International Approaches for Nuclear Waste Disposal in Geological Formations: Report on Fifth Worldwide Review

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

Faybishenko, Boris; Birkholzer, Jens; Persoff, Peter

2016-09-01

The goal of the Fifth Worldwide Review is to document evolution in the state-of-the-art of approaches for nuclear waste disposal in geological formations since the Fourth Worldwide Review that was released in 2006. The last ten years since the previous Worldwide Review has seen major developments in a number of nations throughout the world pursuing geological disposal programs, both in preparing and reviewing safety cases for the operational and long-term safety of proposed and operating repositories. The countries that are approaching implementation of geological disposal will increasingly focus on the feasibility of safely constructing and operating their repositories in short-more » and long terms on the basis existing regulations. The WWR-5 will also address a number of specific technical issues in safety case development along with the interplay among stakeholder concerns, technical feasibility, engineering design issues, and operational and post-closure safety. Preparation and publication of the Fifth Worldwide Review on nuclear waste disposal facilitates assessing the lessons learned and developing future cooperation between the countries. The Report provides scientific and technical experiences on preparing for and developing scientific and technical bases for nuclear waste disposal in deep geologic repositories in terms of requirements, societal expectations and the adequacy of cases for long-term repository safety. The Chapters include potential issues that may arise as repository programs mature, and identify techniques that demonstrate the safety cases and aid in promoting and gaining societal confidence. The report will also be used to exchange experience with other fields of industry and technology, in which concepts similar to the design and safety cases are applied, as well to facilitate the public perception and understanding of the safety of the disposal approaches relative to risks that may increase over long times frames in the absence of a successful implementation of final dispositioning.« less

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.

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

Generalized implementation of software safety policies

NASA Technical Reports Server (NTRS)

Knight, John C.; Wika, Kevin G.

1994-01-01

As part of a research program in the engineering of software for safety-critical systems, we are performing two case studies. The first case study, which is well underway, is a safety-critical medical application. The second, which is just starting, is a digital control system for a nuclear research reactor. Our goal is to use these case studies to permit us to obtain a better understanding of the issues facing developers of safety-critical systems, and to provide a vehicle for the assessment of research ideas. The case studies are not based on the analysis of existing software development by others. Instead, we are attempting to create software for new and novel systems in a process that ultimately will involve all phases of the software lifecycle. In this abstract, we summarize our results to date in a small part of this project, namely the determination and classification of policies related to software safety that must be enforced to ensure safe operation. We hypothesize that this classification will permit a general approach to the implementation of a policy enforcement mechanism.

Verification and Validation in a Rapid Software Development Process

NASA Technical Reports Server (NTRS)

Callahan, John R.; Easterbrook, Steve M.

1997-01-01

The high cost of software production is driving development organizations to adopt more automated design and analysis methods such as rapid prototyping, computer-aided software engineering (CASE) tools, and high-level code generators. Even developers of safety-critical software system have adopted many of these new methods while striving to achieve high levels Of quality and reliability. While these new methods may enhance productivity and quality in many cases, we examine some of the risks involved in the use of new methods in safety-critical contexts. We examine a case study involving the use of a CASE tool that automatically generates code from high-level system designs. We show that while high-level testing on the system structure is highly desirable, significant risks exist in the automatically generated code and in re-validating releases of the generated code after subsequent design changes. We identify these risks and suggest process improvements that retain the advantages of rapid, automated development methods within the quality and reliability contexts of safety-critical projects.

Development of a Reality-Based Multimedia Case Study Teaching Method and Its Effect on Students' Planned Food Safety Behaviors

ERIC Educational Resources Information Center

Alberts, Caitlin M.; Stevenson, Clinton D.

2017-01-01

There is opportunity to decrease the frequency of foodborne illnesses by improving food safety competencies and planned behaviors of college students before they begin careers in the food industry. The objectives of this study were to (1) develop a multimedia case study teaching method that provides real world context for food science education;…

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

Discussion on the Criterion for the Safety Certification Basis Compilation - Brazilian Space Program Case

NASA Astrophysics Data System (ADS)

Niwa, M.; Alves, N. C.; Caetano, A. O.; Andrade, N. S. O.

2012-01-01

The recent advent of the commercial launch and re- entry activities, for promoting the expansion of human access to space for tourism and hypersonic travel, in the already complex ambience of the global space activities, brought additional difficulties over the development of a harmonized framework of international safety rules. In the present work, with the purpose of providing some complementary elements for global safety rule development, the certification-related activities conducted in the Brazilian space program are depicted and discussed, focusing mainly on the criterion for certification basis compilation. The results suggest that the composition of a certification basis with the preferential use of internationally-recognized standards, as is the case of ISO standards, can be a first step toward the development of an international safety regulation for commercial space activities.

Towards Measurement of Confidence in Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Paim Ganesh J.; Habli, Ibrahim

2011-01-01

Arguments in safety cases are predominantly qualitative. This is partly attributed to the lack of sufficient design and operational data necessary to measure the achievement of high-dependability targets, particularly for safety-critical functions implemented in software. The subjective nature of many forms of evidence, such as expert judgment and process maturity, also contributes to the overwhelming dependence on qualitative arguments. However, where data for quantitative measurements is systematically collected, quantitative arguments provide far more benefits over qualitative arguments, in assessing confidence in the safety case. In this paper, we propose a basis for developing and evaluating integrated qualitative and quantitative safety arguments based on the Goal Structuring Notation (GSN) and Bayesian Networks (BN). The approach we propose identifies structures within GSN-based arguments where uncertainties can be quantified. BN are then used to provide a means to reason about confidence in a probabilistic way. We illustrate our approach using a fragment of a safety case for an unmanned aerial system and conclude with some preliminary observations

How Past Loss of Control Accidents May Inform Safety Cases for Advanced Control Systems on Commercial Aircraft

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, C. W.

2008-01-01

This paper describes five loss of control accidents involving commercial aircraft, and derives from those accidents three principles to consider when developing a potential safety case for an advanced flight control system for commercial aircraft. One, among the foundational evidence needed to support a safety case is the availability to the control system of accurate and timely information about the status and health of relevant systems and components. Two, an essential argument to be sustained in the safety case is that pilots are provided with adequate information about the control system to enable them to understand the capabilities that it provides. Three, another essential argument is that the advanced control system will not perform less safely than a good pilot.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

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

Occupational Safety and Health Programs in Career Education.

ERIC Educational Resources Information Center

DiCarlo, Robert D.; And Others

This resource guide was developed in response to the Occupational Safety and Health Act of 1970 and is intended to assist teachers in implementing courses in occupational safety and health as part of a career education program. The material is a synthesis of films, programed instruction, slides and narration, case studies, safety pamphlets,…

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

PubMed

Sahebalzamani, Mohammad; Mohammady, Mohsen

2014-05-01

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

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.

Hard and Soft Safety Verifications

NASA Technical Reports Server (NTRS)

Wetherholt, Jon; Anderson, Brenda

2012-01-01

The purpose of this paper is to examine the differences between and the effects of hard and soft safety verifications. Initially, the terminology should be defined and clarified. A hard safety verification is datum which demonstrates how a safety control is enacted. An example of this is relief valve testing. A soft safety verification is something which is usually described as nice to have but it is not necessary to prove safe operation. An example of a soft verification is the loss of the Solid Rocket Booster (SRB) casings from Shuttle flight, STS-4. When the main parachutes failed, the casings impacted the water and sank. In the nose cap of the SRBs, video cameras recorded the release of the parachutes to determine safe operation and to provide information for potential anomaly resolution. Generally, examination of the casings and nozzles contributed to understanding of the newly developed boosters and their operation. Safety verification of SRB operation was demonstrated by examination for erosion or wear of the casings and nozzle. Loss of the SRBs and associated data did not delay the launch of the next Shuttle flight.

Rocketdyne Safety Algorithm: Space Shuttle Main Engine Fault Detection

NASA Technical Reports Server (NTRS)

Norman, Arnold M., Jr.

1994-01-01

The Rocketdyne Safety Algorithm (RSA) has been developed to the point of use on the TTBE at MSFC on Task 4 of LeRC contract NAS3-25884. This document contains a description of the work performed, the results of the nominal test of the major anomaly test cases and a table of the resulting cutoff times, a plot of the RSA value vs. time for each anomaly case, a logic flow description of the algorithm, the algorithm code, and a development plan for future efforts.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

Relational Safety and Liberating Training Spaces: An Application with a Focus on Sexual Orientation Issues

ERIC Educational Resources Information Center

Hernandez, Pilar; Rankin, Pressley, IV

2008-01-01

This article describes and discusses a teaching case of a clinical training situation involving a gay marriage and family therapy student working with a same-sex affectional couple. The conceptual pillars of this teaching case, relational safety and liberating spaces, are advanced as illustrations of how the student developed his voice in the…

A performance improvement case study in aircraft maintenance and its implications for hazard identification.

PubMed

Ward, Marie; McDonald, Nick; Morrison, Rabea; Gaynor, Des; Nugent, Tony

2010-02-01

Aircraft maintenance is a highly regulated, safety critical, complex and competitive industry. There is a need to develop innovative solutions to address process efficiency without compromising safety and quality. This paper presents the case that in order to improve a highly complex system such as aircraft maintenance, it is necessary to develop a comprehensive and ecologically valid model of the operational system, which represents not just what is meant to happen, but what normally happens. This model then provides the backdrop against which to change or improve the system. A performance report, the Blocker Report, specific to aircraft maintenance and related to the model was developed gathering data on anything that 'blocks' task or check performance. A Blocker Resolution Process was designed to resolve blockers and improve the current check system. Significant results were obtained for the company in the first trial and implications for safety management systems and hazard identification are discussed. Statement of Relevance: Aircraft maintenance is a safety critical, complex, competitive industry with a need to develop innovative solutions to address process and safety efficiency. This research addresses this through the development of a comprehensive and ecologically valid model of the system linked with a performance reporting and resolution system.

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

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

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

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

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

NASA Astrophysics Data System (ADS)

Guo, Jingjing

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

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.

Safety management by walking around (SMBWA): a safety intervention program based on both peer and manager participation.

PubMed

Luria, Gil; Morag, Ido

2012-03-01

"Management by walking around" (MBWA) is a practice that has aroused much interest in management science and practice. The purpose of this study is to demonstrate adaptation of this practice to safety management. We describe a three-year long case study that collected empirical data in which a modified MBWA was practiced in order to improve safety in a semiconductor fabrication facility. The main modification involved integrating an information system with the MBWA in order to create a practice that would generate safety leadership development and an organizational safety learning mechanism, while promoting employee safety participation. The results of the case study demonstrate that the SMBWA practice facilitated thousands of tours in which safety leadership behaviors were practiced by managers and by employees (employees performed five times as many tours as managers). The information system collected information about safety behaviors and safety conditions that could not otherwise be obtained. Thus, this study presents a new organizational safety practice SMBWA, and demonstrates the ways in which SMBWA may improve safety in organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

HSE's safety assessment principles for criticality safety.

PubMed

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

2008-06-01

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

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

Comparative Case Studies Of Corridor Safety Improvement Efforts

DOT National Transportation Integrated Search

1999-12-01

In 1988, following a series of fatal crashes on U.S. Route 322, Pennsylvania's governor directed Pennsylvania's secretary of transportation to develop immediate, short-term measures to improve safety on the roadway. In response, the Pennsylvania Depa...

Risk Assessment in Underground Coalmines Using Fuzzy Logic in the Presence of Uncertainty

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Ala, Charan Kumar

2018-04-01

Fatal accidents are occurring every year as regular events in Indian coal mining industry. To increase the safety conditions, it has become a prerequisite to performing a risk assessment of various operations in mines. However, due to uncertain accident data, it is hard to conduct a risk assessment in mines. The object of this study is to present a method to assess safety risks in underground coalmines. The assessment of safety risks is based on the fuzzy reasoning approach. Mamdani fuzzy logic model is developed in the fuzzy logic toolbox of MATLAB. A case study is used to demonstrate the applicability of the developed model. The summary of risk evaluation in case study mine indicated that mine fire has the highest risk level among all the hazard factors. This study could help the mine management to prepare safety measures based on the risk rankings obtained.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

A Comparison of Two Approaches to Safety Analysis Based on Use Cases

NASA Astrophysics Data System (ADS)

Stålhane, Tor; Sindre, Guttorm

Engineering has a long tradition in analyzing the safety of mechanical, electrical and electronic systems. Important methods like HazOp and FMEA have also been adopted by the software engineering community. The misuse case method, on the other hand, has been developed by the software community as an alternative to FMEA and preliminary HazOp for software development. To compare the two methods misuse case and FMEA we have run a small experiment involving 42 third year software engineering students. In the experiment, the students should identify and analyze failure modes from one of the use cases for a commercial electronic patient journals system. The results of the experiment show that on the average, the group that used misuse cases identified and analyzed more user related failure modes than the persons using FMEA. In addition, the persons who used the misuse cases scored better on perceived ease of use and intention to use.

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

Point-of-Care Detection Devices for Food Safety Monitoring: Proactive Disease Prevention.

PubMed

Wu, Marie Yung-Chen; Hsu, Min-Yen; Chen, Shih-Jen; Hwang, De-Kuang; Yen, Tzung-Hai; Cheng, Chao-Min

2017-04-01

Food safety has become an increasingly significant public concern in both developed and under-developed nations around the world; it increases morbidity, mortality, human suffering, and economic burden. This Opinion focuses on (i) examining the influence of pathogens and chemicals (e.g., food additives and pesticide residue) on food-borne illnesses, (ii) summarizing food hazards that are present in Asia, and (iii) summarizing the array of current point-of-care (POC) detection devices that have potential applications in food safety monitoring. In addition, we provide insight into global healthcare issues in both developing and under-developed nations with a focus on bridging the gap between food safety issues in the public sector (associated with relevant clinical cases) and the use of POC detection devices for food safety monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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

2011-05-27

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

Traveler Trustworthy Autonomy

NASA Technical Reports Server (NTRS)

Skoog, Mark A.

2016-01-01

NASAs Armstrong Flight Research Center has been engaged in the development of highly automatic safety systems for aviation since the mid 80s. For the past three years under Seedling and Center Innovation funding this work has moved toward the development of a software architecture applicable to autonomous safety. This work is now broadening and accelerating to address the airworthiness issues surrounding making a case for trustworthy autonomy. This software architecture is called the expandable variable-autonomy architecture (EVAA) and utilizes a run-time assurance approach to safety assurance.

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

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

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.

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

NASA Astrophysics Data System (ADS)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Safe laser application requires more than laser safety

NASA Astrophysics Data System (ADS)

Frevel, A.; Steffensen, B.; Vassie, L.

1995-02-01

An overview is presented concerning aspects of laser safety in European industrial laser use. Surveys indicate that there is a large variation in the safety strategies amongst industrial laser users. Some key problem areas are highlighted. Emission of hazardous substances is a major problem for users of laser material processing systems where the majority of the particulate is of a sub-micrometre size, presenting a respiratory hazard. Studies show that in many cases emissions are not frequently monitored in factories and uncertainty exists over the hazards. Operators of laser machines do not receive adequate job training or safety training. The problem is compounded by a plethora of regulations and standards which are difficult to interpret and implement, and inspectors who are not conversant with the technology or the issues. A case is demonstrated for a more integrated approach to laser safety, taking into account the development of laser applications, organizational and personnel development, in addition to environmental and occupational health and safety aspects. It is necessary to achieve a harmonization between these elements in any organization involved in laser technology. This might be achieved through establishing technology transfer centres in laser technology.

Safety of Silicone Oil Removal in Cases of Gunshot Perforating Eye Injuries.

PubMed

Ghoraba, Hammouda Hamdy; Elgouhary, Sameh Mohamed; Mansour, Hosam Osman; Abdel-Fattah, Hitham Mamoun; Heikal, Mohamed Amin; Elgemaey, Emad Mohamed

2017-03-01

To evaluate the feasibility and safety of silicone oil (SO) removal in cases of gunshot perforating eye injuries (PEI). A retrospective, consecutive, interventional study from medical records regarding cases of gunshot PEI during the periods of Egyptian political instability (January 2011 until December 2013). The main outcomes were to evaluate the feasibility of SO removal in cases of gunshot PEI and management of retinal detachment (RD) after SO removal in such cases. One hundred ninety-six eyes of 193 patients were reviewed. SO was removed in 72 eyes of 70 patients (36.7%). After SO removal, five eyes (6.9%) developed RD. One case refused any other intervention. RD in the remaining four cases was treated with revision surgery and SO reinjection. The retina remained stable throughout follow-up. None of the eyes developed phthisis bulbi after SO removal. Mean follow-up after SO removal was 10.86 months (range: 3 months to 30 months). Mean follow-up after management of RD after SO removal was 17.7 months (range: 13 months to 21 months). Patients aged younger than 20 years were associated with extensive fibrous proliferation, which might affect the safety profile of SO removal in cases of gunshot PEI. Rate of RD after SO removal in cases of apparent retinal stability and localized fibrous proliferation was 6.9%. Retinal detachment after SO removal in such cases can be treated with revision surgery and SO reinjection. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:242-250.]. Copyright 2017, SLACK Incorporated.

The business case for patient safety.

PubMed

Hwang, Raymond W; Herndon, James H

2007-04-01

Recent trends have focused attention on improving patient safety in the United States healthcare system. Lapses in patient safety create undue, often preventable, morbidity. These include adverse drug events, adverse surgical events and nosocomial infections. From an organizational perspective, these events are both inefficient and expensive. Many safe practices and quality enhancing improvements, such as computer provider order entry, proper infection surveillance, telemedicine intensive care, and registered nurse staffing are in fact cost-effective. However, in order to fully achieve higher quality, better adverse event reporting and a culture of safety must first be developed. Increased provider recognition, models of success, public awareness and consumer demand are propelling improvements. As we will outline in this review of the current literature, the business case for patient safety is a compelling one, offering substantial economic incentives for achieving the necessary goal of improved patient outcomes.

A patient safety objective structured clinical examination.

PubMed

Singh, Ranjit; Singh, Ashok; Fish, Reva; McLean, Don; Anderson, Diana R; Singh, Gurdev

2009-06-01

There are international calls for improving education for health care workers around certain core competencies, of which patient safety and quality are integral and transcendent parts. Although relevant teaching programs have been developed, little is known about how best to assess their effectiveness. The objective of this work was to develop and implement an objective structured clinical examination (OSCE) to evaluate the impact of a patient safety curriculum. The curriculum was implemented in a family medicine residency program with 47 trainees. Two years after commencing the curriculum, a patient safety OSCE was developed and administered at this program and, for comparison purposes, to incoming residents at the same program and to residents at a neighboring residency program. All 47 residents exposed to the training, all 16 incoming residents, and 10 of 12 residents at the neighboring program participated in the OSCE. In a standardized patient case, error detection and error disclosure skills were better among trained residents. In a chart-based case, trained residents showed better performance in identifying deficiencies in care and described more appropriate means of addressing them. Third year residents exposed to a "Systems Approach" course performed better at system analysis and identifying system-based solutions after the course than before. Results suggest increased systems thinking and inculcation of a culture of safety among residents exposed to a patient safety curriculum. The main weaknesses of the study are its small size and suboptimal design. Much further investigation is needed into the effectiveness of patient safety curricula.

Restructuring within an academic health center to support quality and safety: the development of the Center for Quality and Safety at the Massachusetts General Hospital.

PubMed

Bohmer, Richard M J; Bloom, Jonathan D; Mort, Elizabeth A; Demehin, Akinluwa A; Meyer, Gregg S

2009-12-01

Recent focus on the need to improve the quality and safety of health care has created new challenges for academic health centers (AHCs). Whereas previously quality was largely assumed, today it is increasingly quantifiable and requires organized systems for improvement. Traditional structures and cultures within AHCs, although well suited to the tripartite missions of teaching, research, and clinical care, are not easily adaptable to the tasks of measuring, reporting, and improving quality. Here, the authors use a case study of Massachusetts General Hospital's efforts to restructure quality and safety to illustrate the value of beginning with a focus on organizational culture, using a systematic process of engaging clinical leadership, developing an organizational framework dependent on proven business principles, leveraging focus events, and maintaining executive dedication to execution of the initiative. The case provides a generalizable example for AHCs of how applying explicit management design can foster robust organizational change with relatively modest incremental financial resources.

Fire safety: A case study of technology transfer

NASA Technical Reports Server (NTRS)

Heins, C. F.

1975-01-01

Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

The role of production and teamwork practices in construction safety: a cognitive model and an empirical case study.

PubMed

Mitropoulos, Panagiotis Takis; Cupido, Gerardo

2009-01-01

In construction, the challenge for researchers and practitioners is to develop work systems (production processes and teams) that can achieve high productivity and high safety at the same time. However, construction accident causation models ignore the role of work practices and teamwork. This study investigates the mechanisms by which production and teamwork practices affect the likelihood of accidents. The paper synthesizes a new model for construction safety based on the cognitive perspective (Fuller's Task-Demand-Capability Interface model, 2005) and then presents an exploratory case study. The case study investigates and compares the work practices of two residential framing crews: a 'High Reliability Crew' (HRC)--that is, a crew with exceptional productivity and safety over several years, and an average performing crew from the same company. The model explains how the production and teamwork practices generate the work situations that workers face (the task demands) and affect the workers ability to cope (capabilities). The case study indicates that the work practices of the HRC directly influence the task demands and match them with the applied capabilities. These practices were guided by the 'principle' of avoiding errors and rework and included work planning and preparation, work distribution, managing the production pressures, and quality and behavior monitoring. The Task Demand-Capability model links construction research to a cognitive model of accident causation and provides a new way to conceptualize safety as an emergent property of the production practices and teamwork processes. The empirical evidence indicates that the crews' work practices and team processes strongly affect the task demands, the applied capabilities, and the match between demands and capabilities. The proposed model and the exploratory case study will guide further discovery of work practices and teamwork processes that can increase both productivity and safety in construction operations. Such understanding will enable training of construction foremen and crews in these practices to systematically develop high reliability crews.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

A methodology for developing and balancing quantitative design requirements for safety, reliability, and maintainability has been proposed. Conceived as the basis of a more rational approach to the design of spacecraft, the methodology would also be applicable to the design of automobiles, washing machines, television receivers, or almost any other commercial product. Heretofore, it has been common practice to start by determining the requirements for reliability of elements of a spacecraft or other system to ensure a given design life for the system. Next, safety requirements are determined by assessing the total reliability of the system and adding redundant components and subsystems necessary to attain safety goals. As thus described, common practice leaves the maintainability burden to fall to chance; therefore, there is no control of recurring costs or of the responsiveness of the system. The means that have been used in assessing maintainability have been oriented toward determining the logistical sparing of components so that the components are available when needed. The process established for developing and balancing quantitative requirements for safety (S), reliability (R), and maintainability (M) derives and integrates NASA s top-level safety requirements and the controls needed to obtain program key objectives for safety and recurring cost (see figure). Being quantitative, the process conveniently uses common mathematical models. Even though the process is shown as being worked from the top down, it can also be worked from the bottom up. This process uses three math models: (1) the binomial distribution (greaterthan- or-equal-to case), (2) reliability for a series system, and (3) the Poisson distribution (less-than-or-equal-to case). The zero-fail case for the binomial distribution approximates the commonly known exponential distribution or "constant failure rate" distribution. Either model can be used. The binomial distribution was selected for modeling flexibility because it conveniently addresses both the zero-fail and failure cases. The failure case is typically used for unmanned spacecraft as with missiles.

Understanding safety culture in long-term care: a case study.

PubMed

Halligan, Michelle H; Zecevic, Aleksandra; Kothari, Anita R; Salmoni, Alan W; Orchard, Treena

2014-12-01

This case study aimed to understand safety culture in a high-risk secured unit for cognitively impaired residents in a long-term care (LTC) facility. Specific objectives included the following: diagnosing the present level of safety culture maturity using the Patient Safety Culture Improvement Tool (PSCIT), examining the barriers to a positive safety culture, and identifying actions for improvement. A mixed methods design was used within a secured unit for cognitively impaired residents in a Canadian nonprofit LTC facility. Semistructured interviews, a focus group, and the Modified Stanford Patient Safety Culture Survey Instrument were used to explore this topic. Data were synthesized to situate safety maturity of the unit within the PSCIT adapted for LTC. Results indicated a reactive culture, where safety systems were piecemeal and developed only in response to adverse events and/or regulatory requirements. A punitive regulatory environment, inadequate resources, heavy workloads, poor interdisciplinary collaboration, and resident safety training capacity were major barriers to improving safety. This study highlights the importance of understanding a unit's safety culture and identifies the PSCIT as a useful framework for planning future improvements to safety culture maturity. Incorporating mixed methods in the study of health care safety culture provided a good model that can be recommended for future use in research and LTC practice.

[Objectives and limits of test standards].

PubMed

Kaddick, C; Blömer, W

2014-06-01

Test standards are developed worldwide by extremely committed expert groups working mostly in an honorary capacity and have substantially contributed to the currently achieved safety standards in reconstructive orthopedics. Independent of the distribution and quality of a test specification, the specialist knowledge of the user cannot replace a well founded risk analysis and if used unthinkingly can lead to a false estimation of safety. The limits of standardization are reached where new indications or highly innovative products are concerned. In this case the manufacturer must undertake the time and cost-intensive route of a self-developed testing procedure which in the ideal case leads to a further testing standard. Test standards make a substantial contribution to implant safety but cannot replace the expert knowledge of the user. Tests as an end to themselves take the actual objectives of standardization to absurdity.

Relational safety and liberating training spaces: an application with a focus on sexual orientation issues.

PubMed

Hernández, Pilar; Rankin, Pressley

2008-04-01

This article describes and discusses a teaching case of a clinical training situation involving a gay marriage and family therapy student working with a same-sex affectional couple. The conceptual pillars of this teaching case, relational safety and liberating spaces, are advanced as illustrations of how the student developed his voice in the training process. Pivotal moments in this process are discussed, as are implications for training and personal and professional growth.

Interprofessional learning for medication safety.

PubMed

Hardisty, Jessica; Scott, Lesley; Chandler, Sarah; Pearson, Pauline; Powell, Suzanne

2014-07-01

Patient safety is a worldwide priority. Recommendations have been made that doctors, nurses and pharmacists could interact more effectively to improve patient outcomes, and that interprofessional education should be encouraged. In 2009, the North East Strategic Health Authority awarded Workforce Development Initiative funding to Northumbria Healthcare National Health Service (NHS) Foundation Trust to develop an undergraduate interprofessional training activity in medication safety for medicine, pharmacy and nursing students. Interprofessional seminars for medication safety and therapeutics were developed that were delivered across the North East of England. The initial seminars took place between January and April 2011 at 10 teaching hospitals, and were attended by over 400 students (from medicine, pharmacy and nursing). The majority of the workshops were facilitated by an interprofessional team comprised of pharmacists, doctors and nurses, with all students working in small groups with participants from each of the professional groups, where possible. All seminars had standardised materials, but it was up to individual facilitators to choose which of the five case studies were used within the seminar. The seminars lasted between 2 and 3 hours, and depending on which case studies were used, two or three cases could be discussed. Student feedback showed that the seminar was particularly successful in highlighting and improving the students' understanding of each other's roles and responsibilities in relation to medication safety. There are considerable organisational challenges in arranging interprofessional groups. Scenarios need to provide tasks that engage and challenge all of the professions involved. Facilitation is an important element. Interprofessional education should be encouraged. © 2014 John Wiley & Sons Ltd.

Alcohol abuse and traffic safety : a study of fatalities, DWI offenders, alcoholics, and court-related treatment approaches

DOT National Transportation Integrated Search

1970-06-26

Author's abstract: Methodology and conclusions on the role of the abusive use of alcohol in traffic safety were developed through three related projects. Project I is a case-history investigation of 616 traffic fatalities from metropolitan Wayne Coun...

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

PubMed

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

2012-01-01

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

Nutritional and safety assessment of foods and feeds nutritionally improved through biotechnology--case studies by the International Food Biotechnology Committee of ILSI.

PubMed

Glenn, Kevin C

2008-01-01

During the last two decades, the public and private sectors have made substantial research progress internationally toward improving the nutritional value of a wide range of food and feed crops. Nevertheless, significant numbers of people still suffer from the effects of undernutrition. As newly developed crops with nutritionally improved traits come closer to being available to producers and consumers, scientifically sound and efficient processes are needed to assess the safety and nutritional quality of these crops. In 2004, a Task Force of international scientific experts, convened by the International Food Biotechnology Committee (IFBiC) of ILSI, published recommendations for the safety and nutritional assessment of foods and feeds nutritionally improved through modern biotechnology (J. Food Science, 2004, 69:CRH62-CRH68). The comparative safety assessment process is a basic principle in this publication and is the starting point, not the conclusion, of the analysis. Significant differences in composition are expected to be observed in the case of nutritionally enhanced crops and must be assessed on a case-by-case basis. The Golden Rice 2 case study will be presented as an example of a food crop nutritionally enhanced through the application of modern biotechnology (i.e., recombinant DNA techniques) to illustrate how the 2004 recommendations provide a robust paradigm for the safety assessment of "real world" examples of improved nutrition crops.

The Safety "Use Case": Co-Developing Chemical Information Management and Laboratory Safety Skills

ERIC Educational Resources Information Center

Stuart, Ralph B.; McEwen, Leah R.

2016-01-01

The 2015 edition of the American Chemical Society's "Guidelines and Evaluation Procedures for Bachelor's Degree Programs" identifies six skill sets that undergraduate chemistry programs should instill in their students. In our roles as support staff for chemistry departments at two different institutions (one a Primarily Undergraduate…

Ready to Respond: Case Studies in Campus Safety and Security

ERIC Educational Resources Information Center

Hyatt, James A.

2010-01-01

Is your campus primed for the next big emergency? The National Campus Safety and Security Project (NCSSP), led by NACUBO, sought to help colleges and universities develop comprehensive emergency management plans that address the four phases of emergency management: prevention/mitigation, preparedness, response, and recovery. A major component of…

Integrating Safety and Mission Assurance into Systems Engineering Modeling Practices

NASA Technical Reports Server (NTRS)

Beckman, Sean; Darpel, Scott

2015-01-01

During the early development of products, flight, or experimental hardware, emphasis is often given to the identification of technical requirements, utilizing such tools as use case and activity diagrams. Designers and project teams focus on understanding physical and performance demands and challenges. It is typically only later, during the evaluation of preliminary designs that a first pass, if performed, is made to determine the process, safety, and mission quality assurance requirements. Evaluation early in the life cycle, though, can yield requirements that force a fundamental change in design. This paper discusses an alternate paradigm for using the concepts of use case or activity diagrams to identify safety hazard and mission quality assurance risks and concerns using the same systems engineering modeling tools being used to identify technical requirements. It contains two examples of how this process might be used in the development of a space flight experiment, and the design of a Human Powered Pizza Delivery Vehicle, along with the potential benefits to decrease development time, and provide stronger budget estimates.

Application of Gap Analysis to Education: A Case Study of the Food Safety and Quality Assurance Program at the University of Guelph

ERIC Educational Resources Information Center

Fuchs, C.; Wilcock, A.; Aung, M.

2004-01-01

This study was designed to identify the skills and knowledge deemed important for food safety professionals and the degree to which the Food Safety and Quality Assurance (FSQA) program at the Univ. of Guelph helps students to develop these skills. The research included 2 phases: interviews were conducted to identify these skill and knowledge…

Evaluating performance of a Lead Road Safety Agency (LRSA) in a low-income country: a case study from Pakistan.

PubMed

Bhatti, Junaid A; Ahmed, Aizaz

2014-01-01

The World Health Organization recommends identifying a Lead Road Safety Agency (LRSA) within the government to coordinate preventive interventions. As LRSAs in developing countries have rarely been evaluated, this case study describes the performance of the LRSA of Pakistan with respect to the World Bank criteria. The designated LRSA, the National Road Safety Secretariat, was put into operation in 2006 and worked for about two years with World Bank funding. The agency had a stand-alone structure headed by an experienced road safety specialist during the first year only and faced difficulty in recruiting other required experts. The LRSA drafted the first National Road Safety Plan, including strategic review of road safety and existing legislation, articulated multisectorial collaboration nationally and provincially, and collected traffic injury data in some districts. Its progress was halted by its dissolution because of funding problems. Currently, two agencies specialising in traffic enforcement and transport research respectively are fulfilling LRSA functions on an ad-hoc basis. Results suggest that sustainability and consistency of LRSAs in developing countries like Pakistan may only be ensured if they are legally protected, inter-ministerial, have permanent funding and are provided with the required expertise through international cooperation, so they can perform their required functions effectively.

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.

Damage-Tolerant, Affordable Composite Engine Cases Designed and Fabricated

NASA Technical Reports Server (NTRS)

Hopkins, Dale A.; Roberts, Gary D.; Pereira, J. Michael; Bowman, Cheryl L.

2005-01-01

An integrated team of NASA personnel, Government contractors, industry partners, and university staff have developed an innovative new technology for commercial fan cases that will substantially influence the safety and efficiency of future turbine engines. This effective team, under the direction of the NASA Glenn Research Center and with the support of the Federal Aviation Administration, has matured a new class of carbon/polymer composites and demonstrated a 30- to 50-percent improvement in specific containment capacity (blade fragment kinetic energy/containment system weight). As the heaviest engine component, the engine case/containment system greatly affects both the safety and efficiency of aircraft engines. The ballistic impact research team has developed unique test facilities and methods for screening numerous candidate material systems to replace the traditional heavy, metallic engine cases. This research has culminated in the selection of a polymer matrix composite reinforced with triaxially braided carbon fibers and technology demonstration through the fabrication of prototype engine cases for three major commercial engine manufacturing companies.

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.

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 unsafe behaviors and significant increases in safe behaviors. The results of this case study showed that an approach based on goal setting, feedback, and an effective measure of safety behavior if properly applied by committed management, can improve safety performance significantly in construction site environments. The results proved that the BBS management technique can be applied to any country's culture, showing that it would be a good approach for improving the safety of front-line workers and that it has industry wide application for ongoing construction projects. Copyright © 2014 Elsevier Ltd. All rights reserved.

Using narrative text and coded data to develop hazard scenarios for occupational injury interventions

PubMed Central

Lincoln, A; Sorock, G; Courtney, T; Wellman, H; Smith, G; Amoroso, P

2004-01-01

Objective: To determine whether narrative text in safety reports contains sufficient information regarding contributing factors and precipitating mechanisms to prioritize occupational back injury prevention strategies. Design, setting, subjects, and main outcome measures: Nine essential data elements were identified in narratives and coded sections of safety reports for each of 94 cases of back injuries to United States Army truck drivers reported to the United States Army Safety Center between 1987 and 1997. The essential elements of each case were used to reconstruct standardized event sequences. A taxonomy of the event sequences was then developed to identify common hazard scenarios and opportunities for primary interventions. Results: Coded data typically only identified five data elements (broad activity, task, event/exposure, nature of injury, and outcomes) while narratives provided additional elements (contributing factor, precipitating mechanism, primary source) essential for developing our taxonomy. Three hazard scenarios were associated with back injuries among Army truck drivers accounting for 83% of cases: struck by/against events during motor vehicle crashes; falls resulting from slips/trips or loss of balance; and overexertion from lifting activities. Conclusions: Coded data from safety investigations lacked sufficient information to thoroughly characterize the injury event. However, the combination of existing narrative text (similar to that collected by many injury surveillance systems) and coded data enabled us to develop a more complete taxonomy of injury event characteristics and identify common hazard scenarios. This study demonstrates that narrative text can provide the additional information on contributing factors and precipitating mechanisms needed to target prevention strategies. PMID:15314055

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

Space Station Furnace Facility. Volume 2: Requirements Definition and Conceptual Design Study. Appendix 3: Environment Analysis. Volume 2; Appendix 3

NASA Technical Reports Server (NTRS)

1992-01-01

A Preliminary Safety Analysis (PSA) is being accomplished as part of the Space Station Furnace Facility (SSFF) contract. This analysis is intended to support SSFF activities by analyzing concepts and designs as they mature to develop essential safety requirements for inclusion in the appropriate specifications, and designs, as early as possible. In addition, the analysis identifies significant safety concerns that may warrant specific trade studies or design definition, etc. The analysis activity to date concentrated on hazard and hazard cause identification and requirements development with the goal of developing a baseline set of detailed requirements to support trade study, specifications development, and preliminary design activities. The analysis activity will continue as the design and concepts mature. Section 2 defines what was analyzed, but it is likely that the SSFF definitions will undergo further changes. The safety analysis activity will reflect these changes as they occur. The analysis provides the foundation for later safety activities. The hazards identified will in most cases have Preliminary Design Review (PDR) applicability. The requirements and recommendations developed for each hazard will be tracked to ensure proper and early resolution of safety concerns.

Beyond the classroom: a case study of immigrant safety liaisons in residential construction.

PubMed

Ochsner, Michele; Marshall, Elizabeth G; Martino, Carmen; Pabelón, Marién Casillas; Kimmel, Louis; Rostran, Damaris

2012-01-01

Latino day laborers often work at dangerous construction sites with little power to change conditions. We describe the development, implementation, and early-stage results of a program to train immigrant day laborers as safety liaisons. These are construction workers prepared to recognize and respond to health and safety hazards. Based in Newark, NJ, the project involves collaboration between New Labor, a membership-based worker center, and university researchers and labor educators. Safety liaisons undergo training and receive ongoing support for their roles. Both qualitative and quantitative data are collected to monitor progress. Although lacking in formal authority, safety liaisons have prompted improvements at specific sites, filed OSHA complaints, and developed a local worker council. Participatory training methods, opportunities for leadership outside the classroom, and participation in project planning have strengthened liaisons' effectiveness, leadership skills, and commitment. The safety liaison approach could be adapted by worker centers and their partner organizations.

Safety and licensing of a small modular gas-cooled reactor system

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

Brown, N.W.; Kelley, A.P. Jr.

A modular side-by-side high-temperature gas-cooled reactor (SBS-HTGR) is being developed by Interatom/Kraftwerk Union (KWU). The General Electric Company and Interatom/KWU entered into a proprietary working agreement to continue develop jointly of the SBS-HTGR. A study on adapting the SBS-HTGR for application in the US has been completed. The study investigated the safety characteristics and the use of this type of design in an innovative approach to licensing. The safety objective guiding the design of the modular SBS-HTGR is to control radionuclide release by the retention of fission products within the fuel particles with minimal reliance on active design features. Themore » philosophy on which this objective is predicated is that by providing a simple safety case, the safety criteria can be demonstrated as being met with high confidence through conduct of a full-scale module safety test.« less

Using the electronic health record to build a culture of practice safety: evaluating the implementation of trigger tools in one general practice.

PubMed

Margham, Tom; Symes, Natalie; Hull, Sally A

2018-04-01

Identifying patients at risk of harm in general practice is challenging for busy clinicians. In UK primary care, trigger tools and case note reviews are mainly used to identify rates of harm in sample populations. This study explores how adaptions to existing trigger tool methodology can identify patient safety events and engage clinicians in ongoing reflective work around safety. Mixed-method quantitative and narrative evaluation using thematic analysis in a single East London training practice. The project team developed and tested five trigger searches, supported by Excel worksheets to guide the case review process. Project evaluation included summary statistics of completed worksheets and a qualitative review focused on ease of use, barriers to implementation, and perception of value to clinicians. Trigger searches identified 204 patients for GP review. Overall, 117 (57%) of cases were reviewed and 62 (53%) of these cases had patient safety events identified. These were usually incidents of omission, including failure to monitor or review. Key themes from interviews with practice members included the fact that GPs' work is generally reactive and GPs welcomed an approach that identified patients who were 'under the radar' of safety. All GPs expressed concern that the tool might identify too many patients at risk of harm, placing further demands on their time. Electronic trigger tools can identify patients for review in domains of clinical risk for primary care. The high yield of safety events engaged clinicians and provided validation of the need for routine safety checks. © British Journal of General Practice 2018.

The Development and Implementation of Ground Safety Requirements for Project Orion Abort Flight Testing - A Case Study

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul D.; Williams, Jeffrey G.; Condzella, Bill R.

2008-01-01

A rigorous set of detailed ground safety requirements is required to make sure that ground support equipment (GSE) and associated planned ground operations are conducted safely. Detailed ground safety requirements supplement the GSE requirements already called out in NASA-STD-5005. This paper will describe the initial genesis of these ground safety requirements, the establishment and approval process and finally the implementation process for Project Orion. The future of the requirements will also be described. Problems and issues encountered and overcame will be discussed.

Evolution of a holistic systems approach to planning and managing road safety: the Victorian case study, 1970-2015.

PubMed

Muir, Carlyn; Johnston, Ian R; Howard, Eric

2018-06-01

The Victorian Safe System approach to road safety slowly evolved from a combination of the Swedish Vision Zero philosophy and the Sustainable Safety model developed by the Dutch. The Safe System approach reframes the way in which road safety is viewed and managed. This paper presents a case study of the institutional change required to underpin the transformation to a holistic approach to planning and managing road safety in Victoria, Australia. The adoption and implementation of a Safe System approach require strong institutional leadership and close cooperation among all the key agencies involved, and Victoria was fortunate in that it had a long history of strong interagency mechanisms in place. However, the challenges in the implementation of the Safe System strategy in Victoria are generally neither technical nor scientific; they are predominantly social and political. While many governments purport to develop strategies based on Safe System thinking, on-the-ground action still very much depends on what politicians perceive to be publicly acceptable, and Victoria is no exception. This is a case study of the complexity of institutional change and is presented in the hope that the lessons may prove useful for others seeking to adopt more holistic planning and management of road safety. There is still much work to be done in Victoria, but the institutional cultural shift has taken root. Ongoing efforts must be continued to achieve alert and compliant road users; however, major underpinning benefits will be achieved through focusing on road network safety improvements (achieving forgiving infrastructure, such as wire rope barriers) in conjunction with reviews of posted speed limits (to be set in response to the level of protection offered by the road infrastructure) and by the progressive introduction into the fleet of modern vehicle safety features. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

U. K. pressing campaign to improve offshore safety

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

Knott, D.

