Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

PubMed

Hoffmann, B; Müller, V; Rochon, J; Gondan, M; Müller, B; Albay, Z; Weppler, K; Leifermann, M; Mießner, C; Güthlin, C; Parker, D; Hofinger, G; Gerlach, F M

2014-01-01

The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. German Clinical Trials Register (Deutsches Register

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.

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

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

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

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Ex-ante assessment of the safety effects of intelligent transport systems.

PubMed

Kulmala, Risto

2010-07-01

There is a need to develop a comprehensive framework for the safety assessment of Intelligent Transport Systems (ITS). This framework should: (1) cover all three dimensions of road safety-exposure, crash risk and consequence, (2) cover, in addition to the engineering effect, also the effects due to behavioural adaptation and (3) be compatible with the other aspects of state of the art road safety theories. A framework based on nine ITS safety mechanisms is proposed and discussed with regard to the requirements set to the framework. In order to illustrate the application of the framework in practice, the paper presents a method based on the framework and the results from applying that method for twelve intelligent vehicle systems in Europe. The framework is also compared to two recent frameworks applied in the safety assessment of intelligent vehicle safety systems. Copyright 2010 Elsevier Ltd. All rights reserved.

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

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.

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

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

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

Risk-based Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

1992-01-01

Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

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

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

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

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

Safety Auditing and Assessments

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Safety Auditing and Assessments

NASA Astrophysics Data System (ADS)

Goodin, Ronnie

2005-12-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

Safety assessment of Cracked K-joint Structure Based on Fracture Mechanics

NASA Astrophysics Data System (ADS)

Wang, Xin; Pengyu, Yan; Jianwei, Du; Fuhai, Cai

2017-05-01

The K-joint is the main bearing structure of lattice jib crane. During frequent operation of the crane, surface cracks often occur at its weld toe, and then continue to expand until failure. The safety of the weak structure K-joint of the crane jib can be evaluated by BS7910 failure assessment standard in order to improve its utilization. The finite element model of K-joint structure with cracks is established, and its mechanical properties is analyzed by ABAQUS software, the results show that the crack depth has a great influence on the bearing capacity of the structure compared with the crack length. It is assumed that the K-joint with the semi-elliptical surface crack under the action of the tension propagate stably under the condition that the c/a (ratio of short axis to long axis of ellipse) is about 0.3. The safety assessment of K-joint with different lengths crack is presented according to the 2A failure assessment diagram of BS7910, and the critical crack of K-joint under different loads can be obtained.

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

PubMed

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (<72% correct), 6 were about intervention strength, 3 about categorizing error, 1 about workplace culture, and 1 about prioritization of interventions. Of the 13 questions about intervention strength, 6 (46%) were in the lowest quartile, suggesting that this may be a difficult topic for laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Assessment of Electrical Safety in Afghanistan

DTIC Science & Technology

2009-07-24

effectiveness of command efforts to ensure the electrical safety of Department of Defense occupied and constructed facilities in Afghanistan. We...March 31, 2009, we announced the Assessment of Electrical Safety in Afghanistan. The objective of this assessment was to review the effectiveness of...used contractors to review and identify electrical deficiencies to include life, health , and safety issues at FOBs. According to TF POWER

Safety assessment of genetically modified plants with deliberately altered composition

PubMed Central

Halford, Nigel G; Hudson, Elizabeth; Gimson, Amy; Weightman, Richard; Shewry, Peter R; Tompkins, Steven

2014-01-01

The development and marketing of ‘novel’ genetically modified (GM) crops in which composition has been deliberately altered poses a challenge to the European Union (EU)'s risk assessment processes, which are based on the concept of substantial equivalence with a non-GM comparator. This article gives some examples of these novel GM crops and summarizes the conclusions of a report that was commissioned by the European Food Safety Authority on how the EU's risk assessment processes could be adapted to enable their safety to be assessed. PMID:24735114

Fault displacement hazard assessment for nuclear installations based on IAEA safety standards

NASA Astrophysics Data System (ADS)

Fukushima, Y.

2016-12-01

In the IAEA Safety NS-R-3, surface fault displacement hazard assessment (FDHA) is required for the siting of nuclear installations. If any capable faults exist in the candidate site, IAEA recommends the consideration of alternative sites. However, due to the progress in palaeoseismological investigations, capable faults may be found in existing site. In such a case, IAEA recommends to evaluate the safety using probabilistic FDHA (PFDHA), which is an empirical approach based on still quite limited database. Therefore a basic and crucial improvement is to increase the database. In 2015, IAEA produced a TecDoc-1767 on Palaeoseismology as a reference for the identification of capable faults. Another IAEA Safety Report 85 on ground motion simulation based on fault rupture modelling provides an annex introducing recent PFDHAs and fault displacement simulation methodologies. The IAEA expanded the project of FDHA for the probabilistic approach and the physics based fault rupture modelling. The first approach needs a refinement of the empirical methods by building a world wide database, and the second approach needs to shift from kinematic to the dynamic scheme. Both approaches can complement each other, since simulated displacement can fill the gap of a sparse database and geological observations can be useful to calibrate the simulations. The IAEA already supported a workshop in October 2015 to discuss the existing databases with the aim of creating a common worldwide database. A consensus of a unified database was reached. The next milestone is to fill the database with as many fault rupture data sets as possible. Another IAEA work group had a WS in November 2015 to discuss the state-of-the-art PFDHA as well as simulation methodologies. Two groups jointed a consultancy meeting in February 2016, shared information, identified issues, discussed goals and outputs, and scheduled future meetings. Now we may aim at coordinating activities for the whole FDHA tasks jointly.

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.

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.

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 Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Safety Assessment of Dangerous Goods Transport Enterprise Based on the Relative Entropy Aggregation in Group Decision Making Model

PubMed Central

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises. PMID:25477954

Safety assessment of dangerous goods transport enterprise based on the relative entropy aggregation in group decision making model.

PubMed

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises.

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making

PubMed Central

Amcoff, Patric; Benigni, Romualdo; Blackburn, Karen; Carney, Edward; Cronin, Mark; Deluyker, Hubert; Gautier, Francoise; Judson, Richard S.; Kass, Georges E.N.; Keller, Detlef; Knight, Derek; Lilienblum, Werner; Mahony, Catherine; Rusyn, Ivan; Schultz, Terry; Schwarz, Michael; Schüürmann, Gerrit; White, Andrew; Burton, Julien; Lostia, Alfonso M.; Munn, Sharon; Worth, Andrew

2015-01-01

Background Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. Objectives The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data—for example, information from in vitro molecular screening, “-omics” assays and computational models—to reach regulatory acceptance. Methods We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. Conclusions We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. Citation Berggren E, Amcoff P, Benigni R, Blackburn K, Carney E, Cronin M, Deluyker H, Gautier F, Judson RS, Kass GE, Keller D, Knight D, Lilienblum W, Mahony C, Rusyn I, Schultz T, Schwarz M, Schüürmann G, White A, Burton J, Lostia AM, Munn S, Worth A. 2015. Chemical safety assessment using read-across: assessing the use of novel testing methods to strengthen the evidence base for decision making. Environ Health Perspect 123:1232�

Using driving simulators to assess driving safety.

PubMed

Boyle, Linda Ng; Lee, John D

2010-05-01

Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

Pushing and pulling: an assessment tool for occupational health and safety practitioners.

PubMed

Lind, Carl Mikael

2018-03-01

A tool has been developed for supporting practitioners when assessing manual pushing and pulling operations based on an initiative by two global companies in the manufacturing industry. The aim of the tool is to support occupational health and safety practitioners in risk assessment and risk management of pushing and pulling operations in the manufacturing and logistics industries. The tool is based on a nine-multiplier equation that includes a wide range of factors affecting an operator's health risk and capacity in pushing and pulling. These multipliers are based on psychophysical, physiological and biomechanical studies in combination with judgments from an expert group consisting of senior researchers and ergonomists. In order to consider usability, more than 50 occupational health and safety practitioners (e.g., ergonomists, managers, safety representatives and production personnel) participated in the development of the tool. An evaluation by 22 ergonomists supports that the push/pull tool is user friendly in general.

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

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

Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

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.

Assessment of the safety of foods derived from genetically modified (GM) crops.

PubMed

König, A; Cockburn, A; Crevel, R W R; Debruyne, E; Grafstroem, R; Hammerling, U; Kimber, I; Knudsen, I; Kuiper, H A; Peijnenburg, A A C M; Penninks, A H; Poulsen, M; Schauzu, M; Wal, J M

2004-07-01

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative. Copryright 2004 Elsevier Ltd.

[Safety monitoring of cell-based medicinal products (CBMPs)].

PubMed

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

Recommendations of the Oligonucleotide Safety Working Group's Formulated Oligonucleotide Subcommittee for the Safety Assessment of Formulated Oligonucleotide-Based Therapeutics.

PubMed

Marlowe, Jennifer L; Akopian, Violetta; Karmali, Priya; Kornbrust, Douglas; Lockridge, Jennifer; Semple, Sean

2017-08-01

The use of lipid formulations has greatly improved the ability to effectively deliver oligonucleotides and has been instrumental in the rapid expansion of therapeutic development programs using oligonucleotide drugs. However, the development of such complex multicomponent therapeutics requires the implementation of unique, scientifically sound approaches to the nonclinical development of these drugs, based upon a hybrid of knowledge and experiences drawn from small molecule, protein, and oligonucleotide therapeutic drug development. The relative paucity of directly applicable regulatory guidance documents for oligonucleotide therapeutics in general has resulted in the generation of multiple white papers from oligonucleotide drug development experts and members of the Oligonucleotide Safety Working Group (OSWG). The members of the Formulated Oligonucleotide Subcommittee of the OSWG have utilized their collective experience working with a variety of formulations and their associated oligonucleotide payloads, as well as their insights into regulatory considerations and expectations, to generate a series of consensus recommendations for the pharmacokinetic characterization and nonclinical safety assessment of this unique class of therapeutics. It should be noted that the focus of Subcommittee discussions was on lipid nanoparticle and other types of particulate formulations of therapeutic oligonucleotides and not on conjugates or other types of modifications of oligonucleotide structure intended to facilitate delivery.

Integrate genome-based assessment of safety for probiotic strains: Bacillus coagulans GBI-30, 6086 as a case study.

PubMed

Salvetti, Elisa; Orrù, Luigi; Capozzi, Vittorio; Martina, Alessia; Lamontanara, Antonella; Keller, David; Cash, Howard; Felis, Giovanna E; Cattivelli, Luigi; Torriani, Sandra; Spano, Giuseppe

2016-05-01

Probiotics are microorganisms that confer beneficial effects on the host; nevertheless, before being allowed for human consumption, their safety must be verified with accurate protocols. In the genomic era, such procedures should take into account the genomic-based approaches. This study aims at assessing the safety traits of Bacillus coagulans GBI-30, 6086 integrating the most updated genomics-based procedures and conventional phenotypic assays. Special attention was paid to putative virulence factors (VF), antibiotic resistance (AR) genes and genes encoding enzymes responsible for harmful metabolites (i.e. biogenic amines, BAs). This probiotic strain was phenotypically resistant to streptomycin and kanamycin, although the genome analysis suggested that the AR-related genes were not easily transferrable to other bacteria, and no other genes with potential safety risks, such as those related to VF or BA production, were retrieved. Furthermore, no unstable elements that could potentially lead to genomic rearrangements were detected. Moreover, a workflow is proposed to allow the proper taxonomic identification of a microbial strain and the accurate evaluation of risk-related gene traits, combining whole genome sequencing analysis with updated bioinformatics tools and standard phenotypic assays. The workflow presented can be generalized as a guideline for the safety investigation of novel probiotic strains to help stakeholders (from scientists to manufacturers and consumers) to meet regulatory requirements and avoid misleading information.

Safety Assessment of Polyether Lanolins as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan; Heldreth, Bart

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

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

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

PubMed

Haslberger, Alexander G

2006-05-03

Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

PubMed Central

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

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

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.

Safety assessment in primary Mycobacterium tuberculosis smear microscopy centres in Blantyre Malawi: a facility based cross sectional survey.

PubMed

Majamanda, J; Ndhlovu, P; Shawa, I T

2013-12-01

Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is transmitted mainly through aerosolization of infected sputum which puts laboratory workers at risk in spite of the laboratory workers' risk of infection being at 3 to 9 times higher than the general public. Laboratory safety should therefore be prioritized and optimized to provide sufficient safety to laboratory workers. To assess the safety for the laboratory workers in TB primary microscopy centres in Blantyre urban. TB primary microscopy centers in Blantyre urban were assessed in aspects of equipment availability, facility layout, and work practice, using a standardized WHO/AFRO ISO 15189 checklist for the developing countries which sets the minimum safety score at ≥80%. Each center was graded according to the score it earned upon assessment. Only one (1) microscopy center out nine (9) reached the minimum safety requirement. Four (4) centers were awarded 1 star level, four (4) centers were awarded 2 star level and only one (1) center was awarded 3 star level. In Blantyre urban, 89% of the Tuberculosis microscopy centers are failing to provide the minimum safety to the laboratory workers. Government and other stake holders should be committed in addressing the safety challenges of TB microscopy centres in the country to ensure safety for the laboratory workers. It is recommended that the study be conducted at the regional or national level for both public and private laboratories in order to have a general picture of safety in Tb microscopy centres possibly across the country.

Safety assessment and detection methods of genetically modified organisms.

PubMed

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

Aligning the 3Rs with new paradigms in the safety assessment of chemicals.

PubMed

Burden, Natalie; Mahony, Catherine; Müller, Boris P; Terry, Claire; Westmoreland, Carl; Kimber, Ian

2015-04-01

There are currently several factors driving a move away from the reliance on in vivo toxicity testing for the purposes of chemical safety assessment. Progress has started to be made in the development and validation of non-animal methods. However, recent advances in the biosciences provide exciting opportunities to accelerate this process and to ensure that the alternative paradigms for hazard identification and risk assessment deliver lasting 3Rs benefits, whilst improving the quality and relevance of safety assessment. The NC3Rs, a UK-based scientific organisation which supports the development and application of novel 3Rs techniques and approaches, held a workshop recently which brought together over 20 international experts in the field of chemical safety assessment. The aim of this workshop was to review the current scientific, technical and regulatory landscapes, and to identify key opportunities towards reaching these goals. Here, we consider areas where further strategic investment will need to be focused if significant impact on 3Rs is to be matched with improved safety science, and why the timing is right for the field to work together towards an environment where we no longer rely on whole animal data for the accurate safety assessment of chemicals.

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

PubMed

Manapragada, Archana; Bruk-Lee, Valentina

2016-06-01

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

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

DOT National Transportation Integrated Search

2017-06-01

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

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires

Development and application of a safety assessment methodology for waste disposals

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

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

1996-12-31

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

Comparative safety assessment of plant-derived foods.

PubMed

Kok, E J; Keijer, J; Kleter, G A; Kuiper, H A

2008-02-01

The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting plant products. In part of the cases the same crop plant can, however, also be obtained by 'conventional' breeding strategies. The breeder will decide on a case-by-case basis what will be the best strategy to reach the set target and whether genetic modification will form part of this strategy. This article discusses important aspects of the safety assessment of complex products derived from newly bred plant varieties obtained by different breeding strategies. On the basis of this overview, we conclude that the current process of the safety evaluation of GM versus conventionally bred plants is not well balanced. GM varieties are elaborately assessed, yet at the same time other crop plants resulting from conventional breeding strategies may warrant further food safety assessment for the benefit of the consumer. We propose to develop a general screening frame for all newly developed plant varieties to select varieties that cannot, on the basis of scientific criteria, be considered as safe as plant varieties that are already on the market.

Cyber Security Threats to Safety-Critical, Space-Based Infrastructures

NASA Astrophysics Data System (ADS)

Johnson, C. W.; Atencia Yepez, A.

2012-01-01

Space-based systems play an important role within national critical infrastructures. They are being integrated into advanced air-traffic management applications, rail signalling systems, energy distribution software etc. Unfortunately, the end users of communications, location sensing and timing applications often fail to understand that these infrastructures are vulnerable to a wide range of security threats. The following pages focus on concerns associated with potential cyber-attacks. These are important because future attacks may invalidate many of the safety assumptions that support the provision of critical space-based services. These safety assumptions are based on standard forms of hazard analysis that ignore cyber-security considerations This is a significant limitation when, for instance, security attacks can simultaneously exploit multiple vulnerabilities in a manner that would never occur without a deliberate enemy seeking to damage space based systems and ground infrastructures. We address this concern through the development of a combined safety and security risk assessment methodology. The aim is to identify attack scenarios that justify the allocation of additional design resources so that safety barriers can be strengthened to increase our resilience against security threats.

Assessment of Safety and Functional Efficacy of Stem Cell-Based Therapeutic Approaches Using Retinal Degenerative Animal Models

PubMed Central

Lin, Tai-Chi; Zhu, Danhong; Hinton, David R.; Clegg, Dennis O.; Humayun, Mark S.

2017-01-01

Dysfunction and death of retinal pigment epithelium (RPE) and or photoreceptors can lead to irreversible vision loss. The eye represents an ideal microenvironment for stem cell-based therapy. It is considered an “immune privileged” site, and the number of cells needed for therapy is relatively low for the area of focused vision (macula). Further, surgical placement of stem cell-derived grafts (RPE, retinal progenitors, and photoreceptor precursors) into the vitreous cavity or subretinal space has been well established. For preclinical tests, assessments of stem cell-derived graft survival and functionality are conducted in animal models by various noninvasive approaches and imaging modalities. In vivo experiments conducted in animal models based on replacing photoreceptors and/or RPE cells have shown survival and functionality of the transplanted cells, rescue of the host retina, and improvement of visual function. Based on the positive results obtained from these animal experiments, human clinical trials are being initiated. Despite such progress in stem cell research, ethical, regulatory, safety, and technical difficulties still remain a challenge for the transformation of this technique into a standard clinical approach. In this review, the current status of preclinical safety and efficacy studies for retinal cell replacement therapies conducted in animal models will be discussed. PMID:28928775

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.

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

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

Hargis, Barbara C.

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance providedmore » by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.« less

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Drug safety data mining with a tree-based scan statistic.

PubMed

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

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

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

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

2006-07-01

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

Safety management system needs assessment.

DOT National Transportation Integrated Search

2016-04-01

The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

Assessing community child passenger safety efforts in three Northwest Tribes.

PubMed

Smith, M L; Berger, L R

2002-12-01

To identify strengths and weaknesses in community based child passenger safety programs by developing a scoring instrument and conducting observations of child restraint use in three Native American communities. The three communities are autonomous Tribal reservations in the Pacific Northwest. Their per capita incomes and rates of unemployment are comparable. In each community, 100 children under 5 years old were observed for car seat use. A six item community assessment tool (100 points maximum) awarded points for such items as the type (primary or secondary) and enforcement of child restraint laws; availability of car seats from distribution programs; extent of educational programs; and access to data on vehicle injuries. For children from birth to 4 years, the car seat use rate ranged from 12%-21%. Rates for infants (71%-80%) far exceeded rates for 1-4 year old children (5%-14%). Community scores ranged from 0 to 31.5 points. There was no correlation between scores and observed car seat use. One reason was the total lack of enforcement of restraint laws. A community assessment tool can highlight weaknesses in child passenger efforts. Linking such a tool with an objective measure of impact can be applied to other injury problems, such as fire safety or domestic violence. The very process of creating and implementing a community assessment can enhance agency collaboration and publicize evidence based "best practices" for injury prevention. Further study is needed to address methodologic issues and to examine crash and medical data in relation to community child passenger safety scores.

DriveWise: an interdisciplinary hospital-based driving assessment program.

PubMed

O'Connor, Margaret G; Kapust, Lissa R; Hollis, Ann M

2008-01-01

Health care professionals working with the elderly have opportunities through research and clinical practice to shape public policy affecting the older driver. This article describes DriveWise, an interdisciplinary hospital-based driving assessment program developed in response to clinical concerns about the driving safety of individuals with medical conditions. DriveWise clinicians use evidence-based, functional assessments to determine driving competence. In addition, the program was designed to meet the emotional needs of individuals whose driving safety has been called into question. To date, approximately 380 participants have been assessed through DriveWise. The following report details the DriveWise mission, DriveWise team members, and road test results. We continue to refine the assessment process to promote safety and support the dignity and independence of all participants. The DriveWise interdisciplinary approach to practice is a concrete example of how gerontological education across professions can have direct benefits to the older adult.

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

PubMed

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

2012-06-01

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

Safety in Acute Pain Medicine-Pharmacologic Considerations and the Impact of Systems-Based Gaps.

PubMed

Weingarten, Toby N; Taenzer, Andreas H; Elkassabany, Nabil M; Le Wendling, Linda; Nin, Olga; Kent, Michael L

2018-05-02

In the setting of an expanding prevalence of acute pain medicine services and the aggressive use of multimodal analgesia, an overview of systems-based safety gaps and safety concerns in the setting of aggressive multimodal analgesia is provided below. Expert commentary. Recent evidence focused on systems-based gaps in acute pain medicine is discussed. A focused literature review was conducted to assess safety concerns related to commonly used multimodal pharmacologic agents (opioids, nonsteroidal anti-inflammatory drugs, gabapentanoids, ketamine, acetaminophen) in the setting of inpatient acute pain management. Optimization of systems-based gaps will increase the probability of accurate pain assessment, improve the application of uniform evidence-based multimodal analgesia, and ensure a continuum of pain care. While acute pain medicine strategies should be aggressively applied, multimodal regimens must be strategically utilized to minimize risk to patients and in a comorbidity-specific fashion.

