHz band. This document addresses public safety broadband network...

RIFM fragrance ingredient safety assessment, p-Isopropylbenzyl acetate, CAS Registry Number 59230-57-8.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog, benzyl acetate (CAS # 140-11-4), show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using benzyl acetate (CAS # 140-11-4) as a suitable read across analog, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Simulation Framework for Battery Cell Impact Safety Modeling Using LS-DYNA

DOE PAGES

Marcicki, James; Zhu, Min; Bartlett, Alexander; ...

2017-02-04

The development process of electrified vehicles can benefit significantly from computer-aided engineering tools that predict themultiphysics response of batteries during abusive events. A coupled structural, electrical, electrochemical, and thermal model framework has been developed within the commercially available LS-DYNA software. The finite element model leverages a three-dimensional mesh structure that fully resolves the unit cell components. The mechanical solver predicts the distributed stress and strain response with failure thresholds leading to the onset of an internal short circuit. In this implementation, an arbitrary compressive strain criterion is applied locally to each unit cell. A spatially distributed equivalent circuit model providesmore » an empirical representation of the electrochemical responsewith minimal computational complexity.The thermalmodel provides state information to index the electrical model parameters, while simultaneously accepting irreversible and reversible sources of heat generation. The spatially distributed models of the electrical and thermal dynamics allow for the localization of current density and corresponding temperature response. The ability to predict the distributed thermal response of the cell as its stored energy is completely discharged through the short circuit enables an engineering safety assessment. A parametric analysis of an exemplary model is used to demonstrate the simulation capabilities.« less

A novel framework to evaluate pedestrian safety at non-signalized locations.

PubMed

Fu, Ting; Miranda-Moreno, Luis; Saunier, Nicolas

2018-02-01

This paper proposes a new framework to evaluate pedestrian safety at non-signalized crosswalk locations. In the proposed framework, the yielding maneuver of a driver in response to a pedestrian is split into the reaction and braking time. Hence, the relationship of the distance required for a yielding maneuver and the approaching vehicle speed depends on the reaction time of the driver and deceleration rate that the vehicle can achieve. The proposed framework is represented in the distance-velocity (DV) diagram and referred as the DV model. The interactions between approaching vehicles and pedestrians showing the intention to cross are divided in three categories: i) situations where the vehicle cannot make a complete stop, ii) situations where the vehicle's ability to stop depends on the driver reaction time, and iii) situations where the vehicle can make a complete stop. Based on these classifications, non-yielding maneuvers are classified as "non-infraction non-yielding" maneuvers, "uncertain non-yielding" maneuvers and "non-yielding" violations, respectively. From the pedestrian perspective, crossing decisions are classified as dangerous crossings, risky crossings and safe crossings accordingly. The yielding compliance and yielding rate, as measures of the yielding behavior, are redefined based on these categories. Time to crossing and deceleration rate required for the vehicle to stop are used to measure the probability of collision. Finally, the framework is demonstrated through a case study in evaluating pedestrian safety at three different types of non-signalized crossings: a painted crosswalk, an unprotected crosswalk, and a crosswalk controlled by stop signs. Results from the case study suggest that the proposed framework works well in describing pedestrian-vehicle interactions which helps in evaluating pedestrian safety at non-signalized crosswalk locations. Copyright © 2017 Elsevier Ltd. All rights reserved.

Deciphering Rashomon: an approach to verbal autopsies of maternal deaths.

PubMed

Iyer, Aditi; Sen, Gita; Sreevathsa, Anuradha

2013-01-01

The paper discusses an approach to verbal autopsies that engages with the Rashomon phenomenon affecting ex post facto constructions of death and responds to the call for maternal safety. This method differs from other verbal autopsies in its approach to data collection and its framework of analysis. In our approach, data collection entails working with and triangulating multiple narratives, and minimising power inequalities in the investigation process. The framework of analysis focuses on the missed opportunities for death prevention as an alternative to (or deepening of) the Three Delays Model. This framework assesses the behavioural responses of health providers, as well as community and family members at each opportunity for death prevention and categorises them into four groups: non-actions, inadequate actions, inappropriate actions and unavoidably delayed actions. We demonstrate the application of this approach to show how verbal autopsies can delve beneath multiple narratives and rigorously identify health system, behavioural and cultural factors that contribute to avoidable maternal mortality.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

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

Measuring Capability for Healthy Diet and Physical Activity

PubMed Central

Ferrer, Robert L.; Cruz, Inez; Burge, Sandra; Bayles, Bryan; Castilla, Martha I.

2014-01-01

PURPOSE Patterns of diet and physical activity, major drivers of morbidity and mortality, are contingent on people’s feasible opportunities to pursue healthy behaviors. Our objective for this mixed methods study was to develop measures of feasible opportunities for diet and activity. METHODS The Capability Approach framework for evaluating people’s real freedoms to pursue their values guided the research. A community-based participatory model was applied to conduct focus groups of adults with obesity or diabetes mellitus from an economically disadvantaged Latino community. Focus group themes were developed into survey items that assess how individual circumstances and neighborhood contexts influence opportunities for diet and activity. The prevalence of different influences was explored in a sample of 300 patients from a primary care safety net clinic. Scales measuring different aspects of opportunity were created through principal components analysis. RESULTS Availability, convenience, safety, cost of food, and activity resources interact with individual circumstances, such as illness, depression, family and nonfamily supports, and scope of personal agency, to shape practical opportunities. Multiple vulnerabilities in availability of resources and moderators of resource use commonly occur together, intensifying challenges and creating difficult trade-offs. Only one-half of participants reported that physicians understood their difficulties pursuing activity, and just one-third for diet. CONCLUSIONS Our results suggest that practical opportunities for healthy behavior can be measured as a primary target for clinical and public health assessment and intervention. The Capability Approach holds promise as a framework for developing interventions responsive to both personal and environmental determinants. PMID:24445103

Elements of an integrated health monitoring framework

NASA Astrophysics Data System (ADS)

Fraser, Michael; Elgamal, Ahmed; Conte, Joel P.; Masri, Sami; Fountain, Tony; Gupta, Amarnath; Trivedi, Mohan; El Zarki, Magda

2003-07-01

Internet technologies are increasingly facilitating real-time monitoring of Bridges and Highways. The advances in wireless communications for instance, are allowing practical deployments for large extended systems. Sensor data, including video signals, can be used for long-term condition assessment, traffic-load regulation, emergency response, and seismic safety applications. Computer-based automated signal-analysis algorithms routinely process the incoming data and determine anomalies based on pre-defined response thresholds and more involved signal analysis techniques. Upon authentication, appropriate action may be authorized for maintenance, early warning, and/or emergency response. In such a strategy, data from thousands of sensors can be analyzed with near real-time and long-term assessment and decision-making implications. Addressing the above, a flexible and scalable (e.g., for an entire Highway system, or portfolio of Networked Civil Infrastructure) software architecture/framework is being developed and implemented. This framework will network and integrate real-time heterogeneous sensor data, database and archiving systems, computer vision, data analysis and interpretation, physics-based numerical simulation of complex structural systems, visualization, reliability & risk analysis, and rational statistical decision-making procedures. Thus, within this framework, data is converted into information, information into knowledge, and knowledge into decision at the end of the pipeline. Such a decision-support system contributes to the vitality of our economy, as rehabilitation, renewal, replacement, and/or maintenance of this infrastructure are estimated to require expenditures in the Trillion-dollar range nationwide, including issues of Homeland security and natural disaster mitigation. A pilot website (http://bridge.ucsd.edu/compositedeck.html) currently depicts some basic elements of the envisioned integrated health monitoring analysis framework.

Transportation Safety Data and Analysis : volume 3 framework for highway safety mitigation and workforce development.

DOT National Transportation Integrated Search

2011-05-01

Safety has always been an important component in the planning, design, and operation of highways. In an effort : to reduce crashes occurring on highway facilities, the Safe, Accountable, Flexible, and Efficient Transportation : Equity Act - A Legacy ...

Transportation safety data and analysis : Volume 3, Framework for highway safety mitigation and workforce development.

DOT National Transportation Integrated Search

2011-05-01

Safety has always been an important component in the planning, design, and operation of highways. In an effort : to reduce crashes occurring on highway facilities, the Safe, Accountable, Flexible, and Efficient Transportation : Equity Act - A Legacy ...

Highway safety corridors : national experiences and a possible framework for Virginia.

DOT National Transportation Integrated Search

2003-01-01

On March 22, 2003, Governor Mark Warner approved Senate Bill 1093 (SB 1093). SB1093 establishes a highway safety corridor (HSC) program for the Commonwealth. The program will attempt to address safety concerns through a combination of law enforcement...

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.

Assessing the feasibility of a web-based domestic violence intervention using chronic disease frameworks: reducing the burden of 'treatment' and promoting capacity for action in women abused by a partner.

PubMed

Tarzia, Laura; May, Carl; Hegarty, Kelsey

2016-11-24

Domestic violence shares many features with chronic disease, including ongoing physical and mental health problems and eroded self-efficacy. Given the challenges around help-seeking for women experiencing domestic violence, it is essential that they be given support to 'self-manage' their condition. The growing popularity of web-based applications for chronic disease self-management suggests that there may be opportunities to use them as an intervention strategy for women experiencing domestic violence, however, as yet, little is known about whether this might work in practice. It is critical that interventions for domestic violence-whether web-based or otherwise-promote agency and capacity for action rather than adding to the 'workload' of already stressed and vulnerable women. Although randomised controlled trials are vital to determine the effectiveness of interventions, robust theoretical frameworks can complement them as a way of examining the feasibility of implementing an intervention in practice. To date, no such frameworks have been developed for the domestic violence context. Consequently, in this paper we propose that it may be useful to appraise interventions for domestic violence using frameworks developed to help understand the barriers and facilitators around self-management of chronic conditions. Using a case study of an online healthy relationship tool and safety decision aid developed in Australia (I-DECIDE), this paper adapts and applies two theories: Burden of Treatment Theory and Normalisation Process Theory, to assess whether the intervention might increase women's agency and capacity for action. In doing this, it proposes a new theoretical model with which the practical application of domestic violence interventions could be appraised in conjunction with other evaluation frameworks. This paper argues that theoretical frameworks for chronic disease are appropriate to assess the feasibility of implementing interventions for domestic violence in practice. The use of the modified Burden of Treatment/Normalisation Process Theory framework developed in this paper strengthens the case for I-DECIDE and other web-based applications as a way of supporting women experiencing domestic violence.

Explaining the food safety behaviours of food handlers using theories of behaviour change: a systematic review.

PubMed

Young, Ian; Thaivalappil, Abhinand; Greig, Judy; Meldrum, Richard; Waddell, Lisa

2018-06-01

Theories of behaviour change can explain the factors affecting food handlers' use of food safety practices. A systematic review was conducted on this topic to identify which theories have been applied in this area and to determine which theories are the most consistent predictors of food handlers' behaviours. Standard systematic review procedures were followed: comprehensive search strategy; relevance screening of abstracts; article characterization; data extraction; risk-of-bias assessment; and descriptive analysis. Among 19 relevant studies, the most commonly investigated theories were the Theory of Planned Behaviour (n = 9 studies) and Health Belief Model (n = 5). All investigated theories were useful to explain food handlers' behavioural intentions and behaviours related to food safety across different settings, and could serve as useful frameworks for future research and practice. However, there was wide variability in the predictive ability of the theories and their specific constructs, indicating theories should be adapted to the local context of application.

A qualitative review of existing national and international occupational safety and health policies relating to occupational sedentary behaviour.

PubMed

Coenen, Pieter; Gilson, Nicholas; Healy, Genevieve N; Dunstan, David W; Straker, Leon M

2017-04-01

Prolonged sedentary time is now recognised as an emergent ergonomics issue. We aimed to review current occupational safety and health policies relevant to occupational sedentary behaviour. An electronic search for documents was conducted on websites of ergonomics and occupational safety and health organisations from 10 countries and six international/pan-European agencies. Additionally, 43 informants (nine countries) were contacted and an international conference workshop held. 119 documents (e.g. legislation, guidelines, codes of practice) were identified. Using a qualitative synthesis, it was observed that many jurisdictions had legal frameworks establishing a duty of care for employers, designers/manufacturers/suppliers and employees. While no occupational authority policies focusing specifically on sedentary behaviour were found, relevant aspects of existing policies were identified. We highlight implications for ergonomics research and practice and recommend the development of policy to specifically address occupational sedentary behaviour and support workplace initiatives to assess and control the risks of this emergent hazard. Copyright © 2016 Elsevier Ltd. All rights reserved.

Utilizing a Human Factors Nursing Worksystem Improvement Framework to Increase Nurses' Time at the Bedside and Enhance Safety.

PubMed

Probst, C Adam; Carter, Megan; Cadigan, Caton; Dalcour, Cortney; Cassity, Cindy; Quinn, Penny; Williams, Tiana; Montgomery, Donna Cook; Wilder, Claudia; Xiao, Yan

2017-02-01

The aim of this study is to increase nurses' time for direct patient care and improve safety via a novel human factors framework for nursing worksystem improvement. Time available for direct patient care influences outcomes, yet worksystem barriers prevent nurses adequate time at the bedside. A novel human factors framework was developed for worksystem improvement in 3 units at 2 facilities. Objectives included improving nurse efficiency as measured by time-and-motion studies, reducing missing medications and subsequent trips to medication rooms and improving medication safety. Worksystem improvement resulted in time savings of 16% to 32% per nurse per 12-hour shift. Requests for missing medications dropped from 3.2 to 1.3 per day. Nurse medication room trips were reduced by 30% and nurse-reported medication errors fell from a range of 1.2 to 0.8 and 6.3 to 4.0 per month. An innovative human factors framework for nursing worksystem improvement provided practical and high priority targets for interventions that significantly improved the nursing worksystem.

Automated Analysis of Stateflow Models

NASA Technical Reports Server (NTRS)

Bourbouh, Hamza; Garoche, Pierre-Loic; Garion, Christophe; Gurfinkel, Arie; Kahsaia, Temesghen; Thirioux, Xavier

2017-01-01

Stateflow is a widely used modeling framework for embedded and cyber physical systems where control software interacts with physical processes. In this work, we present a framework a fully automated safety verification technique for Stateflow models. Our approach is two-folded: (i) we faithfully compile Stateflow models into hierarchical state machines, and (ii) we use automated logic-based verification engine to decide the validity of safety properties. The starting point of our approach is a denotational semantics of State flow. We propose a compilation process using continuation-passing style (CPS) denotational semantics. Our compilation technique preserves the structural and modal behavior of the system. The overall approach is implemented as an open source toolbox that can be integrated into the existing Mathworks Simulink Stateflow modeling framework. We present preliminary experimental evaluations that illustrate the effectiveness of our approach in code generation and safety verification of industrial scale Stateflow models.

One Health in food safety and security education: A curricular framework.

PubMed

Angelos, J; Arens, A; Johnson, H; Cadriel, J; Osburn, B

2016-02-01

The challenges of producing and distributing the food necessary to feed an anticipated 9 billion people in developed and developing societies by 2050 without destroying Earth's finite soil and water resources present extremely complex problems that lack simple solutions. The ability of modern societies to adequately address these and other food-related problems will require an educated workforce trained not only in traditional food safety, security, and public health, but also in other areas including food production, sustainable practices, and ecosystem health. To help address the need for such an educated workforce, a curricular framework was developed to assist those tasked with designing education and training for future food systems workers. One sentence summary: A curricular framework for education and training in food safety and security was developed that incorporates One Health concepts. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Tracking Progress in Improving Diagnosis: A Framework for Defining Undesirable Diagnostic Events.

PubMed

Olson, Andrew P J; Graber, Mark L; Singh, Hardeep

2018-01-29

Diagnostic error is a prevalent, harmful, and costly phenomenon. Multiple national health care and governmental organizations have recently identified the need to improve diagnostic safety as a high priority. A major barrier, however, is the lack of standardized, reliable methods for measuring diagnostic safety. Given the absence of reliable and valid measures for diagnostic errors, we need methods to help establish some type of baseline diagnostic performance across health systems, as well as to enable researchers and health systems to determine the impact of interventions for improving the diagnostic process. Multiple approaches have been suggested but none widely adopted. We propose a new framework for identifying "undesirable diagnostic events" (UDEs) that health systems, professional organizations, and researchers could further define and develop to enable standardized measurement and reporting related to diagnostic safety. We propose an outline for UDEs that identifies both conditions prone to diagnostic error and the contexts of care in which these errors are likely to occur. Refinement and adoption of this framework across health systems can facilitate standardized measurement and reporting of diagnostic safety.

The interim regulated legal market for NPS ('legal high') products in New Zealand: The impact of new retail restrictions and product licensing.

PubMed

Wilkins, Chris

2014-01-01

New Zealand has recently established the world's first regulated legal market for new psychoactive products (NPS) (i.e. 'legal highs'). While the new regime is currently in a transitional phase, a range of retail restrictions and an interim licensing regime for NPS products and operators has been introduced. A product safety assessment framework has been developed to determine if a product should receive an interim licence. As a result of the licensing requirements, the number of NPS retail outlets fell from 3000- 4000 largely convenience stores to 156 specialty stores, and the number of legally available NPS products fell from 200 to fewer than 46. Some of the licensed products contain potent cannabinoid compounds. The licensing system provided, for the first time, information on all the products and operators involved in the sector, and this will assist future monitoring. The effectiveness of the new product safety assessment framework will depend on the quality of the data available on adverse cases. This is a challenge as self-reported information from users is often unreliable, and some emergency department cases do not have all the information required to make an accurate assessment. These data limitations indicate the need for retrospective studies of NPS adverse cases and additional test data. While the new legislation initially reduced the number of NPS retailers by prohibiting convenience outlets, new specialized NPS retail outlets may emerge as the new sector expands. Empirical research is required to measure the impact of the reduction in retail outlets and products on NPS availability. Copyright © 2014 John Wiley & Sons, Ltd.

Understanding and acknowledging the ice throw hazard - consequences for regulatory frameworks, risk perception and risk communication

NASA Astrophysics Data System (ADS)

Bredesen, R. E.; Drapalik, M.; Butt, B.

2017-11-01

This study attempts to provide the necessary framework required to make sufficiently informed decisions regarding the safety implications of ice throw. The framework elaborates on how to cope with uncertainties, and how to describe results in a meaningful and useful manner to decision makers. Moreover, it points out the moral, judicial and economical obligations of wind turbine owners such that they are able to minimize risk of ice throws as much as possible. Building on the strength of knowledge as well as accounting for uncertainty are also essential in enabling clear communication with stakeholders on the most important/critical/vital issues. With increasing empirical evidence, one can assign a higher confidence level on the expert opinions on safety. Findings regarding key uncertainties of ice risk assessments are presented here to support the ongoing IEA Wind Task 19's work on creating the international guidelines on ice risk assessment due in 2018 (Krenn et al. 2017)[1-6]. In addition the study also incorporates the findings of a Norwegian information project, which focuses on the ice throw hazard for the public (Bredesen, Flage, Butt, Winterwind 2018)[7-9]. This includes measures to reduce damage and hazard from wind turbines for the general public. Recent theory of risk assessment questions the use of risk criteria for achieving optimum risk reduction and favours the use of the ALARA (as low as reasonably achievable) principle. Given the several practical problems associated with the ALARA approach (e.g. judicial realization), a joint approach, which uses a minimum set of criteria as well as the obligation to meet ALARA is suggested (associated with acceptable cost). The actual decision about acceptance criteria or obligations is a societal one, thus suggestions can be made at best. Risk acceptance, risk perception and risk communication are inextricably linked and should thus never be considered separately. Risk communication can shape risk perception, which again is vital for defining risk acceptance. Moreover, risk communication should be seen as an opportunity to demonstrate trustworthiness and an open, responsible and caring attitude. It is important for the wind industry to avoid accidents: In Winterwind 2017 (Ronsten)[10], the importance for the wind power community to proactively take safety measures for passers-by and service personnel was emphasized: Establishing good practices and communication routines is key to avoid accidents. Visually attractive ways of presenting the risk of ice throw are recommended.

The impact of biotechnology on agricultural worker safety and health.

PubMed

Shutske, J M; Jenkins, S M

2002-08-01

Biotechnology applications such as the use and production of genetically modified organisms (GMOs) have been widely promoted, adopted, and employed by agricultural producers throughout the world. Yet, little research exists that examines the implications of agricultural biotechnology on the health and safety of workers involved in agricultural production and processing. Regulatory frameworks do exist to examine key issues related to food safety and environmental protection in GMO applications. However, based on the lack of research and regulatory oversight, it would appear that the potential impact on the safety and health of workers is of limited interest. This article examines some of the known worker health and safety implications related to the use and production of GMOs using the host, agent, and environment framework. The characteristics of employers, workers, inputs, production practices, and socio-economic environments in which future agricultural workers perform various tasks is likely to change based on the research summarized here.

Observations and lessons learnt from more than a decade of water safety planning in South-East Asia.

