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.

Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

PubMed

Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

2013-12-01

This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them.

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.

Development of a Comprehensive Database System for Safety Analyst

PubMed Central

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

2015-01-01

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

Thesis - keeping the management system {open_quotes}live{close_quotes} and reaching the workforce

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

Primrose, M.J.; Bentley, P.D.; Graaf, G.C. van der

1996-12-31

Previous papers given to SPE conferences have described the Shell Group approach to Safety Management Systems and to Safety Cases. Their extension to HSE MS and to HSE Cases has also been addressed. Since 1984 the Enhanced Safety Management (ESM) programme within Shell companies has led to a significant improvement in the management of safety but it was only when structured management systems (based upon an understanding of the business processes) were introduced that true integration of HSE as a line responsibility became a reality. This paper describes the THESIS software package and the way that management systems have beenmore » made {open_quote}live{close_quote} and how workforce involvement can be demonstrated.« less

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

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

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

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

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

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

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.

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.

Health and safety management systems: liability or asset?

PubMed

Bennett, David

2002-01-01

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

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.

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.

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.

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.

Safety and IVHM

NASA Technical Reports Server (NTRS)

Goebel, Kai

2012-01-01

When we address safety in a book on the business case for IVHM, the question arises whether safety isn t inherently in conflict with the need of operators to run their systems as efficiently (and as cost effectively) as possible. The answer may be that the system needs to be just as safe as needed, but not significantly more. That begs the next question: How safe is safe enough? Several regulatory bodies provide guidelines for operational safety, but irrespective of that, operators do not want their systems to be known as lacking safety. We illuminate the role of safety within the context of IVHM.

Improving Performance of the System Safety Function at Marshall Space Flight Center

NASA Technical Reports Server (NTRS)

Kiessling, Ed; Tippett, Donald D.; Shivers, Herb

2004-01-01

The Columbia Accident Investigation Board (CAIB) determined that organizational and management issues were significant contributors to the loss of Space Shuttle Columbia. In addition, the CAIB observed similarities between the organizational and management climate that preceded the Challenger accident and the climate that preceded the Columbia accident. To prevent recurrence of adverse organizational and management climates, effective implementation of the system safety function is suggested. Attributes of an effective system safety program are presented. The Marshall Space Flight Center (MSFC) system safety program is analyzed using the attributes. Conclusions and recommendations for improving the MSFC system safety program are offered in this case study.

Issues in Software System Safety: Polly Ann Smith Co. versus Ned I. Ludd

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2002-01-01

This paper is a work of fiction, but it is fiction with a very real purpose: to stimulate careful thought and friendly discussion about some questions for which thought is often careless and discussion is often unfriendly. To accomplish this purpose, the paper creates a fictional legal case. The most important issue in this fictional case is whether certain proffered expert testimony about software engineering for safety critical systems should be admitted. Resolving this issue requires deciding the extent to which current practices and research in software engineering, especially for safety-critical systems, can rightly be considered based on knowledge, rather than opinion.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

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.

Model-Driven Development of Safety Architectures

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2017-01-01

We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

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.

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.

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.

Certification of highly complex safety-related systems.

PubMed

Reinert, D; Schaefer, M

1999-01-01

The BIA has now 15 years of experience with the certification of complex electronic systems for safety-related applications in the machinery sector. Using the example of machining centres this presentation will show the systematic procedure for verifying and validating control systems using Application Specific Integrated Circuits (ASICs) and microcomputers for safety functions. One section will describe the control structure of machining centres with control systems using "integrated safety." A diverse redundant architecture combined with crossmonitoring and forced dynamization is explained. In the main section the steps of the systematic certification procedure are explained showing some results of the certification of drilling machines. Specification reviews, design reviews with test case specification, statistical analysis, and walk-throughs are the analytical measures in the testing process. Systematic tests based on the test case specification, Electro Magnetic Interference (EMI), and environmental testing, and site acceptance tests on the machines are the testing measures for validation. A complex software driven system is always undergoing modification. Most of the changes are not safety-relevant but this has to be proven. A systematic procedure for certifying software modifications is presented in the last section of the paper.

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.

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.

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.

Mines Systems Safety Improvement Using an Integrated Event Tree and Fault Tree Analysis

NASA Astrophysics Data System (ADS)

Kumar, Ranjan; Ghosh, Achyuta Krishna

2017-04-01

Mines systems such as ventilation system, strata support system, flame proof safety equipment, are exposed to dynamic operational conditions such as stress, humidity, dust, temperature, etc., and safety improvement of such systems can be done preferably during planning and design stage. However, the existing safety analysis methods do not handle the accident initiation and progression of mine systems explicitly. To bridge this gap, this paper presents an integrated Event Tree (ET) and Fault Tree (FT) approach for safety analysis and improvement of mine systems design. This approach includes ET and FT modeling coupled with redundancy allocation technique. In this method, a concept of top hazard probability is introduced for identifying system failure probability and redundancy is allocated to the system either at component or system level. A case study on mine methane explosion safety with two initiating events is performed. The results demonstrate that the presented method can reveal the accident scenarios and improve the safety of complex mine systems simultaneously.

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.

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

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.

Safety management for polluted confined space with IT system: a running case.

PubMed

Hwang, Jing-Jang; Wu, Chien-Hsing; Zhuang, Zheng-Yun; Hsu, Yi-Chang

2015-01-01

This study traced a deployed real IT system to enhance occupational safety for a polluted confined space. By incorporating wireless technology, it automatically monitors the status of workers on the site and upon detected anomalous events, managers are notified effectively. The system, with a redefined standard operations process, is running well at one of Formosa Petrochemical Corporation's refineries. Evidence shows that after deployment, the system does enhance the safety level by real-time monitoring the workers and by managing well and controlling the anomalies. Therefore, such technical architecture can be applied to similar scenarios for safety enhancement purposes.

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.

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

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

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.

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.

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.

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.

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.

Safety Aspects of Big Cryogenic Systems Design

NASA Astrophysics Data System (ADS)

Chorowski, M.; Fydrych, J.; Poliński, J.

2010-04-01

Superconductivity and helium cryogenics are key technologies in the construction of large scientific instruments, like accelerators, fusion reactors or free electron lasers. Such cryogenic systems may contain more than hundred tons of helium, mostly in cold and high-density phases. In spite of the high reliability of the systems, accidental loss of the insulation vacuum, pipe rupture or rapid energy dissipation in the cold helium can not be overlooked. To avoid the danger of over-design pressure rise in the cryostats, they need to be equipped with a helium relief system. Such a system is comprised of safety valves, bursting disks and optionally cold or warm quench lines, collectors and storage tanks. Proper design of the helium safety relief system requires a good understanding of worst case scenarios. Such scenarios will be discussed, taking into account different possible failures of the cryogenic system. In any case it is necessary to estimate heat transfer through degraded vacuum superinsulation and mass flow through the valves and safety disks. Even if the design of the helium relief system does not foresee direct helium venting into the environment, an occasional emergency helium spill may happen. Helium propagation in the atmosphere and the origins of oxygen-deficiency hazards will be discussed.

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.

Model-Driven Safety Analysis of Closed-Loop Medical Systems

PubMed Central

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2013-01-01

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176

Model-Driven Safety Analysis of Closed-Loop Medical Systems.

PubMed

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2012-10-26

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.

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

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.

Managing Safety and Operations: The Effect of Joint Management System Practices on Safety and Operational Outcomes.

PubMed

Tompa, Emile; Robson, Lynda; Sarnocinska-Hart, Anna; Klassen, Robert; Shevchenko, Anton; Sharma, Sharvani; Hogg-Johnson, Sheilah; Amick, Benjamin C; Johnston, David A; Veltri, Anthony; Pagell, Mark

2016-03-01

The aim of this study was to determine whether management system practices directed at both occupational health and safety (OHS) and operations (joint management system [JMS] practices) result in better outcomes in both areas than in alternative practices. Separate regressions were estimated for OHS and operational outcomes using data from a survey along with administrative records on injuries and illnesses. Organizations with JMS practices had better operational and safety outcomes than organizations without these practices. They had similar OHS outcomes as those with operations-weak practices, and in some cases, better outcomes than organizations with safety-weak practices. They had similar operational outcomes as those with safety-weak practices, and better outcomes than those with operations-weak practices. Safety and operations appear complementary in organizations with JMS practices in that there is no penalty for either safety or operational outcomes.

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

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.

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

How Safe Is Control Software

NASA Technical Reports Server (NTRS)

Dunn, William R.; Corliss, Lloyd D.

1991-01-01

Paper examines issue of software safety. Presents four case histories of software-safety analysis. Concludes that, to be safe, software, for all practical purposes, must be free of errors. Backup systems still needed to prevent catastrophic software failures.

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

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

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Impact of Active Control on Passive Safety Response Characteristics of Sodium-cooled Fast Reactors: I - Theoretical background

DOE PAGES

Passerini, Stefano; Ponciroli, Roberto; Vilim, Richard B.