1994-02-14

The U.K. government is making progress in its campaign to improve the safety of personnel working offshore. The government's Health and Safety Executive (HSE) plans to assess and pass judgment on at lease one safety plan, called a safety case, from each U.K. North Sea operator as soon as possible. HSE has agreed with the industry on a list of 61 priority safety cases, known as exemplars. Feedback from exemplar assessment will help operators review safety management and assist in preparation or revision of future safety cases. It also will give HSE practice in assessing a range of case types.more » The requirement for a safety program is part of new U.K. offshore legislation designed to prevent another accident similar to the Piper Alpha platform fire and explosion of 1988. After the transition period it will be against the law to operate an oil and gas installation in British waters without an accepted safety case. Besides existing installations, safety cases are also required for new installations reaching design stage by May 31, 1993, the date safety case regulations went into force. The paper describes the Cullen report, companies' experiences with the new law, and the safety assessment progress so far.« less

An organizational process for promoting home fire safety in two community settings.

PubMed

Lehna, Carlee; Twyman, Stephanie; Fahey, Erin; Coty, Mary-Beth; Williams, Joe; Scrivener, Drane; Wishnia, Gracie; Myers, John

2017-02-01

The purpose of this study was to describe the home fire safety quality improvement model designed to aid organizations in achieving institutional program goals. The home fire safety model was developed from community-based participatory research (CBPR) applying training-the-trainer methods and is illustrated by an institutional case study. The model is applicable to other types of organizations to improve home fire safety in vulnerable populations. Utilizing the education model leaves trained employees with guided experience to build upon, adapt, and modify the home fire safety intervention to more effectively serve their clientele, promote safety, and meet organizational objectives. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study.

PubMed

Misbah, Samreen; Mahboob, Usman

2017-01-01

The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies.

Genetic modification of hematopoietic cells using retroviral and lentiviral vectors: safety considerations for vector design and delivery into target cells.

PubMed

Dropulic, Boro

2005-07-01

The recent development of leukemia in three patients following retroviral vector gene transfer in hematopoietic stem cells, resulting in the death of one patient, has raised safety concerns for the use of integrating gene transfer vectors for human gene therapy. This review discusses these serious adverse events from the perspective of whether restrictions on vector design and vector-modified target cells are warranted at this time. A case is made against presently establishing specific restrictions for vector design and transduced cells; rather, their safety should be ascertained by empiric evaluation in appropriate preclinical models on a case-by-case basis. Such preclinical data, coupled with proper informed patient consent and a risk-benefit ratio analysis, provide the best available prospective evaluation of gene transfer vectors prior to their translation into the clinic.

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

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

Safety analysis in test facility design

NASA Astrophysics Data System (ADS)

Valk, A.; Jonker, R. J.

1990-09-01

The application of safety analysis techniques as developed in, for example nuclear and petrochemical industry, can be very beneficial in coping with the increasing complexity of modern test facility installations and their operations. To illustrate the various techniques available and their phasing in a project, an overview of the most commonly used techniques is presented. Two case studies are described: the hazard and operability study techniques and safety zoning in relation to the possible presence of asphyxiating atmospheres.

Case study: reconciling the quality and safety gap through strategic planning.

PubMed

Jeffs, Lianne; Merkley, Jane; Jeffrey, Jana; Ferris, Ella; Dusek, Janice; Hunter, Catherine

2006-05-01

An essential outcome of professional practice environments is the provision of high-quality, safe nursing care. To mitigate the quality and safety chasm, nursing leadership at St. Michael's Hospital undertook a strategic plan to enhance the nursing professional practice environment. This case study outlines the development of the strategic planning process: the driving forces (platform); key stakeholders (process and players); vision, guiding principles, strategic directions, framework for action and accountability (plan); lessons learned (pearls); and next steps to moving forward the vision, strategic directions and accountability mechanisms (passion and perseverance).

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

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

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

[New international initiatives to create systems of effective risk prediction and food safety].

PubMed

Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V

2016-01-01

Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.

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

PubMed

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

2014-07-01

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

Advancing the hydrogen safety knowledge base

DOE PAGES

Weiner, S. C.

2014-08-29

The International Energy Agency's Hydrogen Implementing Agreement (IEA HIA) was established in 1977 to pursue collaborative hydrogen research and development and information exchange among its member countries. Information and knowledge dissemination is a key aspect of the work within IEA HIA tasks, and case studies, technical reports and presentations/publications often result from the collaborative efforts. The work conducted in hydrogen safety under Task 31 and its predecessor, Task 19, can positively impact the objectives of national programs even in cases for which a specific task report is not published. As a result, the interactions within Task 31 illustrate how technologymore » information and knowledge exchange among participating hydrogen safety experts serve the objectives intended by the IEA HIA.« less

Applying Mechatronics to Improve the Safety of Children in Vehicles - What Can Be Done?

NASA Astrophysics Data System (ADS)

Hazziq Zufar, Khairul; Jazlan, Ahmad

2017-11-01

Nowadays, the media have reported an increasing number of cases where children are accidentally being trapped in vehicles while they parents and guardians are away attending to other matters. In this paper we discuss the feasibility of applying Mechatronics to improve the safety of children in vehicles with the ultimate goal of developing a means for parents,guardians and authorities to be informed if ever there is a child trapped in a vehicle and in need of urgent assistance. We have also presented some preliminary experiments we have carried out for a safety alert system which is currently being developed in our lab.

Best practices for health and safety technology transfer in construction.

PubMed

Welch, Laura S; Russell, Dustin; Weinstock, Deborah; Betit, Eileen

2015-08-01

Construction continues to be a dangerous industry, yet solutions that would prevent injury and illness do exist. Prevention of injury and illness among construction workers requires dissemination, adoption, and implementation of these effective interventions, or "research to practice" (r2p). CPWR recruited participants with experience and insight into effective methods for diffusion of health and safety technologies in this industry for a symposium with 3 group sessions and 3 breakout groups. The organizers reviewed session notes and identified 141 recommendations, which were then assigned to 13 over-arching themes. Recommendations included a guide for researchers on patenting and licensing, a business case model, and in-depth case studies including development, testing, manufacturing, marketing, and diffusion. A more comprehensive understanding of the health and safety technology transfer landscape, the various actors, and their motivators and goals will help to foster the successful commercialization and diffusion of health and safety innovations. © 2015 Wiley Periodicals, Inc.

Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

Safety of Diagnostic Cerebral and Spinal Digital Subtraction Angiography in a Developing Country: A Single-Center Experience.

PubMed

Bashir, Qasim; Ishfaq, Asim; Baig, Ammad Anwar

2018-02-01

Digital subtraction angiography (DSA) remains the gold standard imaging modality for cerebrovascular disorders. In contrast to developed countries, the safety of the procedure is not extensively reported from the developing countries. Herein, we present a retrospective analysis of the basic technique, indications, and outcomes in 286 patients undergoing diagnostic cerebral and spinal angiography in a developing country, Pakistan. A retrospective review of patient demographics, procedural technique and complication rates of 286 consecutive patients undergoing the diagnostic cerebral/spinal angiography procedure at one institution from May 2013 to December 2015 was performed. Neurological, systemic, or local complications occurring within and after 24 h of the procedure were recorded. Mean age reported for all patients was 49.7 years. Of all the 286 cases, 175 were male (61.2%) and the rest female (111, 38.8%). Cerebral DSA was performed in 279 cases (97.6%), with 7 cases of spinal DSA (2.4%). Subarachnoid hemorrhage was the most common indication for DSA accounting for 88 cases (30.8%), closely followed by stroke (26.6%) and arteriosclerotic vascular disease (23.1%). No intra- or post-procedural neurological complications of any severity were seen in any of the 286 cases. One case of asymptomatic aortic dissection was reported (0.3%) in the entire cohort of patient population. Diagnostic cerebral/spinal digital subtraction angiography was found to be safe in Pakistan, with complication rates at par with and comparable to those reported in the developed world.

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

PubMed

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

2015-01-01

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

Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

PubMed

Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

2010-11-01

The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. 2010 Elsevier Ltd. All rights reserved.

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.

Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

PubMed

Campbell, Emma Jean; Turpin, Merrill June

2010-12-01

Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

Risk Assessment at the Cosmetic Product Manufacturer by Expert Judgment Method

NASA Astrophysics Data System (ADS)

Vtorushina, A. N.; Larionova, E. V.; Mezenceva, I. L.; Nikonova, E. D.

2017-05-01

A case study was performed in a cosmetic product manufacturer. We have identified the main risk factors of occupational accidents and their causes. Risk of accidents is assessed by the expert judgment method. Event tree for the most probable accident is built and recommendations on improvement of occupational health and safety protection system at the cosmetic product manufacturer are developed. The results of this paper can be used to develop actions to improve the occupational safety and health system in the chemical industry.

Considerations Related To Human Intrusion In The Context Of Disposal Of Radioactive Waste-The IAEA HIDRA Project

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

Seitz, Roger; Kumano, Yumiko; Bailey, Lucy

2014-01-09

The principal approaches for management of radioactive waste are commonly termed ‘delay and decay’, ‘concentrate and contain’ and ‘dilute and disperse’. Containing the waste and isolating it from the human environment, by burying it, is considered to increase safety and is generally accepted as the preferred approach for managing radioactive waste. However, this approach results in concentrated sources of radioactive waste contained in one location, which can pose hazards should the facility be disrupted by human action in the future. The International Commission on Radiological Protection (ICRP), International Atomic Energy Agency (IAEA), and Organization for Economic Cooperation and Development/Nuclear Energymore » Agency (OECD/NEA) agree that some form of inadvertent human intrusion (HI) needs to be considered to address the potential consequences in the case of loss of institutional control and loss of memory of the disposal facility. Requirements are reflected in national regulations governing radioactive waste disposal. However, in practice, these requirements are often different from country to country, which is then reflected in the actual implementation of HI as part of a safety case. The IAEA project on HI in the context of Disposal of RadioActive waste (HIDRA) has been started to identify potential areas for improved consistency in consideration of HI. The expected outcome is to provide recommendations on how to address human actions in the safety case in the future, and how the safety case may be used to demonstrate robustness and optimize siting, design and waste acceptance criteria within the context of a safety case.« less

A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

2013-08-30

In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd.

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

PubMed

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

2015-07-10

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

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

PubMed

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

2017-12-01

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

Heavy Metal Veggies: A Decision Case for Environmental and Nutrition Education.

ERIC Educational Resources Information Center

Schramm, J.; And Others

1994-01-01

One alternative to continued landfilling or incineration is the development of municipal solid waste (MSW) composting facilities. This case study permits students to examine issues associated with environmental contamination by MSW and to make decisions based on agricultural, environmental, economic, food safety, and ethical considerations. The…

Safety of plant-made pharmaceuticals: product development and regulatory considerations based on case studies of two autologous human cancer vaccines.

PubMed

Tusé, Daniel

2011-03-01

Guidelines issued by regulatory agencies for the development of plant-made pharmaceutical (PMP) products provide criteria for product manufacturing and characterization, safety determination, containment and mitigation of environmental risks. Features of plant-made products do not always enable an easy fit within the criteria subscribed to by regulators. The unconventional nature of plant-based manufacturing processes and peculiarities of plant biology relative to that of traditional biological production systems have led to special considerations in the regulatory scrutiny of PMP. Presented in this review are case studies of two plant-made autologous (patient-specific) cancer vaccines, the nature of which introduced challenges to conventional and standardized development and preclinical evaluation routes. The rationale presented to FDA by the sponsors of each vaccine to build consensus and obtain variances to existing guidelines is discussed. While development of many plant-made biologics can be accomplished within the existing regulatory framework, the development of specialized products can be defended with rational arguments based on strong science.

Neuroendovascular Interventions for Acute Ischemic Strokes in Patients Supported with Left Ventricular Assist Devices: A Single-Center Case Series and Review of the Literature.

PubMed

Al-Mufti, Fawaz; Bauerschmidt, Andrew; Claassen, Jan; Meyers, Philip M; Colombo, Paolo C; Willey, Joshua Z

2016-04-01

With the shortage of donor hearts, increasingly more patients with end-stage heart failure are implanted with left ventricular assist devices (LVADs). LVADs are associated with a significant risk of developing acute ischemic strokes (AISs). Very little is known on about the management of AIS in patients with LVAD, especially with regard to the safety and efficacy of neuroendovascular techniques. We identified 5 patients with heart failure and LVAD implants who developed AIS and underwent neuroendovascular interventions at Columbia University Medical Center. Their cases were reviewed for the safety, efficacy of the interventions, and potential complications. There were no significant complications from the interventions. In all 5 cases, there was at least a 4-point improvement in the National Institutes of Health Stroke scale and none of the cases developed symptomatic hemorrhage. Two patients had substantial improvement and received cardiac transplantations. Neuroendovascular intervention is safe and feasible in patients with LVAD and may potentially contribute to improving the outcome of a disease that has a poor natural history. Further study is recommended. Copyright © 2016 Elsevier Inc. All rights reserved.

A safety management system for an offshore Azerbaijan Caspian Sea Project

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

Brasic, M.F.; Barber, S.W.; Hill, A.S.

1996-11-01

This presentation will describe the Safety Management System that Azerbaijan International Operating Company (AIOC) has structured to assure that Company activities are performed in a manner that protects the public, the environment, contractors and AIOC employees. The Azerbaijan International Oil Company is a consortium of oil companies that includes Socar, the state oil company of Azerbaijan, a number of major westem oil companies, and companies from Russia, Turkey and Saudi Arabia. The Consortium was formed to develop and produce a group of large oil fields in the Caspian Sea. The Management of AIOC, in starting a new operation in Azerbaijan,more » recognized the need for a formal HSE management system to ensure that their HSE objectives for AIOC activities were met. As a consortium of different partners working together in a unique operation, no individual partner company HSE Management system was appropriate. Accordingly AIOC has utilized the E & P Forum {open_quotes}Guidelines for the Development and Application of Health Safety and Environmental Management Systems{close_quotes} as the framework document for the development of the new AIOC system. Consistent with this guideline, AIOC has developed 19 specific HSE Management System Expectations for implementing its HSE policy and objectives. The objective is to establish and continue to maintain operational integrity in all AIOC activities and site operations. An important feature is the use of structured Safety Cases for the design engineering activity. The basis for the Safety Cases is API RP 75 and 14 J for offshore facilities and API RP 750 for onshore facilities both complimented by {open_quotes}Best International Oilfield Practice{close_quotes}. When viewed overall, this approach provides a fully integrated system of HSE management from design into operation.« less

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

A Collaborative Learning Network Approach to Improvement: The CUSP Learning Network.

PubMed

Weaver, Sallie J; Lofthus, Jennifer; Sawyer, Melinda; Greer, Lee; Opett, Kristin; Reynolds, Catherine; Wyskiel, Rhonda; Peditto, Stephanie; Pronovost, Peter J

2015-04-01

Collaborative improvement networks draw on the science of collaborative organizational learning and communities of practice to facilitate peer-to-peer learning, coaching, and local adaption. Although significant improvements in patient safety and quality have been achieved through collaborative methods, insight regarding how collaborative networks are used by members is needed. Improvement Strategy: The Comprehensive Unit-based Safety Program (CUSP) Learning Network is a multi-institutional collaborative network that is designed to facilitate peer-to-peer learning and coaching specifically related to CUSP. Member organizations implement all or part of the CUSP methodology to improve organizational safety culture, patient safety, and care quality. Qualitative case studies developed by participating members examine the impact of network participation across three levels of analysis (unit, hospital, health system). In addition, results of a satisfaction survey designed to evaluate member experiences were collected to inform network development. Common themes across case studies suggest that members found value in collaborative learning and sharing strategies across organizational boundaries related to a specific improvement strategy. The CUSP Learning Network is an example of network-based collaborative learning in action. Although this learning network focuses on a particular improvement methodology-CUSP-there is clear potential for member-driven learning networks to grow around other methods or topic areas. Such collaborative learning networks may offer a way to develop an infrastructure for longer-term support of improvement efforts and to more quickly diffuse creative sustainment strategies.

[Medical fault or professional negligence? Case studies in two recovery nutrition centers in Niger].

PubMed

Halidou Doudou, M; Manzo, M L; Guero, D

2014-12-01

In developing countries such as Niger, the risk of medical malpractice is ubiquitous in health, jeopardizing patient safety. The aim of this work was to contribute to patients' safety and respect of code of ethics and conduct in the exercise of the medical profession. The reported cases involved two children under 5 years who were admitted to nutrition rehabilitation centers, died as a result of medical malpractice. In Niger, there are no statistics on this phenomenon and a few cases found have always been considered "accident" or "fate." The establishment of an observatory collections of such information should improve their frequency, consequences and propose a prevention plan. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Safety Case Patterns: Theory and Applications

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.

2015-01-01

We develop the foundations for a theory of patterns of safety case argument structures, clarifying the concepts involved in pattern specification, including choices, labeling, and well-founded recursion. We specify six new patterns in addition to those existing in the literature. We give a generic way to specify the data required to instantiate patterns and a generic algorithm for their instantiation. This generalizes earlier work on generating argument fragments from requirements tables. We describe an implementation of these concepts in AdvoCATE, the Assurance Case Automation Toolset, showing how patterns are defined and can be instantiated. In particular, we describe how our extended notion of patterns can be specified, how they can be instantiated in an interactive manner, and, finally, how they can be automatically instantiated using our algorithm.

[Application of TB type thermal balloon endometrial ablation for the treatment of abnormal uterine bleeding].

PubMed

Wang, W; Zhai, Y; Zhang, Z H; Li, Y; Zhang, Z Y

2016-11-08

Objective: To investigate the clinical efficacy, safety and promotion value of TB type thermal balloon endometrial ablation in the treatment of abnormal uterine bleeding. Methods: Fourty three patients who had received TB type endometrial ablation system for treatment of abnormal uterine bleeding from January, 2015 to January, 2016 in theDepartment of gynecology, Beijing Chaoyang Hospital were enrolled in this study. The intra-operative and post-operative complications and improvement of abnormal uterine bleeding and dysmenorrhea were observed. Results: There were nointra-operative complication occurred, such as uterine perforation, massive hemorrhage or surrounding organ damage. At 6 months after operation, 32 patients developed amenorrhea, 6 developed menstrual spotting, 3 developed menstruation with a small volume and 1 had a normal menstruation. No menstruation with an increased volume occurred. The occurrence of amenorrhea was 76.19% and the response rate was 97.62%.At 6 months after operation, 1 case had no response, 2 cases had partial response and 11 cases had complete response among the 14 cases of pre-operative dysmenorrhea; only 3 cases still had anemia among the 23 cases of pre-operative anemia. Compared with before treatment, patients with dysmenorrhea and anemia both significantly reduced with a statistically significant difference( P <0.01). Conclusion: TB type thermal balloon endometrial ablation has a significant efficacy with high safety for the treatment of abnormal uterine bleeding, which could have clinical promotion practice.

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

PubMed

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

2017-03-01

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

CAD/CAE-technologies application for assessment of passenger safety on railway transport in emergency

NASA Astrophysics Data System (ADS)

Antipin, D. Ya; Shorokhov, S. G.; Bondarenko, O. I.

2018-03-01

A possibility of using current software products realizing CAD/CAE-technologies for the assessment of passenger safety in emergency cases on railway transport has been analyzed. On the basis of the developed solid computer model of an anthropometric dummy, the authors carried out an analysis of possible levels of passenger injury during accident collision of a train with an obstacle.

Evolution from safety management system (SMS) to HSE MS: Incorporating health aspects into the HSE management system

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

Jong, G. de

1996-12-31

There is increasing recognition within the E&P industry that protection and promotion of the health of people at work is more than taking care of individual health. It is an organizational issue which can be managed using the same principles as for safety and environment. The synergy`s with safety and environmental management provide the link with the management system. However line managers need to under the critical Health issues: what are they are they relevant? How do we manage them? what are the standards? What are the management tools to be used? How do we monitor performance? What is themore » role of the line? What is the role of the health advisers? What training and competencies are needed for health management? What are the benefits? These questions have to be clarified before acceptance can be achieved for full integration of Health aspects into the HSE Management System. Health Risk Assessment was developed as a tool for systematic identification and assessment of health hazards and risks. It specifies the need for and type of controls and recovery measures, which can subsequently be incorporated in HSE Management System and HSE Cases. Our experience to date indicates that Health can successfully be integrated in HSE Management Systems and HSE Cases by using the same principles as developed for Safety Management Systems and Safety Cases. There are still many problems which need to be addressed but the methodology used appears to be sound and will eventually enhance line management understanding of the health management aspects relevant to the E&P Industry.« less

Safety of ceftriaxone in paediatrics: a systematic review protocol.

PubMed

Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

2017-08-21

Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A holistic approach to food safety risks: Food fraud as an example.

PubMed

Marvin, Hans J P; Bouzembrak, Yamine; Janssen, Esmée M; van der Fels-Klerx, H J; van Asselt, Esther D; Kleter, Gijs A

2016-11-01

Production of sufficient, safe and nutritious food is a global challenge faced by the actors operating in the food production chain. The performance of food-producing systems from farm to fork is directly and indirectly influenced by major changes in, for example, climate, demographics, and the economy. Many of these major trends will also drive the development of food safety risks and thus will have an effect on human health, local societies and economies. It is advocated that a holistic or system approach taking into account the influence of multiple "drivers" on food safety is followed to predict the increased likelihood of occurrence of safety incidents so as to be better prepared to prevent, mitigate and manage associated risks. The value of using a Bayesian Network (BN) modelling approach for this purpose is demonstrated in this paper using food fraud as an example. Possible links between food fraud cases retrieved from the RASFF (EU) and EMA (USA) databases and features of these cases provided by both the records themselves and additional data obtained from other sources are demonstrated. The BN model was developed from 1393 food fraud cases and 15 different data sources. With this model applied to these collected data on food fraud cases, the product categories that thus showed the highest probabilities of being fraudulent were "fish and seafood" (20.6%), "meat" (13.4%) and "fruits and vegetables" (10.4%). Features of the country of origin appeared to be important factors in identifying the possible hazards associated with a product. The model had a predictive accuracy of 91.5% for the fraud type and demonstrates how expert knowledge and data can be combined within a model to assist risk managers to better understand the factors and their interrelationships. Copyright © 2016 Elsevier Ltd. All rights reserved.

Rectal perforation secondary to transanal haemorrhoidal dearterialisation.

PubMed

Greensmith, S; Ip, B; Vujovic, Z

2017-05-01

Haemorrhoidal artery ligation has now been established as a treatment modality for symptomatic haemorrhoids. We report a case of a fit 44-year-old male who underwent the procedure as a day case, who subsequently developed pelvic sepsis due to rectal perforation. This case is the first report of a potentially life-threatening complication resulting from this procedure, which has a previously excellent safety profile.

Rectal perforation secondary to transanal haemorrhoidal dearterialisation

PubMed Central

Greensmith, S; Vujovic, Z

2017-01-01

Haemorrhoidal artery ligation has now been established as a treatment modality for symptomatic haemorrhoids. We report a case of a fit 44-year-old male who underwent the procedure as a day case, who subsequently developed pelvic sepsis due to rectal perforation. This case is the first report of a potentially life-threatening complication resulting from this procedure, which has a previously excellent safety profile. PMID:28462643

Protest and survive, the U.K. Construction Safety Campaign: a case study of workers' and victims' family action and legal and regulatory inaction on construction health and safety.

PubMed

Holder, Mick; O'Brien, Tony

2007-01-01

The U.K. Construction Safety Campaign, based on grass-roots rank-and-file trade union activity, has both a domestic agenda and a wider sphere with regard to international developments. Using organized protests and media exposure to achieve its ends, the Campaign has contributed substantially to reducing injuries and fatalities in the U.K. construction industry, as well as achieving some justice for victims of the industry's neglect of safe management practices.

Case studies with new excipients: development, implementation and regulatory approval.

PubMed

Koo, Otilia M Y; Varia, Sailesh A

2011-07-01

The purpose of this article is to describe the process whereby new excipients become accepted and to describe three case studies to illustrate the process. New excipients are defined according to the 2005 FDA Guidance on Nonclinical Safety Evaluation of New Excipients. The requirements for safety data submission for new excipients used in different classes of products for different durations are outlined in the guidance. Currently, the development of new excipients is linked to the development and approval of new drug products that contain them. New excipients that are used in US-approved drug products become listed in the FDA Inactive Ingredients Guide (IIG) database. Thereafter, US Pharmacopeia monographs for the new excipients are proposed. New excipients are reviewed and become accepted in the same way in Europe and Japan, except that there is no equivalent IIG database. Therefore, the focus of this article will be on the FDA review process. Three case studies, polyoxyl 15 hydroxystearate, sulfobutyl ether cyclodextrin and silicified microcrystalline cellulose, are used to illustrate how new excipients are accepted and implemented.

Continuous Improvement and the Safety Case for the Waste Isolation Pilot Plant Geologic Repository - 13467

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

Van Luik, Abraham; Patterson, Russell; Nelson, Roger

2013-07-01

The Waste Isolation Pilot Plant (WIPP) is a geologic repository 2150 feet (650 m) below the surface of the Chihuahuan desert near Carlsbad, New Mexico. WIPP permanently disposes of transuranic waste from national defense programs. Every five years, the U.S. Department of Energy (DOE) submits an application to the U.S. Environmental Protection Agency (EPA) to request regulatory-compliance re-certification of the facility for another five years. Every ten years, DOE submits an application to the New Mexico Environment Department (NMED) for the renewal of its hazardous waste disposal permit. The content of the applications made by DOE to the EPA formore » re-certification, and to the NMED for permit-renewal, reflect any optimization changes made to the facility, with regulatory concurrence if warranted by the nature of the change. DOE points to such changes as evidence for its having taken seriously its 'continuous improvement' operations and management philosophy. Another opportunity for continuous improvement is to look at any delta that may exist between the re-certification and re-permitting cases for system safety and the consensus advice on the nature and content of a safety case as being developed and published by the Nuclear Energy Agency's Integration Group for the Safety Case (IGSC) expert group. DOE at WIPP, with the aid of its Science Advisor and teammate, Sandia National Laboratories, is in the process of discerning what can be done, in a reasonably paced and cost-conscious manner, to continually improve the case for repository safety that is being made to the two primary regulators on a recurring basis. This paper will discuss some aspects of that delta and potential paths forward to addressing them. (authors)« less

Spine Trauma Associated with Off-Road Vehicles.

ERIC Educational Resources Information Center

Reid, David C.; And Others

1988-01-01

A seven-year review of 1,447 cases of spine trauma showed that 53 cases were associated with the use of off-road vehicles, such as all-terrain vehicles, snowmobiles, and motorized dirt bikes. The development of safe riding areas, legislation governing safe operation, and public safety education are advised to curb this trend. (Author/JL)

Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study

PubMed Central

2017-01-01

Purpose The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. Methods A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Results Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. Conclusion The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies. PMID:29284217

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

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

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

Isolation, amplification and characterization of foodborne pathogen disease bacteria gene for rapid kit test development

NASA Astrophysics Data System (ADS)

Nurjayadi, M.; Santoso, I.; Kartika, I. R.; Kurniadewi, F.; Saamia, V.; Sofihan, W.; Nurkhasanah, D.

2017-07-01

There is a lot of public concern over food safety. Food-safety cases recently, including many food poisoning cases in both the developed and developing countries, considered to be the national security threats which involved police investigation. Quick and accurate detection methods are needed to handle the food poisoning cases with a big number of sufferers at the same time. Therefore, the research is aimed to develop a specific, sensitive, and rapid result molecular detection tool for foodborne pathogen bacteria. We, thus, propose genomic level approach with Polymerase Chain Reaction. The research has successfully produced a specific primer to perform amplification to fim-C S. typhi, E. coli, and pef Salmonella typhimurium genes. The electrophoresis result shows that amplification products are 95 base pairs, 121 base pairs, and 139 base pairs; and all three genes are in accordance with the size of the in silico to third genes bacteria. In conclusion, the research has been successfully designed a specific detection tool to three foodborne pathogen bacteria genes. Further stages test and the uses of Real-time PCR in the detection are still in the trial process for better detection method.

Maintaining ocular safety with light exposure, focusing on devices for optogenetic stimulation

PubMed Central

Yan, Boyuan; Vakulenko, Maksim; Min, Seok-Hong; Hauswirth, William W.; Nirenberg, Sheila

2016-01-01

Optogenetics methods are rapidly being developed as therapeutic tools for treating neurological diseases, in particular, retinal degenerative diseases. A critical component of the development is testing the safety of the light stimulation used to activate the optogenetic proteins. While the stimulation needs to be sufficient to produce neural responses in the targeted retinal cell class, it also needs to be below photochemical and photothermal limits known to cause ocular damage. The maximal permissible exposure is determined by a variety of factors, including wavelength, exposure duration, visual angle, pupil size, pulse width, pulse pattern, and repetition frequency. In this paper, we develop utilities to systematically and efficiently assess the contributions of these parameters in relation to the limits, following directly from the 2014 American National Standards Institute (ANSI). We also provide an array of stimulus protocols that fall within the bounds of both safety and effectiveness. Additional verification of safety is provided with a case study in rats using one of these protocols. PMID:26882975

Specific issues, exact locations: case study of a community mapping project to improve safety in a disadvantaged community.

PubMed

Qummouh, Rana; Rose, Vanessa; Hall, Pat

2012-12-01

Safety is a health issue and a significant concern in disadvantaged communities. This paper describes an example of community-initiated action to address perceptions of fear and safety in a suburb in south-west Sydney which led to the development of a local, community-driven research project. As a first step in developing community capacity to take action on issues of safety, a joint resident-agency group implemented a community safety mapping project to identify the extent of safety issues in the community and their exact geographical location. Two aerial maps of the suburb, measuring one metre by two metres, were placed on display at different locations for four months. Residents used coloured stickers to identify specific issues and exact locations where crime and safety were a concern. Residents identified 294 specific safety issues in the suburb, 41.9% (n=123) associated with public infrastructure, such as poor lighting and pathways, and 31.9% (n=94) associated with drug-related issues such as drug activity and discarded syringes. Good health promotion practice reflects community need. In a very practical sense, this project responded to community calls for action by mapping resident knowledge on specific safety issues and exact locations and presenting these maps to local decision makers for further action.

Performance Evaluation and Analysis of Rural Drinking Water Safety Project——A Case Study in Jiangsu, China

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

Water is the basic condition for human survival and development. As China is the most populous country, rural drinking water safety problems are most conspicuous. Therefore, the Chinese government keeps increasing investment and has built a large number of rural drinking water safety projects. Scientific evaluation of project performance is of great significance to promote the sustainable operation of the project and the sustainable development of rural economy. Previous studies mainly focus on the economic benefits of the project, while ignoring the fact that the rural drinking water safety project is quasi-public goods, which has economic, social and ecological benefits. This paper establishes a comprehensive evaluation model for rural drinking water safety performance, which adapts the rules of "5E" (economy, efficiency, effectiveness, equity and environment) as the value orientation, and selects a rural drinking water safety project as object in case study at K District, which is in the north of Jiangsu Province, China. The results shows: 1) the comprehensive performance of K project is in good condition; 2) The performance of every part shows that the scores of criteria "efficiency", "environment" and "effect" are higher than the mean performance, while the "economy" is slightly lower than the mean and the "equity" is the lowest. 3) The performance of indicator layer shows that: the planned completion rate of project, the reduction rate of project cost and the penetration rate of water-use population are significantly lower than other indicators. Based on the achievements of previous studies and the characteristics of rural drinking water safety project, this study integrates the evaluation dimensions of equity and environment, which can contribute to a more comprehensive and systematic assessment of project performance and provide empirical data for performance evaluation and management of rural drinking water safety project. Key Words: Rural drinking water safety project; Performance evaluation; 5E rules; Comprehensive evaluation model

Calculations of reliability predictions for the Apollo spacecraft

NASA Technical Reports Server (NTRS)

Amstadter, B. L.

1966-01-01

A new method of reliability prediction for complex systems is defined. Calculation of both upper and lower bounds are involved, and a procedure for combining the two to yield an approximately true prediction value is presented. Both mission success and crew safety predictions can be calculated, and success probabilities can be obtained for individual mission phases or subsystems. Primary consideration is given to evaluating cases involving zero or one failure per subsystem, and the results of these evaluations are then used for analyzing multiple failure cases. Extensive development is provided for the overall mission success and crew safety equations for both the upper and lower bounds.

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

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.

A General Safety Assessment for Purified Food Ingredients Derived From Biotechnology Crops: Case Study of Brazilian Sugar and Beverages Produced From Insect-Protected Sugarcane.

PubMed

Kennedy, Reese D; Cheavegatti-Gianotto, Adriana; de Oliveira, Wladecir S; Lirette, Ronald P; Hjelle, Jerry J

2018-01-01

Insect-protected sugarcane that expresses Cry1Ab has been developed in Brazil. Analysis of trade information has shown that effectively all the sugarcane-derived Brazilian exports are raw or refined sugar and ethanol. The fact that raw and refined sugar are highly purified food ingredients, with no detectable transgenic protein, provides an interesting case study of a generalized safety assessment approach. In this study, both the theoretical protein intakes and safety assessments of Cry1Ab, Cry1Ac, NPTII, and Bar proteins used in insect-protected biotechnology crops were examined. The potential consumption of these proteins was examined using local market research data of average added sugar intakes in eight diverse and representative Brazilian raw and refined sugar export markets (Brazil, Canada, China, Indonesia, India, Japan, Russia, and the USA). The average sugar intakes, which ranged from 5.1 g of added sugar/person/day (India) to 126 g sugar/p/day (USA) were used to calculated possible human exposure. The theoretical protein intake estimates were carried out in the "Worst-case" scenario, assumed that 1 μg of newly-expressed protein is detected/g of raw or refined sugar; and the "Reasonable-case" scenario assumed 1 ng protein/g sugar. The "Worst-case" scenario was based on results of detailed studies of sugarcane processing in Brazil that showed that refined sugar contains less than 1 μg of total plant protein /g refined sugar. The "Reasonable-case" scenario was based on assumption that the expression levels in stalk of newly-expressed proteins were less than 0.1% of total stalk protein. Using these calculated protein intake values from the consumption of sugar, along with the accepted NOAEL levels of the four representative proteins we concluded that safety margins for the "Worst-case" scenario ranged from 6.9 × 10 5 to 5.9 × 10 7 and for the "Reasonable-case" scenario ranged from 6.9 × 10 8 to 5.9 × 10 10 . These safety margins are very high due to the extremely low possible exposures and the high NOAELs for these non-toxic proteins. This generalized approach to the safety assessment of highly purified food ingredients like sugar illustrates that sugar processed from Brazilian GM varieties are safe for consumption in representative markets globally.

Improving patient safety by instructional systems design

PubMed Central

Battles, J B

2006-01-01

Education and training are important elements in patient safety, both as a potential contributing factor to risks and hazards of healthcare associated injury or harm and as an intervention to be used in eliminating or preventing such harm. All too often we have relied on training as the only interventions for patient safety without examining other alternatives or realizing that, in some cases, the training systems themselves are part of the problem. One way to ensure safety by design is to apply established design principles to education and training. Instructional systems design (ISD) is a systematic method of development of education and training programs for improved learner performance. The ISD process involves five integrated steps: analysis, development, design, implementation, and evaluation (ADDIE). The application of ISD using the ADDIE approach can eliminate or prevent education and training from being a contributing factor of health associated injury or harm, and can also be effective in preventing injury or harm. PMID:17142604

Lost in Translation? Challenges and Opportunities for Raising Health and Safety Awareness among a Multinational Workforce in the United Arab Emirates

PubMed Central

Cooling, Robert Fletcher; Aw, Tar-Ching

2012-01-01

The United Arab Emirates (UAE) has experienced tremendous economic and industrial growth in the petroleum, airline, maritime and construction sectors, especially since the discovery of oil reserves. Mass recruitment of low skilled or unskilled laborers from less-developed countries has been utilized to satisfy the manpower demands of these fast paced industrial developments. Such workforce recruitment has created an unusual populace demographic, with the total UAE population estimated at 8.3 million, composed of 950,000 Emiratis, with the remainder being multinational expatriate workers, with varying educational qualifications, work experience, religious beliefs, cultural practices, and native languages. These unique characteristics pose a challenge for health and safety professionals tasked with ensuring the UAE workforce adheres to specific occupational health and safety procedures. The paper discusses two case studies that employ a novel multimedia approach to raising health and safety awareness among a multinational workforce. PMID:23251846

An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study.

PubMed

Arnaud, Mickael; Bégaud, Bernard; Thiessard, Frantz; Jarrion, Quentin; Bezin, Julien; Pariente, Antoine; Salvo, Francesco

2018-04-01

Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered. Noninsulin glucose-lowering drugs (NIGLDs) were selected as a case study, and hospitalization data were used to select important medical events (IME). Signal detection was performed quarterly from 2008 to 2015 using sequence symmetry analysis. NIGLD/IME associations were screened if one or more exposed case was identified in the quarter, and three or more exposed cases were identified in the population at the date of screening. Detected signals were prioritized using the Longitudinal-SNIP (L-SNIP) algorithm based on strength (S), novelty (N), and potential impact of signal (I), and pattern of drug use (P). Signals scored in the top 10% were identified as of high priority. A reference set was built based on NIGLD summaries of product characteristics (SPCs) to compute the performance of the developed system. A total of 815 associations were screened and 241 (29.6%) were detected as signals; among these, 58 (24.1%) were prioritized. The performance for signal detection was sensitivity = 47%; specificity = 80%; positive predictive value (PPV) 33%; negative predictive value = 82%. The use of the L-SNIP algorithm increased the early identification of positive controls, restricted to those mentioned in the SPCs after 2008: PPV = 100% versus PPV = 14% with its non-use. The system revealed a strong new signal with dipeptidylpeptidase-4 inhibitors and venous thromboembolism. The developed system seems promising for the routine use of healthcare data for safety surveillance of drugs used in chronic diseases.

Nondestructive Testing System for Retreads

DOT National Transportation Integrated Search

1975-11-01

An important problem in retreading tires is the assurance of a satisfactory casing. Since 1972 the National Highway Traffic Safety Administration has had under development an air-coupled through-transmission ultrasonic inspection system for finding a...

Modeling level-of-safety for bus stops in China.

PubMed

Ye, Zhirui; Wang, Chao; Yu, Yongbo; Shi, Xiaomeng; Wang, Wei

2016-08-17

Safety performance at bus stops is generally evaluated by using historical traffic crash data or traffic conflict data. However, in China, it is quite difficult to obtain such data mainly due to the lack of traffic data management and organizational issues. In light of this, the primary objective of this study is to develop a quantitative approach to evaluate bus stop safety performance. The concept of level-of-safety for bus stops is introduced and corresponding models are proposed to quantify safety levels, which consider conflict points, traffic factors, geometric characteristics, traffic signs and markings, pavement conditions, and lighting conditions. Principal component analysis and k-means clustering methods were used to model and quantify safety levels for bus stops. A case study was conducted to show the applicability of the proposed model with data collected from 46 samples for the 7 most common types of bus stops in China, using 32 of the samples for modeling and 14 samples for illustration. Based on the case study, 6 levels of safety for bus stops were defined. Finally, a linear regression analysis between safety levels and the number of traffic conflicts showed that they had a strong relationship (R(2) value of 0.908). The results indicated that the method was well validated and could be practically used for the analysis and evaluation of bus stop safety in China. The proposed model was relatively easy to implement without the requirement of traffic crash data and/or traffic conflict data. In addition, with the proposed method, it was feasible to evaluate countermeasures to improve bus stop safety (e.g., exclusive bus lanes).

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.

Shipping Light: The Case-Oil Trade to Asia, 1870-1915 and Origins of the Supertanker.

ERIC Educational Resources Information Center

Webb, Robert Lloyd

1996-01-01

Recounts the origin and evolution of the America-to-Asia oil shipping business. Originally shipped in tin cans, two to a wooden case, the industry was revolutionized by the development of bulk tankers. Discusses the technological challenges faced by these vessels, safety concerns, and early competition from Russia. (MJP)

Alcohol Highway-Traffic Safety Workshop for Law Enforcement Officers.

ERIC Educational Resources Information Center

Walker, William; And Others

The manual, designed for one- and-one-half-day workshops with 20 to 40 law enforcement professionals who handle driving while intoxicated (DWI) cases, is directed toward recognizing the special role of the police officer as decision-maker in cases involving drunk or impaired driving. It is one of five workshop manuals developed to assist State and…

Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Whiteside, Iain J.

2012-01-01

We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

Development of the major trauma case review tool.

PubMed

Curtis, Kate; Mitchell, Rebecca; McCarthy, Amy; Wilson, Kellie; Van, Connie; Kennedy, Belinda; Tall, Gary; Holland, Andrew; Foster, Kim; Dickinson, Stuart; Stelfox, Henry T

2017-02-28

As many as half of all patients with major traumatic injuries do not receive the recommended care, with variance in preventable mortality reported across the globe. This variance highlights the need for a comprehensive process for monitoring and reviewing patient care, central to which is a consistent peer-review process that includes trauma system safety and human factors. There is no published, evidence-informed standardised tool that considers these factors for use in adult or paediatric trauma case peer-review. The aim of this research was to develop and validate a trauma case review tool to facilitate clinical review of paediatric trauma patient care in extracting information to facilitate monitoring, inform change and enable loop closure. Development of the trauma case review tool was multi-faceted, beginning with a review of the trauma audit tool literature. Data were extracted from the literature to inform iterative tool development using a consensus approach. Inter-rater agreement was assessed for both the pilot and finalised versions of the tool. The final trauma case review tool contained ten sections, including patient factors (such as pre-existing conditions), presenting problem, a timeline of events, factors contributing to the care delivery problem (including equipment, work environment, staff action, organizational factors), positive aspects of care and the outcome of panel discussion. After refinement, the inter-rater reliability of the human factors and outcome components of the tool improved with an average 86% agreement between raters. This research developed an evidence-informed tool for use in paediatric trauma case review that considers both system safety and human factors to facilitate clinical review of trauma patient care. This tool can be used to identify opportunities for improvement in trauma care and guide quality assurance activities. Validation is required in the adult population.