PubMed

Sutherland, David

2017-09-01

In many countries of the World Health Organization (WHO) South-East Asia Region, drinking water is not used directly from the tap and faecal contamination of water sources is prevalent. As reflected in Sustainable Development Goal 6, access to safer drinking water is one of the most successful ways of preventing disease. The WHO Water Safety Framework promotes the use of water safety plans (WSPs), which are structured tools that help identify and mitigate potential risks throughout a water-supply system, from the water source to the point of use. WSPs not only help prevent outbreaks of acute and chronic waterborne diseases but also improve water-supply management and performance. During the past 12 years, through the direct and indirect work of a water quality partnership supported by the Australian Government, more than 5000 urban and rural WSPs have been implemented in the region. An impact assessment based on pre- and post-WSP surveys suggests that WSPs have improved system operations and management, infrastructure and performance; leveraged donor funds; increased stakeholder communication and collaboration; increased testing of water quality; and increased monitoring of consumer satisfaction. These achievements, and their sustainability, are being achieved through national legislation and regulatory frameworks for water supply, including quality standards for drinking water; national training tools and extensive training of sector professionals and creation of WSP experts; model WSPs; WSP auditing systems; and the institution of longterm training and support. More than a decade of water safety planning using the WSP approach has shown that supplying safe drinking water at the tap throughout the WHO South-East Asia Region is a realistic goal.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

PubMed Central

Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis

2013-01-01

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074

Safety Education Syllabus Grades K-12.

ERIC Educational Resources Information Center

New York State Education Dept., Albany. Bureau of Curriculum Development.

This syllabus, designed for use by administrators, program developers, and teachers, provides local education agencies with a framework for establishing a safety education progam in New York's public schools. Information is presented on education laws and commissioner's regulations regarding safety education, as well as philosophies, objectives,…

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.

Safety modelling and testing of lithium-ion batteries in electrified vehicles

NASA Astrophysics Data System (ADS)

Deng, Jie; Bae, Chulheung; Marcicki, James; Masias, Alvaro; Miller, Theodore

2018-04-01

To optimize the safety of batteries, it is important to understand their behaviours when subjected to abuse conditions. Most early efforts in battery safety modelling focused on either one battery cell or a single field of interest such as mechanical or thermal failure. These efforts may not completely reflect the failure of batteries in automotive applications, where various physical processes can take place in a large number of cells simultaneously. In this Perspective, we review modelling and testing approaches for battery safety under abuse conditions. We then propose a general framework for large-scale multi-physics modelling and experimental work to address safety issues of automotive batteries in real-world applications. In particular, we consider modelling coupled mechanical, electrical, electrochemical and thermal behaviours of batteries, and explore strategies to extend simulations to the battery module and pack level. Moreover, we evaluate safety test approaches for an entire range of automotive hardware sets from cell to pack. We also discuss challenges in building this framework and directions for its future development.

Quality and Safety Education for Nurses (QSEN): The Key is Systems Thinking.

PubMed

Dolansky, Mary A; Moore, Shirley M

2013-09-30

Over a decade has passed since the Institute of Medicine's reports on the need to improve the American healthcare system, and yet only slight improvement in quality and safety has been reported. The Quality and Safety Education for Nurses (QSEN) initiative was developed to integrate quality and safety competencies into nursing education. The current challenge is for nurses to move beyond the application of QSEN competencies to individual patients and families and incorporate systems thinking in quality and safety education and healthcare delivery. This article provides a history of QSEN and proposes a framework in which systems thinking is a critical aspect in the application of the QSEN competencies. We provide examples of how using this framework expands nursing focus from individual care to care of the system and propose ways to teach and measure systems thinking. The conclusion calls for movement from personal effort and individual care to a focus on care of the system that will accelerate improvement of healthcare quality and safety.

School safe driving climate: Theoretical and practical considerations for promoting teen driver safety in school settings.

PubMed

Mirman, Jessica H; Roche, Brianne; Higgins-D'Alessandro, Ann

2018-06-21

The aims of this study were to extend the current literature on school climate that is focused on understanding how teacher, administrator, and student perceptions about driving-focused aspects of the social, educational, and institutional climate of schools can affect students' achievement, behavior, and adjustment towards the development of the concept of school safe driving climate (SSDC) and initiate the development of tools and processes for assessing SSDC. A mixed-methods approach was used to develop an initial version of a survey-based measure of SSDC that involved self-report surveys (students) and in-depth interviews (teachers). Exploratory factor analytic procedures identified SSDC constructs and a regression framework was used to examine associations among SSDC constructs and self-reported driver behaviors. Qualitative data were subjected to inductive analysis, with a goal of elucidating teachers' perspectives on SSDC and an SSDC intervention. The study sample consisted of 947 adolescents (48% male) from one large high school and 44 teacher advisors. Participants were recruited from a school participating in a state-wide effort to promote transportation safety through peer-led programming. Two SSDC factors were identified: Administrative Contributions to School Safety and Value of School Safety, which were associated with adolescents' perceptions of their driving behaviors. Adolescents' perceived that the intervention affected administrative safety. Teacher interviews contextualized these results and provided guidance on program revisions. Safe driving climate may be an important, modifiable, and measurable aspect of school climate. Additional research is needed to refine the assessment tool and to use it in longitudinal and experimental studies.

A framework for the evaluation of new interventional procedures.

PubMed

Lourenco, Tania; Grant, Adrian M; Burr, Jennifer M; Vale, Luke

2012-03-01

The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures - the extra facets of skill and training and the difficulty defining a 'new' technology. Currently, there is no framework to evaluate new interventional procedures before they become available in clinical practice as opposed to new pharmaceuticals. This paper proposes a framework to guide the evaluation of a new interventional procedure. A framework was developed consisting of a four-stage progressive evaluation for a new interventional procedure: Stage 1: Development; Stage 2: Efficacy and short-term safety; Stage 3: Effectiveness and cost-effectiveness; and Stage 4: Implementation. The framework also suggests the types of studies or data collection methods that can be used to satisfy each stage. This paper makes a first step on a framework for generating evidence on new interventional procedures. The difficulties and limitations of applying such a framework are discussed. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Inter-professional in-situ simulated team and resuscitation training for patient safety: Description and impact of a programmatic approach.

PubMed

Zimmermann, Katja; Holzinger, Iris Bachmann; Ganassi, Lorena; Esslinger, Peter; Pilgrim, Sina; Allen, Meredith; Burmester, Margarita; Stocker, Martin

2015-10-29

Inter-professional teamwork is key for patient safety and team training is an effective strategy to improve patient outcome. In-situ simulation is a relatively new strategy with emerging efficacy, but best practices for the design, delivery and implementation have yet to be evaluated. Our aim is to describe and evaluate the implementation of an inter-professional in-situ simulated team and resuscitation training in a teaching hospital with a programmatic approach. We designed and implemented a team and resuscitation training program according to Kern's six steps approach for curriculum development. General and specific needs assessments were conducted as independent cross-sectional surveys. Teamwork, technical skills and detection of latent safety threats were defined as specific objectives. Inter-professional in-situ simulation was used as educational strategy. The training was embedded within the workdays of participants and implemented in our highest acuity wards (emergency department, intensive care unit, intermediate care unit). Self-perceived impact and self-efficacy were sampled with an anonymous evaluation questionnaire after every simulated training session. Assessment of team performance was done with the team-based self-assessment tool TeamMonitor applying Van der Vleuten's conceptual framework of longitudinal evaluation after experienced real events. Latent safety threats were reported during training sessions and after experienced real events. The general and specific needs assessments clearly identified the problems, revealed specific training needs and assisted with stakeholder engagement. Ninety-five interdisciplinary staff members of the Children's Hospital participated in 20 in-situ simulated training sessions within 2 years. Participant feedback showed a high effect and acceptance of training with reference to self-perceived impact and self-efficacy. Thirty-five team members experiencing 8 real critical events assessed team performance with TeamMonitor. Team performance assessment with TeamMonitor was feasible and identified specific areas to target future team training sessions. Training sessions as well as experienced real events revealed important latent safety threats that directed system changes. The programmatic approach of Kern's six steps for curriculum development helped to overcome barriers of design, implementation and assessment of an in-situ team and resuscitation training program. This approach may help improve effectiveness and impact of an in-situ simulated training program.

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies.

PubMed

Stone, Vicki; Führ, Martin; Feindt, Peter H; Bouwmeester, Hans; Linkov, Igor; Sabella, Stefania; Murphy, Finbarr; Bizer, Kilian; Tran, Lang; Ågerstrand, Marlene; Fito, Carlos; Andersen, Torben; Anderson, Diana; Bergamaschi, Enrico; Cherrie, John W; Cowan, Sue; Dalemcourt, Jean-Francois; Faure, Michael; Gabbert, Silke; Gajewicz, Agnieszka; Fernandes, Teresa F; Hristozov, Danail; Johnston, Helinor J; Lansdown, Terry C; Linder, Stefan; Marvin, Hans J P; Mullins, Martin; Purnhagen, Kai; Puzyn, Tomasz; Sanchez Jimenez, Araceli; Scott-Fordsmand, Janeck J; Streftaris, George; van Tongeren, Martie; Voelcker, Nicolas H; Voyiatzis, George; Yannopoulos, Spyros N; Poortvliet, P Marijn

2017-12-14

Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk-based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano-specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology. © 2017 Society for Risk Analysis.

Examining occupational health and safety vulnerability among Canadian workers with disabilities.

PubMed

Breslin, F Curtis; Lay, A Morgan; Jetha, Arif; Smith, Peter

2017-05-26

To compare workers with and without disabilities on their reported workplace hazard exposure and the presence of occupational health and safety vulnerability factors. Working-aged adults in Ontario or British Columbia were recruited to participate in a cross-sectional survey (n = 1988). Self-reported measures included demographic factors, work-related variables, perceived level of activity limitation at work, and presence of work safety vulnerability factors utilizing a novel framework. Reporting a disability at work was significantly associated with greater hazard exposure than those without a disability. In addition, those reporting a disability at work were more likely to be employed in conditions where hazard exposure was combined with inadequate policies and procedures, or hazard exposures were combined with inadequate empowerment. Work safety vulnerability is one way that health inequalities can be perpetuated even among those with disabilities who have found work. Our results suggest that employers and policy makers need to focus on assessing and addressing hazard exposures and targeting occupational health and safety resources in the workplace in a way that includes workers with disabilities. Implications for Rehabilitation Workers with disabilities experience greater hazard exposure than those without a disability. Those with moderate and severe disabilities reported occupational health and safety vulnerability, suggesting that workplace accommodations should be available to a broader range of disability levels. It appears that, above and beyond standard safety procedures, providing workplace accommodations for people with disabilities may further reduce their hazard exposure and improve their safety.

Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

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

Moe, Wayne Leland

2016-08-01

Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologiesmore » (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants« less

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

PubMed

Guttman, Nurit

2015-11-01

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

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

PubMed

Guttman, Nurit

2016-12-01

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

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.

A Smartphone-Based Driver Safety Monitoring System Using Data Fusion

PubMed Central

Lee, Boon-Giin; Chung, Wan-Young

2012-01-01

This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416

BEACON: A Summary Framework to Overcome Potential Reimbursement Hurdles.

PubMed

Dunlop, William C N; Mullins, C Daniel; Pirk, Olaf; Goeree, Ron; Postma, Maarten J; Enstone, Ashley; Heron, Louise

2016-10-01

To provide a framework for addressing payers' criteria during the development of pharmaceuticals. A conceptual framework was presented to an international health economic expert panel for discussion. A structured literature search (from 2010 to May 2015), using the following databases in Ovid: Medline(®) and Medline(®) In-Process (PubMed), Embase (Ovid), EconLit (EBSCOhost) and the National Health Service Economic Evaluation Database (NHS EED), and a 'grey literature' search, were conducted to identify existing criteria from the payer perspective. The criteria assessed by existing frameworks and guidelines were collated; the most commonly reported criteria were considered for inclusion in the framework. A mnemonic was conceived as a memory aide to summarise these criteria. Overall, 41 publications were identified as potentially relevant to the objective. Following further screening, 26 were excluded upon full-text review on the basis of no framework presented (n = 13), redundancy (n = 11) or abstract only (n = 2). Frameworks that captured criteria developed for or utilised by the pharmaceutical industry (n = 5) and reimbursement guidance (n = 10) were reviewed. The most commonly identified criteria-unmet need/patient burden, safety, efficacy, quality-of-life outcomes, environment, evidence quality, budget impact and comparator-were incorporated into the summary framework. For ease of communication, the following mnemonic was developed: BEACON (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence). The BEACON framework aims to capture the 'essence' of payer requirements by addressing the most commonly described criteria requested by payers regarding the introduction of a new pharmaceutical.

Consumer trust in food safety--a multidisciplinary approach and empirical evidence from Taiwan.

PubMed

Chen, Mei-Fang

2008-12-01

Food scandals that happened in recent years have increased consumers' risk perceptions of foods and decreased their trust in food safety. A better understanding of the consumer trust in food safety can improve the effectiveness of public policy and allow the development of the best practice in risk communication. This study proposes a research framework from a psychometric approach to investigate the relationships between the consumer's trust in food safety and the antecedents of risk perceptions of foods based on a reflexive modernization perspective and a cultural theory perspective in the hope of benefiting the future empirical study. The empirical results from a structural equation modeling analysis of Taiwan as a case in point reveal that this research framework based on a multidisciplinary perspective can be a valuable tool for a growing understanding of consumer trust in food safety. The antecedents in the psychometric research framework comprised reflexive modernization factors and cultural theory factors have all been supported in this study except the consumer's perception of pessimism toward food. Moreover, the empirical results of repeated measures analysis of variance give more detailed information to grasp empirical implications and to provide some suggestions to the actors and institutions involved in the food supply chain in Taiwan.

Illustrative case using the RISK21 roadmap and matrix: prioritization for evaluation of chemicals found in drinking water.

PubMed

Wolf, Douglas C; Bachman, Ammie; Barrett, Gordon; Bellin, Cheryl; Goodman, Jay I; Jensen, Elke; Moretto, Angelo; McMullin, Tami; Pastoor, Timothy P; Schoeny, Rita; Slezak, Brian; Wend, Korinna; Embry, Michelle R

2016-01-01

The HESI-led RISK21 effort has developed a framework supporting the use of twenty-first century technology in obtaining and using information for chemical risk assessment. This framework represents a problem formulation-based, exposure-driven, tiered data acquisition approach that leads to an informed decision on human health safety to be made when sufficient evidence is available. It provides a transparent and consistent approach to evaluate information in order to maximize the ability of assessments to inform decisions and to optimize the use of resources. To demonstrate the application of the framework's roadmap and matrix, this case study evaluates a large number of chemicals that could be present in drinking water. The focus is to prioritize which of these should be considered for human health risk as individual contaminants. The example evaluates 20 potential drinking water contaminants, using the tiered RISK21 approach in combination with graphical representation of information at each step, using the RISK21 matrix. Utilizing the framework, 11 of the 20 chemicals were assigned low priority based on available exposure data alone, which demonstrated that exposure was extremely low. The remaining nine chemicals were further evaluated, using refined estimates of toxicity based on readily available data, with three deemed high priority for further evaluation. In the present case study, it was determined that the greatest value of additional information would be from improved exposure models and not from additional hazard characterization.

Beyond Effectiveness: A Pragmatic Evaluation Framework for Learning and Continuous Quality Improvement of e-Learning Interventions in Healthcare.

PubMed

Dafalla, Tarig Dafalla Mohamed; Kushniruk, Andre W; Borycki, Elizabeth M

2015-01-01

A pragmatic evaluation framework for evaluating the usability and usefulness of an e-learning intervention for a patient clinical information scheduling system is presented in this paper. The framework was conceptualized based on two different but related concepts (usability and usefulness) and selection of appropriate and valid methods of data collection and analysis that included: (1) Low-Cost Rapid Usability Engineering (LCRUE), (2) Cognitive Task Analysis (CTA), (3) Heuristic Evaluation (HE) criteria for web-based learning, and (4) Software Usability Measurement Inventory (SUMI). The results of the analysis showed some areas where usability that were related to General Interface Usability (GIU), instructional design and content was problematic; some of which might account for the poorly rated aspects of usability when subjectively measured. This paper shows that using a pragmatic framework can be a useful way, not only for measuring the usability and usefulness, but also for providing a practical objective evidences for learning and continuous quality improvement of e-learning systems. The findings should be of interest to educators, developers, designers, researchers, and usability practitioners involved in the development of e-learning systems in healthcare. This framework could be an appropriate method for assessing the usability, usefulness and safety of health information systems both in the laboratory and in the clinical context.

Classifying indicators of quality: a collaboration between Dutch and English regulators.

PubMed

Mears, Alex; Vesseur, Jan; Hamblin, Richard; Long, Paul; Den Ouden, Lya

2011-12-01

Many approaches to measuring quality in healthcare exist, generally employing indicators or metrics. While there are important differences, most of these approaches share three key areas of measurement: safety, effectiveness and patient experience. The European Partnership for Supervisory Organisations in Health Services and Social Care (EPSO) exists as a working group and discussion forum for European regulators. This group undertook to identify a common framework within which European approaches to indicators could be compared. A framework was developed to classify indicators, using four sets of criteria: conceptualization of quality, Donabedian definition (structure, process, outcome), data type (derivable, collectable from routine sources, special collections, samples) and data use (judgement (singular or part of framework) benchmarking, risk assessment). Indicators from English and Dutch hospital measurement programmes were put into the framework, showing areas of agreement and levels of comparability. In the first instance, results are only illustrative. The EPSO has been a powerful driver for undertaking cross-European research, and this project is the first of many to take advantage of the access to international expertize. It has shown that through development of a framework that deconstructs national indicators, commonalities can be identified. Future work will attempt to incorporate other nations' indicators, and attempt cross-national comparison.

The role and functionality of Veterinary Services in food safety throughout the food chain.

PubMed

McKenzie, A I; Hathaway, S C

2006-08-01

Both national Veterinary Services and international standard-setting organisations have now embraced risk assessment as an essential tool for achieving their goals. Veterinarians have key roles in all aspects of the control of food-borne hazards of animal origin, but additional specialist skills are necessary for assessing, managing and communicating risk. Further, the deployment of Veterinary Services must reflect the multi-functional aspects of public and animal health activities. A generic risk management framework provides a systematic process whereby food safety standards and other measures are chosen and implemented on the basis of knowledge of risk and evaluation of other factors relevant to protecting human health and promoting non-discriminatory trade practices. In this context, a number of countries are exploring new administrative and structural arrangements for competent authorities. The traditional focus of veterinary involvement in food safety has been in meat hygiene at the level of the slaughterhouse. While this role continues, the emerging 'risk-based' approach to food control requires increased involvement in other segments of the meat food chain, as well as other areas such as production of milk and fish. This more extensive role requires a wider skill base and establishment of effective networks with a different range of stakeholders.

Review of health safety aspects of nanotechnologies in food production.

PubMed

Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

2009-02-01

Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

Cable median barrier maintenance manual.

DOT National Transportation Integrated Search

2008-08-01

This implementation guide describes the conceptual framework, data requirements, and computational procedures for determining the safety and mobility impacts of work zones in Texas. Researchers designed the framework and procedures to assist district...

Integration of Human Reliability Analysis Models into the Simulation-Based Framework for the Risk-Informed Safety Margin Characterization Toolkit

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

Boring, Ronald; Mandelli, Diego; Rasmussen, Martin

2016-06-01

This report presents an application of a computation-based human reliability analysis (HRA) framework called the Human Unimodel for Nuclear Technology to Enhance Reliability (HUNTER). HUNTER has been developed not as a standalone HRA method but rather as framework that ties together different HRA methods to model dynamic risk of human activities as part of an overall probabilistic risk assessment (PRA). While we have adopted particular methods to build an initial model, the HUNTER framework is meant to be intrinsically flexible to new pieces that achieve particular modeling goals. In the present report, the HUNTER implementation has the following goals: •more » Integration with a high fidelity thermal-hydraulic model capable of modeling nuclear power plant behaviors and transients • Consideration of a PRA context • Incorporation of a solid psychological basis for operator performance • Demonstration of a functional dynamic model of a plant upset condition and appropriate operator response This report outlines these efforts and presents the case study of a station blackout scenario to demonstrate the various modules developed to date under the HUNTER research umbrella.« less

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group.

PubMed

Rao, Sunil V; Eikelboom, John; Steg, Ph Gabriel; Lincoff, A Michael; Weintraub, William S; Bassand, Jean-Pierre; Rao, A Koneti; Gibson, C Michael; Petersen, John L; Mehran, Roxana; Manoukian, Steven V; Charnigo, Richard; Lee, Kerry L; Moscucci, Mauro; Harrington, Robert A

2009-12-01

Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

Exploring the state of health and safety management system performance measurement in mining organizations.