Time pressure in scenario-based online construction safety quizzes and its effect on students' performance

NASA Astrophysics Data System (ADS)

Jaeger, Martin; Adair, Desmond

2017-05-01

Online quizzes have been shown to be effective learning and assessment approaches. However, if scenario-based online construction safety quizzes do not include time pressure similar to real-world situations, they reflect situations too ideally. The purpose of this paper is to compare engineering students' performance when carrying out an online construction safety quiz with time pressure versus an online construction safety quiz without time pressure. Two versions of an online construction safety quiz are developed and administered to randomly assigned engineering students based on a quasi-experimental post-test design. The findings contribute to scenario-based learning and assessment of construction safety in four ways. First, the results confirm earlier findings that 'intrinsic stress' does not seem to impair students' performance. Second, students who carry out the online construction safety quiz with time pressure are less likely to 'learn by trial and error'. Third, students exposed to time pressure appreciate that they become better prepared for real life. Finally, preparing students to work under time pressure is an important industry requirement. The results of this study should encourage engineering educators to explore and implement ways to include time pressure in scenario-based online quizzes and learning.

Smartphone-based assessment of blood alteration severity

NASA Astrophysics Data System (ADS)

Li, Xianglin; Xue, Jiaxin; Li, Wei; Li, Ting

2018-02-01

Blood quality and safety management is a critical issue for cold chain transportation of blood or blood-based biological reagent. The conventional methods of blood alteration severity assessment mainly rely on kit test or blood-gas analysis required opening the blood package to get samples, which cause possible blood pollution and are complicate, timeconsuming, and expensive. Here we proposed to develop a portable, real-time, safety, easy-operated and low cost method aimed at assessing blood alteration severity. Color images of the blood in transparent blood bags were collected with a smartphone and the alteration severity of the blood was assessed by the smartphone app offered analysis of RGB color values of the blood. The algorithm is based on a large number sample of RGB values of blood at different alteration degree. The blood quality results evaluated by the smartphone are in accordance with the actual data. This study indicates the potential of smart phone in real time, convenient, and reliable blood quality assessment.

Implementation of Alternative Test Strategies for the Safety Assessment of Engineered Nanomaterials

PubMed Central

Nel, Andre

2014-01-01

Nanotechnology introduces a new field that requires novel approaches and methods for hazard and risk assessment. For an appropriate scientific platform for safety assessment, nanoscale properties and functions of engineered nanomaterials (ENMs), including how the physicochemical properties of the materials related to mechanisms of injury at the nano-bio interface, must be considered. Moreover, this rapidly advancing new field requires novel test strategies that allow multiple toxicants to be screened in robust, mechanism-based assays in which the bulk of the investigation can be carried out at the cellular and biomolecular level whilst maintaining limited animal use and is based on the contribution of toxicological pathways to the pathophysiology of disease. First, a predictive toxicological approach for the safety assessment of ENMs will be discussed against the background of a ‘21st-century vision’ for using alternative test strategies (ATSs) to perform toxicological assessment of large numbers of untested chemicals, thereby reducing a backlog that could otherwise become a problem for nanotechnology. An ATS is defined here as an alternative/reduction alternative to traditional animal testing. Secondly, the approach of selecting pathways of toxicity to screen for the pulmonary hazard potential of carbon nanotubes and metal oxides will be discussed, as well as how to use these pathways to perform high-content or high-throughput testing and how the data can be used for hazard ranking, risk assessment, regulatory decision-making and ‘safer-by-design’ strategies. Finally, the utility and disadvantages of this predictive toxicological approach to ENM safety assessment, and how it can assist the 21st- century vision, will be addressed PMID:23879741

Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

A novel safety assessment strategy applied to non-selective extracts.

PubMed

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Identification of Behavior Based Safety by Using Traffic Light Analysis to Reduce Accidents

NASA Astrophysics Data System (ADS)

Mansur, A.; Nasution, M. I.

2016-01-01

This work present the safety assessment of a case study and describes an important area within the field production in oil and gas industry, namely behavior based safety (BBS). The company set a rigorous BBS and its intervention program that implemented and deployed continually. In this case, observers requested to have discussion and spread a number of determined questions related with work behavior to the workers during observation. Appraisal of Traffic Light Analysis (TLA) as one tools of risk assessment used to determine the estimated score of BBS questionnaire. Standardization of TLA appraisal in this study are based on Regulation of Minister of Labor and Occupational Safety and Health No:PER.05/MEN/1996. The result shown that there are some points under 84%, which categorized in yellow category and should corrected immediately by company to prevent existing bad behavior of workers. The application of BBS expected to increase the safety performance at work time-by-time and effective in reducing accidents.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

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

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

Evaluation of aviation-based safety team training in a hospital in The Netherlands.

PubMed

De Korne, Dirk F; Van Wijngaarden, Jeroen D H; Van Dyck, Cathy; Hiddema, U Francis; Klazinga, Niek S

2014-01-01

The purpose of this paper is to evaluate the implementation of a broad-scale team resource management (TRM) program on safety culture in a Dutch eye hospital, detailing the program's content and procedures. Aviation-based TRM training is recognized as a useful approach to increase patient safety, but little is known about how it affects safety culture. Pre- and post-assessments of the hospitals' safety culture was based on interviews with ophthalmologists, anesthesiologists, residents, nurses, and support staff. Interim observations were made at training sessions and in daily hospital practice. The program consisted of safety audits of processes and (team) activities, interactive classroom training sessions by aviation experts, a flight simulator session, and video recording of team activities with subsequent feedback. Medical professionals considered aviation experts inspiring role models and respected their non-hierarchical external perspective and focus on medical-technical issues. The post-assessment showed that ophthalmologists and other hospital staff had become increasingly aware of safety issues. The multidisciplinary approach promoted social (team) orientation that replaced the former functionally-oriented culture. The number of reported near-incidents greatly increased; the number of wrong-side surgeries stabilized to a minimum after an initial substantial reduction. The study was observational and the hospital's variety of efforts to improve safety culture prevented us from establishing a causal relation between improvement and any one specific intervention. Aviation-based TRM training can be a useful to stimulate safety culture in hospitals. Safety and quality improvements are not single treatment interventions but complex socio-technical interventions. A multidisciplinary system approach and focus on "team" instead of "profession" seems both necessary and difficult in hospital care.

Research on Early Warning of Chinese Food Safety Based on Social Physics

NASA Astrophysics Data System (ADS)

Ma, Yonghuan; Niu, Wenyuan; Li, Qianqian

Based on social physics, this paper designs the index system of food safety, builds early warning model of food safety, calculates the degree of food safety, and assesses the state of early warning of 2007 in China. The result shows the degree of food safety is near 0.7 in securer state, belonging to slight emergency. It is much lower in eastern areas of developed regions, belonging to insecure state in the mass. That the food safety is ensured in major grain producing areas, Inner Mongolia, Ningxia and Xinjiang is the prerequisite of realizing the food safety of China. The result also shows four significant indices, grain production capacity, grain circulation order, grain demand and grain supply, which are important indicatio to control food safety.

Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

PubMed

Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

2016-10-01

This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

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

PubMed Central

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

2016-01-01

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

Comprehensive safety management and assessment at rugby football competitions.

PubMed

Tajima, T; Chosa, E; Kawahara, K; Nakamura, Y; Yoshikawa, D; Yamaguchi, N; Kashiwagi, T

2014-11-01

The present study aims to improve medical systems by designing objective safety assessment criteria for rugby competitions. We evaluated 195 competitions between 2002 and 2011 using an original safety scale comprising the following sections: 1) competence of staff such as referees, medical attendants and match day doctor; 2) environment such as weather, wet bulb globe temperature and field conditions; and 3) emergency medical care systems at the competitions. Each section was subdivided into groups A, B and C according to good, normal or fair degrees of safety determined by combinations of the results.Overall safety was assessed as A, B and C for 110, 78 and 7 competitions, respectively. The assessments of individual major factors were mostly favorable for staff, but the environment and medical care systems were assessed as C in 25 and 70, respectively, of the 195 competitions. Medical management involves not having a match day doctor, but also comprehensive management including preventive factors and responses from the staff, environment and medical-care systems. 6 cases of severe injuries and accidents occurred between 2002 and 2011, which were observed in Grade A competition. These cases revealed better prognosis without obvious impairment, thus confirming the value of the present assessment scale. © Georg Thieme Verlag KG Stuttgart · New York.

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

PubMed

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

2016-02-12

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

Safety Assessment of Alkyl Esters as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart A; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-09-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin-conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and where there were data gaps, similarity in structure, properties, functions, and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be nonirritating. © The Author(s) 2015.

Patient safety and communication: a new assessment for doctors trained in countries where language differs from that of the host country: results of a pilot using a domain-based assessment.

PubMed

Cushing, Annie M; Ker, Jean S; Kinnersley, Paul; McKeown, Pascal; Silverman, Jonathan; Patterson, John; Westwood, Olwyn M R

2014-06-01

Global migration of healthcare workers places responsibility on employers to comply with legal employment rights whilst ensuring patient safety remains the central goal. We describe the pilot of a communication assessment designed for doctors who trained and communicated with patients and colleagues in a different language from that of the host country. It is unique in assessing clinical communication without assessing knowledge. A 14-station OSCE was developed using a domain-based marking scheme, covering professional communication and English language skills (speaking, listening, reading and writing) in routine, acute and emotionally challenging contexts, with patients, carers and healthcare teams. Candidates (n=43), non-UK trained volunteers applying to the UK Foundation Programme, were provided with relevant station information prior to the exam. The criteria for passing the test included achieving the pass score and passing 10 or more of the 14 stations. Of the 43 candidates, nine failed on the station criteria. Two failed the pass score and also the station criteria. The Cronbach's alpha coefficient was 0.866. This pilot tested 'proof of concept' of a new domain-based communication assessment for non-UK trained doctors. The test would enable employers and regulators to verify communication competence and safety in clinical contexts, independent of clinical knowledge, for doctors who trained in a language different from that of the host country. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-09-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives

NASA Astrophysics Data System (ADS)

Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.

2005-12-01

On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.

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.

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

ERIC Educational Resources Information Center

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

2017-01-01

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

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

PubMed

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

Processes of technology assessment: The National Transportation Safety Board

NASA Technical Reports Server (NTRS)

Weiss, E.

1972-01-01

The functions and operations of the Safety Board as related to technology assessment are described, and a brief history of the Safety Board is given. Recommendations made for safety in all areas of transportation and the actions taken are listed. Although accident investigation is an important aspect of NTSB's activity, it is felt that the greatest contribution is in pressing for development of better accident prevention programs. Efforts of the Safety Board in changing transportation technology to improve safety and prevent accidents are illustrated.

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 ...

Safety impact of an integrated crash warning system based on field test data.

DOT National Transportation Integrated Search

2011-06-13

This paper provides the results of an analysis : conducted to assess the safety impact of an integrated : vehicle-based crash warning system based on : naturalistic driving data collected from a field : operational test. The system incorporates four ...

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements.

PubMed

Dekant, Wolfgang; Fujii, Kenkichi; Shibata, Eiichiro; Morita, Osamu; Shimotoyodome, Akira

2017-08-05

The safety of green tea infusions and green tea extract (GTE)-based products is reviewed regarding catechins. Epigallocatechin 3-gallate (EGCG), the major catechin present in green tea, is suspected of being responsible for liver toxicity reported in humans consuming food supplements. Intake of EGCG with green tea infusions and GTE-based beverages is up to about 450mg EGCG/person/day in Europe and higher in Asia. Consumption of green tea is not associated with liver damage in humans, and green tea infusion and GTE-based beverages are considered safe in the range of historical uses. In animal studies, EGCG's potency for liver effects is highly dependent on conditions of administration. Use of NOAELs from bolus administration to derive a tolerable upper intake level applying the margin of safety concept results in acceptable EGCG-doses lower than those from one cup of green tea. NOAELs from toxicity studies applying EGCG with diet/split of the daily dose are a better point of departure for risk characterization. In clinical intervention studies, liver effects were not observed after intakes below 600mg EGCG/person/day. Thus, a tolerable upper intake level of 300mg EGCG/person/day is proposed for food supplements; this gives a twofold safety margin to clinical studies that did not report liver effects and a margin of safety of 100 to the NOAELs in animal studies with dietary administration of green tea catechins. Copyright © 2017 Elsevier B.V. All rights reserved.

Safety Assessment of Talc as Used in Cosmetics.

PubMed

Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

Safety assessment methodology in management of spent sealed sources.

PubMed

Mahmoud, Narmine Salah

2005-02-14

Environmental hazards can be caused from radioactive waste after their disposal. It was therefore important that safety assessment methodologies be developed and established to study and estimate the possible hazards, and institute certain safety methodologies that lead and prevent the evolution of these hazards. Spent sealed sources are specific type of radioactive waste. According to IAEA definition, spent sealed sources are unused sources because of activity decay, damage, misuse, loss, or theft. Accidental exposure of humans from spent sealed sources can occur at the moment they become spent and before their disposal. Because of that reason, safety assessment methodologies were tailored to suit the management of spent sealed sources. To provide understanding and confidence of this study, validation analysis was undertaken by considering the scenario of an accident that occurred in Egypt, June 2000 (the Meet-Halfa accident from an iridium-192 source). The text of this work includes consideration related to the safety assessment approaches of spent sealed sources which constitutes assessment context, processes leading an active source to be spent, accident scenarios, mathematical models for dose calculations, and radiological consequences and regulatory criteria. The text also includes a validation study, which was carried out by evaluating a theoretical scenario compared to the real scenario of Meet-Halfa accident depending on the clinical assessment of affected individuals.

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.

PubMed

Dobo, Krista L; Greene, Nigel; Cyr, Michelle O; Caron, Stéphane; Ku, Warren W

2006-04-01

Starting materials and intermediates used to synthesize pharmaceuticals are reactive in nature and may be present as impurities in the active pharmaceutical ingredient (API) used for preclinical safety studies and clinical trials. Furthermore, starting materials and intermediates may be known or suspected mutagens and/or carcinogens. Therefore, during drug development due diligence need be applied from two perspectives (1) to understand potential mutagenic and carcinogenic risks associated with compounds used for synthesis and (2) to understand the capability of synthetic processes to control genotoxic impurities in the API. Recently, a task force comprised of experts from pharmaceutical industry proposed guidance, with recommendations for classification, testing, qualification and assessing risk of genotoxic impurities. In our experience the proposed structure-based classification, has differentiated 75% of starting materials and intermediates as mutagenic and non-mutagenic with high concordance (92%) when compared with Ames results. Structure-based assessment has been used to identify genotoxic hazards, and prompted evaluation of fate of genotoxic impurities in API. These two assessments (safety and chemistry) culminate in identification of genotoxic impurities known or suspected to exceed acceptable levels in API, thereby triggering actions needed to assure appropriate control and measurement methods are in place. Hypothetical case studies are presented demonstrating this multi-disciplinary approach.

76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 575 [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION...

High-Throughput Toxicity Testing: New Strategies for Assessing Chemical Safety

EPA Science Inventory

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct add...

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Why the Eurocontrol Safety Regulation Commission Policy on Safety Nets and Risk Assessment is Wrong

NASA Astrophysics Data System (ADS)

Brooker, Peter

2004-05-01

Current Eurocontrol Safety Regulation Commission (SRC) policy says that the Air Traffic Management (ATM) system (including safety minima) must be demonstrated through risk assessments to meet the Target Level of Safety (TLS) without needing to take safety nets (such as Short Term Conflict Alert) into account. This policy is wrong. The policy is invalid because it does not build rationally and consistently from ATM's firm foundations of TLS and hazard analysis. The policy is bad because it would tend to retard safety improvements. Safety net policy must rest on a clear and rational treatment of integrated ATM system safety defences. A new safety net policy, appropriate to safe ATM system improvements, is needed, which recognizes that safety nets are an integrated part of ATM system defences. The effects of safety nets in reducing deaths from mid-air collisions should be fully included in hazard analysis and safety audits in the context of the TLS for total system design.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

PubMed

Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

2018-05-01

To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

Is it time to reassess current safety standards for glyphosate-based herbicides?

PubMed Central

Blumberg, Bruce; Antoniou, Michael N; Benbrook, Charles M; Carroll, Lynn; Colborn, Theo; Everett, Lorne G; Hansen, Michael; Landrigan, Philip J; Lanphear, Bruce P; Mesnage, Robin; vom Saal, Frederick S; Welshons, Wade V; Myers, John Peterson

2017-01-01

Use of glyphosate-based herbicides (GBHs) increased ∼100-fold from 1974 to 2014. Additional increases are expected due to widespread emergence of glyphosate-resistant weeds, increased application of GBHs, and preharvest uses of GBHs as desiccants. Current safety assessments rely heavily on studies conducted over 30 years ago. We have considered information on GBH use, exposures, mechanisms of action, toxicity and epidemiology. Human exposures to glyphosate are rising, and a number of in vitro and in vivo studies challenge the basis for the current safety assessment of glyphosate and GBHs. We conclude that current safety standards for GBHs are outdated and may fail to protect public health or the environment. To improve safety standards, the following are urgently needed: (1) human biomonitoring for glyphosate and its metabolites; (2) prioritisation of glyphosate and GBHs for hazard assessments, including toxicological studies that use state-of-the-art approaches; (3) epidemiological studies, especially of occupationally exposed agricultural workers, pregnant women and their children and (4) evaluations of GBHs in commercially used formulations, recognising that herbicide mixtures likely have effects that are not predicted by studying glyphosate alone. PMID:28320775

Geriatric Patient Safety Indicators Based on Linked Administrative Health Data to Assess Anticoagulant-Related Thromboembolic and Hemorrhagic Adverse Events in Older Inpatients: A Study Proposal

PubMed Central

Quantin, Catherine; Reich, Oliver; Tuppin, Philippe; Fagot-Campagna, Anne; Paccaud, Fred; Peytremann-Bridevaux, Isabelle; Burnand, Bernard

2017-01-01

Background Frail older people with multiple interacting conditions, polypharmacy, and complex care needs are particularly exposed to health care-related adverse events. Among these, anticoagulant-related thromboembolic and hemorrhagic events are particularly frequent and serious in older inpatients. The growing use of anticoagulants in this population and their substantial risk of toxicity and inefficacy have therefore become an important patient safety and public health concern worldwide. Anticoagulant-related adverse events and the quality of anticoagulation management should thus be routinely assessed to improve patient safety in vulnerable older inpatients. Objective This project aims to develop and validate a set of outcome and process indicators based on linked administrative health data (ie, insurance claims data linked to hospital discharge data) assessing older inpatient safety related to anticoagulation in both Switzerland and France, and enabling comparisons across time and among hospitals, health territories, and countries. Geriatric patient safety indicators (GPSIs) will assess anticoagulant-related adverse events. Geriatric quality indicators (GQIs) will evaluate the management of anticoagulants for the prevention and treatment of arterial or venous thromboembolism in older inpatients. Methods GPSIs will measure cumulative incidences of thromboembolic and bleeding adverse events based on hospital discharge data linked to insurance claims data. Using linked administrative health data will improve GPSI risk adjustment on patients’ conditions that are present at admission and will capture in-hospital and postdischarge adverse events. GQIs will estimate the proportion of index hospital stays resulting in recommended anticoagulation at discharge and up to various time frames based on the same electronic health data. The GPSI and GQI development and validation process will comprise 6 stages: (1) selection and specification of candidate indicators, (2

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

There is more to risk and safety planning than dramatic risks: Mental health nurses' risk assessment and safety-management practice.

PubMed

Higgins, Agnes; Doyle, Louise; Downes, Carmel; Morrissey, Jean; Costello, Paul; Brennan, Michael; Nash, Michael

2016-04-01

Risk assessment and safety planning are considered a cornerstone of mental health practice, yet limited research exists into how mental health nurses conceptualize 'risk' and how they engage with risk assessment and safety planning. The aim of the present study was to explore mental health nurses' practices and confidence in risk assessment and safety planning. A self-completed survey was administered to 381 mental health nurses in Ireland. The findings indicate that nurses focus on risk to self and risk to others, with the risk of suicide, self-harm, substance abuse, and violence being most frequently assessed. Risk from others and 'iatrogenic' risk were less frequently considered. Overall, there was limited evidence of recovery-oriented practice in relation to risk. The results demonstrate a lack of meaningful engagement with respect to collaborative safety planning, the identification and inclusion of protective factors, and the inclusion of positive risk-taking opportunities. In addition, respondents report a lack of confidence working with positive risk taking and involving family/carers in the risk-assessment and safety-planning process. Gaps in knowledge about risk-assessment and safety-planning practice, which could be addressed through education, are identified, as are the implications of the findings for practice and research. © 2015 Australian College of Mental Health Nurses Inc.

Compressed natural gas bus safety: a quantitative risk assessment.

PubMed

Chamberlain, Samuel; Modarres, Mohammad

2005-04-01

This study assesses the fire safety risks associated with compressed natural gas (CNG) vehicle systems, comprising primarily a typical school bus and supporting fuel infrastructure. The study determines the sensitivity of the results to variations in component failure rates and consequences of fire events. The components and subsystems that contribute most to fire safety risk are determined. Finally, the results are compared to fire risks of the present generation of diesel-fueled school buses. Direct computation of the safety risks associated with diesel-powered vehicles is possible because these are mature technologies for which historical performance data are available. Because of limited experience, fatal accident data for CNG bus fleets are minimal. Therefore, this study uses the probabilistic risk assessment (PRA) approach to model and predict fire safety risk of CNG buses. Generic failure data, engineering judgments, and assumptions are used in this study. This study predicts the mean fire fatality risk for typical CNG buses as approximately 0.23 fatalities per 100-million miles for all people involved, including bus passengers. The study estimates mean values of 0.16 fatalities per 100-million miles for bus passengers only. Based on historical data, diesel school bus mean fire fatality risk is 0.091 and 0.0007 per 100-million miles for all people and bus passengers, respectively. One can therefore conclude that CNG buses are more prone to fire fatality risk by 2.5 times that of diesel buses, with the bus passengers being more at risk by over two orders of magnitude. The study estimates a mean fire risk frequency of 2.2 x 10(-5) fatalities/bus per year. The 5% and 95% uncertainty bounds are 9.1 x 10(-6) and 4.0 x 10(-5), respectively. The risk result was found to be affected most by failure rates of pressure relief valves, CNG cylinders, and fuel piping.