2017-06-21

Here, the interaction of the active control system with passive safety behavior is investigated for sodium-cooled fast reactors. A claim often made of advanced reactors is that they are passively safe against unprotected upset events. In practice, such upset events are not analyzed in the context of the plant control system, but rather the analyses are performed without considering the normally programmed response of the control system (open-loop approach). This represents an oversimplification of the safety case. The issue of passive safety override arises since the control system commands actuators whose motions have safety consequences. Depending on the upset involvingmore » the control system ( operator error, active control system failure, or inadvertent control system override), an actuator does not necessarily go in the same direction as needed for safety. So neglecting to account for control system action during an unprotected upset is nonconservative from a safety standpoint. It is important then, during the design of the plant, to consider the potential for the control system to work against the inherent and safe regulating effects of purposefully engineered temperature feedbacks.« less

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

2006-01-01

The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

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.

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.

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

[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.

Investment appraisal using quantitative risk analysis.

PubMed

Johansson, Henrik

2002-07-01

Investment appraisal concerned with investments in fire safety systems is discussed. Particular attention is directed at evaluating, in terms of the Bayesian decision theory, the risk reduction that investment in a fire safety system involves. It is shown how the monetary value of the change from a building design without any specific fire protection system to one including such a system can be estimated by use of quantitative risk analysis, the results of which are expressed in terms of a Risk-adjusted net present value. This represents the intrinsic monetary value of investing in the fire safety system. The method suggested is exemplified by a case study performed in an Avesta Sheffield factory.

Methods of quantitative risk assessment: The case of the propellant supply system

NASA Astrophysics Data System (ADS)

Merz, H. A.; Bienz, A.

1984-08-01

As a consequence of the disastrous accident in Lapua (Finland) in 1976, where an explosion in a cartridge loading facility killed 40 and injured more than 70 persons, efforts were undertaken to examine and improve the safety of such installations. An ammunition factory in Switzerland considered the replacement of the manual supply of propellant hoppers by a new pneumatic supply system. This would reduce the maximum quantity of propellant in the hoppers to a level, where an accidental ignition would no longer lead to a detonation, and this would drastically limit the effects on persons. A quantitative risk assessment of the present and the planned supply system demonstrated that, in this particular case, the pneumatic supply system would not reduce the risk enough to justify the related costs. In addition, it could be shown that the safety of the existing system can be improved more effectively by other safety measures at considerably lower costs. Based on this practical example, the advantages of a strictly quantitative risk assessment for the safety planning in explosives factories are demonstrated. The methodological background of a risk assessment and the steps involved in the analysis are summarized. In addition, problems of quantification are discussed.

Metropolitan transportation management center : a case study : Michigan intelligent transportation system : improving safety and air quality while reducing stress for motorists

DOT National Transportation Integrated Search

1999-10-01

The following case study provides a snapshot of Michigan's Intelligent Transportation Systems transportation management center (MITSC). It follows the outline provided in the companion document, Metropolitan Transportation Management Center Concepts ...

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.

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

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.

Comprehensive safety management and assessment at rugby football competitions.

PubMed

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

2014-11-01

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

Certification Strategies using Run-Time Safety Assurance for Part 23 Autopilot Systems

NASA Technical Reports Server (NTRS)

Hook, Loyd R.; Clark, Matthew; Sizoo, David; Skoog, Mark A.; Brady, James

2016-01-01

Part 23 aircraft operation, and in particular general aviation, is relatively unsafe when compared to other common forms of vehicle travel. Currently, there exists technologies that could increase safety statistics for these aircraft; however, the high burden and cost of performing the requisite safety critical certification processes for these systems limits their proliferation. For this reason, many entities, including the Federal Aviation Administration, NASA, and the US Air Force, are considering new options for certification for technologies that will improve aircraft safety. Of particular interest, are low cost autopilot systems for general aviation aircraft, as these systems have the potential to positively and significantly affect safety statistics. This paper proposes new systems and techniques, leveraging run-time verification, for the assurance of general aviation autopilot systems, which would be used to supplement the current certification process and provide a viable path for near-term low-cost implementation. In addition, discussions on preliminary experimentation and building the assurance case for a system, based on these principles, is provided.

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

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.

Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

PubMed

Balka, Ellen; Tolar, Marianne; Coates, Shannon; Whitehouse, Sandra

2013-12-01

Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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.

The procedure safety system

NASA Technical Reports Server (NTRS)

Obrien, Maureen E.

1990-01-01

Telerobotic operations, whether under autonomous or teleoperated control, require a much more sophisticated safety system than that needed for most industrial applications. Industrial robots generally perform very repetitive tasks in a controlled, static environment. The safety system in that case can be as simple as shutting down the robot if a human enters the work area, or even simply building a cage around the work space. Telerobotic operations, however, will take place in a dynamic, sometimes unpredictable environment, and will involve complicated and perhaps unrehearsed manipulations. This creates a much greater potential for damage to the robot or objects in its vicinity. The Procedural Safety System (PSS) collects data from external sensors and the robot, then processes it through an expert system shell to determine whether an unsafe condition or potential unsafe condition exists. Unsafe conditions could include exceeding velocity, acceleration, torque, or joint limits, imminent collision, exceeding temperature limits, and robot or sensor component failure. If a threat to safety exists, the operator is warned. If the threat is serious enough, the robot is halted. The PSS, therefore, uses expert system technology to enhance safety thus reducing operator work load, allowing him/her to focus on performing the task at hand without the distraction of worrying about violating safety criteria.

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.

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.

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

Use of the levonorgestrel 52-mg intrauterine system in adolescent and young adult solid organ transplant recipients: a case series.

PubMed

Huguelet, P S; Sheehan, C; Spitzer, R F; Scott, S

2017-04-01

This case series reports on the safety and efficacy of the levonorgestrel 52-mg intrauterine system in adolescent and young adult solid organ transplant recipients. All patients used the device for contraception, with no documented cases of disseminated pelvic infection or unplanned pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

77 FR 11353 - Defense Federal Acquisition Regulation Supplement: Award Fee Reduction or Denial for Health or...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... Denial for Health or Safety Issues (DFARS Case 2011-D033) AGENCY: Defense Acquisition Regulations System... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government...

The Impact of Patient Safety Training on Oral and Maxillofacial Surgery Residents' Attitudes and Knowledge: A Mixed Method Case Study

ERIC Educational Resources Information Center

Buhrow, Suzanne

2013-01-01

It is estimated that in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Patient safety experts and graduate medical education accreditation leaders recognize that medical education reform must include the integration of safety training focused on error causation, system engineering, and…

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.

Argument-Based Airworthiness Assurance of Small UAS

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Presently, there are three avenues by which Unmanned Aircraft System (UAS) operations are authorized in the U.S. National Airspace System (NAS): obtaining either (i) a certificate of authorization (COA), or (ii) a special airworthiness certificate (SAC) in either the experimental, or the restricted category, or (iii) an exemption from an airworthiness certificate together with a civil COA. The first is meant primarily for public entities, such as NASA; the remaining two are the only available means for civil UAS operations. Recently, the Federal Aviation Administration (FAA) has also proposed a regulatory framework targeted for certain small UAS, specifically those weighing 55 pounds or less, although final rulemaking remains pending. We have previously shown how an assurance case can aggregate heterogeneous reasoning and safety evidence, with application to UAS safety. In this paper, we describe how assurance cases can serve as a common framework to justify overall system safety, unifying both operational aspects and airworthiness, in particular system design assurance. We also show how this approach can coexist with, and augment, existing safety analysis processes and best-practices, by transforming the artifacts they produce into structured assurance arguments. To illustrate the applicability and utility of our approach, we have been applying it for the design assurance of an unmanned rotorcraft system, intended for precision agriculture operations, as part of the NASA Unmanned Aircraft System (UAS) Integration in the National Airspace System (NAS) project.

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.

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.

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.

PubMed

Raschi, Emanuel; Girardi, Anna; Poluzzi, Elisabetta; Forcesi, Emanuele; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio

2018-03-26

Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still incompletely characterized. We described and compared adverse events (AEs) associated with RYR products submitted to reporting systems maintained by the Food and Drug Administration (FDA), with a focus on liver and muscular events. We extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% confidence interval (CI) calculation and case-by-case inspection were performed, with a focus on muscular and hepatic AEs. One thousand three hundred AEs were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). In FAERS, a large number of reports emerged for "general disorders and administration site conditions," whereas CAERS received also a high number of reports for "investigations" and "musculoskeletal and connective tissue disorders". Disproportionality analyses confirmed higher reporting of serious muscular and liver injuries: in FAERS, five cases of hepatic disorders (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy (8.44; 5.44-13.10). Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

Idaho National Laboratory Integrated Safety Management System FY 2016 Effectiveness Review and Declaration Report

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

Hunt, Farren J.