PubMed

Haas, Emily Joy; Yorio, Patrick

2016-03-01

Complex arguments continue to be articulated regarding the theoretical foundation of health and safety management system (HSMS) performance measurement. The culmination of these efforts has begun to enhance a collective understanding. Despite this enhanced theoretical understanding, however, there are still continuing debates and little consensus. The goal of the current research effort was to empirically explore common methods to HSMS performance measurement in mining organizations. The purpose was to determine if value and insight could be added into the ongoing approaches of the best ways to engage in health and safety performance measurement. Nine site-level health and safety management professionals were provided with 133 practices corresponding to 20 HSMS elements, each fitting into the plan, do, check, act phases common to most HSMS. Participants were asked to supply detailed information as to how they (1) assess the performance of each practice in their organization, or (2) would assess each practice if it were an identified strategic imperative. Qualitative content analysis indicated that the approximately 1200 responses provided could be described and categorized into interventions , organizational performance , and worker performance . A discussion of how these categories relate to existing indicator frameworks is provided. The analysis also revealed divergence in two important measurement issues; (1) quantitative vs qualitative measurement and reporting; and (2) the primary use of objective or subjective metrics. In lieu of these findings we ultimately recommend a balanced measurement and reporting approach within the three metric categories and conclude with suggestions for future research.

Exploring the state of health and safety management system performance measurement in mining organizations

PubMed Central

Haas, Emily Joy; Yorio, Patrick

2016-01-01

Complex arguments continue to be articulated regarding the theoretical foundation of health and safety management system (HSMS) performance measurement. The culmination of these efforts has begun to enhance a collective understanding. Despite this enhanced theoretical understanding, however, there are still continuing debates and little consensus. The goal of the current research effort was to empirically explore common methods to HSMS performance measurement in mining organizations. The purpose was to determine if value and insight could be added into the ongoing approaches of the best ways to engage in health and safety performance measurement. Nine site-level health and safety management professionals were provided with 133 practices corresponding to 20 HSMS elements, each fitting into the plan, do, check, act phases common to most HSMS. Participants were asked to supply detailed information as to how they (1) assess the performance of each practice in their organization, or (2) would assess each practice if it were an identified strategic imperative. Qualitative content analysis indicated that the approximately 1200 responses provided could be described and categorized into interventions, organizational performance, and worker performance. A discussion of how these categories relate to existing indicator frameworks is provided. The analysis also revealed divergence in two important measurement issues; (1) quantitative vs qualitative measurement and reporting; and (2) the primary use of objective or subjective metrics. In lieu of these findings we ultimately recommend a balanced measurement and reporting approach within the three metric categories and conclude with suggestions for future research. PMID:26823642

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

PubMed

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

2015-04-01

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

A theory-driven, longitudinal evaluation of the impact of team training on safety culture in 24 hospitals.

PubMed

Jones, Katherine J; Skinner, Anne M; High, Robin; Reiter-Palmon, Roni

2013-05-01

Effective teamwork facilitates collective learning, which is integral to safety culture. There are no rigorous evaluations of the impact of team training on the four components of safety culture-reporting, just, flexible and learning cultures. We evaluated the impact of a year-long team training programme on safety culture in 24 hospitals using two theoretical frameworks. We used two quasi-experimental designs: a cross-sectional comparison of hospital survey on patient safety culture (HSOPS) results from an intervention group of 24 hospitals to a static group of 13 hospitals and a pre-post comparison of HSOPS results within intervention hospitals. Dependent variables were HSOPS items representing the four components of safety culture; independent variables were derived from items added to the HSOPS that measured the extent of team training, learning and transfer. We used a generalised linear mixed model approach to account for the correlated nature of the data. 59% of 2137 respondents from the intervention group reported receiving team training. Intervention group HSOPS scores were significantly higher than static group scores in three dimensions assessing the flexible and learning components of safety culture. The distribution of the adoption of team behaviours (transfer) varied in the intervention group from 2.8% to 31.0%. Adoption of team behaviours was significantly associated with odds of an individual reacting more positively at reassessment than baseline to nine items reflecting all four components of safety culture. Team training can result in transformational change in safety culture when the work environment supports the transfer of learning to new behaviour.

What stage are low-income and middle-income countries (LMICs) at with patient safety curriculum implementation and what are the barriers to implementation? A two-stage cross-sectional study

PubMed Central

Ginsburg, Liane R; Dhingra-Kumar, Neelam; Donaldson, Liam J

2017-01-01

Objectives The improvement of safety in healthcare worldwide depends in part on the knowledge, skills and attitudes of staff providing care. Greater patient safety content in health professional education and training programmes has been advocated internationally. While WHO Patient Safety Curriculum Guides (for Medical Schools and Multi-Professional Curricula) have been widely disseminated in low-income and middle-income countries (LMICs) over the last several years, little is known about patient safety curriculum implementation beyond high-income countries. The present study examines patient safety curriculum implementation in LMICs. Methods Two cross-sectional surveys were carried out. First, 88 technical officers in Ministries of Health and WHO country offices were surveyed to identify the pattern of patient safety curricula at country level. A second survey followed that gathered information from 71 people in a position to provide institution-level perspectives on patient safety curriculum implementation. Results The majority, 69% (30/44), of the countries were either considering whether to implement a patient safety curriculum or actively planning, rather than actually implementing, or embedding one. Most organisations recognised the need for patient safety education and training and felt a safety curriculum was compatible with the values of their organisation; however, important faculty-level barriers to patient safety curriculum implementation were identified. Key structural markers, such as dedicated financial resources and relevant assessment tools to evaluate trainees’ patient safety knowledge and skills, were in place in fewer than half of organisations studied. Conclusions Greater attention to patient safety curriculum implementation is needed. The barriers to patient safety curriculum implementation we identified in LMICs are not unique to these regions. We propose a framework to act as a global standard for patient safety curriculum implementation. Educating leaders through the system in order to embed patient safety culture in education and clinical settings is a critical first step. PMID:28619782

Safety culture and the 5 steps to safer surgery: an intervention study.

PubMed

Hill, M R; Roberts, M J; Alderson, M L; Gale, T C E

2015-06-01

Improvements in safety culture have been postulated as one of the mechanisms underlying the association between the introduction of the World Health Organisation (WHO) Surgical Safety Checklist with perioperative briefings and debriefings, and enhanced patient outcomes. The 5 Steps to Safer Surgery (5SSS) incorporates pre-list briefings, the three steps of the WHO Surgical Safety Checklist (SSC) and post-list debriefings in one framework. We aimed to identify any changes in safety culture associated with the introduction of the 5SSS in orthopaedic operating theatres. We assessed the safety culture in the elective orthopaedic theatres of a large UK teaching hospital before and after introduction of the 5SSS using a modified version of the Safety Attitude Questionnaire - Operating Room (SAQ-OR). Primary outcome measures were pre-post intervention changes in the six safety culture domains of the SAQ-OR. We also analysed changes in responses to two items regarding perioperative briefings. The SAQ-OR survey response rate was 80% (60/75) at baseline and 74% (53/72) one yr later. There were significant improvements in both the reported frequency (P<0.001) and perceived importance (P=0.018) of briefings, and in five of the six safety culture domain scores (Working Conditions, Perceptions of Management, Job Satisfaction, Safety Climate and Teamwork Climate) of the SAQ-OR (P<0.001 in all cases). Scores in the sixth domain (Stress Recognition) decreased significantly (P=0.028). Implementation of the 5SSS was associated with a significant improvement in the safety culture of elective orthopaedic operating theatres. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Counterheroism, Common Knowledge, and Ergonomics: Concepts from Aviation That Could Improve Patient Safety

PubMed Central

Lewis, Geraint H; Vaithianathan, Rhema; Hockey, Peter M; Hirst, Guy; Bagian, James P

2011-01-01

Context: Many safety initiatives have been transferred successfully from commercial aviation to health care. This article develops a typology of aviation safety initiatives, applies this to health care, and proposes safety measures that might be adopted more widely. It then presents an economic framework for determining the likely costs and benefits of different patient safety initiatives. Methods: This article describes fifteen examples of error countermeasures that are used in public transport aviation, many of which are not routinely used in health care at present. Examples are the sterile cockpit rule, flight envelope protection, the first-names-only rule, and incentivized no-fault reporting. It develops a conceptual schema that is then used to argue why analogous initiatives might be usefully applied to health care and why physicians may resist them. Each example is measured against a set of economic criteria adopted from the taxation literature. Findings: The initiatives considered in the article fall into three themes: safety concepts that seek to downplay the role of heroic individuals and instead emphasize the importance of teams and whole organizations; concepts that seek to increase and apply group knowledge of safety information and values; and concepts that promote safety by design. The salient costs to be considered by organizations wishing to adopt these suggestions are the compliance costs to clinicians, the administration costs to the organization, and the costs of behavioral distortions. Conclusions: This article concludes that there is a range of safety initiatives used in commercial aviation that could have a positive impact on patient safety, and that adopting such initiatives may alter the safety culture of health care teams. The desirability of implementing each initiative, however, depends on the projected costs and benefits, which must be assessed for each situation. PMID:21418311

Counterheroism, common knowledge, and ergonomics: concepts from aviation that could improve patient safety.

PubMed

Lewis, Geraint H; Vaithianathan, Rhema; Hockey, Peter M; Hirst, Guy; Bagian, James P

2011-03-01

Many safety initiatives have been transferred successfully from commercial aviation to health care. This article develops a typology of aviation safety initiatives, applies this to health care, and proposes safety measures that might be adopted more widely. It then presents an economic framework for determining the likely costs and benefits of different patient safety initiatives. This article describes fifteen examples of error countermeasures that are used in public transport aviation, many of which are not routinely used in health care at present. Examples are the sterile cockpit rule, flight envelope protection, the first-names-only rule, and incentivized no-fault reporting. It develops a conceptual schema that is then used to argue why analogous initiatives might be usefully applied to health care and why physicians may resist them. Each example is measured against a set of economic criteria adopted from the taxation literature. The initiatives considered in the article fall into three themes: safety concepts that seek to downplay the role of heroic individuals and instead emphasize the importance of teams and whole organizations; concepts that seek to increase and apply group knowledge of safety information and values; and concepts that promote safety by design. The salient costs to be considered by organizations wishing to adopt these suggestions are the compliance costs to clinicians, the administration costs to the organization, and the costs of behavioral distortions. This article concludes that there is a range of safety initiatives used in commercial aviation that could have a positive impact on patient safety, and that adopting such initiatives may alter the safety culture of health care teams. The desirability of implementing each initiative, however, depends on the projected costs and benefits, which must be assessed for each situation. © 2011 Milbank Memorial Fund. Published by Wiley Periodicals Inc.

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

How compatible are participatory ergonomics programs with occupational health and safety management systems?

PubMed

Yazdani, Amin; Neumann, W Patrick; Imbeau, Daniel; Bigelow, Philip; Pagell, Mark; Theberge, Nancy; Hilbrecht, Margo; Wells, Richard

2015-03-01

Musculoskeletal disorders (MSD) are a major cause of pain, disability, and costs. Prevention of MSD at work is frequently described in terms of implementing an ergonomics program, often a participatory ergonomics (PE) program. Most other workplace injury prevention activities take place under the umbrella of a formal or informal occupational health and safety management system (OHSMS). This study assesses the similarities and differences between OHSMS and PE as such knowledge could help improve MSD prevention activities. Methods Using the internationally recognized Occupational Health and Safety Assessment Series (OHSAS 18001), 21 OHSMS elements were extracted. In order to define PE operationally, we identified the 20 most frequently cited papers on PE and extracted content relevant to each of the OHSAS 18001 elements. The PE literature provided a substantial amount of detail on five elements: (i) hazard identification, risk assessment and determining controls; (ii) resources, roles, responsibility, accountability, and authority; (iii) competence, training and awareness; (iv) participation and consultation; and (v) performance measurement and monitoring. However, of the 21 OHSAS elements, the PE literature was silent on 8 and provided few details on 8 others. The PE literature did not speak to many elements described in OHSMS and even when it did, the language used was often different. This may negatively affect the effectiveness and sustainability of PE initiatives within organizations. It is expected that paying attention to the approaches and language used in management system frameworks could make prevention of MSD activities more effective and sustainable.

A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

NASA Astrophysics Data System (ADS)

Tabibzadeh, Maryam

According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test misinterpretation. Finally, a rational decision making model is introduced to quantify a section of the developed conceptual framework in the previous step and analyze the impact of different decision making biases on negative pressure test results. Along with the corroborating findings of previous studies, the analysis of the developed conceptual framework in this paper indicates that organizational factors are root causes of accumulated errors and questionable decisions made by personnel or management. Further analysis of this framework identifies procedural issues, economic pressure, and personnel management issues as the organizational factors with the highest influence on misinterpreting a negative pressure test. It is noteworthy that the captured organizational factors in the introduced conceptual framework are not only specific to the scope of the NPT. Most of these organizational factors have been identified as not only the common contributing causes of other offshore drilling accidents but also accidents in other oil and gas related operations as well as high-risk operations in other industries. In addition, the proposed rational decision making model in this research introduces a quantitative structure for analysis of the results of a conducted NPT. This model provides a structure and some parametric derived formulas to determine a cut-off point value, which assists personnel in accepting or rejecting an implemented negative pressure test. Moreover, it enables analysts to assess different decision making biases involved in the process of interpreting a conducted negative pressure test as well as the root organizational factors of those biases. In general, although the proposed integrated research methodology in this dissertation is developed for the risk assessment of human and organizational factors contributions in negative pressure test misinterpretation, it can be generalized and be potentially useful for other well control situations, both offshore and onshore; e.g. fracking. In addition, this methodology can be applied for the analysis of any high-risk operations, in not only the oil and gas industry but also in other industries such as nuclear power plants, aviation industry, and transportation sector.

Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review

PubMed Central

McEachan, Rosemary R C; Giles, Sally J; Sirriyeh, Reema; Watt, Ian S; Wright, John

2012-01-01

Objective The aim of this systematic review was to develop a ‘contributory factors framework’ from a synthesis of empirical work which summarises factors contributing to patient safety incidents in hospital settings. Design A mixed-methods systematic review of the literature was conducted. Data sources Electronic databases (Medline, PsycInfo, ISI Web of knowledge, CINAHL and EMBASE), article reference lists, patient safety websites, registered study databases and author contacts. Eligibility criteria Studies were included that reported data from primary research in secondary care aiming to identify the contributory factors to error or threats to patient safety. Results 1502 potential articles were identified. 95 papers (representing 83 studies) which met the inclusion criteria were included, and 1676 contributory factors extracted. Initial coding of contributory factors by two independent reviewers resulted in 20 domains (eg, team factors, supervision and leadership). Each contributory factor was then coded by two reviewers to one of these 20 domains. The majority of studies identified active failures (errors and violations) as factors contributing to patient safety incidents. Individual factors, communication, and equipment and supplies were the other most frequently reported factors within the existing evidence base. Conclusions This review has culminated in an empirically based framework of the factors contributing to patient safety incidents. This framework has the potential to be applied across hospital settings to improve the identification and prevention of factors that cause harm to patients. PMID:22421911

Ensuring the Environmental and Industrial Safety in Solid Mineral Deposit Surface Mining

NASA Astrophysics Data System (ADS)

Trubetskoy, Kliment; Rylnikova, Marina; Esina, Ekaterina

2017-11-01

The growing environmental pressure of mineral deposit surface mining and severization of industrial safety requirements dictate the necessity of refining the regulatory framework governing safe and efficient development of underground resources. The applicable regulatory documentation governing the procedure of ore open-pit wall and bench stability design for the stage of pit reaching its final boundary was issued several decades ago. Over recent decades, mining and geomechanical conditions have changed significantly in surface mining operations, numerous new software packages and computer developments have appeared, opportunities of experimental methods of source data collection and processing, grounding of the permissible parameters of open pit walls have changed dramatically, and, thus, methods of risk assessment have been perfected [10-13]. IPKON RAS, with the support of the Federal Service for Environmental Supervision, assumed the role of the initiator of the project for the development of Federal norms and regulations of industrial safety "Rules for ensuring the stability of walls and benches of open pits, open-cast mines and spoil banks", which contribute to the improvement of economic efficiency and safety of mineral deposit surface mining and enhancement of the competitiveness of Russian mines at the international level that is very important in the current situation.

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

PubMed

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

2016-08-03

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

Risk analysis and its link with standards of the World Organisation for Animal Health.

PubMed

Sugiura, K; Murray, N

2011-04-01

Among the agreements included in the treaty that created the World Trade Organization (WTO) in January 1995 is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) that sets out the basic rules for food safety and animal and plant health standards. The SPS Agreement designates the World Organisation for Animal Health (OIE) as the organisation responsible for developing international standards for animal health and zoonoses. The SPS Agreement requires that the sanitary measures that WTO members apply should be based on science and encourages them to either apply measures based on the OIE standards or, if they choose to adopt a higher level of protection than that provided by these standards, apply measures based on a science-based risk assessment. The OIE also provides a procedural framework for risk analysis for its Member Countries to use. Despite the inevitable challenges that arise in carrying out a risk analysis of the international trade in animals and animal products, the OIE risk analysis framework provides a structured approach that facilitates the identification, assessment, management and communication of these risks.

Assessing the impact of federal and state preemption in public health: a framework for decision makers.

PubMed

Pertschuk, Mark; Pomeranz, Jennifer L; Aoki, Julie Ralston; Larkin, Michelle A; Paloma, Marjorie

2013-01-01

In the United States, state and local public health policies play a fundamental role in innovation and progress. Preemption, by which Congress or the state legislatures limit the authority of lower jurisdictions, can eliminate the benefits of state and local policy initiatives. Preemption can also have a negative impact on enforcement, civic engagement, and grassroots movement building.In June 2011, the Institute of Medicine published a groundbreaking report on policy and law that considered preemption as a crosscutting issue in public health. The Institute of Medicine recommended that federal and state policy makers "should set minimum standards...allowing states and localities to further protect the health and safety of their inhabitants," and "should avoid language that hinders public health action."The Preemption Framework is a tool to support effective decision making by helping the public health field anticipate, assess, and, if necessary, counter preemptive policy proposals. We review the consequences of preemption, including its potential impact on grassroots public health movements, and propose practical questions and considerations to assist decision makers in responding to preemptive proposals.

Drinking water quality management: a holistic approach.

PubMed

Rizak, S; Cunliffe, D; Sinclair, M; Vulcano, R; Howard, J; Hrudey, S; Callan, P

2003-01-01

A growing list of water contaminants has led to some water suppliers relying primarily on compliance monitoring as a mechanism for managing drinking water quality. While such monitoring is a necessary part of drinking water quality management, experiences with waterborne disease threats and outbreaks have shown that compliance monitoring for numerical limits is not, in itself, sufficient to guarantee the safety and quality of drinking water supplies. To address these issues, the Australian National Health and Medical Research Council (NHMRC) has developed a Framework for Management of Drinking Water Quality (the Framework) for incorporation in the Australian Drinking Water Guidelines, the primary reference on drinking water quality in Australia. The Framework was developed specifically for drinking water supplies and provides a comprehensive and preventive risk management approach from catchment to consumer. It includes holistic guidance on a range of issues considered good practice for system management. The Framework addresses four key areas: Commitment to Drinking Water Quality Management, System Analysis and System Management, Supporting Requirements, and Review. The Framework represents a significantly enhanced approach to the management and regulation of drinking water quality and offers a flexible and proactive means of optimising drinking water quality and protecting public health. Rather than the primary reliance on compliance monitoring, the Framework emphasises prevention, the importance of risk assessment, maintaining the integrity of water supply systems and application of multiple barriers to assure protection of public health. Development of the Framework was undertaken in collaboration with the water industry, regulators and other stakeholder, and will promote a common and unified approach to drinking water quality management throughout Australia. The Framework has attracted international interest.

Electrochemical genosensors in food safety assessment.

PubMed

Martín-Fernández, Begoña; Manzanares-Palenzuela, C Lorena; Sánchez-Paniagua López, Marta; de-Los-Santos-Álvarez, Noemí; López-Ruiz, Beatriz

2017-09-02

The main goal of food safety assessment is to provide reliable information on the identity and composition of food and reduce the presence of harmful components. Nowadays, there are many countries where rather than the presence of pathogens, common public concerns are focused on the presence of hidden allergens, fraudulent practices, and genetic modifications in food. Accordingly, food regulations attempt to offer a high level of protection and to guarantee transparent information to the consumers. The availability of analytical methods is essential to comply these requirements. Protein-based strategies are usually employed for this purpose, but present some limitations. Because DNA is a more stable molecule, present in most tissues, and can be amplified, there has been an increasing interest in developing DNA-based approaches (polymerase chain reaction, microarrays, and genosensors). In this regard, electrochemical genosensors may play a major role in fulfilling the needs of food industry, such as reliable, portable, and affordable devices. This work reviews the achievements of this technology applied to allergen detection, species identification, and genetically modified organisms testing. We summarized the legislative framework, current design strategies in sensor development, their analytical characteristics, and future prospects.

A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals.