Recent Cases: Administrative Law--Occupational Safety and Health Act

ERIC Educational Resources Information Center

Harvard Law Review, 1976

1976-01-01

Implications of the Occupational Safety and Health Act of 1970 are described in two cases: Brennan v. Occupational Safety and Health Review Commission (Underhill Construction Corp.), and Anning-Johnson Co. v. United States Occupational Safety and Health Review Commission. (LBH)

Evaluation of protein safety in the context of agricultural biotechnology.

PubMed

Delaney, Bryan; Astwood, James D; Cunny, Helen; Conn, Robin Eichen; Herouet-Guicheney, Corinne; Macintosh, Susan; Meyer, Linda S; Privalle, Laura; Gao, Yong; Mattsson, Joel; Levine, Marci

2008-05-01

One component of the safety assessment of agricultural products produced through biotechnology is evaluation of the safety of newly expressed proteins. The ILSI International Food Biotechnology Committee has developed a scientifically based two-tiered, weight-of-evidence strategy to assess the safety of novel proteins used in the context of agricultural biotechnology. Recommendations draw upon knowledge of the biological and chemical characteristics of proteins and testing methods for evaluating potential intrinsic hazards of chemicals. Tier I (potential hazard identification) includes an assessment of the biological function or mode of action and intended application of the protein, history of safe use, comparison of the amino acid sequence of the protein to other proteins, as well as the biochemical and physico-chemical properties of the proteins. Studies outlined in Tier II (hazard characterization) are conducted when the results from Tier I are not sufficient to allow a determination of safety (reasonable certainty of no harm) on a case-by-case basis. These studies may include acute and repeated dose toxicology studies and hypothesis-based testing. The application of these guidelines is presented using examples of transgenic proteins applied for agricultural input and output traits in genetically modified crops along with recommendations for future research considerations related to protein safety assessment.

FY16 Summary Report: Participation in the KOSINA Project

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

Matteo, Edward N.; Hansen, Francis D.

Salt formations represent a promising host for disposal of nuclear waste in the United States and Germany. Together, these countries provided fully developed safety cases for bedded salt and domal salt, respectively. Today, Germany and the United States find themselves in similar positions with respect to salt formations serving as repositories for heat-generating nuclear waste. German research centers are evaluating bedded and pillow salt formations to contrast with their previous safety case made for the Gorleben dome. Sandia National Laboratories is collaborating on this effort as an Associate Partner, and this report summarizes that teamwork. Sandia and German research groupsmore » have a long-standing cooperative approach to repository science, engineering, operations, safety assessment, testing, modeling and other elements comprising the basis for salt disposal. Germany and the United States hold annual bilateral workshops, which cover a spectrum of issues surrounding the viability of salt formations. Notably, recent efforts include development of a database for features, events, and processes applying broadly and generically to bedded and domal salt. Another international teaming activity evaluates salt constitutive models, including hundreds of new experiments conducted on bedded salt from the Waste Isolation Pilot Plant. These extensive collaborations continue to build the scientific basis for salt disposal. Repository deliberations in the United States are revisiting bedded and domal salt for housing a nuclear waste repository. By agreeing to collaborate with German peers, our nation stands to benefit by assurance of scientific position, exchange of operational concepts, and approach to elements of the safety case, all reflecting cost and time efficiency.« less

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

PubMed

Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J

2016-11-01

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2008-11-01

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

What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study.

PubMed

O'Hara, Jane K; Reynolds, Caroline; Moore, Sally; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Watt, Ian; Wright, John; Lawton, Rebecca

2018-03-15

Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. ISRCTN07689702; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Calculation of the state of safety (SOS) for lithium ion batteries

NASA Astrophysics Data System (ADS)

Cabrera-Castillo, Eliud; Niedermeier, Florian; Jossen, Andreas

2016-08-01

As lithium ion batteries are adopted in electric vehicles and stationary storage applications, the higher number of cells and greater energy densities increases the risks of possible catastrophic events. This paper shows a definition and method to calculate the state of safety of an energy storage system based on the concept that safety is inversely proportional to the concept of abuse. As the latter increases, the former decreases to zero. Previous descriptions in the literature are qualitative in nature but don't provide a numerical quantification of the safety of a storage system. In the case of battery testing standards, they only define pass or fail criteria. The proposed state uses the same range as other commonly used state quantities like the SOC, SOH, and SOF, taking values between 0, completely unsafe, and 1, completely safe. The developed function combines the effects of an arbitrary number of subfunctions, each of which describes a particular case of abuse, in one or more variables such as voltage, temperature, or mechanical deformation, which can be detected by sensors or estimated by other techniques. The state of safety definition can be made more general by adding new subfunctions, or by refining the existing ones.

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

Soubies, B.; Henry, J.Y.; Le Meur, M.

1300 MWe pressurised water reactors (PWRs), like the 1400 MWe reactors, operate with microprocessor-based safety systems. This is particularly the case for the Digital Integrated Protection System (SPIN), which trips the reactor in an emergency and sets in action the safeguard functions. The softwares used in these systems must therefore be highly dependable in the execution of their functions. In the case of SPIN, three players are working at different levels to achieve this goal: the protection system manufacturer, Merlin Gerin; the designer of the nuclear steam supply system, Framatome; the operator of the nuclear power plants, Electricite de Francemore » (EDF), which is also responsible for the safety of its installations. Regulatory licenses are issued by the French safety authority, the Nuclear Installations Safety Directorate (French abbreviation DSIN), subsequent to a successful examination of the technical provisions adopted by the operator. This examination is carried out by the IPSN and the standing group on nuclear reactors. This communication sets out: the methods used by the manufacturer to develop SPIN software for the 1400 MWe PWRs (N4 series); the approach adopted by the IPSN to evaluate the safety software of the protection system for the N4 series of reactors.« less

Fault Injection Validation of a Safety-Critical TMR Sysem

NASA Astrophysics Data System (ADS)

Irrera, Ivano; Madeira, Henrique; Zentai, Andras; Hergovics, Beata

2016-08-01

Digital systems and their software are the core technology for controlling and monitoring industrial systems in practically all activity domains. Functional safety standards such as the European standard EN 50128 for railway applications define the procedures and technical requirements for the development of software for railway control and protection systems. The validation of such systems is a highly demanding task. In this paper we discuss the use of fault injection techniques, which have been used extensively in several domains, particularly in the space domain, to complement the traditional procedures to validate a SIL (Safety Integrity Level) 4 system for railway signalling, implementing a TMR (Triple Modular Redundancy) architecture. The fault injection tool is based on JTAG technology. The results of our injection campaign showed a high degree of tolerance to most of the injected faults, but several cases of unexpected behaviour have also been observed, helping understanding worst-case scenarios.

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

PubMed

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

2008-04-01

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

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US

PubMed Central

Cunningham, Thomas R.; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries’ planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator–intermediary–small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system. PMID:26300585

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US.

PubMed

Cunningham, Thomas R; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries' planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator-intermediary-small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system.

ECDA of Cased Pipeline Segments

DOT National Transportation Integrated Search

2010-06-01

On June 28, 2007, PHMSA released a Broad Agency Announcement (BAA), DTPH56-07-BAA-000002, seeking white papers on individual projects and consolidated Research and Development (R&D) programs addressing topics on pipeline safety program. Although, not...

76 FR 12214 - Motor Carrier Safety Advisory Committee Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-04

..., FMCSA requests that the Committee identify concepts and ideas the Agency should consider in developing... volume of cases and appeals. The MCSAC began deliberations on these issues at its December 2010 meeting...

Using an Animated Case Scenario Based on Constructivist 5E Model to Enhance Pre-Service Teachers' Awareness of Electrical Safety

ERIC Educational Resources Information Center

Hirca, Necati

2013-01-01

The objective of this study is to get pre-service teachers to develop an awareness of first aid knowledge and skills related to electrical shocking and safety within a scenario based animation based on a Constructivist 5E model. The sample of the study was composed of 78 (46 girls and 32 boys) pre-service classroom teachers from two faculties of…

Dynamic Safety Cases for Through-Life Safety Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

2015-01-01

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

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

International Approaches for Nuclear Waste Disposal in Geological Formations: Geological Challenges in Radioactive Waste Isolation—Fifth Worldwide Review

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

Faybishenko, Boris; Birkholzer, Jens; Sassani, David

The overall objective of the Fifth Worldwide Review (WWR-5) is to document the current state-of-the-art of major developments in a number of nations throughout the World pursuing geological disposal programs, and to summarize challenging problems and experience that have been obtained in siting, preparing and reviewing cases for the operational and long-term safety of proposed and operating nuclear waste repositories. The scope of the Review is to address current specific technical issues and challenges in safety case development along with the interplay of technical feasibility, siting, engineering design issues, and operational and post-closure safety. In particular, the chapters included inmore » the report present the following types of information: the current status of the deep geological repository programs for high level nuclear waste and low- and intermediate level nuclear waste in each country, concepts of siting and radioactive waste and spent nuclear fuel management in different countries (with the emphasis of nuclear waste disposal under different climatic conditions and different geological formations), progress in repository site selection and site characterization, technology development, buffer/backfill materials studies and testing, support activities, programs, and projects, international cooperation, and future plans, as well as regulatory issues and transboundary problems.« less

Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration.

PubMed

Taylor, Jennifer A; Gerwin, Daniel; Morlock, Laura; Miller, Marlene R

2011-12-01

To evaluate the need for triangulating case-finding tools in patient safety surveillance. This study applied four case-finding tools to error-associated patient safety events to identify and characterise the spectrum of events captured by these tools, using puncture or laceration as an example for in-depth analysis. Retrospective hospital discharge data were collected for calendar year 2005 (n=48,418) from a large, urban medical centre in the USA. The study design was cross-sectional and used data linkage to identify the cases captured by each of four case-finding tools. Three case-finding tools (International Classification of Diseases external (E) and nature (N) of injury codes, Patient Safety Indicators (PSI)) were applied to the administrative discharge data to identify potential patient safety events. The fourth tool was Patient Safety Net, a web-based voluntary patient safety event reporting system. The degree of mutual exclusion among detection methods was substantial. For example, when linking puncture or laceration on unique identifiers, out of 447 potential events, 118 were identical between PSI and E-codes, 152 were identical between N-codes and E-codes and 188 were identical between PSI and N-codes. Only 100 events that were identified by PSI, E-codes and N-codes were identical. Triangulation of multiple tools through data linkage captures potential patient safety events most comprehensively. Existing detection tools target patient safety domains differently, and consequently capture different occurrences, necessitating the integration of data from a combination of tools to fully estimate the total burden.

Using ADOPT Algorithm and Operational Data to Discover Precursors to Aviation Adverse Events

NASA Technical Reports Server (NTRS)

Janakiraman, Vijay; Matthews, Bryan; Oza, Nikunj

2018-01-01

The US National Airspace System (NAS) is making its transition to the NextGen system and assuring safety is one of the top priorities in NextGen. At present, safety is managed reactively (correct after occurrence of an unsafe event). While this strategy works for current operations, it may soon become ineffective for future airspace designs and high density operations. There is a need for proactive management of safety risks by identifying hidden and "unknown" risks and evaluating the impacts on future operations. To this end, NASA Ames has developed data mining algorithms that finds anomalies and precursors (high-risk states) to safety issues in the NAS. In this paper, we describe a recently developed algorithm called ADOPT that analyzes large volumes of data and automatically identifies precursors from real world data. Precursors help in detecting safety risks early so that the operator can mitigate the risk in time. In addition, precursors also help identify causal factors and help predict the safety incident. The ADOPT algorithm scales well to large data sets and to multidimensional time series, reduce analyst time significantly, quantify multiple safety risks giving a holistic view of safety among other benefits. This paper details the algorithm and includes several case studies to demonstrate its application to discover the "known" and "unknown" safety precursors in aviation operation.

National Space Agencies vs. Commercial Space: Towards Improved Space Safety

NASA Astrophysics Data System (ADS)

Pelton, J.

2013-09-01

Traditional space policies as developed at the national level includes many elements but they are most typically driven by economic and political objectives. Legislatively administered programs apportion limited public funds to achieve "gains" that can involve employment, stimulus to the economy, national defense or other advancements. Yet political advantage is seldom far from the picture.Within the context of traditional space policies, safety issues cannot truly be described as "afterthoughts", but they are usually, at best, a secondary or even tertiary consideration. "Space safety" is often simply assumed to be "in there" somewhere. The current key question is can "safety and risk minimization", within new commercial space programs actually be elevated in importance and effectively be "designed in" at the outset. This has long been the case with commercial aviation and there is at least reasonable hope that this could also be the case for the commercial space industry in coming years. The cooperative role that the insurance industry has now played for centuries in the shipping industry and for decades in aviation can perhaps now play a constructive role in risk minimization in the commercial space domain as well. This paper begins by examining two historical case studies in the context of traditional national space policy development to see how major space policy decisions involving "manned space programs" have given undue primacy to "political considerations" over "safety" and other factors. The specific case histories examined here include first the decision to undertake the Space Shuttle Program (i.e. 1970-1972) and the second is the International Space Station. In both cases the key and overarching decisions were driven by political, schedule and cost considerations, and safety seems absence as a prime consideration. In publicly funded space programs—whether in the United States, Europe, Russia, Japan, China, India or elsewhere—it seems realistic to assume that thiscondition will not change. This seems particularly true for high profile, multi-billion dollar programs.The second part of the paper focuses on new commercial space programs that appear to be undertaken in a less restrictive manner; i.e. outside the constraints of politically-driven national space policies. Here the drivers—even within international consortia—seem to be on reliable performance and commercial return. Since sustained accident-free performance is critical to commercial programs very existence and profitability, the inherent role of safety in commercial space industry would seem clear. The question of prime interest for this paper is whether or not it might be possible for smaller and more focused commercial space entities, free from the constraints of space agency organizational and political constraints, to be more "risk adverse" and thus be more nimble in designing "safe" vehicles? If so how can this "safety first" corporate philosophy and management practice be detected and even objectively measured? Could, in the future, risk reduction at the level of design, quality verification, etc., be objectively measured?

Radioactive waste management in France: safety demonstration fundamentals.

PubMed

Ouzounian, G; Voinis, S; Boissier, F

2012-01-01

The main challenge in development of the safety case for deep geological disposal is associated with the long periods of time over which high- and intermediate-level long-lived wastes remain hazardous. A wide range of events and processes may occur over hundreds of thousands of years. These events and processes are characterised by specific timescales. For example, the timescale for heat generation is much shorter than any geological timescale. Therefore, to reach a high level of reliability in the safety case, it is essential to have a thorough understanding of the sequence of events and processes likely to occur over the lifetime of the repository. It then becomes possible to assess the capability of the repository to fulfil its safety functions. However, due to the long periods of time and the complexity of the events and processes likely to occur, uncertainties related to all processes, data, and models need to be understood and addressed. Assessment is required over the lifetime of the radionuclides contained in the radioactive waste. Copyright © 2012. Published by Elsevier Ltd.

Safety Early Warning Research for Highway Construction Based on Case-Based Reasoning and Variable Fuzzy Sets

PubMed Central

Liu, Yan; Xu, Zhen-Jun

2013-01-01

As a high-risk subindustry involved in construction projects, highway construction safety has experienced major developments in the past 20 years, mainly due to the lack of safe early warnings in Chinese construction projects. By combining the current state of early warning technology with the requirements of the State Administration of Work Safety and using case-based reasoning (CBR), this paper expounds on the concept and flow of highway construction safety early warnings based on CBR. The present study provides solutions to three key issues, index selection, accident cause association analysis, and warning degree forecasting implementation, through the use of association rule mining, support vector machine classifiers, and variable fuzzy qualitative and quantitative change criterion modes, which fully cover the needs of safe early warning systems. Using a detailed description of the principles and advantages of each method and by proving the methods' effectiveness and ability to act together in safe early warning applications, effective means and intelligent technology for a safe highway construction early warning system are established. PMID:24191134

Safety early warning research for highway construction based on case-based reasoning and variable fuzzy sets.

PubMed

Liu, Yan; Yi, Ting-Hua; Xu, Zhen-Jun

2013-01-01

As a high-risk subindustry involved in construction projects, highway construction safety has experienced major developments in the past 20 years, mainly due to the lack of safe early warnings in Chinese construction projects. By combining the current state of early warning technology with the requirements of the State Administration of Work Safety and using case-based reasoning (CBR), this paper expounds on the concept and flow of highway construction safety early warnings based on CBR. The present study provides solutions to three key issues, index selection, accident cause association analysis, and warning degree forecasting implementation, through the use of association rule mining, support vector machine classifiers, and variable fuzzy qualitative and quantitative change criterion modes, which fully cover the needs of safe early warning systems. Using a detailed description of the principles and advantages of each method and by proving the methods' effectiveness and ability to act together in safe early warning applications, effective means and intelligent technology for a safe highway construction early warning system are established.

Application of an aviation model of incident reporting and investigation to the neurosurgical scenario: method and preliminary data.

PubMed

Ferroli, Paolo; Caldiroli, Dario; Acerbi, Francesco; Scholtze, Maurizio; Piro, Alfonso; Schiariti, Marco; Orena, Eleonora F; Castiglione, Melina; Broggi, Morgan; Perin, Alessandro; DiMeco, Francesco

2012-11-01

Incident reporting systems are universally recognized as important tools for quality improvement in all complex adaptive systems, including the operating room. Nevertheless, introducing a safety culture among neurosurgeons is a slow process, and few studies are available in the literature regarding the implementation of an incident reporting system within a neurosurgical department. The authors describe the institution of an aviation model of incident reporting and investigation in neurosurgery, focusing on the method they have used and presenting some preliminary results. In 2010, the Inpatient Safety On-Board project was developed through cooperation between a team of human factor and safety specialists with aviation backgrounds (DgSky team) and the general manager of the Fondazione Istituto Neurologico Carlo Besta. In 2011, after specific training in safety culture, the authors implemented an aviation-derived prototype of incident reporting within the Department of Neurosurgery. They then developed an experimental protocol to track, analyze, and categorize any near misses that happened in the operating room. This project officially started in January 2012, when a dedicated team of assessors was established. All members of the neurosurgical department were asked to report near misses on a voluntary, confidential, and protected form (Patient Incident Reporting System form, Besta Safety Management Programme). Reports were entered into an online database and analyzed by a dedicated team of assessors with the help of a facilitator, and an aviation-derived root cause analysis was performed. Since January 2012, 14 near misses were analyzed and classified. The near-miss contributing factors were mainly related to human factors (9 of 14 cases), technology (1 of 14 cases), organizational factors (3 of 14 cases), or procedural factors (1 of 14 cases). Implementing an incident reporting system is quite demanding; the process should involve all of the people who work within the environment under study. Persistence and strong commitment are required to enact the culture change essential in shifting from a paradigm of infallible operators to the philosophy of errare humanum est. For this paradigm shift to be successful, contributions from aviation and human factor experts are critical.

The Integrated Medical Model: A Decision Support Tool for In-flight Crew Health Care

NASA Technical Reports Server (NTRS)

Butler, Doug

2009-01-01

This viewgraph presentation reviews the development of an Integrated Medical Model (IMM) decision support tool for in-flight crew health care safety. Clinical methods, resources, and case scenarios are also addressed.

Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

PubMed

Jones, Sarahjane

2016-10-01

The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

RESTORING SAFETY: AN ATTACHMENT-BASED APPROACH TO CLINICAL WORK WITH A TRAUMATIZED TODDLER.

PubMed

Ribaudo, Julie

2016-01-01

This clinical case study explores the integration of infancy research, brain development, attachment theory, and models of infant-parent/child-parent psychotherapy to address the needs of abused and neglected young children placed in foster or adoptive homes. Traumatized children employ defensive strategies to survive when there is no "good enough" caregiver (D.W. Winnicott, 1953, p. 94), and helping professionals can provide therapeutic experiences to develop or restore a child's sense of safety. With the case example of Anthony and his foster/adoptive parents, I illustrate how to manage and contain a traumatized child's terror, rage, and grief through therapeutic sessions with the parent and child together, and supportive parental guidance. I promote attention to the child's ability to self-integrate and to regulate his own affect, and encourages secure-base parental responses that facilitate a child's shift toward secure attachment behavior. © 2015 Michigan Association for Infant Mental Health.

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

PubMed

Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

2018-02-05

A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

PharmARTS: terminology web services for drug safety data coding and retrieval.

PubMed

Alecu, Iulian; Bousquet, Cédric; Degoulet, Patrice; Jaulent, Marie-Christine

2007-01-01

MedDRA and WHO-ART are the terminologies used to encode drug safety reports. The standardisation achieved with these terminologies facilitates: 1) The sharing of safety databases; 2) Data mining for the continuous reassessment of benefit-risk ratio at national or international level or in the pharmaceutical industry. There is some debate about the capacity of these terminologies for retrieving case reports related to similar medical conditions. We have developed a resource that allows grouping similar medical conditions more effectively than WHO-ART and MedDRA. We describe here a software tool facilitating the use of this terminological resource thanks to an RDF framework with support for RDF Schema inferencing and querying. This tool eases coding and data retrieval in drug safety.

SLUDGE TREATMENT PROJECT KOP DISPOSITION - THERMAL AND GAS ANALYSIS FOR THE COLD VACUUM DRYING FACILITY

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

SWENSON JA; CROWE RD; APTHORPE R

2010-03-09

The purpose of this document is to present conceptual design phase thermal process calculations that support the process design and process safety basis for the cold vacuum drying of K Basin KOP material. This document is intended to demonstrate that the conceptual approach: (1) Represents a workable process design that is suitable for development in preliminary design; and (2) Will support formal safety documentation to be prepared during the definitive design phase to establish an acceptable safety basis. The Sludge Treatment Project (STP) is responsible for the disposition of Knock Out Pot (KOP) sludge within the 105-K West (KW) Basin.more » KOP sludge consists of size segregated material (primarily canister particulate) from the fuel and scrap cleaning process used in the Spent Nuclear Fuel process at K Basin. The KOP sludge will be pre-treated to remove fines and some of the constituents containing chemically bound water, after which it is referred to as KOP material. The KOP material will then be loaded into a Multi-Canister Overpack (MCO), dried at the Cold Vacuum Drying Facility (CVDF) and stored in the Canister Storage Building (CSB). This process is patterned after the successful drying of 2100 metric tons of spent fuel, and uses the same facilities and much of the same equipment that was used for drying fuel and scrap. Table ES-l present similarities and differences between KOP material and fuel and between MCOs loaded with these materials. The potential content of bound water bearing constituents limits the mass ofKOP material in an MCO load to a fraction of that in an MCO containing fuel and scrap; however, the small particle size of the KOP material causes the surface area to be significantly higher. This relatively large reactive surface area represents an input to the KOP thermal calculations that is significantly different from the calculations for fuel MCOs. The conceptual design provides for a copper insert block that limits the volume available to receive KOP material, enhances heat conduction, and functions as a heat source and sink during drying operations. This use of the copper insert represents a significant change to the thermal model compared to that used for the fuel calculations. A number of cases were run representing a spectrum of normal and upset conditions for the drying process. Dozens of cases have been run on cold vacuum drying of fuel MCOs. Analysis of these previous calculations identified four cases that provide a solid basis for judgments on the behavior of MCO in drying operations. These four cases are: (1) Normal Process; (2) Degraded vacuum pumping; (3) Open MCO with loss of annulus water; and (4) Cool down after vacuum drying. The four cases were run for two sets of input parameters for KOP MCOs: (1) a set of parameters drawn from safety basis values from the technical data book and (2) a sensitivity set using parameters selected to evaluate the impact of lower void volume and smaller particle size on MCO behavior. Results of the calculations for the drying phase cases are shown in Table ES-2. Cases using data book safety basis values showed dry out in 9.7 hours and heat rejection sufficient to hold temperature rise to less than 25 C. Sensitivity cases which included unrealistically small particle sizes and corresponding high reactive surface area showed higher temperature increases that were limited by water consumption. In this document and in the attachment (Apthorpe, R. and M.G. Plys, 2010) cases using Technical Databook safety basis values are referred to as nominal cases. In future calculations such cases will be called safety basis cases. Also in these documents cases using parameters that are less favorable to acceptable performance than databook safety values are referred to as safety cases. In future calculations such cases will be called sensitivity cases or sensitivity evaluations Calculations to be performed in support of the detailed design and formal safety basis documentation will expand the calculations presented in this document to include: additional features of the drying cycle, more realistic treatment of uranium metal consumption during oxidation, larger water inventory, longer time scales, and graphing of results of hydrogen gas concentration.« less

A Review of Safety and Design Requirements of the Artificial Pancreas.

PubMed

Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

2016-11-01

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

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

PubMed

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

2009-04-01

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

The Safety Argumentation Schools of Thought

NASA Technical Reports Server (NTRS)

Graydon, Patrick John

2017-01-01

Safety cases have been produced and researched for decades. Definitions of `safety case' agree on both the need to generate suitable evidence and the central role of argument. But the relevant literature seems to exhibit multiple schools of thought that are largely unrecognized and somewhat at odds with each other. This paper presents preliminary results from research to identify and characterize the safety case schools of thought so as to reduce confusion and discord in research and practice.

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

NASA Astrophysics Data System (ADS)

Elliott, Kevin C.; Volz, David C.

2012-01-01

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

MetaPath: An Electronic Knowledge Base for Collating, Exchanging and Analyzing Case Studies of Xenobiotic Metabolism

EPA Science Inventory

A new MetaPath information system was developed through a collaborative effort between the Laboratory of Mathematical Chemistry (Bourgas, Bulgaria), EPA’s Office of Research and Development (NHEERL, MED, Duluth, MN and NERL, ERD, Athens, GA), and EPA’s Office of Chemical Safety a...

The development and application of electronic information system for safety administration of newborns in the rooming-in care.

PubMed

Wang, Fang; Dong, Jian-Cheng; Chen, Jian-Rong; Wu, Hui-Qun; Liu, Man-Hua; Xue, Li-Ly; Zhu, Xiang-Hua; Wang, Jian

2015-01-01

To independently research and develop an electronic information system for safety administration of newborns in the rooming-in care, and to investigate the effects of its clinical application. By VS 2010 SQL SERVER 2005 database and adopting Microsoft visual programming tool, an interactive mobile information system was established, with integrating data, information and knowledge with using information structures, information processes and information technology. From July 2011 to July 2012, totally 210 newborns from the rooming-in care of the Obstetrics Department of the Second Affiliated Hospital of Nantong University were chosen and randomly divided into two groups: the information system monitoring group (110 cases) and the regular monitoring group (100 cases). Incidence of abnormal events and degree of satisfaction were recorded and calculated. ① The wireless electronic information system has four main functions including risk scaling display, identity recognition display, nursing round notes board and health education board; ② statistically significant differences were found between the two groups both on the active or passive discovery rate of abnormal events occurred in the newborns (P<0.05) and the satisfaction degree of the mothers and their families (P<0.05); ③ the system was sensitive and reliable, and the wireless transmission of information was correct and safety. The system is with high practicability in the clinic and can ensure the safety for the newborns with improved satisfactions.

Lessons learnt from the development of the Patient Safety Incidents Reporting an Learning System for the Spanish National Health System: SiNASP.

PubMed

Vallejo-Gutiérrez, Paula; Bañeres-Amella, Joaquim; Sierra, Eduardo; Casal, Jesús; Agra, Yolanda

2014-01-01

To describe the development process and characteristics of a patient safety incidents reporting system to be implemented in the Spanish National Health System, based on the context and the needs of the different stakeholders. Literature review and analysis of most relevant reporting systems, identification of more than 100 stakeholder's (patients, professionals, regional governments representatives) expectations and requirements, analysis of the legal context, consensus of taxonomy, development of the software and pilot test. Patient Safety Events Reporting and Learning system (Sistema de Notificación y Aprendizajepara la Seguridad del Paciente, SiNASP) is a generic reporting system for all types of incidents related to patient safety, voluntary, confidential, non punitive, anonymous or nominative with anonimization, system oriented, with local analysis of cases and based on the WHO International Classification for Patient Safety. The electronic program has an on-line form for reporting, a software to manage the incidents and improvement plans, and a scoreboard with process indicators to monitor the system. The reporting system has been designed to respond to the needs and expectations identified by the stakeholders, taking into account the lessons learned from the previous notification systems, the characteristics of the National Health System and the existing legal context. The development process presented and the characteristics of the system provide a comprehensive framework that can be used for future deployments of similar patient safety systems. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

Understanding the relationship between safety culture dimensions and safety performance of construction projects through partial least square method

NASA Astrophysics Data System (ADS)

Latief, Yusuf; Machfudiyanto, Rossy A.; Arifuddin, Rosmariani; Yogiswara, Yoko

2017-03-01

Based on the data, 32% of accidental cases in Indonesia occurs on constructional sectors. It is supported by the data from Public Work and Housing Department that 27.43% of the implementation level of Safety Management System policy at construction companies in Indonesia remains unsafe categories. Moreover, there are dimensions of occupational safety culture formed including leadership, behavior, strategy, policy, process, people, safety cost, value and contract system. The aim of this study is to determine the model of an effective safety culture and know the relationship between dimensions in construction industry. The method used in this research was questionnaire survey which was distributed to the sample of construction companies either in a national private one in Indonesia. The result of this research is supposed to be able to illustrate the development of the relationship among occupational safety culture dimensions which have influences to the performances of constructional companies in Indonesia.

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

PubMed

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

2012-09-01

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

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.

Smeed's law and expected road fatality reduction: An assessment of the Italian case.

PubMed

Persia, Luca; Gigli, Roberto; Usami, Davide Shingo

2015-12-01

Smeed's law defines the functional relationship existing between the fatality rate and the motorization rate.While focusing on the Italian case and based on the Smeed's law, the study assesses the possibility for Italy of reaching the target of halving the number of road fatalities by 2020, in light of the evolving socioeconomic situation. A Smeed's model has been calibrated based on the recorded Italian data. The evolution of the two indicators, fatality and motorization rates, has been estimated using the predictions of the main parameters (population, fleet size and fatalities). Those trends have been compared with the natural decreasing trend derived from the Smeed's law. Nine scenarios have been developed showing the relationship between the fatality rate and the motorization rate. In case of a limited increase (logistic regression) of the vehicle fleet and according to the estimated evolution of the population, the path defined by motorization and fatality rate is very steep, diverging from the estimated confidence interval of the Smeed's model. In these scenarios the motorization rate is almost constant during the decade. In the actual economic context, a limited development of the vehicle fleet is more plausible. In these conditions the target achievement of halving the number of fatalities in Italy may occur only in case of a structural break (i.e., the introduction of highly effective road safety policies). Practical application: The proposed tools can be used both to evaluate retrospectively the effectiveness of road safety improvements and to assess if a relevant effort is needed to reach the established road safety targets.

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

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

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

2007-07-01

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

Evaluation of Margins of Safety in Brazed Joints

NASA Technical Reports Server (NTRS)

Flom, Yury; Wang, Len; Powell, Mollie M.; Soffa, Matthew A.; Rommel, Monica L.

2009-01-01

One of the essential steps in assuring reliable performance of high cost critical brazed structures is the assessment of the Margin of Safety (MS) of the brazed joints. In many cases the experimental determination of the failure loads by destructive testing of the brazed assembly is not practical and cost prohibitive. In such cases the evaluation of the MS is performed analytically by comparing the maximum design loads with the allowable ones and incorporating various safety or knock down factors imposed by the customer. Unfortunately, an industry standard methodology for the design and analysis of brazed joints has not been developed. This paper provides an example of an approach that was used to analyze an AlBeMet 162 (38%Be-62%Al) structure brazed with the AWS BAlSi-4 (Al-12%Si) filler metal. A practical and conservative interaction equation combining shear and tensile allowables was developed and validated to evaluate an acceptable (safe) combination of tensile and shear stresses acting in the brazed joint. These allowables are obtained from testing of standard tensile and lap shear brazed specimens. The proposed equation enables the assessment of the load carrying capability of complex brazed joints subjected to multi-axial loading.

Improving safety culture through the health and safety organization: a case study.

PubMed

Nielsen, Kent J

2014-02-01

International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

Analysis of car-to-bicycle approach patterns for developing active safety devices.

PubMed

Matsui, Yasuhiro; Oikawa, Shoko; Hitosugi, Masahito

2016-05-18

To reduce the severity of injuries and the number of cyclist deaths in traffic accidents, active safety devices providing cyclist detection are considered to be effective countermeasures. The features of car-to-bicycle collisions need to be known in detail to develop such safety devices. The study investigated near-miss situations captured by drive recorders installed in passenger cars. Because similarities in the approach patterns between near-miss incidents and real-world fatal cyclist accidents in Japan were confirmed, we analyzed the 229 near-miss incident data via video capturing bicycles crossing the road in front of forward-moving cars. Using a video frame captured by a drive recorder, the time to collision (TTC) was calculated from the car's velocity and the distance between the car and bicycle at the moment when the bicycle initially appeared. The average TTC in the cases where bicycles emerged from behind obstructions was shorter than that in the cases where drivers had unobstructed views of the bicycles. In comparing the TTC of car-to-bicycle near-miss incidents to the previously obtained results of car-to-pedestrian near-miss incidents, it was determined that the average TTC in car-to-bicycle near-miss incidents was significantly longer than that in car-to-pedestrian near-miss incidents. When considering the TTC in the test protocol of evaluation for safety performance of active safety devices, we propose individual TTCs for evaluation of cyclist and pedestrian detections, respectively. In the test protocols, the following 2 scenarios should be employed: bicycle emerging from behind an unobstructed view and bicycle emerging from behind obstructions.

Focus on patient safety all day, every day.

PubMed

2015-06-01

Case managers may think their job doesn't involve patient safety, but they promote safety by ensuring a safe discharge and are in a position to see safety breaches and mistakes all over the hospital. CMS includes discharge planning in its worksheets for surveyors to use to assess a hospital's compliance with Medicare Conditions of Participation. Because they work with patients from admission to discharge, case managers know which clinicians are competent, those who are not, and may observe safety breaches like failure to wash hands and leaving the catheter in too long. Case managers should spend enough time with their patients to know their situations at home and their support systems and use the information to create workable and safe discharge plans. Hospitals should create an environment and a culture where case managers and other clinicians feel comfortable speaking up when they see safety breaches.

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients

PubMed Central

Spera, Allison L.; Saxen, Mark A.; Yepes, Juan F.; Jones, James E.; Sanders, Brian J.

2017-01-01

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010–2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients. PMID:28858554

Case-control study on the prevention of occupational eye injuries.

PubMed

Ho, Chi-Kung; Yen, Ya-Lin; Chang, Cheng-Hsien; Chiang, Hung-Che; Shen, Ying-Ying; Chang, Po-Ya

2008-01-01

The risk factors for occupational eye injuries have never been published in Taiwan. We conducted a case-control study to analyze the differences among workers on their knowledge, attitude to and practice (KAP) of occupational accident prevention. In the study, a statistical model was also set up for predicting the occupational problem. Subjects, including 31 cases of work-related eye injuries and 62 controls, completed a structured questionnaire on KAP, which revealed that 80.6% and 62.7% of workers in the case and control groups, respectively, did not wear eye protection during work. Furthermore, we found that temporary employment (OR, 10.7; 95% CI, 3.03-36.16) and fewer than 10 years of education (OR, 4.44; 95% CI, 1.73-11.44) were the major risk factors for occupational eye injuries. In addition, we developed a logistic regression model with four predictors (temporary employment, education years less than 10, poor management of industrial health and safety in the workplace, and poor attitude towards accident prevention) for the occurrence of occupational eye injuries. In conclusion, in Taiwan, compulsory regulation of wearing eye protection during work, good education, management of work safety and hygiene and employee (especially temporary worker) commitment to safety and health are strongly recommended prevention strategies.

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients.

PubMed

Spera, Allison L; Saxen, Mark A; Yepes, Juan F; Jones, James E; Sanders, Brian J

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010-2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients.

A review of nondestructive examination technology for polyethylene pipe in nuclear power plant

NASA Astrophysics Data System (ADS)

Zheng, Jinyang; Zhang, Yue; Hou, Dongsheng; Qin, Yinkang; Guo, Weican; Zhang, Chuck; Shi, Jianfeng

2018-05-01

Polyethylene (PE) pipe, particularly high-density polyethylene (HDPE) pipe, has been successfully utilized to transport cooling water for both non-safety- and safety-related applications in nuclear power plant (NPP). Though ASME Code Case N755, which is the first code case related to NPP HDPE pipe, requires a thorough nondestructive examination (NDE) of HDPE joints. However, no executable regulations presently exist because of the lack of a feasible NDE technique for HDPE pipe in NPP. This work presents a review of current developments in NDE technology for both HDPE pipe in NPP with a diameter of less than 400 mm and that of a larger size. For the former category, phased array ultrasonic technique is proven effective for inspecting typical defects in HDPE pipe, and is thus used in Chinese national standards GB/T 29460 and GB/T 29461. A defect-recognition technique is developed based on pattern recognition, and a safety assessment principle is summarized from the database of destructive testing. On the other hand, recent research and practical studies reveal that in current ultrasonic-inspection technology, the absence of effective ultrasonic inspection for large size was lack of consideration of the viscoelasticity effect of PE on acoustic wave propagation in current ultrasonic inspection technology. Furthermore, main technical problems were analyzed in the paper to achieve an effective ultrasonic test method in accordance to the safety and efficiency requirements of related regulations and standards. Finally, the development trend and challenges of NDE test technology for HDPE in NPP are discussed.

Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.

PubMed

Gold, Michael R; Kanal, Emanuel; Schwitter, Juerg; Sommer, Torsten; Yoon, Hyun; Ellingson, Michael; Landborg, Lynn; Bratten, Tara

2015-03-01

Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system. The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI. MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin. Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards. A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Assessing the Biological Safety Profession's Evaluation and Control of Risks Associated with the Field Collection of Potentially Infectious Specimens.

PubMed

Patlovich, Scott J; Emery, Robert J; Whitehead, Lawrence W; Brown, Eric L; Flores, Rene

2015-03-01

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting field collection activities) indicated that training on field research safety issues would be helpful, and even more (71% overall; 93% from institutions conducting field collection activities) would consider participation in such a training course. Results obtained from this study can be used to develop a field research safety toolkit and associated training curricula specifically targeted to biological safety professionals.

[Case Study] CityCenter and Cosmopolitan Construction Projects, Las Vegas, Nevada: lessons learned from the use of multiple sources and mixed methods in a safety needs assessment.

PubMed

Gittleman, Janie L; Gardner, Paige C; Haile, Elizabeth; Sampson, Julie M; Cigularov, Konstantin P; Ermann, Erica D; Stafford, Pete; Chen, Peter Y

2010-06-01

The present study describes a response to eight tragic deaths over an eighteen month times span on a fast track construction project on the largest commercial development project in U.S. history. Four versions of a survey were distributed to workers, foremen, superintendents, and senior management. In addition to standard Likert-scale safety climate scale items, an open-ended item was included at the end of the survey. Safety climate perceptions differed by job level. Specifically, management perceived a more positive safety climate as compared to workers. Content analysis of the open-ended item was used to identify important safety and health concerns which might have been overlooked with the qualitative portion of the survey. The surveys were conducted to understand workforce issues of concern with the aim of improving site safety conditions. Such efforts can require minimal investment of resources and time and result in critical feedback for developing interventions affecting organizational structure, management processes, and communication. The most important lesson learned was that gauging differences in perception about site safety can provide critical feedback at all levels of a construction organization. Implementation of multi-level organizational perception surveys can identify major safety issues of concern. Feedback, if acted upon, can potentially result in fewer injuries and fatal events. (c) 2010 Elsevier Ltd. All rights reserved.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database.

PubMed

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-09-01

A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%-47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others' behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. © 2017 Annals of Family Medicine, Inc.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database

PubMed Central

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-01-01

PURPOSE A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. METHODS We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. RESULTS Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%–47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. CONCLUSIONS The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others’ behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. PMID:28893816

Do failures in non-technical skills contribute to fatal medical accidents in Japan? A review of the 2010–2013 national accident reports

PubMed Central

Uramatsu, Masashi; Fujisawa, Yoshikazu; Mizuno, Shinya; Souma, Takahiro; Komatsubara, Akinori; Miki, Tamotsu

2017-01-01

Objectives We sought to clarify how large a proportion of fatal medical accidents can be considered to be caused by poor non-technical skills, and to support development of a policy to reduce number of such accidents by making recommendations about possible training requirements. Design Summaries of reports of fatal medical accidents, published by the Japan Medical Safety Research Organization, were reviewed individually. Three experienced clinicians and one patient safety expert conducted the reviews to determine the cause of death. Views of the patient safety expert were given additional weight in the overall determination. Setting A total of 73 summary reports of fatal medical accidents were reviewed. These reports had been submitted by healthcare organisations across Japan to the Japan Medical Safety Research Organization between April 2010 and March 2013. Primary and secondary outcome measures The cause of death in fatal medical accidents, categorised into technical skills, non-technical skills and inevitable progress of disease were evaluated. Non-technical skills were further subdivided into situation awareness, decision making, communication, team working, leadership, managing stress and coping with fatigue. Results Overall, the cause of death was identified as non-technical skills in 34 cases (46.6%), disease progression in 33 cases (45.2%) and technical skills in two cases (5.5%). In two cases, no consensual determination could be achieved. Further categorisation of cases of non-technical skills were identified as 14 cases (41.2%) of problems with situation awareness, eight (23.5%) with team working and three (8.8%) with decision making. These three subcategories, or combinations of them, were identified as the cause of death in 33 cases (97.1%). Conclusions Poor non-technical skills were considered to be a significant cause of adverse events in nearly half of the fatal medical accidents examined. Improving non-technical skills may be effective for reducing accidents, and training in particular subcategories of non-technical skills may be especially relevant. PMID:28209605

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

PubMed

Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

2013-09-01

In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

MO-F-16A-04: Case Study: Estimation of Peak Skin Dose Following a Physician Reported “High Dose” Case and Sentinel Event Considerations

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

Supanich, M; Chu, J; Wehmeyer, A

2014-06-15

Purpose: This work offers as a teaching example a reported high dose fluoroscopy case and the workflow the institution followed to self-report a radiation overdose sentinel event to the Joint Commission. Methods: Following the completion of a clinical case in a hybrid OR room with a reported air kerma of >18 Gy at the Interventional Reference Point (IRP) the physicians involved in the case referred study to the institution's Radiation Safety Committee (RSC) for review. The RSC assigned a Diagnostic Medical Physicist (DMP) to estimate the patient's Peak Skin Dose (PSD) and analyze the case. Following the DMP's analysis andmore » estimate of a PSD of >15 Gy the institution's adverse event committee was convened to discuss the case and to self-report the case as a radiation overdose sentinel event to the Joint Commission. The committee assigned a subgroup to perform the root cause analysis and develop institutional responses to the event. Results: The self-reporting of the sentinel event and the associated root cause analysis resulted in several institutional action items that are designed to improve process and safety. A formal reporting and analysis mechanism was adopted to review fluoroscopy cases with air kerma greater than 6 Gy at the IRP. An improved and formalized radiation safety training program for physicians using fluoroscopy equipment was implemented. Additionally efforts already under way to monitor radiation exposure in the Radiology department were expanded to include all fluoroscopy equipment capable of automated dose reporting. Conclusion: The adverse event review process and the root cause analysis following the self-reporting of the sentinel event resulted in policies and procedures that are expected to improve the quality and safe usage of fluoroscopy throughout the institution.« less

Attention-Deficit/Hyperactivity Disorder and Fatal Accidents in Aviation Medicine.