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

PubMed

Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

PubMed

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Development of Safety Assessment Code for Decommissioning of Nuclear Facilities

NASA Astrophysics Data System (ADS)

Shimada, Taro; Ohshima, Soichiro; Sukegawa, Takenori

A safety assessment code, DecDose, for decommissioning of nuclear facilities has been developed, based on the experiences of the decommissioning project of Japan Power Demonstration Reactor (JPDR) at Japan Atomic Energy Research Institute (currently JAEA). DecDose evaluates the annual exposure dose of the public and workers according to the progress of decommissioning, and also evaluates the public dose at accidental situations including fire and explosion. As for the public, both the internal and the external doses are calculated by considering inhalation, ingestion, direct radiation from radioactive aerosols and radioactive depositions, and skyshine radiation from waste containers. For external dose for workers, the dose rate from contaminated components and structures to be dismantled is calculated. Internal dose for workers is calculated by considering dismantling conditions, e.g. cutting speed, cutting length of the components and exhaust velocity. Estimation models for dose rate and staying time were verified by comparison with the actual external dose of workers which were acquired during JPDR decommissioning project. DecDose code is expected to contribute the safety assessment for decommissioning of nuclear facilities.

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.

Are automatic systems the future of motorcycle safety? A novel methodology to prioritize potential safety solutions based on their projected effectiveness.

PubMed

Gil, Gustavo; Savino, Giovanni; Piantini, Simone; Baldanzini, Niccolò; Happee, Riender; Pierini, Marco

2017-11-17

Motorcycle riders are involved in significantly more crashes per kilometer driven than passenger car drivers. Nonetheless, the development and implementation of motorcycle safety systems lags far behind that of passenger cars. This research addresses the identification of the most effective motorcycle safety solutions in the context of different countries. A knowledge-based system of motorcycle safety (KBMS) was developed to assess the potential for various safety solutions to mitigate or avoid motorcycle crashes. First, a set of 26 common crash scenarios was identified from the analysis of multiple crash databases. Second, the relative effectiveness of 10 safety solutions was assessed for the 26 crash scenarios by a panel of experts. Third, relevant information about crashes was used to weigh the importance of each crash scenario in the region studied. The KBMS method was applied with an Italian database, with a total of more than 1 million motorcycle crashes in the period 2000-2012. When applied to the Italian context, the KBMS suggested that automatic systems designed to compensate for riders' or drivers' errors of commission or omission are the potentially most effective safety solution. The KBMS method showed an effective way to compare the potential of various safety solutions, through a scored list with the expected effectiveness of each safety solution for the region to which the crash data belong. A comparison of our results with a previous study that attempted a systematic prioritization of safety systems for motorcycles (PISa project) showed an encouraging agreement. Current results revealed that automatic systems have the greatest potential to improve motorcycle safety. Accumulating and encoding expertise in crash analysis from a range of disciplines into a scalable and reusable analytical tool, as proposed with the use of KBMS, has the potential to guide research and development of effective safety systems. As the expert assessment of the crash

On the safety assessment of human exposure in the proximity of cellular communications base-station antennas at 900, 1800 and 2170 MHz.

PubMed

Martínez-Búrdalo, M; Martín, A; Anguiano, M; Villar, R

2005-09-07

In this work, the procedures for safety assessment in the close proximity of cellular communications base-station antennas at three different frequencies (900, 1800 and 2170 MHz) are analysed. For each operating frequency, we have obtained and compared the distances to the antenna from the exposure places where electromagnetic fields are below reference levels and the distances where the specific absorption rate (SAR) values in an exposed person are below the basic restrictions, according to the European safety guidelines. A high-resolution human body model has been located, in front of each base-station antenna as a worst case, at different distances, to compute whole body averaged SAR and maximum 10 g averaged SAR inside the exposed body. The finite-difference time-domain method has been used for both electromagnetic fields and SAR calculations. This paper shows that, for antenna-body distances in the near zone of the antenna, the fact that averaged field values be below the reference levels could, at certain frequencies, not guarantee guidelines compliance based on basic restrictions.

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

PubMed

Becker, Lillian C; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

Development of a methodology for assessing the safety of embedded software systems

NASA Technical Reports Server (NTRS)

Garrett, C. J.; Guarro, S. B.; Apostolakis, G. E.

1993-01-01

A Dynamic Flowgraph Methodology (DFM) based on an integrated approach to modeling and analyzing the behavior of software-driven embedded systems for assessing and verifying reliability and safety is discussed. DFM is based on an extension of the Logic Flowgraph Methodology to incorporate state transition models. System models which express the logic of the system in terms of causal relationships between physical variables and temporal characteristics of software modules are analyzed to determine how a certain state can be reached. This is done by developing timed fault trees which take the form of logical combinations of static trees relating the system parameters at different point in time. The resulting information concerning the hardware and software states can be used to eliminate unsafe execution paths and identify testing criteria for safety critical software functions.

Safety analysis of interchanges

DOT National Transportation Integrated Search

2007-06-01

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

A Study on Urban Road Traffic Safety Based on Matter Element Analysis

PubMed Central

Hu, Qizhou; Zhou, Zhuping; Sun, Xu

2014-01-01

This paper examines a new evaluation of urban road traffic safety based on a matter element analysis, avoiding the difficulties found in other traffic safety evaluations. The issue of urban road traffic safety has been investigated through the matter element analysis theory. The chief aim of the present work is to investigate the features of urban road traffic safety. Emphasis was placed on the construction of a criterion function by which traffic safety achieved a hierarchical system of objectives to be evaluated. The matter element analysis theory was used to create the comprehensive appraisal model of urban road traffic safety. The technique was used to employ a newly developed and versatile matter element analysis algorithm. The matter element matrix solves the uncertainty and incompatibility of the evaluated factors used to assess urban road traffic safety. The application results showed the superiority of the evaluation model and a didactic example was included to illustrate the computational procedure. PMID:25587267

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

Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making.

PubMed

Berggren, Elisabet; Amcoff, Patric; Benigni, Romualdo; Blackburn, Karen; Carney, Edward; Cronin, Mark; Deluyker, Hubert; Gautier, Francoise; Judson, Richard S; Kass, Georges E N; Keller, Detlef; Knight, Derek; Lilienblum, Werner; Mahony, Catherine; Rusyn, Ivan; Schultz, Terry; Schwarz, Michael; Schüürmann, Gerrit; White, Andrew; Burton, Julien; Lostia, Alfonso M; Munn, Sharon; Worth, Andrew

2015-12-01

Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data--for example, information from in vitro molecular screening, "-omics" assays and computational models--to reach regulatory acceptance. We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015.

Safety assessment of modified terephthalate polymers as used in cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

INPRO Assessment of an INS in the Area of Safety of Fuel Cycle Installations

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

Raj, B.; Busurin, Y.; Depisch, F.

2006-07-01

INPRO has defined requirements organized in a hierarchy of Basic Principles, User Requirements and Criteria (consisting of an indicator and an acceptance limit) to be met by innovative nuclear reactor systems (INS) in six areas, namely: economics, safety, waste management, environment, proliferation resistance, and infrastructure. If an INS meets all requirements in all areas it represents a sustainable system for the supply of energy, capable of making a significant contribution to meeting the energy needs of the 21. century. Draft manuals have been developed, for each INPRO area, to provide guidance for performing an assessment of whether an INS meetsmore » the INPRO requirements in a given area. The manuals set out the information that needs to be assembled to perform an assessment and provide guidance on selecting the acceptance limits and, for a given INS, for determining the value of the indicators for comparison with the associated acceptance limits. Each manual also includes an example of a specific assessment to illustrate the guidance. This paper discusses the manual for performing an INPRO assessment in the area of safety of fuel cycle installations. The example, chosen solely for the purpose of illustrating the INPRO methodology, describes an assessment of an MOX fuel fabrication plant based on sol-gel technology and illustrates an assessment performed for an INS at an early stage of development. The safety issues and the assessment steps are presented in detail in the paper. (authors)« less

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

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

Geriatric Patient Safety Indicators Based on Linked Administrative Health Data to Assess Anticoagulant-Related Thromboembolic and Hemorrhagic Adverse Events in Older Inpatients: A Study Proposal.

PubMed

Le Pogam, Marie-Annick; Quantin, Catherine; Reich, Oliver; Tuppin, Philippe; Fagot-Campagna, Anne; Paccaud, Fred; Peytremann-Bridevaux, Isabelle; Burnand, Bernard

2017-05-11

Frail older people with multiple interacting conditions, polypharmacy, and complex care needs are particularly exposed to health care-related adverse events. Among these, anticoagulant-related thromboembolic and hemorrhagic events are particularly frequent and serious in older inpatients. The growing use of anticoagulants in this population and their substantial risk of toxicity and inefficacy have therefore become an important patient safety and public health concern worldwide. Anticoagulant-related adverse events and the quality of anticoagulation management should thus be routinely assessed to improve patient safety in vulnerable older inpatients. This project aims to develop and validate a set of outcome and process indicators based on linked administrative health data (ie, insurance claims data linked to hospital discharge data) assessing older inpatient safety related to anticoagulation in both Switzerland and France, and enabling comparisons across time and among hospitals, health territories, and countries. Geriatric patient safety indicators (GPSIs) will assess anticoagulant-related adverse events. Geriatric quality indicators (GQIs) will evaluate the management of anticoagulants for the prevention and treatment of arterial or venous thromboembolism in older inpatients. GPSIs will measure cumulative incidences of thromboembolic and bleeding adverse events based on hospital discharge data linked to insurance claims data. Using linked administrative health data will improve GPSI risk adjustment on patients' conditions that are present at admission and will capture in-hospital and postdischarge adverse events. GQIs will estimate the proportion of index hospital stays resulting in recommended anticoagulation at discharge and up to various time frames based on the same electronic health data. The GPSI and GQI development and validation process will comprise 6 stages: (1) selection and specification of candidate indicators, (2) definition of administrative data-based

Earth based approaches to enhancing the health and safety of space operations

NASA Technical Reports Server (NTRS)

Koller, A. M., Jr.

1985-01-01

This paper provides an overview of the current state of our earth based knowledge of space safety hazards; identification of several key areas of concern for space operations; and proposed approaches to providing technology enhancement and information needed to improve the health and safety to those conducting space operations. Included are a review of the identified hazards for space oeprations by hazard classification; a summarization of the information currently available on space experiences and an assessment of potential hazards for long duration spaceflight; a discussion of potential failure modes and their significance for Space Station work: and an assessment of current work which indicates additional research and experimentation which can only be accomplished in actual space missions.

Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

NASA Technical Reports Server (NTRS)

Luxhoj, James T.

2003-01-01

Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

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

PubMed

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

2018-01-01

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

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

Assessment of elementary school safety restraint programs.

DOT National Transportation Integrated Search

1985-06-01

The purpose of this research was to identify elementary school (K-6) safety belt : education programs in use in the United States, to review their development, and : to make administrative and impact assessments of their use in selected States. : Six...

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Health, safety and environmental unit performance assessment model under uncertainty (case study: steel industry).

PubMed

Shamaii, Azin; Omidvari, Manouchehr; Lotfi, Farhad Hosseinzadeh

2017-01-01

Performance assessment is a critical objective of management systems. As a result of the non-deterministic and qualitative nature of performance indicators, assessments are likely to be influenced by evaluators' personal judgments. Furthermore, in developing countries, performance assessments by the Health, Safety and Environment (HSE) department are based solely on the number of accidents. A questionnaire is used to conduct the study in one of the largest steel production companies in Iran. With respect to health, safety, and environment, the results revealed that control of disease, fire hazards, and air pollution are of paramount importance, with coefficients of 0.057, 0.062, and 0.054, respectively. Furthermore, health and environment indicators were found to be the most common causes of poor performance. Finally, it was shown that HSE management systems can affect the majority of performance safety indicators in the short run, whereas health and environment indicators require longer periods of time. The objective of this study is to present an HSE-MS unit performance assessment model in steel industries. Moreover, we seek to answer the following question: what are the factors that affect HSE unit system in the steel industry? Also, for each factor, the extent of impact on the performance of the HSE management system in the organization is determined.

A TIERED APPROACH TO LIFE STAGES TESTING FOR AGRICULTURAL CHEMICAL SAFETY ASSESSMENT

EPA Science Inventory

A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studie...

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.

Environmental Assessment for Construction of Radial Arm Spill Gates MacDill Air Force Base, Florida

DTIC Science & Technology

2012-05-01

requires that Federal agencies identify and assess environmental health and safety risks that might disproportionately affect children. The Proposed...Action would not pose any adverse or disproportionate environmental health or safety risks to children living near the base. Safety precautions...Department of Envir. Protection 3900 Commonwealth Blvd, Mail Station 47 Tallahassee, FL 32399-3000 RE: Draft Environmental Assessment and Draft

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

PubMed

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

2014-07-01

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

Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 8 dialkyl sulfosuccinate salts for use in cosmetics, finding that these ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be nonirritating. The dialkyl sulfosuccinate salts primarily function as surfactants in cosmetics. The Panel reviewed the new and existing available animal and clinical data in making its determination of safety. The Panel found it appropriate to extrapolate the data on diethylhexyl sodium sulfosuccinate to assess the safety of the entire group because all of the diesters are of a similar alkyl chain length, all are symmetrically substituted, and all have similar functions in cosmetic formulations. © The Author(s) 2016.

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

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

Post-earthquake building safety assessments for the Canterbury Earthquakes

USGS Publications Warehouse

Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

2012-01-01

This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

Method of operator safety assessment for underground mobile mining equipment

NASA Astrophysics Data System (ADS)

Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

2018-01-01

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

Safety assessment of discharge chute isolation barrier preparation and installation. Revision 1

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

Meichle, R.H.

1994-10-10

This revision responds to RL comments and increases the discussion of the ``effective hazard categorization`` and the readiness review basis. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparison of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions were made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classification.

Validation of a physically based catchment model for application in post-closure radiological safety assessments of deep geological repositories for solid radioactive wastes.

PubMed

Thorne, M C; Degnan, P; Ewen, J; Parkin, G

2000-12-01

The physically based river catchment modelling system SHETRAN incorporates components representing water flow, sediment transport and radionuclide transport both in solution and bound to sediments. The system has been applied to simulate hypothetical future catchments in the context of post-closure radiological safety assessments of a potential site for a deep geological disposal facility for intermediate and certain low-level radioactive wastes at Sellafield, west Cumbria. In order to have confidence in the application of SHETRAN for this purpose, various blind validation studies have been undertaken. In earlier studies, the validation was undertaken against uncertainty bounds in model output predictions set by the modelling team on the basis of how well they expected the model to perform. However, validation can also be carried out with bounds set on the basis of how well the model is required to perform in order to constitute a useful assessment tool. Herein, such an assessment-based validation exercise is reported. This exercise related to a field plot experiment conducted at Calder Hollow, west Cumbria, in which the migration of strontium and lanthanum in subsurface Quaternary deposits was studied on a length scale of a few metres. Blind predictions of tracer migration were compared with experimental results using bounds set by a small group of assessment experts independent of the modelling team. Overall, the SHETRAN system performed well, failing only two out of seven of the imposed tests. Furthermore, of the five tests that were not failed, three were positively passed even when a pessimistic view was taken as to how measurement errors should be taken into account. It is concluded that the SHETRAN system, which is still being developed further, is a powerful tool for application in post-closure radiological safety assessments.

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

Validity of instruments to assess students' travel and pedestrian safety.

PubMed

Mendoza, Jason A; Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

2010-05-18

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. The SRTS travel survey had high test-retest reliability (kappa = 0.97, n = 96, p < 0.001) and convergent validity (kappa = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p = < 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

Validity of instruments to assess students' travel and pedestrian safety

PubMed Central

2010-01-01

Background Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p < 0.001) and convergent validity (κ = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p =< 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work. PMID:20482778

Is it time to reassess current safety standards for glyphosate-based herbicides?

PubMed

Vandenberg, Laura N; Blumberg, Bruce; Antoniou, Michael N; Benbrook, Charles M; Carroll, Lynn; Colborn, Theo; Everett, Lorne G; Hansen, Michael; Landrigan, Philip J; Lanphear, Bruce P; Mesnage, Robin; Vom Saal, Frederick S; Welshons, Wade V; Myers, John Peterson

2017-06-01

Use of glyphosate-based herbicides (GBHs) increased ∼100-fold from 1974 to 2014. Additional increases are expected due to widespread emergence of glyphosate-resistant weeds, increased application of GBHs, and preharvest uses of GBHs as desiccants. Current safety assessments rely heavily on studies conducted over 30 years ago. We have considered information on GBH use, exposures, mechanisms of action, toxicity and epidemiology. Human exposures to glyphosate are rising, and a number of in vitro and in vivo studies challenge the basis for the current safety assessment of glyphosate and GBHs. We conclude that current safety standards for GBHs are outdated and may fail to protect public health or the environment. To improve safety standards, the following are urgently needed: (1) human biomonitoring for glyphosate and its metabolites; (2) prioritisation of glyphosate and GBHs for hazard assessments, including toxicological studies that use state-of-the-art approaches; (3) epidemiological studies, especially of occupationally exposed agricultural workers, pregnant women and their children and (4) evaluations of GBHs in commercially used formulations, recognising that herbicide mixtures likely have effects that are not predicted by studying glyphosate alone. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

NASA Astrophysics Data System (ADS)

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

2017-11-01

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

Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient Safety

PubMed Central

Frankel, Allan; Grillo, Sarah Pratt; Pittman, Mary; Thomas, Eric J; Horowitz, Lisa; Page, Martha; Sexton, Bryan

2008-01-01

Objective To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient

SCAP: a new methodology for safety management based on feedback from credible accident-probabilistic fault tree analysis system.

PubMed

Khan, F I; Iqbal, A; Ramesh, N; Abbasi, S A

2001-10-12

As it is conventionally done, strategies for incorporating accident--prevention measures in any hazardous chemical process industry are developed on the basis of input from risk assessment. However, the two steps-- risk assessment and hazard reduction (or safety) measures--are not linked interactively in the existing methodologies. This prevents a quantitative assessment of the impacts of safety measures on risk control. We have made an attempt to develop a methodology in which risk assessment steps are interactively linked with implementation of safety measures. The resultant system tells us the extent of reduction of risk by each successive safety measure. It also tells based on sophisticated maximum credible accident analysis (MCAA) and probabilistic fault tree analysis (PFTA) whether a given unit can ever be made 'safe'. The application of the methodology has been illustrated with a case study.

Approaches to the safety assessment of engineered nanomaterials (ENM) in food.

PubMed

Cockburn, Andrew; Bradford, Roberta; Buck, Neil; Constable, Anne; Edwards, Gareth; Haber, Bernd; Hepburn, Paul; Howlett, John; Kampers, Frans; Klein, Christoph; Radomski, Marek; Stamm, Hermann; Wijnhoven, Susan; Wildemann, Tanja

2012-06-01

A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potential for systemic translocation, are insoluble or only partially soluble over time or are particulate and bio-persistent. Where ENM-specific assessment is triggered, Tier 1 screening considers the potential for translocation across biological barriers, cytotoxicity, generation of reactive oxygen species, inflammatory response, genotoxicity and general toxicity. In silico and in vitro studies, together with a sub-acute repeat-dose rodent study, could be considered for this phase. Tier 2 hazard characterisation is based on a sentinel 90-day rodent study with an extended range of endpoints, additional parameters being investigated case-by-case. Physicochemical characterisation should be performed in a range of food and biological matrices. A default assumption of 100% bioavailability of the ENM provides a 'worst case' exposure scenario, which could be refined as additional data become available. The safety testing strategy is considered applicable to variations in ENM size within the nanoscale and to new generations of ENM. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety and risk assessment of ceramide 3 in cosmetic products.

PubMed

Choi, Seul Min; Lee, Byung-Mu

2015-10-01

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety assessment for In-service Pressure Bending Pipe Containing Incomplete Penetration Defects

NASA Astrophysics Data System (ADS)

Wang, M.; Tang, P.; Xia, J. F.; Ling, Z. W.; Cai, G. Y.

2017-12-01

Incomplete penetration defect is a common defect in the welded joint of pressure pipes. While the safety classification of pressure pipe containing incomplete penetration defects, according to periodical inspection regulations in present, is more conservative. For reducing the repair of incomplete penetration defect, a scientific and applicable safety assessment method for pressure pipe is needed. In this paper, the stress analysis model of the pipe system was established for the in-service pressure bending pipe containing incomplete penetration defects. The local finite element model was set up to analyze the stress distribution of defect location and the stress linearization. And then, the applicability of two assessment methods, simplified assessment and U factor assessment method, to the assessment of incomplete penetration defects located at pressure bending pipe were analyzed. The results can provide some technical supports for the safety assessment of complex pipelines in the future.

An assessment of traffic safety culture related to engagement efforts to improve traffic safety : research programs.

DOT National Transportation Integrated Search

2016-12-01

The Center for Health and Safety Culture at Montana State University developed a survey to investigate the traffic safety culture related to engagement in traffic safety citizenship behaviors. The development of the survey was based on an augmented f...

Safety assessment of personal care products/cosmetics and their ingredients.

PubMed

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.