Idaho National Laboratory’s (INL’s) Integrated Safety Management System (ISMS) effectiveness review of fiscal year (FY) 2016 shows that INL has integrated management programs and safety elements throughout the oversight and operational activities performed at INL. The significant maturity of Contractor Assurance System (CAS) processes, as demonstrated across INL’s management systems and periodic reporting through the Management Review Meeting process, over the past two years has provided INL with current real-time understanding and knowledge pertaining to the health of the institution. INL’s sustained excellence of the Integrated Safety and effective implementation of the Worker Safety and Health Program is also evidencedmore » by other external validations and key indicators. In particular, external validations include VPP, ISO 14001, DOELAP accreditation, and key Laboratory level indicators such as ORPS (number, event frequency and severity); injury/illness indicators such as Days Away, Restricted and Transfer (DART) case rate, back & shoulder metric and open reporting indicators, demonstrate a continuous positive trend and therefore improved operational performance over the last few years. These indicators are also reflective of the Laboratory’s overall organizational and safety culture improvement. Notably, there has also been a step change in ESH&Q Leadership actions that have been recognized both locally and complex-wide. Notwithstanding, Laboratory management continues to monitor and take action on lower level negative trends in numerous areas including: Conduct of Operations, Work Control, Work Site Analysis, Risk Assessment, LO/TO, Fire Protection, and Life Safety Systems, to mention a few. While the number of severe injury cases has decreased, as evidenced by the reduction in the DART case rate, the two hand injuries and the fire truck/ambulance accident were of particular concern. Aggressive actions continue in order to understand the causes and define actions needed to prevent similar injuries and accidents in the future. While our injury rate is not where we want it to be, it is not the only indicator that defines our ISMS program, safety culture, and efforts to be a continuous learning organization. When reviewing the entire year’s performance, and all areas that integrate ISMS principles and core functions, INL has an “effective” ISMS program that is continually improving.« less

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

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.

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.

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.

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

An Intelligent System Proposal for Improving the Safety and Accessibility of Public Transit by Highway

PubMed Central

García, Carmelo R.; Quesada-Arencibia, Alexis; Cristóbal, Teresa; Padrón, Gabino; Pérez, Ricardo; Alayón, Francisco

2015-01-01

The development of public transit systems that are accessible and safe for everyone, including people with special needs, is an objective that is justified from the civic and economic points of view. Unfortunately, public transit services are conceived for people who do not have reduced physical or cognitive abilities. In this paper, we present an intelligent public transit system by highway with the goal of facilitating access and improving the safety of public transit for persons with special needs. The system is deployed using components that are commonly available in transport infrastructure, e.g., sensors, mobile communications systems, and positioning systems. In addition, the system can operate in non-urban transport contexts, e.g., isolated rural areas, where the availability of basic infrastructure, such as electricity and communications infrastructures, is not always guaranteed. To construct the system, the principles and techniques of Ubiquitous Computing and Ambient Intelligence have been employed. To illustrate the utility of the system, two cases of services rendered by the system are described: the first case involves a surveillance system to guarantee accessibility at bus stops; the second case involves a route assistant for blind people. PMID:26295234

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.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

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.

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.

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

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/.

Efficacy and safety of the remOVE System for OTSC® and FTRD® clip removal: data from a PMCF analysis.

PubMed

Caputo, Antonio; Schmidt, Arthur; Caca, Karel; Bauerfeind, Peter; Schostek, Sebastian; Ho, Chi-Nghia; Gottwald, Thomas; Schurr, Marc O

2018-06-01

The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system. A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip. Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%). Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.

Managing pedestrian safety II : A case-control study of collision locations on state routes in King County and Seattle, Washington

DOT National Transportation Integrated Search

2008-01-01

The safety of non-motorized transportation systems is essential to the public acceptance and overall success of Washington State's and local jurisdictions' efforts to reduce congestion. The State's and the jurisdictions' goals to increase non-SOV (si...

Improving Safety of the Surface Transportation System by Addressing the Issues of Vulnerable Road Users : Case of the Motorcyclists

DOT National Transportation Integrated Search

2012-07-01

Over the past few years, motorcycle fatalities have increased at an alarming rate in the United States. Motorcycle safety issues in Kansas : are no different from the national scenario. Accordingly, this study examines motorcycle crashes in Kansas in...

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.

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

Impact of the time-out process on safety attitude in a tertiary neurosurgical department.

PubMed

McLaughlin, Nancy; Winograd, Deborah; Chung, Hallie R; Van de Wiele, Barbara; Martin, Neil A

2014-11-01

In July 2011, the UCLA Health System released its current time-out process protocol used across the Health System. Numerous interventions were performed to improve checklist completion and time-out process observance. This study assessed the impact of the current protocol for the time-out on healthcare providers' safety attitude and operating room safety climate. All members involved in neurosurgical procedures in the main operating room of the Ronald Reagan UCLA Medical Center were asked to anonymously complete an online survey on their overall perception of the time-out process. The survey was completed by 93 of 128 members of the surgical team. Overall, 98.9% felt that performing a pre-incision time-out improves patient safety. The majority of respondents (97.8%) felt that the team member introductions helped to promote a team spirit during the case. In addition, 93.5% felt that performing a time-out helped to ensure all team members were comfortable to voice safety concerns throughout the case. All respondents felt that the attending surgeon should be present during the time-out and 76.3% felt that he/she should lead the time-out. Unanimously, it was felt that the review of anticipated critical elements by the attending surgeon was helpful to respondents' role during the case. Responses revealed that although the time-out brings the team together physically, it does not necessarily reinforce teamwork. The time-out process favorably impacted team members' safety attitudes and perception as well as overall safety climate in neurosurgical ORs. Survey responses identified leadership training and teamwork training as two avenues for future improvement. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

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.

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.

Significance of Waterway Navigation Positioning Systems On Ship's Manoeuvring Safety

NASA Astrophysics Data System (ADS)

Galor, W.

The main goal of navigation is to lead the ship to the point of destination safety and efficiently. Various factors may affect ship realisating this process. The ship movement on waterway are mainly limited by water area dimensions (surface and depth). These limitations cause the requirement to realise the proper of ship movement trajectory. In case when this re requirement cant't fulfil then marine accident may happend. This fact is unwanted event caused losses of human health and life, damage or loss of cargo and ship, pollution of natural environment, damage of port structures or blocking the port of its ports and lost of salvage operation. These losses in same cases can be catas- trophical especially while e.i. crude oil spilling could be place. To realise of safety navigation process is needed to embrace the ship's movement trajectory by waterways area. The ship's trajectory is described by manoeuvring lane as a surface of water area which is require to realise of safety ship movement. Many conditions affect to ship manoeuvring line. The main are following: positioning accuracy, ship's manoeuvring features and phenomena's of shore and ship's bulk common affecting. The accuracy of positioning system is most important. This system depends on coast navigation mark- ing which can range many kinds of technical realisation. Mainly used systems based on lights (line), radionavigation (local system or GPS, DGPS), or radars. If accuracy of positiong is higer, then safety of navigation is growing. This article presents these problems exemplifying with approaching channel to ports situated on West Pomera- nian water region.

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...

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.

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

Safety assessment of a home-based telecare system for adults with developmental disabilities in Indiana: a multi-stakeholder perspective.

PubMed

Brewer, Jeffrey L; Taber-Doughty, Teresa; Kubik, Sara

2010-01-01

We investigated the perceptions of people about the safety, security and privacy of a telecare monitoring system for adults with developmental disabilities living in residential settings. The telecare system was used by remote caregivers overnight, when staff were not present in the homes. We surveyed 127 people from different stakeholder groups in the state of Indiana. The people surveyed included those with knowledge or experience of telecare, and those without. The stakeholders were clients, their advocates, service provider administrators and independent case coordinators. The responses in each category for every group were positive except one: only 4 of the 11 telecare case coordinators agreed that the telecare system provided a secure environment. Overall, the telecare system was perceived to be as safe, secure and private as the conventional alternative of having staff in the home.

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

PubMed

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

1998-06-01

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

Making safety an integral part of 5S in healthcare.

PubMed

Ikuma, Laura H; Nahmens, Isabelina

2014-01-01

Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

49 CFR 238.431 - Brake system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... train is operating under worst-case adhesion conditions. (b) The brake system shall be designed to allow... a brake rate consistent with prevailing adhesion, passenger safety, and brake system thermal... adhesion control system designed to automatically adjust the braking force on each wheel to prevent sliding...

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.

Aircraft fire safety research

NASA Technical Reports Server (NTRS)

Botteri, Benito P.

1987-01-01

During the past 15 years, very significant progress has been made toward enhancing aircraft fire safety in both normal and hostile (combat) operational environments. Most of the major aspects of the aircraft fire safety problem are touched upon here. The technology of aircraft fire protection, although not directly applicable in all cases to spacecraft fire scenarios, nevertheless does provide a solid foundation to build upon. This is particularly true of the extensive research and testing pertaining to aircraft interior fire safety and to onboard inert gas generation systems, both of which are still active areas of investigation.

The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

PubMed Central

2014-01-01

The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

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.

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.

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.

A review of wiring system safety in space power systems

NASA Technical Reports Server (NTRS)

Stavnes, Mark W.; Hammoud, Ahmad N.

1993-01-01

Wiring system failures have resulted from arc propagation in the wiring harnesses of current aerospace vehicles. These failures occur when the insulation becomes conductive upon the initiation of an arc. In some cases, the conductive path of the carbon arc track displays a high enough resistance such that the current is limited, and therefore may be difficult to detect using conventional circuit protection. Often, such wiring failures are not simply the result of insulation failure, but are due to a combination of wiring system factors. Inadequate circuit protection, unforgiving system designs, and careless maintenance procedures can contribute to a wiring system failure. This paper approaches the problem with respect to the overall wiring system, in order to determine what steps can be taken to improve the reliability, maintainability, and safety of space power systems. Power system technologies, system designs, and maintenance procedures which have led to past wiring system failures will be discussed. New technologies, design processes, and management techniques which may lead to improved wiring system safety will be introduced.