PubMed

Vandenberg, Laura N; Ågerstrand, Marlene; Beronius, Anna; Beausoleil, Claire; Bergman, Åke; Bero, Lisa A; Bornehag, Carl-Gustaf; Boyer, C Scott; Cooper, Glinda S; Cotgreave, Ian; Gee, David; Grandjean, Philippe; Guyton, Kathryn Z; Hass, Ulla; Heindel, Jerrold J; Jobling, Susan; Kidd, Karen A; Kortenkamp, Andreas; Macleod, Malcolm R; Martin, Olwenn V; Norinder, Ulf; Scheringer, Martin; Thayer, Kristina A; Toppari, Jorma; Whaley, Paul; Woodruff, Tracey J; Rudén, Christina

2016-07-14

The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation. Objective methods are needed for integrating the multiple streams of evidence (epidemiology, wildlife, laboratory animal, in vitro, and in silico data) that are relevant in assessing EDCs. We have developed a framework for the systematic review and integrated assessment (SYRINA) of EDC studies. The framework was designed for use with the International Program on Chemical Safety (IPCS) and World Health Organization (WHO) definition of an EDC, which requires appraisal of evidence regarding 1) association between exposure and an adverse effect, 2) association between exposure and endocrine disrupting activity, and 3) a plausible link between the adverse effect and the endocrine disrupting activity. Building from existing methodologies for evaluating and synthesizing evidence, the SYRINA framework includes seven steps: 1) Formulate the problem; 2) Develop the review protocol; 3) Identify relevant evidence; 4) Evaluate evidence from individual studies; 5) Summarize and evaluate each stream of evidence; 6) Integrate evidence across all streams; 7) Draw conclusions, make recommendations, and evaluate uncertainties. The proposed method is tailored to the IPCS/WHO definition of an EDC but offers flexibility for use in the context of other definitions of EDCs. When using the SYRINA framework, the overall objective is to provide the evidence base needed to support decision making, including any action to avoid/minimise potential adverse effects of exposures. This framework allows for the evaluation and synthesis of evidence from multiple evidence streams. Finally, a decision regarding regulatory action is not only dependent on the strength of evidence, but also the consequences of action/inaction, e.g. limited or weak evidence may be sufficient to justify action if consequences are serious or irreversible.

Integration of Behaviour-Based Safety Programme into Engineering Laboratories and Workshops Conceptually

ERIC Educational Resources Information Center

Koo, Kean Eng; Zain, Ahmad Nurulazam Md; Zainal, Siti Rohaida Mohamed

2012-01-01

The purpose of this conceptual research framework is to develop and integrate a safety training model using a behaviour-based safety training programme into laboratories for young adults, during their tertiary education, particularly in technical and vocational education. Hence, this research will be investigating the outcome of basic safety…

The link between descriptors 8 and 9 of the Marine Strategy Framework Directive: lessons learnt in Spain.

PubMed

Gago, J; Viñas, L; Besada, V; Bellas, J

2014-12-01

The aim of this note is to discuss the relevance of the interaction/integration of monitoring of contaminants for the protection of the marine environment and for human health safety (descriptors 8 and 9, respectively) within the Marine Strategy Framework Directive (MSFD). The identification of possible relations between contaminant levels in sediments and tissues of fish and other seafood, as well as the association of those levels to pollution sources, are major challenges for marine researchers. The Spanish initial assessment in the North-East Atlantic marine region was used as an example to show some gaps and loopholes when dealing with the relationship between descriptors 8 and 9. The main problem to deal with is that monitoring programmes intended for the assessment of marine environmental quality and for human health safety usually apply different approaches and methodologies, and even different tissues are analysed in some species (mainly fish). It is therefore recommended to make a profound revision of current sampling strategies, procedures and methodologies, including the selection of target species and tissues and to improve the traceability of samples of fish and other seafood for human consumption. On the other hand, despite the scope of descriptor 9 which is limited to commercially relevant species, this fact should not be an obstacle in the application of the 'ecosystem approach' within the MSFD. In order to appropriately solve these shortcomings, an information exchange system between authorities dealing with descriptors 8 and 9 should be strongly encouraged for the next steps of the MSFD's implementation.

A probabilistic technique for the assessment of complex dynamic system resilience

NASA Astrophysics Data System (ADS)

Balchanos, Michael Gregory

In the presence of operational uncertainty, one of the greatest challenges in systems engineering is to ensure system effectiveness, mission capability and survivability for large scale, complex system architectures. Historic events such as the 2003 Northeastern Blackout, and the 2005 Hurricane Katrina, have underlined the great importance of system safety, and survivability. With safety management currently applied on a reactive basis to emerging incidents and risk challenges, there is a paradigm shift from passive, reactive and diagnosis-based approaches to the development of architectures that will autonomously manage safety and survivability through active, proactive and prognosis-based engineering solutions. The shift aims to bring safety considerations early in the engineering design process, in order to reduce retrofitting and additional safety certification costs, increase flexibility in risk management, and essentially make safety be "built-in" the design. As a possible enabling research direction, resilience engineering is an emerging discipline, pertinent to safety management, which offers alternative insights on the design of more safe and survivable system architectures. Conceptually, resilience engineering brings new perspectives on the understanding of system safety, accidents, failures, performance degradations and risk. A resilient system can "absorb" the impact of change due to unexpected disturbances, while it "adapts" to change, in order to maintain the system's physical integrity and capability to carry on with its mission. The leading hypothesis advocates that if a complex dynamic system is more resilient, then it would be more survivable, thus more effective, despite the unexpected disturbances that could affect its normal operating conditions. For investigating the impact of more resilient systems on survivability and safety, a framework for theoretical resilience estimations has been formulated. It constitutes the basis for quantitative techniques for total system resilience evaluation, based on scenario-based, dynamic system simulations. Physics-based Modeling and Simulation (M&S) is applied for dynamical system behavior analysis, which includes system performance, health monitoring, damage propagation and overall mission capability. For the development of the assessment framework and testing of a resilience assessment technique, a small-scale canonical problem has been formulated, involving a computational model of a degradable and reconfigurable spring-mass-damper SDOF system, in a multiple main and redundant spring configuration. A rule-based feedback controller is responsible for system performance recovery, through the application of different reconfiguration strategies and strategic activation of the necessary main or redundant springs. Uncertainty effects on system operation are introduced through disturbance factors, such as external forces with varying magnitude, input frequency, event duration and occurrence time. Such factors are the basis for scenario formulation, in support of a Monte Carlo simulation analysis. Case studies with varying levels of damping and different reconfiguration strategies, involve the investigation of operational uncertainty effects on system performance, mission capability, and system survivability. These studies furthermore explore uncertainty effects on resilience functions that describe the system's capacities on "restoring" mission capability, on "absorbing" the effects of changing conditions, and on "adapting" to the occurring change. The proposed resilience assessment technique or the Topological Investigation for Resilient and Effective Systems, through Increased Architecture Survivability (TIRESIAS) is then applied and demonstrated for a naval system application, in the form of a reduced scale, reconfigurable cooling network of a naval combatant. Uncertainty effects are modeled through combinations of different number of network fluid leaks. The TIRESIAS approach on the system baseline (32-control valve configuration) has allowed for the investigation of leak effects on survival times, mission capability degradations, as well as the resilience function capacities. As part of the technique demonstration, case studies were conducted for different architecture configurations, which have been generated for different total number of control valves and valve locations on the topology.

Application of elements of microbiological risk assessment in the food industry via a tiered approach.

PubMed

van Gerwen, Suzanne J C; Gorris, Leon G M

2004-09-01

Food safety control is a matter for concern for all parts of the food supply chain, including governments that develop food safety policy, food industries that must control potential hazards, and consumers who need to keep to the intended use of the food. In the future, food safety policy may be set using the framework of risk analysis, part of which is the development of (inter)national microbiological risk assessment (MRA) studies. MRA studies increase our understanding of the impact of risk management interventions and of the relationships among subsequent parts of food supply chains with regard to the safety of the food when it reaches the consumer. Application of aspects of MRA in the development of new food concepts has potential benefits for the food industry. A tiered approach to applying MRA can best realize these benefits. The tiered MRA approach involves calculation of microbial fate for a product and process design on the basis of experimental data (e.g., monitoring data on prevalence) and predictive microbiological models. Calculations on new product formulations and novel processing technologies provide improved understanding of microbial fate beyond currently known boundaries, which enables identification of new opportunities in process design. The outcome of the tiered approach focuses on developing benchmarks of potential consumer exposure to hazards associated with new products by comparison with exposure associated with products that are already on the market and have a safe history of use. The tiered prototype is a tool to be used by experienced microbiologists as a basis for advice to product developers and can help to make safety assurance for new food concepts transparent to food inspection services.

Certification Framework Based on Effective Trapping for Geologic Carbon Sequestration

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

Oldenburg, Curtis M.; Bryant, Steven L.; Nicot, Jean-Philippe

2009-01-15

We have developed a certification framework (CF) for certifying the safety and effectiveness of geologic carbon sequestration (GCS) sites. Safety and effectiveness are achieved if CO{sub 2} and displaced brine have no significant impact on humans, other living things, resources, or the environment. In the CF, we relate effective trapping to CO{sub 2} leakage risk which takes into account both the impact and probability of leakage. We achieve simplicity in the CF by using (1) wells and faults as the potential leakage pathways, (2) compartments to represent environmental resources that may be impacted by leakage, (3) CO{sub 2} fluxes andmore » concentrations in the compartments as proxies for impact to vulnerable entities, (4) broad ranges of storage formation properties to generate a catalog of simulated plume movements, and (5) probabilities of intersection of the CO{sub 2} plume with the conduits and compartments. We demonstrate the approach on a hypothetical GCS site in a Texas Gulf Coast saline formation. Through its generality and flexibility, the CF can contribute to the assessment of risk of CO{sub 2} and brine leakage as part of the certification process for licensing and permitting of GCS sites around the world regardless of the specific regulations in place in any given country.« less

Model Based Mission Assurance in a Model Based Systems Engineering (MBSE) Framework: State-of-the-Art Assessment

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Feather, Martin S.

2016-01-01

This report explores the current state of the art of Safety and Mission Assurance (S&MA) in projects that have shifted towards Model Based Systems Engineering (MBSE). Its goal is to provide insight into how NASA's Office of Safety and Mission Assurance (OSMA) should respond to this shift. In MBSE, systems engineering information is organized and represented in models: rigorous computer-based representations, which collectively make many activities easier to perform, less error prone, and scalable. S&MA practices must shift accordingly. The "Objective Structure Hierarchies" recently developed by OSMA provide the framework for understanding this shift. Although the objectives themselves will remain constant, S&MA practices (activities, processes, tools) to achieve them are subject to change. This report presents insights derived from literature studies and interviews. The literature studies gleaned assurance implications from reports of space-related applications of MBSE. The interviews with knowledgeable S&MA and MBSE personnel discovered concerns and ideas for how assurance may adapt. Preliminary findings and observations are presented on the state of practice of S&MA with respect to MBSE, how it is already changing, and how it is likely to change further. Finally, recommendations are provided on how to foster the evolution of S&MA to best fit with MBSE.

Using Geographical Information Systems (GIS) as an instrument of water resource management: a case study from a GIS-based Water Safety Plan in Germany.

PubMed

Wienand, I; Nolting, U; Kistemann, T

2009-01-01

Following international developments and the new WHO Drinking Water Guidelines (WHO 2004) a process-orientated concept for risk, monitoring and incident management has been developed and implemented in this study. The concept will be reviewed with special consideration for resource protection (first barrier of the multi-barrier system) and in turn, for the Water Safety Plan (WSP) which adequately considers-beyond the current framework of legal requirements-possible new hygienic-microbiologically relevant risks (especially emerging pathogens) for the drinking water supply. The development of a WSP within the framework of risk, monitoring and incident management includes the application of Geographical Information Systems (GIS). In the present study, GIS was used for visualization and spatial analysis in decisive steps in the WSP. The detailed process of GIS-supported implementation included the identification of local participants and their tasks and interactions as an essential part of risk management. A detailed ecological investigation of drinking water conditions in the catchment area was conducted in addition to hazard identification, risk assessment and the monitoring of control measures. The main task of our study was to find out in which steps of the WSP the implementation of GIS could be integrated as a useful, and perhaps even an essential tool.

Integrated Risk-Informed Decision-Making for an ALMR PRISM

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

Muhlheim, Michael David; Belles, Randy; Denning, Richard S.

Decision-making is the process of identifying decision alternatives, assessing those alternatives based on predefined metrics, selecting an alternative (i.e., making a decision), and then implementing that alternative. The generation of decisions requires a structured, coherent process, or a decision-making process. The overall objective for this work is that the generalized framework is adopted into an autonomous decision-making framework and tailored to specific requirements for various applications. In this context, automation is the use of computing resources to make decisions and implement a structured decision-making process with limited or no human intervention. The overriding goal of automation is to replace ormore » supplement human decision makers with reconfigurable decision-making modules that can perform a given set of tasks rationally, consistently, and reliably. Risk-informed decision-making requires a probabilistic assessment of the likelihood of success given the status of the plant/systems and component health, and a deterministic assessment between plant operating parameters and reactor protection parameters to prevent unnecessary trips and challenges to plant safety systems. The probabilistic portion of the decision-making engine of the supervisory control system is based on the control actions associated with an ALMR PRISM. Newly incorporated into the probabilistic models are the prognostic/diagnostic models developed by Pacific Northwest National Laboratory. These allow decisions to incorporate the health of components into the decision–making process. Once the control options are identified and ranked based on the likelihood of success, the supervisory control system transmits the options to the deterministic portion of the platform. The deterministic portion of the decision-making engine uses thermal-hydraulic modeling and components for an advanced liquid-metal reactor Power Reactor Inherently Safe Module. The deterministic multi-attribute decision-making framework uses various sensor data (e.g., reactor outlet temperature, steam generator drum level) and calculates its position within the challenge state, its trajectory, and its margin within the controllable domain using utility functions to evaluate current and projected plant state space for different control decisions. The metrics that are evaluated are based on reactor trip set points. The integration of the deterministic calculations using multi-physics analyses and probabilistic safety calculations allows for the examination and quantification of margin recovery strategies. This also provides validation of the control options identified from the probabilistic assessment. Thus, the thermalhydraulics analyses are used to validate the control options identified from the probabilistic assessment. Future work includes evaluating other possible metrics and computational efficiencies, and developing a user interface to mimic display panels at a modern nuclear power plant.« less

Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.

PubMed

Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney

2018-04-01

Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining levels of patient engagement. As more patient engagement studies are conducted, this framework should be evaluated for associations with patient outcomes.

Communications and radar-supported transportation operations and planning : final report.

DOT National Transportation Integrated Search

2017-03-01

This project designs a conceptual framework to harness and mature wireless technology to improve : transportation safety, with a focus on frontal collision warning/collision avoidance (CW/CA) systems. The : framework identifies components of the tech...

GMO Reignited in Science but Not in Law: A Flawed Framework Fuels France's Stalemate.

PubMed

Robbins, Patricia B

2014-01-01

Following a statement released by a multitude of prominent scientists contesting the idea that there is a consensus on the safety of genetically modified organisms ("GMO"), this article addresses the European Union's ("EU") GMO regulatory framework, which has reluctantly permitted France to maintain an illegal ban on. MON8 10 for over a decade now. It notes that while the statement did nothing more than reignite the debate on GMO, much could and should be done to improve the framework to accommodate for the lack of true scientific understanding about the effects of GMO. This article identifies the specific areas of weakness in the EU GMO regulatory framework and recommends specific alterations. It concludes that although France's MON810 ban is illegal under existing law, the country's fears are neither unfounded nor unsupported and that the EU should work to alter its existing legal structure to parallel today's scientific uncertainty regarding GMO safety.

Nanotechnology in food processing sector-An assessment of emerging trends.

PubMed

Kalpana Sastry, R; Anshul, Shrivastava; Rao, N H

2013-10-01

Use of nanoscience based technology in the food industry is fast emerging as new area for research and development. Several research groups including private companies in the industry have initiated research programmes for exploring the wide scope of nanotechnology into the value chain of food processing and manufacturing. This paper discusses the current focus of research in this area and assesses its potential impacts. Using the developed relational database framework with R&D indicators like literature and patent documents for assessment of the potential of nanotechnology in food sector, a model to organize and map nanoresearch areas to the food processing sector was developed. The study indicates that the about five basic categories of nanotechnology applications and functionalities currently in the development of food sector, include food processing, packaging, nutraceuticals delivery, food safety and functional foods.

Potential chemical and microbiological risks on human health from urban wastewater reuse in agriculture. Case study of wastewater effluents in Spain.

PubMed

Muñoz, Ivan; Tomàs, Núria; Mas, Jordi; García-Reyes, Juan Fracisco; Molina-Díaz, Antonio; Fernández-Alba, Amadeo R

2010-05-01

Potential health risks derived from wastewater reuse in agriculture have been evaluated with Risk Assessment modelling techniques, in a case study involving the effluents of two Spanish wastewater treatment plants. One of the plants applies primary and secondary treatment, and the other one applies an additional tertiary treatment. Health risks were assessed on the basis of ingesting contaminated food, due to exposure to: (i) 22 chemical pollutants, namely pharmaceuticals and personal care products (PPCPs), and priority pollutants included in the European Framework Directive, and (ii) microorganisms, namely enterovirus. Chemical Risk Assessment has been carried out following the European Commission's technical guidelines, while risks from exposure to viruses have been evaluated by means of Quantitative Microbial Risk Assessment, assuming a virus to coliform ratio of 1:10(5). The results of the chemical assessment show that there is a margin of safety above 100 for all substances, with the exception of gemfibrozil, for which the mean margin of safety (MOS) is above 100, but the lower bound of MOS with a 95 % confidence interval lies in the 3-4 range. A MOS under 100 was also found for 2,3,7,8-TCDD in one of the effluents. The assessment of risks from viruses shows a very low probability of infection. The overall results show that risks are lower for the plant applying tertiary treatment, especially concerning microbiological parameters.

Writing a Cochrane systematic review on preventive interventions to improve safety: the case of the construction industry.

PubMed

van der Molen, H F; Hoonakker, P L T; Lehtola, Marika M; Hsiao, H; Haslam, R A; Hale, A R; Verbeek, J H

2009-01-01

The objective of this paper is to describe the main steps and to conduct a systematic literature review on preventive interventions concerning work-related injuries and to illustrate the process. Based on the Cochrane handbook, a structured framework of six steps was outlined for the development of a systematic review. This framework was used to describe a Cochrane systematic review (CSR) on the effectiveness of interventions to prevent work related injuries in the construction industry. The 6 main steps to write a CSR were: formulating the problem and objectives; locating and selecting studies; assessing study quality; collecting data; analysing data and presenting results; and interpreting results. The CSR on preventing injuries in the construction industry yielded five eligible intervention studies. Re-analysis of original injury data of the studies on regulatory interventions, through correcting for pre-intervention injury trends led to different conclusions about the effectiveness of interventions than those reported in the original studies. The Cochrane handbook for systematic reviews of interventions provides a practical and feasible six-step framework for developing and reporting a systematic review for preventive interventions.

What should a radiation regulator do about naturally occurring radioactive material?

PubMed

Loy, J

2015-06-01

The standard regulatory framework of authorisation, review and assessment, inspection and enforcement, and regulation making is directed principally towards ensuring the regulatory control of planned exposure situations. Some mining and industrial activities involving exposures to naturally occurring radioactive material (NORM), such as uranium mining or the treatment and conditioning of NORM residues, may fit readily within this standard framework. In other cases, such as oil and gas exploration and production, the standard regulatory framework needs to be adjusted. For example, it is not sensible to require that an oil company seek a licence from the radiation regulator before drilling a well. The paper discusses other approaches that a regulator might take to assure protection and safety in such activities involving exposures to NORM, including the use of conditional exemptions from regulatory controls. It also suggests some areas where further guidance from the International Commission on Radiological Protection on application of the system of radiological protection to NORM would assist both regulators and operators. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Evolving Models of Rehabilitation-Related Patient Safety and Quality: PIECES.

PubMed

Gans, Bruce M

2018-06-01

A conceptual framework for measuring and reporting safety and quality in medical rehabilitation is described in this special communication. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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.

An Organizational Learning Framework for Patient Safety.

PubMed

Edwards, Marc T

Despite concerted effort to improve quality and safety, high reliability remains a distant goal. Although this likely reflects the challenge of organizational change, persistent controversy over basic issues suggests that weaknesses in conceptual models may contribute. The essence of operational improvement is organizational learning. This article presents a framework for identifying leverage points for improvement based on organizational learning theory and applies it to an analysis of current practice and controversy. Organizations learn from others, from defects, from measurement, and from mindfulness. These learning modes correspond with contemporary themes of collaboration, no blame for human error, accountability for performance, and managing the unexpected. The collaborative model has dominated improvement efforts. Greater attention to the underdeveloped modes of organizational learning may foster more rapid progress in patient safety by increasing organizational capabilities, strengthening a culture of safety, and fixing more of the process problems that contribute to patient harm.