Safety assessment of personal care products/cosmetics and their ingredients

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

Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

2010-03-01

sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.« less

Safety analysis, risk assessment, and risk acceptance criteria

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

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

1997-08-01

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

Behavior-Based Safety and Occupational Risk Management

ERIC Educational Resources Information Center

Geller, E. Scott

2005-01-01

The behavior-based approach to managing occupational risk and preventing workplace injuries is reviewed. Unlike the typical top-down control approach to industrial safety, behavior-based safety (BBS) provides tools and procedures workers can use to take personal control of occupational risks. Strategies the author and his colleagues have been…

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

PubMed Central

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

2014-01-01

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

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Towards a Food Safety Knowledge Base Applicable in Crisis Situations and Beyond.

PubMed

Falenski, Alexander; Weiser, Armin A; Thöns, Christian; Appel, Bernd; Käsbohrer, Annemarie; Filter, Matthias

2015-01-01

In case of contamination in the food chain, fast action is required in order to reduce the numbers of affected people. In such situations, being able to predict the fate of agents in foods would help risk assessors and decision makers in assessing the potential effects of a specific contamination event and thus enable them to deduce the appropriate mitigation measures. One efficient strategy supporting this is using model based simulations. However, application in crisis situations requires ready-to-use and easy-to-adapt models to be available from the so-called food safety knowledge bases. Here, we illustrate this concept and its benefits by applying the modular open source software tools PMM-Lab and FoodProcess-Lab. As a fictitious sample scenario, an intentional ricin contamination at a beef salami production facility was modelled. Predictive models describing the inactivation of ricin were reviewed, relevant models were implemented with PMM-Lab, and simulations on residual toxin amounts in the final product were performed with FoodProcess-Lab. Due to the generic and modular modelling concept implemented in these tools, they can be applied to simulate virtually any food safety contamination scenario. Apart from the application in crisis situations, the food safety knowledge base concept will also be useful in food quality and safety investigations.

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

Safety assessment in pediatric studies.

PubMed

Koren, Gideon; Elzagallaai, Abdelbasset; Etwel, Fatma

2011-01-01

It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.

A Framework for Assessment of Aviation Safety Technology Portfolios

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.

2014-01-01

The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

A systematic review of Human Factors and Ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety

PubMed Central

Xie, Anping; Carayon, Pascale

2014-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how Human Factors and Ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified twelve projects representing 23 studies and addressing different physical, cognitive and organizational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care. Practitioner Summary Existing evidence shows that HFE-based healthcare system redesign has the potential to improve quality of care and patient safety. Healthcare organizations need to recognize the importance of HFE-based healthcare system redesign to quality of care and patient safety, and invest resources to integrate HFE in healthcare improvement activities. PMID:25323570

Manned space flight nuclear system safety. Volume 5: Nuclear System safety guidelines. Part 1: Space base nuclear safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space base nuclear system safety are presented. Guidelines and requirements are presented for the space base subsystems, nuclear hardware (reactor, isotope sources, dynamic generator equipment), experiments, interfacing vehicles, ground support systems, range safety and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

AGRICULTURAL CHEMICAL SAFETY ASSESSMENT: A MULTISECTOR APPROACH TO THE MODERNIZATION OF HUMAN SAFETY REQUIREMENTS.

EPA Science Inventory

Better understanding of toxicological mechanisms, enhanced testing capabilities, and demands for more sophisticated data for safety and health risk assessment have generated international interest in improving the current testing paradigm for agricultural chemicals. To address th...

Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics.

PubMed

Fiume, Monice; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 16 alkyl ethylhexanoates for use in cosmetics, concluding that these ingredients are safe in cosmetic formulations in the present practices of use and concentrations when formulated to be nonirritating. The alkyl ethylhexanoates primarily function as skin-conditioning agents in cosmetics. The highest concentration of use reported for any of the alkyl ethylhexanoates is 77.3% cetyl ethylhexanoate in rinse-off formulations used near the eye, and the highest leave-on use reported is 52% cetyl ethylhexanoate in lipstick formulations. The Panel reviewed available animal and clinical data related to these ingredients, and the similarities in structure, properties, functions, and uses of ingredients from previous CIR assessments on constituent alcohols that allowed for extrapolation of the available toxicological data to assess the safety of the entire group. © The Author(s) 2015.

[Evidence-based effectiveness of road safety interventions: a literature review].

PubMed

Novoa, Ana M; Pérez, Katherine; Borrell, Carme

2009-01-01

Only road safety interventions with scientific evidence supporting their effectiveness should be implemented. The objective of this study was to identify and summarize the available evidence on the effectiveness of road safety interventions in reducing road traffic collisions, injuries and deaths. All literature reviews published in scientific journals that assessed the effectiveness of one or more road safety interventions and whose outcome measure was road traffic crashes, injuries or fatalities were included. An exhaustive search was performed in scientific literature databases. The interventions were classified according to the evidence of their effectiveness in reducing road traffic injuries (effective interventions, insufficient evidence of effectiveness, ineffective interventions) following the structure of the Haddon matrix. Fifty-four reviews were included. Effective interventions were found before, during and after the collision, and across all factors: a) the individual: the graduated licensing system (31% road traffic injury reduction); b) the vehicle: electronic stability control system (2 to 41% reduction); c) the infrastructure: area-wide traffic calming (0 to 20%), and d) the social environment: speed cameras (7 to 30%). Certain road safety interventions are ineffective, mostly road safety education, and others require further investigation. The most successful interventions are those that reduce or eliminate the hazard and do not depend on changes in road users' behavior or on their knowledge of road safety issues. Interventions based exclusively on education are ineffective in reducing road traffic injuries.

Assessment of insurance incentives for safety belt usage

DOT National Transportation Integrated Search

1983-05-12

This study assesses the feasibility of insurance companies to offer incentives, in the form of premium reductions or additional benefits, which would be effective in increasing safety belt usage. The insurance types considered in this report are auto...

Safety Assessment for the Kozloduy National Disposal Facility in Bulgaria - 13507

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

Biurrun, E.; Haverkamp, B.; Lazaro, A.

2013-07-01

Due to the early decommissioning of four Water-Water Energy Reactors (WWER) 440-V230 reactors at the Nuclear Power Plant (NPP) near the city of Kozloduy in Bulgaria, large amounts of low and intermediate radioactive waste will arise much earlier than initially scheduled. In or-der to manage the radioactive waste from the early decommissioning, Bulgaria has intensified its efforts to provide a near surface disposal facility at Radiana with the required capacity. To this end, a project was launched and assigned in international competition to a German-Spanish consortium to provide the complete technical planning including the preparation of the Intermediate Safety Assessmentmore » Report. Preliminary results of operational and long-term safety show compliance with the Bulgarian regulatory requirements. The long-term calculations carried out for the Radiana site are also a good example of how analysis of safety assessment results can be used for iterative improvements of the assessment by pointing out uncertainties and areas of future investigations to reduce such uncertainties in regard to the potential radiological impact. The computer model used to estimate the long-term evolution of the future repository at Radiana predicted a maximum total annual dose for members of the critical group, which is carried to approximately 80 % by C-14 for a specific ingestion pathway. Based on this result and the outcome of the sensitivity analysis, existing uncertainties were evaluated and areas for reasonable future investigations to reduce these uncertainties were identified. (authors)« less

A Team, Case-based Examination and Its Impact on Student Performance in a Patient Safety and Informatics Course

PubMed Central

Etheridge, Kierstan; DeLellis, Teresa

2017-01-01

Objective. To describe the redesigned assessment plan for a patient safety and informatics course and assess student pharmacist performance and perceptions. Methods. The final examination of a patient safety course was redesigned from traditional multiple choice and short answer to team-based, open-ended, and case-based. Faculty for each class session developed higher level activities, focused on developing key skills or attitudes deemed essential for practice, for a progressive patient case consisting of nine activities. Student performance and perceptions were analyzed with pre- and post-surveys using 5-point scales. Results. Mean performance on the examination was 93.6%; median scores for each assessed course outcome ranged from 90% to 100%. Eighty-five percent of students completed both surveys. Confidence performing skills and demonstrating attitudes improved for each item on post-survey compared with pre-survey. Eighty-one percent of students indicated the experience of taking the examination was beneficial for their professional development. Conclusion. A team, case-based examination was associated with high student performance and improved self-confidence in performing medication safety-related skills. PMID:28970618

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Evaluation of the Quality of Occupational Health and Safety Management Systems Based on Key Performance Indicators in Certified Organizations.

PubMed

Mohammadfam, Iraj; Kamalinia, Mojtaba; Momeni, Mansour; Golmohammadi, Rostam; Hamidi, Yadollah; Soltanian, Alireza

2017-06-01

Occupational Health and Safety Management Systems are becoming more widespread in organizations. Consequently, their effectiveness has become a core topic for researchers. This paper evaluates the performance of the Occupational Health and Safety Assessment Series 18001 specification in certified companies in Iran. The evaluation is based on a comparison of specific criteria and indictors related to occupational health and safety management practices in three certified and three noncertified companies. Findings indicate that the performance of certified companies with respect to occupational health and safety management practices is significantly better than that of noncertified companies. Occupational Health and Safety Assessment Series 18001-certified companies have a better level of occupational health and safety; this supports the argument that Occupational Health and Safety Management Systems play an important strategic role in health and safety in the workplace.

Market-based control mechanisms for patient safety

PubMed Central

Coiera, E; Braithwaite, J

2009-01-01

A new model is proposed for enhancing patient safety using market-based control (MBC), inspired by successful approaches to environmental governance. Emissions trading, enshrined in the Kyoto protocol, set a carbon price and created a carbon market—is it possible to set a patient safety price and let the marketplace find ways of reducing clinically adverse events? To “cap and trade,” a regulator would need to establish system-wide and organisation-specific targets, based on the cost of adverse events, create a safety market for trading safety credits and then police the market. Organisations are given a clear policy signal to reduce adverse event rates, are told by how much, but are free to find mechanisms best suited to their local needs. The market would inevitably generate novel ways of creating safety credits, and accountability becomes hard to evade when adverse events are explicitly measured and accounted for in an organisation’s bottom line. PMID:19342522

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

NASA Astrophysics Data System (ADS)

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

2017-06-01

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

Improving construction site safety through leader-based verbal safety communication.

PubMed

Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

2010-10-01

The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

Evidence-based safety (EBS) management: A new approach to teaching the practice of safety management (SM).

PubMed

Wang, Bing; Wu, Chao; Shi, Bo; Huang, Lang

2017-12-01

In safety management (SM), it is important to make an effective safety decision based on the reliable and sufficient safety-related information. However, many SM failures in organizations occur for a lack of the necessary safety-related information for safety decision-making. Since facts are the important basis and foundation for decision-making, more efforts to seek the best evidence relevant to a particular SM problem would lead to a more effective SM solution. Therefore, the new paradigm for decision-making named "evidence-based practice (EBP)" can hold important implications for SM, because it uses the current best evidence for effective decision-making. Based on a systematic review of existing SM approaches and an analysis of reasons why we need new SM approaches, we created a new SM approach called evidence-based safety (EBS) management by introducing evidence-based practice into SM. It was necessary to create new SM approaches. A new SM approach called EBS was put forward, and the basic questions of EBS such as its definition and core were analyzed in detail. Moreover, the determinants of EBS included manager's attitudes towards EBS; evidence-based consciousness in SM; evidence sources; technical support; EBS human resources; organizational culture; and individual attributes. EBS is a new and effective approach to teaching the practice of SM. Of course, further research on EBS should be carried out to make EBS a reality. Practical applications: Our work can provide a new and effective idea and method to teach the practice of SM. Specifically, EBS proposed in our study can help safety professionals make an effective safety decision based on a firm foundation of high-grade evidence. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2011-01-01

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

Use of assessment to reinforce patient safety as a habit

PubMed Central

Galbraith, R M; Holtman, M C; Clyman, S G

2006-01-01

The US spends far more than any other nation on health care. Physicians undergo lengthy and comprehensive training that is carefully scrutinized, and are held to high standards in national examinations. At best the care delivered matches or exceeds that in any other country. And yet, often simple preventable medical errors occur at alarming and unacceptable rates. The public, corporate consumers of health care, large payors and malpractice insurance carriers are all becoming impatient with the pace of improvement. The medical profession recognizes that dealing with this problem is an urgent priority and is grappling to find the best approaches. This paper focuses on the constructive use of assessment to embed a pervasive and proactive culture of patient safety into practice, starting with the trainee and extending out into the practice years. This strategy is based on the adage that “assessment drives curriculum” and proposes a series of new assessment tools to be added to all phases of the training‐practice continuum. PMID:17142605

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

Terrain Safety Assessment in Support of the Mars Science Laboratory Mission

NASA Technical Reports Server (NTRS)

Kipp, Devin

2012-01-01

In August 2012, the Mars Science Laboratory (MSL) mission will pioneer the next generation of robotic Entry, Descent, and Landing (EDL) systems by delivering the largest and most capable rover to date to the surface of Mars. The process to select the MSL landing site took over five years and began with over 50 initial candidate sites from which four finalist sites were chosen. The four finalist sites were examined in detail to assess overall science merit, EDL safety, and rover traversability on the surface. Ultimately, the engineering assessments demonstrated a high level of safety and robustness at all four finalist sites and differences in the assessment across those sites were small enough that neither EDL safety nor rover traversability considerations could significantly discriminate among the final four sites. Thus the MSL landing site at Gale Crater was selected from among the four finalists primarily on the basis of science considerations.

Use of Foodomics for Control of Food Processing and Assessing of Food Safety.

PubMed

Josić, D; Peršurić, Ž; Rešetar, D; Martinović, T; Saftić, L; Kraljević Pavelić, S

Food chain, food safety, and food-processing sectors face new challenges due to globalization of food chain and changes in the modern consumer preferences. In addition, gradually increasing microbial resistance, changes in climate, and human errors in food handling remain a pending barrier for the efficient global food safety management. Consequently, a need for development, validation, and implementation of rapid, sensitive, and accurate methods for assessment of food safety often termed as foodomics methods is required. Even though, the growing role of these high-throughput foodomic methods based on genomic, transcriptomic, proteomic, and metabolomic techniques has yet to be completely acknowledged by the regulatory agencies and bodies. The sensitivity and accuracy of these methods are superior to previously used standard analytical procedures and new methods are suitable to address a number of novel requirements posed by the food production sector and global food market. © 2017 Elsevier Inc. All rights reserved.

A web-based tool for the Comprehensive Unit-based Safety Program (CUSP).

PubMed

Pronovost, Peter J; King, Jay; Holzmueller, Christine G; Sawyer, Melinda; Bivens, Shauna; Michael, Michelle; Haig, Kathy; Paine, Lori; Moore, Dana; Miller, Marlene

2006-03-01

An organization's ability to change is driven by its culture, which in turn has a significant impact on safety. The six-step Comprehensive Unit-Based Safety Program (CUSP) is intended to improve local culture and safety. A Web-based project management tool for CUSP was developed and then pilot tested at two hospitals. HOW ECUSP WORKS: Once a patient safety concern is identified (step 3), a unit-level interdisciplinary safety committee determines issue criticality and starts up the projects (step 4), which are managed using project management tools within eCUSP (step 5). On a project's completion, the results are disseminated through a shared story (step 6). OSF St. Joseph's Medical Center-The Medical Birthing Center (Bloomington, Illinois), identified 11 safety issues, implemented 11 projects, and created 9 shared stories--including one for its Armband Project. The Johns Hopkins Hospital (Baltimore) Medical Progressive Care (MPC4) Unit identified 5 safety issues and implemented 4 ongoing projects, including the intravenous (IV) Tubing Compliance Project. The eCUSP tool's success depends on an organizational commitment to creating a culture of safety.

Safety from Crime and Physical Activity among Older Adults: A Population-Based Study in Brazil

PubMed Central

Weber Corseuil, Maruí; Hallal, Pedro Curi; Xavier Corseuil, Herton; Jayce Ceola Schneider, Ione; d'Orsi, Eleonora

2012-01-01

Objective. To evaluate the association between safety from crime and physical activity among older adults. Methods. A population-based survey including 1,656 older adults (60+ years) took place in Florianopolis, Brazil, in 2009-2010. Commuting and leisure time physical activity were assessed through the long version of the International Physical Activity Questionnaire. Perception of safety from crime was assessed using the Neighbourhood Environment Walkability Scale. Results. Perceiving the neighbourhood as safe during the day was related to a 25% increased likelihood of being active in leisure time (95% CI 1.02–1.53); general perception of safety was also associated with a 25% increase in the likelihood of being active in leisure time (95% CI 1.01–1.54). Street lighting was related to higher levels of commuting physical activity (prevalence ratio: 1.89; 95% CI 1.28–2.80). Conclusions. Safety investments are essential for promoting physical activity among older adults in Brazil. PMID:22291723

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

Applying Sensor-Based Technology to Improve Construction Safety Management.

PubMed

Zhang, Mingyuan; Cao, Tianzhuo; Zhao, Xuefeng

2017-08-11

Construction sites are dynamic and complicated systems. The movement and interaction of people, goods and energy make construction safety management extremely difficult. Due to the ever-increasing amount of information, traditional construction safety management has operated under difficult circumstances. As an effective way to collect, identify and process information, sensor-based technology is deemed to provide new generation of methods for advancing construction safety management. It makes the real-time construction safety management with high efficiency and accuracy a reality and provides a solid foundation for facilitating its modernization, and informatization. Nowadays, various sensor-based technologies have been adopted for construction safety management, including locating sensor-based technology, vision-based sensing and wireless sensor networks. This paper provides a systematic and comprehensive review of previous studies in this field to acknowledge useful findings, identify the research gaps and point out future research directions.

Assessment of occupational safety risks in Floridian solid waste systems using Bayesian analysis.

PubMed

Bastani, Mehrad; Celik, Nurcin

2015-10-01

Safety risks embedded within solid waste management systems continue to be a significant issue and are prevalent at every step in the solid waste management process. To recognise and address these occupational hazards, it is necessary to discover the potential safety concerns that cause them, as well as their direct and/or indirect impacts on the different types of solid waste workers. In this research, our goal is to statistically assess occupational safety risks to solid waste workers in the state of Florida. Here, we first review the related standard industrial codes to major solid waste management methods including recycling, incineration, landfilling, and composting. Then, a quantitative assessment of major risks is conducted based on the data collected using a Bayesian data analysis and predictive methods. The risks estimated in this study for the period of 2005-2012 are then compared with historical statistics (1993-1997) from previous assessment studies. The results have shown that the injury rates among refuse collectors in both musculoskeletal and dermal injuries have decreased from 88 and 15 to 16 and three injuries per 1000 workers, respectively. However, a contrasting trend is observed for the injury rates among recycling workers, for whom musculoskeletal and dermal injuries have increased from 13 and four injuries to 14 and six injuries per 1000 workers, respectively. Lastly, a linear regression model has been proposed to identify major elements of the high number of musculoskeletal and dermal injuries. © The Author(s) 2015.

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

Towards a Food Safety Knowledge Base Applicable in Crisis Situations and Beyond

PubMed Central

Falenski, Alexander; Weiser, Armin A.; Thöns, Christian; Appel, Bernd; Käsbohrer, Annemarie; Filter, Matthias

2015-01-01

In case of contamination in the food chain, fast action is required in order to reduce the numbers of affected people. In such situations, being able to predict the fate of agents in foods would help risk assessors and decision makers in assessing the potential effects of a specific contamination event and thus enable them to deduce the appropriate mitigation measures. One efficient strategy supporting this is using model based simulations. However, application in crisis situations requires ready-to-use and easy-to-adapt models to be available from the so-called food safety knowledge bases. Here, we illustrate this concept and its benefits by applying the modular open source software tools PMM-Lab and FoodProcess-Lab. As a fictitious sample scenario, an intentional ricin contamination at a beef salami production facility was modelled. Predictive models describing the inactivation of ricin were reviewed, relevant models were implemented with PMM-Lab, and simulations on residual toxin amounts in the final product were performed with FoodProcess-Lab. Due to the generic and modular modelling concept implemented in these tools, they can be applied to simulate virtually any food safety contamination scenario. Apart from the application in crisis situations, the food safety knowledge base concept will also be useful in food quality and safety investigations. PMID:26247028

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

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

Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

PubMed

Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

2015-01-01

Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

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

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

A systematic review of human factors and ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety.

PubMed

Xie, Anping; Carayon, Pascale

2015-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how human factors and ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified 12 projects representing 23 studies and addressing different physical, cognitive and organisational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care.

Food Safety Practices Assessment Tool: An Innovative Way to Test Food Safety Skills among Individuals with Special Needs

ERIC Educational Resources Information Center

Carbone, Elena T.; Scarpati, Stanley E.; Pivarnik, Lori F.

2013-01-01

This article describes an innovative assessment tool designed to evaluate the effectiveness of a food safety skills curriculum for learners receiving special education services. As schools respond to the increased demand for training students with special needs about food safety, the need for effective curricula and tools is also increasing. A…

Applying Sensor-Based Technology to Improve Construction Safety Management

PubMed Central

Zhang, Mingyuan; Cao, Tianzhuo; Zhao, Xuefeng

2017-01-01

Construction sites are dynamic and complicated systems. The movement and interaction of people, goods and energy make construction safety management extremely difficult. Due to the ever-increasing amount of information, traditional construction safety management has operated under difficult circumstances. As an effective way to collect, identify and process information, sensor-based technology is deemed to provide new generation of methods for advancing construction safety management. It makes the real-time construction safety management with high efficiency and accuracy a reality and provides a solid foundation for facilitating its modernization, and informatization. Nowadays, various sensor-based technologies have been adopted for construction safety management, including locating sensor-based technology, vision-based sensing and wireless sensor networks. This paper provides a systematic and comprehensive review of previous studies in this field to acknowledge useful findings, identify the research gaps and point out future research directions. PMID:28800061

An outline of a risk assessment-based system of meat safety assurance and its future prospects.