PubMed

Laukkala, Tanja; Bor, Robert; Budowle, Bruce; Sajantila, Antti; Navathe, Pooshan; Sainio, Markku; Vuorio, Alpo

2017-09-01

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with symptoms of inattention and/or hyperactivity-impulsivity that interfere with functioning and/or development. ADHD occurs in about 2.5% of adults. ADHD can be an excluding medical condition among pilots due to the risk of attentional degradation and therefore impact on flight safety. Diagnosis of ADHD is complex, which complicates aeromedical assessment. This study highlights fatal accident cases among pilots with ADHD and discusses protocols to detect its presence to help to assess its importance to flight safety. To identify fatal accidents in aviation (including airplanes, helicopters, balloons, and gliders) in the United States between the years 2000 to 2015, the National Transportation Safety Board (NTSB) database was searched with the terms ADHD, attention deficit hyperactivity disorder, and attention deficit disorder (ADD). The NTSB database search for fatal aviation accidents possibly associated with ADHD yielded four accident cases of interest in the United States [4/4894 (0.08%)]. Two of the pilots had ADHD diagnosed by a doctor, one was reported by a family member, and one by a flight instructor. An additional five cases were identified searching for ADD [5/4894 (0.1%)]. Altogether, combined ADHD and ADD cases yielded nine accident cases of interest (0.18%). It is generally accepted by aviation regulatory authorities that ADHD is a disqualifying neurological condition. Yet FAA and CASA provide specific protocols for tailor-made pilot assessment. Accurate evaluation of ADHD is essential because of its potential negative impact on aviation safety.Laukkala T, Bor R, Budowle B, Sajantila A, Navathe P, Sainio M, Vuorio A. Attention-deficit/hyperactivity disorder and fatal accidents in aviation medicine. Aerosp Med Hum Perform. 2017; 88(9):871-875.

Maximizing Team Performance: The Critical Role of the Nurse Leader.

PubMed

Manges, Kirstin; Scott-Cawiezell, Jill; Ward, Marcia M

2017-01-01

Facilitating team development is challenging, yet critical for ongoing improvement across healthcare settings. The purpose of this exemplary case study is to examine the role of nurse leaders in facilitating the development of a high-performing Change Team in implementing a patient safety initiative (TeamSTEPPs) using the Tuckman Model of Group Development as a guiding framework. The case study is the synthesis of 2.5 years of critical access hospital key informant interviews (n = 50). Critical juncture points related to team development and key nurse leader actions are analyzed, suggesting that nurse leaders are essential to maximize clinical teams' performance. © 2016 Wiley Periodicals, Inc.

A simulation model for determining the optimal size of emergency teams on call in the operating room at night.

PubMed

van Oostrum, Jeroen M; Van Houdenhoven, Mark; Vrielink, Manon M J; Klein, Jan; Hans, Erwin W; Klimek, Markus; Wullink, Gerhard; Steyerberg, Ewout W; Kazemier, Geert

2008-11-01

Hospitals that perform emergency surgery during the night (e.g., from 11:00 pm to 7:30 am) face decisions on optimal operating room (OR) staffing. Emergency patients need to be operated on within a predefined safety window to decrease morbidity and improve their chances of full recovery. We developed a process to determine the optimal OR team composition during the night, such that staffing costs are minimized, while providing adequate resources to start surgery within the safety interval. A discrete event simulation in combination with modeling of safety intervals was applied. Emergency surgery was allowed to be postponed safely. The model was tested using data from the main OR of Erasmus University Medical Center (Erasmus MC). Two outcome measures were calculated: violation of safety intervals and frequency with which OR and anesthesia nurses were called in from home. We used the following input data from Erasmus MC to estimate distributions of all relevant parameters in our model: arrival times of emergency patients, durations of surgical cases, length of stay in the postanesthesia care unit, and transportation times. In addition, surgeons and OR staff of Erasmus MC specified safety intervals. Reducing in-house team members from 9 to 5 increased the fraction of patients treated too late by 2.5% as compared to the baseline scenario. Substantially more OR and anesthesia nurses were called in from home when needed. The use of safety intervals benefits OR management during nights. Modeling of safety intervals substantially influences the number of emergency patients treated on time. Our case study showed that by modeling safety intervals and applying computer simulation, an OR can reduce its staff on call without jeopardizing patient safety.

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

Time Safety Margin: Theory and Practice

DTIC Science & Technology

2016-09-01

Basic Dive Recovery Terminology The Simplest Definition of TSM: Time Safety Margin is the time to directly travel from the worst-case vector to an...Safety Margin (TSM). TSM is defined as the time in seconds to directly travel from the worst case vector (i.e. worst case combination of parameters...invoked by this AFI, base recovery planning and risk management upon the calculated TSM. TSM is the time in seconds to di- rectly travel from the worst case

Ending on a positive: Examining the role of safety leadership decisions, behaviours and actions in a safety critical situation.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Horberry, Timothy; Lenné, Michael G

2018-01-01

Safety leadership is an important factor in supporting safe performance in the workplace. The present case study examined the role of safety leadership during the Bingham Canyon Mine high-wall failure, a significant mining incident in which no fatalities or injuries were incurred. The Critical Decision Method (CDM) was used in conjunction with a self-reporting approach to examine safety leadership in terms of decisions, behaviours and actions that contributed to the incidents' safe outcome. Mapping the analysis onto Rasmussen's Risk Management Framework (Rasmussen, 1997), the findings demonstrate clear links between safety leadership decisions, and emergent behaviours and actions across the work system. Communication and engagement based decisions featured most prominently, and were linked to different leadership practices across the work system. Further, a core sub-set of CDM decision elements were linked to the open flow and exchange of information across the work system, which was critical to supporting the safe outcome. The findings provide practical implications for the development of safety leadership capability to support safety within the mining industry. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Case Report of Severe Corneal Toxicity following 0.5% Topical Moxifloxacin Use.

PubMed

Vignesh, A P; Srinivasan, Renuka; Karanth, Swathi

2015-01-01

Moxifloxacin is a widely used topical antibiotic in various bacterial infections of the eye. Its safety and efficacy have been proved by many studies. We report a case of a rare adverse effect following its use. A 10-year-old female who had presented with acute bacterial conjunctivitis in both eyes with no corneal involvement was started on preservative-free 0.5% topical moxifloxacin four times a day. The child developed a severe form of corneal toxicity in both eyes with circumcorneal congestion and corneal edema following its use. The child's visual acuity had dropped from 20/20 to 20/400 in both the eyes. Topical moxifloxacin was discontinued, following which the cornea cleared dramatically and the visual acuity became normal. This case indicates that though rare, topical moxifloxacin can cause severe keratitis and that more studies need to be conducted to evaluate its safety.

FHWA study tour for road safety audits. Part 2 : case studies and checklists

DOT National Transportation Integrated Search

1998-01-01

This is the fifth plenary symposium on public policy issues in global freight logistics conducted by the Organization for Economic Cooperation and Development (OECD). OECD's Trilateral Logistics Project, Trilog Project, is aimed at clarifying the pub...

INTEGRATED RISK ASSESSMENT - RESULTS FROM AN INTERNATIONAL WORKSHOP

EPA Science Inventory

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

Practical Results from the Application of Model Checking and Test Generation from UML/SysML Models of On-Board Space Applications

NASA Astrophysics Data System (ADS)

Faria, J. M.; Mahomad, S.; Silva, N.

2009-05-01

The deployment of complex safety-critical applications requires rigorous techniques and powerful tools both for the development and V&V stages. Model-based technologies are increasingly being used to develop safety-critical software, and arguably, turning to them can bring significant benefits to such processes, however, along with new challenges. This paper presents the results of a research project where we tried to extend current V&V methodologies to be applied on UML/SysML models and aiming at answering the demands related to validation issues. Two quite different but complementary approaches were investigated: (i) model checking and the (ii) extraction of robustness test-cases from the same models. These two approaches don't overlap and when combined provide a wider reaching model/design validation ability than each one alone thus offering improved safety assurance. Results are very encouraging, even though they either fell short of the desired outcome as shown for model checking, or still appear as not fully matured as shown for robustness test case extraction. In the case of model checking, it was verified that the automatic model validation process can become fully operational and even expanded in scope once tool vendors help (inevitably) to improve the XMI standard interoperability situation. For the robustness test case extraction methodology, the early approach produced interesting results but need further systematisation and consolidation effort in order to produce results in a more predictable fashion and reduce reliance on expert's heuristics. Finally, further improvements and innovation research projects were immediately apparent for both investigated approaches, which point to either circumventing current limitations in XMI interoperability on one hand and bringing test case specification onto the same graphical level as the models themselves and then attempting to automate the generation of executable test cases from its standard UML notation.

Developing Appropriate Workforce Skills for Australia's Emerging Digital Economy: Working Paper

ERIC Educational Resources Information Center

Gekara, Victor; Molla, Alemayehu; Snell, Darryn; Karanasios, Stan; Thomas, Amanda

2017-01-01

This working paper is the first publication coming out of a project investigating the role of vocational education and training (VET) in developing digital skills in the Australian workforce, using two sectors as case studies--Transport and Logistics, and Public Safety and Correctional Services. The study employs a mixed method approach, combining…

Safety assurance of cosmetics in Japan: current situation and future prospects.

PubMed

Inomata, Shinji

2014-01-01

The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

A toolbox for safety instrumented system evaluation based on improved continuous-time Markov chain

NASA Astrophysics Data System (ADS)

Wardana, Awang N. I.; Kurniady, Rahman; Pambudi, Galih; Purnama, Jaka; Suryopratomo, Kutut

2017-08-01

Safety instrumented system (SIS) is designed to restore a plant into a safe condition when pre-hazardous event is occur. It has a vital role especially in process industries. A SIS shall be meet with safety requirement specifications. To confirm it, SIS shall be evaluated. Typically, the evaluation is calculated by hand. This paper presents a toolbox for SIS evaluation. It is developed based on improved continuous-time Markov chain. The toolbox supports to detailed approach of evaluation. This paper also illustrates an industrial application of the toolbox to evaluate arch burner safety system of primary reformer. The results of the case study demonstrates that the toolbox can be used to evaluate industrial SIS in detail and to plan the maintenance strategy.

Asbestos-related occupational cancers compensated under the Industrial Accident Compensation Insurance in Korea.

PubMed

Ahn, Yeon-Soon; Kang, Seong-Kyu

2009-04-01

Compensation for asbestos-related cancers occurring in occupationally-exposed workers is a global issue; this is also an issue in Korea. To provide basic information regarding compensation for workers exposed to asbestos, 60 cases of asbestos-related occupational lung cancer and mesothelioma that were compensated during 15 yr; from 1993 (the year the first case was compensated) to 2007 by the Korea Labor Welfare Corporation (KLWC) are described. The characteristics of the cases were analyzed using the KLWC electronic data and the epidemiologic investigation data conducted by the Occupational Safety and Health Research Institute (OSHRI) of the Korea Occupational Safety and Health Agency (KOSHA). The KLWC approved compensation for 41 cases of lung cancer and 19 cases of mesothelioma. Males accounted for 91.7% (55 cases) of the approved cases. The most common age group was 50-59 yr (45.0%). The mean duration of asbestos exposure for lung cancer and mesothelioma cases was 19.2 and 16.0 yr, respectively. The mean latency period for lung cancer and mesothelioma cases was 22.1 and 22.6 yr, respectively. The major industries associated with mesothelioma cases were shipbuilding and maintenance (4 cases) and manufacture of asbestos textiles (3 cases). The major industries associated with lung cancer cases were shipbuilding and maintenance (7 cases), construction (6 cases), and manufacture of basic metals (4 cases). The statistics pertaining to asbestos-related occupational cancers in Korea differ from other developed countries in that more cases of mesothelioma were compensated than lung cancer cases. Also, the mean latency period for disease onset was shorter than reported by existing epidemiologic studies; this discrepancy may be related to the short history of occupational asbestos use in Korea. Considering the current Korean use of asbestos, the number of compensated cases in Korea is expected to increase in the future but not as much as developed countries.

Application Side Casing on Open Deck RoRo to Improve Ship Stability

NASA Astrophysics Data System (ADS)

Hasanudin; K. A. P Utama, I.; Chen, Jeng-Horng

2018-03-01

RoRo is a vessel that can transport passengers, cargo, container and cars. Open Car Deck is favourite RoRo Vessel in developing countries due to its small GT, small tax and spacious car deck, but it has poor survival of stability. Many accident involve Open Car Deck RoRo which cause fatalities and victim. In order to ensure the safety of the ship, IMO had applied intact stability criteria IS Code 2008 which adapted from Rahola’s Research, but since 2008 IMO improved criteria become probabilistic damage stability SOLAS 2009. The RoRo type Open Car Deck has wide Breadth (B), small Draft (D) and small freeboard. It has difficulties to satisfy the ship’s stability criteria. Side Casings which has been applied in some RoRo have be known reduce freeboard or improve ship’s safety. In this paper investigated the effect side casings to survival of intact dan damage ship’s stability. Calculation has been conducted for four ships without, existing and full side casings. The investigation results shows that defect stability of Open Deck RoRo can be reduce with fitting side casing.

MANAGING UNCERTAINTIES ASSOCIATED WITH RADIOACTIVE WASTE DISPOSAL: TASK GROUP 4 OF THE IAEA PRISM PROJECT

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

Seitz, R.

2011-03-02

It is widely recognized that the results of safety assessment calculations provide an important contribution to the safety arguments for a disposal facility, but cannot in themselves adequately demonstrate the safety of the disposal system. The safety assessment and a broader range of arguments and activities need to be considered holistically to justify radioactive waste disposal at any particular site. Many programs are therefore moving towards the production of what has become known as a Safety Case, which includes all of the different activities that are conducted to demonstrate the safety of a disposal concept. Recognizing the growing interest inmore » the concept of a Safety Case, the International Atomic Energy Agency (IAEA) is undertaking an intercomparison and harmonization project called PRISM (Practical Illustration and use of the Safety Case Concept in the Management of Near-surface Disposal). The PRISM project is organized into four Task Groups that address key aspects of the Safety Case concept: Task Group 1 - Understanding the Safety Case; Task Group 2 - Disposal facility design; Task Group 3 - Managing waste acceptance; and Task Group 4 - Managing uncertainty. This paper addresses the work of Task Group 4, which is investigating approaches for managing the uncertainties associated with near-surface disposal of radioactive waste and their consideration in the context of the Safety Case. Emphasis is placed on identifying a wide variety of approaches that can and have been used to manage different types of uncertainties, especially non-quantitative approaches that have not received as much attention in previous IAEA projects. This paper includes discussions of the current results of work on the task on managing uncertainty, including: the different circumstances being considered, the sources/types of uncertainties being addressed and some initial proposals for approaches that can be used to manage different types of uncertainties.« less

[Agricultural biotechnology safety assessment].

PubMed

McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

2015-01-01

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be comparable to their nontransgenic counterparts and safe . The crops upon which GM development are based are generally considered safe.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

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

PubMed

Abdelrazik, Abeer Mohamed; Ezzat Ahmed, Ghada M

2016-02-01

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

Exploring the sociotechnical intersection of patient safety and electronic health record implementation

PubMed Central

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-01-01

Objective The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). Methods We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). Results The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human–computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. Discussion We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Conclusions Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology. PMID:24052536

Exploring the sociotechnical intersection of patient safety and electronic health record implementation.

PubMed

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-02-01

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.

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

PubMed

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

2017-02-01

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

Public risk perception of food additives and food scares. The case in Suzhou, China.

PubMed

Wu, Linhai; Zhong, Yingqi; Shan, Lijie; Qin, Wei

2013-11-01

This study examined the factors affecting public risk perception of food additive safety and possible resulting food scares using a survey conducted in Suzhou, Jiangsu Province, China. The model was proposed based on literature relating to the role of risk perception and information perception of public purchase intention under food scares. Structural equation modeling (SEM) was used for data analysis. The results showed that attitude towards behavior, subjective norm and information perception exerted moderate to high effect on food scares, and the effects were also mediated by risk perceptions of additive safety. Significant covariance was observed between attitudes toward behavior, subjective norm and information perception. Establishing an effective mechanism of food safety risk communication, releasing information of government supervision on food safety in a timely manner, curbing misleading media reports on public food safety risk, and enhancing public knowledge of the food additives are key to the development and implementation of food safety risk management policies by the Chinese government. Copyright © 2013 Elsevier Ltd. All rights reserved.

Health Informatics in Developing Countries: A Review of Unintended Consequences of IT Implementations, as They Affect Patient Safety and Recommendations on How to Address Them.

PubMed

Park, Hyeoun-Ae

2016-11-10

Patient safety concerns every healthcare organization. Adoption of Health information technology (HIT) appears to have the potential to address this issue, however unanticipated and undesirable consequences from implementing HIT could lead to new and more complex hazards. This could be particularly problematic in developing countries, where regulations, policies and implementations are few, less standandarized and in some cases almost non-existing. Based on the available information and our own experience, we conducted a review of unintended consequences of HIT implementations, as they affect patient safety in developing countries. We found that user dependency on the system, alert fatigue, less communications among healthcare actors and workarounds topics should be prioritize. Institution should consider existing knowledge, learn from other experiences and model their implementations to avoid known consequences. We also recommend that they monitor and communicate their own efforts to expand knowledge in the region.

Assurance Cases for Medical Devices

DTIC Science & Technology

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Safety of medium-chain triglycerides used as an intraocular tamponading agent in an experimental vitrectomy model rabbit.

PubMed

Auriol, Sylvain; Mahieu, Laurence; Brousset, Pierre; Malecaze, François; Mathis, Véronique

2013-01-01

To evaluate safety of medium-chain triglycerides used as a possible intraocular tamponading agent. A 20-gauge pars plana vitrectomy was performed in the right eye of 28 rabbits. An ophthalmologic examination was performed every week until rabbits were killed. At days 7, 30, 60, and 90, rabbits were killed and the treated eyes were examined macroscopically and prepared for histologic examination. Principal outcome was retinal toxicity evaluated by light and electron microscopy, and secondary outcomes were the presence of medium-chain triglyceride emulsification, inflammatory reactions, and the development of cataract. Histologic examination did not reveal any retinal toxicity. Two cases of moderate emulsification were observed, but in these cases, emulsification was caused by the perioperative injection of the agent and did not increase during the postoperative period. We noted 13 cases of inflammatory reaction in vitreous cavity and no case of inflammatory reaction in anterior chamber. Two eyes developed cataract as a result of perioperative trauma to the lens with the vitreous cutter and not secondary to the presence of medium-chain triglycerides in the vitreous cavity. Medium-chain triglycerides did not induce morphologic evidence of retinal toxicity. The results suggest that medium-chain triglycerides could be a promising alternative intraocular tamponading agent for the treatment of retinal detachments.

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...

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety.

PubMed

Waterson, Patrick; Robertson, Michelle M; Cooke, Nancy J; Militello, Laura; Roth, Emilie; Stanton, Neville A

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a 'roadmap' for future work.

The second “time-out”: a surgical safety checklist for lengthy robotic surgeries

PubMed Central

2013-01-01

Robotic surgeries of long duration are associated with both increased risks to patients as well as distinct challenges for care providers. We propose a surgical checklist, to be completed during a second “time-out”, aimed at reducing peri-operative complications and addressing obstacles presented by lengthy robotic surgeries. A review of the literature was performed to identify the most common complications of robotic surgeries with extended operative times. A surgical checklist was developed with the goal of addressing these issues and maximizing patient safety. Extended operative times during robotic surgery increase patient risk for position-related complications and other adverse events. These cases also raise concerns for surgical, anesthesia, and nursing staff which are less common in shorter, non-robotic operations. Key elements of the checklist were designed to coordinate operative staff in verifying patient safety while addressing the unique concerns within each specialty. As robotic surgery is increasingly utilized, operations with long surgical times may become more common due to increased case complexity and surgeons overcoming the learning curve. A standardized surgical checklist, conducted three to four hours after the start of surgery, may enhance perioperative patient safety and quality of care. PMID:23731776

Measuring Health Information Dissemination and Identifying Target Interest Communities on Twitter: Methods Development and Case Study of the @SafetyMD Network.

PubMed

Kandadai, Venk; Yang, Haodong; Jiang, Ling; Yang, Christopher C; Fleisher, Linda; Winston, Flaura Koplin

2016-05-05

Little is known about the ability of individual stakeholder groups to achieve health information dissemination goals through Twitter. This study aimed to develop and apply methods for the systematic evaluation and optimization of health information dissemination by stakeholders through Twitter. Tweet content from 1790 followers of @SafetyMD (July-November 2012) was examined. User emphasis, a new indicator of Twitter information dissemination, was defined and applied to retweets across two levels of retweeters originating from @SafetyMD. User interest clusters were identified based on principal component analysis (PCA) and hierarchical cluster analysis (HCA) of a random sample of 170 followers. User emphasis of keywords remained across levels but decreased by 9.5 percentage points. PCA and HCA identified 12 statistically unique clusters of followers within the @SafetyMD Twitter network. This study is one of the first to develop methods for use by stakeholders to evaluate and optimize their use of Twitter to disseminate health information. Our new methods provide preliminary evidence that individual stakeholders can evaluate the effectiveness of health information dissemination and create content-specific clusters for more specific targeted messaging.

Opportunities for crash and injury reduction: A multiharm approach for crash data analysis.

PubMed

Mallory, Ann; Kender, Allison; Moorhouse, Kevin

2017-05-29

A multiharm approach for analyzing crash and injury data was developed for the ultimate purpose of getting a richer picture of motor vehicle crash outcomes for identifying research opportunities in crash safety. Methods were illustrated using a retrospective analysis of 69,597 occupant cases from NASS CDS from 2005 to 2015. Occupant cases were analyzed by frequency and severity of outcome: fatality, injury by Abbreviated Injury Scale (AIS), number of cases, attributable fatality, disability, and injury costs. Comparative analysis variables included precrash scenario, impact type, and injured body region. Crash and injury prevention opportunities vary depending on the search parameters. For example, occupants in rear-end crash scenarios were more frequent than in any other precrash configuration, yet there were significantly more fatalities and serious injury cases in control loss, road departure, and opposite direction crashes. Fatality is most frequently associated with head and thorax injury, and disability is primarily associated with extremity injury. Costs attributed to specific body regions are more evenly distributed, dominated by injuries to the head, thorax, and extremities but with contributions from all body regions. Though AIS 3+ can be used as a single measure of harm, an analysis based on multiple measures of harm gives a much more detailed picture of the risk presented by a particular injury or set of crash conditions. The developed methods represent a new approach to crash data mining that is expected to be useful for the identification of research priorities and opportunities for reduction of crashes and injuries. As the pace of crash safety improvement accelerates with innovations in both active and passive safety, these techniques for combining outcome measures for insights beyond fatality and serious injury will be increasingly valuable.

Digital pathology for the primary diagnosis of breast histopathological specimens: an innovative validation and concordance study on digital pathology validation and training.

PubMed

Williams, Bethany Jill; Hanby, Andrew; Millican-Slater, Rebecca; Nijhawan, Anju; Verghese, Eldo; Treanor, Darren

2018-03-01

To train and individually validate a group of breast pathologists in specialty-specific digital primary diagnosis by using a novel protocol endorsed by the Royal College of Pathologists' new guideline for digital pathology. The protocol allows early exposure to live digital reporting, in a risk-mitigated environment, and focuses on patient safety and professional development. Three specialty breast pathologists completed training in the use of a digital microscopy system, and were exposed to a training set of 20 challenging cases, designed to help them identify personal digital diagnostic pitfalls. Following this, the three pathologists viewed a total of 694 live, entire breast cases. All primary diagnoses were made on digital slides, with immediate glass slide review and reconciliation before final case sign-out. There was complete clinical concordance between the glass and digital impression of the case in 98.8% of cases. Only 1.2% of cases had a clinically significant difference in diagnosis/prognosis on glass and digital slide reads. All pathologists elected to continue using the digital microscope as the standard for breast histopathology specimens, with deferral to glass for a limited number of clinical/histological scenarios as a safety net. Individual training and validation for digital primary diagnosis allows pathologists to develop competence and confidence in their digital diagnostic skills, and aids safe and responsible transition from the light microscope to the digital microscope. © 2017 John Wiley & Sons Ltd.

High-performance work systems in health care management, part 2: qualitative evidence from five case studies.

PubMed

McAlearney, Ann Scheck; Garman, Andrew N; Song, Paula H; McHugh, Megan; Robbins, Julie; Harrison, Michael I

2011-01-01

: A capable workforce is central to the delivery of high-quality care. Research from other industries suggests that the methodical use of evidence-based management practices (also known as high-performance work practices [HPWPs]), such as systematic personnel selection and incentive compensation, serves to attract and retain well-qualified health care staff and that HPWPs may represent an important and underutilized strategy for improving quality of care and patient safety. : The aims of this study were to improve our understanding about the use of HPWPs in health care organizations and to learn about their contribution to quality of care and patient safety improvements. : Guided by a model of HPWPs developed through an extensive literature review and synthesis, we conducted a series of interviews with key informants from five U.S. health care organizations that had been identified based on their exemplary use of HPWPs. We sought to explore the applicability of our model and learn whether and how HPWPs were related to quality and safety. All interviews were recorded, transcribed, and subjected to qualitative analysis. : In each of the five organizations, we found emphasis on all four HPWP subsystems in our conceptual model-engagement, staff acquisition/development, frontline empowerment, and leadership alignment/development. Although some HPWPs were common, there were also practices that were distinctive to a single organization. Our informants reported links between HPWPs and employee outcomes (e.g., turnover and higher satisfaction/engagement) and indicated that HPWPs made important contributions to system- and organization-level outcomes (e.g., improved recruitment, improved ability to address safety concerns, and lower turnover). : These case studies suggest that the systematic use of HPWPs may improve performance in health care organizations and provide examples of how HPWPs can impact quality and safety in health care. Further research is needed to specify which HPWPs and systems are of greatest potential for health care management.

The village/commune safety policy and HIV prevention efforts among key affected populations in Cambodia: finding a balance

PubMed Central

2012-01-01

The Village/Commune Safety Policy was launched by the Ministry of Interior of the Kingdom of Cambodia in 2010 and, due to a priority focus on “cleaning the streets”, has created difficulties for HIV prevention programs attempting to implement programs that work with key affected populations including female sex workers and people who inject drugs. The implementation of the policy has forced HIV program implementers, the UN and various government counterparts to explore and develop collaborative ways of delivering HIV prevention services within this difficult environment. The following case study explores some of these efforts and highlights the promising development of a Police Community Partnership Initiative that it is hoped will find a meaningful balance between the Village/Commune Safety Policy and HIV prevention efforts with key affected populations in Cambodia. PMID:22770267

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

PubMed

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

Checklists in Neurosurgery to Decrease Preventable Medical Errors: A Review

PubMed Central

Enchev, Yavor

2015-01-01

Neurosurgery represents a zero tolerance environment for medical errors, especially preventable ones like all types of wrong site surgery, complications due to the incorrect positioning of patients for neurosurgical interventions and complications due to failure of the devices required for the specific procedure. Following the excellent and encouraging results of the safety checklists in intensive care medicine and in other surgical areas, the checklist was naturally introduced in neurosurgery. To date, the reported world experience with neurosurgical checklists is limited to 15 series with fewer than 20,000 cases in various neurosurgical areas. The purpose of this review was to study the reported neurosurgical checklists according to the following parameters: year of publication; country of origin; area of neurosurgery; type of neurosurgical procedure-elective or emergency; person in charge of the checklist completion; participants involved in completion; whether they prevented incorrect site surgery; whether they prevented complications due to incorrect positioning of the patients for neurosurgical interventions; whether they prevented complications due to failure of the devices required for the specific procedure; their specific aims; educational preparation and training; the time needed for checklist completion; study duration and phases; number of cases included; barriers to implementation; efforts to implementation; team appreciation; and safety outcomes. Based on this analysis, it could be concluded that neurosurgical checklists represent an efficient, reliable, cost-effective and time-saving tool for increasing patient safety and elevating the neurosurgeons’ self-confidence. Every neurosurgical department must develop its own neurosurgical checklist or adopt and modify an existing one according to its specific features and needs in an attempt to establish or develop its safety culture. The world, continental, regional and national neurosurgical societies could promote safety checklists and their benefits. PMID:26740891

Piloted Well Clear Performance Evaluation of Detect and Avoid Systems with Suggestive Guidance

NASA Technical Reports Server (NTRS)

Mueller, Eric; Santiago, Confesor; Watza, Spencer

2016-01-01

Regulations to establish operational and performance requirements for unmanned aircraft systems (UAS) are being developed by a consortium of government, industry and academic institutions (RTCA, 2013). Those requirements will apply to the new detect-and-avoid (DAA) systems and other equipment necessary to integrate UAS with the United States (U.S) National Airspace System (NAS) and will be determined according to their contribution to the overall safety case. That safety case requires demonstration that DAA-equipped UAS collectively operating in the NAS meet an airspace safety threshold (AST). Several key gaps must be closed in order to link equipment requirements to an airspace safety case. Foremost among these is calculation of the systems risk ratio, the degree to which a particular system mitigates violation of an aircraft separation standard (FAA, 2013). The risk ratio of a DAA system, in combination with risk ratios of other collision mitigation mechanisms, will determine the overall safety of the airspace measured in terms of the number of collisions per flight hour. It is not known what the effectiveness is of a pilot-in-the-loop DAA system or even what parameters of the DAA system most improve the pilots ability to maintain separation. The relationship between the DAA system design and the overall effectiveness of the DAA system that includes the pilot, expressed as a risk ratio, must be determined before DAA operational and performance requirements can be finalized. Much research has been devoted to integrating UAS into non-segregated airspace (Dalamagkidis, 2009, Ostwald, 2007, Gillian, 2012, Hesselink, 2011, Santiago, 2015, Rorie 2015 and 2016). Several traffic displays intended for use as part of a DAA system have gone through human-in-the-loop simulation and flight-testing. Most of these evaluations were part of development programs to produce a deployable system, so it is unclear how to generalize particular aspects of those designs to general requirements for future traffic displays (Calhoun, 2014). Other displays have undergone testing to collect data that may generalize to new displays, but have not been evaluated in the context of the development of an overall safety case for UAS equipped with DAA systems in the NAS (Bell, 2012). Other research efforts focus on DAA surveillance performance and separation standards. Together with this work, they are expected to facilitate validation of the airspace safety case (Park, 2014 and Johnson, 2015). The contribution of the present work is to quantify the effectiveness of the pilot-automation system to remain well clear as a function of display features and surveillance sensor error. This quantification will help enable selection of a minimum set of DAA design features that meets the AST, a set that may not be unique for all UAS platforms. A second objective is to collect and analyze pilot performance parameters that will improve the modeling of overall DAA system performance in non-human-in-the-loop simulations. Simulating the DAA-equipped UAS in such batch experiments will allow investigation of a much larger number of encounters than is possible in human simulations. This capability is necessary to demonstrate that a particular set of DAA requirements meets the AST under all foreseeable operational conditions.

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 information. An integrated assessment might help to focus and save capacities in highly technical areas such as molecular characterization or profiling, which are often necessary for both assessments. In the area of establishing international standards for traded foods, such as for the newly created Standards in Trade and Development Facility (STDF), an integrated assessment might help in the consideration of important environmental aspects involved in health and food safety. Furthermore, an established integrated view on GMOs may create greater consumer confidence in the technology.

[Safe Use of Recent New Drugs-Current Status and Challenges].

PubMed

Ohashi, Yoshiaki

2018-01-01

　In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.

Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study

PubMed Central

2014-01-01

Background Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. Methods In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. Results After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. Conclusion In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety. PMID:25559675

Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study.

PubMed

Yu, Ke; Zhang, Jie; Chen, Minjun; Xu, Xiaowei; Suzuki, Ayako; Ilic, Katarina; Tong, Weida

2014-01-01

Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety.

Additional nuclear criticality safety calculations for small-diameter containers

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

Hone, M.J.

This report documents additional criticality safety analysis calculations for small diameter containers, which were originally documented in Reference 1. The results in Reference 1 indicated that some of the small diameter containers did not meet the criteria established for criticality safety at the Portsmouth facility (K{sub eff} +2{sigma}<.95) when modeled under various contingency assumptions of reflection and moderation. The calculations performed in this report reexamine those cases which did not meet the criticality safety criteria. In some cases, unnecessary conservatism is removed, and in other cases mass or assay limits are established for use with the respective containers.

Drinking driver and traffic safety project. Volume 2, Probabilities for drinking drivers

DOT National Transportation Integrated Search

1973-10-01

This is the second volume of a final report of a four-year study of drinking drivers. It includes a brief description of a prediction model developed from over 4000 cases, including drinking drivers, recidivist drinking drivers and drivers license ap...

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

DOT National Transportation Integrated Search

1995-09-01

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

Are signalized intersections with cycle tracks safer? A case-control study based on automated surrogate safety analysis using video data.

PubMed

Zangenehpour, Sohail; Strauss, Jillian; Miranda-Moreno, Luis F; Saunier, Nicolas

2016-01-01

Cities in North America have been building bicycle infrastructure, in particular cycle tracks, with the intention of promoting urban cycling and improving cyclist safety. These facilities have been built and expanded but very little research has been done to investigate the safety impacts of cycle tracks, in particular at intersections, where cyclists interact with turning motor-vehicles. Some safety research has looked at injury data and most have reached the conclusion that cycle tracks have positive effects of cyclist safety. The objective of this work is to investigate the safety effects of cycle tracks at signalized intersections using a case-control study. For this purpose, a video-based method is proposed for analyzing the post-encroachment time as a surrogate measure of the severity of the interactions between cyclists and turning vehicles travelling in the same direction. Using the city of Montreal as the case study, a sample of intersections with and without cycle tracks on the right and left sides of the road were carefully selected accounting for intersection geometry and traffic volumes. More than 90h of video were collected from 23 intersections and processed to obtain cyclist and motor-vehicle trajectories and interactions. After cyclist and motor-vehicle interactions were defined, ordered logit models with random effects were developed to evaluate the safety effects of cycle tracks at intersections. Based on the extracted data from the recorded videos, it was found that intersection approaches with cycle tracks on the right are safer than intersection approaches with no cycle track. However, intersections with cycle tracks on the left compared to no cycle tracks seem to be significantly safer. Results also identify that the likelihood of a cyclist being involved in a dangerous interaction increases with increasing turning vehicle flow and decreases as the size of the cyclist group arriving at the intersection increases. The results highlight the important role of cycle tracks and the factors that increase or decrease cyclist safety. Results need however to be confirmed using longer periods of video data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Situations of car-to-pedestrian contact.

PubMed

Matsui, Yasuhiro; Hitosugi, Masahito; Takahashi, Kunio; Doi, Tsutomu

2013-01-01

To reduce the severity of injuries and the number of pedestrian deaths in traffic accidents, active safety devices providing pedestrian detection are considered effective countermeasures. The features of car-to-pedestrian collisions need to be known in detail to develop such safety devices. Because information on real-world accidents is limited, this study investigated near-miss situations captured by drive recorders installed in passenger cars. We showed similarities of the contact situation between near-miss incidents and real-world fatal pedestrian accidents in Japan. We analyzed the near-miss incident data via video capturing pedestrians crossing the road in front of forward-moving cars. Using a video frame captured by a drive recorder, the time to collision (TTC) was calculated from the car velocity and the distance between the car and pedestrian at the moment that the pedestrian initially appeared. The average TTC in the cases where pedestrians were not using a pedestrian crossing was shorter than that in the cases where pedestrians were using a pedestrian crossing. The average TTC in the cases where pedestrians emerged from behind obstructions was shorter than that in the cases where drivers had unobstructed views of the pedestrians. We propose that the specifications of the safety device for pedestrian detection and automatic braking should reflect the severe approach situation for a pedestrian and car including the TTC observed for near-miss incidents.

[GP medication prioritisation in older patients with multiple comorbidities recently discharged from hospital: a case-based bottom-up approach].

PubMed

Herrmann, M L H; von Waldegg, G H; Kip, M; Lehmann, B; Andrusch, S; Straub, H; Robra, B-P

2015-01-01

After the hospital discharge of older patients with multiple morbidities, GPs are often faced with the task of prioritising the patients' drug regimens so as to reduce the risk of overmedication. How do GPs prioritise such medications in multimorbid elderly patients at the transition between inpatient and home care? The experience by the GPs is documented in typical case vignettes. 44 GPs in Sachsen-Anhalt were recruited--they were engaged in focus group discussions and interviewed using semi-standardised questionnaires. Typical case vignettes were developed, relevant to the everyday care that elderly patients would typically receive from their GPs with respect to their drug optimisation. According to the results of the focus groups, the following issues affect GPs' decisions: drug and patient safety, their own competence in the health system, patient health literacy, evidence base, communication between secondary and primary care (and their respective influences on each other). When considering individual cases, patient safety, patient wishes, and quality of life were central. This is demonstrated by the drug dispositions of one exemplary case vignette. GPs do prioritise drug regimens with rational criteria. Initial problem delineation, process documentation and the design of a transferable product are interlinking steps in the development of case vignettes. Care issues of drug therapy in elderly patients with multiple morbidities should be investigated further with larger representative samples in order to clarify whether the criteria used here are applied contextually or consistently. Embedding case vignettes into further education concepts is also likely to be useful. © Georg Thieme Verlag KG Stuttgart · New York.

Draugen HSE-case - occupational health risk management

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

Glas, J.J.P.; Kjaer, E.

1996-12-31

The Draugen HSE-Case serves as a risk management tool. Originally, risk management included only major safety hazards to personnel, environment and assets. Work Environment risks such as ergonomics, psycho-social factors and exposure to chemicals and noise, was not given the same attention. The Draugen HSE-Case addresses this weakness and extends all work environment risks. In order to promote line responsibility and commitment, relevant personnel is involved in the Case development. {open_quotes}THESIS{degrees}, a software application, is used to systematize input and to generate reports. The Draugen HSE-case encompasses: HSE risk analyses related to specific activities; Control of risk related to workmore » environment; Established tolerability criteria; Risk reducing measures; Emergency contingency measures; and Requirements for Competence and Follow-up. The development of Draugen HSE-Case is a continuous process. It will serve to minimize the potential of occupational illnesses, raise general awareness, and make occupational health management more cost-effective.« less

Lean manufacturing comes to China: a case study of its impact on workplace health and safety.

PubMed

Brown, Garrett D; O'Rourke, Dara

2007-01-01

Lean manufacturing, which establishes small production "cells," or teams of workers, who complete an entire product from raw material processing through final assembly and shipment, increases health and safety hazards by mixing previously separated exposures to various chemicals (with possible additive and cumulative effects) and noise. The intensification of work leads to greater ergonomic and stress-related adverse health effects, as well as increased safety hazards. The standard industrial hygiene approach of anticipation, recognition, evaluation, and hazard control is applicable to lean operations. A focus on worker participation in identifying and solving problems is critical for reducing negative impacts. A key to worker safety in lean production operations is the development of informed, empowered, and active workers with the knowledge, skills, and opportunity to act in the workplace to eliminate or reduce hazards.

An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.

PubMed

Booth, Nancy L; Kruger, Claire L; Wallace Hayes, A; Clemens, Roger

2012-09-01

Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves. Copyright © 2012. Published by Elsevier Ltd.

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Specific features of medicines safety and pharmacovigilance in Africa

PubMed Central

Pal, Shanthi N.; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

2012-01-01

The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern. PMID:25083223

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Newcomer, Sophia; Nelson, Jennifer; Qian, Lei; McClure, David; Pan, Yi; Zeng, Chan; Glanz, Jason

2014-05-01

The Vaccine Safety Datalink project captures electronic health record data including vaccinations and medically attended adverse events on 8.8 million enrollees annually from participating managed care organizations in the United States. While the automated vaccination data are generally of high quality, a presumptive adverse event based on diagnosis codes in automated health care data may not be true (misclassification). Consequently, analyses using automated health care data can generate false positive results, where an association between the vaccine and outcome is incorrectly identified, as well as false negative findings, where a true association or signal is missed. We developed novel conditional Poisson regression models and fixed effects models that accommodate misclassification of adverse event outcome for self-controlled case series design. We conducted simulation studies to evaluate their performance in signal detection in vaccine safety hypotheses generating (screening) studies. We also reanalyzed four previously identified signals in a recent vaccine safety study using the newly proposed models. Our simulation studies demonstrated that (i) outcome misclassification resulted in both false positive and false negative signals in screening studies; (ii) the newly proposed models reduced both the rates of false positive and false negative signals. In reanalyses of four previously identified signals using the novel statistical models, the incidence rate ratio estimates and statistical significances were similar to those using conventional models and including only medical record review confirmed cases. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Using Dust Assessment Technology to Leverage Mine Site Manager-Worker Communication and Health Behavior: A Longitudinal Case Study

PubMed Central

Haas, Emily J.; Cecala, Andrew B.; Hoebbel, Cassandra L.