A Validation Metrics Framework for Safety-Critical Software-Intensive Systems

DTIC Science & Technology

2009-03-01

so does its definition, tools, and techniques, including means for measuring the validation activity, its outputs, and impact on development...independent of the SDLP. When considering the above SDLPs from the safety engineering team’s perspective, there are also large impacts on the way... impact . Interpretation of any actionable metric data will need to be undertaken in the context of the SDLP. 2. Safety Input The software safety

Nursing physical assessment for patient safety in general wards: reaching consensus on core skills.

PubMed

Douglas, Clint; Booker, Catriona; Fox, Robyn; Windsor, Carol; Osborne, Sonya; Gardner, Glenn

2016-07-01

To determine consensus across acute care specialty areas on core physical assessment skills necessary for early recognition of changes in patient status in general wards. Current approaches to physical assessment are inconsistent and have not evolved to meet increased patient and system demands. New models of nursing assessment are needed in general wards that ensure a proactive and patient safety approach. A modified Delphi study. Focus group interviews with 150 acute care registered nurses at a large tertiary referral hospital generated a framework of core skills that were developed into a web-based survey. We then sought consensus with a panel of 35 senior acute care registered nurses following a classical Delphi approach over three rounds. Consensus was predefined as at least 80% agreement for each skill across specialty areas. Content analysis of focus group transcripts identified 40 discrete core physical assessment skills. In the Delphi rounds, 16 of these were consensus validated as core skills and were conceptually aligned with the primary survey: (Airway) Assess airway patency; (Breathing) Measure respiratory rate, Evaluate work of breathing, Measure oxygen saturation; (Circulation) Palpate pulse rate and rhythm, Measure blood pressure by auscultation, Assess urine output; (Disability) Assess level of consciousness, Evaluate speech, Assess for pain; (Exposure) Measure body temperature, Inspect skin integrity, Inspect and palpate skin for signs of pressure injury, Observe any wounds, dressings, drains and invasive lines, Observe ability to transfer and mobilise, Assess bowel movements. Among a large and diverse group of experienced acute care registered nurses consensus was achieved on a structured core physical assessment to detect early changes in patient status. Although further research is needed to refine the model, clinical application should promote systematic assessment and clinical reasoning at the bedside. © 2016 John Wiley & Sons Ltd.

Adapting Certified Safe Farm to North Carolina Agriculture: An Implementation Study.

PubMed

Storm, Julia F; LePrevost, Catherine E; Tutor-Marcom, Robin; Cope, W Gregory

2016-01-01

Certified Safe Farm (CSF) is a multimodal safety and health program developed and assessed through multiple controlled intervention studies in Iowa. Although developed with the intent to be broadly applicable to agriculture, CSF has not been widely implemented outside the midwestern United States. This article describes the CSF implementation process in North Carolina (NC), as piloted on a large-scale in three agriculturally diverse and productive counties of NC, and reports its effectiveness using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. Implementation involved (1) capacity building through safety and health training, (2) adaptation of components of Iowa's CSF model to NC agriculture, (3) marketing and recruitment, and (4) formative evaluation, including an online survey and focus group discussion. From 2009 to 2012, 113 farms participated in at least one component of the CSF intervention, representing a NC farm participation rate of 3.1% in the study area. A major adaptation of NC implementation was the utilization of NC Cooperative Extension as the local driver of implementation in contrast to local AgriSafe clinics in Iowa. The most innovative adaptation to CSF components was the development of a defined economic incentive in the form of a cost-share program. The RE-AIM framework was found to be useful and relevant to the field of agricultural health and safety translational research. This study provides effectiveness measures and implementation alternatives useful for those considering implementing CSF. It informs current efforts to move CSF from research to practice through the National Sustainable Model CSF Program initiative.

Status of microbial based cleaning products in statutory regulations and ecolabelling in Europe, the USA, and Canada.

PubMed

Spök, Armin; Arvanitakis, George; McClung, Gwendolyn

2018-06-01

Cleaning products containing living microorganisms as active ingredients are increasingly being used in household, professional and industrial cleaning applications. Microorganisms can degrade soiling associated with dirt, food residues, and grease by enzymatic and metabolic action and out-compete microorganisms associated with odor problems. Their potential for odor control seems to result in a competitive advantage over conventional chemically-based cleaning products. Moreover, producers of microbial-based cleaning products (MBCPs) claim that their products are less harmful to the environment. These promising prospects have triggered interest from consumer and environmental organizations, professional users, and regulators in understanding if there are also possible negative health and environmental impacts which require attention and how the safety of these products is ensured. Unfortunately, there is little information on these issues in the public domain. Moreover, regulatory oversight in Europe is essentially limited to pathogenic properties in the context of worker protection. Canada, in contrast, has a regulatory framework in place to assess risks to human health and the environment from the manufacture, import and/or use of new microorganisms contained in MBCPs. In the absence of mandatory standards, safety assessment and hygienic practices seem to vary considerably across companies. Recently developed ecolabelling standards are - for the time being - the only option for transparent compliance to minimum standards in terms of safety as well as assessments of manufacturer information by third parties. These standards highlight in particular the need for precise taxonomic information for assessing the pathogenic properties and the need to ensure the absence of potentially harmful microorganisms as contaminants. Ecolabelling standards are, however, voluntary and do not cover all relevant safety issues. In order to develop a more comprehensive set of mandatory standards for health and safety, a number of areas would benefit from further research (e.g. the role in plant pathogenicity and other environmental properties of the microorganisms used; the relevance of chronic exposure to dusts and aerosols containing vegetative cells and spores; the relevance of strains which belong to species known to include opportunistic pathogens and possible hazards for particularly sensitive risk groups). Improved knowledge in these areas will contribute to a predictable level of product safety. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

New risk metrics and mathematical tools for risk analysis: Current and future challenges

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

Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) themore » Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and “momentary” expressed spoilage and safety level.« less

New risk metrics and mathematical tools for risk analysis: Current and future challenges

NASA Astrophysics Data System (ADS)

Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

2015-01-01

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and "momentary" expressed spoilage and safety level.

An Integrated Data-Driven Strategy for Safe-by-Design Nanoparticles: The FP7 MODERN Project.

PubMed

Brehm, Martin; Kafka, Alexander; Bamler, Markus; Kühne, Ralph; Schüürmann, Gerrit; Sikk, Lauri; Burk, Jaanus; Burk, Peeter; Tamm, Tarmo; Tämm, Kaido; Pokhrel, Suman; Mädler, Lutz; Kahru, Anne; Aruoja, Villem; Sihtmäe, Mariliis; Scott-Fordsmand, Janeck; Sorensen, Peter B; Escorihuela, Laura; Roca, Carlos P; Fernández, Alberto; Giralt, Francesc; Rallo, Robert

2017-01-01

The development and implementation of safe-by-design strategies is key for the safe development of future generations of nanotechnology enabled products. The safety testing of the huge variety of nanomaterials that can be synthetized is unfeasible due to time and cost constraints. Computational modeling facilitates the implementation of alternative testing strategies in a time and cost effective way. The development of predictive nanotoxicology models requires the use of high quality experimental data on the structure, physicochemical properties and bioactivity of nanomaterials. The FP7 Project MODERN has developed and evaluated the main components of a computational framework for the evaluation of the environmental and health impacts of nanoparticles. This chapter describes each of the elements of the framework including aspects related to data generation, management and integration; development of nanodescriptors; establishment of nanostructure-activity relationships; identification of nanoparticle categories; hazard ranking and risk assessment.

A Computational Framework to Control Verification and Robustness Analysis

NASA Technical Reports Server (NTRS)

Crespo, Luis G.; Kenny, Sean P.; Giesy, Daniel P.

2010-01-01

This paper presents a methodology for evaluating the robustness of a controller based on its ability to satisfy the design requirements. The framework proposed is generic since it allows for high-fidelity models, arbitrary control structures and arbitrary functional dependencies between the requirements and the uncertain parameters. The cornerstone of this contribution is the ability to bound the region of the uncertain parameter space where the degradation in closed-loop performance remains acceptable. The size of this bounding set, whose geometry can be prescribed according to deterministic or probabilistic uncertainty models, is a measure of robustness. The robustness metrics proposed herein are the parametric safety margin, the reliability index, the failure probability and upper bounds to this probability. The performance observed at the control verification setting, where the assumptions and approximations used for control design may no longer hold, will fully determine the proposed control assessment.

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

PubMed

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

2017-10-01

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

Structural monitoring via microwave tomography-enhanced GPR: the Montagnole test site

NASA Astrophysics Data System (ADS)

Catapano, Ilaria; Di Napoli, Rosario; Soldovieri, Francesco; Bavusi, Massimo; Loperte, Antonio; Dumoulin, Jean

2012-08-01

Structural integrity assessment and monitoring of infrastructures are key factors to prevent and manage crisis events (natural disasters, terrorist attacks and so on) and ensure urban safety. This necessity motivates huge interest towards design, optimization and integration of non-invasive remote and in situ diagnostic techniques. In this framework, ground penetrating radar (GPR) is a well-assessed instrumentation, which allows one to attain information on the inner status of man-made structures while avoiding invasive tests. However, despite its potential, a more widespread use of GPR is actually affected by the difficulties in providing highly informative and easily interpretable images as an outcome of the overall diagnostics procedure. This drawback can be mitigated thanks to the use of microwave tomography (MT) as a data processing tool able to enhance the achievable reconstruction capabilities, and several proofs of its effectiveness have been already shown. In this paper, the potential of the MT approach is investigated in the framework of structural monitoring by an experiment carried out in the Montagnole test site in the French Alps, where the progressive damage of a one-scale concrete beam has been monitored thanks to the integration of several electromagnetic sensing techniques. In this framework, the capability of the MT-enhanced GPR strategy is examined with respect to the possibility of providing information about the damage of the rebar grid of the beam.

Defining and measuring patient safety.

PubMed

Pronovost, Peter J; Thompson, David A; Holzmueller, Christine G; Lubomski, Lisa H; Morlock, Laura L

2005-01-01

Despite the growing demand for improved safety in health care, debate remains regarding the magnitude of the problem and the degree to which harm is preventable. To a great extent, this debate stems from variation in the definition and methods for measuring safety, its "shadow" error, and the degree of preventability. This article reviews the definition of safety and error, discusses approaches to measuring safety, and provides a framework for investigating incidents that unveils how the systems under which care is delivered may contribute to adverse incidents.

Assessment and Mmanagement of North American horseshoe crab populations, with emphasis on a multispecies framework for Delaware Bay, U.S.A. populations: Chapter 24

USGS Publications Warehouse

Millard, Michael J.; Sweka, John A.; McGowan, Conor P.; Smith, David R.

2015-01-01

The horseshoe crab fishery on the US Atlantic coast represents a compelling fishery management story for many reasons, including ecological complexity, health and human safety ramifications, and socio-economic conflicts. Knowledge of stock status and assessment and monitoring capabilities for the species have increased greatly in the last 15 years and permitted managers to make more informed harvest recommendations. Incorporating the bioenergetics needs of migratory shorebirds, which feed on horseshoe crab eggs, into the management framework for horseshoe crabs was identified as a goal, particularly in the Delaware Bay region where the birds and horseshoe crabs exhibit an important ecological interaction. In response, significant effort was invested in studying the population dynamics, migration ecology, and the ecologic relationship of a key migratory shorebird, the Red Knot, to horseshoe crabs. A suite of models was developed that linked Red Knot populations to horseshoe crab populations through a mass gain function where female spawning crab abundance determined what proportion of the migrating Red Knot population reached a critical body mass threshold. These models were incorporated in an adaptive management framework wherein optimal harvest decisions for horseshoe crab are recommended based on several resource-based and value-based variables and thresholds. The current adaptive framework represents a true multispecies management effort where additional data over time are employed to improve the predictive models and reduce parametric uncertainty. The possibility of increasing phenologic asynchrony between the two taxa in response to climate change presents a potential challenge to their ecologic interaction in Delaware Bay.

The role of the physical environment in crossing the quality chasm.

PubMed

Henriksen, Kerm; Isaacson, Sandi; Sadler, Blair L; Zimring, Craig M

2007-11-01

Evidence-based design findings are available to help inform hospital decision makers of opportunities for ensuring that quality and safety are designed into new and refurbished facilities. The Institute of Medicine's six quality aims of patient centeredness, safety, effectiveness, efficiency, timeliness, and equity provide an organizing framework for introducing a representative portion of the evidence. Design improvements include single-bed and variable-acuity rooms; electronic access to medical records; greater accommodation for families and visitors; handrails to prevent patient falls; standardization (room layout, equipment, and supplies for improved efficiencies); improved work process flow to reduce delays and wait times; and better assessment of changing demographics, disease conditions, and community needs for appropriately targeted health care services. A recent analysis of the business case suggests that a slight, one-time incremental cost for ensuring safety and quality would be paid back in two to three years in the form of operational savings and increased revenues. Hospitals leaders anticipating new construction projects should take advantage of evidence-based design findings that have the potential of raising the quality of acute care for decades to come.

Applying a sociotechnical framework for improving safety at highway-railroad grade crossings

DOT National Transportation Integrated Search

2007-10-05

To understand drivers' decisions and actions at grade crossings, we examined human factors contributing to noncompliance at grade crossings using a sociotechnical framework. This perspective allows driver behavior at grade crossings to be examined no...

A Simple Demonstration of Concrete Structural Health Monitoring Framework

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

Mahadevan, Sankaran; Agarwal, Vivek; Cai, Guowei

Assessment and management of aging concrete structures in nuclear power plants require a more systematic approach than simple reliance on existing code margins of safety. Structural health monitoring of concrete structures aims to understand the current health condition of a structure based on heterogeneous measurements to produce high confidence actionable information regarding structural integrity that supports operational and maintenance decisions. This ongoing research project is seeking to develop a probabilistic framework for health diagnosis and prognosis of aging concrete structures in a nuclear power plant subjected to physical, chemical, environment, and mechanical degradation. The proposed framework consists of four elements—damagemore » modeling, monitoring, data analytics, and uncertainty quantification. This report describes a proof-of-concept example on a small concrete slab subjected to a freeze-thaw experiment that explores techniques in each of the four elements of the framework and their integration. An experimental set-up at Vanderbilt University’s Laboratory for Systems Integrity and Reliability is used to research effective combination of full-field techniques that include infrared thermography, digital image correlation, and ultrasonic measurement. The measured data are linked to the probabilistic framework: the thermography, digital image correlation data, and ultrasonic measurement data are used for Bayesian calibration of model parameters, for diagnosis of damage, and for prognosis of future damage. The proof-of-concept demonstration presented in this report highlights the significance of each element of the framework and their integration.« less

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

Coaching the Debriefer: Peer Coaching to Improve Debriefing Quality in Simulation Programs.

PubMed

Cheng, Adam; Grant, Vincent; Huffman, James; Burgess, Gavin; Szyld, Demian; Robinson, Traci; Eppich, Walter

2017-10-01

Formal faculty development programs for simulation educators are costly and time-consuming. Peer coaching integrated into the teaching flow can enhance an educator's debriefing skills. We provide a practical guide for the who, what, when, where, why, and how of peer coaching for debriefing in simulation-based education. Peer coaching offers advantages such as psychological safety and team building, and it can benefit both the educator who is receiving feedback and the coach who is providing it. A feedback form for effective peer coaching includes the following: (1) psychological safety, (2) framework, (3) method/strategy, (4) content, (5) learner centeredness, (6) co-facilitation, (7) time management, (8) difficult situations, (9) debriefing adjuncts, and (10) individual style and experience. Institutional backing of peer coaching programs can facilitate implementation and sustainability. Program leaders should communicate the need and benefits, establish program goals, and provide assessment tools, training, structure, and evaluation to optimize chances of success.

Did you have an impact? A theory-based method for planning and evaluating knowledge-transfer and exchange activities in occupational health and safety.

PubMed

Kramer, Desré M; Wells, Richard P; Carlan, Nicolette; Aversa, Theresa; Bigelow, Philip P; Dixon, Shane M; McMillan, Keith

2013-01-01

Few evaluation tools are available to assess knowledge-transfer and exchange interventions. The objective of this paper is to develop and demonstrate a theory-based knowledge-transfer and exchange method of evaluation (KEME) that synthesizes 3 theoretical frameworks: the promoting action on research implementation of health services (PARiHS) model, the transtheoretical model of change, and a model of knowledge use. It proposes a new term, keme, to mean a unit of evidence-based transferable knowledge. The usefulness of the evaluation method is demonstrated with 4 occupational health and safety knowledge transfer and exchange (KTE) implementation case studies that are based upon the analysis of over 50 pre-existing interviews. The usefulness of the evaluation model has enabled us to better understand stakeholder feedback, frame our interpretation, and perform a more comprehensive evaluation of the knowledge use outcomes of our KTE efforts.

RIFM fragrance ingredient safety assessment, 3,7-dimethyl-1,6-nonadien-3-ol, CAS Registry Number 10339-55-6.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Miyachi, Y; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog linalool (CAS # 78-70-6) show that this material is not genotoxic nor does it have skin sensitization potential and also provided a MOE > 100 for the local respiratory endpoint. The repeated dose, developmental and reproductive toxicity endpoints were completed using nerolidol (isomer unspecified, CAS # 7212-44-4) as a suitable read across analog, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

RIFM fragrance ingredient safety assessment, 2-ethyl-1-hexanol, CAS registry number 104-76-7.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic. Data from the suitable read across analog 2-butyloctan-1-ol (CAS # 3913-02-8) show that this material does not have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental and repeat dose toxicity endpoints were completed data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications.

PubMed

Singh, Karandeep; Drouin, Kaitlin; Newmark, Lisa P; Rozenblum, Ronen; Lee, Jaeho; Landman, Adam; Pabo, Erika; Klinger, Elissa V; Bates, David W

2016-02-01

Rising ownership of smartphones and tablets across social and demographic groups has made mobile applications, or apps, a potentially promising tool for engaging patients in their health care, particularly those with high health care needs. Through a systematic search of iOS (Apple) and Android app stores and an analysis of apps targeting individuals with chronic illnesses, we assessed the degree to which apps are likely to be useful in patient engagement efforts. Usefulness was determined based on the following criteria: description of engagement, relevance to the targeted patient population, consumer ratings and reviews, and most recent app update. Among the 1,046 health care-related, patient-facing applications identified by our search, 43 percent of iOS apps and 27 percent of Android apps appeared likely to be useful. We also developed criteria for evaluating the patient engagement, quality, and safety of mobile apps.

Predictive framework for estimating exposure of birds to pharmaceuticals

USGS Publications Warehouse

Bean, Thomas G.; Arnold, Kathryn E.; Lane, Julie M.; Bergström, Ed; Thomas-Oates, Jane; Rattner, Barnett A.; Boxall, Allistair B.A.

2017-01-01

We present and evaluate a framework for estimating concentrations of pharmaceuticals over time in wildlife feeding at wastewater treatment plants (WWTPs). The framework is composed of a series of predictive steps involving the estimation of pharmaceutical concentration in wastewater, accumulation into wildlife food items, and uptake by wildlife with subsequent distribution into, and elimination from, tissues. Because many pharmacokinetic parameters for wildlife are unavailable for the majority of drugs in use, a read-across approach was employed using either rodent or human data on absorption, distribution, metabolism, and excretion. Comparison of the different steps in the framework against experimental data for the scenario where birds are feeding on a WWTP contaminated with fluoxetine showed that estimated concentrations in wastewater treatment works were lower than measured concentrations; concentrations in food could be reasonably estimated if experimental bioaccumulation data are available; and read-across from rodent data worked better than human to bird read-across. The framework provides adequate predictions of plasma concentrations and of elimination behavior in birds but yields poor predictions of distribution in tissues. The approach holds promise, but it is important that we improve our understanding of the physiological similarities and differences between wild birds and domesticated laboratory mammals used in pharmaceutical efficacy/safety trials, so that the wealth of data available can be applied more effectively in ecological risk assessments.

Predictive framework for estimating exposure of birds to pharmaceuticals.

PubMed

Bean, Thomas G; Arnold, Kathryn E; Lane, Julie M; Bergström, Ed; Thomas-Oates, Jane; Rattner, Barnett A; Boxall, Alistair B A

2017-09-01

We present and evaluate a framework for estimating concentrations of pharmaceuticals over time in wildlife feeding at wastewater treatment plants (WWTPs). The framework is composed of a series of predictive steps involving the estimation of pharmaceutical concentration in wastewater, accumulation into wildlife food items, and uptake by wildlife with subsequent distribution into, and elimination from, tissues. Because many pharmacokinetic parameters for wildlife are unavailable for the majority of drugs in use, a read-across approach was employed using either rodent or human data on absorption, distribution, metabolism, and excretion. Comparison of the different steps in the framework against experimental data for the scenario where birds are feeding on a WWTP contaminated with fluoxetine showed that estimated concentrations in wastewater treatment works were lower than measured concentrations; concentrations in food could be reasonably estimated if experimental bioaccumulation data are available; and read-across from rodent data worked better than human to bird read-across. The framework provides adequate predictions of plasma concentrations and of elimination behavior in birds but yields poor predictions of distribution in tissues. The approach holds promise, but it is important that we improve our understanding of the physiological similarities and differences between wild birds and domesticated laboratory mammals used in pharmaceutical efficacy/safety trials, so that the wealth of data available can be applied more effectively in ecological risk assessments. Environ Toxicol Chem 2017;36:2335-2344. © 2017 SETAC. © 2017 SETAC.