PubMed

Berends, B R; van Knapen, F

1999-10-01

Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences

DriveWise: An Interdisciplinary Hospital-Based Driving Assessment Program

ERIC Educational Resources Information Center

O'Connor, Margaret G.; Kapust, Lissa R.; Hollis, Ann M.

2008-01-01

Health care professionals working with the elderly have opportunities through research and clinical practice to shape public policy affecting the older driver. This article describes DriveWise, an interdisciplinary hospital-based driving assessment program developed in response to clinical concerns about the driving safety of individuals with…

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

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

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

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

Assessment of patient safety culture in Palestinian public hospitals.

PubMed

Hamdan, Motasem; Saleem, Abed Alra'oof

2013-04-01

To assess the prevalent patient safety culture in Palestinian public hospitals. A cross-sectional design, Arabic translated version of the Hospital Survey on Patient Safety Culture was used. All the 11 general public hospitals in the West Bank. A total of 1460 clinical and non-clinical hospital staff. No. Twelve patient safety culture composites and 2 outcome variables (patient safety grade and events reported in the past year) were measured. Most of the participants were nurses and physicians (69.2%) with direct contact with patients (92%), mainly employed in medical/surgical units (55.1%). The patient safety composites with the highest positive scores were teamwork within units (71%), organizational learning and continuous improvement (62%) and supervisor/manager expectations and actions promoting patient safety (56%). The composites with the lowest scores were non-punitive response to error (17%), frequency of events reported (35%), communication openness (36%), hospital management support for patient safety (37%) and staffing (38%). Although 53.2% of the respondents did not report any event in the past year, 63.5% rated patient safety level as 'excellent/very good'. Significant differences in patient safety scores and outcome variables were found between hospitals of different size and in relation to staff positions and work hours. This study highlights the existence of a punitive and blame culture, under-reporting of events, lack of communication openness and inadequate management support that are key challenges for patient safe hospital care. The baseline survey results are valuable for designing and implementing the patient safety program and for measuring future progress.

Impact of biomarker development on drug safety assessment

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

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

2010-03-01

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

Simulating Geriatric Home Safety Assessments in a Three-Dimensional Virtual World

ERIC Educational Resources Information Center

Andrade, Allen D.; Cifuentes, Pedro; Mintzer, Michael J.; Roos, Bernard A.; Anam, Ramanakumar; Ruiz, Jorge G.

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with…

[Clinical assessment of drug safety].

PubMed

Imbs, J-L; Welsch, M

2007-09-01

The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.

The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

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.

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

Featured Article: Evaluating Smartphone-Based Virtual Reality to Improve Chinese Schoolchildren's Pedestrian Safety: A Nonrandomized Trial.

PubMed

Schwebel, David C; Wu, Yue; Li, Peng; Severson, Joan; He, Yefei; Xiang, Henry; Hu, Guoqing

2018-06-01

This nonrandomized trial evaluated whether classroom-based training in a smartphone-based virtual reality (VR) pedestrian environment (a) teaches schoolchildren to cross streets safely, and (b) increases their self-efficacy for street-crossing. Fifty-six children, aged 8-10 years, attending primary school in Changsha, China participated. Baseline pedestrian safety assessment occurred in the VR environment and through unobtrusive observation of a subsample crossing a street for 11 days outside school. Self-efficacy was assessed through both self-report and observation. Following baseline, children engaged in the VR for 12 days in their classrooms, honing complex cognitive-perceptual skills required to engage safely in traffic. Follow-up assessment replicated baseline. Probability of crash in the VR decreased posttraining (0.40 vs. 0.09), and observational data found the odds of looking at oncoming traffic while crossing the first lane of traffic increased (odds ratio [OR] = 2.4). Self-efficacy increases occurred in self-report (proportional OR = 4.7 crossing busy streets) and observation of following crossing-guard signals (OR = 0.2, first lane). Pedestrian safety training via smartphone-based VR provides children the repeated practice needed to learn the complex skills required to cross streets safely, and also helps them improve self-efficacy to cross streets. Given rapid motorization and global smartphone penetration, plus epidemiological findings that about 75,000 children die annually worldwide in pedestrian crashes, smartphone-based VR could supplement existing policy and prevention efforts to improve global child pedestrian safety.

Making the message meaningful: a qualitative assessment of media promoting all-terrain vehicle safety.

PubMed

Brann, Maria; Mullins, Samantha Hope; Miller, Beverly K; Eoff, Shane; Graham, James; Aitken, Mary E

2012-08-01

Millions of all-terrain vehicles (ATV) are used around the world for recreation by both adults and youth. This increase in use has led to a substantial increase in the number of injuries and fatalities each year. Effective strategies for reducing this incidence are clearly needed; however, minimal research exists regarding effective educational interventions. This study was designed to assess rural ATV riders' preferences for and assessment of safety messages. 13 focus group discussions with youth and adult ATV riders were conducted. 88 formative research participants provided feedback on existing ATV safety materials, which was used to develop more useful ATV safety messages. 60 evaluative focus group participants critiqued the materials developed for this project. Existing ATV safety materials have limited effectiveness, in part because they may not address the content or design needs of the target population. ATV riders want educational and action-oriented safety messages that inform youth and adult riders about their responsibilities to learn, educate and implement safety behaviours (eg, appropriate-sized ATV, safety gear, solo riding, speed limits, riding locations). In addition, messages should be clear, realistic, visually appealing and easily accessible. Newly designed ATV safety materials using the acronym TRIPSS (training, ride off-road, impairment, plan ahead, safety gear, single rider) meet ATV riders' safety messaging needs. To reach a target population, it is crucial to include them in the development and assessment of safety messages. Germane to this particular study, ATV riders provided essential information for creating useful ATV safety materials.

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.

A Safety Program that Integrated Behavior-Based Safety and Traditional Safety Methods and Its Effects on Injury Rates of Manufacturing Workers

ERIC Educational Resources Information Center

Hermann, Jaime A.; Ibarra, Guillermo V.; Hopkins, B. L.

2010-01-01

The present research examines the effects of a complex safety program that combined Behavior-Based Safety (BBS) and traditional safety methods. The study was conducted in an automobile parts plant in Mexico. Two sister plants served as comparison. Some of the components of the safety programs addressed behaviors of managers and included methods…

Nature-Based Strategies for Improving Urban Health and Safety.

PubMed

Kondo, Michelle C; South, Eugenia C; Branas, Charles C

2015-10-01

Place-based programs are being noticed as key opportunities to prevent disease and promote public health and safety for populations at-large. As one key type of place-based intervention, nature-based and green space strategies can play an especially large role in improving health and safety for dwellers in urban environments such as US legacy cities that lack nature and greenery. In this paper, we describe the current understanding of place-based influences on public health and safety. We focus on nonchemical environmental factors, many of which are related to urban abandonment and blight. We then review findings from studies of nature-based interventions regarding impacts on health, perceptions of safety, and crime. Based on our findings, we suggest that further research in this area will require (1) refined measures of green space, nature, and health and safety for cities, (2) interdisciplinary science and cross-sector policy collaboration, (3) observational studies as well as randomized controlled experiments and natural experiments using appropriate spatial counterfactuals and mixed methods, and (4) return-on-investment calculations of potential economic, social, and health costs and benefits of urban greening initiatives.

Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.

PubMed

Sahota, Tarjinder; Danhof, Meindert; Della Pasqua, Oscar

2016-05-01

Despite ongoing efforts to better understand the mechanisms underlying safety and toxicity, ~30% of the attrition in drug discovery and development is still due to safety concerns. Changes in current practice regarding the assessment of safety and toxicity are required to reduce late stage attrition and enable effective development of novel medicines. This review focuses on the implications of empirical evidence generation for the evaluation of safety and toxicity during drug development. A shift in paradigm is needed to (i) ensure that pharmacological concepts are incorporated into the evaluation of safety and toxicity; (ii) facilitate the integration of historical evidence and thereby the translation of findings across species as well as between in vitro and in vivo experiments and (iii) promote the use of experimental protocols tailored to address specific safety and toxicity questions. Based on historical examples, we highlight the challenges for the early characterisation of the safety profile of a new molecule and discuss how model-based methodologies can be applied for the design and analysis of experimental protocols. Issues relative to the scientific rationale are categorised and presented as a hierarchical tree describing the decision-making process. Focus is given to four different areas, namely, optimisation, translation, analytical construct and decision criteria. From a methodological perspective, the relevance of quantitative methods for estimation and extrapolation of risk from toxicology and safety pharmacology experimental protocols, such as points of departure and potency, is discussed in light of advancements in population and Bayesian modelling techniques (e.g. non-linear mixed effects modelling). Their use in the evaluation of pharmacokinetics (PK) and pharmacokinetic-pharmacodynamic relationships (PKPD) has enabled great insight into the dose rationale for medicines in humans, both in terms of efficacy and adverse events. Comparable benefits

LNG safety assessment evaluation methods : task 3 letter report.

DOT National Transportation Integrated Search

2016-07-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

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.

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration (NASA) Space-Based Telemetry and Range Safety (STARS) study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety [global positioning system (GPS) metric tracking data, flight termination command and range safety data relay] and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California, USA) using the NASA Tracking and Data Relay Satellite System (TDRSS) as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit (RSU) provided real-time video for three days during the historic Global Flyer (Scaled Composites, Mojave, California, USA) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This paper discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety (global positioning system metric tracking data, flight termination command and range safety data relay) and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California) using the NASA Tracking and Data Relay Satellite System as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit provided real-time video for three days during the historic GlobalFlyer (Scaled Composites, Mojave, California) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This report discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

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

PubMed

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

2014-02-01

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

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

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

PubMed

Delaney, Bryan

2015-12-01

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

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

Safety assessment in the urban park environment in Alborz Province, Iran.

PubMed

Oostakhan, Morteza; Babaei, Aliakbar

2013-01-01

Urban parks, as one of the recreational and sports sectors, could cause serious injuries among different ages if the safety issues in their design are not considered. These injuries can result from the equipment in the park, including play and sports equipment, or even from environmental factors, too. Lack of safety benchmark in parks will impact on the development of future proposals. In this article, attempts are made to survey the important safety factors in the urban parks including playgrounds, fitness equipment, pedestrian surface and environmental factors into a risk assessment. Hence, a checklist of safety factors was used. A Yes or No descriptor was allocated to any factor for determining safety level. The study also suggests recommendations for future planning concerning existing failures for designers. It was found that the safety level of the regional and local parks differ from each other.

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.

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

Comparison of AIHA ISO 9001-based occupational health and safety management system guidance document with a manufacturer's occupational health and safety assessment instrument.

PubMed

Dyjack, D T; Levine, S P; Holtshouser, J L; Schork, M A

1998-06-01

Numerous manufacturing and service organizations have integrated or are considering integration of their respective occupational health and safety management and audit systems into the International Organization for Standardization-based (ISO) audit-driven Quality Management Systems (ISO 9000) or Environmental Management Systems (ISO 14000) models. Companies considering one of these options will likely need to identify and evaluate several key factors before embarking on such efforts. The purpose of this article is to identify and address the key factors through a case study approach. Qualitative and quantitative comparisons of the key features of the American Industrial Hygiene Association ISO-9001 harmonized Occupational Health and Safety Management System with The Goodyear Tire & Rubber Co. management and audit system were conducted. The comparisons showed that the two management systems and their respective audit protocols, although structured differently, were not substantially statistically dissimilar in content. The authors recommend that future studies continue to evaluate the advantages and disadvantages of various audit protocols. Ideally, these studies would identify those audit outcome measures that can be reliably correlated with health and safety performance.

A systems-based food safety evaluation: an experimental approach.

PubMed

Higgins, Charles L; Hartfield, Barry S

2004-11-01

Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

Justification of system of assessment of ecological safety degree of housing construction objects

NASA Astrophysics Data System (ADS)

Kankhva, Vadim

2017-10-01

In article characteristics and properties of competitiveness of housing construction objects are investigated, criteria and points of national systems of ecological building’s standardization are structured, the compliance assessment form on stages of life cycle of a capital construction project is developed. The main indicators of level of ecological safety considering requirements of the international ISO standards 9000 and ISO 14000 and which are based on the basic principles of general quality management (TQM) are presented.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

PubMed

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity

An Operational Safety and Certification Assessment of a TASAR EFB Application

NASA Technical Reports Server (NTRS)

Koczo, Stefan; Wing, David

2013-01-01

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

Biomarkers: Dynamic "Tools" for Health and Safety Risk Assessment

EPA Science Inventory

Today informational flow from biomarkers contributes importantly to various types of health effects research, risk assessment and risk management decisions that impact, or have the potential to impact, public health and safety. Therefore, dependent upon the nature of the health r...

Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

NASA Technical Reports Server (NTRS)

1972-01-01

A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Simulation-based assessment in anesthesiology: requirements for practical implementation.

PubMed

Boulet, John R; Murray, David J

2010-04-01

Simulations have taken a central role in the education and assessment of medical students, residents, and practicing physicians. The introduction of simulation-based assessments in anesthesiology, especially those used to establish various competencies, has demanded fairly rigorous studies concerning the psychometric properties of the scores. Most important, major efforts have been directed at identifying, and addressing, potential threats to the validity of simulation-based assessment scores. As a result, organizations that wish to incorporate simulation-based assessments into their evaluation practices can access information regarding effective test development practices, the selection of appropriate metrics, the minimization of measurement errors, and test score validation processes. The purpose of this article is to provide a broad overview of the use of simulation for measuring physician skills and competencies. For simulations used in anesthesiology, studies that describe advances in scenario development, the development of scoring rubrics, and the validation of assessment results are synthesized. Based on the summary of relevant research, psychometric requirements for practical implementation of simulation-based assessments in anesthesiology are forwarded. As technology expands, and simulation-based education and evaluation takes on a larger role in patient safety initiatives, the groundbreaking work conducted to date can serve as a model for those individuals and organizations that are responsible for developing, scoring, or validating simulation-based education and assessment programs in anesthesiology.

Safety assessment in schools: beyond risk: the role of child psychiatrists and other mental health professionals.

PubMed

Rappaport, Nancy; Pollack, William S; Flaherty, Lois T; Schwartz, Sarah E O; McMickens, Courtney

2015-04-01

This article presents an overview of a comprehensive school safety assessment approach for students whose behavior raises concern about their potential for targeted violence. Case vignettes highlight the features of 2 youngsters who exemplify those seen, the comprehensive nature of the assessment, and the kind of recommendations that enhance a student's safety, connection, well-being; engage families; and share responsibility of assessing safety with the school. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparing REACH Chemical Safety Assessment information with practice-a case-study of polymethylmethacrylate (PMMA) in floor coating in The Netherlands.

PubMed

Spee, Ton; Huizer, Daan

2017-10-01

On June 1st, 2007 the European regulation on Registration, Evaluation and Restriction of Chemical substances (REACH) came into force. Aim of the regulation is safe use of chemicals for humans and for the environment. The core element of REACH is chemical safety assessment of chemicals and communication of health and safety hazards and risk management measures throughout the supply chain. Extended Safety Data Sheets (Ext-SDS) are the primary carriers of health and safety information. The aim of our project was to find out whether the actual exposure to methyl methacrylate (MMA) during the application of polymethylmethacrylate (PMMA) in floor coatings as assessed in the chemical safety assessment, reflect the exposure situations as observed in the Dutch building practice. Use of PMMA flooring and typical exposure situations during application were discussed with twelve representatives of floor laying companies. Representative situations for exposure measurements were designated on the basis of this inventory. Exposure to MMA was measured in the breathing zone of the workers at four construction sites, 14 full shift samples and 14 task based samples were taken by personal air sampling. The task-based samples were compared with estimates from the Targeted Risk Assessment Tool (v3.1) of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC-TRA) as supplied in the safety assessment from the manufacturer. For task-based measurements, in 12 out of 14 (86%) air samples measured exposure was higher than estimated exposure. Recalculation with a lower ventilation rate (50% instead of 80%) together with a higher temperature during mixing (40°C instead of 20°C) in comparison with the CSR, reduced the number of underestimated exposures to 10 (71%) samples. Estimation with the EMKG-EXPO-Tool resulted in unsafe exposure situations for all scenarios, which is in accordance with the measurement outcomes. In indoor situations, 5 out of 8 full shift exposures (62

Use of evidential reasoning and AHP to assess regional industrial safety

PubMed Central

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China’s fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others. PMID:29795593

Error disclosure: a new domain for safety culture assessment.

PubMed

Etchegaray, Jason M; Gallagher, Thomas H; Bell, Sigall K; Dunlap, Ben; Thomas, Eric J

2012-07-01

To (1) develop and test survey items that measure error disclosure culture, (2) examine relationships among error disclosure culture, teamwork culture and safety culture and (3) establish predictive validity for survey items measuring error disclosure culture. All clinical faculty from six health institutions (four medical schools, one cancer centre and one health science centre) in The University of Texas System were invited to anonymously complete an electronic survey containing questions about safety culture and error disclosure. The authors found two factors to measure error disclosure culture: one factor is focused on the general culture of error disclosure and the second factor is focused on trust. Both error disclosure culture factors were unique from safety culture and teamwork culture (correlations were less than r=0.85). Also, error disclosure general culture and error disclosure trust culture predicted intent to disclose a hypothetical error to a patient (r=0.25, p<0.001 and r=0.16, p<0.001, respectively) while teamwork and safety culture did not predict such an intent (r=0.09, p=NS and r=0.12, p=NS). Those who received prior error disclosure training reported significantly higher levels of error disclosure general culture (t=3.7, p<0.05) and error disclosure trust culture (t=2.9, p<0.05). The authors created and validated a new measure of error disclosure culture that predicts intent to disclose an error better than other measures of healthcare culture. This measure fills an existing gap in organisational assessments by assessing transparent communication after medical error, an important aspect of culture.

Nature-based strategies for improving urban health and safety

Treesearch

Michelle C. Kondo; Eugenia C. South; Charles C. Branas

2015-01-01

Place-based programs are being noticed as key opportunities to prevent disease and promote public health and safety for populations at-large. As one key type of place-based intervention, nature-based and green space strategies can play an especially large role in improving health and safety for dwellers in urban environments such as US legacy cities that lack nature...

Risk-Based Explosive Safety Analysis

DTIC Science & Technology

2016-11-30

safety siting of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed...liquids or propellants . 15. SUBJECT TERMS N/A 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed personnel and the

Planning the Unplanned Experiment: Towards Assessing the Efficacy of Standards for Safety-Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. M.

2015-01-01

Safe use of software in safety-critical applications requires well-founded means of determining whether software is fit for such use. While software in industries such as aviation has a good safety record, little is known about whether standards for software in safety-critical applications 'work' (or even what that means). It is often (implicitly) argued that software is fit for safety-critical use because it conforms to an appropriate standard. Without knowing whether a standard works, such reliance is an experiment; without carefully collecting assessment data, that experiment is unplanned. To help plan the experiment, we organized a workshop to develop practical ideas for assessing software safety standards. In this paper, we relate and elaborate on the workshop discussion, which revealed subtle but important study design considerations and practical barriers to collecting appropriate historical data and recruiting appropriate experimental subjects. We discuss assessing standards as written and as applied, several candidate definitions for what it means for a standard to 'work,' and key assessment strategies and study techniques and the pros and cons of each. Finally, we conclude with thoughts about the kinds of research that will be required and how academia, industry, and regulators might collaborate to overcome the noted barriers.

The attitude of Canadian university students toward a behavior-based blood donor health assessment questionnaire.

PubMed

Go, Stephanie L; Lam, Cindy T Y; Lin, Yahui T; Wong, Deborah J; Lazo-Langner, Alejandro; Chin-Yee, Ian

2011-04-01

In Canada, all men who have sex with men (MSM) are indefinitely deferred from donating blood. The purpose of this study was to determine the acceptability of an alternative behavior-based donor health questionnaire among Canadian university students. Further we sought to determine the perception of blood safety associated with specific risk behaviors. Questions found on the Canadian Blood Services' donor health assessment questionnaire as well as from studies assessing high-risk behavior for human immunodeficiency virus infection were included. For each question participants were asked to rate the acceptability, comfort in answering, perceived effect on blood safety, and whether the question would deter them from donating blood. Data were analyzed using nonparametric tests. A total of 741 students participated in the study. Questions regarding sexual practices of the donor were rated less important for blood safety compared to those assessing for sexually transmitted infections, sex for money, and injection drug use (30%-62% vs. 69%-95% unsafe). A total of 24.4% of students rated both questions on MSM status and a behavior-based alternative as equally unacceptable. We found an inverse correlation between perception of safety and acceptability of questions. Our findings suggest that a behavior-based screening modification is unlikely to change opinions or satisfy those who object to the MSM current policy in place. Acceptability of these questions might be related to a poor understanding of the effect of sexual practices on blood supply safety. © 2010 American Association of Blood Banks.

Dependability modeling and assessment in UML-based software development.

PubMed

Bernardi, Simona; Merseguer, José; Petriu, Dorina C

2012-01-01

Assessment of software nonfunctional properties (NFP) is an important problem in software development. In the context of model-driven development, an emerging approach for the analysis of different NFPs consists of the following steps: (a) to extend the software models with annotations describing the NFP of interest; (b) to transform automatically the annotated software model to the formalism chosen for NFP analysis; (c) to analyze the formal model using existing solvers; (d) to assess the software based on the results and give feedback to designers. Such a modeling→analysis→assessment approach can be applied to any software modeling language, be it general purpose or domain specific. In this paper, we focus on UML-based development and on the dependability NFP, which encompasses reliability, availability, safety, integrity, and maintainability. The paper presents the profile used to extend UML with dependability information, the model transformation to generate a DSPN formal model, and the assessment of the system properties based on the DSPN results.

Dependability Modeling and Assessment in UML-Based Software Development

PubMed Central

Bernardi, Simona; Merseguer, José; Petriu, Dorina C.