The Decision Making Trial and Evaluation Laboratory (Dematel) and Analytic Network Process (ANP) for Safety Management System Evaluation Performance

NASA Astrophysics Data System (ADS)

Rolita, Lisa; Surarso, Bayu; Gernowo, Rahmat

2018-02-01

In order to improve airport safety management system (SMS) performance, an evaluation system is required to improve on current shortcomings and maximize safety. This study suggests the integration of the DEMATEL and ANP methods in decision making processes by analyzing causal relations between the relevant criteria and taking effective analysis-based decision. The DEMATEL method builds on the ANP method in identifying the interdependencies between criteria. The input data consists of questionnaire data obtained online and then stored in an online database. Furthermore, the questionnaire data is processed using DEMATEL and ANP methods to obtain the results of determining the relationship between criteria and criteria that need to be evaluated. The study cases on this evaluation system were Adi Sutjipto International Airport, Yogyakarta (JOG); Ahmad Yani International Airport, Semarang (SRG); and Adi Sumarmo International Airport, Surakarta (SOC). The integration grades SMS performance criterion weights in a descending order as follow: safety and destination policy, safety risk management, healthcare, and safety awareness. Sturges' formula classified the results into nine grades. JOG and SMG airports were in grade 8, while SOG airport was in grade 7.

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.

Implications of case managers' perceptions and attitude on safety of home-delivered care.

PubMed

Jones, Sarahjane

2015-12-01

Perceptions on safety in community care have been relatively unexplored. A project that sought to understand the multiple perspectives on safety in the NHS case-management programme was carried out in relation to the structure, process, and outcome of care. This article presents a component of the nursing perspective that highlights an important element in the structure of nursing care that could potentially impede the nurses' ability to be fully effective and safe. A single case study of the case-management programme was undertaken. Three primary care organisations from three strategic health authorities participated, and three focus groups were conducted (one within each organisation). In total, 17 case management nurses participated. Data were audiotaped and transcribed verbatim and subjected to framework analysis. Nursing staff attitudes were identified as a structure of care that influence safety outcomes, particularly their perceptions of the care setting and the implications it has on their role and patient behaviour. Greater understanding of the expected role of the community nurse is necessary, and relevant training is required for nurses to be successful in empowering patients to perform more safely. In addition, efforts need to be made to improve patients' trust in the health-care system to prevent harm and promote more effective utilisation of resources.

A flooding induced station blackout analysis for a pressurized water reactor using the RISMC toolkit

DOE PAGES

Mandelli, Diego; Prescott, Steven; Smith, Curtis; ...

2015-05-17

In this paper we evaluate the impact of a power uprate on a pressurized water reactor (PWR) for a tsunami-induced flooding test case. This analysis is performed using the RISMC toolkit: the RELAP-7 and RAVEN codes. RELAP-7 is the new generation of system analysis codes that is responsible for simulating the thermal-hydraulic dynamics of PWR and boiling water reactor systems. RAVEN has two capabilities: to act as a controller of the RELAP-7 simulation (e.g., component/system activation) and to perform statistical analyses. In our case, the simulation of the flooding is performed by using an advanced smooth particle hydrodynamics code calledmore » NEUTRINO. The obtained results allow the user to investigate and quantify the impact of timing and sequencing of events on system safety. The impact of power uprate is determined in terms of both core damage probability and safety margins.« less

Hair removal for Fitzpatrick skin types V and VI using light and heat energy technology.

PubMed

Sadick, Neil S; Krespi, Yoseph

2006-09-01

To determine the safety and efficacy of a light and heat energy (LHE)-based system (SkinStaion system; Radiancy Inc, Orangeburg, NY, USA) for hair removal in subjects with skin types V and VI. Thirty-one subjects with Fitzpatrick skin types V and VI were consented for treatment with the system. Twenty-six subjects completed the 12-week follow-up. Safety was evaluated at each visit and efficacy was evaluated at both follow-up visits. An average hair clearance of 41.7% from 57 treatment sites was reported at the 6-week follow-up visit and a 35.5% average hair clearance was reported at the 12-week follow-up. Edema was only reported in 2 cases (7.7%) of the study population. Eleven cases of erythema were reported following treatment. Treatment with the modified LHE system was safe and effective for hair removal in patients with skin types V and VI.

Safety and Suitability for Service Assessment Testing of Large Caliber Ammunition Greater Than 40MM

DTIC Science & Technology

2013-07-02

2 July 2013 2 Page Paragraph 9.2 Insensitive Munitions Assessment ........................................ 14 9.3 Munition Software System ...encounter during storage and transportation. 3.12 Weapon System . A weapon and those components required for its operation, comprising the aggregate of...Provide a positive indexing system on the cartridge case to ensure proper orientation of the case when it is loaded into the weapon. 6.9 Weapon

Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts.

PubMed

Wallace, Louise M; Spurgeon, Peter; Benn, Jonathan; Koutantji, Maria; Vincent, Charles

2009-08-01

This paper describes practical implications and learning from a multi-method study of feedback from patient safety incident reporting systems. The study was performed using the Safety Action and Information Feedback from Incident Reporting model, a model of the requirements of the feedback element of a patient safety incident reporting and learning system, derived from a scoping review of research and expert advice from world leaders in safety in high-risk industries. We present the key findings of the studies conducted in the National Health Services (NHS) trusts in England and Wales in 2006. These were a survey completed by risk managers for 351 trusts in England and Wales, three case studies including interviews with staff concerning an example of good practice feedback and an audit of 90 trusts clinical risk staff newsletters. We draw on an Expert Workshop that included 71 experts from the NHS, from regulatory bodies in health care, Royal Colleges, Health and Safety Executive and safety agencies in health care and high-risk industries (commercial aviation, rail and maritime industries). We draw recommendations of enduring relevance to the UK NHS that can be used by trust staff to improve their systems. The recommendations will be of relevance in general terms to health services worldwide.

Safety interventions on the labor and delivery unit.

PubMed

Kacmar, Rachel M

2017-06-01

The present review highlights recent advances in efforts to improve patient safety on labor and delivery units and well tolerated care for pregnant patients in general. Recent studies in obstetric patient safety have a broad focus but repetitive themes for interdisciplinary training include: simulating critical events, having open multidisciplinary communication, frequent reviews of cases of maternal morbidity, and implementing maternal early warning systems. The National Partnership for Maternal Safety is also active in promoting care bundles across many topics on maternal safety. A culture of safety is the goal for all obstetric units. Achieving that ideal requires multidisciplinary collaboration, frequent reassessment for areas of improvement, and a culture of openness to change when improvement opportunities arise.

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.

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

10 CFR Appendix E to Part 50 - Emergency Planning and Preparedness for Production and Utilization Facilities

Code of Federal Regulations, 2011 CFR

2011-01-01

... could communicate with a safety system. In this case, appropriate isolation devices would be required at..., feedwater flow, and reactor power; (2) Safety injection: Reactor core isolation cooling flow, high-pressure... data points identified in the ERDS Data Point Library 9 (site specific data base residing on the ERDS...

10 CFR Appendix E to Part 50 - Emergency Planning and Preparedness for Production and Utilization Facilities

Code of Federal Regulations, 2010 CFR

2010-01-01

... could communicate with a safety system. In this case, appropriate isolation devices would be required at..., feedwater flow, and reactor power; (2) Safety injection: Reactor core isolation cooling flow, high-pressure... data points identified in the ERDS Data Point Library 9 (site specific data base residing on the ERDS...

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.

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.

The HSE management system in practice-implementation

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

Primrose, M.J.; Bentley, P.D.; Sykes, R.M.

1996-11-01

This paper sets out the necessary strategic issues that must be dealt with when setting up a management system for HSE. It touches on the setting of objectives using a form of risk matrix and the establishment of corporate risk tolerability levels. Such issue management is vital but can be seen as yet another corporate HQ initiative. It must therefore be linked, and made relevant to those in middle management tasked with implementing the system and also to those at risk {open_quote}at the sharp end{close_quote} of the business. Setting acceptance criteria is aimed at demonstrating a necessary and sufficient levelmore » of control or coverage for those hazards considered as being within the objective setting of the Safety or HSE Case. Critical risk areas addressed via the Safety Case, within Shell companies at least, must show how this coverage is extended to critical health and environmental issues. Methods of achieving this are various ranging from specific Case deliverables (like the Hazard Register and Accountability Matrices) through to the incorporation of topics from the hazard analysis in toolbox talks and meetings. Risk analysis techniques are increasingly seen as complementary rather than separate with environmental assessments, health risk assessment sand safety risk analyses taking place together and results being considered jointly. The paper ends with some views on the way ahead regarding the linking of risk decisions to target setting at the workplace and views on how Case information may be retrieved and used on a daily basis.« less

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.

A perspective on emerging law, consumer trust and social responsibility in China's food sector: the "bleaching" case study.