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

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

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

Pesticide management approach towards protecting the safety and health of farmers in Southeast Asia.

PubMed

Mohammad, Norsyazwani; Abidin, Emilia Zainal; How, Vivien; Praveena, Sarva Mangala; Hashim, Zailina

2018-06-27

It is estimated that pesticide production and use have increased continuously in the countries of Southeast Asia in recent years. Within the context of protecting the safety and health of workers in the agricultural sector, there is an existing gap in the implementation of the pesticide management framework because safety and health effects arising from occupational exposures continue to be reported. This study aims to provide narrative similarities, differences and weaknesses of the existing pesticide management system in Southeast Asian countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) within the context of occupational safety and health. This is preliminary traditional review study. Pesticide regulation and management at the country level were identified using web-based search engines such as Scopus, ScienceDirect, PubMed and Google. Book, reports, legislation document and other documents retrieved were also gathered from international organizations and specific websites of governmental agency in Southeast Asian countries. The scope of this review is only limited to literature written in English. In total, 44 review articles, reports and documents were gathered for this study. The approach of pesticide management in protecting safety and health in the agricultural setting were benchmarked according to the elements introduced by the United States Environmental Protection Agency, namely, (1) the protection of workers and (2) the practice of safety. All countries have assigned a local authority and government organization to manage and control pesticide use in the agricultural sector. The countries with the highest usage of pesticide are Thailand, Philippines and Malaysia. Most Southeast Asian countries have emphasized safety practice in the management of pesticide usage, but there were less emphasis on the element of protection of workers within the framework in Indonesia, Myanmar, Thailand and Vietnam. The governing bodies in the countries of Southeast Asia have placed significant effort to develop framework related to pesticide management at the country level. The implementation of pesticide management based on the existing framework is evident in most of the countries but needs to be improved. It is suggested that emphasis be given to the implementation of diagnosis, health surveillance and reporting system as well as following or adopting standard guidelines for the protection of workers in terms of safety and health in the agricultural sector.

Evaluation of the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers: a systematic review and documentary analysis.

PubMed

McGraw, Caroline; Drennan, Vari M

2015-02-01

To evaluate the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers. The objective was to identify the extent to which these frameworks take account of the setting where the ulcer originated as being the person's home rather than a hospital setting. Pressure ulcers involving full-thickness skin loss are increasingly being regarded as indicators of nursing patient safety failure, requiring investigation using root cause analysis frameworks. Evidence suggests that root cause analysis frameworks developed in hospital settings ignore the unique dimensions of risk in home healthcare settings. A systematic literature review and documentary analysis of frameworks used to investigate community-acquired grade three and four pressure ulcers by home nursing services in England. No published papers were identified for inclusion in the review. Fifteen patient safety investigative frameworks were collected and analysed. Twelve of the retrieved frameworks were intended for the investigation of community-acquired pressure ulcers; seven of which took account of the setting where the ulcer originated as being the patient's home. This study provides evidence to suggest that many of the root cause analysis frameworks used to investigate community-acquired pressure ulcers in England are unsuitable for this purpose. This study provides researchers and practitioners with evidence of the need to develop appropriate home nursing root cause analysis frameworks to investigate community-acquired pressure ulcers. © 2014 John Wiley & Sons Ltd.

Review article: A systematic review of emergency department incident classification frameworks.

PubMed

Murray, Matthew; McCarthy, Sally

2018-06-01

As in any part of the hospital system, safety incidents can occur in the ED. These incidents arguably have a distinct character, as the ED involves unscheduled flows of urgent patients who require disparate services. To aid understanding of safety issues and support risk management of the ED, a comparison of published ED specific incident classification frameworks was performed. A review of emergency medicine, health management and general medical publications, using Ovid SP to interrogate Medline (1976-2016) was undertaken to identify any type of taxonomy or classification-like framework for ED related incidents. These frameworks were then analysed and compared. The review identified 17 publications containing an incident classification framework. Comparison of factors and themes making up the classification constituent elements revealed some commonality, but no overall consistency, nor evolution towards an ideal framework. Inconsistency arises from differences in the evidential basis and design methodology of classifications, with design itself being an inherently subjective process. It was not possible to identify an 'ideal' incident classification framework for ED risk management, and there is significant variation in the selection of categories used by frameworks. The variation in classification could risk an unbalanced emphasis in findings through application of a particular framework. Design of an ED specific, ideal incident classification framework should be informed by a much wider range of theories of how organisations and systems work, in addition to clinical and human factors. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

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

NASA Technical Reports Server (NTRS)

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

2008-01-01

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

Improving the quality of the surgical morbidity and mortality conference: a prospective intervention study.

PubMed

Mitchell, Erica L; Lee, Dae Y; Arora, Sonal; Kenney-Moore, Pat; Liem, Timothy K; Landry, Gregory J; Moneta, Gregory L; Sevdalis, Nick

2013-06-01

Surgical morbidity and mortality conferences (M&MCs) provide surgeons with an opportunity to confront medical errors, discuss adverse events, and learn from their mistakes. Yet, no standardized format for these conferences exists. The authors hypothesized that introducing a standardized presentation format using a validated framework would improve presentation quality and educational outcomes for all attendees. Following a review of the literature and the solicitation of experts' opinions, the authors adapted a validated communication tool-the SBAR (Situation, Background, Assessment, Recommendations) framework. In 2010, they then introduced this novel standardized presentation format into the surgical M&MCs at the Oregon Health & Science University. The authors assessed three outcome measures--user satisfaction, presentation quality, and education outcomes--before and after implementation of their standardized presentation format. Over the six-month study period, residents delivered 66 presentations to 197 faculty, resident, and medical student attendees. Attendees' performance on the multiple-choice questionnaires improved after the intervention, indicating an improvement in their knowledge. Presentation quality also improved significantly after the intervention, according to evaluations by trained faculty assessors. They noted specific improvements in the quality of the Background, Assessment, and Recommendation sections. The M&MC plays a pivotal role in educating residents and improving patient safety. Standardizing the M&MC presentation format using an adapted SBAR framework improved the quality of residents' presentations and attendees' educational outcomes. The authors recommend using such a standardized presentation format to enhance the educational value of M&MCs, with the goal of improving surgeons' knowledge, skills, and patient care practices.

Review of Qualitative Approaches for the Construction Industry: Designing a Risk Management Toolbox

PubMed Central

Spee, Ton; Gillen, Matt; Lentz, Thomas J.; Garrod, Andrew; Evans, Paul; Swuste, Paul

2011-01-01

Objectives This paper presents the framework and protocol design for a construction industry risk management toolbox. The construction industry needs a comprehensive, systematic approach to assess and control occupational risks. These risks span several professional health and safety disciplines, emphasized by multiple international occupational research agenda projects including: falls, electrocution, noise, silica, welding fumes, and musculoskeletal disorders. Yet, the International Social Security Association says, "whereas progress has been made in safety and health, the construction industry is still a high risk sector." Methods Small- and medium-sized enterprises (SMEs) employ about 80% of the world's construction workers. In recent years a strategy for qualitative occupational risk management, known as Control Banding (CB) has gained international attention as a simplified approach for reducing work-related risks. CB groups hazards into stratified risk 'bands', identifying commensurate controls to reduce the level of risk and promote worker health and safety. We review these qualitative solutions-based approaches and identify strengths and weaknesses toward designing a simplified CB 'toolbox' approach for use by SMEs in construction trades. Results This toolbox design proposal includes international input on multidisciplinary approaches for performing a qualitative risk assessment determining a risk 'band' for a given project. Risk bands are used to identify the appropriate level of training to oversee construction work, leading to commensurate and appropriate control methods to perform the work safely. Conclusion The Construction Toolbox presents a review-generated format to harness multiple solutions-based national programs and publications for controlling construction-related risks with simplified approaches across the occupational safety, health and hygiene professions. PMID:22953194

Review of qualitative approaches for the construction industry: designing a risk management toolbox.

PubMed

Zalk, David M; Spee, Ton; Gillen, Matt; Lentz, Thomas J; Garrod, Andrew; Evans, Paul; Swuste, Paul

2011-06-01

This paper presents the framework and protocol design for a construction industry risk management toolbox. The construction industry needs a comprehensive, systematic approach to assess and control occupational risks. These risks span several professional health and safety disciplines, emphasized by multiple international occupational research agenda projects including: falls, electrocution, noise, silica, welding fumes, and musculoskeletal disorders. Yet, the International Social Security Association says, "whereas progress has been made in safety and health, the construction industry is still a high risk sector." Small- and medium-sized enterprises (SMEs) employ about 80% of the world's construction workers. In recent years a strategy for qualitative occupational risk management, known as Control Banding (CB) has gained international attention as a simplified approach for reducing work-related risks. CB groups hazards into stratified risk 'bands', identifying commensurate controls to reduce the level of risk and promote worker health and safety. We review these qualitative solutions-based approaches and identify strengths and weaknesses toward designing a simplified CB 'toolbox' approach for use by SMEs in construction trades. This toolbox design proposal includes international input on multidisciplinary approaches for performing a qualitative risk assessment determining a risk 'band' for a given project. Risk bands are used to identify the appropriate level of training to oversee construction work, leading to commensurate and appropriate control methods to perform the work safely. The Construction Toolbox presents a review-generated format to harness multiple solutions-based national programs and publications for controlling construction-related risks with simplified approaches across the occupational safety, health and hygiene professions.

Workshop-based methodology to understand the risks in grain export inspection and certification.

PubMed

Wilson, John R; Vaegen-Lloyd, Jo-Roxy; Caponecchia, Carlo

2009-07-01

Much of the human factors contribution in risk assessment and risk management has been focused on systems or product safety; the profession has a much smaller research base regarding risks to do with regulation, certification and public policy, for example. This paper discusses an explicitly human factors contribution to understanding and managing risk for the inspection and export certification of grain and plant products in Australia. Training and awareness workshops, incorporating elements of focus groups, were run for 12 groups of staff and managers from the government department concerned. As well as training in risk management the workshops were used to come to an understanding of the work of the inspectors and other staff, to identify the sources of risk to the successful completion of their work and to develop the basis for a risk assessment framework and tool. The paper is methodological in focus and describes the development and running of the workshops and explains how a human factors oriented risk register was developed on the basis of identification of potential threats and errors in the system. Whilst the contribution of ergonomics is increasingly important as regards safety risk assessment, professionals have been less active as regards business, public policy and even engineering risk. This paper describes an approach within which a new domain was studied and the risks of all kinds identified, preparatory to development of a risk assessment tool.

Drinking Water Management and Governance in Canada: An Innovative Plan-Do-Check-Act (PDCA) Framework for a Safe Drinking Water Supply

NASA Astrophysics Data System (ADS)

Bereskie, Ty; Rodriguez, Manuel J.; Sadiq, Rehan

2017-08-01

Drinking water management in Canada is complex, with a decentralized, three-tiered governance structure responsible for safe drinking water throughout the country. The current approach has been described as fragmented, leading to governance gaps, duplication of efforts, and an absence of accountability and enforcement. Although there have been no major waterborne disease outbreaks in Canada since 2001, a lack of performance improvement, especially in small drinking water systems, is evident. The World Health Organization water safety plan approach for drinking water management represents an alternative preventative management framework to the current conventional, reactive drinking water management strategies. This approach has seen successful implementation throughout the world and has the potential to address many of the issues with drinking water management in Canada. This paper presents a review and strengths-weaknesses-opportunities-threats analysis of drinking water management and governance in Canada at the federal, provincial/territorial, and municipal levels. Based on this analysis, a modified water safety plan (defined as the plan-do-check-act (PDCA)-WSP framework) is proposed, established from water safety plan recommendations and the principles of PDCA for continuous performance improvement. This proposed framework is designed to strengthen current drinking water management in Canada and is designed to fit within and incorporate the existing governance structure.

Drinking Water Management and Governance in Canada: An Innovative Plan-Do-Check-Act (PDCA) Framework for a Safe Drinking Water Supply.

PubMed

Bereskie, Ty; Rodriguez, Manuel J; Sadiq, Rehan

2017-08-01

Drinking water management in Canada is complex, with a decentralized, three-tiered governance structure responsible for safe drinking water throughout the country. The current approach has been described as fragmented, leading to governance gaps, duplication of efforts, and an absence of accountability and enforcement. Although there have been no major waterborne disease outbreaks in Canada since 2001, a lack of performance improvement, especially in small drinking water systems, is evident. The World Health Organization water safety plan approach for drinking water management represents an alternative preventative management framework to the current conventional, reactive drinking water management strategies. This approach has seen successful implementation throughout the world and has the potential to address many of the issues with drinking water management in Canada. This paper presents a review and strengths-weaknesses-opportunities-threats analysis of drinking water management and governance in Canada at the federal, provincial/territorial, and municipal levels. Based on this analysis, a modified water safety plan (defined as the plan-do-check-act (PDCA)-WSP framework) is proposed, established from water safety plan recommendations and the principles of PDCA for continuous performance improvement. This proposed framework is designed to strengthen current drinking water management in Canada and is designed to fit within and incorporate the existing governance structure.

Systems-based accident analysis in the led outdoor activity domain: application and evaluation of a risk management framework.

PubMed

Salmon, P; Williamson, A; Lenné, M; Mitsopoulos-Rubens, E; Rudin-Brown, C M

2010-08-01

Safety-compromising accidents occur regularly in the led outdoor activity domain. Formal accident analysis is an accepted means of understanding such events and improving safety. Despite this, there remains no universally accepted framework for collecting and analysing accident data in the led outdoor activity domain. This article presents an application of Rasmussen's risk management framework to the analysis of the Lyme Bay sea canoeing incident. This involved the development of an Accimap, the outputs of which were used to evaluate seven predictions made by the framework. The Accimap output was also compared to an analysis using an existing model from the led outdoor activity domain. In conclusion, the Accimap output was found to be more comprehensive and supported all seven of the risk management framework's predictions, suggesting that it shows promise as a theoretically underpinned approach for analysing, and learning from, accidents in the led outdoor activity domain. STATEMENT OF RELEVANCE: Accidents represent a significant problem within the led outdoor activity domain. This article presents an evaluation of a risk management framework that can be used to understand such accidents and to inform the development of accident countermeasures and mitigation strategies for the led outdoor activity domain.

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

PubMed

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

2014-12-01

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

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

Measuring patient safety culture in maternal and child health institutions in China: a qualitative study.

PubMed

Wang, Yuanyuan; Liu, Weiwei; Shi, Huifeng; Liu, Chaojie; Wang, Yan

2017-07-12

Patient safety culture (PSC) plays a critical role in ensuring safe and quality care. Extensive PSC studies have been undertaken in hospitals. However, little is known about PSC in maternal and child health (MCH) institutions in China, which provide both population-based preventive services as well as individual care for patients. This study aimed to develop a theoretical framework for conceptualising PSC in MCH institutions in China. The study was undertaken in six MCH institutions (three in Hebei and three in Beijing). Participants (n=118) were recruited through stratified purposive sampling: 20 managers/administrators, 59 care providers and 39 patients. In-depth interviews were conducted with the participants. The interview data were coded using both inductive (based on the existing PSC theory developed by the Agency for Healthcare Research and Quality) and deductive (open coding arising from data) approaches. A PSC framework was formulated through axial coding that connected initial codes and selective coding that extracted a small number of themes. The interviewees considered patient safety in relation to six aspects: safety and security in public spaces, safety of medical services, privacy and information security, financial security, psychological safety and gap in services. A 12-dimensional PSC framework was developed, containing 69 items. While the existing PSC theory was confirmed by this study, some new themes emerged from the data. Patients expressed particular concerns about psychological safety and financial security. Defensive medical practices emerged as a PSC dimension that is associated with not only medical safety but also financial security and psychological safety. Patient engagement was also valued by the interviewees, especially the patients, as part of PSC. Although there are some common features in PSC across different healthcare delivery systems, PSC can also be context specific. In MCH settings in China, the meaning of 'patient safety' goes beyond the traditional definition of patients. General well-being, health and disease prevention are important anchor points for defining PSC in such settings. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The impact of council directive 2011/70/EURATOM and IAEA joint convention review meetings on the ongoing establishment of the Portuguese regulatory framework and on the future of national radioactive waste

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

Paiva, Isabel; Trindade, Romao B.

Council Directive 2011/70/EURATOM of 19 July 2011, establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste will enter in force August 2013 in all EU Member States. Portugal has already started preparing its legislative framework to accommodate the new legislative piece. However, the first report of Portugal to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management of the IAEA, in Vienna, 2012, has shown that Portugal still has many steps to overcome to establish a successful and effective basic regulatory framework. The existencemore » of many competent authorities related to the radiological protection area and a newly independent commission that is still looking on how to fulfill its regulator role in other areas such as the radioactive waste management makes quite challenging the full application of the new directive as well as compliance that Portugal will have to show in the next Joint Convention review meeting in order to meet the obligations of the Convention. In this paper, the reality of the regulatory Portuguese framework on radiological protection, nuclear safety and radioactive waste management is presented. Discussion of the future impact of the new legislation and its consequences such as the need to setup the national program on radioactive waste management is critical discussed. (authors)« less

The Event Chain of Survival in the Context of Music Festivals: A Framework for Improving Outcomes at Major Planned Events.

PubMed

Lund, Adam; Turris, Sheila

2017-08-01

Despite the best efforts of event producers and on-site medical teams, there are sometimes serious illnesses, life-threatening injuries, and fatalities related to music festival attendance. Producers, clinicians, and researchers are actively seeking ways to reduce the mortality and morbidity associated with these events. After analyzing the available literature on music festival health and safety, several major themes emerged. Principally, stakeholder groups planning in isolation from one another (ie, in silos) create fragmentation, gaps, and overlap in plans for major planned events (MPEs). The authors hypothesized that one approach to minimizing this fragmentation may be to create a framework to "connect the dots," or join together the many silos of professionals responsible for safety, security, health, and emergency planning at MPEs. Adapted from the well-established literature regarding the management of cardiac arrests, both in and out of hospital, the "chain of survival" concept is applied to the disparate groups providing services that support event safety in the context of music festivals. The authors propose this framework for describing, understanding, coordinating and planning around the integration of safety, security, health, and emergency service for events. The adapted Event Chain of Survival contains six interdependent links, including: (1) event producers; (2) police and security; (3) festival health; (4) on-site medical services; (5) ambulance services; and (6) off-site medical services. The authors argue that adapting and applying this framework in the context of MPEs in general, and music festivals specifically, has the potential to break down the current disconnected approach to event safety, security, health, and emergency planning. It offers a means of shifting the focus from a purely reactive stance to a more proactive, collaborative, and integrated approach. Improving health outcomes for music festival attendees, reducing gaps in planning, promoting consistency, and improving efficiency by reducing duplication of services will ultimately require coordination and collaboration from the beginning of event production to post-event reporting. Lund A , Turris SA . The Event Chain of Survival in the context of music festivals: a framework for improving outcomes at major planned events. Prehosp Disaster Med. 2017;32(4):437-443.

The Importance of Economic Perspective and Quantitative Approaches in Oncology Value Frameworks of Drug Selection and Shared Decision Making.

PubMed

Waldeck, A Reginald; Botteman, Marc F; White, Richard E; van Hout, Ben A

2017-06-01

The debate around value in oncology drug selection has been prominent in recent years, and several professional bodies have furthered this debate by advocating for so-called value frameworks. Herein, we provide a viewpoint on these value frameworks, emphasizing the need to consider 4 key aspects: (1) the economic underpinnings of value; (2) the importance of the perspective adopted in the valuation; (3) the importance of the difference between absolute and relative measures of risk and measuring patient preferences; and (4) the recognition of multiple quality-of-life (QoL) domains, and the aggregation and valuation of those domains, through utilities within a multicriteria decision analysis, may allow prioritization of QoL above the tallying of safety events, particularly in a value framework focusing on the individual patient. While several frameworks exist, they incorporate different attributes and-importantly-assess value from alternative perspectives, including those of patients, regulators, payers, and society. The various perspectives necessarily lead to potentially different, if not sometimes divergent, conclusions about the valuation. We show that the perspective of the valuation affects the framing of the risk/benefit question and the methodology to measure the individual patient choice, or preference, as opposed to the collective, or population, choice. We focus specifically on the American Society of Clinical Oncology (ASCO) Value Framework. We argue that its laudable intent to assist in shared clinician-patient decision making can be augmented by more formally adopting methodology underpinned by micro- and health economic concepts, as well as application of formal quantitative approaches. Our recommendations for value frameworks focusing on the individual patient, such as the ASCO Value Framework, are 3-fold: (1) ensure that stakeholders understand the importance of the adopted (economic) perspective; (2) consider using exclusively absolute measures of risk and formal patient-preference methodology; and (3) consider foregoing safety parameters for higher-order utility considerations. No funding was received for conceptualizing, writing, and/or editing this manuscript. Waldeck and White are employees of, and received stock option grants from, Celldex Therapeutics. Van Hout and Botteman are employees and shareholders of Pharmerit International. Pharmerit International is a research contractor for Celldex. All authors have retained editorial control of the content of the manuscript. Conceptualization of this viewpoint article was contributed primarily by Waldeck, along with Botteman, White, and van Hout. Data analysis and revision of the manuscript was contributed equally by all the authors. The manuscript was written by Waldeck, Botteman, van Hout, and White.