2012-01-01

Assessment of software nonfunctional properties (NFP) is an important problem in software development. In the context of model-driven development, an emerging approach for the analysis of different NFPs consists of the following steps: (a) to extend the software models with annotations describing the NFP of interest; (b) to transform automatically the annotated software model to the formalism chosen for NFP analysis; (c) to analyze the formal model using existing solvers; (d) to assess the software based on the results and give feedback to designers. Such a modeling→analysis→assessment approach can be applied to any software modeling language, be it general purpose or domain specific. In this paper, we focus on UML-based development and on the dependability NFP, which encompasses reliability, availability, safety, integrity, and maintainability. The paper presents the profile used to extend UML with dependability information, the model transformation to generate a DSPN formal model, and the assessment of the system properties based on the DSPN results. PMID:22988428

Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS

EPA Science Inventory

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

A multi-stakeholder series of discussions d...

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

Risk Assessment in the UK Health and Safety System: Theory and Practice.

PubMed

Russ, Karen

2010-09-01

In the UK, a person or organisation that creates risk is required to manage and control that risk so that it is reduced 'So Far As Is Reasonably Practicable' (SFAIRP). How the risk is managed is to be determined by those who create the risk. They have a duty to demonstrate that they have taken action to ensure all risk is reduced SFAIRP and must have documentary evidence, for example a risk assessment or safety case, to prove that they manage the risks their activities create. The UK Health and Safety Executive (HSE) does not tell organisations how to manage the risks they create but does inspect the quality of risk identification and management. This paper gives a brief overview of where responsibility for occupational health and safety lies in the UK, and how risk should be managed through risk assessment. The focus of the paper is three recent major UK incidents, all involving fatalities, and all of which were wholly avoidable if risks had been properly assessed and managed. The paper concludes with an analysis of the common failings of risk assessments and key actions for improvement.

[Hazard assessment and occupational safety measures in surgery : Relevant knowledge on occupational medicine].

PubMed

Darius, S; Meyer, F; Böckelmann, I

2016-11-01

Surgeons routinely work in an environment with occupational risks and hazards about which they are often uninformed. Based on the currently available scientific literature this review article describes the various hazards in the operating theater and their effects on personnel, particularly from the surgical perspective. A further aim of this article is to describe the occupational safety measures to reduce the burdens and to maintain the long-term health of personnel. Ultimately, surgeons should be equipped with the necessary knowledge for implementing hazard assessments according to the German Occupational Health and Safety Act. Surgeons are exposed to increased risks and hazards by working in awkward positions with a high risk for musculoskeletal pain and injuries. They are also commonly exposed to inhalational anesthetics, surgical smoke, radiation, noise and infectious agents. Furthermore, the mental and emotional stress associated with these activities is also high. Meaningful occupational safety measures for reduction of burdens are from a technical aspect the installation of effective air extraction systems, measures to reduce exposure to radiation and noise and the use of safer instruments to prevent needle stick injuries. Furthermore, individual occupational safety measures, such as the use of personal protective equipment (e.g. radiation protective clothing and double gloves) must be observed. The consistent implementation and also adherence to these described occupational safety measures and regulations can reduce the burden on operating theater personnel and contribute to maintaining health. Furthermore, periodic preventive healthcare controls and health checks by the company medical officer and individually initiated additional prevention measures can be a sensible augmentation to these safety measures.

Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-07-01

The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

Interchange Safety Analysis Tool (ISAT) : user manual

DOT National Transportation Integrated Search

2007-06-01

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

Assessment of School-Based Quasi-Experimental Nutrition and Food Safety Health Education for Primary School Students in Two Poverty-Stricken Counties of West China.

PubMed

Shen, Minxue; Hu, Ming; Sun, Zhenqiu

2015-01-01

Few studies on nutrition and food safety education intervention for students in remote areas of China were reported. The study aimed to assess the questionnaire used to measure the knowledge, attitude and behavior with respect to nutrition and food safety, and to evaluate the effectiveness of a quasi-experimental nutrition and food safety education intervention among primary school students in poverty-stricken counties of west China. Twelve primary schools in west China were randomly selected from Zhen'an of Shaanxi province and Huize of Yunnan province. Six geographically dispersed schools were assigned to the intervention group in a nonrandom way. Knowledge, attitude and behavior questionnaire was developed, assessed, and used for outcome measurement. Students were investigated at baseline and the end of the study respectively without follow-up. Students in intervention group received targeted nutrition and food safety lectures 0.5 hour per week for two semesters. Item response theory was applied for assessment of questionnaire, and a two-level difference-in-differences model was applied to assess the effectiveness of the intervention. The Cronbach's alpha of the original questionnaire was 0.84. According to item response model, 22 knowledge items, 6 attitude items and 8 behavior items showed adequate discrimination parameter and were retained. 378 and 478 valid questionnaires were collected at baseline and the end point. Differences of demographic characteristics were statistically insignificant between the two groups. Two-level difference-in-differences models showed that health education improved 2.92 (95% CI: 2.06-3.78) and 2.92 (95% CI: 1.37-4.47) in knowledge and behavior scores respectively, but had no effect on attitude. The questionnaire met the psychometric standards and showed good internal consistence and discrimination power. The nutrition and food safety education was effective in improving the knowledge and behavior of primary school students in

Safety Assessment of Panax spp Root-Derived Ingredients as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

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.

Safety Assessment of Alkyl PEG/PPG Ethers as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-07-01

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 131 alkyl polyethylene glycol (PEG)/polypropylene glycol ethers as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating. Most of the alkyl PEG/PPG ethers included in this review are reported to function in cosmetics as surfactants, skin-conditioning agents, and/or emulsifying agents. The alkyl PEG/PPG ethers share very similar physiochemical properties as the alkyl PEG ethers, which were reviewed previously by the CIR Expert Panel and found safe when formulated to be nonirritating. The alkyl PEG ethers differ by the inclusion of PPG repeat units, which are used to fine-tune the surfactant properties of this group. The Panel relied heavily on data on analogous ingredients, extracted from the alkyl PEG ethers and PPG reports, when making its determination of safety. © The Author(s) 2016.

A methodology to model causal relationships on offshore safety assessment focusing on human and organizational factors.

PubMed

Ren, J; Jenkinson, I; Wang, J; Xu, D L; Yang, J B

2008-01-01

Focusing on people and organizations, this paper aims to contribute to offshore safety assessment by proposing a methodology to model causal relationships. The methodology is proposed in a general sense that it will be capable of accommodating modeling of multiple risk factors considered in offshore operations and will have the ability to deal with different types of data that may come from different resources. Reason's "Swiss cheese" model is used to form a generic offshore safety assessment framework, and Bayesian Network (BN) is tailored to fit into the framework to construct a causal relationship model. The proposed framework uses a five-level-structure model to address latent failures within the causal sequence of events. The five levels include Root causes level, Trigger events level, Incidents level, Accidents level, and Consequences level. To analyze and model a specified offshore installation safety, a BN model was established following the guideline of the proposed five-level framework. A range of events was specified, and the related prior and conditional probabilities regarding the BN model were assigned based on the inherent characteristics of each event. This paper shows that Reason's "Swiss cheese" model and BN can be jointly used in offshore safety assessment. On the one hand, the five-level conceptual model is enhanced by BNs that are capable of providing graphical demonstration of inter-relationships as well as calculating numerical values of occurrence likelihood for each failure event. Bayesian inference mechanism also makes it possible to monitor how a safety situation changes when information flow travel forwards and backwards within the networks. On the other hand, BN modeling relies heavily on experts' personal experiences and is therefore highly domain specific. "Swiss cheese" model is such a theoretic framework that it is based on solid behavioral theory and therefore can be used to provide industry with a roadmap for BN modeling and

Use of a computerized kiosk in an assessment of food safety knowledge of high school students and science teachers.

PubMed

Endres, J; Welch, T; Perseli, T

2001-01-01

A multimedia touch-screen kiosk was used to assess food safety knowledge and convey food safety principles to 93 high school science teachers and 165 students. The kiosk program based on the FightBAC messages informed users of correct responses and reasons for the response. Teachers correctly answered more questions than students; however, for the areas of hand washing, sources of foodborne illness, and handling of leftover foods, at least 40% of both students and teachers provided incorrect answers.

Is there agreement between worker self and supervisor assessment of worker safety performance? An examination in the construction industry.

PubMed

Xia, Nini; Griffin, Mark A; Wang, Xueqing; Liu, Xing; Wang, Dan

2018-06-01

Individual safety performance (behavior) critically influences safety outcomes in high-risk workplaces. Compared to the study of generic work performance on different measurements, few studies have investigated different measurements of safety performance, typically relying on employees' self-reflection of their safety behavior. This research aims to address this limitation by including worker self-reflection and other (i.e., supervisor) assessment of two worker safety performance dimensions, safety compliance and safety participation. A sample of 105 workers and 17 supervisors in 17 groups in the Chinese construction industry participated in this study. Comparisons were made between worker compliance and participation in each measurement, and between workers' and supervisors' assessment of workers' compliance and participation. Multilevel modeling was adopted to test the moderating effects on the worker self-reflection and supervisor-assessment relationship by group safety climate and the work experience of supervisors. Higher levels of safety compliance than participation were found for self-reflection and supervisor assessment. The discrepancy between the two measurements in each safety performance dimension was significant. The work experience of supervisors attenuated the discrepancy between self- and supervisor-assessment of compliance. Contrary to our expectations, the moderating effect of group safety climate was not supported. The discrepancy between worker self- and supervisor-assessment of worker safety performance, thus, suggests the importance of including alternative measurements of safety performance in addition to self-reflection. Lower levels of participation behavior in both raters suggest more research on the motivators of participatory behavior. Practical applications The discrepancy between different raters can lead to negative reactions of ratees, suggesting that managers should be aware of that difference. Assigning experienced supervisors as

Guide for the Development of Safety Assessment Report (SAR)

DTIC Science & Technology

1987-08-01

Di ’:t ib ityioe I A,;!i~abiiity Codes Dist SpdIt ora bloe INSia OEapy r TABLE OF CONTENTS PAGE III SAFETY ASSESSMENT REPORT...above. Potential hazards associated with the maintenance of the turbine engine (i.e., use of cleaning agents ) are not addressed .in the accompanying

Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

PubMed

Dzingirayi, Garikayi; Korsten, Lise

2016-07-01

Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

Use of read-across and computer-based predictive analysis for the safety assessment of PEG cocamines.

PubMed

Skare, Julie A; Blackburn, Karen; Wu, Shengde; Re, Thomas A; Duche, Daniel; Ringeissen, Stephanie; Bjerke, Donald L; Srinivasan, Viny; Eisenmann, Carol

2015-04-01

In the European Union animal testing has been eliminated for cosmetic ingredients while the US Cosmetic Ingredient Review Expert Panel may request data from animal studies. The use of read-across and predictive toxicology provides a path for filling data gaps without additional animal testing. The PEG cocamines are tertiary amines with an alkyl group derived from coconut fatty acids and two PEG chains of varying length. Toxicology data gaps for the PEG cocamines can be addressed by read-across based on structure-activity relationship using the framework described by Wu et al. (2010) for identifying suitable structural analogs. Data for structural analogs supports the conclusion that the PEG cocamines are non-genotoxic and not expected to exhibit systemic or developmental/reproductive toxicity with use in cosmetics. Due to lack of reliable dermal sensitization data for suitable analogs, this endpoint was addressed using predictive software (TIMES SS) as a first step (Laboratory of Mathematical Chemistry). The prediction for PEG cocamines was the same as that for PEGs, which have been concluded to not present a significant concern for dermal sensitization. This evaluation for PEG cocamines demonstrates the utility of read-across and predictive toxicology tools to assess the safety of cosmetic ingredients. Copyright © 2015 Elsevier Inc. All rights reserved.

Safety and efficacy evaluation of gelatin-based nanoparticles associated with UV filters.

PubMed

Oliveira, Camila Areias de; Dario, Michelli Ferrera; Sarruf, Fernanda Daud; Mariz, Inês Fátima Afonso; Velasco, Maria Valéria Robles; Rosado, Catarina; Baby, André Rolim

2016-04-01

The safety and efficacy assessment of nanomaterials is a major concern of industry and academia. These materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. The encapsulation of natural ingredients can provide marked improvements in sun protection efficacy. This strategy promotes solubility enhancement of flavonoids and yields an improved active ingredient with innovative physical, physicochemical and functional characteristics. Rutin, a flavonoid, has chemical and functional stability in topical vehicles exerting a synergistic effect in association with ultraviolet (UV) filters. However, the solubility of rutin is a limiting factor. Additionally, this bioactive compound does not have tendency to permeate across the stratum corneum. As an alternative to common synthetic based sunscreens, rutin-entrapped gelatin nanoparticles were designed. The present study investigated the pre-clinical safety of gelatin nanoparticles (GNPs) using an in vitro method and also assessed the clinical safety and efficacy of the association of GNPs with three commonly used chemical UV filters (ethylhexyl dimethyl PABA, ethylhexyl methoxycinnamate and methoxydibenzoylmethane). The non-irritant and adequate safety profile under sun-exposed skin conditions of the nanomaterials and the emulsions qualified the products for clinical efficacy assays. The in vivo results indicated that the GNPs increased the antioxidant protection of the emulsions developed. However, the presence of rutin in the nanosized material did not enhance performance on the SPF test. In conclusion, these findings characterized the nanomaterials as an innovative platform for multifunctional bioactive sunscreens. Copyright © 2015 Elsevier B.V. All rights reserved.

The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

PubMed

Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

2015-12-01

School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools.

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

PubMed

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

2015-01-01

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

A measurement tool to assess culture change regarding patient safety in hospital obstetrical units.

PubMed

Kenneth Milne, J; Bendaly, Nicole; Bendaly, Leslie; Worsley, Jill; FitzGerald, John; Nisker, Jeff

2010-06-01

Clinical error in acute care hospitals can only be addressed by developing a culture of safety. We sought to develop a cultural assessment survey (CAS) to assess patient safety culture change in obstetrical units. Interview prompts and a preliminary questionnaire were developed through a literature review of patient safety and "high reliability organizations," followed by interviews with members of the Managing Obstetrical Risk Efficiently (MOREOB) Program of the Society of Obstetricians and Gynaecologists of Canada. Three hundred preliminary questionnaires were mailed, and 21 interviews and 9 focus groups were conducted with the staff of 11 hospital sites participating in the program. To pilot test the CAS, 350 surveys were mailed to staff in participating hospitals, and interviews were conducted with seven nurses and five physicians who had completed the survey. Reliability analysis was conducted on four units that completed the CAS prior to and following the implementation of the first MOREOB module. Nineteen values and 105 behaviours, practices, and perceptions relating to patient safety were identified and included in the preliminary questionnaire, of which 143 of 300 (47.4%) were returned. Among the 220 cultural assessment surveys returned (62.9%), six cultural scales emerged: (1) patient safety as everyone's priority; (2) teamwork; (3) valuing individuals; (4) open communication; (5) learning; and (6) empowering individuals. The reliability analysis found all six scales to have internal reliability (Cronbach alpha), ranging from 0.72 (open communication) to 0.84 (valuing individuals). The CAS developed for this study may enable obstetrical units to assess change in patient safety culture.

Understanding the relationship between safety investment and safety performance of construction projects through agent-based modeling.

PubMed

Lu, Miaojia; Cheung, Clara Man; Li, Heng; Hsu, Shu-Chien

2016-09-01

The construction industry in Hong Kong increased its safety investment by 300% in the past two decades; however, its accident rate has plateaued to around 50% for one decade. Against this backdrop, researchers have found inconclusive results on the causal relationship between safety investment and safety performance. Using agent-based modeling, this study takes an unconventional bottom-up approach to study safety performance on a construction site as an outcome of a complex system defined by interactions among a worksite, individual construction workers, and different safety investments. Instead of focusing on finding the absolute relationship between safety investment and safety performance, this study contributes to providing a practical framework to investigate how different safety investments interacting with different parameters such as human and environmental factors could affect safety performance. As a result, we could identify cost-effective safety investments under different construction scenarios for delivering optimal safety performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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

2014-01-30

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

Epidemiological designs for vaccine safety assessment: methods and pitfalls.

PubMed

Andrews, Nick

2012-09-01

Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Time Pressure in Scenario-Based Online Construction Safety Quizzes and Its Effect on Students' Performance

ERIC Educational Resources Information Center

Jaeger, Martin; Adair, Desmond

2017-01-01

Online quizzes have been shown to be effective learning and assessment approaches. However, if scenario-based online construction safety quizzes do not include time pressure similar to real-world situations, they reflect situations too ideally. The purpose of this paper is to compare engineering students' performance when carrying out an online…

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.

Assessment of the safety-relevance of pedestrian and bicyclist programs. Volume 1, Conduct and results

DOT National Transportation Integrated Search

1983-04-01

This document (Volume One of a Two Volume Report) describes the development of a paper-and-pencil instrument for assessing the safety relevance of pedestrian and bicyclist safety education programs. The safety relevance of the program is the extent t...

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

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

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

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

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

Korsah, Kofi; Muhlheim, Michael David; Wood, Richard

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRCmore » Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.« less

Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

PubMed

Chittaro, Luca; Buttussi, Fabio

2015-04-01

Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

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

PubMed

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

2018-05-19

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

Implementation and evaluation of a patient safety course in a problem-based learning program.

PubMed

Eltony, Sarah Ahmed; El-Sayed, Nahla Hassan; El-Araby, Shimaa El-Sayed; Kassab, Salah Eldin

2017-01-01

Since the development of the WHO patient safety curriculum guide, there has been insufficient reporting regarding the implementation and evaluation of patient safety courses in undergraduate problem-based learning (PBL) programs. This study is designed to implement a patient safety course to undergraduate students in a PBL medical school and evaluate this course by examining its effects on students' knowledge and satisfaction. The target population included year 6 medical students (n = 71) at the Faculty of Medicine, Suez Canal University in Egypt. A 3-day course was conducted addressing three principal topics from the WHO patient safety curriculum guide. The methods of instruction included reflection on students' past experiences, PBL case discussions, and tasks with incident report cards. A pre- and post-test design was used to assess the effect of the course on students' knowledge of inpatient safety topics. Furthermore, students' perceptions of the quality of the course were assessed through a structured self-administered course evaluation questionnaire. The results of the pre- and post-test demonstrated a significant increase (P < 0.05) in the students' mean multiple choice question (MCQ) scores. The MCQ scores for "what is patient safety" topic increased by 50% (P < 0.01). Similarly, the MCQ scores for the "infection control" topic increased by 39% (P < 0.01), and scores for the "medication safety" topic increased by 45% (P < 0.01). The majority of students perceived the different aspects of the course positively, including the structure and introduction of the course (75%) and the communication skills (83.2%) and teamwork skills they had developed (94.4%). The findings of the incident report cards indicated that 46.7% of the students perceived that incidents most commonly take place in the emergency room while only 6.7% in the outpatient clinic. This patient safety education program within a PBL curriculum is positively perceived by students. Furthermore

Safety Assessment of Nitrocellulose and Collodion as Used in Cosmetics.

PubMed

Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-07-01

The Cosmetic Ingredient Review Expert Panel (the Panel) assessed the safety of nitrocellulose and collodion as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration in cosmetic formulations. Both ingredients are used almost exclusively in nail product formulations. The maximum concentration of use of nitrocellulose in nail polish and enamels is 22%; for collodion, the maximum reported concentration of use in nail polish and enamel is 14%. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

Characteristics and safety assessment of intractable proteins in genetically modified crops.

PubMed

Bushey, Dean F; Bannon, Gary A; Delaney, Bryan F; Graser, Gerson; Hefford, Mary; Jiang, Xiaoxu; Lee, Thomas C; Madduri, Krishna M; Pariza, Michael; Privalle, Laura S; Ranjan, Rakesh; Saab-Rincon, Gloria; Schafer, Barry W; Thelen, Jay J; Zhang, John X Q; Harper, Marc S

2014-07-01

Genetically modified (GM) crops may contain newly expressed proteins that are described as "intractable". Safety assessment of these proteins may require some adaptations to the current assessment procedures. Intractable proteins are defined here as those proteins with properties that make it extremely difficult or impossible with current methods to express in heterologous systems; isolate, purify, or concentrate; quantify (due to low levels); demonstrate biological activity; or prove equivalency with plant proteins. Five classes of intractable proteins are discussed here: (1) membrane proteins, (2) signaling proteins, (3) transcription factors, (4) N-glycosylated proteins, and (5) resistance proteins (R-proteins, plant pathogen recognition proteins that activate innate immune responses). While the basic tiered weight-of-evidence approach for assessing the safety of GM crops proposed by the International Life Sciences Institute (ILSI) in 2008 is applicable to intractable proteins, new or modified methods may be required. For example, the first two steps in Tier I (hazard identification) analysis, gathering of applicable history of safe use (HOSU) information and bioinformatics analysis, do not require protein isolation. The extremely low level of expression of most intractable proteins should be taken into account while assessing safety of the intractable protein in GM crops. If Tier II (hazard characterization) analyses requiring animal feeding are judged to be necessary, alternatives to feeding high doses of pure protein may be needed. These alternatives are discussed here. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

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

PubMed

Custer, Brian; Janssen, Mart P

2015-08-01

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

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

PubMed

Orenstein, Lauren A V; Orenstein, Evan W; Teguete, Ibrahima; Kodio, Mamoudou; Tapia, Milagritos; Sow, Samba O; Levine, Myron M

2012-01-01

Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa. We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM), low birth weight (LBW), prematurity, and major congenital malformations (MCM) in Sub-Saharan African countries were also performed. Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3) per 1,000 total births, and the most common causes were hemorrhage (34%), dystocia (22%), and severe hypertensive disorders of pregnancy (22%). Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4) or premature (median 15.4%, IQR: 10.6-19.1) were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6), with the musculoskeletal system comprising 30%. Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of adverse

Overview of Design, Lifecycle, and Safety for Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This document describes the need and justification for the development of a design guide for safety-relevant computer-based systems. This document also makes a contribution toward the design guide by presenting an overview of computer-based systems design, lifecycle, and safety.