PubMed

Roberts, Michael T

2011-01-01

Trust underpins the Chinese social system, and yet it is lacking from a Chinese food system that is riddled with safety disasters and disgruntled consumers. Government and industry play a major role in rehabilitating consumer trust in China. To this end, food safety and quality laws have been constructed to foster this process; however, safety scandals continue even in the face of stricter regulations and increased enforcement. A potential toll to abate food-safety problems and to build trust is the implementation of Corporate Social Responsibility ("CSR"). Mandates by the government promote CSR in enterprise activity, including Article 3 of the 2009 China Food Safety Law. Officials have also recently touted the need for "moral education" of operators in the food industry. Regardless of government activity or whether CSR is employed by food enterprises, it is imperative that the food industry recognizes how critical it is to establish trust with Chinese consumers, who increasingly expect safe, quality food. The case study with pistachios highlights this evolving consumer expectation and the principles of social responsibility in the framework of the relationship between government and industry and consumers, while demonstrating the benefits of doing the right thing for food companies doing business in China.

Road Safety Barriers, the Need and Influence on Road Traffic Accidents

NASA Astrophysics Data System (ADS)

Butāns, Ž.; Gross, K. A.; Gridnevs, A.; Karzubova, E.

2015-11-01

Constantly increasing intensity of road traffic and the allowed speed limits seem to impose stronger requirements on road infrastructure and use of road safety systems. One of the ways to improve road safety is the use of road restraint systems. Road safety barriers allow not only reducing the number of road traffic accidents, but also lowering the severity of accidents. The paper provides information on the technical requirements of road safety barriers. Various types of road safety barriers and their selection criteria for different types of road sections are discussed. The article views an example of a road traffic accident, which is also modelled by PC-Crash computer program. The given example reflects a road accident mechanism in case of a car-to-barrier collision, and provides information about the typical damage to the car and the barrier. The paper describes an impact of the road safety barrier type and its presence on the road traffic accident mechanism. Implementation and maintenance costs of different barrier types are viewed. The article presents a discussion on the necessity to use road safety barriers, as well as their optimal choice.

A Case Study of Environmental, Health and Safety Issues Involving the Burlington, Massachusetts Public School System. "Tips, Suggestions, and Resources for Investigating and Resolving EHS Issues in Schools."

ERIC Educational Resources Information Center

Dresser, Todd H.

An investigation was initiated concerning the environmental health within the Burlington, Massachusetts public school system to determine what specific environmental hazards were present and determine ways of eliminating them. This report presents 20 case studies that detail the environmental health issues involved, the approaches taken in…

Certifying Domain-Specific Policies

NASA Technical Reports Server (NTRS)

Lowry, Michael; Pressburger, Thomas; Rosu, Grigore; Koga, Dennis (Technical Monitor)

2001-01-01

Proof-checking code for compliance to safety policies potentially enables a product-oriented approach to certain aspects of software certification. To date, previous research has focused on generic, low-level programming-language properties such as memory type safety. In this paper we consider proof-checking higher-level domain -specific properties for compliance to safety policies. The paper first describes a framework related to abstract interpretation in which compliance to a class of certification policies can be efficiently calculated Membership equational logic is shown to provide a rich logic for carrying out such calculations, including partiality, for certification. The architecture for a domain-specific certifier is described, followed by an implemented case study. The case study considers consistency of abstract variable attributes in code that performs geometric calculations in Aerospace systems.

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

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

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

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

PubMed

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

2014-01-01

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

Impact of biomarker development on drug safety assessment

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

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

2010-03-01

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

Guaranteeing safety in spatially situated agents

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

Kohout, R.C.; Hendler, J.A.; Musliner, D.J.

1996-12-31

{open_quote}Mission-critical{close_quotes} systems, which include such diverse applications as nuclear power plant controllers, {open_quotes}fly-by-wire{close_quotes} airplanes, medical care and monitoring systems, and autonomous mobile vehicles, are characterized by the fact that system failure is potentially catastrophic. The high cost of failure justifies the expenditure of considerable effort at design-time in order to guarantee the correctness of system behavior. This paper examines the problem of guaranteeing safety in a well studied class of robot motion problems known as the {open_quotes}asteroid avoidance problem.{close_quotes} We establish necessary and sufficient conditions for ensuring safety in the simple version of this problem which occurs most frequently inmore » the literature, as well as sufficient conditions for a more general and realistic case. In doing so, we establish functional relationships between the number, size and speed of obstacles, the robot`s maximum speed and the conditions which must be maintained in order to ensure safety.« less

Use of car crashes resulting in fatal and serious injuries to analyze a safe road transport system model and to identify system weaknesses.

PubMed

Stigson, Helena; Hill, Julian

2009-10-01

The objective of this study was to evaluate a model for a safe road transport system, based on some safety performance indicators regarding the road user, the vehicle, and the road, by using crashes with fatally and seriously injured car occupants. The study also aimed to evaluate whether the model could be used to identify system weaknesses and components (road user, vehicles, and road) where improvements would yield the highest potential for further reductions in serious injuries. Real-life car crashes with serious injury outcomes (Maximum Abbreviated Injury Scale 2+) were classified according to the vehicle's safety rating by Euro NCAP (European New Car Assessment Programme) and whether the vehicle was fitted with ESC (Electronic Stability Control). For each crash, the road was also classified according to EuroRAP (European Road Assessment Programme) criteria, and human behavior in terms of speeding, seat belt use, and driving under the influence of alcohol/drugs. Each crash was compared and classified according to the model criteria. Crashes where the safety criteria were not met in more than one of the 3 components were reclassified to identify whether all the components were correlated to the injury outcome. In-depth crash injury data collected by the UK On The Spot (OTS) accident investigation project was used in this study. All crashes in the OTS database occurring between 2000 and 2005 with a car occupant with injury rated MAIS2+ were included, for a total of 101 crashes with 120 occupants. It was possible to classify 90 percent of the crashes according to the model. Eighty-six percent of the occupants were injured when more than one of the 3 components were noncompliant with the safety criteria. These cases were reclassified to identify whether all of the components were correlated to the injury outcome. In 39 of the total 108 cases, at least two components were still seen to interact. The remaining cases were only related to one of the safety criteria, namely, the road user (26), the vehicle (19), and the road (24). The criteria for the road and the vehicle did not address multiple event crashes, rear-end crashes, hitting stationary/parked vehicles, or trailers. The model for a safe road transport system was found useful to classify fatal and serious road vehicle crashes. It was possible to classify 90 percent of the crashes according to the safety road transport model. For all these cases it was possible to identify weaknesses and parts of the road transport system with the highest potential to prevent fatal and serious injuries. Injury outcomes were mostly related to an interaction between the 3 components: the road, the vehicle, and the road user.

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

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.

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.

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.

Inherent Safety Characteristics of Advanced Fast Reactors

NASA Astrophysics Data System (ADS)

Bochkarev, A. S.; Korsun, A. S.; Kharitonov, V. S.; Alekseev, P. N.

2017-01-01

The study presents SFR transient performance for ULOF events initiated by pump trip and pump seizure with simultaneous failure of all shutdown systems in both cases. The most severe cases leading to the pin cladding rupture and possible sodium boiling are demonstrated. The impact of various features on SFR inherent safety performance for ULOF events was analysed. The decrease in hydraulic resistance of primary loop and increase in primary pump coast down time were investigated. Performing analysis resulted in a set of recommendations to varying parameters for the purpose of enhancing the inherent safety performance of SFR. In order to prevent the safety barrier rupture for ULOF events the set of thermal hydraulic criteria defining the ULOF transient processes dynamics and requirements to these criteria were recommended based on achieved results: primary sodium flow dip under the natural circulation asymptotic level and natural circulation rise time.

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

Advances in our understanding of immunization and vaccines for patients with systemic lupus erythematosus.

PubMed

Bragazzi, Nicola Luigi; Watad, Abdulla; Sharif, Kassem; Adawi, Mohammad; Aljadeff, Gali; Amital, Howard; Shoenfeld, Yehuda

2017-10-01

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease. In SLE, immune system dysfunction is postulated to result by virtue of the disease itself as well as by the impact of treatment modalities employed. A myriad of immune dysregulations occur including complement system dysfunction among others. Infectious agents are known to complicate the disease course in close to 25-45% of SLE patients. Areas covered: In this review a discussion of the immunogenicity and safety of viral and bacterial vaccinations in SLE was performed. The search included ISI Web of Science (WoS), Scopus, MEDLINE/PubMed, Google-Scholar, DOAJ, EbscoHOST, Scirus, Science Direct, Cochrane Library and ProQuest. Proper string made up of a key-words including 'SLE', 'vaccination', 'safety' and 'efficacy' was used. Expert commentary: Vaccination of SLE patients is proven to be immunogenic. Concerns regarding vaccine safety are postulated, yet no direct relationship between vaccination and disease exacerbation were established. While live virus vaccines are generally contraindicated in immunosuppressive states, generally live attenuated vaccinations are recommended in SLE patients on a case-to-case basis. In SLE patients, clinical parameters such as vaccination during disease exacerbations have not been intensively studied and therefore while apparently safe, vaccination is generally recommended while disease is quiescent.

Safety of Mixed Model Access Control in a Multilevel System

DTIC Science & Technology

2014-06-01

SOFTWARE ENGINEERING from the NAVAL POSTGRADUATE SCHOOL June 2014 Author: Randall J. Arvay Approved by: James Bret Michael Dan C . Boger...5  B.  HYPOTHESIS..................................................................................................7  C .  BACKGROUND...27  C .  USE CASE ANALYSIS .................................................................................30  1.  Use Case

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.