2016-01-01

Research continues to investigate barriers to managing occupational health and safety behaviors among the workforce. Recent literature argues that (1) there is a lack of consistent, multilevel communication and application of health and safety practices, and (2) social scientific methods are absent when determining how to manage injury prevention in the workplace. In response, the current study developed and tested a multilevel intervention case study at two industrial mineral mines to help managers and workers communicate about and reduce respirable silica dust exposures at their mine sites. A dust assessment technology, the Helmet-CAM, was used to identify and encourage communication about potential problem areas and tasks on site that contributed to elevated exposures. The intervention involved pre- and post-assessment field visits, four weeks apart that included multiple forms of data collection from workers and managers. Results revealed that mine management can utilize dust assessment technology as a risk communication tool to prompt and communicate about healthier behaviors with their workforce. Additionally, when workers were debriefed with the Helmet-CAM data through the device software, the dust exposure data can help improve the knowledge and awareness of workers, empowering them to change subtle behaviors that could reduce future elevated exposures to respirable silica dust. This case study demonstrates that incorporating social scientific methods into the application of health and safety management strategies, such as behavioral modification and technology integration, can leverage managers’ communication practices with workers, subsequently improving health and safety behaviors. PMID:26807445

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Case-control analysis in highway safety: Accounting for sites with multiple crashes.

PubMed

Gross, Frank

2013-12-01

There is an increased interest in the use of epidemiological methods in highway safety analysis. The case-control and cohort methods are commonly used in the epidemiological field to identify risk factors and quantify the risk or odds of disease given certain characteristics and factors related to an individual. This same concept can be applied to highway safety where the entity of interest is a roadway segment or intersection (rather than a person) and the risk factors of interest are the operational and geometric characteristics of a given roadway. One criticism of the use of these methods in highway safety is that they have not accounted for the difference between sites with single and multiple crashes. In the medical field, a disease either occurs or it does not; multiple occurrences are generally not an issue. In the highway safety field, it is necessary to evaluate the safety of a given site while accounting for multiple crashes. Otherwise, the analysis may underestimate the safety effects of a given factor. This paper explores the use of the case-control method in highway safety and two variations to account for sites with multiple crashes. Specifically, the paper presents two alternative methods for defining cases in a case-control study and compares the results in a case study. The first alternative defines a separate case for each crash in a given study period, thereby increasing the weight of the associated roadway characteristics in the analysis. The second alternative defines entire crash categories as cases (sites with one crash, sites with two crashes, etc.) and analyzes each group separately in comparison to sites with no crashes. The results are also compared to a "typical" case-control application, where the cases are simply defined as any entity that experiences at least one crash and controls are those entities without a crash in a given period. In a "typical" case-control design, the attributes associated with single-crash segments are weighted the same as the attributes of segments with multiple crashes. The results support the hypothesis that the "typical" case-control design may underestimate the safety effects of a given factor compared to methods that account for sites with multiple crashes. Compared to the first alternative case definition (where multiple crash segments represent multiple cases) the results from the "typical" case-control design are less pronounced (i.e., closer to unity). The second alternative (where case definitions are constructed for various crash categories and analyzed separately) provides further evidence that sites with single and multiple crashes should not be grouped together in a case-control analysis. This paper indicates a clear need to differentiate sites with single and multiple crashes in a case-control analysis. While the results suggest that sites with multiple crashes can be accounted for using a case-control design, further research is needed to determine the optimal method for addressing this issue. This paper provides a starting point for that research. Copyright © 2012 Elsevier Ltd. All rights reserved.

Waste collection in developing countries - Tackling occupational safety and health hazards at their source

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

Bleck, Daniela, E-mail: bleck.daniela@baua.bund.de; Wettberg, Wieland, E-mail: wettberg.wieland@baua.bund.de

2012-11-15

Waste management procedures in developing countries are associated with occupational safety and health risks. Gastro-intestinal infections, respiratory and skin diseases as well as muscular-skeletal problems and cutting injuries are commonly found among waste workers around the globe. In order to find efficient, sustainable solutions to reduce occupational risks of waste workers, a methodological risk assessment has to be performed and counteractive measures have to be developed according to an internationally acknowledged hierarchy. From a case study in Addis Ababa, Ethiopia suggestions for the transferral of collected household waste into roadside containers are given. With construction of ramps to dump collectedmore » household waste straight into roadside containers and an adaptation of pushcarts and collection procedures, the risk is tackled at the source.« less

Morbidity and Mortality Conferences: A Narrative Review of Strategies to Prioritize Quality Improvement.

PubMed

Giesbrecht, Vanessa; Au, Selena

2016-11-01

The morbidity and mortality conference (MMC) provides a valuable opportunity to review patient care processes and safety concerns, aligning with a growing quality improvement (QI) mandate. Yet the structure, processes, and aims of many MMCs are often ill-defined. This review summarizes strategies employed by medical, surgical, and critical care departments in the development of patient safety-centered MMCs. A structured narrative review of literature was conducted using combinations of the search terms "morbidity and mortality conference(s)," "morbidity and mortality meetings," or "morbidity and mortality round(s)." The titles and abstracts of 250 returned articles were screened; 76 articles were reviewed in full, with 32 meeting the full inclusion criteria. The literature review elicited a number of methods used by medical, surgical, and critical care MMCs to emphasize QI and patient safety outcomes. A list of actionable changes made in each article was compiled. Five themes common to QI-centered MMCs were identified: (1) defining the role of the MMC, (2) involving stakeholders, (3) detecting and selecting appropriate cases for presentation, (4) structuring goal-directed discussion, and (5) forming recommendations and assigning follow-up. Innovative methods to pair adverse event screening with MMCs were superior to nonstructured voluntary reporting and case selection for overall morbidity detection. Structured case review, discussion, and follow-up were more likely to lead to implementing systems-based change, and interdisciplinary MMCs were associated with a greater likelihood of forming an action item. The modern patient safety-centered MMC shares common themes of practices that can be adopted by institutions looking to create a venue for analysis of care processes, a platform to launch QI initiatives, and a culture of safety. Copyright 2016 The Joint Commission.

Building a safety culture in global health: lessons from Guatemala.

PubMed

Rice, Henry E; Lou-Meda, Randall; Saxton, Anthony T; Johnston, Bria E; Ramirez, Carla C; Mendez, Sindy; Rice, Eli N; Aidar, Bernardo; Taicher, Brad; Baumgartner, Joy Noel; Milne, Judy; Frankel, Allan S; Sexton, J Bryan

2018-01-01

Programmes to modify the safety culture have led to lasting improvements in patient safety and quality of care in high-income settings around the world, although their use in low-income and middle-income countries (LMICs) has been limited. This analysis explores (1) how to measure the safety culture using a health culture survey in an LMIC and (2) how to use survey data to develop targeted safety initiatives using a paediatric nephrology unit in Guatemala as a field test case. We used the Safety, Communication, Operational Reliability, and Engagement survey to assess staff views towards 13 health climate and engagement domains. Domains with low scores included personal burnout, local leadership, teamwork and work-life balance. We held a series of debriefings to implement interventions targeted towards areas of need as defined by the survey. Programmes included the use of morning briefings, expansion of staff break resources and use of teamwork tools. Implementation challenges included the need for education of leadership, limited resources and hierarchical work relationships. This report can serve as an operational guide for providers in LMICs for use of a health culture survey to promote a strong safety culture and to guide their quality improvement and safety programmes.

Building a safety culture in global health: lessons from Guatemala

PubMed Central

Rice, Henry E; Lou-Meda, Randall; Saxton, Anthony T; Johnston, Bria E; Ramirez, Carla C; Mendez, Sindy; Rice, Eli N; Aidar, Bernardo; Taicher, Brad; Baumgartner, Joy Noel; Milne, Judy; Frankel, Allan S; Sexton, J Bryan

2018-01-01

Programmes to modify the safety culture have led to lasting improvements in patient safety and quality of care in high-income settings around the world, although their use in low-income and middle-income countries (LMICs) has been limited. This analysis explores (1) how to measure the safety culture using a health culture survey in an LMIC and (2) how to use survey data to develop targeted safety initiatives using a paediatric nephrology unit in Guatemala as a field test case. We used the Safety, Communication, Operational Reliability, and Engagement survey to assess staff views towards 13 health climate and engagement domains. Domains with low scores included personal burnout, local leadership, teamwork and work–life balance. We held a series of debriefings to implement interventions targeted towards areas of need as defined by the survey. Programmes included the use of morning briefings, expansion of staff break resources and use of teamwork tools. Implementation challenges included the need for education of leadership, limited resources and hierarchical work relationships. This report can serve as an operational guide for providers in LMICs for use of a health culture survey to promote a strong safety culture and to guide their quality improvement and safety programmes. PMID:29607099

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

Development and validation of techniques for improving software dependability

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

A collection of document abstracts are presented on the topic of improving software dependability through NASA grant NAG-1-1123. Specific topics include: modeling of error detection; software inspection; test cases; Magnetic Stereotaxis System safety specifications and fault trees; and injection of synthetic faults into software.

Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

PubMed

Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

2017-07-01

Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

Patient safety reporting systems: sustained quality improvement using a multidisciplinary team and "good catch" awards.

PubMed

Herzer, Kurt R; Mirrer, Meredith; Xie, Yanjun; Steppan, Jochen; Li, Matthew; Jung, Clinton; Cover, Renee; Doyle, Peter A; Mark, Lynette J

2012-08-01

Since 1999, hospitals have made substantial commitments to health care quality and patient safety through individual initiatives of executive leadership involvement in quality, investments in safety culture, education and training for medical students and residents in quality and safety, the creation of patient safety committees, and implementation of patient safety reporting systems. At the Weinberg Surgical Suite at The Johns Hopkins Hospital (Baltimore), a 16-operating-room inpatient/outpatient cancer center, a patient safety reporting process was developed to maximize the usefulness of the reports and the long-term sustainability of quality improvements arising from them. A six-phase framework was created incorporating UHC's Patient Safety Net (PSN): Identify, report, analyze, mitigate, reward, and follow up. Unique features of this process included a multidisciplinary team to review reports, mitigate hazards, educate and empower providers, recognize the identifying/reporting individuals or groups with "Good Catch" awards, and follow up to determine if quality improvements were sustained over time. Good Catch awards have been given in recognition of 29 patient safety hazards identified since 2008; in each of these cases, an initiative was developed to mitigate the original hazard. Twenty-five (86%) of the associated quality improvements have been sustained. Two Good Catch award-winning projects--vials of heparin with an unusually high concentration of the drug that posed a potential overdose hazard and a rapid infusion device that resisted practitioner control--are described in detail. A multidisciplinary team's analysis and mitigation of hazards identified in a patient safety reporting process entailed positive recognition with a Good Catch award, education of practitioners, and long-term follow-up.

19 CFR 122.187 - Revocation or suspension of access.

Code of Federal Regulations, 2010 CFR

2010-04-01

... that continued access might pose an unacceptable risk to public health, interest or safety, national security, aviation safety, the revenue, or the security of the area. In this case the port director will... health, safety, or security is involved and, in such a case, a final notice of revocation or suspension...

76 FR 14641 - Defense Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS Case 2010-D022... contract clause that clearly identifies any items being purchased that are critical safety items so that.... SUPPLEMENTARY INFORMATION: I. Background This DFARS case was initiated at the request of the Defense Contract...

Key aspects in managing safety when working with multiple contractors: A case study.

PubMed

Drupsteen, Linda; Rasmussen, Hanna B; Ustailieva, Erika; van Kampen, Jakko

2015-01-01

Working with multiple contractors in a shared workplace can introduce and increase safety risks due to complexity. The aim of this study was to explore how safety issues are recognized in a specific case and to identify whether clients and contractors perceive problems similarly. The safety issues are explored through a brief survey and a workshop in the maintenance department of a logistics company. The results indicate that culture and behavior are recognized differently by clients and by contractors. The contractors and client had different perceptions of involvement of contractors by the client. The contractors complained on lack of involvement, which was not fully recognized by the client. The case study used a practical approach to show differences in perception of safety within a project. The study illustrates the need for more applied studies and interventions on contractor safety.

Using systems thinking in patient safety: a case study on medicines management.

PubMed

Brimble, Mandy; Jones, Aled

2017-06-29

Systems thinking is used as a way of understanding behaviours and actions in complex healthcare organisations. An important premise of the concept is that every action in a system causes a reaction elsewhere in that system. These reactions can lead to unintended consequences, sometimes long after the original action, and so are not always attributed to them. This article applies systems thinking to a medicines management case study, to highlight how quality-improvement practitioners can use the approach to underpin planning and implementation of patient-safety initiatives. The case study is specific to transcribing in children's hospices, but the strategies can be applied to other areas. The article explains that, while root cause analysis tools are useful for identifying the cause of, and possible solutions to, problems, they need to be considered carefully in terms of unintended consequences, and how the system into which the solution is implemented can be affected by the change. Analysis of problems using a systems-thinking approach can help practitioners to develop robust and well informed business cases to present to decision makers.

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

PubMed

Ahasan, M R; Partanen, T

2001-03-01

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

Do failures in non-technical skills contribute to fatal medical accidents in Japan? A review of the 2010-2013 national accident reports.

PubMed

Uramatsu, Masashi; Fujisawa, Yoshikazu; Mizuno, Shinya; Souma, Takahiro; Komatsubara, Akinori; Miki, Tamotsu

2017-02-16

We sought to clarify how large a proportion of fatal medical accidents can be considered to be caused by poor non-technical skills, and to support development of a policy to reduce number of such accidents by making recommendations about possible training requirements. Summaries of reports of fatal medical accidents, published by the Japan Medical Safety Research Organization, were reviewed individually. Three experienced clinicians and one patient safety expert conducted the reviews to determine the cause of death. Views of the patient safety expert were given additional weight in the overall determination. A total of 73 summary reports of fatal medical accidents were reviewed. These reports had been submitted by healthcare organisations across Japan to the Japan Medical Safety Research Organization between April 2010 and March 2013. The cause of death in fatal medical accidents, categorised into technical skills, non-technical skills and inevitable progress of disease were evaluated. Non-technical skills were further subdivided into situation awareness, decision making, communication, team working, leadership, managing stress and coping with fatigue. Overall, the cause of death was identified as non-technical skills in 34 cases (46.6%), disease progression in 33 cases (45.2%) and technical skills in two cases (5.5%). In two cases, no consensual determination could be achieved. Further categorisation of cases of non-technical skills were identified as 14 cases (41.2%) of problems with situation awareness, eight (23.5%) with team working and three (8.8%) with decision making. These three subcategories, or combinations of them, were identified as the cause of death in 33 cases (97.1%). Poor non-technical skills were considered to be a significant cause of adverse events in nearly half of the fatal medical accidents examined. Improving non-technical skills may be effective for reducing accidents, and training in particular subcategories of non-technical skills may be especially relevant. 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/.

Space experiment development process

NASA Technical Reports Server (NTRS)

Depauw, James F.

1987-01-01

Described is a process for developing space experiments utilizing the Space Shuttle. The role of the Principal Investigator is described as well as the Principal Investigator's relation with the project development team. Described also is the sequence of events from an early definition phase through the steps of hardware development. The major interactions between the hardware development program and the Shuttle integration and safety activities are also shown. The presentation is directed to people with limited Shuttle experiment experience. The objective is to summarize the development process, discuss the roles of major participants, and list some lessons learned. Two points should be made at the outset. First, no two projects are the same so the process varies from case to case. Second, the emphasis here is on Code EN/Microgravity Science and Applications Division (MSAD).

Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment.

PubMed Central

Collet, J. P.; MacDonald, N.; Cashman, N.; Pless, R.

2000-01-01

Monitoring vaccine safety is a complex and shared responsibility. It can be carried out in many ways, one of which is the reporting of individual cases of adverse reactions thought to be due to vaccination. The task is difficult because ascribing causality to an individual case report is fraught with challenges. A standardized evaluation instrument--known as the causality assessment form--was therefore developed for use by an expert advisory committee to facilitate the process. By following the several sections in this form, the members of the committee are taken through a series of points to establish causality. These points include the basic criteria for causation such as biological plausibility, the time elapsed between the vaccine administration and the onset of the adverse event, and whether other factors (drugs, chemicals or underlying disease) could account for the adverse symptoms. The form concludes with a consensus assessment of causality, a commentary about the assessment, and advice for further study or follow-up. This method of assessing the more serious cases of adverse reaction reported to vaccination has proven useful in evaluating ongoing safety of vaccines in Canada. Through analyses such as this, new signals can be identified and investigated further. PMID:10743282

Macroergonomic analysis and design for improved safety and quality performance.

PubMed

Kleiner, B M

1999-01-01

Macroergonomics, which emerged historically after sociotechnical systems theory, quality management, and ergonomics, is presented as the basis for a needed integrative methodology. A macroergonomics methodology was presented in some detail to demonstrate how aspects of microergonomics, total quality management (TQM), and sociotechnical systems (STS) can be triangulated in a common approach. In the context of this methodology, quality and safety were presented as 2 of several important performance criteria. To demonstrate aspects of the methodology, 2 case studies were summarized with safety and quality performance results where available. The first case manipulated both personnel and technical factors to achieve a "safety culture" at a nuclear site. The concept of safety culture is defined in INSAG-4 (International Atomic Energy Agency, 1991). as "that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance." The second case described a tire manufacturing intervention to improve quality (as defined by Sink and Tuttle, 1989) through joint consideration of technical and social factors. It was suggested that macroergonomics can yield greater performance than can be achieved through ergonomic intervention alone. Whereas case studies help to make the case, more rigorous formative and summative research is needed to refine and validate the proposed methodology respectively.

Foot model for tracking temperature of safety boot insoles: application to different insole materials in firefighter boots.

PubMed

García-Hernández, César; Sánchez-Álvarez, Eduardo J; Huertas-Talón, José-Luis

2016-01-01

This research is based on the development of a human foot model to study the temperature conditions of a foot bottom surface under extreme external conditions. This foot model is made by combining different manufacturing techniques to enable the simulation of bones and tissues, allowing the placement of sensors on its surface to track the temperature values of different points inside a shoe. These sensors let researchers capture valuable data during a defined period of time, making it possible to compare the features of different safety boots, socks or soles, among others. In this case, it has been applied to compare different plantar insole materials, placed into safety boots on a high-temperature surface.

Motorcycles that See: Multifocal Stereo Vision Sensor for Advanced Safety Systems in Tilting Vehicles

PubMed Central

2018-01-01

Advanced driver assistance systems, ADAS, have shown the possibility to anticipate crash accidents and effectively assist road users in critical traffic situations. This is not the case for motorcyclists, in fact ADAS for motorcycles are still barely developed. Our aim was to study a camera-based sensor for the application of preventive safety in tilting vehicles. We identified two road conflict situations for which automotive remote sensors installed in a tilting vehicle are likely to fail in the identification of critical obstacles. Accordingly, we set two experiments conducted in real traffic conditions to test our stereo vision sensor. Our promising results support the application of this type of sensors for advanced motorcycle safety applications. PMID:29351267

The advantages of creating a positive radiation safety culture in the higher education and research sectors.

PubMed

Coldwell, T; Cole, P; Edwards, C; Makepeace, J; Murdock, C; Odams, H; Whitcher, R; Willis, S; Yates, L

2015-12-01

The safety culture of any organisation plays a critical role in setting the tone for both effective delivery of service and high standards of performance. By embedding safety at a cultural level, organisations are able to influence the attitudes and behaviours of stakeholders. To achieve this requires the ongoing commitment of heads of organisations and also individuals to prioritise safety no less than other competing goals (e.g. in universities, recruitment and retention are key) to ensure the protection of both people and the environment. The concept of culture is the same whatever the sector, e.g. medical, nuclear, industry, education, and research, but the higher education and research sectors within the UK are a unique challenge in developing a strong safety culture. This report provides an overview of the challenges presented by the sector, the current status of radiation protection culture, case studies to demonstrate good and bad practice in the sector and the practical methods to influence change.

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

NASA Astrophysics Data System (ADS)

Barr, Douglas H.

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

Moving research to practice through partnership: a case study in Asphalt Paving.

PubMed

Chang, Charlotte; Nixon, Laura; Baker, Robin

2015-08-01

Multi-stakeholder partnerships play a critical role in dissemination and implementation in health and safety. To better document and understand construction partnerships that have successfully scaled up effective interventions to protect workers, this case study focused on the collaborative processes of the Asphalt Paving Partnership. In the 1990s, this partnership developed, evaluated, disseminated, and achieved near universal, voluntary adoption of paver engineering controls to reduce exposure to asphalt fumes. We used in-depth interviews (n = 15) and document review in the case study. We describe contextual factors that both facilitated and challenged the formation of the collaboration, central themes and group processes, and research to practice (r2p) outcomes. The Asphalt Paving Partnership offers insight into how multi-stakeholder partnerships in construction can draw upon the strengths of diverse members to improve the dissemination and adoption of health and safety innovations and build a collaborative infrastructure to sustain momentum over time. © 2015 Wiley Periodicals, Inc.

Correlated Topics in a Scalable Multidimensional Text Cube: Algorithms and Aviation Safety Case Study

NASA Technical Reports Server (NTRS)

Zhao, Bo; Lin, Cindy X.; Srivastava, Ashok N.; Oza, Nikunj C.; Han, Jiawei

2010-01-01

As world-wide air traffic continues to grow even at a modest pace, the overall complexity of the system will increase significantly. This increased complexity can lead to a larger number of fatalities per year even if the extremely low fatality rate that we currently enjoy is maintained. One important source of information about the safety of the aviation system is in Aviation Safety Text Reports which are written by members of the flight crew, air traffic controllers, and other parties involved with the aviation system. These anonymized narrative reports contain fixed-field contextual information about the flight but also contain free-form narratives that describe, in the author s own words, the nature of the safety incident and, in many cases, the contributing factors that led to the safety incident. Several thousand such reports are filed each month, each of which is read and analyzed by highly trained experts. However, it is possible that there are emerging safety issues due to the fact that they may be reported very infrequently and in different contexts with different descriptions. The goal of this research paper is to develop correlated topic models which uncover correlations in the subspaces defined by the intersection of numerous fixed fields and discovered correlated topics. This task requires the discovery of latent topics in the text reports and the creation of a topic cube. Furthermore, because the number of potential cells in the topic cube is very large, we discuss novel methods of pruning the search space in the topic cells, thereby making the analysis feasible. We demonstrate the new algorithms on an analysis of pilot fatigue and its contributing factors, as well as the safety incidents that are correlated with this phenomenon.

Computer-Based Assessment in Safety-Critical Industries: The Case of Shipping

ERIC Educational Resources Information Center

Gekara, Victor Oyaro; Bloor, Michael; Sampson, Helen

2011-01-01

Vocational education and training (VET) concerns the cultivation and development of specific skills and competencies, in addition to broad underpinning knowledge relating to paid employment. VET assessment is, therefore, designed to determine the extent to which a trainee has effectively acquired the knowledge, skills, and competencies required by…

Safety Guided Design of Crew Return Vehicle in Concept Design Phase Using STAMP/STPA

NASA Astrophysics Data System (ADS)

Nakao, H.; Katahira, M.; Miyamoto, Y.; Leveson, N.

2012-01-01

In the concept development and design phase of a new space system, such as a Crew Vehicle, designers tend to focus on how to implement new technology. Designers also consider the difficulty of using the new technology and trade off several system design candidates. Then they choose an optimal design from the candidates. Safety should be a key aspect driving optimal concept design. However, in past concept design activities, safety analysis such as FTA has not used to drive the design because such analysis techniques focus on component failure and component failure cannot be considered in the concept design phase. The solution to these problems is to apply a new hazard analysis technique, called STAMP/STPA. STAMP/STPA defines safety as a control problem rather than a failure problem and identifies hazardous scenarios and their causes. Defining control flow is the essential in concept design phase. Therefore STAMP/STPA could be a useful tool to assess the safety of system candidates and to be part of the rationale for choosing a design as the baseline of the system. In this paper, we explain our case study of safety guided concept design using STPA, the new hazard analysis technique, and model-based specification technique on Crew Return Vehicle design and evaluate benefits of using STAMP/STPA in concept development phase.

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

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2015-01-01

One focus area of the National Aeronautics and Space Administration (NASA) is to improve aviation safety. Runway safety is one such thrust of investigation and research. The two primary components of this runway safety research are in runway incursion (RI) and runway excursion (RE) events. These are adverse ground-based aviation incidents that endanger crew, passengers, aircraft and perhaps other nearby people or property. A runway incursion is the incorrect presence of an aircraft, vehicle or person on the protected area of a surface designated for the landing and take-off of aircraft; one class of RI events simultaneously involves two aircraft, such as one aircraft incorrectly landing on a runway while another aircraft is taking off from the same runway. A runway excursion is an incident involving only a single aircraft defined as a veer-off or overrun off the runway surface. Within the scope of this effort at NASA Langley Research Center (LaRC), generic RI, RE and combined (RI plus RE, or RUNSAFE) event models have each been developed and implemented as a Bayesian Belief Network (BBN). Descriptions of runway safety issues from the literature searches have been used to develop the BBN models. Numerous considerations surrounding the process of developing the event models have been documented in this report. The event models were then thoroughly reviewed by a Subject Matter Expert (SME) panel through multiple knowledge elicitation sessions. Numerous improvements to the model structure (definitions, node names, node states and the connecting link topology) were made by the SME panel. Sample executions of the final RUNSAFE model have been presented herein for baseline and worst-case scenarios. Finally, a parameter sensitivity analysis for a given scenario was performed to show the risk drivers. The NASA and LaRC research in runway safety event modeling through the use of BBN technology is important for several reasons. These include: 1) providing a means to clearly understand the cause and effect patterns leading to safety issues, incidents and accidents, 2) enabling the prioritization of specialty areas needing more attention to improve aviation safety, and 3) enabling the identification of gaps within NASA's Aviation Safety funding portfolio

Securing Safety - Spaceflight Standards for the Mass Market

NASA Astrophysics Data System (ADS)

Goh, G.

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

Motorcycle safety among motorcycle taxi drivers and nonoccupational motorcyclists in developing countries: A case study of Maoming, South China.

PubMed

Wu, Connor Y H; Loo, Becky P Y

2016-01-01

An increasing number of motorcycle taxis have been involved in traffic crashes in many developing countries. This study examines the characteristics of both motorcycle taxi drivers and nonoccupational motorcyclists, investigates the risks they pose to road safety, and provides recommendations to minimize their risks. Based on the data collected from a questionnaire survey of 867 motorcycle taxi drivers and 2,029 nonoccupational motorcyclists in Maoming, South China, comparisons were made to analyze differences of personal attributes, attitudes toward road safety, and self-reported behavior of the 2 groups. Results of the chi-square tests show that not only motorcycle taxi drivers but also nonoccupational motorcyclists in Maoming held poor attitudes toward road safety and both groups reported unsafe driving behavior. There is much room for improving local road safety education among all motorcyclists in Maoming. Yet, motorcycle taxi drivers were more likely to pose road safety risks than nonoccupational motorcyclists under some circumstances, such as speeding late at night or early in the morning, not requiring passengers to wear helmets, and running a red light. The results of the binary logistic regression model show that possessing a vehicle license for a motorcycle or not was the common significant predictor for unsafe driving behavior of motorcycle taxi drivers and nonoccupational motorcyclists. Therefore, enforcement against all motorcyclists not showing vehicle licenses for their motorcycles should be stepped up. Motorcycle safety is largely poor in Maoming. Therefore, efforts to improve motorcycle safety should be strengthened by targeting not only motorcycle taxi drivers but also nonoccupational motorcyclists.

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

PubMed Central

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

2015-01-01

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

Accounting for heterogeneity among treatment sites and time trends in developing crash modification functions.

PubMed

Sacchi, Emanuele; Sayed, Tarek

2014-11-01

Collision modification factors (CMFs) are commonly used to quantify the impact of safety countermeasures. The CMFs obtained from observational before-after (BA) studies are usually estimated by averaging the safety impact (i.e., index of effectiveness) for a group of treatment sites. The heterogeneity among the treatment locations, in terms of their characteristics, and the effect of this heterogeneity on safety treatment effectiveness are usually ignored. This is in contrast to treatment evaluations in other fields like medical statistics where variations in the magnitude (or in the direction) of response to the same treatment given to different patients are considered. This paper introduces an approach for estimating a CMFunction from BA safety studies that account for variable treatment location characteristics (heterogeneity). The treatment sites heterogeneity was incorporated into the CMFunction using fixed-effects and random-effects regression models. In addition to heterogeneity, the paper also advocates the use of CMFunctions with a time variable to acknowledge that the safety treatment (intervention) effects do not occur instantaneously but are spread over future time. This is achieved using non-linear intervention (Koyck) models, developed within a hierarchical full Bayes (FB) context. To demonstrate the approach, a case study is presented to evaluate the safety effectiveness of the "Signal Head Upgrade Program" recently implemented in the city of Surrey (British Columbia, Canada), where signal visibility was improved at several urban signalized intersections. The results demonstrated the importance of considering treatment sites heterogeneity and time trends when developing CMFunctions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Influence of safety measures on the risks of transporting dangerous goods through road tunnels.

PubMed

Saccomanno, Frank; Haastrup, Palle

2002-12-01

Quantitative risk assessment (QRA) models are used to estimate the risks of transporting dangerous goods and to assess the merits of introducing alternative risk reduction measures for different transportation scenarios and assumptions. A comprehensive QRA model recently was developed in Europe for application to road tunnels. This model can assess the merits of a limited number of "native safety measures." In this article, we introduce a procedure for extending its scope to include the treatment of a number of important "nonnative safety measures" of interest to tunnel operators and decisionmakers. Nonnative safety measures were not included in the original model specification. The suggested procedure makes use of expert judgment and Monte Carlo simulation methods to model uncertainty in the revised risk estimates. The results of a case study application are presented that involve the risks of transporting a given volume of flammable liquid through a 10-km road tunnel.

Quality assessment of occupational health and safety management at the level of business units making up the organizational structure of a coal mine: a case study.

PubMed

Korban, Zygmunt

2015-01-01

The audit of the health and safety management system is understood as a form and tool of controlling. The objective of the audit is to define whether the undertaken measures and the obtained results are in conformity with the predicted assumptions or plans, whether the agreed decisions have been implemented and whether they are suitable in view of the accepted health and safety policy. This paper presents the results of an audit examination carried out on the system of health and safety management between 2002 and 2012 on a group of respondents, the employees of two mining departments (G-1 and G-2) of Jan, a coal mine. The audit was carried out using the questionnaire developed by the author based on the MERIT-APBK survey.

A new patient safety smartphone application for prevention of "forgotten" ureteral stents: results from a clinical pilot study in 194 patients.

PubMed

Molina, Wilson R; Pessoa, Rodrigo; Donalisio da Silva, Rodrigo; Kenny, McCabe C; Gustafson, Diedra; Nogueira, Leticia; Leo, Mark E; Yu, Michael K; Kim, Fernando J

2017-01-01

Approximately 12% of all ureteral stents placed are retained or "forgotten." Forgotten stents are associated with significant safety concerns as well as increased costs and legal issues. Retained ureteral stents (RUS) often occur due to lack of clinical follow-up, communication or language barriers, and economic concerns. We describe a multiplatform application that facilitates data collection to prevent RUS. The "Stent Tracker" application can be installed on mobile devices and computers. The encrypted and password-protected information is accessible from any device and provides information about each procedure, stent placement and removal dates, as well as product description. This multicenter retrospective study included 194 patients who underwent stent placement between July and October 2015. Nominal data was tallied and ordinal data was divided into quartiles of 25, 50, and 75%. A total of 194 patients from three institutions underwent ureteral stent placement. Reasons for stent placement include 122 cases post ureteroscopy (63%), 8 cases post percutaneous nephrolithotomy (PCNL) (4%), 14 cases post extracorporeal shock wave lithotripsy (SWL) (7%), 18 cases of cancer-related ureteral obstruction (9%), 21 cases of hydronephrosis (11%), and 11 for other reasons (6%). Of these patients, only one patient was lost to follow-up (0.5%). On average, ureteral stents were removed within 14 days of placement (IQR: 8-26 days). The "Stent Tracker" is a patient safety application that provides a secure and simplified interface, which can significantly reduce the incidence of RUS. Further developments could include automated notifications to patients and staff, color-coding, and integrated information with electronic patient charts.

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety

PubMed Central

Waterson, Patrick; Robertson, Michelle M.; Cooke, Nancy J.; Militello, Laura; Roth, Emilie; Stanton, Neville A.

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. Practitioner Summary: We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a ‘roadmap’ for future work. PMID:25832121

Managing risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE).

PubMed

Dourson, Michael L; Gadagbui, Bernard K; Thompson, Rod B; Pfau, Edward J; Lowe, John

2016-10-01

A method for determining a safety range for non-cancer risks is proposed, similar in concept to the range used for cancer in the management of waste sites. This safety range brings transparency to the chemical specific Reference Dose or Concentration by replacing their "order of magnitude" definitions with a scientifically-based range. EPA's multiple RfCs for trichloroethylene (TCE) were evaluated as a case study. For TCE, a multi-endpoint safety range was judged to be 3 μg/m(3) to 30 μg/m,(3) based on a review of kidney effects found in NTP (1988), thymus effects found in Keil et al. (2009) and cardiac effects found in the Johnson et al. (2003) study. This multi-endpoint safety range is derived from studies for which the appropriate averaging time corresponds to different exposure durations, and, therefore, can be applied to both long- and short-term exposures with appropriate consideration of exposure averaging times. For shorter-term exposures, averaging time should be based on the time of cardiac development in humans during fetal growth, an average of approximately 20-25 days. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

PubMed

Roberts, Stanley A; Andrews, Paul A; Blanset, Diann; Flagella, Kelly M; Gorovits, Boris; Lynch, Carmel M; Martin, Pauline L; Kramer-Stickland, Kimberly; Thibault, Stephane; Warner, Garvin

2013-12-01

Antibody drug conjugates (ADCs) include monoclonal antibodies that are linked to cytotoxic small molecules. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells. This paper presents primary considerations for the nonclinical safety evaluation of ADCs and includes strategies for the evaluation of the entire ADC or the various individual components (i.e., antibody, linker or the cytotoxin). Considerations are presented on how to design a nonclinical safety assessment program to identify the on- and off-target toxicities to enable first-in-human (FIH) studies. Specific discussions are also included that provide details as to the need and how to conduct the studies for evaluating ADCs in genetic toxicology, tissue cross-reactivity, safety pharmacology, carcinogenicity, developmental and reproductive toxicology, biotransformation, toxicokinetic monitoring, bioanalytical assays, immunogenicity testing, test article stability and the selection of the FIH dose. Given the complexity of these molecules and our evolving understanding of their properties, there is no single all-encompassing nonclinical strategy. Instead, each ADC should be evaluated on a case-by-case scientifically-based approach that is consistent with ICH and animal research guidelines. Copyright © 2013 Elsevier Inc. All rights reserved.

TOOKUIL: A case study in user interface development for safety code application

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

Gray, D.L.; Harkins, C.K.; Hoole, J.G.

1997-07-01

Traditionally, there has been a very high learning curve associated with using nuclear power plant (NPP) analysis codes. Even for seasoned plant analysts and engineers, the process of building or modifying an input model for present day NPP analysis codes is tedious, error prone, and time consuming. Current cost constraints and performance demands place an additional burden on today`s safety analysis community. Advances in graphical user interface (GUI) technology have been applied to obtain significant productivity and quality assurance improvements for the Transient Reactor Analysis Code (TRAC) input model development. KAPL Inc. has developed an X Windows-based graphical user interfacemore » named TOOKUIL which supports the design and analysis process, acting as a preprocessor, runtime editor, help system, and post processor for TRAC. This paper summarizes the objectives of the project, the GUI development process and experiences, and the resulting end product, TOOKUIL.« less

Further safety enhancement of a specialized power assisted tricycle for a child with osteogenesis imperfecta type III and design of an adjustble hand power tricycle.

PubMed

Geu, Matthew; Madsen, Robert; Weber, Erica; Burnett, Michael; Barrett, Steven

2006-01-01

Several tricycles, one a customized power assisted tricycle, and the second a hand powered tricycle were developed, which offered a unique opportunity to serve multiple purposes in several children's development throughout Wyoming. In Both cases these tricycles provide the children with the opportunity to gain muscle mass, strength, coordination, and confidence. The power assisted tricycle was completed as a senior design project in 2002, and over time safety enhancements have been completed to make the tricycle safer for operation. Unfortunately, the safety system enhancements were not acceptable for it to be released for use. For this reason the tricycle was further redesigned to include more redundant safety systems which will allow the tricycle to be safe for the child's use. The second tricycle was designed to allow for a group of children who have limited use of their legs, to be able to use the same tricycle to give them more upper body strength. A gear system using multiple gear sprockets was adapted to a preexisting tricycle to provide hand power rather than foot power. Without these improvements, the children would not have the opportunity to use these tricycles to help with their development.

Safety of liposuction using exclusively tumescent local anesthesia in 3,240 consecutive cases.

PubMed

Habbema, Louis

2009-11-01

Many surgeons consider liposuction using tumescent local anesthesia (TLA) to be a safe technique, but when TLA has been combined with other techniques, such as general anesthesia or intravenous medication, or when the guidelines associated with TLA have been violated, serious complications and deaths have occurred. This has resulted in uncertainty concerning the safety of liposuction using TLA, which this article seeks to resolve. To investigate whether liposuction using TLA is a safe procedure. The same surgeon performed liposuction using exclusively TLA in 3,240 procedures. Detailed records were kept of the complications that occurred. In a series of 3,240 procedures, no deaths occurred, and no complications requiring hospitalization were experienced. In nine cases, complications developed that needed further action. Liposuction using exclusively TLA is a proven safe procedure provided that the existing guidelines are meticulously followed.

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

PubMed

Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

2013-04-18

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide. Copyright © 2012 Elsevier Ltd. All rights reserved.

DISPELLING MYTHS AND MISCONCEPTIONS TO IMPLEMENT A SAFETY CULTURE

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

Potts, T. Todd; Smith, Ken; Hylko, James M.

2003-02-27

Industrial accidents are typically reported in terms of technological malfunctions, ignoring the human element in accident causation. However, over two-thirds of all accidents are attributable to human and organizational factors (e.g., planning, written procedures, job factors, training, communication, and teamwork), thereby affecting risk perception, behavior and attitudes. This paper reviews the development of WESKEM, LLC's Environmental, Safety, and Health (ES&H) Program that addresses human and organizational factors from a top-down, bottom-up approach. This approach is derived from the Department of Energy's Integrated Safety Management System. As a result, dispelling common myths and misconceptions about safety, while empowering employees to ''STOPmore » work'' if necessary, have contributed to reducing an unusually high number of vehicle, ergonomic and slip/trip/fall incidents successfully. Furthermore, the safety culture that has developed within WESKEM, LLC's workforce consists of three common characteristics: (1) all employees hold safety as a value; (2) each individual feels responsible for the safety of their co-workers as well as themselves; and (3) each individual is willing and able to ''go beyond the call of duty'' on behalf of the safety of others. WESKEM, LLC as a company, upholds the safety culture and continues to enhance its existing ES&H program by incorporating employee feedback and lessons learned collected from other high-stress industries, thereby protecting its most vital resource - the employees. The success of this program is evident by reduced accident and injury rates, as well as the number of safe work hours accrued while performing hands-on field activities. WESKEM, LLC (Paducah + Oak Ridge) achieved over 800,000 safe work hours through August 2002. WESKEM-Paducah has achieved over 665,000 safe work hours without a recordable injury or lost workday case since it started operations on February 28, 2000.« less

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

EPA Pesticide Factsheets

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

System Safety in Early Manned Space Program: A Case Study of NASA and Project Mercury

NASA Technical Reports Server (NTRS)

Hansen, Frederick D.; Pitts, Donald

2005-01-01

This case study provides a review of National Aeronautics and Space Administration s (NASA's) involvement in system safety during research and evolution from air breathing to exo-atmospheric capable flight systems culminating in the successful Project Mercury. Although NASA has been philosophically committed to the principals of system safety, this case study points out that budget and manpower constraints-as well as a variety of internal and external pressures can jeopardize even a well-designed system safety program. This study begins with a review of the evolution and early years of NASA's rise as a project lead agency and ends with the lessons learned from Project Mercury.

Station Blackout: A case study in the interaction of mechanistic and probabilistic safety analysis

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

Curtis Smith; Diego Mandelli; Cristian Rabiti

2013-11-01

The ability to better characterize and quantify safety margins is important to improved decision making about nuclear power plant design, operation, and plant life extension. As research and development (R&D) in the light-water reactor (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. The purpose of the Risk Informed Safety Margin Characterization (RISMC) Pathway R&D is to support plant decisions for risk-informed margin management with the aim tomore » improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe the RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario.« less

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

Dynamic safety assessment of natural gas stations using Bayesian network.

PubMed

Zarei, Esmaeil; Azadeh, Ali; Khakzad, Nima; Aliabadi, Mostafa Mirzaei; Mohammadfam, Iraj

2017-01-05

Pipelines are one of the most popular and effective ways of transporting hazardous materials, especially natural gas. However, the rapid development of gas pipelines and stations in urban areas has introduced a serious threat to public safety and assets. Although different methods have been developed for risk analysis of gas transportation systems, a comprehensive methodology for risk analysis is still lacking, especially in natural gas stations. The present work is aimed at developing a dynamic and comprehensive quantitative risk analysis (DCQRA) approach for accident scenario and risk modeling of natural gas stations. In this approach, a FMEA is used for hazard analysis while a Bow-tie diagram and Bayesian network are employed to model the worst-case accident scenario and to assess the risks. The results have indicated that the failure of the regulator system was the worst-case accident scenario with the human error as the most contributing factor. Thus, in risk management plan of natural gas stations, priority should be given to the most probable root events and main contribution factors, which have identified in the present study, in order to reduce the occurrence probability of the accident scenarios and thus alleviate the risks. Copyright © 2016 Elsevier B.V. All rights reserved.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

? Click Here! Resources for MSD Safety MSD Safety MSD's Integrated Safety Management Plan [PDF] Safety culture and policies at MSD MSD0010: Integrated Safety Management: Principles and Case Studies Calendar for MSD classes on Integrated Safety Management MSD0015 Handout - Waste Briefing Document [PDF] Waste

Factors associated with the relationship between motorcycle deaths and economic growth.