An open-source framework for testing tracking devices using Lego Mindstorms

NASA Astrophysics Data System (ADS)

Jomier, Julien; Ibanez, Luis; Enquobahrie, Andinet; Pace, Danielle; Cleary, Kevin

2009-02-01

In this paper, we present an open-source framework for testing tracking devices in surgical navigation applications. At the core of image-guided intervention systems is the tracking interface that handles communication with the tracking device and gathers tracking information. Given that the correctness of tracking information is critical for protecting patient safety and for ensuring the successful execution of an intervention, the tracking software component needs to be thoroughly tested on a regular basis. Furthermore, with widespread use of extreme programming methodology that emphasizes continuous and incremental testing of application components, testing design becomes critical. While it is easy to automate most of the testing process, it is often more difficult to test components that require manual intervention such as tracking device. Our framework consists of a robotic arm built from a set of Lego Mindstorms and an open-source toolkit written in C++ to control the robot movements and assess the accuracy of the tracking devices. The application program interface (API) is cross-platform and runs on Windows, Linux and MacOS. We applied this framework for the continuous testing of the Image-Guided Surgery Toolkit (IGSTK), an open-source toolkit for image-guided surgery and shown that regression testing on tracking devices can be performed at low cost and improve significantly the quality of the software.

Human error analysis of commercial aviation accidents: application of the Human Factors Analysis and Classification system (HFACS).

PubMed

Wiegmann, D A; Shappell, S A

2001-11-01

The Human Factors Analysis and Classification System (HFACS) is a general human error framework originally developed and tested within the U.S. military as a tool for investigating and analyzing the human causes of aviation accidents. Based on Reason's (1990) model of latent and active failures, HFACS addresses human error at all levels of the system, including the condition of aircrew and organizational factors. The purpose of the present study was to assess the utility of the HFACS framework as an error analysis and classification tool outside the military. The HFACS framework was used to analyze human error data associated with aircrew-related commercial aviation accidents that occurred between January 1990 and December 1996 using database records maintained by the NTSB and the FAA. Investigators were able to reliably accommodate all the human causal factors associated with the commercial aviation accidents examined in this study using the HFACS system. In addition, the classification of data using HFACS highlighted several critical safety issues in need of intervention research. These results demonstrate that the HFACS framework can be a viable tool for use within the civil aviation arena. However, additional research is needed to examine its applicability to areas outside the flight deck, such as aircraft maintenance and air traffic control domains.

Framework for a space shuttle main engine health monitoring system

NASA Technical Reports Server (NTRS)

Hawman, Michael W.; Galinaitis, William S.; Tulpule, Sharayu; Mattedi, Anita K.; Kamenetz, Jeffrey

1990-01-01

A framework developed for a health management system (HMS) which is directed at improving the safety of operation of the Space Shuttle Main Engine (SSME) is summarized. An emphasis was placed on near term technology through requirements to use existing SSME instrumentation and to demonstrate the HMS during SSME ground tests within five years. The HMS framework was developed through an analysis of SSME failure modes, fault detection algorithms, sensor technologies, and hardware architectures. A key feature of the HMS framework design is that a clear path from the ground test system to a flight HMS was maintained. Fault detection techniques based on time series, nonlinear regression, and clustering algorithms were developed and demonstrated on data from SSME ground test failures. The fault detection algorithms exhibited 100 percent detection of faults, had an extremely low false alarm rate, and were robust to sensor loss. These algorithms were incorporated into a hierarchical decision making strategy for overall assessment of SSME health. A preliminary design for a hardware architecture capable of supporting real time operation of the HMS functions was developed. Utilizing modular, commercial off-the-shelf components produced a reliable low cost design with the flexibility to incorporate advances in algorithm and sensor technology as they become available.

Defining the Role and Responsibility of the Fire Service Within Homeland Security

DTIC Science & Technology

2010-03-01

Occupational Safety and Health NPS Naval Postgraduate School NRF National Response Framework OSHA Occupational Safety and Health Administration ...Kingdom USAR Urban Search and Rescue USFA United States Fire Administration USMA United States Military Academy xiii ACKNOWLEDGMENTS I want...Association (NFPA), the Occupational Safety and Health Administration (OSHA), the United States Fire Administration (USFA), and the National Institute for

General Framework for Animal Food Safety Traceability Using GS1 and RFID

NASA Astrophysics Data System (ADS)

Cao, Weizhu; Zheng, Limin; Zhu, Hong; Wu, Ping

GS1 is global traceability standard, which is composed by the encoding system (EAN/UCC, EPC), the data carriers identified automatically (bar codes, RFID), electronic data interchange standards (EDI, XML). RFID is a non-contact, multi-objective automatic identification technique. Tracing of source food, standardization of RFID tags, sharing of dynamic data are problems to solve urgently for recent traceability systems. The paper designed general framework for animal food safety traceability using GS1 and RFID. This framework uses RFID tags encoding with EPCglobal tag data standards. Each information server has access tier, business tier and resource tier. These servers are heterogeneous and distributed, providing user access interfaces by SOAP or HTTP protocols. For sharing dynamic data, discovery service and object name service are used to locate dynamic distributed information servers.

Formulating accident occurrence as a survival process.

PubMed

Chang, H L; Jovanis, P P

1990-10-01

A conceptual framework for accident occurrence is developed based on the principle of the driver as an information processor. The framework underlies the development of a modeling approach that is consistent with the definition of exposure to risk as a repeated trial. Survival theory is proposed as a statistical technique that is consistent with the conceptual structure and allows the exploration of a wide range of factors that contribute to highway operating risk. This survival model of accident occurrence is developed at a disaggregate level, allowing safety researchers to broaden the scope of studies which may be limited by the use of traditional aggregate approaches. An application of the approach to motor carrier safety is discussed as are potential applications to a variety of transportation industries. Lastly, a typology of highway safety research methodologies is developed to compare the properties of four safety methodologies: laboratory experiments, on-the-road studies, multidisciplinary accident investigations, and correlational studies. The survival theory formulation has a mathematical structure that is compatible with each safety methodology, so it may facilitate the integration of findings across methodologies.

Multiscale modeling and characterization for performance and safety of lithium-ion batteries

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

Pannala, Sreekanth; Turner, John A.; Allu, Srikanth

Lithium-ion batteries are highly complex electrochemical systems whose performance and safety are governed by coupled nonlinear electrochemical-electrical-thermal-mechanical processes over a range of spatiotemporal scales. In this paper we describe a new, open source computational framework for Lithium-ion battery simulations that is designed to support a variety of model types and formulations. This framework has been used to create three-dimensional cell and battery pack models that explicitly simulate all the battery components (current collectors, electrodes, and separator). The models are used to predict battery performance under normal operations and to study thermal and mechanical safety aspects under adverse conditions. The modelmore » development and validation are supported by experimental methods such as IR-imaging, X-ray tomography and micro-Raman mapping.« less

Multiscale modeling and characterization for performance and safety of lithium-ion batteries

DOE PAGES

Pannala, Sreekanth; Turner, John A.; Allu, Srikanth; ...

2015-08-19

Lithium-ion batteries are highly complex electrochemical systems whose performance and safety are governed by coupled nonlinear electrochemical-electrical-thermal-mechanical processes over a range of spatiotemporal scales. In this paper we describe a new, open source computational framework for Lithium-ion battery simulations that is designed to support a variety of model types and formulations. This framework has been used to create three-dimensional cell and battery pack models that explicitly simulate all the battery components (current collectors, electrodes, and separator). The models are used to predict battery performance under normal operations and to study thermal and mechanical safety aspects under adverse conditions. The modelmore » development and validation are supported by experimental methods such as IR-imaging, X-ray tomography and micro-Raman mapping.« less

[Improvement of sanitary and epidemiological safety of rail transport--a requirement of the new legislation of the Russian Federation].

PubMed

2012-01-01

Brief analysis of the legal framework in recent years, both in the sphere of technical regulation, and in the field of sanitary and epidemiological welfare of the population is presented in this article. The necessity of inclusion in the technical regulations for the safety of railway rolling stock and elements of railway infrastructure the requirements for sanitary-epidemiological safety and hygiene regulations has been proved. Fragments of technical regulations for railway equipment and infrastructure elements, including the basic requirements for the sanitary-epidemiological security are presented. The position of authors in the processing of the regulatory framework in the field of sanitary-epidemiological welfare of population in standardization documents in accordance with the requirements of federal law "On technical regulation" has been reflected.

What stage are low-income and middle-income countries (LMICs) at with patient safety curriculum implementation and what are the barriers to implementation? A two-stage cross-sectional study.

PubMed

Ginsburg, Liane R; Dhingra-Kumar, Neelam; Donaldson, Liam J

2017-06-15

The improvement of safety in healthcare worldwide depends in part on the knowledge, skills and attitudes of staff providing care. Greater patient safety content in health professional education and training programmes has been advocated internationally. While WHO Patient Safety Curriculum Guides (for Medical Schools and Multi-Professional Curricula) have been widely disseminated in low-income and middle-income countries (LMICs) over the last several years, little is known about patient safety curriculum implementation beyond high-income countries. The present study examines patient safety curriculum implementation in LMICs. Two cross-sectional surveys were carried out. First, 88 technical officers in Ministries of Health and WHO country offices were surveyed to identify the pattern of patient safety curricula at country level. A second survey followed that gathered information from 71 people in a position to provide institution-level perspectives on patient safety curriculum implementation. The majority, 69% (30/44), of the countries were either considering whether to implement a patient safety curriculum or actively planning, rather than actually implementing, or embedding one. Most organisations recognised the need for patient safety education and training and felt a safety curriculum was compatible with the values of their organisation; however, important faculty-level barriers to patient safety curriculum implementation were identified. Key structural markers, such as dedicated financial resources and relevant assessment tools to evaluate trainees' patient safety knowledge and skills, were in place in fewer than half of organisations studied. Greater attention to patient safety curriculum implementation is needed. The barriers to patient safety curriculum implementation we identified in LMICs are not unique to these regions. We propose a framework to act as a global standard for patient safety curriculum implementation. Educating leaders through the system in order to embed patient safety culture in education and clinical settings is a critical first step. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinician perceptions of personal safety and confidence to manage inpatient aggression in a forensic psychiatric setting.

PubMed

Martin, T; Daffern, M

2006-02-01

Inpatient mental health clinicians need to feel safe in the workplace. They also require confidence in their ability to work with aggressive patients, allowing the provision of therapeutic care while protecting themselves and other patients from psychological and physical harm. The authors initiated this study with the predetermined belief that a comprehensive and integrated organizational approach to inpatient aggression was required to support clinicians and that this approach increased confidence and staff perceptions of personal safety. To assess perceptions of personal safety and confidence, clinicians in a forensic psychiatric hospital were surveyed using an adapted version of the Confidence in Coping With Patient Aggression Instrument. In this study clinicians reported the hospital as safe. They reported confidence in their work with aggressive patients. The factors that most impacted on clinicians' confidence to manage aggression were colleagues' knowledge, experience and skill, management of aggression training, use of prevention and intervention strategies, teamwork and the staff profile. These results are considered with reference to an expanding literature on inpatient aggression. It is concluded that organizational resources, policies and frameworks support clinician perceptions of safety and confidence to manage inpatient aggression. However, how these are valued by clinicians and translated into practice at unit level needs ongoing attention.

Using the Donabedian framework to examine the quality and safety of nursing service innovation.

PubMed

Gardner, Glenn; Gardner, Anne; O'Connell, Jane

2014-01-01

To evaluate the safety and quality of nurse practitioner service using the audit framework of Structure, Process and Outcome. Health service and workforce reform are on the agenda of governments and other service providers seeking to contain healthcare costs whilst providing safe and effective health care to communities. The nurse practitioner service is one health workforce innovation that has been adopted globally to improve timely access to clinical care, but there is scant literature reporting evaluation of the quality of this service innovation. A mixed-methods design within the Donabedian evaluation framework was used. The Donabedian framework was used to evaluate the Structure, Process and Outcome of nurse practitioner service. A range of data collection approaches was used, including stakeholder survey (n = 36), in-depth interviews (11 patients and 13 nurse practitioners) and health records data on service processes. The study identified that adequate and detailed preparation of Structure and Process is essential for the successful implementation of a service innovation. The multidisciplinary team was accepting of the addition of nurse practitioner service, and nurse practitioner clinical care was shown to be effective, satisfactory and safe from the perspective of the clinician stakeholders and patients. This study demonstrated that the Donabedian framework of Structure, Process and Outcome evaluation is a valuable and validated approach to examine the safety and quality of a service innovation. Furthermore, in this study, specific Structure elements were shown to influence the quality of service processes further validating the framework and the interdependence of the Structure, Process and Outcome components. Understanding the Structure and Process requirements for establishing nursing service innovation lays the foundation for safe, effective and patient-centred clinical care. © 2013 John Wiley & Sons Ltd.

Regulatory challenges to global harmonization and expanded access to concentrates: how will regulators balance the increasing cost of new safety requirements with the desire to increase the availability of affordable product?

PubMed

Farrugia, A

2004-10-01

The provision of concentrates of the deficient coagulation factors is an essential component of the provision of comprehensive haemophilia care. Their safety, quality and efficacy need to be assured independently of the measures dictated by the market and the individual manufacturers. Over the past 20 years, this assurance has become the role of regulatory authorities, which in the developed world have generated a framework that assesses haemophilia products as medicines in the highest category of risk relative to other therapeutic agents. Systems of official regulation mandating standards and other measures are now coupled with voluntary standards adopted by industry bodies as additional features of a comprehensive nexus of arrangements contributing to product quality and risk minimization. Currently, the regulation of products for haemophilia in less developed economies relies on reference to decisions in the first-world authorities. This may not always result in optimal outcomes as most of the haemophilia care in the developing world is through local plasma and cryoprecipitate, which are not subject to the oversight of mainstream regulators. Furthermore, the emergence of companies based outside the developed world and seeking to supply the emerging economies of the developing world with haemophilia concentrates has necessitated new strategies for regulation that are independent of the established frameworks. Overall, the principles used by mainstream agencies may be applied in all environments seeking to assure the quality of haemophilia care. Applied properly, they can contribute to maintaining the delivery of a form of therapy that is nowadays amongst the safest in therapeutic practice. A rigid interpretation can seriously impede access to treatment, and therefore the development of independent expertise and appropriate strategies in assuring product safety and quality in the developing world is essential if patient safety and access to products can be assured.

European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.

PubMed

Qu, Liping; Zou, Wenjun; Wang, YiTao; Wang, Mei

2018-03-15

The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs. A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected. The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States. The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing procedure in Europe could be of great benefit. Furthermore, this model is well worth learning from for other countries and regions outside the EU to help the establishment of legislation in countries with strong traditional use of herbal remedies and contribute to the safe use of traditional herbal medicine. Copyright © 2018 Elsevier GmbH. All rights reserved.

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

PubMed

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Fundamentally updating fundamentals.

PubMed

Armstrong, Gail; Barton, Amy

2013-01-01

Recent educational research indicates that the six competencies of the Quality and Safety Education for Nurses initiative are best introduced in early prelicensure clinical courses. Content specific to quality and safety has traditionally been covered in senior level courses. This article illustrates an effective approach to using quality and safety as an organizing framework for any prelicensure fundamentals of nursing course. Providing prelicensure students a strong foundation in quality and safety in an introductory clinical course facilitates early adoption of quality and safety competencies as core practice values. Copyright © 2013 Elsevier Inc. All rights reserved.

ITIL{sup ®} and information security

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

Jašek, Roman; Králík, Lukáš; Popelka, Miroslav

2015-03-10

This paper discusses the context of ITIL framework and management of information security. It is therefore a summary study, where the first part is focused on the safety objectives in connection with the ITIL framework. First of all, there is a focus on ITIL process ISM (Information Security Management), its principle and system management. The conclusion is about link between standards, which are related to security, and ITIL framework.

Demonstrating compliance with protection objectives for non-human biota within post-closure safety cases for radioactive waste repositories.

PubMed

Jackson, D; Smith, K; Wood, M D

2014-07-01

Over recent years, a number of approaches have been developed that enable the calculation of dose rates to animals and plants following the release of radioactivity to the environment. These approaches can be used to assess the potential impacts of activities that may release radioactivity to the environment, such as the operation of waste repositories. A number of national and international studies have identified screening criteria to indicate those assessment results below which further consideration is not generally required. However no internationally agreed criteria are currently available and consistency in criteria between countries has not been achieved. Furthermore, since screening criteria are not intended to be applied as limits, it is clear that they cannot always form a sufficient basis for assessing the adequacy of protection afforded. Typically, exceeding a screening value leads to a regulatory requirement to undertake a further, more detailed assessment. It does not, per se, imply that there is inadequate protection of the organism types at the specific site under assessment. Therefore, there is a need to develop a more structured approach to dealing with situations in which current screening criteria are exceeded. As a contribution to the developing international discussions, and as an interim measure for application where assessments are required currently, a two-tier, three zone framework is proposed here, relevant to the long term assessment of potential impacts from the deep disposal of radioactive wastes. The purpose of the proposed framework is to promote a proportionate and risk-based approach to the level of effort required in undertaking and interpreting an assessment. Copyright © 2013. Published by Elsevier Ltd.

Shared Information Framework and Technology (SHIFT) Handbook

DTIC Science & Technology

2009-02-01

field. Such a patchwork of separate systems neither improves information sharing nor guarantees the safety and security of communities and personnel in...analysis. In many organizations, security may not necessarily be the expertise of people working in the field, or security and safety issues may be...the safety and security of all crisis management personnel in crisis areas. Functioning information sharing between organisations improves situational

Development of an effective risk management system in a teaching hospital.

PubMed

Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

2012-09-21

Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

Epistemological Development in First-Year Nursing Students Undertaking Cultural Safety Education.

PubMed

Greenwood, Sallie; Fyers, Katrina

2018-04-01

The process of teaching cultural safety is emancipatory, focused on wider social relations and the context in which they arise. As teachers of cultural safety, we are interested in the way that ideas are formed, held, and changed. The aim of this research was to examine whether epistemological shifts were demonstrated by nursing students over one semester of cultural safety teaching-learning. NVivo software was used to analyze 34 nursing students' reflective journals, applying a cognitive-developmental framework. The framework comprised three epistemological positions-dualism, relativism, and propositional-and two in-between locations, referred to as stretching. The results showed student movement between early epistemological positions and students' efforts to stretch to new, yet untried, ways of thinking. In the classroom, these shifts may be subtle; thus, paying careful attention to evidence that students are trying out new ways of thinking is essential. Appreciating that these small but significant shifts are perhaps more important than 'aha' moments is crucial. [J Nurs Educ. 2018;57(4):229-232.]. Copyright 2018, SLACK Incorporated.

Toward a Safety Risk-Based Classification of Unmanned Aircraft

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2016-01-01

There is a trend of growing interest and demand for greater access of unmanned aircraft (UA) to the National Airspace System (NAS) as the ongoing development of UA technology has created the potential for significant economic benefits. However, the lack of a comprehensive and efficient UA regulatory framework has constrained the number and kinds of UA operations that can be performed. This report presents initial results of a study aimed at defining a safety-risk-based UA classification as a plausible basis for a regulatory framework for UA operating in the NAS. Much of the study up to this point has been at a conceptual high level. The report includes a survey of contextual topics, analysis of safety risk considerations, and initial recommendations for a risk-based approach to safe UA operations in the NAS. The next phase of the study will develop and leverage deeper clarity and insight into practical engineering and regulatory considerations for ensuring that UA operations have an acceptable level of safety.

Laser safety programs in general surgery.

PubMed

Lanzafame, R J

1994-06-01

General surgery represents a speciality where, while any procedure can be performed with lasers, there are no procedures for which the laser is the sine quo non. The general surgeon may perform a variety of procedures with a multitude of laser wavelengths and technologies. Laser safety in general surgery requires a multidisciplinary approach. Effective laser safety requires the oversight of the hospital's "laser usage committee" and "laser safety officer" while providing a workable framework for daily laser use in a variety of clinical scenarios simultaneously. This framework must be user-friendly rather than oppressive. This presentation will describe laser safety at the Rochester General Hospital, a tertiary care, community-based teaching hospital. The safety program incorporates the following components: input to physician credentialing and training, education and in-servicing of nursing and technical personnel, equipment purchase and maintenance, quality assurance, and safety monitoring. The University of Rochester general surgery residency training program mandates laser training during the PGY-2 year. This program stresses the safe use of lasers and provides the basis for graded hands-on experience during the surgical residency. The greatest challenge for laser safety in general surgery centers on the burgeoning field of minimally invasive surgery. Safety assurance must be balanced so as to maintain a safe operating-room environment while ensuring patient safety and the ability to permit the surgery to proceed efficiently. Safety measures for laparoscopic procedures must be sensitive to the needs of the surgical team while not providing confusing signals for the "gallery" observers. This task is critical for the safe operation of lasers in general surgery. Effective laser safety in general surgery requires constant vigilance tempered with sensitivity to the needs of the surgeon and the patient as laser technology and its applications continue to evolve.