US and Dutch nurse experiences with fall prevention technology within nursing home environment and workflow: A qualitative study.

PubMed

Vandenberg, Ann E; van Beijnum, Bert-Jan; Overdevest, Vera G P; Capezuti, Elizabeth; Johnson, Theodore M

Falls remain a major geriatric problem, and the search for new solutions continues. We investigated how existing fall prevention technology was experienced within nursing home nurses' environment and workflow. Our NIH-funded study in an American nursing home was followed by a cultural learning exchange with a Dutch nursing home. We constructed two case reports from interview and observational data and compared the magnitude of falls, safety cultures, and technology characteristics and effectiveness. Falls were a high-magnitude problem at the US site, with a collectively vigilant safety culture attending to non-directional audible alarms; falls were a low-magnitude problem at the NL site which employed customizable, infrared sensors that directed text alerts to assigned staff members' mobile devices in patient-centered care culture. Across cases, 1) a coordinated communication system was essential in facilitating effective fall prevention alert response, and 2) nursing home safety culture is tightly associated with the chosen technological system. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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

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

PubMed

Masso, Märt

2015-01-01

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

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.

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

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.

Consumer Choice between Food Safety and Food Quality: The Case of Farm-Raised Atlantic Salmon

PubMed Central

Haghiri, Morteza

2016-01-01

Since the food incidence of polychlorinated biphenyls in farm-raised Atlantic salmon, its market demand has drastically changed as a result of consumers mistrust in both the quality and safety of the product. Policymakers have been trying to find ways to ensure consumers that farm-raised Atlantic salmon is safe. One of the suggested policies is the implementation of integrated traceability methods and quality control systems. This article examines consumer choice between food safety and food quality to purchase certified farm-raised Atlantic salmon, defined as a product that has passed through various stages of traceability systems in the province of Newfoundland and Labrador, Canada. PMID:28231118

[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'.

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.

Safety analysis

NASA Technical Reports Server (NTRS)

Knight, John C.

1995-01-01

We are engaged in a research program in safety-critical computing that is based on two case studies. We use these case studies to provide application-specific details of the various research issues, and as targets for evaluation of research ideas. The first case study is the Magnetic Stereotaxis System (MSS), an investigational device for performing human neurosurgery being developed in a joint effort between the Department of Physics at the University of Virginia and the Department of Neurosurgery at the University of Iowa. The system operates by manipulating a small permanent magnet (known as a 'seed') within the brain using an externally applied magnetic field. By varying the magnitude and gradient of the external magnetic field, the seed can be moved along a non-linear path and positioned at a site requiring therapy, e.g., a tumor. The magnetic field required for movement through brain tissue is extremely high, and is generated by a set of six superconducting magnets located in a housing surrounding the patient's head. The system uses two X-ray cameras positioned at right angles to detect in real time the locations of the seed and of X-ray opaque markers affixed to the patient's skull. the X-ray images are used to locate the objects of interest in a canonical frame of reference. the second case study is the University of Virginia Research Nuclear Reactor (UVAR). It is a 2 MW thermal, concrete-walled pool reactor. The system operates using 20 to 25 plate-type fuel assemblies placed on a rectangular grid plate. There are three scramable safety rods, and one non-scramable regulating rod that can be put in automatic mode. It was originally constructed in 1959 as a 1 MW system, and it was upgraded to 2 MW in 1973. Though only a research reactor rather than a power reactor, the issues raised are significant and can be related to the problems faced by full-scale reactor systems.

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

Beyond the cold hit: measuring the impact of the national DNA data bank on public safety at the city and county level.

PubMed

Gabriel, Matthew; Boland, Cherisse; Holt, Cydne

2010-01-01

Over the past decade, the Combined DNA Index System (CODIS) has increased solvability of violent crimes by linking evidence DNA profiles to known offenders. At present, an in-depth analysis of the United States National DNA Data Bank effort has not assessed the success of this national public safety endeavor. Critics of this effort often focus on laboratory and police investigators unable to provide timely investigative support as a root cause(s) of CODIS' failure to increase public safety. By studying a group of nearly 200 DNA cold hits obtained in SFPD criminal investigations from 2001-2006, three key performance metrics (Significance of Cold Hits, Case Progression & Judicial Resolution, and Potential Reduction of Future Criminal Activity) provide a proper context in which to define the impact of CODIS at the City and County level. Further, the analysis of a recidivist group of cold hit offenders and their past interaction with law enforcement established five noteworthy criminal case resolution trends; these trends signify challenges to CODIS in achieving meaningful case resolutions. CODIS' effectiveness and critical activities to support case resolutions are the responsibility of all criminal justice partners in order to achieve long-lasting public safety within the United States.

Multiple Response System: Evaluation of Policy Change in North Carolina's Child Welfare System.

PubMed

Lawrence, C Nicole; Rosanbalm, Katie D; Dodge, Kenneth A

2011-11-01

Systemic challenges within child welfare have prompted many states to explore new strategies aimed at protecting children while meeting the needs of families, but doing so within the confines of shrinking budgets. Differential Response has emerged as a promising practice for low or moderate risk cases of child maltreatment. This mixed methods evaluation explored various aspects of North Carolina's differential response system, known as the Multiple Response System (MRS), including: child safety, timeliness of response and case decision, frontloading of services, case distribution, implementation of Child and Family Teams, collaboration with community-based service providers and Shared Parenting. Utilizing Child Protective Services (CPS) administrative data, researchers found that compared to matched control counties, MRS: had a positive impact on child safety evidenced by a decline in the rates of substantiations and re-assessments; temporarily disrupted timeliness of response in pilot counties but had no effect on time to case decision; and increased the number of upfront services provided to families during assessment. Qualitative data collected through focus groups with providers and phone interviews with families provided important information on key MRS strategies, highlighting aspects that families and social workers like as well as identifying areas for improvement. This information is useful for continuous quality improvement efforts, particularly related to the development of training and technical assistance programs at the state and local level.

The medico-legal aspects of road traffic deaths in children under 5 years of age.

PubMed

Terranova, Claudio

2015-11-01

The family tragedy that results from a child who dies in a road traffic accident may be exacerbated by judicial consequences for the adult/parent driving the vehicle, carrying the child, or responsible for properly immobilising the child in the safety device that was used. The author presents two court cases of the road traffic accident deaths of two children under the age of five years. The two cases are presented using a methodological approach, which integrates competencies in other fields into the medico-legal aspects. An analysis of the two cases provides the opportunity to discuss the driver's responsibility to properly use child safety seat and to analyse and evaluate the efficacy and limits of child restraint systems. In the two cases, the responsibility for the application of a child safety device was excluded. It was confirmed that child protective devices are not always sufficient to avoid lesions or death in road accidents that occur with significant speed or other specific dynamics. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

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.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

Redefining the Moral Responsibilities for Food Safety: The Case of Red Meat in New Zealand

ERIC Educational Resources Information Center

Tanaka, Keiko

2005-01-01

Food safety governance is shaped by social relationships among the state, the industry, and the public in the food system in a given country. This paper examines the contestation among actors in New Zealand's red meat chain over the implementation of the Animal Product Act of 1999 (APA), which became a cornerstone in the reform of food safety…

AMDIS Case Conference: Intrusive Medication Safety Alerts.

PubMed

Graham, J; Levick, D; Schreiber, R

2010-01-01

Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center's dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.

A risk-based decision support framework for selection of appropriate safety measure system for underground coal mines.

PubMed

Samantra, Chitrasen; Datta, Saurav; Mahapatra, Siba Sankar

2017-03-01

In the context of underground coal mining industry, the increased economic issues regarding implementation of additional safety measure systems, along with growing public awareness to ensure high level of workers safety, have put great pressure on the managers towards finding the best solution to ensure safe as well as economically viable alternative selection. Risk-based decision support system plays an important role in finding such solutions amongst candidate alternatives with respect to multiple decision criteria. Therefore, in this paper, a unified risk-based decision-making methodology has been proposed for selecting an appropriate safety measure system in relation to an underground coal mining industry with respect to multiple risk criteria such as financial risk, operating risk, and maintenance risk. The proposed methodology uses interval-valued fuzzy set theory for modelling vagueness and subjectivity in the estimates of fuzzy risk ratings for making appropriate decision. The methodology is based on the aggregative fuzzy risk analysis and multi-criteria decision making. The selection decisions are made within the context of understanding the total integrated risk that is likely to incur while adapting the particular safety system alternative. Effectiveness of the proposed methodology has been validated through a real-time case study. The result in the context of final priority ranking is seemed fairly consistent.

Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report.