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A toxicity-based method for evaluating safety of reclaimed water for environmental reuses.

PubMed

Xu, Jianying; Zhao, Chuntao; Wei, Dongbin; Du, Yuguo

2014-10-01

A large quantity of toxic chemical pollutants possibly remains in reclaimed water due to the limited removal efficiency in traditional reclamation processes. It is not enough to guarantee the safety of reclaimed water using conventional water quality criteria. An integrated assessment method based on toxicity test is necessary to vividly depict the safety of reclaimed water for reuse. A toxicity test battery consisting of lethality, genotoxicity and endocrine disrupting effect was designed to screen the multiple biological effects of residual toxic chemicals in reclaimed water. The toxicity results of reclaimed water were converted into the equivalent concentrations of the corresponding positive reference substances (EQC). Simultaneously, the predicted no-effect concentration (PNEC) of each positive reference substance was obtained by analyzing the species sensitivity distribution (SSD) of toxicity data. An index "toxicity score" was proposed and valued as 1, 2, 3, or 4 depending on the ratio of the corresponding EQC to PNEC. For vividly ranking the safety of reclaimed water, an integrated assessment index "toxicity rank" was proposed, which was classified into A, B, C, or D rank with A being the safest. The proposed method was proved to be effective in evaluating reclaimed water samples in case studies. Copyright © 2014. Published by Elsevier B.V.

Assessment of cognitive safety in clinical drug development

PubMed Central

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

2016-01-01

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

Safety impacts of red light cameras at signalized intersections based on cellular automata models.

PubMed

Chai, C; Wong, Y D; Lum, K M

2015-01-01

This study applies a simulation technique to evaluate the hypothesis that red light cameras (RLCs) exert important effects on accident risks. Conflict occurrences are generated by simulation and compared at intersections with and without RLCs to assess the impact of RLCs on several conflict types under various traffic conditions. Conflict occurrences are generated through simulating vehicular interactions based on an improved cellular automata (CA) model. The CA model is calibrated and validated against field observations at approaches with and without RLCs. Simulation experiments are conducted for RLC and non-RLC intersections with different geometric layouts and traffic demands to generate conflict occurrences that are analyzed to evaluate the hypothesis that RLCs exert important effects on road safety. The comparison of simulated conflict occurrences show favorable safety impacts of RLCs on crossing conflicts and unfavorable impacts for rear-end conflicts during red/amber phases. Corroborative results are found from broad analysis of accident occurrence. RLCs are found to have a mixed effect on accident risk at signalized intersections: crossing collisions are reduced, whereas rear-end collisions may increase. The specially developed CA model is found to be a feasible safety assessment tool.

Office-based surgery: embracing patient safety strategies.

PubMed

Shapiro, Fred E; Punwani, Nathan; Urman, Richard D

2013-01-01

Office-based surgery continues to grow as more procedures are being performed in the outpatient setting. With this exponential growth, there is an increasing emphasis on safe and effective patient care. Current research shows both gaps in safety and opportunities for improvement. Practice managers, clinicians, and other personnel should be cognizant that office procedures are coming under intense regulatory scrutiny. Effective strategies to maintain quality and patient safety include the use of checklists, obtaining office accreditation, encouraging board-certification and proper credentialing of proceduralists, and appropriate patient and procedure selection. There is increasing regulation of ambulatory surgery on state and national levels that will likely affect the financial and care quality aspects of office-based practice. Socioeconomic and political forces will continue to shape the future of office-based surgery.

New safety rules challenge U. K. operators, regulators

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

Hudson, J.

1994-08-15

Offshore safety regulations based on lessons learned from the Piper Alpha blast of 1988 have been in operation in the U.K. for a year. The Offshore Installations (Safety Case) Regulations 1992 make operators of fixed and mobile installations (the duty holders'') responsible for producing a formal safety assessment, or safety case, for each installation. After the end of November 1995 it will be an offense to operate an installation without a safety case which has been approved by the government's Health and Safety Executive (HSE). Producing safety cases for installations is a major task for duty holder, while assessing themmore » is a huge under taking for HSE's Offshore Safety Division (OSD). This paper reviews how HSE has established management arrangements to handle safety cases, considers progress in assessment, highlights some of the important lessons learned, and look to the future.« less

Assessment of Native Languages for Food Safety Training Programs for Meat Industry Employees

ERIC Educational Resources Information Center

Olsen, Sherrlyn S.; Cordray, Joseph C.; Sapp, Stephen; Sebranek, Joseph G.; Anderson, Barbara; Wenger, Matt

2012-01-01

Challenges arise when teaching food safety to culturally diverse employees working in meatpacking and food manufacturing industries. A food safety training program was developed in English, translated into Spanish, and administered to 1,265 adult learners. Assessments were conducted by comparing scores before and immediately following training.…

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.

PubMed

Rawson, Nigel S B; D'Arcy, Carl

2018-04-30

Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resources they use and to ensure that they and the users of their research understand the limitations of the data that are the foundation on which their research is built. Fundamental issues regarding data validity should be addressed in each use of administrative data for drug safety research.

L-Band Digital Aeronautical Communications System Engineering - Initial Safety and Security Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.

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

PubMed Central

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

2015-01-01

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

Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

PubMed

Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

2014-08-01

The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have

75 FR 15485 - Pipeline Safety: Workshop on Guidelines for Integrity Assessment of Cased Pipe

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID...: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of workshop. SUMMARY... ``Guidelines for Integrity Assessment of Cased Pipe in Gas Transmission Pipelines'' and related Frequently...

PROBABILISTIC SAFETY ASSESSMENT OF OPERATIONAL ACCIDENTS AT THE WASTE ISOLATION PILOT PLANT

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

Rucker, D.F.

2000-09-01

This report presents a probabilistic safety assessment of radioactive doses as consequences from accident scenarios to complement the deterministic assessment presented in the Waste Isolation Pilot Plant (WIPP) Safety Analysis Report (SAR). The International Council of Radiation Protection (ICRP) recommends both assessments be conducted to ensure that ''an adequate level of safety has been achieved and that no major contributors to risk are overlooked'' (ICRP 1993). To that end, the probabilistic assessment for the WIPP accident scenarios addresses the wide range of assumptions, e.g. the range of values representing the radioactive source of an accident, that could possibly have beenmore » overlooked by the SAR. Routine releases of radionuclides from the WIPP repository to the environment during the waste emplacement operations are expected to be essentially zero. In contrast, potential accidental releases from postulated accident scenarios during waste handling and emplacement could be substantial, which necessitates the need for radiological air monitoring and confinement barriers (DOE 1999). The WIPP Safety Analysis Report (SAR) calculated doses from accidental releases to the on-site (at 100 m from the source) and off-site (at the Exclusive Use Boundary and Site Boundary) public by a deterministic approach. This approach, as demonstrated in the SAR, uses single-point values of key parameters to assess the 50-year, whole-body committed effective dose equivalent (CEDE). The basic assumptions used in the SAR to formulate the CEDE are retained for this report's probabilistic assessment. However, for the probabilistic assessment, single-point parameter values were replaced with probability density functions (PDF) and were sampled over an expected range. Monte Carlo simulations were run, in which 10,000 iterations were performed by randomly selecting one value for each parameter and calculating the dose. Statistical information was then derived from the 10

Home-Based Comprehensive Assessment of Rural Elderly Persons: The CARE Project

ERIC Educational Resources Information Center

Cravens, David D.; Mehr, David R.; Campbell, James D.; Armer, Jane; Kruse, Robin L.; Rubenstein, Laurence Z.

2005-01-01

Context: Home-based comprehensive geriatric assessment (CGA) has been effective in urban areas but has had little study in rural areas. CGA involves medical history taking, a physical exam, and evaluation of functional status, mental status, cognitive status, gait and balance, medications, vision, extent of social supports, and home safety. We…

Safety Assessment of Probiotics

NASA Astrophysics Data System (ADS)

Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

Validity of instruments to assess students' travel and pedestrian safety

USDA-ARS?s Scientific Manuscript database

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school,safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research...

Exploring the role of emotional intelligence in behavior-based safety coaching.

PubMed

Wiegand, Douglas M

2007-01-01

Safety coaching is an applied behavior analysis technique that involves interpersonal interaction to understand and manipulate environmental conditions that are directing (i.e., antecedent to) and motivating (i.e., consequences of) safety-related behavior. A safety coach must be skilled in interacting with others so as to understand their perspectives, communicate a point clearly, and be persuasive with behavior-based feedback. This article discusses the evidence-based "ability model" of emotional intelligence and its relevance to the interpersonal aspect of the safety coaching process. Emotional intelligence has potential for improving safety-related efforts and other aspects of individuals' work and personal lives. Safety researchers and practitioners are therefore encouraged to gain an understanding of emotional intelligence and conduct and support research applying this construct toward injury prevention.

Ports and Waterways Safety Assessment Workshop Report. Kahului Harbor, Maui, Hawaii, 27-28 August 2009

DTIC Science & Technology

2009-08-28

and Waterways Safety Assessment Workshop Report Maui, Hawaii 27 - 28 August 2009 Kahului Harbor Report Documentation Page Form ApprovedOMB...00-00-2009 to 00-00-2009 4. TITLE AND SUBTITLE Ports and Waterways Safety Assessment: Maui, Hawaii 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c...Harbor, Maui, Hawaii 27 - 28 August 2009 Table of Contents Page Introduction

Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

NASA Astrophysics Data System (ADS)

Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

2014-11-01

All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

Nanotechnology and MEMS-based systems for civil infrastructure safety and security: Opportunities and challenges

NASA Astrophysics Data System (ADS)

Robinson, Nidia; Saafi, Mohamed

2006-03-01

Critical civil infrastructure systems such as bridges, high rises, dams, nuclear power plants and pipelines present a major investment and the health of the United States' economy and the lifestyle of its citizens both depend on their safety and security. The challenge for engineers is to maintain the safety and security of these large structures in the face of terrorism threats, natural disasters and long-term deterioration, as well as to meet the demands of emergency response times. With the significant negative impact that these threats can have on the structural environment, health monitoring of civil infrastructure holds promise as a way to provide information for near real-time condition assessment of the structure's safety and security. This information can be used to assess the integrity of the structure for post-earthquake and terrorist attacks rescue and recovery, and to safely and rapidly remove the debris and to temporary shore specific structural elements. This information can also be used for identification of incipient damage in structures experiencing long-term deterioration. However, one of the major obstacles preventing sensor-based monitoring is the lack of reliable, easy-to-install, cost-effective and harsh environment resistant sensors that can be densely embedded into large-scale civil infrastructure systems. Nanotechnology and MEMS-based systems which have matured in recent years represent an innovative solution to current damage detection systems, leading to wireless, inexpensive, durable, compact, and high-density information collection. In this paper, ongoing research activities at Alabama A&M University (AAMU) Center for Transportation Infrastructure Safety and Security on the application of nanotechnology and MEMS to Civil Infrastructure for health monitoring will presented. To date, research showed that nanotechnology and MEMS-based systems can be used to wirelessly detect and monitor different damage mechanisms in concrete structures

Use and misuse of motor-vehicle crash death rates in assessing highway-safety performance.

PubMed

O'Neill, Brian; Kyrychenko, Sergey Y

2006-12-01

The objectives of the article are to assess the extent to which comparisons of motor-vehicle crash death rates can be used to determine the effectiveness of highway-safety policies over time in a country or to compare policy effectiveness across countries. Motor-vehicle crash death rates per mile traveled in the 50 U.S. states from 1980 to 2003 are used to show the influence on these rates of factors independent of highway-safety interventions. Multiple regression models relating state death rates to various measures related to urbanization and demographics are used. The analyses demonstrate strong relationships between state death rates and urbanization and demographics. Almost 60% of the variability among the state death rates can be explained by the independent variables in the multiple regression models. When the death rates for passenger vehicle occupants (i.e., excluding motorcycle, pedestrian, and other deaths) are used in the regression models, almost 70% of the variability in the rates can be explained by urbanization and demographics. The analyses presented in the article demonstrate that motor-vehicle crash death rates are strongly influenced by factors unrelated to highway-safety countermeasures. Overall death rates should not be used as a basis for judging the effectiveness (or ineffectiveness) of specific highway-safety countermeasures or to assess overall highway-safety policies, especially across jurisdictions. There can be no substitute for the use of carefully designed scientific evaluations of highway-safety interventions that use outcome measures directly related to the intervention; e.g., motorcyclist deaths should be used to assess the effectiveness of motorcycle helmet laws. While this may seem obvious, there are numerous examples in the literature of death rates from all crashes being used to assess the effectiveness of interventions aimed at specific subsets of crashes.

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.

Safety Assessment of Methyl Glucose Polyethers and Esters as Used in Cosmetics.

PubMed

Johnson, Wilbur; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of methyl glucose polyethers and esters which function in cosmetics as skin/hair-conditioning agents, surfactants, or viscosity increasing agents. The esters included in this assessment are mono-, di-, or tricarboxyester substituted methyl glucosides, and the polyethers are mixtures of various chain lengths. The Panel reviewed available animal and clinical data, including the molecular weights, log K ow s, and other properties in making its determination of safety on these ingredients. Where there were data gaps, similarities between molecular structures, physicochemical and biological characteristics, and functions and concentrations in cosmetics allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that there likely would be no significant systemic exposure from cosmetic use of these ingredients, and that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. © The Author(s) 2016.

Analysis of School Food Safety Programs Based on HACCP Principles

ERIC Educational Resources Information Center

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

2014-01-01

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

Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

PubMed Central

Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

2013-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

PubMed

Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

2012-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

Major food safety episodes in Taiwan: implications for the necessity of international collaboration on safety assessment and management.

PubMed

Li, Jih-Heng; Yu, Wen-Jing; Lai, Yuan-Hui; Ko, Ying-Chin

2012-07-01

The major food safety episodes that occurred in Taiwan during the past decade are briefly reviewed in this paper. Among the nine major episodes surveyed, with the exception of a U.S. beef (associated with Creutzfeldt-Jakob disease)-related incident, all the others were associated with chemical toxicants. The general public, which has a layperson attitude of zero tolerance toward food safety, may panic over these food-safety-associated incidents. However, the health effects and impacts of most incidents, with the exception of the melamine incident, were essentially not fully evaluated. The mass media play an important role in determining whether a food safety concern becomes a major incident. A well-coordinated and harmonized system for domestic and international collaboration to set up standards and regulations is critical, as observed in the incidents of pork with ractopamine, Chinese hairy crab with nitrofuran antibiotics, and U.S. wheat with malathion. In the future, it can be anticipated that food safety issues will draw more attention from the general public. For unknown new toxicants or illicit adulteration of food, the establishment of a more proactive safety assessment system to monitor potential threats and provide real-time information exchange is imperative. Copyright © 2012. Published by Elsevier B.V.

The Impact of Community-Based Outreach on Psychological Distress and Victim Safety in Women Exposed to Intimate Partner Abuse

ERIC Educational Resources Information Center

DePrince, Anne P.; Labus, Jennifer; Belknap, Joanne; Buckingham, Susan; Gover, Angela

2012-01-01

Objective: Using a longitudinal, randomized controlled trial, this study assessed the impact of a community-based outreach versus a more traditional criminal justice system-based referral program on women's distress and safety following police-reported intimate partner abuse (IPA). Method: Women (N = 236 women) with police-reported IPA were…

Mitigating Motion Base Safety Issues: The NASA LaRC CMF Implementation

NASA Technical Reports Server (NTRS)

Bryant, Richard B., Jr.; Grupton, Lawrence E.; Martinez, Debbie; Carrelli, David J.

2005-01-01

The NASA Langley Research Center (LaRC), Cockpit Motion Facility (CMF) motion base design has taken advantage of inherent hydraulic characteristics to implement safety features using hardware solutions only. Motion system safety has always been a concern and its implementation is addressed differently by each organization. Some approaches rely heavily on software safety features. Software which performs safety functions is subject to more scrutiny making its approval, modification, and development time consuming and expensive. The NASA LaRC's CMF motion system is used for research and, as such, requires that the software be updated or modified frequently. The CMF's customers need the ability to update the simulation software frequently without the associated cost incurred with safety critical software. This paper describes the CMF engineering team's approach to achieving motion base safety by designing and implementing all safety features in hardware, resulting in applications software (including motion cueing and actuator dynamic control) being completely independent of the safety devices. This allows the CMF safety systems to remain intact and unaffected by frequent research system modifications.

Nanotechnology in food science: Functionality, applicability, and safety assessment.

PubMed

He, Xiaojia; Hwang, Huey-Min

2016-10-01

Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted. Copyright © 2016. Published by Elsevier B.V.

School-Based and Community-Based Gun Safety Educational Strategies for Injury Prevention.

PubMed

Holly, Cheryl; Porter, Sallie; Kamienski, Mary; Lim, Aubrianne

2018-05-01

Nearly 1,300 children in the United States die because of firearm-related injury each year and another 5,790 survive gunshot wounds, making the prevention of firearm-related unintentional injury to children of vital importance to families, health professionals, and policy makers. To systematically review the evidence on school-based and community-based gun safety programs for children aged 3 to 18 years. Systematic review. Twelve databases were searched from their earliest records to December 2016. Interventional and analytic studies were sought, including randomized controlled trials, quasi-experimental studies, as well as before-and-after studies or cohort studies with or without a control that involved an intervention. The low level of evidence, heterogeneity of studies, and lack of consistent outcome measures precluded a pooled estimate of results. A best evidence synthesis was performed. Results support the premise that programs using either knowledge-based or active learning strategies or a combination of these may be insufficient for teaching gun safety skills to children. Gun safety programs do not improve the likelihood that children will not handle firearms in an unsupervised situation. Stronger research designs with larger samples are needed to determine the most effective way to transfer the use of the gun safety skills outside the training session and enable stronger conclusions to be drawn.

Recommendations for assessing water quality and safety on board merchant ships.

PubMed

Grappasonni, Iolanda; Cocchioni, Mario; Degli Angioli, Rolando; Saturnino, Andrea; Sibilio, Fabio; Scuri, Stefania; Amenta, Francesco

2013-01-01

Health and diseases on board ships may depend on water. Interventions to improve the quality of water may bring to significant benefits to health and water stores/supply and should be controlledto protect health. This paper has reviewed the main regulations for the control of water safety and qualityon board ships and presents some practical recommendations for keeping water healthy and safe in passenger and cargo merchant ships. The main international regulations and guidelines on the topic were analysed. Guidelines forWater Quality on Board Merchant Ships Including Passenger Vessels of Health Protection Agency, World Health Organisation (WHO) Guide to Ship Sanitation, WHO Guidelines for Drinking Water Quality, WHO Water Safety Plan and the United States Center for Disease Control and Prevention Vessel Sanitation Program were examined. Recommendations for passenger and, if available, for cargo ships were collected and compared. Recommended questionnaire: A questionnaire summarising the main information to collect for assessingthe enough quality of water for the purposes it should be used on board is proposed. The need of havinga crew member with water assessment duties on board, trained for performing these activities properlyis discussed. Water quality on board ships should be monitored routinely. Monitoring should be directedto chemical and microbiological parameters for identifying possible contamination sources, using specifickits by a designed crew member. More detailed periodic assessments should be under the responsibility ofspecialised personnel/laboratories and should be based on sample collection from all tanks and sites of waterdistribution. It is important to select a properly trained crew member on board for monitoring water quality.

Medication Safety During Pregnancy: Improving Evidence-Based Practice.

PubMed

Sinclair, Susan M; Miller, Richard K; Chambers, Christina; Cooper, Elizabeth M

2016-01-01

Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy. © 2016 by the American College of Nurse-Midwives.

Concern-driven integrated approaches to nanomaterial testing and assessment – report of the NanoSafety Cluster Working Group 10

PubMed Central

Oomen, Agnes G.; Bos, Peter M. J.; Fernandes, Teresa F.; Hund-Rinke, Kerstin; Boraschi, Diana; Byrne, Hugh J.; Aschberger, Karin; Gottardo, Stefania; von der Kammer, Frank; Kühnel, Dana; Hristozov, Danail; Marcomini, Antonio; Migliore, Lucia; Scott-Fordsmand, Janeck; Wick, Peter

2014-01-01

Bringing together topic-related European Union (EU)-funded projects, the so-called “NanoSafety Cluster” aims at identifying key areas for further research on risk assessment procedures for nanomaterials (NM). The outcome of NanoSafety Cluster Working Group 10, this commentary presents a vision for concern-driven integrated approaches for the (eco-)toxicological testing and assessment (IATA) of NM. Such approaches should start out by determining concerns, i.e., specific information needs for a given NM based on realistic exposure scenarios. Recognised concerns can be addressed in a set of tiers using standardised protocols for NM preparation and testing. Tier 1 includes determining physico-chemical properties, non-testing (e.g., structure–activity relationships) and evaluating existing data. In tier 2, a limited set of in vitro and in vivo tests are performed that can either indicate that the risk of the specific concern is sufficiently known or indicate the need for further testing, including details for such testing. Ecotoxicological testing begins with representative test organisms followed by complex test systems. After each tier, it is evaluated whether the information gained permits assessing the safety of the NM so that further testing can be waived. By effectively exploiting all available information, IATA allow accelerating the risk assessment process and reducing testing costs and animal use (in line with the 3Rs principle implemented in EU Directive 2010/63/EU). Combining material properties, exposure, biokinetics and hazard data, information gained with IATA can be used to recognise groups of NM based upon similar modes of action. Grouping of substances in return should form integral part of the IATA themselves. PMID:23641967

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

PubMed

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

2017-12-01

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

The potential application of behavior-based safety in the trucking industry

DOT National Transportation Integrated Search

2000-04-01

Behavior-based safety (BBS) is a set of methods to improve safety performance in the workplace by engaging workers in the improvement process, identifying critical safety behaviors, performing observations to gather data, providing feedback to encour...