PubMed

Law, Teik Hua; Noland, Robert B; Evans, Andrew W

2009-03-01

This paper examines the Kuznets curve relationship for motorcycle deaths. The Kuznets curve describes the inverted U-shape relationship between economic development and, in this case, motorcycle deaths. In early stages of development we expect deaths to increase with increasing motorization. Eventually deaths decrease as technical, policy and political institutions respond to demands for increased safety. We examine this effect as well as some of the factors which might explain the Kuznets relationship: in particular motorcycle helmet laws, medical care and technology improvements, and variables representing the quality of political institutions. We apply a fixed effects negative binomial regression analysis on a panel of 25 countries covering the period 1970-1999. Our results broadly suggest that implementation of road safety regulation, improvement in the quality of political institutions, and medical care and technology developments have contributed to reduced motorcycle deaths.

Making a Case for Organizational Change in Patient Safety Initiatives

DTIC Science & Technology

2005-05-01

or medical staff could be required to directly observe patient care processes. Such firsthand encounters with process flaws are particularly...can actually make patient safety worse. Take, for example, the previously described situation where nurses stopped reporting when the medication ...455 Making a Case for Organizational Change in Patient Safety Initiatives Rangaraj Ramanujam, Donna J. Keyser, Carl A. Sirio Abstract

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Stephen B.

2010-01-01

Software plays an increasingly larger role in all aspects of NASA's science missions. This has been extended to the identification, management and control of faults which affect safety-critical functions and by default, the overall success of the mission. Traditionally, the analysis of fault identification, management and control are hardware based. Due to the increasing complexity of system, there has been a corresponding increase in the complexity in fault management software. The NASA Independent Validation & Verification (IV&V) program is creating processes and procedures to identify, and incorporate safety-critical software requirements along with corresponding software faults so that potential hazards may be mitigated. This Specific to Generic ... A Case for Reuse paper describes the phases of a dependability and safety study which identifies a new, process to create a foundation for reusable assets. These assets support the identification and management of specific software faults and, their transformation from specific to generic software faults. This approach also has applications to other systems outside of the NASA environment. This paper addresses how a mission specific dependability and safety case is being transformed to a generic dependability and safety case which can be reused for any type of space mission with an emphasis on software fault conditions.

Safety Education and Science.

ERIC Educational Resources Information Center

Ralph, Richard

1980-01-01

Safety education in the science classroom is discussed, including the beginning of safe management, attitudes toward safety education, laboratory assistants, chemical and health regulation, safety aids, and a case study of a high school science laboratory. Suggestions for safety codes for science teachers, student behavior, and laboratory…

Modelling safety of gantry crane operations using Petri nets.

PubMed

Singh, Karmveer; Raj, Navneet; Sahu, S K; Behera, R K; Sarkar, Sobhan; Maiti, J

2017-03-01

Being a powerful tool in modelling industrial and service operations, Petri net (PN) has been extremely used in different domains, but its application in safety study is limited. In this study, we model the gantry crane operations used for industrial activities using generalized stochastic PNs. The complete cycle of operations of the gantry crane is split into three parts namely inspection and loading, movement of load, and unloading of load. PN models are developed for all three parts and the whole system as well. The developed PN models have captured the safety issues through reachability tree. The hazardous states are identified and how they ultimately lead to some unwanted accidents is demonstrated. The possibility of falling of load and failure of hook, sling, attachment and hoist rope are identified. Possible suggestions based on the study are presented for redesign of the system. For example, mechanical stoppage of operations in case of loosely connected load, and warning system for use of wrong buttons is tested using modified models.

Strangles in horses can be caused by vaccination with Pinnacle I. N.

PubMed

Cursons, Ray; Patty, Olivia; Steward, Karen F; Waller, Andrew S

2015-07-09

The differentiation of live attenuated vaccine strains from their progenitor and wild-type counterparts is important for ongoing surveillance of product safety and improved guidelines on their use. We utilised a genome sequencing approach to confirm that two cases of strangles in previously healthy horses that had received the Pinnacle I. N. vaccine (Zoetis) were caused by the vaccine strain. Our data shed new light on the safety of this vaccine and suggest that factors beyond the maturity of the animal's immune system influence the development of adverse reactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Quest for quality care and patient safety: the case of Singapore

PubMed Central

Lim, M

2004-01-01



 Quality of care in Singapore has seen a paradigm shift from a traditional focus on structural approaches to a broader multidimensional concept which includes the monitoring of clinical indicators and medical errors. Strong political commitment and institutional capacities have been important factors for making the transition. What is still lacking, however, is a culture of rigorous programme evaluation, public involvement, and patient empowerment. Despite these imperfections, Singapore has made considerable strides and its experience may hold lessons for other small developing countries in the common quest for quality care and patient safety. PMID:14757804

Community Campaigns, Supply Chains, and Protecting the Health and Well-Being of Workers

PubMed Central

Quinlan, Michael

2009-01-01

The growth of contingent work (also known as precarious employment), the informal sector, and business practices that diffuse employer responsibility for worker health and safety (such as outsourcing and the development of extended national and international contracting networks [supply chains]) pose a serious threat to occupational health and safety that disproportionately affects low-wage, ethnic minority, and immigrant workers. Drawing on cases from the United States and Australia, we examine the role that community-based campaigns can play in meeting these challenges, including several successful campaigns that incorporate supply chain regulation. PMID:19890154

Community campaigns, supply chains, and protecting the health and well-being of workers.

PubMed

Quinlan, Michael; Sokas, Rosemary K

2009-11-01

The growth of contingent work (also known as precarious employment), the informal sector, and business practices that diffuse employer responsibility for worker health and safety (such as outsourcing and the development of extended national and international contracting networks [supply chains]) pose a serious threat to occupational health and safety that disproportionately affects low-wage, ethnic minority, and immigrant workers. Drawing on cases from the United States and Australia, we examine the role that community-based campaigns can play in meeting these challenges, including several successful campaigns that incorporate supply chain regulation.

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective.

PubMed

Xu, Xiao Ping; Deng, Dong Ning; Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong's patient safety strategies in the context of Mainland China. A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff's patient safety culture mind-set, to realize a "bottom-up" approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety.

Structural equation model to investigate the dimensions influencing safety culture improvement in construction sector: A case in Indonesia

NASA Astrophysics Data System (ADS)

Machfudiyanto, Rossy Armyn; Latief, Yusuf; Yogiswara, Yoko; Setiawan, R. Mahendra Fitra

2017-06-01

In facing the ASEAN Economic Community, the level of prevailing working accidents becomes one of the competitiveness factors among the companies. A construction industry is one of the industries prone to high level of accidents. Improving the safety record will not be completely effective unless the occupational safety and healthy culture is enhanced. The aim of this research was to develop a model and to conduct empirical investigation on the relationships among the dimensions of construction occupational safety culture. This research used the structural equation model as a means to examine the hypothesis of positive relationships between dimensions and objectives. The method used in this research was questionnaire survey which was distributed to the respondents from construction companies in a state-owned enterprise in Indonesia. Moreover, there were dimensions of occupational safety culture that was established, such as leadership, behavior, value, strategy, policy, process, employee, safety cost, and contract system. The results of this study indicated that all dimensions were significant and inter-related in forming the safety culture. The result of R2 yielded the safety performance was 54%, which means it was in low category and evaluation of policies on construction companies was required in addressing the issue of working accidents.

Summary of U.S. Injuries and Fatalities Involving Entrapment and Suffocation in Grain Transport Vehicles.

PubMed

Cheng, Yuan-Hsin; Field, William E; Issa, Salah F; Kelley, Kevin; Heber, Matthew; Turner, Robert

2018-05-07

Since 1978, the Purdue University Agricultural Safety and Health Program has managed a surveillance effort and database to collect information on documented injuries and fatalities in all forms of U.S. agricultural confined spaces. The database currently contains 1,968 cases documented in the U.S. between 1964 and 2016. Of these cases, 174 (8.8%) involved entrapment or suffocation in grain transport vehicles (GTVs), including gravity-flow wagons, semi-truck trailers, and other agricultural transport vehicles that have limited access and are not considered normal work spaces or are classified as confined spaces. These GTV cases represent the overwhelming majority of documented cases involving all forms of agricultural transport vehicles, including forage and manure transport vehicles. Of the incidents documented, 64.3% resulted in fatalities and 71.8% involved children and youth age 20 years and under, when the age was determined. For the GTV cases, the typical victim was male (88.5%), and the average age of the victim was 19.9 (median 12), with over 63.5% of the cases involving children under the age of 15. In numerous incidents, more than one victim became entrapped, including one incident involving five victims. The number of documented cases decreased sharply from a peak of approximately 7 cases per year in the early 1990s to an average of 3.1 cases per year over the past two decades, with no cases documented in 1998 and 2013. However, there is a linear increase in the frequency of incidents since the first case was documented in 1964. This trend is partially due to peaks in 2011 and 2014, when 10 and 9 cases, respectively, were documented, along with more vigilant surveillance methods due to online search capabilities. The general decline, more recently, in the annual number of cases is attributed to increased awareness of the hazards to youth during transport in GTVs, increased use of warnings on GTVs, and the increased size of GTVs, which makes human access more difficult and less practical. Efforts over the past decade to bring attention to the risk of entrapment in GTVs should be recognized as a success of the educational and technological strategies initiated due to earlier high-profile incidents. However, with 6, 10, 9, and 4 cases documented in 2010, 2011, 2014, and 2016, respectively, continued efforts to address the problem are justified. Recommendations for future actions include development of a safety standard for GTVs that includes placement of safety messages on all new GTVs, use of windows above outlets, retrofitting older GTVs with appropriate warnings, and continuing to address the hazard with safety resources targeting all workers exposed to grain handling and transport. Copyright© by the American Society of Agricultural Engineers.

The potential of novel infrared food processing technologies: case studies of those developed at the USDA-ARS

USDA-ARS?s Scientific Manuscript database

Infrared (IR) radiation heating has been considered as an alternative to current food and agricultural processing methods for improving product quality and safety, increasing energy and processing efficiency, and reducing water and chemical usage. As part of the electromagnetic spectrum, IR has the ...

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

PubMed

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

2016-01-01

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

A meta-model for computer executable dynamic clinical safety checklists.

PubMed

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

Safety Case Notations: Alternatives for the Non-Graphically Inclined?

NASA Technical Reports Server (NTRS)

Holloway, C. M.

2008-01-01

This working paper presents preliminary ideas of five possible text-based notations for representing safety cases, which may be easier for non-graphically inclined people to use and understand than the currently popular graphics-based representations.

Strategic Accident Reduction in an Energy Company and Its Resulting Financial Benefits.

PubMed

Reiman, Arto; Räisänen, Tuomo; Väyrynen, Seppo; Autio, Tommi

2018-04-10

This study provides a case example of an energy company that prioritised occupational safety and health and accident reduction as long-term, strategic development targets. Furthermore, this study describes the monetary benefits of this strategic decision. Company-specific accident indicators and monetary costs and benefits are evaluated. During the observation period (2010-2016), strategic investments in occupational safety and health cost the company EUR 0.8 million. However, EUR 1.8 million were saved in the same period, resulting in a 2.20 cost-benefit ratio. The trend in cost savings is strongly positive. Annual accident costs were EUR 0.4 million lower in 2016 compared to costs in 2010. This study demonstrates that long-term, strategic commitment to occupational safety and health provides monetary value.

Patient Safety in the Context of Neonatal Intensive Care: Research and Educational Opportunities

PubMed Central

Raju, Tonse N. K.; Suresh, Gautham; Higgins, Rosemary D.

2012-01-01

Case reports and observational studies continue to report adverse events from medical errors. However, despite considerable attention to patient safety in the popular media, this topic is not a regular component of medical education, and much research needs to be carried out to understand the causes, consequences, and prevention of healthcare-related adverse events during neonatal intensive care. To address the knowledge gaps and to formulate a research and educational agenda in neonatology, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invited a panel of experts to a workshop in August 2010. Patient safety issues discussed were: the reasons for errors, including systems design, working conditions, and worker fatigue; a need to develop a “culture” of patient safety; the role of electronic medical records, information technology, and simulators in reducing errors; error disclosure practices; medico-legal concerns; and educational needs. Specific neonatology-related topics discussed were: errors during resuscitation, mechanical ventilation, and performance of invasive procedures; medication errors including those associated with milk feedings; diagnostic errors; and misidentification of patients. This article provides an executive summary of the workshop. PMID:21386749

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

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-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. As the lead Department of Energy (DOE) Laboratory for this Pathway, the Idaho National Laboratory (INL) is tasked with developing and deploying methods and tools that support the quantification and management of safety margin and uncertainty.« less

Lessons learned from measuring safety culture: an Australian case study.

PubMed

Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

2010-10-01

adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture. Undertaking research in this way requires local engagement, commitment and capacity from the study site. The absence of these factors is likely to limit the practicality of this approach in the clinical setting. the use of safety culture surveys as the only method of assessing safety culture is of limited value in identifying strategies to potentially improve the safety culture. Copyright © 2010 Elsevier Ltd. All rights reserved.

Identifying, Developing and Releasing Insect Biocontrol Agents for the Management of Phragmites australis

DTIC Science & Technology

2013-07-01

major safety factor if this can be confirmed in the future. ERDC/EL TN-13-3 July 2013 10 Figure 2. Adult A. geminipuncta females marked... food after two weeks. In neither case did the larvae successfully develop to adult. With both species, over 50% of larvae-fed diet died within the...internally feeding larvae require hollow tubes with food lining the walls for a successful development. That most larvae died in the early instars is

Transformational leadership in nursing and medication safety education: a discussion paper.

PubMed

Vaismoradi, Mojtaba; Griffiths, Pauline; Turunen, Hannele; Jordan, Sue

2016-10-01

This paper discusses the application of transformational leadership to the teaching and learning of safe medication management. The prevalence of adverse drug events (ADEs) and medication-related hospitalisations (one hundred thousand each year in the USA) are of concern. This discussion is based on a narrative literature review and scrutiny of international nursing research to synthesise pedagogical strategies for the application of transformational leadership to teaching medication safety. The four elements relating transformational leadership to medication safety education are: 'Idealised influence' or role modelling, both actual and exemplary, 'Inspirational motivation' providing students with commitment to medication safety, 'Intellectual stimulation' encouraging students to value improvement and change, and 'Individualised consideration' of individual students' educational goals, practice development and patient outcomes. The model lends itself to experiential learning and a case-study approach to teaching, offering an opportunity to reduce nursing's theory-practice gap. Transformational leadership for medication safety education is characterised by a focus on the role of nurse educators and mentors in the development of students' abilities, creation of a supportive culture, and enhancement of students' creativity, motivation and ethical behaviour. This will prepare nursing graduates with the competencies necessary to be diligent about medication safety and the prevention of errors. Teaching medication safety through transformational leadership requires the close collaboration of educators, managers and policy makers. Investigation of strategies to reduced medication errors and consequent patient harm should include exploration of the application of transformational leadership to education and its impact on the number and severity of medication errors. © 2016 John Wiley & Sons Ltd.

Software life cycle methodologies and environments

NASA Technical Reports Server (NTRS)

Fridge, Ernest

1991-01-01

Products of this project will significantly improve the quality and productivity of Space Station Freedom Program software processes by: improving software reliability and safety; and broadening the range of problems that can be solved with computational solutions. Projects brings in Computer Aided Software Engineering (CASE) technology for: Environments such as Engineering Script Language/Parts Composition System (ESL/PCS) application generator, Intelligent User Interface for cost avoidance in setting up operational computer runs, Framework programmable platform for defining process and software development work flow control, Process for bringing CASE technology into an organization's culture, and CLIPS/CLIPS Ada language for developing expert systems; and methodologies such as Method for developing fault tolerant, distributed systems and a method for developing systems for common sense reasoning and for solving expert systems problems when only approximate truths are known.

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

PubMed

Donnelly, Helen; Alemayehu, Demissie; Botgros, Radu; Comic-Savic, Sabrina; Eisenstein, Barry; Lorenz, Benjamin; Merchant, Kunal; Pelfrene, Eric; Reith, Christina; Santiago, Jonas; Tiernan, Rosemary; Wunderink, Richard; Tenaerts, Pamela; Knirsch, Charles

2016-08-15

Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting certain data on the case report form as opposed to recording of data as part of routine clinical care. The ABDD Project Team developed strategies for streamlining safety data collection in HABP/VABP trials using a Quality by Design approach. Current safety data collection processes in HABP/VABP trials often include extraneous information. More targeted strategies for safety data collection in HABP/VABP trials will rely on optimal protocol design and prespecification of which safety data are essential to satisfy regulatory reporting requirements. A consensus and a cultural change in clinical trial design and conduct, which involve recognition of the need for more efficient data collection, are urgently needed to advance ABDD and to improve HABP/VABP trials in particular. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

[Pigment dispersion and Artisan implants: crystalline lens rise as a safety criterion].

PubMed

Baikoff, G; Bourgeon, G; Jodai, H Jitsuo; Fontaine, A; Vieira Lellis, F; Trinquet, L

2005-06-01

To validate the theoretical notion of a crystalline lens rise as a safety criterion for ARTISAN implants in order to prevent the development of pigment dispersion in the implanted eye. Crystalline lens rise is defined by the distance between the crystalline lens's anterior pole and the horizontal plane joining the opposite iridocorneal recesses. We analyzed the biometric measurements of 87 eyes with an Artisan implant. A comparative analysis of the crystalline lens rise was carried out on the nine eyes having developed pigment dispersion and 78 eyes with no problems. Among the modern anterior segment imaging devices (Artemis, Scheimpflug photography, optical coherence tomography, radiology exploration, magnetic resonance imaging, TDM), an anterior chamber optical coherence tomography (AC-OCT) prototype was used. This working hypothesis was confirmed by this study: the crystalline lens rise must be considered as a new safety criterion for implanting Artisan phakic lenses. Indeed, the higher the crystalline lens's rise, the greater the risk of developing pigment dispersion in the pupil area. This complication is more frequent in hyperopes than in myopes. We can consider that there is little or no risk of pigment dispersion if the rise is below 600 microm; however, at 600 microm or greater, there is a 67% rate of pupillary pigment dispersion. In certain cases, when the implant was loosely fixed, there was no traction on the iris root. This is a complication that can be avoided or delayed. The crystalline lens rise must be part of new safety criteria to be taken into consideration when inserting an Artisan implant. This notion must also be applied to other types of phakic implants. The distance remaining between the crystalline lens rise and a 600-micromm theoretical safety level allows one to calculate a safety time interval.

'Worst case' methodology for the initial assessment of societal risk from proposed major accident installations.

PubMed

Carter, D A; Hirst, I L

2000-01-07

This paper considers the application of one of the weighted risk indicators used by the Major Hazards Assessment Unit (MHAU) of the Health and Safety Executive (HSE) in formulating advice to local planning authorities on the siting of new major accident hazard installations. In such cases the primary consideration is to ensure that the proposed installation would not be incompatible with existing developments in the vicinity, as identified by the categorisation of the existing developments and the estimation of individual risk values at those developments. In addition a simple methodology, described here, based on MHAU's "Risk Integral" and a single "worst case" even analysis, is used to enable the societal risk aspects of the hazardous installation to be considered at an early stage of the proposal, and to determine the degree of analysis that will be necessary to enable HSE to give appropriate advice.

A challenge-response endoscopic sinus surgery specific checklist as an add-on to standard surgical checklist: an evaluation of potential safety and quality improvement issues.

PubMed

Sommer, Doron D; Arbab-Tafti, Sadaf; Farrokhyar, Forough; Tewfik, Marc; Vescan, Allan; Witterick, Ian J; Rotenberg, Brian; Chandra, Rakesh; Weitzel, Erik K; Wright, Erin; Ramakrishna, Jayant

2018-02-27

The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery-specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery. This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method. Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%). The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting. © 2018 ARS-AAOA, LLC.

Silkwood vs. Kerr-McGee Corporation: unpredicted fallout

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

Silvestrini, L.V.F.

1985-01-01

The Silkwood suit is extolled as important precedent because it arguably gives states and private citizens acting as jurors the right to establish de facto nuclear regulatory policy. The Court's rationale in allowing punitive damages based on state tort law principles to be awarded against a private nuclear developer for injuries caused by the release of hazardous radioactive material from its plant is inconsistent with that used in a case involving Pacific Gas and Electric the year before. The author reviews the doctrine of preemption, discusses the legal and factural setting of the Silkwood case, and concludes that the Courtmore » could have provided a test similar to that invoked in labor law disputes to determine the available exceptions to total federal preemption of nuclear safety. Without such a test, the results of future litigation over nuclear safety concerns are unpredictable.« less

Assessing the home fire safety of urban older adults: a case study.

PubMed

Twyman, Stephanie; Fahey, Erin; Lehna, Carlee

2014-01-01

Older adults are at a higher risk for fatal house fire injury due to decreased mobility, chronic illness, and lack of smoke alarms. The purpose of this illustrative case study is to describe the home fire safety (HFS) status of an urban older adult who participated in a large study funded by the Federal Emergency Management Agency (FEMA). During a home visit with the participant, HFS data were collected from documents, observation, physical artifacts, reflective logs, and interviews. Numerous HFS hazards were identified including non-working smoke alarms, inadequate number and inappropriate placement of smoke alarms, lack of carbon monoxide (CO) alarms, inability to identify a home fire escape plan, hot water heater temperature set too high, and cooking hazards. Identification of HFS risk factors will assist in the development of educational materials that can be tailored to the older adult population to decrease their risk of fire-related injuries and death.

Decision making with epistemic uncertainty under safety constraints: An application to seismic design

USGS Publications Warehouse

Veneziano, D.; Agarwal, A.; Karaca, E.

2009-01-01

The problem of accounting for epistemic uncertainty in risk management decisions is conceptually straightforward, but is riddled with practical difficulties. Simple approximations are often used whereby future variations in epistemic uncertainty are ignored or worst-case scenarios are postulated. These strategies tend to produce sub-optimal decisions. We develop a general framework based on Bayesian decision theory and exemplify it for the case of seismic design of buildings. When temporal fluctuations of the epistemic uncertainties and regulatory safety constraints are included, the optimal level of seismic protection exceeds the normative level at the time of construction. Optimal Bayesian decisions do not depend on the aleatory or epistemic nature of the uncertainties, but only on the total (epistemic plus aleatory) uncertainty and how that total uncertainty varies randomly during the lifetime of the project. ?? 2009 Elsevier Ltd. All rights reserved.

Patient safety in primary care: a survey of general practitioners in The Netherlands.

PubMed

Gaal, Sander; Verstappen, Wim; Wensing, Michel

2010-01-21

Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

Flow Diverter Stents for the Treatment of Anterior Cerebral Artery Aneurysms: Safety and Effectiveness.

PubMed

Clarençon, F; Di Maria, F; Gabrieli, J; Shotar, E; Zeghal, C; Nouet, A; Chiras, J; Sourour, N-A

2017-03-01

Flow diverter stents (FDSs) are increasingly used for the treatment of intracranial aneurysms. Initially developed for the management of giant and large aneurysms, their indications have progressively expanded. The purpose of our study was to evaluate the safety and effectiveness of FDSs for the treatment of anterior cerebral artery (ACA) aneurysms. Among the 94 consecutive patients treated for 100 intracranial aneurysms by means of FDSs in our institution from October 2010 to January 2015, eight aneurysms (8 %) in seven patients were located on the ACA. Three aneurysms were located on the A1 segment, three aneurysms on the anterior communicating artery (ACom) and two on the A2-A3 junction. In three cases, FDS was used for angiographic recurrence after coiling. Five patients were treated with a Pipeline embolization device, one with a NeuroEndograft and the last one with a Silk FDS. Treatment was feasible in all cases. No technical difficulty was reported. No acute or delayed clinical complication was recorded. Modified Rankin Scale was 0 for six patients and one for one patient. Mean angiographic follow-up was 9.7 ± 3.9 months (range 6-15). Total exclusion was observed in five aneurysms (71.4 %) and neck remnant in two (28.6 %) cases. One patient refused the control DSA. Our series shows the safety and effectiveness of FDSs for the treatment of ACA aneurysms.

The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

PubMed

Morrato, Elaine H; Ling, Sarah B

2012-11-01

The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making. We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods. DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA. Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.

A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

PubMed

Chan, Cheng Leng; Ang, Pei San; Li, Shu Chuen

2017-06-01

Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

Development of requirements on safety cases of machine industry products for power engineering

NASA Astrophysics Data System (ADS)

Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

2016-12-01

This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and elaboration of tentative guidelines for reducing hazard and risk levels.

Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

PubMed

Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

2018-06-01

Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study.

PubMed

Cook, S; Vermersch, P; Comi, G; Giovannoni, G; Rammohan, K; Rieckmann, P; Sørensen, P Soelberg; Hamlett, A; Miret, M; Weiner, J; Viglietta, V; Musch, B; Greenberg, S J

2011-05-01

Cladribine is a synthetic deoxyadenosine analogue in development as an oral multiple sclerosis (MS) therapy. To report in detail the safety findings from the 96-week, phase III, double-blind CLARITY study, which evaluated treatment with cladribine tablets in relapsing-remitting MS. A total of 1,326 patients were randomized 1:1:1 to two short-course regimens of cladribine tablets (3.5 or 5.25 mg/kg cumulative dose over 96 weeks) or placebo. Safety assessments included monitoring for adverse events (AEs), routine physical and neurologic examinations and frequent laboratory parameter assessments. Of the randomized patients, 88.6% completed treatment with cladribine tablets versus 86.3% with placebo. Lymphopenia was the most commonly reported AE in patients treated with cladribine tablets and was anticipated based on the mechanism of action. The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators. Herpes zoster infections developed in 20 (2.3%) cladribine-treated patients; all cases were dermatomal. There were no herpes zoster infections in the placebo group. Nine (1.0%) patients experienced events related to uterine leiomyomas in the cladribine tablets groups versus one (0.2%) with placebo. Three isolated cases of malignancy were reported in cladribine-treated patients during the study; a fourth was reported during post-study surveillance. A pre-malignant cervical carcinoma in situ was also reported. The incidence of malignancies during the study did not exceed the expected rate in a population standardized for country, gender and age. The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.

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

PubMed

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

2017-08-01

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

Prevalence of Post-tonsillectomy Bleeding as Day-case Surgery with Combination Method; Cold Dissection Tonsillectomy and Bipolar Diathermy Hemostasis

PubMed Central

Faramarzi, Abolahassan; Heydari, Seyed Taghi

2010-01-01

Objective Post-tonsillectomy hemorrhage remains an important factor in determining the safety of performing tonsillectomy as a day case procedure. The aim of this study was to determine the safety of day case tonsillectomy by using combination method, cold dissection tonsillectomy and bipolar diathermy hemostasis. Methods A prospective randomized clinical study conducted on the patients who had undergone day case tonsillectomy (DCT). There were two groups (DCT and control group) each group consisting of 150 cases. Tonsillectomy was performed by using combination method; cold dissection and hemostasis was achieved by ligation of vessels with bipolar electerocautery. Findings We found 3 cases of post-tonsillectomy bleeding in DCT group and 4 cases in the control group. There was no statistically significant difference in the rate of post-operative hemorrhage between the two groups. Conclusion The findings suggest the safety of the combination of cold dissection tonsillectomy and bipolar diathermy hemostasis as day case tonsillectomy. PMID:23056702

New-onset asthma after exposure to the steam system additive 2-diethylaminoethanol. A descriptive study.

PubMed

Gadon, M E; Melius, J M; McDonald, G J; Orgel, D

1994-06-01

Through a leak in the steam heating system, the anticorrosive agent 2-diethylaminoethanol was released into the air of a large office building. Irritative symptoms were experienced by most of the 2500 employees, and 14 workers developed asthma within 3 months of exposure. This study was undertaken to review clinical characteristics of these asthmatics. Environmental exposure monitoring data and medical records were reviewed. Seven of 14 cases were defined as "confirmed" and 7 of 14 as "suspect," using the National Institute for Occupational Safety and Health surveillance case definition of occupational asthma. Spirometry was positive in 4 of 14 of the cases and peak flow testing in 10 of 14. Three cases were diagnosed on the basis of work-related symptoms and physical examination alone. The study suggests that acute exposure to the irritating steam additive 2-diethylaminoethanol was a contributing factor in the development of clinical asthma in this population.

Regenerative braking strategies, vehicle safety and stability control systems: critical use-case proposals

NASA Astrophysics Data System (ADS)

Oleksowicz, Selim A.; Burnham, Keith J.; Southgate, Adam; McCoy, Chris; Waite, Gary; Hardwick, Graham; Harrington, Cian; McMurran, Ross

2013-05-01

The sustainable development of vehicle propulsion systems that have mainly focused on reduction of fuel consumption (i.e. CO2 emission) has led, not only to the development of systems connected with combustion processes but also to legislation and testing procedures. In recent years, the low carbon policy has made hybrid vehicles and fully electric vehicles (H/EVs) popular. The main virtue of these propulsion systems is their ability to restore some of the expended energy from kinetic movement, e.g. the braking process. Consequently new research and testing methods for H/EVs are currently being developed. This especially concerns the critical 'use-cases' for functionality tests within dynamic events for both virtual simulations, as well as real-time road tests. The use-case for conventional vehicles for numerical simulations and road tests are well established. However, the wide variety of tests and their great number (close to a thousand) creates a need for selection, in the first place, and the creation of critical use-cases suitable for testing H/EVs in both virtual and real-world environments. It is known that a marginal improvement in the regenerative braking ratio can significantly improve the vehicle range and, therefore, the economic cost of its operation. In modern vehicles, vehicle dynamics control systems play the principal role in safety, comfort and economic operation. Unfortunately, however, the existing standard road test scenarios are insufficient for H/EVs. Sector knowledge suggests that there are currently no agreed tests scenarios to fully investigate the effects of brake blending between conventional and regenerative braking as well as the regenerative braking interaction with active driving safety systems (ADSS). The paper presents seven manoeuvres, which are considered to be suitable and highly informative for the development and examination of H/EVs with regenerative braking capability. The critical manoeuvres presented are considered to be appropriate for examination of the regenerative braking mode according to ADSS. The manoeuvres are also important for investigation of regenerative braking system properties/functionalities that are specified by the legal requirements concerning H/EVs braking systems. The last part of this paper shows simulation results for one of the proposed manoeuvres that explicitly shows the usefulness of the manoeuvre.

In search of the autologous clip: a case for experimental standardization.

PubMed

Krugman, Kimberly A; Martin, Kimberly E; Cosgriff, Ned; Slakey, Douglas P

2011-10-01

In an effort to enable faster and, at times, more challenging surgeries without compromising patient or physician safety, medical device manufacturers have created myriad solutions to vascular ligation through the development of novel tools. The speed of development, FDA approval, and dissemination of these devices into the hands of surgeons often outpaces the ability of investigators to critically evaluate comparative effectiveness of these devices. The Medline database was searched for energy-based vessel ligation devices. To remove any perception bias against non-Covidien instruments, critical review was applied only to the devices manufactured by our company. We report on the variability present in published results and offer vital metrics for future studies. Standardized testing and reporting for measures of safety and efficacy of these surgical instruments awaits definition from a consensus group.

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

PubMed Central

Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

How do chiropractors manage clinical risk? A questionnaire study.

PubMed

Wangler, Martin; Peterson, Cynthia; Zaugg, Beatrice; Thiel, Haymo; Finch, Rob

2013-06-08

The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent's practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann-Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite '% positive agreement' score calculated for each dimension. Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. Gender differences were observed with female chiropractors appearing to be more risk averse. Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by re-evaluating the case. The unlikeliness of safety incident reporting is probably due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.

Decision support environment for medical product safety surveillance.

PubMed

Botsis, Taxiarchis; Jankosky, Christopher; Arya, Deepa; Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Wang, Wei; Zhang, Guangfan; Forshee, Richard; Goud, Ravi; Menschik, David; Walderhaug, Mark; Woo, Emily Jane; Scott, John

2016-12-01

We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization. Published by Elsevier Inc.

Development of a Software Safety Process and a Case Study of Its Use

NASA Technical Reports Server (NTRS)

Knight, J. C.

1996-01-01

Research in the year covered by this reporting period has been primarily directed toward: continued development of mock-ups of computer screens for operator of a digital reactor control system; development of a reactor simulation to permit testing of various elements of the control system; formal specification of user interfaces; fault-tree analysis including software; evaluation of formal verification techniques; and continued development of a software documentation system. Technical results relating to this grant and the remainder of the principal investigator's research program are contained in various reports and papers.

Assuring Ground-Based Detect and Avoid for UAS Operations

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

2014-01-01

One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

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

PubMed

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

2017-09-01

Hospital electronic prescribing (ePrescribing) systems offer a wide range of patient safety benefits. Like other hospital health information technology interventions, however, they may also introduce new areas of risk. Despite recent advances in identifying these risks, the development and use of ePrescribing systems is still leading to numerous unintended consequences, which may undermine improvement and threaten patient safety. These negative consequences need to be analysed in the design, implementation and use of these systems. We therefore aimed to understand the roots of these reported threats and identify candidate avoidance/mitigation strategies. We analysed a longitudinal, qualitative study of the implementation and adoption of ePrescribing systems in six English hospitals, each being conceptualised as a case study. Data included semistructured interviews, observations of implementation meetings and system use, and a collection of relevant documents. We analysed data first within and then across the case studies. Our dataset included 214 interviews, 24 observations and 18 documents. We developed a taxonomy of factors underlying unintended safety threats in: (1) suboptimal system design, including lack of support for complex medication administration regimens, lack of effective integration between different systems, and lack of effective automated decision support tools; (2) inappropriate use of systems-in particular, too much reliance on the system and introduction of workarounds; and (3) suboptimal implementation strategies resulting from partial roll-outs/dual systems and lack of appropriate training. We have identified a number of system and organisational strategies that could potentially avoid or reduce these risks. Imperfections in the design, implementation and use of ePrescribing systems can give rise to unintended consequences, including safety threats. Hospitals and suppliers need to implement short- and long-term strategies in terms of the technology and organisation to minimise the unintended safety risks. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A Case History Introducing the Oregon Ag Seminar Series-Keys to Program and Research-to-Practice Success.

PubMed

Harrington, Marcy J; Lloyd, Kirk

2017-01-01

This case history of Oregon state's Ag Seminar Series is consistent with the Socio-Ecological Model, demonstrating how policy at a state level can influence an organizational approach with impacts that ultimately influence safety practices on the farm. From modest beginnings, the Ag Seminar Series, offered through a workers compensation insurance company, now serves over 2,300 Oregon farmers annually in English and Spanish. This case offers unique but also replicable methods for educators, insurers, and researchers in safety education, safety motivators, and research-to-practice (r2p).

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, patient safety education in clinical settings should focus on emergencies, where students perceive most errors.

Lamotrigine rechallenge after a skin rash. A combined study of open cases and a meta-analysis.

PubMed

Serrani Azcurra, Daniel J L

2013-01-01

To determine the safety of lamotrigine rechallenge after a first episode of skin rash in bipolar patients. An open cases prospective study was conducted with patients who, developed a skin rash when first treated with lamotrigine, were refractory to other treatments, and were offered lamotrigine rechallenge using a different dose titration. Additionally a review was performed on previous skin rash management strategies and lamotrigine rechallenge reports. Every 3 out of 10 lamotrigine rechallenge patients required drug interruption due to persistent rash. One of them was potentially serious and resolved by stopping the lamotrigine. The review of available literature identified several lamotrigine rechallenge studies with rates of positive results varying between 70% and 87% depending on the study. No patient developed Stevens-Johnson syndrome or toxic epidermal necrolysis after rechallenge. The rate of rash was higher when rechallenge began between 4 weeks from initial rash (19% vs. 7%, P=.001) and decreased when first rash showed no potentially serious signs (0% vs.19%, P=.01). Rechallenge is a viable option after a benign lamotrigine-induced rash, and can even be rechallenged after rash with greater precautions when there exists one or two potentially serious signs. In cases of more serious rash there are no reliable data available on rechallenge safety and it may pose a significant risk. In those cases rechallenge should better be avoided between 4 weeks from first rash. Copyright © 2011 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

Federal and tribal lands road safety audits : case studies

DOT National Transportation Integrated Search

2009-12-01

A road safety audit (RSA) is a formal safety performance examination by an independent, multidisciplinary team. RSAs are an effective tool for proactively improving the safety performance of a road project during the planning and design stages, and f...

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

PubMed

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

2017-05-01

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

Safety of Gadobutrol

PubMed Central

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

2016-01-01

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

Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

PubMed

Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

2017-06-01

The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological health - can improve the safety performance of an organization. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks.

PubMed

Fujikawa, Makoto; Ono, Shunsuke

2017-01-01

Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access. This study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan. We studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014. We focused on three different types of SRRAs: (1) all-SRRAs (i.e. SRRAs from domestic cases and other countries), (2) domestic-SRRAs (i.e. SRRAs from domestic cases) and (3) domestic unknown-SRRAs (i.e. SRRAs of unknown risks from domestic cases). Occurrences of the three types of SRRAs were analyzed using Kaplan-Meier analysis and Cox-regression. SRRAs tended to occur sooner for NMEs launched in recent years versus those launched towards the beginning of the study period. Risk of SRRA was high for antineoplastics. Drugs for cardiovascular diseases, central nervous system, and diabetes had positive associations with all-SRRAs, but the associations were weaker with domestic-SRRAs. Domestic-SRRAs were more likely for drugs with relatively novel modes of action (MOAs). Longer lag to Japanese launch after first global launch significantly lowered SRRA risks. While most of the variables showed similar associations across the three types of SRRAs, adoption of bridging strategies showed higher risks only for domestic-SRRAs, not for all-SRRAs. FDA safety labeling changes and non-orphan priority review drugs presented higher domestic-SRRA risks. The number of adverse drug reactions (ADRs) from spontaneous reports had positive correlations with the three types of SRRAs, whereas the number from company-led surveillance showed no association. Our results indicated that global clinical development pathways and marketing status should be considered more seriously in implementing locally optimized pharmacovigilance activities. Caution may be needed not only for drugs with novel MOAs, but also for drugs for which local dose-finding studies have been skipped, expedited review status has been given, timing of launch is close to those in the USA and the EU, and spontaneous reports rather than company-lead surveillance suggest possible safety risks.

The Shirts on Our Backs: Teleological Perspectives on Factory Safety in Bangladesh

ERIC Educational Resources Information Center

Dhooge, Lucien J.

2016-01-01

This case study addresses the issue of factory safety in the garment industry through an examination of two recent catastrophic failures in Bangladesh. The case study was designed for students in Business Ethics in the MBA curriculum at the Scheller College of Business at the Georgia Institute of Technology. The case study has also been adapted…

Predicting the velocity and azimuth of fragments generated by the range destruction or random failure of rocket casings and tankage

NASA Astrophysics Data System (ADS)

Eck, M.; Mukunda, M.

The proliferation of space vehicle launch sites and the projected utilization of these facilities portends an increase in the number of on-pad, ascent, and on-orbit solid-rocket motor (SRM) casings and liquid-rocket tanks which will randomly fail or will fail from range destruct actions. Beyond the obvious safety implications, these failures may have serious resource implications for mission system and facility planners. SRM-casing failures and liquid-rocket tankage failures result in the generation of large, high velocity fragments which may be serious threats to the safety of launch support personnel if proper bunkers and exclusion areas are not provided. In addition, these fragments may be indirect threats to the general public's safety if they encounter hazardous spacecraft payloads which have not been designed to withstand shrapnel of this caliber. They may also become threats to other spacecraft if, by failing on-orbit, they add to the ever increasing space-junk collision cross-section. Most prior attempts to assess the velocity of fragments from failed SRM casings have simply assigned the available chamber impulse to available casing and fuel mass and solved the resulting momentum balance for velocity. This method may predict a fragment velocity which is high or low by a factor of two depending on the ratio of fuel to casing mass extant at the time of failure. Recognizing the limitations of existing methods, the authors devised an analytical approach which properly partitions the available impulse to each major system-mass component. This approach uses the Physics International developed PISCES code to couple the forces generated by an Eulerian modeled gas flow field to a Lagrangian modeled fuel and casing system. The details of a predictive analytical modeling process as well as the development of normalized relations for momentum partition as a function of SRM burn time and initial geometry are discussed in this paper. Methods for applying similar modeling techniques to liquid-tankage-over-pressure failures are also discussed. These methods have been calibrated against observed SRM ascent failures and on-orbit tankage failures. Casing-quadrant sized fragments with velocities exceeding 100 m/s resulted from Titan 34D-SRM range destruct actions at 10 s mission elapsed time (MET). Casing-quadrant sized fragments with velocities of approx. 200 m/s resulted from STS-SRM range destruct actions at 110 s MET. Similar sized fragments for Ariane third stage and Delta second stage tankage were predicted to have maximum velocities of 260 and 480 m/s respectively. Good agreement was found between the predictions and observations for five specific events and it was concluded that the methods developed have good potential for use in predicting the fragmentation process of a number of generically similar casing and tankage systems.

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience.