PubMed

Edwards, B J; Laumann, A E; Nardone, B; Miller, F H; Restaino, J; Raisch, D W; McKoy, J M; Hammel, J A; Bhatt, K; Bauer, K; Samaras, A T; Fisher, M J; Bull, C; Saddleton, E; Belknap, S M; Thomsen, H S; Kanal, E; Cowper, S E; Abu Alfa, A K; West, D P

2014-10-01

To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts. The Research on Adverse Drug events And Reports methodology was used for assessment-the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration. The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA. Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA. This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

Multidisciplinary analysis of invasive meningococcal disease as a framework for continuous quality and safety improvement in regional Australia

PubMed Central

Taylor, Kathryn A; Durrheim, David N; Merritt, Tony; Massey, Peter; Ferguson, John; Ryan, Nick; Hullick, Carolyn

2018-01-01

Background System factors in a regional Australian health district contributed to avoidable care deviations from invasive meningococcal disease (IMD) management guidelines. Traditional root cause analysis (RCA) is not well-suited to IMD, focusing on individual cases rather than system improvements. As IMD requires complex care across healthcare silos, it presents an opportunity to explore and address system-based patient safety issues. Context Baseline assessment of IMD cases (2005–2006) identified inadequate triage, lack of senior clinician review, inconsistent vital sign recording and laboratory delays as common issues, resulting in antibiotic administration delays and inappropriate or premature discharge. Methods Clinical governance, in partnership with clinical and public health services, established a multidisciplinary Meningococcal Reference Group (MRG) to routinely review management of all IMD cases. The MRG comprised representatives from primary care, acute care, public health, laboratory medicine and clinical governance. Baseline data were compared with two subsequent evaluation points (2011–2012 and 2013–2015). Interventions Phase I involved multidisciplinary process mapping and development of a standardised audit tool from national IMD management guidelines. Phase II involved formalisation of group processes and advocacy for operational change. Phase III focused on dissemination of findings to clinicians and managers. Results Greatest care improvements were observed in the final evaluation. Median antibiotic delay decreased from 72 to 42 min and proportion of cases triaged appropriately improved from 38% to 75% between 2013 and 2015. Increasing fatal outcomes were attributed to the emergence of more virulent meningococcal serotypes. Conclusions The MRG was a key mechanism for identifying system gaps, advocating for change and enhancing communication and coordination across services. Employing IMD case review as a focus for district-level process reflection presents an innovative patient safety approach, combining the strengths of prospective hazard analysis with more traditional RCA methodologies. PMID:29527576

Hybrid boosters for future launch vehicles

NASA Astrophysics Data System (ADS)

Dargies, E.; Lo, R. E.

1987-10-01

Hybrid rocket propulsion systems furnish the advantages of much higher safety levels, due both to shut-down capability in case of ignition failure to one unit and the potential choice of nontoxic propellant combinations, such as LOX/polyethylene; they nevertheless yield performance levels comparable or superior to those of solid rocket boosters. Attention is presently given to the results of DFVLR analytical model studies of hybrid propulsion systems, with attention to solid fuel grain geometrical design and propellant grain surface ablation rate. The safety of hybrid rockets recommends them for use by manned spacecraft.

Implementing a bar-coded bedside medication administration system.

PubMed

Yates, Cindy

2007-01-01

Hospitals across the nation are struggling with implementing electronic medication administration and reporting (eMAR) systems as part of patient safety programs. St Luke's Hospital in Chesterfield, Mo, initiated their eMAR initiative in June 2003, initiating program start-up in September 2004. This case study documents how the project was approached, its overall success, and what was learned along the way. Also included is a recent update highlighting the expansion of St Luke's patient safety initiative, adapting eMAR to two specialty units: dialysis and laboratory processes.

Effects of a case-based interactive e-learning course on knowledge and attitudes about patient safety: a quasi-experimental study with third-year medical students.

PubMed

Gaupp, Rainer; Körner, Mirjam; Fabry, Götz

2016-07-11

Patient safety (PS) is influenced by a set of factors on various levels of the healthcare system. Therefore, a systems-level approach and systems thinking is required to understand and improve PS. The use of e-learning may help to develop a systems thinking approach in medical students, as case studies featuring audiovisual media can be used to visualize systemic relationships in organizations. The goal of this quasi-experimental study was to determine if an e-learning can be utilized to improve systems thinking, knowledge, and attitudes towards PS. A quasi-experimental, longitudinal within- subjects design was employed. Participants were 321 third-year medical students who received online surveys before and after they participated in an e-learning course on PS. Primary outcome measures where levels of systems thinking and attitudes towards PS. Secondary outcome measures were the improvement of PS specific knowledge through the e-learning course. Levels of systems thinking showed significant improvement (58.72 vs. 61.27; p < .001) after the e-learning. Student's attitudes towards patient safety improved in several dimensions: After the course, students rated the influence of fatigue on safety higher (6.23 vs. 6.42, p < .01), considered patient empowerment more important (5.16 vs. 5.93, p < .001) and realized more often that human error is inevitable (5.75 vs. 5.97, p < .05). Knowledge on PS improved from 36.27 % correct answers before to 76.45 % after the e-learning (p < .001). Our results suggest that e-learning can be used to teach PS. Attitudes towards PS improved on several dimensions. Furthermore, we were able to demonstrate that a specifically designed e-learning program can foster the development of conceptual frameworks such as systems thinking, which facilitates the understanding of complex socio-technical systems within healthcare organisations.

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.

Schools Located Near Highways: Problems and Prospects. Final Report [and] Case Studies.

ERIC Educational Resources Information Center

Wells, Leslie J.; Shapiro, Richard; Felsburg, Robert W.

In this 1977 publication, findings and recommendations are presented from 22 case studies involving the impact on schools adjacent to highway systems in the states of California, New Mexico, Colorado, Texas, Missouri, Maryland, and Virginia. The impacts described include: noise; vehicular and pedestrian safety; air pollution; access; circulation…

Methods and Case Studies for Teaching and Learning about Failure and Safety.

ERIC Educational Resources Information Center

Bignell, Victor

1999-01-01

Discusses methods for analyzing case studies of failures of technological systems. Describes two distance learning courses that compare standard models of failure and success with the actuality of given scenarios. Provides teaching and learning materials and information sources for application to aspects of design, manufacture, inspection, use,…

Fidget Spinner Ingestions in Children-A Problem that Spun Out of Nowhere.

PubMed

Reeves, Patrick T; Nylund, Cade M; Noel, James M; Jones, David S; Chumpitazi, Bruno P; Milczuk, Henry A; Noel, R Adam

2018-06-01

The Consumer Product Safety Risk Management System's injury and potential injury database records 13 cases of fidget spinner ingestion since 2016. In addition to a database query, we report 3 additional cases of fidget spinner ingestion to describe patient presentations and subsequent management strategies. Published by Elsevier Inc.

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.

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

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

Acute acalculous cholecystitis: A new safety risk for patients with MS treated with alemtuzumab.

PubMed

Croteau, David; Flowers, Charlene; Kulick, Corrinne G; Brinker, Allen; Kortepeter, Cindy M

2018-05-01

To evaluate acute acalculous cholecystitis (AAC) as a potential safety risk for patients treated with alemtuzumab. The Food and Drug Administration Adverse Event Reporting System and the medical literature were searched for cases of AAC in conjunction with alemtuzumab for all clinical indications. Eight spontaneously reported cases meeting the case definition of AAC in close temporal association with alemtuzumab use were identified. Based on established criteria within the Food and Drug Administration Division of Pharmacovigilance for causality assessment, 4 cases were assessed as probable while 4 were possible. All cases occurred in patients with relapsing-remitting multiple sclerosis. Seven of the 8 cases presented with AAC during or shortly after alemtuzumab treatment, thereby suggesting an acute cytokine release syndrome as a putative pathogenic mechanism. The cases identified in this review differ from the typical AAC cases described in the medical literature based on female preponderance, lack of concurrent critical illnesses, inconsistent presence of other risk factors, and resolution with conservative treatment in the majority of cases. AAC represents a new and potentially life-threatening adverse event associated with alemtuzumab use in relapsing-remitting multiple sclerosis. In cases seen to date, early and conservative treatment resulted in good clinical outcome, although the natural history of AAC in this population without critical illness is not well defined. Awareness of this safety risk by general and specialty neurologists is important for prompt recognition and optimal management. © 2018 American Academy of Neurology.

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.

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 role of individual diligence in improving safety.

PubMed

Corbett, Angus; Travaglia, Jo; Braithwaite, Jeffrey

2011-01-01

This paper aims to be a theoretical examination of the role of individuals in sponsoring and facilitating effective, systemic change in organisations. Using reports of a number of high-profile initiatives to improve patient safety, it seeks to analyse the role of individual health care professionals in developing and facilitating new systems of care that improve safety and quality. The paper uses recent work in sociology that is concerned with the phenomenon of "sociological citizenship". The authors test whether successful initiators of change in health care can be described as sociological citizens. This notion of sociological citizens is applied to a number of highly successful initiatives to improve safety and quality to extrapolate the factors associated with individual clinician leadership, which may have affected the success of such endeavours. In each of the examples analysed the initiators of change can be characterised as sociological citizens. In reviewing the roles of these charismatic individuals it is evident that they see the relational interdependence between the individuals and organisations and that they use this information to achieve both professional and organisational objectives. The paper uses a case study method to investigate the usefulness of the role of sociological citizenship in interventions that aim to improve patient safety. The paper reviews the key concepts and uses of the concept of sociological citizenship to produce a framework against which the case studies were assessed. The authors suggest that a goal of policy for improving patient safety should be directed to the problem of how hospitals and health care organisations can create the conditions for encouraging the individual diligence and care that is needed to support reliable, safe health care practices. Improving the safety and quality of health care is an important public health initiative. It has also proven to be difficult to achieve sustained reductions in the harm caused by the occurrence of adverse events in health care. The process of linking individual diligence with service outcomes may help to overcome one of the enduring struggles of health care systems around the world: the policy-practice divide. The paper directs attention towards the role of sociological citizenship in health care systems and organisations.