The Geohazard Safety Classification: how resilience could play a role in the geo-hydrological hazards assessment of school buildings.

NASA Astrophysics Data System (ADS)

Pazzi, Veronica; Morelli, Stefano; Casagli, Nicola

2016-04-01

The impacts of adverse events related to geological hazards are unevenly distributed among communities and groups of individuals concentrated in restricted workplaces. Their consequent safety level is the result of differential exposures to these events and of diversified levels of preparation to them. Nowadays, the exposure and coping ability as co-determinants of people's safety are of particular interest for institutions managing the schools systems. According to the disaster risk reduction experts, the geo-hydrological processes can be mitigated with knowledge and planning, physical and environmental protection measures, and response preparedness. UNISDR is promoting a global culture of safety and resilience through the integration of disaster risk reduction in school curricula. The Comprehensive School Safety (CSS) framework is intended to advance the goals of the Worldwide Initiative for Safe Schools and the Global Alliance for Disaster Risk Reduction and Resilience in the Education Sector, and to promote school safety as a priority area of post-2015 frameworks for sustainable development, risk reduction and resilience. In Italy, according the latest ministerial survey (June 2010), there are 41,902 school buildings. Their alarming condition in terms of safety for their daily occupants is reflected by 39 fatalities ascribable to structural failures in the last 21 years. In 95% of these cases victims are a sad tribute due to natural phenomena. A rigorous evaluation of the total risk of a school building, as defined by the well known risk equation (R=HxVxE), would require a complete probability density function describing the exposure to specific types of events of all the pupils and personnel in the school. In addition, the probability that the inhabitants are present in the school during an event should be estimated depending on the time of day, day of week, or month of the year, as well as on local holiday schedules. The inclusion of resilience as a component of risk allows us to refine the risk awareness, focusing attention on the cultural and social meaning of risk as a shared practice among communities that are potentially at risk. This project developed a method for assessing school hazard exposure (landslide, seismic, flood) and structural fragility/safe learning facilities (seismic response, dampness, plan configuration) which is non-invasive, fairly quick and objective. This tool, which is based on the GSC (Geohazard Safety Classification) definition, was tested in central Italy and optimized for a very wide variety of situations, so that it may be exported in schools (or in similar working places) of other geographical areas. The GSC was obtained as the complementary to one of the Index of Geohazard Impact (IGI), calculated modifying the equation of the specific risk, taking into account also the resilience as a damper, amplifier or invariant of the specific risk itself (IGI=max(HixVi)/rho). The variables of this new equation (hazard, vulnerability and resilience) can be quantified on the basis of ancillary data (thematic maps), results of the data processing of field surveys (seismic noise measure according to the H/V technique, thermographic images, GPS surveys) and the answers to an online questionnaire implemented on purpose.

Regulatory control of Chinese Proprietary Medicines in Singapore.

PubMed

Yee, Shen-Kuan; Chu, Swee-Seng; Xu, Yi-Min; Choo, Peck-Lin

2005-02-01

In Singapore, there has been a growing public interest in traditional Chinese medicine (TCM), which plays an important role in the healthcare system. With effect from 1 September 1999, the control on Chinese Proprietary Medicines (CPM) was implemented in three phases over a span of 3 years. Under the CPM regulatory framework, CPM importers, wholesalers, manufacturers and re-packers must be licensed and CPM products assessed and listed by the health authority before they are allowed for sale. Product assessment is based on the criteria of safety and quality which include limits of toxic heavy metals and microbial contents. During the 3-year CPM listing exercise, irregularities were detected, including intrinsic toxicity, adulteration, substitution, contamination, misidentification, non-traditional and/or inappropriate usage, incorrect preparation, inappropriate labelling, exaggerated claims and/or advertising. The full implementation of CPM control by September 2001 saw the listing of 7943 CPM products and brought about an improvement in the quality and safety of CPM in Singapore as well as the removal of sub-standard, fake/imitation and adulterated products. The standards of practices by local CPM dealers have also been raised. These improvements have, in turn, increased the level of public confidence in CPM products in Singapore.

[Procedure for the marketing authorization of an antibacterial agent].

PubMed

López Navas, Antonio; García-Escribano Ráez, Nuria; Flores Juberías, Ángela; Suárez Gea, María Luisa

2014-10-01

The marketing authorization of a new medicinal product is the first step before being placed on the market, and includes the full investigation programme. In order to ensure their quality, safety and efficacy, medicinal products are closely regulated from their initial phases of investigation to their use in clinical practice. For registration purposes, the results of all the clinical and preclinical studies, along with quality data and the description of the manufacturing process should be submitted. All information collected is presented for review by the competent authority. The European Medicines Agency regulates the registration of medicines in Europe, and national agencies in each EU member state are responsible for the assessment of the marketing authorisation application. To facilitate the development of clinical programmes, there is a common framework for the evaluation of an antibacterial, which includes guidelines and an addendum, detailing the specific requirements that must be carried out in clinical trials to assess the efficacy and safety for most of the infections. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Expert Intraoperative Judgment and Decision-Making: Defining the Cognitive Competencies for Safe Laparoscopic Cholecystectomy.

PubMed

Madani, Amin; Watanabe, Yusuke; Feldman, Liane S; Vassiliou, Melina C; Barkun, Jeffrey S; Fried, Gerald M; Aggarwal, Rajesh

2015-11-01

Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. This qualitative study aimed to define and characterize higher-order cognitive competencies required to safely perform a laparoscopic cholecystectomy. Hierarchical and cognitive task analyses for establishing a critical view of safety during laparoscopic cholecystectomy were performed using qualitative methods to map the thoughts and practices that characterize expert performance. Experts with more than 5 years of experience, and who have performed at least 100 laparoscopic cholecystectomies, participated in semi-structured interviews and field observations. Verbal data were transcribed verbatim, supplemented with content from published literature, coded, thematically analyzed using grounded-theory by 2 independent reviewers, and synthesized into a list of items. A conceptual framework was created based on 10 interviews with experts, 9 procedures, and 18 literary sources. Experts included 6 minimally invasive surgeons, 2 hepato-pancreatico-biliary surgeons, and 2 acute care general surgeons (median years in practice, 11 [range 8 to 14]). One hundred eight cognitive elements (35 [32%] related to situation awareness, 47 [44%] involving decision-making, and 26 [24%] action-oriented subtasks) and 75 potential errors were identified and categorized into 6 general themes and 14 procedural tasks. Of the 75 potential errors, root causes were mapped to errors in situation awareness (24 [32%]), decision-making (49 [65%]), or either one (61 [81%]). This study defines the competencies that are essential to establishing a critical view of safety and avoiding bile duct injuries during laparoscopic cholecystectomy. This framework may serve as the basis for instructional design, assessment tools, and quality-control metrics to prevent injuries and promote a culture of patient safety. Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Corrective Action Plan in response to the March 1992 Tiger Team Assessment of the Ames Laboratory

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

Not Available

1992-11-20

On March 5, 1992, a Department of Energy (DOE) Tiger Team completed an assessment of the Ames Laboratory, located in Ames, Iowa. The purpose of the assessment was to provide the Secretary of Energy with a report on the status and performance of Environment, Safety and Health (ES H) programs at Ames Laboratory. Detailed findings of the assessment are presented in the report, DOE/EH-0237, Tiger Team Assessment of the Ames Laboratory. This document, the Ames Laboratory Corrective Action Plan (ALCAP), presents corrective actions to overcome deficiencies cited in the Tiger Team Assessment. The Tiger Team identified 53 Environmental findings, frommore » which the Team derived four key findings. In the Safety and Health (S H) area, 126 concerns were identified, eight of which were designated Category 11 (there were no Category I concerns). Seven key concerns were derived from the 126 concerns. The Management Subteam developed 19 findings which have been summarized in four key findings. The eight S H Category 11 concerns identified in the Tiger Team Assessment were given prompt management attention. Actions to address these deficiencies have been described in individual corrective action plans, which were submitted to DOE Headquarters on March 20, 1992. The ALCAP includes actions described in this early response, as well as a long term strategy and framework for correcting all remaining deficiencies. Accordingly, the ALCAP presents the organizational structure, management systems, and specific responses that are being developed to implement corrective actions and to resolve root causes identified in the Tiger Team Assessment. The Chicago Field Office (CH), IowaState University (ISU), the Institute for Physical Research and Technology (IPRT), and Ames Laboratory prepared the ALCAP with input from the DOE Headquarters, Office of Energy Research (ER).« less

Corrective Action Plan in response to the March 1992 Tiger Team Assessment of the Ames Laboratory

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

Not Available

1992-11-20

On March 5, 1992, a Department of Energy (DOE) Tiger Team completed an assessment of the Ames Laboratory, located in Ames, Iowa. The purpose of the assessment was to provide the Secretary of Energy with a report on the status and performance of Environment, Safety and Health (ES&H) programs at Ames Laboratory. Detailed findings of the assessment are presented in the report, DOE/EH-0237, Tiger Team Assessment of the Ames Laboratory. This document, the Ames Laboratory Corrective Action Plan (ALCAP), presents corrective actions to overcome deficiencies cited in the Tiger Team Assessment. The Tiger Team identified 53 Environmental findings, from whichmore » the Team derived four key findings. In the Safety and Health (S&H) area, 126 concerns were identified, eight of which were designated Category 11 (there were no Category I concerns). Seven key concerns were derived from the 126 concerns. The Management Subteam developed 19 findings which have been summarized in four key findings. The eight S&H Category 11 concerns identified in the Tiger Team Assessment were given prompt management attention. Actions to address these deficiencies have been described in individual corrective action plans, which were submitted to DOE Headquarters on March 20, 1992. The ALCAP includes actions described in this early response, as well as a long term strategy and framework for correcting all remaining deficiencies. Accordingly, the ALCAP presents the organizational structure, management systems, and specific responses that are being developed to implement corrective actions and to resolve root causes identified in the Tiger Team Assessment. The Chicago Field Office (CH), IowaState University (ISU), the Institute for Physical Research and Technology (IPRT), and Ames Laboratory prepared the ALCAP with input from the DOE Headquarters, Office of Energy Research (ER).« less

Just Culture: A Foundation for Balanced Accountability and Patient Safety

PubMed Central

Boysen, Philip G.

2013-01-01

Background The framework of a just culture ensures balanced accountability for both individuals and the organization responsible for designing and improving systems in the workplace. Engineering principles and human factors analysis influence the design of these systems so they are safe and reliable. Methods Approaches for improving patient safety introduced here are (1) analysis of error, (2) specific tools to enhance safety, and (3) outcome engineering. Conclusion The just culture is a learning culture that is constantly improving and oriented toward patient safety. PMID:24052772

MRI-guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations.

PubMed

Larson, Paul S; Willie, Jon T; Vadivelu, Sudhakar; Azmi-Ghadimi, Hooman; Nichols, Amy; Fauerbach, Loretta Litz; Johnson, Helen Boehm; Graham, Denise

2017-07-01

The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI. There are currently no safe practice guidelines or parameters available for facilities looking to integrate this technology into practice in conventional MRI suites. Performing neurosurgical procedures in a diagnostic MRI suite does require precautionary measures. The relative novelty of technology and workflows for direct MRI-guided procedures requires consideration of safe practice recommendations, including those pertaining to infection control and magnet safety issues. This article proposes a framework of safe practice recommendations designed for assessing readiness and optimization of MRI-guided neurosurgical interventions in the diagnostic MRI suite in an effort to mitigate patient risk. The framework is based on existing clinical evidence, recommendations, and guidelines related to infection control and prevention, health care-associated infections, and magnet safety, as well as the clinical and practical experience of neurosurgeons utilizing this technology. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

Symbolic Interactionism: A Framework for Understanding Risk-Taking Behaviors in Farm Communities.

PubMed

Sorensen, Julie A; Tinc, Pamela J; Weil, Rebecca; Droullard, David

2017-01-01

Risk behaviors are key drivers of occupationally related injuries and illnesses, considerably impacting the uptake and success of injury interventions, technologies, and practices. This is certainly true in the agricultural sector, where farmers often ignore recommended safety practices or have even been known to disable safety technologies. Although research studies have characterized specific individual safety or risk behaviors, few studies have thoroughly examined farmers' risk and safety orientations or how these develop in response to environmental and societal exposures. This study utilizes data collected over the past decade with a variety of small to midsize farm personnel to explore the meanings that farmers ascribe to risk and safety and how these influence risk and safety behaviors. In all, over 90 interviews with farmers, farm-wives, and family members were reviewed. Researchers used a grounded theory approach to identify patterns of environmental and societal exposures, as well as their impact on farmers' risk and safety orientations. Analysis revealed exposures and orientations to risk and safety, which could be largely explained through the lens of symbolic interactionism. This framework posits that people create a sense-of-self as a way of adjusting and adapting to their environment. For farmers in this study, belief in their ability to persevere allows them to succeed, despite the considerable stressors and challenges they face each day. However, this identity can, at times, be maladaptive when it is applied to safety decisions and hazard exposures. The authors discuss the implications of this research and how it may be used to productively inform future farm safety efforts.

Coupled dam safety analysis using WinDAM

USDA-ARS?s Scientific Manuscript database

Windows® Dam Analysis Modules (WinDAM) is a set of modular software components that can be used to analyze overtopping and internal erosion of embankment dams. Dakota is an extensive software framework for design exploration and simulation. These tools can be coupled to create a powerful framework...

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

PubMed Central

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research. PMID:28715491

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

PubMed

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

Is an ecosystem services-based approach developed for setting specific protection goals for plant protection products applicable to other chemicals?

PubMed

Maltby, Lorraine; Jackson, Mathew; Whale, Graham; Brown, A Ross; Hamer, Mick; Solga, Andreas; Kabouw, Patrick; Woods, Richard; Marshall, Stuart

2017-02-15

Clearly defined protection goals specifying what to protect, where and when, are required for designing scientifically sound risk assessments and effective risk management of chemicals. Environmental protection goals specified in EU legislation are defined in general terms, resulting in uncertainty in how to achieve them. In 2010, the European Food Safety Authority (EFSA) published a framework to identify more specific protection goals based on ecosystem services potentially affected by plant protection products. But how applicable is this framework to chemicals with different emission scenarios and receptor ecosystems? Four case studies used to address this question were: (i) oil refinery waste water exposure in estuarine environments; (ii) oil dispersant exposure in aquatic environments; (iii) down the drain chemicals exposure in a wide range of ecosystems (terrestrial and aquatic); (iv) persistent organic pollutant exposure in remote (pristine) Arctic environments. A four-step process was followed to identify ecosystems and services potentially impacted by chemical emissions and to define specific protection goals. Case studies demonstrated that, in principle, the ecosystem services concept and the EFSA framework can be applied to derive specific protection goals for a broad range of chemical exposure scenarios. By identifying key habitats and ecosystem services of concern, the approach offers the potential for greater spatial and temporal resolution, together with increased environmental relevance, in chemical risk assessments. With modifications including improved clarity on terminology/definitions and further development/refinement of the key concepts, we believe the principles of the EFSA framework could provide a methodical approach to the identification and prioritization of ecosystems, ecosystem services and the service providing units that are most at risk from chemical exposure. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Assessment of the Draft AIAA S-119 Flight Dynamic Model Exchange Standard

NASA Technical Reports Server (NTRS)

Jackson, E. Bruce; Murri, Daniel G.; Hill, Melissa A.; Jessick, Matthew V.; Penn, John M.; Hasan, David A.; Crues, Edwin Z.; Falck, Robert D.; McCarthy, Thomas G.; Vuong, Nghia;

Use of limited data to construct Bayesian networks for probabilistic risk assessment.

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

Groth, Katrina M.; Swiler, Laura Painton

2013-03-01

Probabilistic Risk Assessment (PRA) is a fundamental part of safety/quality assurance for nuclear power and nuclear weapons. Traditional PRA very effectively models complex hardware system risks using binary probabilistic models. However, traditional PRA models are not flexible enough to accommodate non-binary soft-causal factors, such as digital instrumentation&control, passive components, aging, common cause failure, and human errors. Bayesian Networks offer the opportunity to incorporate these risks into the PRA framework. This report describes the results of an early career LDRD project titled %E2%80%9CUse of Limited Data to Construct Bayesian Networks for Probabilistic Risk Assessment%E2%80%9D. The goal of the work was tomore » establish the capability to develop Bayesian Networks from sparse data, and to demonstrate this capability by producing a data-informed Bayesian Network for use in Human Reliability Analysis (HRA) as part of nuclear power plant Probabilistic Risk Assessment (PRA). This report summarizes the research goal and major products of the research.« less

Evidence-Based and Value-Based Decision Making About Healthcare Design: An Economic Evaluation of the Safety and Quality Outcomes.

PubMed

Zadeh, Rana; Sadatsafavi, Hessam; Xue, Ryan

2015-01-01

This study describes a vision and framework that can facilitate the implementation of evidence-based design (EBD), scientific knowledge base into the process of the design, construction, and operation of healthcare facilities and clarify the related safety and quality outcomes for the stakeholders. The proposed framework pairs EBD with value-driven decision making and aims to improve communication among stakeholders by providing a common analytical language. Recent EBD research indicates that the design and operation of healthcare facilities contribute to an organization's operational success by improving safety, quality, and efficiency. However, because little information is available about the financial returns of evidence-based investments, such investments are readily eliminated during the capital-investment decision-making process. To model the proposed framework, we used engineering economy tools to evaluate the return on investments in six successful cases, identified by a literature review, in which facility design and operation interventions resulted in reductions in hospital-acquired infections, patient falls, staff injuries, and patient anxiety. In the evidence-based cases, calculated net present values, internal rates of return, and payback periods indicated that the long-term benefits of interventions substantially outweighed the intervention costs. This article explained a framework to develop a research-based and value-based communication language on specific interventions along the planning, design and construction, operation, and evaluation stages. Evidence-based and value-based design frameworks can be applied to communicate the life-cycle costs and savings of EBD interventions to stakeholders, thereby contributing to more informed decision makings and the optimization of healthcare infrastructures. © The Author(s) 2015.

Industry Leader Perceptions of Workplace Safety

ERIC Educational Resources Information Center

Dunlap, Erik Scott

2009-01-01

This study investigated the perceptions of workplace safety held by industry leaders who were near completion of a Master of Business Administration (MBA) degree. This was a qualitative study that utilized interpretivism as the theoretical framework. The study sought to answer four research questions. (1) How do participants conceptualize…

Safety and Science Teaching.

ERIC Educational Resources Information Center

Virginia State Dept. of Education, Richmond. Div. of Sciences and Elementary Administration.

This 10-chapter handbook (designed for science teachers and school administrators) describes known hazards associated with science teaching and provides information to develop a framework for local safety programs specifically designed to avoid or neutralize the effects of such hazards. Major areas addressed in the chapters include: (1) the nature…

Deriving a Framework for a Systems Approach to Agitated Patient Care in the Emergency Department.

PubMed

Wong, Ambrose H; Ruppel, Halley; Crispino, Lauren J; Rosenberg, Alana; Iennaco, Joanne D; Vaca, Federico E

2018-05-01

The rising agitated patient population presenting to the emergency department (ED) has caused increasing safety threats for health care workers and patients. Development of evidence-based strategies has been limited by the lack of a structured framework to examine agitated patient care in the ED. In this study, a systems approach from the patient safety literature was used to derive a comprehensive theoretical framework for addressing ED patient agitation. A mixed-methods approach was used with ED staff members at an academic site and a community site of a regional health care network. Participants consisted of resident and attending physicians, physician assistants/nurse practitioners, nurses, technicians, and security officers. After a simulated agitated patient encounter to prime participants, uniprofessional and interprofessional focus groups were conducted, followed by a structured thematic analysis using a grounded theory approach. Quantitative data consisted of surveys of violence exposure and attitudes toward patient aggression and management. Data saturation was reached with 57 participants. Violence exposure was higher for technicians, nurses, and officers. Conflicting priorities and management challenges occurred due to four main interconnected elements: perceived complex patient motivations; a patient care paradox between professional duty and personal safety; discordant interprofessional dynamics mitigated by respect and trust; and logistical challenges impeding care delivery and long-term outcomes. Using a systems approach, five interconnected levels of ED agitated patient care delivery were identified: patient, staff, team, ED microsystem, and health care macrosystem. These care dimensions were synthesized to form a novel patient safety-based framework that can help guide future research, practice, and policy. Copyright © 2018 The Joint Commission. Published by Elsevier Inc. All rights reserved.