PubMed

Marcinak, John F; Munsaka, Melvin S; Watkins, Paul B; Ohira, Takashi; Smith, Neila

2018-06-01

Fasiglifam (TAK-875) is a G protein-coupled receptor 40 agonist that was being investigated for treatment of type 2 diabetes mellitus (T2DM). A development program was terminated late in phase III clinical trials due to liver safety concerns. The liver safety of fasiglifam was assessed from data based on six phase II and nine phase III double-blind studies and two open-label studies with emphasis on pooled data from 15 double-blind studies from both global and Japanese development programs. Taking into consideration different daily doses of fasiglifam administered in clinical studies, the primary comparisons were between all patients exposed to fasiglifam (any dose) versus placebo, and, where applicable, versus the two active comparators, sitagliptin or glimepiride. A Liver Safety Evaluation Committee consisting of hepatologists blinded to treatment assignments evaluated hepatic adverse events (AEs) and serious AEs (SAEs) for causal relationship to study drug. The analysis included data from 9139 patients with T2DM in 15 double-blind controlled studies who received either fasiglifam (n = 5359, fasiglifam group), fasiglifam and sitagliptin (n = 123), or a comparator agent (n = 3657, non-exposed group consisting of placebo and other antidiabetic agents). Exposure to treatment for more than 1 year ranged from 249 patients in the placebo arm, to 370 patients in the glimepiride arm and 617 patients in the fasiglifam 50 mg arm. The primary focus of the analysis was on the hepatic safety of fasiglifam. The overall safety profile based on treatment-emergent AEs (TEAEs), SAEs, deaths, and withdrawal due to AEs was similar between fasiglifam and placebo (excluding liver test abnormalities). However, there was an increased incidence rate of serum alanine aminotransferase (ALT) elevations > 3 × upper limit of normal (ULN), 5 × ULN, and 10 × ULN in fasiglifam-treated patients compared with those treated with placebo or active comparators. ALT elevations > 3 × ULN for fasiglifam were 2.7% compared with 0.8 and 0.5% for the active comparators and placebo. There did not appear to be a clear dose response in incidence of ALT elevations between patients receiving 25 or 50 mg daily. The cumulative incidence of elevations in serum ALT > 3 × ULN was higher in the first 6 months of treatment with fasiglifam compared with both placebo and the active comparators, but the rate of new ALT elevations appeared to be similar across all treatment groups thereafter. No demographic or baseline patient characteristics were identified to predict elevations exceeding ALT > 3 × ULN in fasiglifam-treated patients. The pattern of liver injury with fasiglifam was hepatocellular, and there were no reports of liver-related deaths, liver failure or life-threatening liver injury. Most fasiglifam-associated ALT elevations were asymptomatic and resolved promptly upon discontinuing treatment, but in two patients the recovery was prolonged. Importantly, three important serious liver injury cases were identified among fasiglifam-treated patients; one case was adjudicated to be a clear Hy's Law case and the two remaining cases were considered to closely approximate Hy's Law cases. Although the incidence of overall AEs, SAEs, and deaths was similar between fasiglifam and placebo, a liver signal was identified based primarily on the difference in liver chemistry values in the fasiglifam group compared with the placebo and active comparator groups. Three serious liver injuries were attributed to fasiglifam treatment. Clinical development of fasiglifam was halted due to these liver safety concerns.

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

PubMed

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

2016-07-01

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

Application of seismic interpretation in the development of Jerneh Field, Malay Basin

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

Yusoff, Z.

1994-07-01

Development of the Jerneh gas field has been significantly aided by the use of 3-D and site survey seismic interpretations. The two aspects that have been of particular importance are identification of sea-floor and near-surface safety hazards for safe platform installation/development drilling and mapping of reservoirs/hydrocarbons within gas-productive sands of the Miocene groups B, D, and E. Choice of platform location as well as casing design require detailed analysis of sea-floor and near-surface safety hazards. At Jerneh, sea-floor pockmarks near-surface high amplitudes, distributary channels, and minor faults were recognized as potential operational safety hazards. The integration of conventional 3-D andmore » site survey seismic data enabled comprehensive understanding of the occurrence and distribution of potential hazards to platform installation and development well drilling. Three-dimensional seismic interpretation has been instrumental not only in the field structural definition but also in recognition of reservoir trends and hydrocarbon distribution. Additional gas reservoirs were identified by their DHI characteristics and subsequently confirmed by development wells. The innovative use of seismic attribute mapping techniques has been very important in defining both fluid and reservoir distribution in groups B and D. Integration of 3-D seismic data and well-log interpretations has helped in optimal field development, including the planning of well locations and drilling sequence.« less

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.

PubMed

Yim, Haejun; Yang, Hyeong-Tae; Cho, Yong-Suk; Kim, Dohern; Kim, Jong-Hyun; Chun, Wook; Hur, Jun

2014-12-01

This study is a phase 1 and 2 clinical trial for investigating the safety profile, effective treatment dose and effectiveness of the newly developed thermosensitive hydrogel-type cultured epidermal allograft. For phase 1, the keratinocytes were divided into 3 groups as follows, with 5 patients in each group: (1) low-dose group (6.7×10(6)/1.5mL), (2) medium-dose group (2×10(7)/1.5mL), and (3) high-dose group (6.0×10(7)/1.5mL). The second phase of the trial proceeded with 10 cases after choosing the most effective dose based on the analysis of the first phase. When comparing re-epithelialization time, medium- and high-dose group showed significantly shorter re-epithelialization time than low-dose group (p=0.003 and p=0.002). A total of 15 cases, 5 cases selected from phase 1 and 10 cases test in phase 2 with the medium dose, were compared with the re-epithelialization period. The re-epithelialization period was 9.6±4.0 days in the test site and 12.4±4.8 days in the control site. In the test site, re-epithelialization was 2.8±1.8 days faster than in the control site (p<0.0001). There was no significant adverse reaction in our clinical trial. In conclusion, this new type of CEAllo accelerates wound healing time and shows the safety. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Determinants of Downtown Image and Retail Patronage: A Case of Fargo, North Dakota

ERIC Educational Resources Information Center

Lee, Jaeha; Park, Kwangsoo

2017-01-01

We sought to identify determinants of downtown image and retail patronage, which contribute to tourism development in small and mid-sized communities. The purpose of our research was twofold: (a) to understand how visitors perceive the business mix, safety, and atmosphere of the Fargo, North Dakota, downtown and (b) to identify what factors…

Dynamic characteristics of timber bridges as a measure of structural integrity

Treesearch

Angus Morison; C.D. VanKarsen; H.A. Evensen; J.B. Ligon; J.R. Erickson; R.J. Ross; J.W. Forsman

2003-01-01

Bridges require periodic inspections to ensure the safety of those using the structure. A myriad of techniques have been developed in order to quickly and accurately determine a structure's health. Unfortunately, timber structures are still, in most cases, subjectively evaluated. Decay is one of the most common damage mechanisms in these structures, and often...

The potential of novel infrared food processing technologies: case studies of those developed at the USDA-ARS WRRC and the University of California Davis

USDA-ARS?s Scientific Manuscript database

Infrared (IR) radiation heating has been considered as an alternative to current food and agricultural processing methods for improving product quality and safety, increasing energy and processing efficiency, and reducing water and chemical usage. As part of the electromagnetic spectrum, IR has the ...

"A Game for All Shapes and Sizes": Safeguarding Children from Sporting Mismatches

ERIC Educational Resources Information Center

Greenfield, Steve

2015-01-01

Sport is an increasingly important area of society both inside and outside of the school environment although this has not always been the case. Greater interest in sports policy is also emerging at both a European and International level with the prospective of a "Rights" based approach developing. The safety of those playing sport is…

Integrating Public Relations and Legal Responses during a Crisis: The Case of Odwalla, Inc.

ERIC Educational Resources Information Center

Martinelli, Kathleen A.; Briggs, William

1998-01-01

Examines the crisis-communication strategies employed by Odwalla, Inc. during its juice contamination crisis, a crisis whose impact on public health and safety gave it the potential for developing into an issue that required public policy relief. Finds that public-relations response strategies dominated legal response strategies, followed by mixed…

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

PubMed

Anderson, Devon E; Watts, Bradley V

2013-09-01

Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

Toxic release consequence analysis tool (TORCAT) for inherently safer design plant.

PubMed

Shariff, Azmi Mohd; Zaini, Dzulkarnain

2010-10-15

Many major accidents due to toxic release in the past have caused many fatalities such as the tragedy of MIC release in Bhopal, India (1984). One of the approaches is to use inherently safer design technique that utilizes inherent safety principle to eliminate or minimize accidents rather than to control the hazard. This technique is best implemented in preliminary design stage where the consequence of toxic release can be evaluated and necessary design improvements can be implemented to eliminate or minimize the accidents to as low as reasonably practicable (ALARP) without resorting to costly protective system. However, currently there is no commercial tool available that has such capability. This paper reports on the preliminary findings on the development of a prototype tool for consequence analysis and design improvement via inherent safety principle by utilizing an integrated process design simulator with toxic release consequence analysis model. The consequence analysis based on the worst-case scenarios during process flowsheeting stage were conducted as case studies. The preliminary finding shows that toxic release consequences analysis tool (TORCAT) has capability to eliminate or minimize the potential toxic release accidents by adopting the inherent safety principle early in preliminary design stage. 2010 Elsevier B.V. All rights reserved.

International trade standards for commodities and products derived from animals: the need for a system that integrates food safety and animal disease risk management.

PubMed

Thomson, G R; Penrith, M-L; Atkinson, M W; Thalwitzer, S; Mancuso, A; Atkinson, S J; Osofsky, S A

2013-12-01

A case is made for greater emphasis to be placed on value chain management as an alternative to geographically based disease risk mitigation for trade in commodities and products derived from animals. The geographic approach is dependent upon achievement of freedom in countries or zones from infectious agents that cause so-called transboundary animal diseases, while value chain-based risk management depends upon mitigation of animal disease hazards potentially associated with specific commodities or products irrespective of the locality of production. This commodity-specific approach is founded on the same principles upon which international food safety standards are based, viz. hazard analysis critical control points (HACCP). Broader acceptance of a value chain approach enables animal disease risk management to be combined with food safety management by the integration of commodity-based trade and HACCP methodologies and thereby facilitates 'farm to fork' quality assurance. The latter is increasingly recognized as indispensable to food safety assurance and is therefore a pre-condition to safe trade. The biological principles upon which HACCP and commodity-based trade are based are essentially identical, potentially simplifying sanitary control in contrast to current separate international sanitary standards for food safety and animal disease risks that are difficult to reconcile. A value chain approach would not only enable more effective integration of food safety and animal disease risk management of foodstuffs derived from animals but would also ameliorate adverse environmental and associated socio-economic consequences of current sanitary standards based on the geographic distribution of animal infections. This is especially the case where vast veterinary cordon fencing systems are relied upon to separate livestock and wildlife as is the case in much of southern Africa. A value chain approach would thus be particularly beneficial to under-developed regions of the world such as southern Africa specifically and sub-Saharan Africa more generally where it would reduce incompatibility between attempts to expand and commercialize livestock production and the need to conserve the subcontinent's unparalleled wildlife and wilderness resources. © 2013 Blackwell Verlag GmbH.

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

NASA Astrophysics Data System (ADS)

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

2013-09-01

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

Learning about patient safety: organizational context and culture in the education of health care professionals.

PubMed

Pearson, Pauline; Steven, Alison; Howe, Amanda; Sheikh, Aziz; Ashcroft, Darren; Smith, Pam

2010-01-01

This study investigated the formal and informal ways pre-registration students from medicine, nursing, physiotherapy and pharmacy learn about keeping patients safe. This paper gives an overview of the study and explores findings in relation to organizational context and culture. The study employed a phased design using multiple qualitative methods. The overall approach drew on 'illuminative evaluation'. Ethical approval was obtained. Phase 1 employed a convenience sample of 13 pre-registration courses across the UK. Curriculum documents were gathered, and course directors interviewed. Phase 2 used eight case studies, two for each professional group, to develop an in-depth investigation of learning across university and practice by students and newly-qualified practitioners in relation to patient safety, and to examine the organizational culture that students and newly-qualified staff are exposed to. Analysis was iterative and ongoing throughout the study, using frameworks agreed by all researchers. Patient safety was felt to have become a higher priority for the health care system in recent years. Incident reporting was a key feature of the patient safety agenda within the organizations examined. Staff were often unclear or too busy to report. On the whole, students were not engaged and may not be aware of incident reporting schemes. They may not have access to existing systems in their organization. Most did not access employers' induction programmes. Some training sessions occasionally included students but this did not appear to be routine. Action is needed to develop an efficient interface between employers and education providers to develop up-to-date curricula for patient safety.

An Australasian model license reassessment procedure for identifying potentially unsafe drivers.

PubMed

Fildes, Brian N; Charlton, Judith; Pronk, Nicola; Langford, Jim; Oxley, Jennie; Koppel, Sjaanie

2008-08-01

Most licensing jurisdictions in Australia currently employ age-based assessment programs as a means to manage older driver safety, yet available evidence suggests that these programs have no safety benefits. This paper describes a community referral-based model license re assessment procedure for identifying and assessing potentially unsafe drivers. While the model was primarily developed for assessing older driver fitness to drive, it could be applicable to other forms of driver impairment associated with increased crash risk. It includes a three-tier process of assessment, involving the use of validated and relevant assessment instruments. A case is argued that this process is a more systematic, transparent and effective process for managing older driver safety and thus more likely to be widely acceptable to the target community and licensing authorities than age-based practices.

Does availability of mental health resources prevent recurrent suicidal behavior? An ecological analysis.

PubMed

Cooper, Sara L; Lezotte, Dennis; Jacobellis, Jillian; Diguiseppi, Carolyn

2006-08-01

This study examines whether availability of mental health resources in the county of residence is associated with subsequent suicidal behavior after a previous suicide attempt. Among 10,922 individuals who attempted suicide in Colorado between 1998 and 2002, residence in a county that offered a minimum safety-net of mental health services significantly reduced the risk of suicidal behavior for at least 1 year after the index attempt. Safety-net services included mental health treatment, crisis treatment, and case management. These results suggest one strategy for prevention of suicidal behavior that could inform state-level health policy development and resource allocation.

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

Polymer optical fiber sensors in human life safety

NASA Astrophysics Data System (ADS)

Marques, C. A. F.; Webb, D. J.; Andre, P.

2017-07-01

The current state of research into polymer optical fiber (POF) sensors linked to safety in human life is summarized in this paper. This topic is directly related with new solutions for civil aircraft, structural health monitoring, healthcare and biomedicine fields. In the last years, the properties of polymers have been explored to identify situations offering potential advantages over conventional silica fiber sensing technology, replacing, in some cases, problematic electronic technology used in these mentioned fields, where there are some issues to overcome. POFs could preferably replace their silica counterparts, with improved performance and biocompatibility. Finally, new developments are reported which use the unique properties of POF.

Effective communications strategies: engaging the media, policymakers, and the public.

PubMed

Blake, Allison; Bonk, Kathy; Heimpel, Daniel; Wright, Cathy S

2013-01-01

Too often, strategic communication is too little, or comes too late, when involved with a child fatality or serious injury. This article explores the challenges arising from negative publicity around child safety issues and the opportunities for communications strategies that employ a proactive public health approach to engaging media, policymakers, and the public. The authors provide a case study and review methods by which child welfare agencies across the nation are building public engagement and support for improved outcomes in child safety while protecting legitimate confidentiality requirements. Finally, the piece articulates the rationale for agency investments in the resources necessary to develop and implement an effective communications plan.

How to reduce your inventory: a real world case study.

PubMed

Mack, J A; Jordan, H H

1994-08-01

This case study describes the use of a performance analysis system at the Safety Products Division of Mine Safety Appliances Company, which contributed to the reduction of excess inventories by more than $8,000,000 during the first two years of implementation.

TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.

PubMed

Weld, Lancaster R; Stringer, Matthew T; Ebertowski, James S; Baumgartner, Timothy S; Kasprenski, Matthew C; Kelley, Jeremy C; Cho, Doug S; Tieva, Erwin A; Novak, Thomas E

2016-09-01

The objective was to evaluate the effect of TeamSTEPPS on operating room efficiency and patient safety. TeamSTEPPS consisted of briefings attended by all health care personnel assigned to the specific operating room to discuss issues unique to each case scheduled for that day. The operative times, on-time start rates, and turnover times of all cases performed by the urology service during the initial year with TeamSTEPPS were compared to the prior year. Patient safety issues identified during postoperative briefings were analyzed. The mean case time was 12.7 minutes less with TeamSTEPPS (P < .001). The on-time first-start rate improved by 21% with TeamSTEPPS (P < .001). The mean room turnover time did not change. Patient safety issues declined from an initial rate of 16% to 6% at midyear and remained stable (P < 0.001). TeamSTEPPS was associated with improved operating room efficiency and diminished patient safety issues in the operating room. © The Author(s) 2015.

Maintenance and Safety Practices of Escalator in Commercial Buildings

NASA Astrophysics Data System (ADS)

Afida Isnaini Janipha, Nurul; Nur Aina Syed Alwee, Sharifah; Ariff, Raihan Mohd; Ismail, Faridah

2018-02-01

The escalator is very crucial to transport a person from one place to another. Nevertheless, there are many cases recorded the accidents in relation to escalator. These may occur due to lack of maintenance which leads to systems breakdown, poor safety practices, wear and tear, users’ negligence and others. Thus, proper maintenance systems need to be improvised to prevent and reduce escalator accident in future. This research was aimed to determine the escalator maintenance activities and safety practices in a commercial building. Three case studies were selected within Selangor area. Semi-structured interviews were conducted for collecting data from these three case studies. To achieve the aim of this research, the study was carried out on the maintenance activities, safety practices and cost related to escalator maintenance. As one of the important means of access in building, it is very crucial to increase effectiveness of escalator particularly in commercial building. It is expected that readers will get clear information on the maintenance activities and safety practices of escalator in commercial building.

[Feasibility and relevance of an operating room safety checklist for developing countries: Study in a French hospital in Djibouti].

PubMed

Becret, A; Clapson, P; Andro, C; Chapelier, X; Gauthier, J; Kaiser, E

2013-01-01

The use of the World Health Organization surgical safety checklist, mandatory in operating rooms (OR) in France, significantly reduces morbidity and mortality. Our objective was to evaluate the use of this checklist in the OR of a French military hospital in Djibouti (Horn of Africa). The study was performed in three stages: a retrospective evaluation of the checklist use over the previous two months, to assess the utilization and completeness rates; provision of information to the OR staff; and thereafter, prospective evaluation for a one-month period of checklist use, the reasons for non-compliance, and the cases in which the checklist identified errors and thus prevented serious adverse events. The initial utilization rate was 49%, with only 24% complete. After staff training and during the study these rates reached 100% and 99%. The staff encountered language difficulties in 53% of cases, and an interpreter was available for 81% of them. The capacity of the surgical safety checklist to detect serious adverse events was highlighted. The utilization and completeness rates were initially worse than those observed in metropolitan French ORs, but a simple staff information program was rapidly effective. Language difficulties are frequent but an interpreter is often available, unlike in developed countries where language problems are uncommon and the availability of interpreters difficult. Moreover, this study illustrates the ability of the checklist to detect and therefore prevent potentially serious adverse events.

Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

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

Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.

Safety tests were conducted on fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800 °C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during 15 of these safety tests. Comparisons between PARFUME predictions and post-irradiation examination results of the safety tests were conducted on two types of AGR-1 compacts: compactsmore » containing only intact particles and compacts containing one or more particles whose SiC layers failed during safety testing. In both cases, PARFUME globally over-predicted the experimental release fractions by several orders of magnitude: more than three (intact) and two (failed SiC) orders of magnitude for silver, more than three and up to two orders of magnitude for strontium, and up to two and more than one orders of magnitude for krypton. The release of cesium from intact particles was also largely over-predicted (by up to five orders of magnitude) but its release from particles with failed SiC was only over-predicted by a factor of about 3. These over-predictions can be largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. The integral release nature of the data makes it difficult to estimate the individual over-estimations in the kernel or each coating layer. Nevertheless, a tentative assessment of correction factors to these diffusivities was performed to enable a better match between the modeling predictions and the safety testing results. The method could only be successfully applied to silver and cesium. In the case of strontium, correction factors could not be assessed because potential release during the safety tests could not be distinguished from matrix content released during irradiation. Furthermore, in the case of krypton, all the coating layers are partly retentive and the available data did not allow the level of retention in individual layers to be determined, hence preventing derivation of any correction factors.« less

Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

DOE PAGES

Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.; ...

2016-04-07

Safety tests were conducted on fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800 °C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during 15 of these safety tests. Comparisons between PARFUME predictions and post-irradiation examination results of the safety tests were conducted on two types of AGR-1 compacts: compactsmore » containing only intact particles and compacts containing one or more particles whose SiC layers failed during safety testing. In both cases, PARFUME globally over-predicted the experimental release fractions by several orders of magnitude: more than three (intact) and two (failed SiC) orders of magnitude for silver, more than three and up to two orders of magnitude for strontium, and up to two and more than one orders of magnitude for krypton. The release of cesium from intact particles was also largely over-predicted (by up to five orders of magnitude) but its release from particles with failed SiC was only over-predicted by a factor of about 3. These over-predictions can be largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. The integral release nature of the data makes it difficult to estimate the individual over-estimations in the kernel or each coating layer. Nevertheless, a tentative assessment of correction factors to these diffusivities was performed to enable a better match between the modeling predictions and the safety testing results. The method could only be successfully applied to silver and cesium. In the case of strontium, correction factors could not be assessed because potential release during the safety tests could not be distinguished from matrix content released during irradiation. Furthermore, in the case of krypton, all the coating layers are partly retentive and the available data did not allow the level of retention in individual layers to be determined, hence preventing derivation of any correction factors.« less

Pay Matters: The Piece Rate and Health in the Developing World.

PubMed

Davis, Mary E

Piece rate pay remains a common form of compensation in developing-world industries. While the piece rate may boost productivity, it has been shown to have unintended consequences for occupational safety and health, including increased accident and injury risk. This paper explores the relationship between worker pay and physical and emotional health, and questions the modern day business case for piece rate pay in the developing world. The relationship between piece rate and self-reported measures of physical and emotional health is estimated using a large survey of garment workers in 109 Vietnamese factories between 2010 and 2014. A random effects logit model controls for factory and year, predicting worker health as a function of pay type, demographics, and factory characteristics. Workers paid by the piece report worse physical and emotional health than workers paid by the hour (OR = 1.38-1.81). Wage incentives provide the most consistently significant evidence of all demographic and factory-level variables, including the factory's own performance on occupational safety and health compliance measures. These results highlight the importance of how workers are paid to understanding the variability in worker health outcomes. More research is needed to better understand the business case supporting the continued use of piece rate pay in the developing world. Copyright © 2016 The Author. Published by Elsevier Inc. All rights reserved.

Car Safety Seat Usage and Selection Among Families Attending University Hospital Limerick.

PubMed

Scully, P; Finner, N; Letshwiti, J B; O'Gorman, C

2016-05-10

The safest way for children to travel within a car is by provision of a weight-appropriate safety-seat. To investigate this, we conducted a cross-sectional study of adult parents who had children under 12 years, and collected information related to: car use, safety-seat legislation, and type of safety-seat employed. Data were reviewed on 120 children from 60 respondents. Ninety-eight (81.7%) children were transported daily by car. Forty-eight (81.4%) respondents were aware that current safety-seat legislation is based on the weight of the child. One hundred and seven (89.9%) children were restrained during travel using a car safety-seat. One hundred and two (96.2%) safety seats were newly purchased, installed in 82.3% (88) cases by family members with installation instructions fully read in 58 (55.2%) cases. Ninety-nine (83.2%) children were restrained using an appropriate safety-seat for their weight. The results show that four out of five families are employing the most appropriate safety-seat for their child, so providing an effective mechanism to reduce car-related injury. However, the majority of safety-seats are installed by family members, which may have child safety consequences.

Neurobehavioural methods, effects and prevention: workers' human rights are why the field matters for developing countries.

PubMed

London, L

2009-11-01

Little research into neurobehavioural methods and effects occurs in developing countries, where established neurotoxic chemicals continue to pose significant occupational and environmental burdens, and where agents newly identified as neurotoxic are also widespread. Much of the morbidity and mortality associated with neurotoxic agents remains hidden in developing countries as a result of poor case detection, lack of skilled personnel, facilities and equipment for diagnosis, inadequate information systems, limited resources for research and significant competing causes of ill-health, such as HIV/AIDS and malaria. Placing the problem in a human rights context enables researchers and scientists in developing countries to make a strong case for why the field of neurobehavioural methods and effects matters because there are numerous international human rights commitments that make occupational and environmental health and safety a human rights obligation.

The Unexpected Education: What We Can Learn from Disaster News Stories.

ERIC Educational Resources Information Center

Garner, Ana C.

A study explored the safety education provided by six newspapers, using the 1988 crash of Delta Flight 1141 as a case study. A total of 351 "Delta 1141" news stories were analyzed for five key areas: overall story category, passenger safety theme, flight personnel safety theme, plane safety theme, and rescue safety. Of the stories…

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.

Acute And Long-Term Bioeffects And Lamp Safety

NASA Astrophysics Data System (ADS)

Andersen, F. Alan

1980-10-01

Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

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 Training--A Special Case?

ERIC Educational Resources Information Center

Cooper, Mark; Cotton, David

2000-01-01

Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

Future challenges to microbial food safety.

PubMed

Havelaar, Arie H; Brul, Stanley; de Jong, Aarieke; de Jonge, Rob; Zwietering, Marcel H; Ter Kuile, Benno H

2010-05-30

Despite significant efforts by all parties involved, there is still a considerable burden of foodborne illness, in which micro-organisms play a prominent role. Microbes can enter the food chain at different steps, are highly versatile and can adapt to the environment allowing survival, growth and production of toxic compounds. This sets them apart from chemical agents and thus their study from food toxicology. We summarize the discussions of a conference organized by the Dutch Food and Consumer Products Safety Authority and the European Food Safety Authority. The goal of the conference was to discuss new challenges to food safety that are caused by micro-organisms as well as strategies and methodologies to counter these. Management of food safety is based on generally accepted principles of Hazard Analysis Critical Control Points and of Good Manufacturing Practices. However, a more pro-active, science-based approach is required, starting with the ability to predict where problems might arise by applying the risk analysis framework. Developments that may influence food safety in the future occur on different scales (from global to molecular) and in different time frames (from decades to less than a minute). This necessitates development of new risk assessment approaches, taking the impact of different drivers of change into account. We provide an overview of drivers that may affect food safety and their potential impact on foodborne pathogens and human disease risks. We conclude that many drivers may result in increased food safety risks, requiring active governmental policy setting and anticipation by food industries whereas other drivers may decrease food safety risks. Monitoring of contamination in the food chain, combined with surveillance of human illness and epidemiological investigations of outbreaks and sporadic cases continue to be important sources of information. New approaches in human illness surveillance include the use of molecular markers for improved outbreak detection and source attribution, sero-epidemiology and disease burden estimation. Current developments in molecular techniques make it possible to rapidly assemble information on the genome of various isolates of microbial species of concern. Such information can be used to develop new tracking and tracing methods, and to investigate the behavior of micro-organisms under environmentally relevant stress conditions. These novel tools and insight need to be applied to objectives for food safety strategies, as well as to models that predict microbial behavior. In addition, the increasing complexity of the global food systems necessitates improved communication between all parties involved: scientists, risk assessors and risk managers, as well as consumers. Copyright 2009 Elsevier B.V. All rights reserved.

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

PubMed

Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel

2009-01-01

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

Road safety forecasts in five European countries using structural time series models.

PubMed

Antoniou, Constantinos; Papadimitriou, Eleonora; Yannis, George

2014-01-01

Modeling road safety development is a complex task and needs to consider both the quantifiable impact of specific parameters as well as the underlying trends that cannot always be measured or observed. The objective of this research is to apply structural time series models for obtaining reliable medium- to long-term forecasts of road traffic fatality risk using data from 5 countries with different characteristics from all over Europe (Cyprus, Greece, Hungary, Norway, and Switzerland). Two structural time series models are considered: (1) the local linear trend model and the (2) latent risk time series model. Furthermore, a structured decision tree for the selection of the applicable model for each situation (developed within the Road Safety Data, Collection, Transfer and Analysis [DaCoTA] research project, cofunded by the European Commission) is outlined. First, the fatality and exposure data that are used for the development of the models are presented and explored. Then, the modeling process is presented, including the model selection process, introduction of intervention variables, and development of mobility scenarios. The forecasts using the developed models appear to be realistic and within acceptable confidence intervals. The proposed methodology is proved to be very efficient for handling different cases of data availability and quality, providing an appropriate alternative from the family of structural time series models in each country. A concluding section providing perspectives and directions for future research is presented.

Worldwide advanced nuclear power reactors with passive and inherent safety: What, why, how, and who

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

Forsberg, C.W.; Reich, W.J.

1991-09-01

The political controversy over nuclear power, the accidents at Three Mile Island (TMI) and Chernobyl, international competition, concerns about the carbon dioxide greenhouse effect and technical breakthroughs have resulted in a segment of the nuclear industry examining power reactor concepts with PRIME safety characteristics. PRIME is an acronym for Passive safety, Resilience, Inherent safety, Malevolence resistance, and Extended time after initiation of an accident for external help. The basic ideal of PRIME is to develop power reactors in which operator error, internal sabotage, or external assault do not cause a significant release of radioactivity to the environment. Several PRIME reactormore » concepts are being considered. In each case, an existing, proven power reactor technology is combined with radical innovations in selected plant components and in the safety philosophy. The Process Inherent Ultimate Safety (PIUS) reactor is a modified pressurized-water reactor, the Modular High Temperature Gas-Cooled Reactor (MHTGR) is a modified gas-cooled reactor, and the Advanced CANDU Project is a modified heavy-water reactor. In addition to the reactor concepts, there is parallel work on super containments. The objective is the development of a passive box'' that can contain radioactivity in the event of any type of accident. This report briefly examines: why a segment of the nuclear power community is taking this new direction, how it differs from earlier directions, and what technical options are being considered. A more detailed description of which countries and reactor vendors have undertaken activities follows. 41 refs.« less

Analysis of developed transition road safety barrier systems.

PubMed

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

2013-10-01

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

Parent Involvement in Novice Teen Driving: Rationale, Evidence of Effects, and Potential for Enhancing Graduated Driver Licensing Effectiveness

PubMed Central

Simons-Morton, Bruce

2007-01-01

Motor vehicle crash rates are highly elevated immediately after licensure and then decline gradually over a period of years. Young age, risk taking, and inexperience contribute to the problem, but inexperience is particularly important early on. Driving is like other complex, skilled behaviors in which subtle improvements in perception and judgment develop gradually over a period of years. After all, safe driving is more a matter of attention and perception than physical management of the vehicle. Inexperience is particularly linked to driving performance and safety outcomes under certain driving conditions, with driving at night and with teen passengers as the most important cases. Surprisingly, driving outcomes do not appear to be affected by the pre-license training or supervised practice driving. Given the limits of training, safety effects can best be achieved by countermeasures that delay licensure or limit driving novice teen driving under high risk driving conditions while novices gain experience and develop safety competence. The two complementary approaches of Graduated Driver Licensing policies and parent management have been shown to provide safety effects by limiting the driving conditions of novice teenagers. Impact on Research, Practice, Policy, and Industry: Advances in GDL and improvements in parent management practices have the potential to reduce crashes and save lives. PMID:17478190

International regulations on labour health and safety applied to fishing and maritime transport sectors. Are maritime workers under-protected.

PubMed

Rodríguez, Julio Louro; Portela, Rosa Mary de la Campa; Pardo, Guadalupe Martín

2012-01-01

The work activity developed on board is of great importance in our nearby environment, and it has a series of peculiarities that determine the service rendering of sea workers. On the other hand, work at sea is developed on an international basis. Nowadays such work becomes a completely globalised industrial sector in relation to the elements that make up the ship's operation, including manpower. For that reason several relevant international organisations have paid attention to this industrial sector and have adopted a broad regulation on this matter. In the case of the European Union, the Community procedure emphasises enormous interest in providing specific and comprehensive training to seafarers, as well as in regulating working time on board with the aim of minimising the safety problems caused by fatigue. In the present article a schematic presentation of regulations on workers' health and occupational safety protection derived from the European Union, the International Maritime Organisation, and the International Labour Organisation has been done. Also it shows what parts of these regulations are not applicable to the work on board, and it reveals how the workers of fishing and maritime transport sectors are under-protected with regard to the guarantee of their health and occupational safety compared to workers in other sectors.

Talking about the Automobile Braking System

NASA Astrophysics Data System (ADS)

Xu, Zhiqiang

2017-12-01

With the continuous progress of society, the continuous development of the times, people’s living standards continue to improve, people continue to improve the pursuit. With the rapid development of automobile manufacturing, the car will be all over the tens of thousands of households, the increase in car traffic, a direct result of the incidence of traffic accidents. Brake system is the guarantee of the safety of the car, its technical condition is good or bad, directly affect the operational safety and transportation efficiency, so the brake system is absolutely reliable. The requirements of the car on the braking system is to have a certain braking force to ensure reliable work in all cases, light and flexible operation. Normal braking should be good performance, in addition to a foot sensitive, the emergency brake four rounds can not be too long, not partial, not ring.

Value of shared preclinical safety studies - The eTOX database.

PubMed

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

2015-01-01

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

77 FR 75443 - Draft Safety Culture Policy Statement: Request for Public Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... personal and organizational characteristics are present in a positive safety culture. A characteristic, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal...

Influences on Young Children's Knowledge: The Case of Road Safety Education.

ERIC Educational Resources Information Center

Cullen, Joy

1998-01-01

Argues that effective road safety education for young children needs to incorporate constructivist and socio-cultural perspectives on learning. Excerpts interviews with young children highlighting the variety of influences affecting children's road safety knowledge and examination of a road safety curriculum to illustrate the value of a dual…

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.3 - Actions for which Safety Integration Plan is required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false Actions for which Safety Integration Plan is... TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.3 Actions for which Safety Integration Plan is required. A SIP...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

A behaviourally anchored rating scale for evaluating the use of the WHO surgical safety checklist: development and initial evaluation of the WHOBARS.

PubMed

Devcich, Daniel A; Weller, Jennifer; Mitchell, Simon J; McLaughlin, Scott; Barker, Lauren; Rudolph, Jenny W; Raemer, Daniel B; Zammert, Martin; Singer, Sara J; Torrie, Jane; Frampton, Chris Ma; Merry, Alan F

2016-10-01

Realising the full potential of the WHO Surgical Safety Checklist (SSC) to reduce perioperative harm requires the constructive engagement of all operating room (OR) team members during its administration. To facilitate research on SSC implementation, a valid and reliable instrument is needed for measuring OR team behaviours during its administration. We developed a behaviourally anchored rating scale (BARS) for this purpose. We used a modified Delphi process, involving 16 subject matter experts, to compile a BARS with behavioural domains applicable to all three phases of the SSC. We evaluated the instrument in 80 adult OR cases and 30 simulated cases using two medical student raters and seven expert raters, respectively. Intraclass correlation coefficients were calculated to assess inter-rater reliability. Internal consistency and instrument discrimination were explored. Sample size estimates for potential study designs using the instrument were calculated. The Delphi process resulted in a BARS instrument (the WHOBARS) with five behavioural domains. Intraclass correlation coefficients calculated from the OR cases exceeded 0.80 for 80% of the instrument's domains across the SSC phases. The WHOBARS showed high internal consistency across the three phases of the SSC and ability to discriminate among surgical cases in both clinical and simulated settings. Fewer than 20 cases per group would be required to show a difference of 1 point between groups in studies of the SSC, where α=0.05 and β=0.8. We have developed a generic instrument for comprehensively rating the administration of the SSC and informing initiatives to realise its full potential. We have provided data supporting its capacity for discrimination, internal consistency and inter-rater reliability. Further psychometric evaluation is warranted. 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/

Effectiveness of Direct Safety Regulations on Manufacturers and Users of Industrial Machines: Its Implications on Industrial Safety Policies in Republic of Korea.

PubMed

Choi, Gi Heung

2017-03-01

Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

EPA Pesticide Factsheets

EPA News Release: IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

Advanced Booster Composite Case/Polybenzimidazole Nitrile Butadiene Rubber Insulation Development

NASA Technical Reports Server (NTRS)

Gentz, Steve; Taylor, Robert; Nettles, Mindy

2015-01-01

The NASA Engineering and Safety Center (NESC) was requested to examine processing sensitivities (e.g., cure temperature control/variance, debonds, density variations) of polybenzimidazole nitrile butadiene rubber (PBI-NBR) insulation, case fiber, and resin systems and to evaluate nondestructive evaluation (NDE) and damage tolerance methods/models required to support human-rated composite motor cases. The proposed use of composite motor cases in Blocks IA and II was expected to increase performance capability through optimizing operating pressure and increasing propellant mass fraction. This assessment was to support the evaluation of risk reduction for large booster component development/fabrication, NDE of low mass-to-strength ratio material structures, and solid booster propellant formulation as requested in the Space Launch System NASA Research Announcement for Advanced Booster Engineering Demonstration and/or Risk Reduction. Composite case materials and high-energy propellants represent an enabling capability in the Agency's ability to provide affordable, high-performing advanced booster concepts. The NESC team was requested to provide an assessment of co- and multiple-cure processing of composite case and PBI-NBR insulation materials and evaluation of high-energy propellant formulations.

Seven Experiment Designs Addressing Problems of Safety and Capacity on Two-Lane Rural Highways : Volume 7. Experimental Design to Develop and Evaluate Measures for Reducing the Effects of Roadside Friction on Traffic Flow

DOT National Transportation Integrated Search

1994-04-01

This operational test case study is one of six performed in response to a Volpe National Transportation Systems Center technical task directive (TTD) to Science Applications International Corporation (SAIC) entitled, "IVHS Institutional Issues and Ca...

Working Together for Safety: A State Team Approach to Preventing Occupational Injuries in Young People

ERIC Educational Resources Information Center

Posner, Marc

2005-01-01

This report describes the Northeast Young Worker Resource Center. It begins with two case studies that demonstrate the value of the State team approach. The remainder of the document describes the experiences and activities of the State teams in the Northeast; the products developed by the teams for teens, parents, employers, school staff, health…

Seven Experiment Designs Addressing Problems of Safety and Capacity on Two-Lane Rural Highways : Volume 4. Experimental Design to Develop and Evaluate Remedial Aids to Urban Drivers of Slow Moving Vehicles on a Grade

DOT National Transportation Integrated Search

1994-04-01

This operational test case study is one of six performed in response to a Volpe National Transportation Systems Center technical task directive (TTD) to Science Applications International Corporation (SAIC) entitled, IVHS Institutional Issues and ...

Student Injuries and Negligence: Lessons from the International Scene with Implications for Singapore's Educators

ERIC Educational Resources Information Center

Teh, Kim

2008-01-01

Many jurisdictions are showing a trend of school-related negligence cases being taken to court. This article explores the legal principles applied by the courts in England, Australia, Canada, the United States, and New Zealand to ensure the safety of students in schools. As we look at the developments in these countries, we can see student injury…

Implementation Procedure for STS Payloads, System Safety Requirements

NASA Technical Reports Server (NTRS)

1979-01-01

Guidelines and instructions for the implementation of the SP&R system safety requirements applicable to STS payloads are provided. The initial contact meeting with the payload organization and the subsequent safety reviews necessary to comply with the system safety requirements of the SP&R document are described. Waiver instructions are included for the cases in which a safety requirement cannot be met.

Herb-Induced Liver Injuries in Developing Nations: An Update.

PubMed

Amadi, Cecilia Nwadiuto; Orisakwe, Orish Ebere

2018-04-17

The last few decades have seen a rise in the use of herbal supplements, natural products, and traditional medicines. However, there are growing concerns related to the safety and toxicities of these medicines. These herbal medicines are associated with complications such as liver damage with a high incidence of mortalities and morbidities. Clinical manifestations range from asymptomatic cases with abnormal liver functions tests to sudden and severe liver failure necessitating liver transplantation. This work aimed to review the etiology, risk factors, diagnosis, clinical manifestations and selected clinical case reports of herbal hepatotoxicity in developing nations. PubMed and Google Scholar searches were undertaken to identify relevant literature. Furthermore, we scanned the reference lists of the primary and review articles to identify publications not retrieved by electronic searches. Little data exists on clinical cases of herb-induced liver injury in some developing countries such as Nigeria, as most incidences are either not reported to health care providers or reports from hospitals go unpublished. Studies in Nigeria have highlighted a possible correlation between use of herbs and liver disease. In Uganda, and association between the use of traditional herbal medicine with liver fibrosis in HIV-infected and non-HIV patients was demonstrated. Reports from China have revealed incidences of acute liver failure as a result of herbal medicine use. The actual incidence and prevalence of HILI in developing nations remain largely unknown due to both poor pharmacovigilance programs and non-application of emerging technologies. Improving education and public awareness of the potential risks of herbals and herbal products is desirable to ensure that suspected adverse effects are formally reported. There is need for stricter regulations and pre-clinical studies necessary for efficacy and safety.

Pediatric dental sedation: challenges and opportunities

PubMed Central

Nelson, Travis M; Xu, Zheng

2015-01-01

High levels of dental caries, challenging child behavior, and parent expectations support a need for sedation in pediatric dentistry. This paper reviews modern developments in pediatric sedation with a focus on implementing techniques to enhance success and patient safety. In recent years, sedation for dental procedures has been implicated in a disproportionate number of cases that resulted in death or permanent neurologic damage. The youngest children and those with more complicated medical backgrounds appear to be at greatest risk. To reduce complications, practitioners and regulatory bodies have supported a renewed focus on health care quality and safety. Implementation of high fidelity simulation training and improvements in patient monitoring, including end-tidal carbon dioxide, are becoming recognized as a new standard for sedated patients in dental offices and health care facilities. Safe and appropriate case selection and appropriate dosing for overweight children is also paramount. Oral sedation has been the mainstay of pediatric dental sedation; however, today practitioners are administering modern drugs in new ways with high levels of success. Employing contemporary transmucosal administration devices increases patient acceptance and sedation predictability. While recently there have been many positive developments in sedation technology, it is now thought that medications used in sedation and anesthesia may have adverse effects on the developing brain. The evidence for this is not definitive, but we suggest that practitioners recognize this developing area and counsel patients accordingly. Finally, there is a clear trend of increased use of ambulatory anesthesia services for pediatric dentistry. Today, parents and practitioners have become accustomed to children receiving general anesthesia in the outpatient setting. As a result of these changes, it is possible that dental providers will abandon the practice of personally administering large amounts of sedation to patients, and focus instead on careful case selection for lighter in-office sedation techniques. PMID:26345425

Pediatric dental sedation: challenges and opportunities.