Behavior based safety. A different way of looking at an old problem.

PubMed

Haney, L; Anderson, M

1999-09-01

1. The occupational and environmental health nurse role in behavioral safety initiatives can very to include: serving as a leader, change agent, collaborator with safety professionals, consultant, team participant, educator, coach, and supporter to employees and management. 2. Behavior based safety and health initiatives add to existing knowledge and techniques for improving the health and safety of workers. 3. Behavior based safety relies on employee involvement and places a strong emphasis on observation, measurement, feedback, positive reinforcement, and evaluation. It focuses on identification of system improvements and prevention.

3S (Safeguards, Security, Safety) based pyroprocessing facility safety evaluation plan

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

Ku, J.H.; Choung, W.M.; You, G.S.

The big advantage of pyroprocessing for the management of spent fuels against the conventional reprocessing technologies lies in its proliferation resistance since the pure plutonium cannot be separated from the spent fuel. The extracted materials can be directly used as metal fuel in a fast reactor, and pyroprocessing reduces drastically the volume and heat load of the spent fuel. KAERI has implemented the SBD (Safeguards-By-Design) concept in nuclear fuel cycle facilities. The goal of SBD is to integrate international safeguards into the entire facility design process since the very beginning of the design phase. This paper presents a safety evaluationmore » plan using a conceptual design of a reference pyroprocessing facility, in which 3S (Safeguards, Security, Safety)-By-Design (3SBD) concept is integrated from early conceptual design phase. The purpose of this paper is to establish an advanced pyroprocessing hot cell facility design concept based on 3SBD for the successful realization of pyroprocessing technology with enhanced safety and proliferation resistance.« less

Promoting the safety performance of industrial radiography using a quantitative assessment system.

PubMed

Kardan, M R; Mianji, F A; Rastkhah, N; Babakhani, A; Azad, S Borhan

2006-12-01

The increasing number of industrial radiographers and their considerable occupational exposure has been one of the main concerns of the Iran Nuclear Regulatory Authority (INRA) in recent years. In 2002, a quantitative system of evaluating the safety performance of licensees and a complementary enforcement system was introduced by the National Radiation Protection Department (NRPD). Each parameter of the practice is given a weighting factor according to its importance to safety. Assessment of the licensees is done quantitatively by summing up their scores using prepared tables. Implementing this system of evaluation showed a considerable decrease in deficiencies in the various centres. Tables are updated regularly as a result of findings during the inspections. This system is used in addition to enforcement to promote safety performance and to increase the culture of safety in industrial radiography.

Assessing Student Perceptions of School Victimization and School Safety: A Psychometric Assessment of Relevant Instruments

ERIC Educational Resources Information Center

Soderstrom, Irina R.; Elrod, Preston

2006-01-01

In an effort to assess students' perceptions of victimization in their schools, as well as their schools' safety, over 1,900 students from elementary, middle, high, and alternative schools were administered a 154-item questionnaire. The responses on the items were used to establish the psychometric properties of 19 theoretically driven scales and…

Student threat assessment as a standard school safety practice: Results from a statewide implementation study.

PubMed

Cornell, Dewey; Maeng, Jennifer L; Burnette, Anna Grace; Jia, Yuane; Huang, Francis; Konold, Timothy; Datta, Pooja; Malone, Marisa; Meyer, Patrick

2018-06-01

Threat assessment has been widely endorsed as a school safety practice, but there is little research on its implementation. In 2013, Virginia became the first state to mandate student threat assessment in its public schools. The purpose of this study was to examine the statewide implementation of threat assessment and to identify how threat assessment teams distinguish serious from nonserious threats. The sample consisted of 1,865 threat assessment cases reported by 785 elementary, middle, and high schools. Students ranged from pre-K to Grade 12, including 74.4% male, 34.6% receiving special education services, 51.2% White, 30.2% Black, 6.8% Hispanic, and 2.7% Asian. Survey data were collected from school-based teams to measure student demographics, threat characteristics, and assessment results. Logistic regression indicated that threat assessment teams were more likely to identify a threat as serious if it was made by a student above the elementary grades (odds ratio 0.57; 95% lower and upper bound 0.42-0.78), a student receiving special education services (1.27; 1.00-1.60), involved battery (1.61; 1.20-2.15), homicide (1.40; 1.07-1.82), or weapon possession (4.41; 2.80-6.96), or targeted an administrator (3.55; 1.73-7.30). Student race and gender were not significantly associated with a serious threat determination. The odds ratio that a student would attempt to carry out a threat classified as serious was 12.48 (5.15-30.22). These results provide new information on the nature and prevalence of threats in schools using threat assessment that can guide further work to develop this emerging school safety practice. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review

PubMed Central

de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

2014-01-01

Aim: To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Methods: Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. Results: In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Conclusion: Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods. PMID:26770720

Hospital-based health technology assessment: developments to date.

PubMed

Gagnon, Marie-Pierre

2014-09-01

Health technology assessment (HTA) uses a multidisciplinary approach to answer relevant questions regarding the safety, efficacy, effectiveness and cost-effectiveness of health technologies. There is growing interest in implementing HTA methods at the hospital level because it could facilitate decision-making regarding acquisition, implementation or discontinuation of technologies or interventions within the hospital. First, this article provides an overview of current international experiences and knowledge of hospital-based HTA. Then, it presents the different types of hospital-based HTA, providing examples of each of these models, as well as their strengths and limitations. Finally, it proposes a set of emerging issues that could help inform decision-makers who consider implementing hospital-based HTA, or other stakeholders interested in the field.

A National Estimate of Performance: Statewide Highway Safety Program Assessment.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

A nationwide systematic approach to assess the developments and achievements of highway safety activities was conducted to measure program outputs from 1969 through 1974 using key indicators of performance such as ratios and percentages. A sample of 10 states was selected with overall sample of 105 local jurisdictions which would provide estimated…

Towards a Competency-based Vision for Construction Safety Education

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

Integrated Safety Assessment of 2′-O-Methoxyethyl Chimeric Antisense Oligonucleotides in NonHuman Primates and Healthy Human Volunteers

PubMed Central

Crooke, Stanley T; Baker, Brenda F; Kwoh, T Jesse; Cheng, Wei; Schulz, Dan J; Xia, Shuting; Salgado, Nelson; Bui, Huynh-Hoa; Hart, Christopher E; Burel, Sebastien A; Younis, Husam S; Geary, Richard S; Henry, Scott P; Bhanot, Sanjay

2016-01-01

The common chemical and biological properties of antisense oligonucleotides provide the opportunity to identify and characterize chemical class effects across species. The chemical class that has proven to be the most versatile and best characterized is the 2′-O-methoxyethyl chimeric antisense oligonucleotides. In this report we present an integrated safety assessment of data obtained from controlled dose-ranging studies in nonhuman primates (macaques) and healthy human volunteers for 12 unique 2′-O-methoxyethyl chimeric antisense oligonucleotides. Safety was assessed by the incidence of safety signals in standardized laboratory tests for kidney and liver function, hematology, and complement activation; as well as by the mean test results as a function of dose level over time. At high doses a number of toxicities were observed in nonhuman primates. However, no class safety effects were identified in healthy human volunteers from this integrated data analysis. Effects on complement in nonhuman primates were not observed in humans. Nonhuman primates predicted safe doses in humans, but over predicted risk of complement activation and effects on platelets. Although limited to a single chemical class, comparisons from this analysis are considered valid and accurate based on the carefully controlled setting for the specified study populations and within the total exposures studied. PMID:27357629

Effectiveness of web-based tailored advice on parents' child safety behaviors: randomized controlled trial.

PubMed

van Beelen, Mirjam Elisabeth Johanna; Beirens, Tinneke Monique Jozef; den Hertog, Paul; van Beeck, Eduard Ferdinand; Raat, Hein

2014-01-24

Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. To evaluate the effect of E-Health4Uth home safety on parents' safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents' child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs. 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs. 71.94%; OR 0

Effectiveness of Web-Based Tailored Advice on Parents’ Child Safety Behaviors: Randomized Controlled Trial

PubMed Central

2014-01-01

Background Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. Objective To evaluate the effect of E-Health4Uth home safety on parents’ safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. Methods A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents’ child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. Results A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of

Do we know what foundation year doctors think about patient safety incident reporting? Development of a Web based tool to assess attitude and knowledge.

PubMed

Robson, Jean; de Wet, Carl; McKay, John; Bowie, Paul

2011-11-01

Making healthcare safer is an international priority. Patient safety modules are now taught in medical schools, and methods to assess related student knowledge and attitudes have been developed. However, little is known about the attitudes and knowledge which foundation doctors are developing to patient safety and incident reporting in the healthcare workplace, since a specific assessment tool appears to be lacking. To develop, content validate and pilot test an online questionnaire survey to elicit foundation doctors' knowledge and experience of patient safety and incident reporting, and assess related attitudes and behaviours. Questionnaire content validity was facilitated through: a steering group; literature review; feedback from foundation year doctors and consultant staff; a modified Delphi group; and completion of a content validity index by experts. In 2010 a cross-sectional online survey of 110 foundation year 1 and 2 doctors was then undertaken in three Scottish NHS board areas, utilising the developed 25 item questionnaire. The questionnaire was validated, and piloted among 69 foundation year doctors who responded to the questionnaire. The pilot has provided valuable insights into trainee attitudes and experience. For example, 32 (48%) believed that most safety incidents were due to things that they could not do anything about; and 31 (43%) admitted to being involved in medication errors which were not formally reported. The pilot study was successful in taking the first steps to developing a validated survey questionnaire for a key staff group, foundation year doctors, in a priority area. However, the findings raise concerns about trainee experience of and attitudes to reporting, and the frequency with which incidents go unreported.

Computer-based training for safety: comparing methods with older and younger workers.

PubMed

Wallen, Erik S; Mulloy, Karen B

2006-01-01

Computer-based safety training is becoming more common and is being delivered to an increasingly aging workforce. Aging results in a number of changes that make it more difficult to learn from certain types of computer-based training. Instructional designs derived from cognitive learning theories may overcome some of these difficulties. Three versions of computer-based respiratory safety training were shown to older and younger workers who then took a high and a low level learning test. Younger workers did better overall. Both older and younger workers did best with the version containing text with pictures and audio narration. Computer-based training with pictures and audio narration may be beneficial for workers over 45 years of age. Computer-based safety training has advantages but workers of different ages may benefit differently. Computer-based safety programs should be designed and selected based on their ability to effectively train older as well as younger learners.

An assessment by the Statin Muscle Safety Task Force: 2014 update.

PubMed

Rosenson, Robert S; Baker, Steven K; Jacobson, Terry A; Kopecky, Stephen L; Parker, Beth A; The National Lipid Association's Muscle Safety Expert Panel

2014-01-01

The National Lipid Association's Muscle Safety Expert Panel was charged with the duty of examining the definitions for statin-associated muscle adverse events, development of a clinical index to assess myalgia, and the use of diagnostic neuromuscular studies to investigate muscle adverse events. We provide guidance as to when a patient should be considered for referral to neuromuscular specialists and indications for the performance of a skeletal muscle biopsy. Based on this review of evidence, we developed an algorithm for the evaluation and treatment of patients who may be intolerant to statins as the result of adverse muscle events. The panel was composed of clinical cardiologists, clinical lipidologists, an exercise physiologist, and a neuromuscular specialist. Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.

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

PubMed

Tosoni, Edoardo; Salo, Ahti; Zio, Enrico

2018-04-01

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

Core principles of assessment in competency-based medical education.

PubMed

Lockyer, Jocelyn; Carraccio, Carol; Chan, Ming-Ka; Hart, Danielle; Smee, Sydney; Touchie, Claire; Holmboe, Eric S; Frank, Jason R

2017-06-01

The meaningful assessment of competence is critical for the implementation of effective competency-based medical education (CBME). Timely ongoing assessments are needed along with comprehensive periodic reviews to ensure that trainees continue to progress. New approaches are needed to optimize the use of multiple assessors and assessments; to synthesize the data collected from multiple assessors and multiple types of assessments; to develop faculty competence in assessment; and to ensure that relationships between the givers and receivers of feedback are appropriate. This paper describes the core principles of assessment for learning and assessment of learning. It addresses several ways to ensure the effectiveness of assessment programs, including using the right combination of assessment methods and conducting careful assessor selection and training. It provides a reconceptualization of the role of psychometrics and articulates the importance of a group process in determining trainees' progress. In addition, it notes that, to reach its potential as a driver in trainee development, quality care, and patient safety, CBME requires effective information management and documentation as well as ongoing consideration of ways to improve the assessment system.

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

Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

PubMed

Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

2010-01-01

Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

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.

Behavior-based safety on construction sites: a case study.

PubMed

Choudhry, Rafiq M

2014-09-01

This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

Amended Safety Assessment of Isethionate Salts as Used in Cosmetics.

PubMed

Burnett, Christina L; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) rereviewed the safety of 12 isethionate salts as used in cosmetics and concluded that these ingredients are safe in the present practices of use and concentration, when formulated to be nonirritating. These isethionate salts are reported to function mostly as surfactants and cleansing agents in cosmetic products. The Panel reviewed the available animal and clinical data as well as information from previous CIR reports. Although there are data gaps, the shared chemical core structure, expected similarities in physicochemical properties, and similar functions and concentrations in cosmetics enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each ingredient.

Patient safety room of horrors: a novel method to assess medical students and entering residents' ability to identify hazards of hospitalisation.

PubMed

Farnan, Jeanne M; Gaffney, Sean; Poston, Jason T; Slawinski, Kris; Cappaert, Melissa; Kamin, Barry; Arora, Vineet M

2016-03-01

Patient safety curricula in undergraduate medical education (UME) are often didactic format with little focus on skills training. Despite recent focus on safety, practical training in residency education is also lacking. Assessments of safety skills in UME and graduate medical education (GME) are generally knowledge, and not application-focused. We aimed to develop and pilot a safety-focused simulation with medical students and interns to assess knowledge regarding hazards of hospitalisation. A simulation demonstrating common hospital-based safety threats was designed. A case scenario was created including salient patient information and simulated safety threats such as the use of upper-extremity restraints and medication errors. After entering the room and reviewing the mock chart, learners were timed and asked to identify and document as many safety hazards as possible. Learner satisfaction was assessed using constructed-response evaluation. Descriptive statistics, including per cent correct and mean correct hazards, were performed. All 86 third-year medical students completed the encounter. Some hazards were identified by a majority of students (fall risk, 83% of students) while others were rarely identified (absence of deep venous thrombosis prophylaxis, 13% of students). Only 5% of students correctly identified pressure ulcer risk. 128 of 131 interns representing 49 medical schools participated in the GME implementation. Incoming interns were able to identify a mean of 5.1 hazards out of the 9 displayed (SD 1.4) with 40% identifying restraints as a hazard, and 20% identifying the inappropriate urinary catheter as a hazard. A simulation showcasing safety hazards was a feasible and effective way to introduce trainees to safety-focused content. Both students and interns had difficulty identifying common hazards of hospitalisation. Despite poor performance, learners appreciated the interactive experience and its clinical utility. Published by the BMJ Publishing

Assessing Patient Activation among High-Need, High-Cost Patients in Urban Safety Net Care Settings.

PubMed

Napoles, Tessa M; Burke, Nancy J; Shim, Janet K; Davis, Elizabeth; Moskowitz, David; Yen, Irene H

2017-12-01

We sought to examine the literature using the Patient Activation Measure (PAM) or the Patient Enablement Instrument (PEI) with high-need, high-cost (HNHC) patients receiving care in urban safety net settings. Urban safety net care management programs serve low-income, racially/ethnically diverse patients living with multiple chronic conditions. Although many care management programs track patient progress with the PAM or the PEI, it is not clear whether the PAM or the PEI is an effective and appropriate tool for HNHC patients receiving care in urban safety net settings in the United States. We searched PubMed, EMBASE, Web of Science, and PsycINFO for articles published between 2004 and 2015 that used the PAM and between 1998 and 2015 that used the PEI. The search was limited to English-language articles conducted in the United States and published in peer-reviewed journals. To assess the utility of the PAM and the PEI in urban safety net care settings, we defined a HNHC patient sample as racially/ethnically diverse, low socioeconomic status (SES), and multimorbid. One hundred fourteen articles used the PAM. All articles using the PEI were conducted outside the U.S. and therefore were excluded. Nine PAM studies (8%) included participants similar to those receiving care in urban safety net settings, three of which were longitudinal. Two of the three longitudinal studies reported positive changes following interventions. Our results indicate that research on patient activation is not commonly conducted on racially and ethnically diverse, low SES, and multimorbid patients; therefore, there are few opportunities to assess the appropriateness of the PAM in such populations. Investigators expressed concerns with the potential unreliability and inappropriate nature of the PAM on multimorbid, older, and low-literacy patients. Thus, the PAM may not be able to accurately assess patient progress among HNHC patients receiving care in urban safety net settings. Assessing

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

Environmental, health and safety assessment of photovoltaics

NASA Technical Reports Server (NTRS)

Rose, E. C.

1983-01-01

The environmental, health, and safety (E, H and S) concerns associated with the fabrication, deployment, and decommissioning of photovoltaic (PV) systems in terrestial applications are identified and assessed. Discussion is limited to crystalline silicon technologies. The primary E, H, and S concerns that arise during collector fabrication are associated with occupational exposure to materials of undetermined toxicity or to materials that are known to be hazardous, but for which process control technology may be inadequate. Stricter exposure standards are anticipated for some materials and may indicate a need for further control technology development. Minimizing electric shock hazards is a significant concern during system construction, operation and maintenance, and decommissioning.

Correspondence between Simulator and On-Road Drive Performance: Implications for Assessment of Driving Safety.

PubMed

Aksan, Nazan; Hacker, Sarah D; Sager, Lauren; Dawson, Jeffrey; Anderson, Steven; Rizzo, Matthew

2016-03-01

Forty-two younger (Mean age = 35) and 37 older drivers (Mean age = 77) completed four similar simulated drives. In addition, 32 younger and 30 older drivers completed a standard on-road drive in an instrumented vehicle. Performance in the simulated drives was evaluated using both electronic drive data and video-review of errors. Safety errors during the on-road drive were evaluated by a certified driving instructor blind to simulator performance, using state Department of Transportation criteria. We examined the degree of convergence in performance across the two platforms on various driving tasks including lane change, lane keeping, speed control, stopping, turns, and overall performance. Differences based on age group indicated a pattern of strong relative validity for simulator measures. However, relative rank-order in specific metrics of performance suggested a pattern of moderate relative validity. The findings have implications for the use of simulators in assessments of driving safety as well as its use in training and/or rehabilitation settings.

Correspondence between Simulator and On-Road Drive Performance: Implications for Assessment of Driving Safety

PubMed Central

Aksan, Nazan; Hacker, Sarah D.; Sager, Lauren; Dawson, Jeffrey; Anderson, Steven; Rizzo, Matthew

2017-01-01

Forty-two younger (Mean age = 35) and 37 older drivers (Mean age = 77) completed four similar simulated drives. In addition, 32 younger and 30 older drivers completed a standard on-road drive in an instrumented vehicle. Performance in the simulated drives was evaluated using both electronic drive data and video-review of errors. Safety errors during the on-road drive were evaluated by a certified driving instructor blind to simulator performance, using state Department of Transportation criteria. We examined the degree of convergence in performance across the two platforms on various driving tasks including lane change, lane keeping, speed control, stopping, turns, and overall performance. Differences based on age group indicated a pattern of strong relative validity for simulator measures. However, relative rank-order in specific metrics of performance suggested a pattern of moderate relative validity. The findings have implications for the use of simulators in assessments of driving safety as well as its use in training and/or rehabilitation settings. PMID:28649572

Safety of antisense oligonucleotide and siRNA-based therapeutics.

PubMed

Chi, Xuan; Gatti, Philip; Papoian, Thomas

2017-05-01

Oligonucleotide-based therapy is an active area of drug development designed to treat a variety of gene-specific diseases. Two of the more promising platforms are the antisense oligonucleotides (ASOs) and short interfering RNAs (siRNAs), both of which are often directed against similar targets. In light of recent reports on clinical trials of severe thrombocytopenia with two different ASO drugs and increased peripheral neuropathy with an siRNA drug, we compared and contrasted the specific safety characteristics of these two classes of oligonucleotide therapeutic. The objectives were to assess factors that could contribute to the specific toxicities observed with these two classes of promising drugs, and get a better understanding of the potential mechanism(s) responsible for these rare, but serious, adverse events. Published by Elsevier Ltd.

Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

ERIC Educational Resources Information Center

Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

2015-01-01

Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

A safety-based decision making architecture for autonomous systems

NASA Technical Reports Server (NTRS)

Musto, Joseph C.; Lauderbaugh, L. K.

1991-01-01

Engineering systems designed specifically for space applications often exhibit a high level of autonomy in the control and decision-making architecture. As the level of autonomy increases, more emphasis must be placed on assimilating the safety functions normally executed at the hardware level or by human supervisors into the control architecture of the system. The development of a decision-making structure which utilizes information on system safety is detailed. A quantitative measure of system safety, called the safety self-information, is defined. This measure is analogous to the reliability self-information defined by McInroy and Saridis, but includes weighting of task constraints to provide a measure of both reliability and cost. An example is presented in which the safety self-information is used as a decision criterion in a mobile robot controller. The safety self-information is shown to be consistent with the entropy-based Theory of Intelligent Machines defined by Saridis.

Road Risk Modeling and Cloud-Aided Safety-Based Route Planning.