PubMed

Nelson, Travis M; Xu, Zheng

2015-01-01

High levels of dental caries, challenging child behavior, and parent expectations support a need for sedation in pediatric dentistry. This paper reviews modern developments in pediatric sedation with a focus on implementing techniques to enhance success and patient safety. In recent years, sedation for dental procedures has been implicated in a disproportionate number of cases that resulted in death or permanent neurologic damage. The youngest children and those with more complicated medical backgrounds appear to be at greatest risk. To reduce complications, practitioners and regulatory bodies have supported a renewed focus on health care quality and safety. Implementation of high fidelity simulation training and improvements in patient monitoring, including end-tidal carbon dioxide, are becoming recognized as a new standard for sedated patients in dental offices and health care facilities. Safe and appropriate case selection and appropriate dosing for overweight children is also paramount. Oral sedation has been the mainstay of pediatric dental sedation; however, today practitioners are administering modern drugs in new ways with high levels of success. Employing contemporary transmucosal administration devices increases patient acceptance and sedation predictability. While recently there have been many positive developments in sedation technology, it is now thought that medications used in sedation and anesthesia may have adverse effects on the developing brain. The evidence for this is not definitive, but we suggest that practitioners recognize this developing area and counsel patients accordingly. Finally, there is a clear trend of increased use of ambulatory anesthesia services for pediatric dentistry. Today, parents and practitioners have become accustomed to children receiving general anesthesia in the outpatient setting. As a result of these changes, it is possible that dental providers will abandon the practice of personally administering large amounts of sedation to patients, and focus instead on careful case selection for lighter in-office sedation techniques.

[Results of a post-marketing surveillance of meropenem for febrile neutropenia].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-08-01

The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

The reduction of a ""safety catastrophic'' potential hazard: A case history

NASA Technical Reports Server (NTRS)

Jones, J. P.

1971-01-01

A worst case analysis is reported on the safety of time watch movements for triggering explosive packages on the lunar surface in an experiment to investigate physical lunar structural characteristics through induced seismic energy waves. Considered are the combined effects of low pressure, low temperature, lunar gravity, gear train error, and position. Control measures constitute a seal control cavity and design requirements to prevent overbanking in the mainspring torque curve. Thus, the potential hazard is reduced to safety negligible.

Tuberculosis in Anti-Tumour Necrosis Factor-treated Inflammatory Bowel Disease Patients After the Implementation of Preventive Measures: Compliance With Recommendations and Safety of Retreatment.

PubMed

Carpio, D; Jauregui-Amezaga, A; de Francisco, R; de Castro, L; Barreiro-de Acosta, M; Mendoza, J L; Mañosa, M; Ollero, V; Castro, B; González-Conde, B; Hervías, D; Sierra Ausin, M; Sancho Del Val, L; Botella-Mateu, B; Martínez-Cadilla, J; Calvo, M; Chaparro, M; Ginard, D; Guerra, I; Maroto, N; Calvet, X; Fernández-Salgado, E; Gordillo, J; Rojas Feria, M

2016-10-01

Despite having adopted preventive measures, tuberculosis (TB) may still occur in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF). Data on the causes and characteristics of TB cases in this scenario are lacking. Our aim was to describe the characteristics of TB in anti-TNF-treated IBD patients after the publication of the Spanish TB prevention guidelines in IBD patients and to evaluate the safety of restarting anti-TNF after a TB diagnosis. In this multicentre, retrospective, descriptive study, TB cases from Spanish hospitals were collected. Continuous variables were reported as mean and standard deviation or median and interquartile range. Categorical variables were described as absolute and relative frequencies and their confidence intervals when necessary. We collected 50 TB cases in anti-TNF-treated IBD patients, 60% male, median age 37.3 years (interquartile range [IQR] 30.4-47). Median latency between anti-TNF initiation and first TB symptoms was 155.5 days (IQR 88-301); 34% of TB cases were disseminated and 26% extrapulmonary. In 30 patients (60%), TB cases developed despite compliance with recommended preventive measures; *not performing 2-step TST (tuberculin skin test) was the main failure in compliance with recommendations. In 17 patients (34%) anti-TNF was restarted after a median of 13 months (IQR 7.1-17.3) and there were no cases of TB reactivation. Tuberculosis could still occur in anti-TNF-treated IBD patients despite compliance with recommended preventive measures. A significant number of cases developed when these recommendations were not followed. Restarting anti-TNF treatment in these patients seems to be safe. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

A systematic review of occupational safety and health business cases.

PubMed

Verbeek, Jos; Pulliainen, Marjo; Kankaanpää, Eila

2009-12-01

Business cases are commonly developed as means to rationalize investment. We systematically reviewed 26 reported cases on occupational safety and health (OSH) interventions to assess if health and productivity arguments make a good business case. To be included in the review, studies had to analyze the costs and benefits, including productivity, of an OSH intervention at the enterprise level. We searched Medline and Embase for studies and used Google search in addition. Two reviewers independently selected studies and extracted data. The intervention profitability was calculated in euros (euro in 2008) as the first year's benefits minus the total intervention costs per worker. The payback period was calculated as the intervention costs divided by the first year's benefits. We found three ex-ante and 23 ex-post cases. In 20 cases, the study design was a before-after comparison without a control group. Generally a 100% reduction of injuries or sickness absence was assumed. In two cases, productivity and quality increases were very large. The main benefit was avoided sick leave. Depreciation or discounting was applied only in a minority of cases. The intervention profitability was negative in seven studies, up to euro 500 per employee in 12 studies and more than euro 500 per employee in seven studies. The payback period was less than half a year for 19 studies. Only a few studies included sensitivity analyses. Few ex-ante business cases for management decisions on OSH are reported. Guidelines for reporting and evaluation are needed. Business cases need more sound assumptions on the effectiveness of interventions and should incorporate greater uncertainty into their design. Ex-post evaluation should be based preferably on study designs that control for trends at a time different from that of the intervention.

Use of Tubular Retractor for Resection of Deep-Seated Cerebral Tumors and Colloid Cysts: Single Surgeon Experience and Review of the Literature.

PubMed

Eichberg, Daniel G; Buttrick, Simon; Brusko, G Damian; Ivan, Michael; Starke, Robert M; Komotar, Ricardo J

2018-04-01

Brain retraction is often required to develop a surgical corridor during the resection of deep-seated intracranial lesions. Traditional blade retractors distribute pressure asymmetrically and may case local tissue damage. Tubular retractors minimize this pitfall by distributing pressure evenly, which has been shown to translate to significant safety and efficacy data. Further qualified reports regarding the use of tubular retractors are of interest. We performed a retrospective analysis of 1 surgeon's experience with 20 cases of minimally invasive resection with the ViewSite Brain Access System (n = 7) and BrainPath (n = 13) systems. In addition, a comprehensive review of all published cases of tubular retractor systems used for resection of subcortical neoplastic, cystic, infectious, vascular, and hemorrhagic lesions was conducted. Of the 20 cases analyzed, gross total resection was achieved in 18, with an associated 10% immediate postoperative complication rate and 5% long-term complication rate. A comprehensive review of the literature showed 30 articles describing 536 cases of resection of deep neoplastic or colloid cysts with an overall complication rate of 9.1%. Tubular retractor systems have a favorable safety profile and are an important tool in the armamentarium of a neurosurgeon for the resection of deep intracranial lesions. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of traffic oscillations on freeway crash occurrences.

PubMed

Zheng, Zuduo; Ahn, Soyoung; Monsere, Christopher M

2010-03-01

Traffic oscillations are typical features of congested traffic flow that are characterized by recurring decelerations followed by accelerations (stop-and-go driving). The negative environmental impacts of these oscillations are widely accepted, but their impact on traffic safety has been debated. This paper describes the impact of freeway traffic oscillations on traffic safety. This study employs a matched case-control design using high-resolution traffic and crash data from a freeway segment. Traffic conditions prior to each crash were taken as cases, while traffic conditions during the same periods on days without crashes were taken as controls. These were also matched by presence of congestion, geometry and weather. A total of 82 cases and about 80,000 candidate controls were extracted from more than three years of data from 2004 to 2007. Conditional logistic regression models were developed based on the case-control samples. To verify consistency in the results, 20 different sets of controls were randomly extracted from the candidate pool for varying control-case ratios. The results reveal that the standard deviation of speed (thus, oscillations) is a significant variable, with an average odds ratio of about 1.08. This implies that the likelihood of a (rear-end) crash increases by about 8% with an additional unit increase in the standard deviation of speed. The average traffic states prior to crashes were less significant than the speed variations in congestion. Published by Elsevier Ltd.

Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

PubMed

Ricci-Cabello, Ignacio; Reeves, David; Bell, Brian G; Valderas, Jose M

2017-11-01

To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm. Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures. Practices distributed across five regions in the North, Centre and South of England. 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation). Self-reported safety problems, harm and overall perception of safety. Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety. Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

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

Zhao, Haihua; Zhang, Hongbin; Zou, Ling

2014-10-01

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

Improving the safety and quality of nursing care through standardized operating procedures in Bosnia and Herzegovina.

PubMed

Ausserhofer, Dietmar; Rakic, Severin; Novo, Ahmed; Dropic, Emira; Fisekovic, Eldin; Sredic, Ana; Van Malderen, Greet

2016-06-01

We explored how selected 'positive deviant' healthcare facilities in Bosnia and Herzegovina approach the continuous development, adaptation, implementation, monitoring and evaluation of nursing-related standard operating procedures. Standardized nursing care is internationally recognized as a critical element of safe, high-quality health care; yet very little research has examined one of its key instruments: nursing-related standard operating procedures. Despite variability in Bosnia and Herzegovina's healthcare and nursing care quality, we assumed that some healthcare facilities would have developed effective strategies to elevate nursing quality and safety through the use of standard operating procedures. Guided by the 'positive deviance' approach, we used a multiple-case study design to examine a criterion sample of four facilities (two primary healthcare centres and two hospitals), collecting data via focus groups and individual interviews. In each studied facility, certification/accreditation processes were crucial to the initiation of continuous development, adaptation, implementation, monitoring and evaluation of nursing-related SOPs. In one hospital and one primary healthcare centre, nurses working in advanced roles (i.e. quality coordinators) were responsible for developing and implementing nursing-related standard operating procedures. Across the four studied institutions, we identified a consistent approach to standard operating procedures-related processes. The certification/accreditation process is enabling necessary changes in institutions' organizational cultures, empowering nurses to take on advanced roles in improving the safety and quality of nursing care. Standardizing nursing procedures is key to improve the safety and quality of nursing care. Nursing and Health Policy are needed in Bosnia and Herzegovina to establish a functioning institutional framework, including regulatory bodies, educational systems for developing nurses' capacities or the inclusion of nursing-related standard operating procedures in certification/accreditation standards. © 2016 International Council of Nurses.

Space power development impact on technology requirements

NASA Technical Reports Server (NTRS)

Cassidy, J. F.; Fitzgerald, T. J.; Gilje, R. I.; Gordon, J. D.

1986-01-01

The paper is concerned with the selection of a specific spacecraft power technology and the identification of technology development to meet system requirements. Requirements which influence the selection of a given technology include the power level required, whether the load is constant or transient in nature, and in the case of transient loads, the time required to recover the power, and overall system safety. Various power technologies, such as solar voltaic power, solar dynamic power, nuclear power systems, and electrochemical energy storage, are briefly described.

Enterobacter aerogenes Needle Stick Leads to Improved Biological Management System

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

Johanson, Richard E.

2004-08-01

A laboratory worker who received a needle stick from a contaminated needle while working with a culture containing Enterobactor aerogenes developed a laboratory acquired infection. Although this organism has been shown to cause community and nosocomial infections, there have been no documented cases of a laboratory acquired infections. Lessons learned from the event led to corrective actions which included modification of lab procedures, development of a biological inventory tracking and risk identification system and the establishment of an effective biological safety program.

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

2001-01-01

An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

Asphyxiation Incidents by Hydrogen Sulfide at Manure Storage Facilities of Swine Livestock Farms in Korea.

PubMed

Park, Jihoon; Kang, Taesun; Jin, Suhyun; Heo, Yong; Kim, Kyungran; Lee, Kyungsuk; Tsai, Perngjy; Yoon, Chungsik

2016-01-01

Livestock workers are involved in a variety of tasks, such as caring for animals, maintaining the breeding facilities, cleaning, and manure handling, and are exposed to health and safety risks. Hydrogen sulfide is considered the most toxic by-product of the manure handling process at livestock facilities. Except for several reports in developed countries, the statistics and cause of asphyxiation incidents in farms have not been collected and reported systematically, although the number of these incidents is expected to increase in developing and underdeveloped countries. In this study, the authors compiled the cases of work-related asphyxiation incidents at livestock manure storage facilities and analyzed the main causes. In this survey, a total of 17 incidents were identified through newspapers or online searches and public reports. Thirty workers died and eight were injured due to work-related tasks and rescue attempts from 1998 to 2013 in Korea. Of the 30 fatalities, 18 occurred during manure handling/maintenance tasks and 12 during rescue attempts. All incidents except for one case occurred during the warm season from the late spring (April) to early autumn (September) when manure is likely to decompose rapidly. It is important to train employees involved in the operation of the facilities (i.e., owners, managers, employees) regarding the appropriate prevention strategies for confined space management, such as hazard identification before entry, periodical facility inspection, restriction of unnecessary access, proper ventilation, and health and safety. Sharing information or case reports on previous incidents could also help prevent similar cases from occurring and reduce the number of fatalities and injuries.

[Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

PubMed

Axelsen, Karina Rahbek; Nafei, Hanne; Jakobsen, Stine Finne; Gandrup, Per; Knudsen, Janne Lehmann

2014-10-13

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the function and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been narrowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

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).

Static-stress analysis of dual-axis safety vessel

NASA Astrophysics Data System (ADS)

Bultman, D. H.

1992-11-01

An 8 ft diameter safety vessel, made of HSLA-100 steel, is evaluated to determine its ability to contain the quasi-static residual pressure from a high explosive (HE) blast. The safety vessel is designed for use with the Dual-Axis Radiographic Hydrotest (DARHT) facility being developed at Los Alamos National Laboratory. A smaller confinement vessel fits inside the safety vessel and contains the actual explosion, and the safety vessel functions as a second layer of containment in the unlikely case of a confinement vessel leak. The safety vessel is analyzed as a pressure vessel based on the ASME Boiler and Pressure Vessel Code, Section 8, Division 1, and the Welding Research Council Bulletin, WRC107. Combined stresses that result from internal pressure and external loads on nozzles are calculated and compared to the allowable stresses for HSLA-100 steel. Results confirm that the shell and nozzle components are adequately designed for a static pressure of 830 psi, plus the maximum expected external loads. Shell stresses at the 'shell to nozzle' interface, produced from external loads on the nozzles, were less than 700 psi. The maximum combined stress resulting from the internal pressure plus external loads was 17,384 psi, which is significantly less than the allowable stress of 42,375 psi for HSLA-100 steel.

Safety of pharmacotherapy options for bulimia nervosa and binge eating disorder.

PubMed

Bello, Nicholas T; Yeomans, Bryn L

2018-01-01

Eating disorders represent a set of psychiatric illnesses with lifelong complications and high relapse rates. Individuals with eating disorders are often stigmatized and clinicians have a limited set of treatments options. Pharmacotherapy has the potential to improve long term compliance and patient commitment to treatment for eating disorders. Areas covered: This review will examine the efficacy and safety profile of the FDA-approved medications for the treatment of bulimia nervosa (BN) and binge eating disorder (BED). This will include the evaluation of fluoxetine for BN, and lisdexamfetamine for BED. Safety information will be review from randomized control trials (RCT), open label trials, and case reports. Expert opinion: Fluoxetine for BN and lisdexamfetamine for BED are relatively safe and well-tolerated. Despite these properties, these two medications represent a limited arsenal for the pharmacological treatment of eating disorders. Thus, more research-based strategies are needed to develop safe, effective, and more targeted therapies for eating disorders.

Capitalizing on Federal Agencies' Intentions To Protect Youth Working in Agriculture.

PubMed

Murphy, Dennis J

2017-01-01

Nearly 750,000 youth work on farms across the United States. The U.S. Department of Labor's (U.S. DOL) Fair Labor Standards Act (FLSA) Hazardous Occupations Orders for Agriculture (HOOA) applies to approximately 37% of these youth. The HOOA regulations had not been updated since their inception in the late 1960s and the early 1970s. An attempt by U.S. DOL to update the regulations in 2011 was met with fierce opposition by the agricultural community, and the proposed updated regulations were withdrawn. One impactful outcome of these two events was a rededication by USDA and the farm community to address agricultural youth farm safety through education rather than through regulation. An agriculturally based National Steering Committee has developed consensus Belief Statements and Guiding Principles to proactively influence agricultural youth safety. In this case, USDA was clearly a 'sphere of influence' for youth agricultural safety.

Dynamic event tree analysis with the SAS4A/SASSYS-1 safety analysis code

DOE PAGES

Jankovsky, Zachary K.; Denman, Matthew R.; Aldemir, Tunc

2018-02-02

The consequences of a transient in an advanced sodium-cooled fast reactor are difficult to capture with the traditional approach to probabilistic risk assessment (PRA). Numerous safety-relevant systems are passive and may have operational states that cannot be represented by binary success or failure. In addition, the specific order and timing of events may be crucial which necessitates the use of dynamic PRA tools such as ADAPT. The modifications to the SAS4A/SASSYS-1 sodium-cooled fast reactor safety analysis code for linking it to ADAPT to perform a dynamic PRA are described. A test case is used to demonstrate the linking process andmore » to illustrate the type of insights that may be gained with this process. Finally, newly-developed dynamic importance measures are used to assess the significance of reactor parameters/constituents on calculated consequences of initiating events.« less

Dynamic event tree analysis with the SAS4A/SASSYS-1 safety analysis code

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

Jankovsky, Zachary K.; Denman, Matthew R.; Aldemir, Tunc

The consequences of a transient in an advanced sodium-cooled fast reactor are difficult to capture with the traditional approach to probabilistic risk assessment (PRA). Numerous safety-relevant systems are passive and may have operational states that cannot be represented by binary success or failure. In addition, the specific order and timing of events may be crucial which necessitates the use of dynamic PRA tools such as ADAPT. The modifications to the SAS4A/SASSYS-1 sodium-cooled fast reactor safety analysis code for linking it to ADAPT to perform a dynamic PRA are described. A test case is used to demonstrate the linking process andmore » to illustrate the type of insights that may be gained with this process. Finally, newly-developed dynamic importance measures are used to assess the significance of reactor parameters/constituents on calculated consequences of initiating events.« less

Core Dynamics Analysis for Reactivity Insertion and Loss of Coolant Flow Tests Using the High Temperature Engineering Test Reactor

NASA Astrophysics Data System (ADS)

Takamatsu, Kuniyoshi; Nakagawa, Shigeaki; Takeda, Tetsuaki

Safety demonstration tests using the High Temperature Engineering Test Reactor (HTTR) are in progress to verify its inherent safety features and improve the safety technology and design methodology for High-temperature Gas-cooled Reactors (HTGRs). The reactivity insertion test is one of the safety demonstration tests for the HTTR. This test simulates the rapid increase in the reactor power by withdrawing the control rod without operating the reactor power control system. In addition, the loss of coolant flow tests has been conducted to simulate the rapid decrease in the reactor power by tripping one, two or all out of three gas circulators. The experimental results have revealed the inherent safety features of HTGRs, such as the negative reactivity feedback effect. The numerical analysis code, which was named-ACCORD-, was developed to analyze the reactor dynamics including the flow behavior in the HTTR core. We have modified this code to use a model with four parallel channels and twenty temperature coefficients. Furthermore, we added another analytical model of the core for calculating the heat conduction between the fuel channels and the core in the case of the loss of coolant flow tests. This paper describes the validation results for the newly developed code using the experimental results. Moreover, the effect of the model is formulated quantitatively with our proposed equation. Finally, the pre-analytical result of the loss of coolant flow test by tripping all gas circulators is also discussed.

Study concerning the loads over driver's chests in car crashes with cars of the same or different generation

NASA Astrophysics Data System (ADS)

Ispas, N.; Năstăsoiu, M.

2016-08-01

Reducing occupant injuries for cars involves in traffic accidents is a main target of today cars designers. Known as active or passive safety, many technological solutions were developing over the time for an actual better car's occupant safety. In the real world, in traffic accidents are often involved cars from different generations with various safety historical solutions. The main aim of these papers are to quantify the influences over the car driver chest loads in cases of same or different generation of cars involved in side car crashes. Both same and different cars generations were used for the study. Other goal of the paper was the study of in time loads conformity for diver's chests from both cars involved in crash. The paper's experimental results were obtained by support of DSD, Dr. Steffan Datentechnik GmbH - Linz, Austria. The described tests were performed in full test facility of DSD Linz, in “Easter 2015 PC-Crash Seminar”. In all crashes we obtaining results from both dummy placed in impacted and hits car. The novelty of the paper are the comparisons of data set from each of driver (dummy) of two cars involved in each of six experimental crashes. Another novelty of this paper consists in possibilities to analyse the influences of structural historical cars solutions over deformation and loads in cases of traffic accidents involved. Paper's conclusions can be future used for car passive safety improvement.

A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System.

PubMed

Bao, Yulong; Li, Yongle; Ding, Jiajie

2016-11-10

A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study

PubMed Central

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-01

Introduction Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. Methods This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. Ethics and dissemination This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. PMID:28132001

A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System

PubMed Central

Bao, Yulong; Li, Yongle; Ding, Jiajie

2016-01-01

A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety. PMID:27834923

Utilization of the Seniors Falls Investigation Methodology to identify system-wide causes of falls in community-dwelling seniors.

PubMed

Zecevic, Aleksandra A; Salmoni, Alan W; Lewko, John H; Vandervoort, Anthoney A; Speechley, Mark

2009-10-01

As a highly heterogeneous group, seniors live in complex environments influenced by multiple physical and social structures that affect their safety. Until now, the major approach to falls research has been person centered. However, in industrial settings, the individuals involved in an accident are seen as the inheritors of system defects. The objective of the present study was to investigate safety deficiencies that contributed to falls in community-dwelling seniors using a systems approach. The investigations were conducted using the Seniors Falls Investigation Methodology (SFIM), an adapted version of a method used to examine transportation accidents, such as airplane crashes. Fifteen seniors, who experienced a fall or near fall, participated in multiple case studies. A cross-case synthesis was used to summarize findings and identify common patterns of causes and safety deficiencies. Falls and near falls are a result of latent unsafe conditions, and unsafe acts and decisions combined in a diverse set of circumstances. If not identified and removed, these unsafe conditions can cause falls for other seniors. This study provided compelling evidence that causes of falling are systemic and develop over time. It demonstrated that the systems approach is needed to expand the focus from the individual to multilayered organizational and supervisory causes. The SFIM demonstrated capability to identify causes of falls that will allow better prevention and management programs, hence advancing seniors' safety. SFIM shows great potential for implementation in organized settings, such as hospitals and long-term care homes.

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

Toward an understanding of the impact of production pressure on safety performance in construction operations.

PubMed

Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

2014-07-01

It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. Copyright © 2013 Elsevier Ltd. All rights reserved.

Prevalence and test characteristics of national health safety network ventilator-associated events.

PubMed

Lilly, Craig M; Landry, Karen E; Sood, Rahul N; Dunnington, Cheryl H; Ellison, Richard T; Bagley, Peter H; Baker, Stephen P; Cody, Shawn; Irwin, Richard S

2014-09-01

The primary aim of the study was to measure the test characteristics of the National Health Safety Network ventilator-associated event/ventilator-associated condition constructs for detecting ventilator-associated pneumonia. Its secondary aims were to report the clinical features of patients with National Health Safety Network ventilator-associated event/ventilator-associated condition, measure costs of surveillance, and its susceptibility to manipulation. Prospective cohort study. Two inpatient campuses of an academic medical center. Eight thousand four hundred eight mechanically ventilated adults discharged from an ICU. None. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs detected less than a third of ventilator-associated pneumonia cases with a sensitivity of 0.325 and a positive predictive value of 0.07. Most National Health Safety Network ventilator-associated event/ventilator-associated condition cases (93%) did not have ventilator-associated pneumonia or other hospital-acquired complications; 71% met the definition for acute respiratory distress syndrome. Similarly, most patients with National Health Safety Network probable ventilator-associated pneumonia did not have ventilator-associated pneumonia because radiographic criteria were not met. National Health Safety Network ventilator-associated event/ventilator-associated condition rates were reduced 93% by an unsophisticated manipulation of ventilator management protocols. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs failed to detect many patients who had ventilator-associated pneumonia, detected many cases that did not have a hospital complication, and were susceptible to manipulation. National Health Safety Network ventilator-associated event/ventilator-associated condition surveillance did not perform as well as ventilator-associated pneumonia surveillance and had several undesirable characteristics.

[Dual chamber safety vacuum--initial experiences with a new suction cup].

PubMed

Korell, M; King, S; Hepp, H

1994-06-01

The main problem with vacuum extraction methods, alongside the cephalhaematoma produced, is the premature separation of the suction cup under traction, since the resulting sudden change in pressure can lead to severe intra-cerebral damage to the child. To reduce the risk of vaginal operative delivery, a new double-chamber safety vacuum extractor has been developed by Hepp/King. The basic feature of this instrument is an additional chamber with a thin overlapping area, which surrounds the actual suction cup and serves as a safety vacuum. If the suction cup starts to slip, the external vacuum is released and sounds an alarm. In addition, the inner vacuum has been designed to be convex and to reduce the volume of scalp, which is sucked into the vacuum, thus reducing the size of the cephalhaematoma produced. First experiences in clinical use demonstrated the reliability of the early warning signal, if the direction of traction is false or the applied traction is too strong. The inner vacuum remains constant at 0.8 atu, so that with care, the extraction can continue without interruption. We have used the new instrument in 18 deliveries. In 15 cases, the indication was failure to progress into the second stage of labour; in one case history of retinal detachment and in two cases signs of foetal asphyxia. In all cases, the child was delivered following one or two contractions with traction, without losing the vacuum. The average weight of the newborn was 3566 g. As expected, the cephalohaematoma produced was very much smaller than usual. Further clinical trials are necessary before the value of this new instrument can be assessed.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of complete EHS0470, General Employee Radiation Safety (on-line course). Escort is required for visitors who Safety (on-line course) ii. EHS0348 Chemical Hygiene and Safety (on-line course) iii. EHS0470 General

Exploring the Effects of Cultural Variables in the Implementation of Behavior-Based Safety in Two Organizations

ERIC Educational Resources Information Center

Bumstead, Alaina; Boyce, Thomas E.

2005-01-01

The present case study examines how culture can influence behavior-based safety in different organizational settings and how behavior-based safety can impact different organizational cultures. Behavior-based safety processes implemented in two culturally diverse work settings are described. Specifically, despite identical implementation plans,…

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

PubMed

Goh, Yang Miang; Askar Ali, Mohamed Jawad

2016-08-01

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

Advancing interprofessional patient safety education for medical, nursing, and pharmacy learners during clinical rotations.

PubMed

Thom, Kerri A; Heil, Emily L; Croft, Lindsay D; Duffy, Alison; Morgan, Daniel J; Johantgen, Mary

2016-11-01

Clinical errors are common and can lead to adverse events and patient death. Health professionals must work within interprofessional teams to provide safe and effective care to patients, yet current curricula is lacking with regards to interprofessional education and patient safety. We describe the development and implementation of an interprofessional course aimed at medical, nursing, and pharmacy learners during their clinical training at a large academic medical centre. The course objectives were based on core competencies for interprofessional education and patient safety. The course was offered as recurring three 1-hour sessions, including case-based discussions and a mock root cause analysis. Forty-three students attended at least one session over a 7-month period. We performed a cross-sectional survey of participants to assess readiness for interprofessional learning and a before and after comparison of patient safety knowledge. All students reported a high level of readiness for interprofessional learning, indicating an interest in interprofessional opportunities. In general, understanding and knowledge of the four competency domains in patient safety was low before the course and 100% of students reported an increase in knowledge in these domains after participating in the course.

30 CFR 56.4530 - Exits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control... a sufficient number of exits to permit prompt escape in case of fire. ...

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2014 CFR

2014-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2012 CFR

2012-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

Violence and School Safety. Case Citations, 2002.

ERIC Educational Resources Information Center

Russo, Charles J., Ed.; Mawdsley, Ralph D., Ed.

This publication highlights and explains some 400 court cases from 2002 involving issues of school violence and safety. It is divided into four sections, or topics: (1) "The Fourth Amendment: Search and Seizure" (R. Mawdsley); (2) "Negligence" (W. Evans, Jr.); (3) "Assault on School Personnel" (M. Yates); and (4) "Drugs and Weapons in Schools" (M.…

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

PubMed

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

2016-08-02

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

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-12-01

Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS ® software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Effects of sweet bee venom pharmacopuncture treatment for chemotherapy-induced peripheral neuropathy: a case series.

PubMed

Park, Jae-Woo; Jeon, Ju-Hyun; Yoon, Jeungwon; Jung, Tae-Young; Kwon, Ki-Rok; Cho, Chong-Kwan; Lee, Yeon-Weol; Sagar, Stephen; Wong, Raimond; Yoo, Hwa-Seung

2012-06-01

This is a case series reporting safety and degree of response to 1 dose level of sweet bee venom pharmacopuncture (SBVP) or melittin as a symptom-control therapy for chemotherapy-induced peripheral neuropathy (CIPN). All treatments were conducted at the East West Cancer Center (EWCC), Dunsan Oriental Hospital, Daejeon University, Republic of Korea, an institution that uses complementary therapies for cancer patients. Five consecutive patients with CIPN were referred to the EWCC from March 20, 2010, to April 10, 2010. Patients with World Health Organization Chemotherapy-Induced Peripheral Neuropathy (WHO CIPN) grade 2 or more were treated with SBVP for 3 treatment sessions over a 1-week period. Measures of efficacy and safety. Validated Visual Analog System (VAS) pain scale, WHO CIPN grade, and Functional Assessment of Cancer Therapy-General (FACT-G) were compared before and after the 1-week course of treatment. To ensure the safety of SBVP, pretreatment skin response tests were given to patients to avoid any potential anaphylactic adverse effects. All patients were closely examined for any allergenic responses following each treatment session. One patient discontinued treatment after the first session, and 4 patients completed all treatment sessions. Using each patient as their own comparator, marked improvements of VAS, WHO CIPN grade, and physical section scores of FACT-G were seen in 3 patients. Most important, there were no related adverse side effects found. This safety results of the SBVP therapy merits further investigations in a larger size trial for it to develop into a potential intervention for managing CIPN symptoms. This study will be extended to a dose-response evaluation to further establish safety and response, prior to a randomized trial.

Public perception of drinking water safety in South Africa 2002–2009: a repeated cross-sectional study

PubMed Central

2012-01-01

Background In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. Methods This repeated cross-sectional study draws on General Household Surveys from 2002–2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002–2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. Results The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000–02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. Conclusion This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period. PMID:22834485

Public perception of drinking water safety in South Africa 2002-2009: a repeated cross-sectional study.

PubMed

Wright, Jim A; Yang, Hong; Rivett, Ulrike; Gundry, Stephen W

2012-07-27

In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. This repeated cross-sectional study draws on General Household Surveys from 2002-2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002-2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000-02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period.

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Perspectives on Home Care Quality

PubMed Central

Kane, Rosalie A.; Kane, Robert L.; Illston, Laurel H.; Eustis, Nancy N.

1994-01-01

Home care quality assurance (QA) must consider features inherent in home care, including: multiple goals, limited provider control, and unique family roles. Successive panels of stakeholders were asked to rate the importance of selected home care outcomes. Most highly rated outcomes were freedom from exploitation, satisfaction with care, physical safety, affordability, and physical functioning. Panelists preferred outcome indicators to process and structure, and all groups emphasized “enabling” criteria. Themes highlighted included: interpersonal components of care; normalizing life for clientele; balancing quality of life with safety; developing flexible, negotiated care plans; mechanisms for accountability and case management. These themes were formulated differently according to the stakeholders' role. Providers preferred intermediate outcomes, akin to process. PMID:10140158

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

PubMed

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

2015-08-01

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

Assessment of a specifically developed bullet casing gun for the stunning of water buffaloes.

PubMed

Meichtry, Carmen; Glauser, Urs; Glardon, Matthieu; Ross, Steffen G; Lechner, Isabel; Kneubuehl, Beat P; Gascho, Dominic; Spadavecchia, Claudia; von Rotz, Alois; Stojiljkovic, Ana; Stoffel, Michael H

2018-01-01

Water buffaloes and cattle differ considerably with respect to the anatomy of the head. As a result, captive bolt stunners often fail to reliably produce adequate loss of consciousness in water buffaloes and, thus, do not fulfill animal welfare requirements. The goal of the present study was to assess and validate a new stunning device for water buffaloes meeting animal welfare and occupational safety requirements. The newly designed bullet casing gun uses .357Mag/10.2g hollow point bullets and has additional safety features. Its effectiveness and usability were assessed under practical conditions in an abattoir as based on widely accepted criteria. Stunning resulted in deep unconsciousness in 19 out of 20 water buffaloes. One 9-year old male did not immediately collapse. Except for very old bulls, the device presented herewith provides a means to stun water buffaloes of both sexes effectively and reliably while keeping occupational hazards to a minimum. Copyright © 2017 Elsevier Ltd. All rights reserved.

Recommendations for toxicological investigation of drug-impaired driving and motor vehicle fatalities.

PubMed

Logan, Barry K; Lowrie, Kayla J; Turri, Jennifer L; Yeakel, Jillian K; Limoges, Jennifer F; Miles, Amy K; Scarneo, Colleen E; Kerrigan, Sarah; Farrell, Laurel J

2013-10-01

This report describes the review and update of a set of minimum recommendations for the toxicological investigation of suspected alcohol and drug-impaired driving cases and motor vehicle fatalities involving drugs or alcohol. The recommendations have the goal of ensuring that a consistent set of data regarding the most frequently encountered drugs linked to driving impairment is collected for practical application in the investigation of these cases and to allow epidemiological monitoring and the development of evidence-based public policy on this important public safety issue. The recommendations are based on a survey of practices in US laboratories performing this kind of analysis, consideration of existing epidemiological crash and arrest data and practical considerations of widely available technology platforms in laboratories performing this work. The final recommendations were derived from a consensus meeting of experts recruited from survey respondents and the membership of the National Safety Council's Alcohol, Drug and Impairment Division (formerly known as the Committee on Alcohol and Other Drugs, CAOD).

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Occupational Asthma in Korea

PubMed Central

Kim, Kyoo Sang

2010-01-01

Occupational asthma (OA) is the leading occupational respiratory disease. Cases compensated as OA by the Korea Workers' Compensation and Welfare Service (COMWEL) (218 cases), cases reported by a surveillance system (286 cases), case reports by related scientific journals and cases confirmed by the Occupational Safety and Health Research Institute (OSHRI) over 15 yr from 1992 to 2006 were analyzed. Annual mean incidence rate was 1.6 by compensation and 3.5 by surveillance system, respectively. The trend appeared to increase according to the surveillance system. Incidence was very low compared with other countries. The most frequently reported causative agent was isocyanate followed by reactive dye in dyeing factories. Other chemicals, metals and dust were also found as causative agents. OA was underreported according to compensation and surveillance system data. In conclusion, a more effective surveillance system is needed to evaluate OA causes and distribution, and to effectively prevent newly developing OA. PMID:21258586

Risk and protective factors for falls from furniture in young children: multicenter case-control study.

PubMed

Kendrick, Denise; Maula, Asiya; Reading, Richard; Hindmarch, Paul; Coupland, Carol; Watson, Michael; Hayes, Mike; Deave, Toity

2015-02-01

Falls from furniture are common in young children but there is little evidence on protective factors for these falls. To estimate associations for risk and protective factors for falls from furniture in children aged 0 to 4 years. Multicenter case-control study at hospitals, minor injury units, and general practices in and around 4 UK study centers. Recruitment commenced June 14, 2010, and ended April 27, 2012. Participants included 672 children with falls from furniture and 2648 control participants matched on age, sex, calendar time, and study center. Thirty-five percent of cases and 33% of control individuals agreed to participate. The mean age was 1.74 years for cases and 1.91 years for control participants. Fifty-four percent of cases and 56% of control participants were male. Exposures included safety practices, safety equipment use, and home hazards. Falls from furniture occurring at the child's home resulting in attendance at an emergency department, minor injury unit, or hospital admission. Compared with parents of control participants, parents of cases were significantly more likely not to use safety gates in the home (adjusted odds ratio [AOR], 1.65; 95% CI, 1.29-2.12) and not to have taught their children rules about climbing on kitchen objects (AOR, 1.58; 95% CI, 1.16-2.15). Cases aged 0 to 12 months were significantly more likely to have been left on raised surfaces (AOR, 5.62; 95% CI, 3.62-8.72), had their diapers changed on raised surfaces (AOR, 1.89; 95% CI, 1.24-2.88), and been put in car/bouncing seats on raised surfaces (AOR, 2.05; 95% CI, 1.29-3.27). Cases 3 years and older were significantly more likely to have played or climbed on furniture (AOR, 9.25; 95% CI, 1.22-70.07). Cases were significantly less likely to have played or climbed on garden furniture (AOR, 0.74; 95% CI, 0.56-0.97). If estimated associations are causal, some falls from furniture may be prevented by incorporating advice into child health contacts, personal child health records, and home safety assessments about use of safety gates; not leaving children, changing diapers, or putting children in car/bouncing seats on raised surfaces; allowing children to play or climb on furniture; and teaching children safety rules about climbing on objects.

Abused women's experiences of a primary care identification and referral intervention: a case study analysis.

PubMed

Bradbury-Jones, Caroline; Clark, Maria; Taylor, Julie

2017-12-01

The aim of this study was to report the findings of a qualitative case study that investigated abused women's experiences of an identification and referral intervention and to discuss the implications for nurses, specifically those working in primary and community care. Domestic violence and abuse is a significant public health issue globally but it is a hidden problem that is under-reported. In the UK, Identification and Referral to Improve Safety is a primary care-based intervention that has been found to increase referral rates of abused women to support and safety services. This paper reports on the findings of an evaluation study of two sites in England. Qualitative study with a case study design. In line with case study design, the entire evaluation study employed multiple data collection methods. We report on the qualitative interviews with women referred through the programme. The aim was to elicit their experiences of the three aspects of the intervention: identification; referral; safety. Data collection took place March 2016. Ten women took part. Eight had exited the abusive relationship but two remained with the partner who had perpetrated the abuse. Women were overwhelmingly positive about the programme and irrespective of whether they had remained or exited the relationship all reported perceptions of increased safety and improved health. Nurses have an important role to play in identifying domestic violence and abuse and in referral and safety planning. As part of a portfolio of domestic violence and abuse interventions, those that empower women to take control of their safety (such as Identification and Referral to Improve Safety) are important. © 2017 John Wiley & Sons Ltd.

Casing pipe damage detection with optical fiber sensors: a case study in oil well constructions

NASA Astrophysics Data System (ADS)

Zhou, Zhi; He, Jianping; Huang, Minghua; He, Jun; Ou, Jinping; Chen, Genda

2010-04-01

Casing pipes in oil well constructions may suddenly buckle inward as their inside and outside hydrostatic pressure difference increases. For the safety of construction workers and the steady development of oil industries, it is critically important to measure the stress state of a casing pipe. This study develops a rugged, real-time monitoring, and warning system that combines the distributed Brillouin Scattering Time Domain Reflectometry (BOTDR) and the discrete fiber Bragg grating (FBG) measurement. The BOTDR optical fiber sensors were embedded with no optical fiber splice joints in a fiber reinforced polymer (FRP) rebar and the FBG sensors were wrapped in epoxy resins and glass clothes, both installed during the segmental construction of casing pipes. In-situ tests indicate that the proposed sensing system and installation technique can survive the downhole driving process of casing pipes, withstand a harsh service environment, and remain in tact with the casing pipes for compatible strain measurements. The relative error of the measured strains between the distributed and discrete sensors is less than 12%. The FBG sensors successfully measured the maximum horizontal principal stress with a relative error of 6.7% in comparison with a cross multi-pole array acoustic instrument.

Total Quality Management and the System Safety Secretary

NASA Technical Reports Server (NTRS)

Elliott, Suzan E.

1993-01-01

The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

Next generation safety performance monitoring at signalized intersections using connected vehicle technology.

DOT National Transportation Integrated Search

2014-08-01

Crash-based safety evaluation is often hampered by randomness, lack of timeliness, and rarity of crash : occurrences. This is particularly the case for technology-driven safety improvement projects that are : frequently updated or replaced by newer o...

An application of multiattribute decision analysis to the Space Station Freedom program. Case study: Automation and robotics technology evaluation

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Levin, Richard R.; Carpenter, Elisabeth J.

1990-01-01

The results are described of an application of multiattribute analysis to the evaluation of high leverage prototyping technologies in the automation and robotics (A and R) areas that might contribute to the Space Station (SS) Freedom baseline design. An implication is that high leverage prototyping is beneficial to the SS Freedom Program as a means for transferring technology from the advanced development program to the baseline program. The process also highlights the tradeoffs to be made between subsidizing high value, low risk technology development versus high value, high risk technology developments. Twenty one A and R Technology tasks spanning a diverse array of technical concepts were evaluated using multiattribute decision analysis. Because of large uncertainties associated with characterizing the technologies, the methodology was modified to incorporate uncertainty. Eight attributes affected the rankings: initial cost, operation cost, crew productivity, safety, resource requirements, growth potential, and spinoff potential. The four attributes of initial cost, operations cost, crew productivity, and safety affected the rankings the most.

Influence of professional drivers' personality traits on road traffic safety: case study.

PubMed

Živković, Snežana; Nikolić, Vesna; Markič, Mirko

2015-01-01

The purpose of this paper is to present basic elements of the research directed at identifying and determining the personality traits of professional drivers that affect safe, secure and enjoyable ride on public roads. A quantitative method has been used here, whereas data were acquired from a questionnaire based on a sample of 59 professional drivers. Determining personality traits of professional drivers that are in correlation with a safe and pleasant ride on the roads has been enabled by applying the five-factor model of personality ('Big Five') and the Personality Inventory NEO-PI. From these results it was concluded that safe operation of the vehicle in traffic involves the successful 'conduct' of oneself, which recognises the importance of certain personality traits of professional drivers for traffic safety and the need for appropriate professional selection in the case of employment of professional drivers. Research results implicate development of educational programmes aimed at achieving harmony of psychological, physical and sensory health, that is, programmes for permanent informing, educating and training professional drivers for defensive driving. The research opens the way for new research tasks that should help in creating a specific structure of curricula that can be used in a variety of transportation companies and enterprises to improve general and public safety.