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.

Patient safety education to change medical students' attitudes and sense of responsibility.

PubMed

Roh, Hyerin; Park, Seok Ju; Kim, Taekjoong

2015-01-01

This study examined changes in the perceptions and attitudes as well as the sense of individual and collective responsibility in medical students after they received patient safety education. A three-day patient safety curriculum was implemented for third-year medical students shortly before entering their clerkship. Before and after training, we administered a questionnaire, which was analysed quantitatively. Additionally, we asked students to answer questions about their expected behaviours in response to two case vignettes. Their answers were analysed qualitatively. There was improvement in students' concepts of patient safety after training. Before training, they showed good comprehension of the inevitability of error, but most students blamed individuals for errors and expressed a strong sense of individual responsibility. After training, students increasingly attributed errors to system dysfunction and reported more self-confidence in speaking up about colleagues' errors. However, due to the hierarchical culture, students still described difficulties communicating with senior doctors. Patient safety education effectively shifted students' attitudes towards systems-based thinking and increased their sense of collective responsibility. Strategies for improving superior-subordinate communication within a hierarchical culture should be added to the patient safety curriculum.

Monitoring drug safety in Astrakhan, Russia.

PubMed

Kirilochev, O O; Dorfman, I P; Umerova, A R

2015-01-01

The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring.2. To analyze the outcomes of registered adverse drug reactions.3. To determine the causality of adverse drug reactions.4. To identify reports on the ineffectiveness of drugs.5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning.The decrease of adverse event reporting in 2013 and 2014 was due to the fact that doctors in the region had access to better ADR drug information. Along with the increasing number of adverse event reporting we also noted the increase in the number of health facilities that monitored drug safety. The number of health facilities that reported, doubled from 2010 to 2014. We observed the increase in the number of adverse event reports submitted by pharmaceutical companies. General anti-infective drugs for systemic use (class J) were the most common cause of all registered ADRs (44%). Drugs for treatment of tuberculosis (group J04A) were the cause of adverse drug reactions in 34% of reports. ADRs associated with drugs used for treating diseases of cardiovascular system accounted for 16% of case-reports; drugs belonging to the group of Alimentary tract and metabolism (class A) and to the group of Nervous System (class A) were reported to cause ADRs in 10% of cases each. Type A adverse drug reactions, which are usually a consequence of a drug's primary pharmacological effect, were detected in 45% of cases. These reactions were often registered for drugs affecting cardiovascular system (class C), nervous system (class N), dlood and blood forming organs (class B). Type B ADRs were reported in 54% of cases. These were "idiosyncratic" reactions, which could not be predicted on the basis of the drug's main pharmacological action, were not dose-related and were severe [3]. The most frequent cause of type B adverse drug reactions was the General anti-infective medicines for systemic use (Class J). The fatality rate associated with ADRs was 0.3%. Type A adverse drug reactions resulted in death in 38% of cases. Type B ADR (anaphylactic shock) accounted for 62% of the patient's deaths. The Naranjo scale determined the causality of ADRs. The "definite" ADRs were detected in 14% of reports, "probable" - in 47%, and "possible" - in 39% of cases. The rate of reporting associated with ineffectiveness of drugs amounted to 1%. Most often the lack of therapeutic effect was reported in patients receiving drugs of class C (Cardiovascular system, 31% of all cases of inefficiency of drugs). These drugs were used in accordance with their official instructions for use. The proportion of ADR reports for drugs prescribed off-label was 1.4%. The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis.

Patient safety in nursing education: contexts, tensions and feeling safe to learn.

PubMed

Steven, Alison; Magnusson, Carin; Smith, Pam; Pearson, Pauline H

2014-02-01

Education is crucial to how nurses practice, talk and write about keeping patients safe. The aim of this multisite study was to explore the formal and informal ways the pre-registration medical, nursing, pharmacy and physiotherapy students learn about patient safety. This paper focuses on findings from nursing. A multi-method design underpinned by the concept of knowledge contexts and illuminative evaluation was employed. Scoping of nursing curricula from four UK university programmes was followed by in-depth case studies of two programmes. Scoping involved analysing curriculum documents and interviews with 8 programme leaders. Case-study data collection included focus groups (24 students, 12 qualified nurses, 6 service users); practice placement observation (4 episodes=19 hrs) and interviews (4 Health Service managers). Within academic contexts patient safety was not visible as a curricular theme: programme leaders struggled to define it and some felt labelling to be problematic. Litigation and the risk of losing authorisation to practise were drivers to update safety in the programmes. Students reported being taught idealised skills in university with an emphasis on 'what not to do'. In organisational contexts patient safety was conceptualised as a complicated problem, addressed via strategies, systems and procedures. A tension emerged between creating a 'no blame' culture and performance management. Few formal mechanisms appeared to exist for students to learn about organisational systems and procedures. In practice, students learnt by observing staff who acted as variable role models; challenging practice was problematic, since they needed to 'fit in' and mentors were viewed as deciding whether they passed or failed their placements. The study highlights tensions both between and across contexts, which link to formal and informal patient safety education and impact negatively on students' feelings of emotional safety in their learning. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

Design, implementation and evaluation of an independent real-time safety layer for medical robotic systems using a force-torque-acceleration (FTA) sensor.

PubMed

Richter, Lars; Bruder, Ralf

2013-05-01

Most medical robotic systems require direct interaction or contact with the robot. Force-Torque (FT) sensors can easily be mounted to the robot to control the contact pressure. However, evaluation is often done in software, which leads to latencies. To overcome that, we developed an independent safety system, named FTA sensor, which is based on an FT sensor and an accelerometer. An embedded system (ES) runs a real-time monitoring system for continuously checking of the readings. In case of a collision or error, it instantaneously stops the robot via the robot's external emergency stop. We found that the ES implementing the FTA sensor has a maximum latency of [Formula: see text] ms to trigger the robot's emergency stop. For the standard settings in the application of robotized transcranial magnetic stimulation, the robot will stop after at most 4 mm. Therefore, it works as an independent safety layer preventing patient and/or operator from serious harm.

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

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.

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.

Light Water Reactor Sustainability Program: Risk-Informed Safety Margins Characterization (RISMC) Pathway Technical Program Plan

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

Smith, Curtis; Rabiti, Cristian; Martineau, Richard

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 (SSCs) 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 high degreemore » 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.”« less

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.

Avulsed Nasoenteric Bridle System Magnet as an Intranasal Foreign Body.

PubMed

Puricelli, Michael D; Newberry, Christopher Ian; Gov-Ari, Eliav

2016-02-01

Nasoenteric tubes provide short-term nutrition support to patients unable to take an adequate oral diet. Bridling systems may be used to secure tubes to guard against displacement. We present the first case of an avulsed magnet from a bridling system to raise awareness of this potential complication. The primary methods of securing a nasogastric tube are reviewed, and comparative assessment of the 3 main systems is presented. Diagnosis and management of nasal foreign bodies relevant to this case are reviewed and prevention/safety considerations discussed. © 2015 American Society for Parenteral and Enteral Nutrition.

Evaluation of a Broad-Spectrum Partially Automated Adverse Event Surveillance System: A Potential Tool for Patient Safety Improvement in Hospitals With Limited Resources.

PubMed

Saikali, Melody; Tanios, Alain; Saab, Antoine

2017-11-21

The aim of the study was to evaluate the sensitivity and resource efficiency of a partially automated adverse event (AE) surveillance system for routine patient safety efforts in hospitals with limited resources. Twenty-eight automated triggers from the hospital information system's clinical and administrative databases identified cases that were then filtered by exclusion criteria per trigger and then reviewed by an interdisciplinary team. The system, developed and implemented using in-house resources, was applied for 45 days of surveillance, for all hospital inpatient admissions (N = 1107). Each trigger was evaluated for its positive predictive value (PPV). Furthermore, the sensitivity of the surveillance system (overall and by AE category) was estimated relative to incidence ranges in the literature. The surveillance system identified a total of 123 AEs among 283 reviewed medical records, yielding an overall PPV of 52%. The tool showed variable levels of sensitivity across and within AE categories when compared with the literature, with a relatively low overall sensitivity estimated between 21% and 44%. Adverse events were detected in 23 of the 36 AE categories defined by an established harm classification system. Furthermore, none of the detected AEs were voluntarily reported. The surveillance system showed variable sensitivity levels across a broad range of AE categories with an acceptable PPV, overcoming certain limitations associated with other harm detection methods. The number of cases captured was substantial, and none had been previously detected or voluntarily reported. For hospitals with limited resources, this methodology provides valuable safety information from which interventions for quality improvement can be formulated.

Exploring safety systems for dispensing in community pharmacies: focusing on how staff relate to organizational components.

PubMed

Harvey, Jasmine; Avery, Anthony J; Ashcroft, Darren; Boyd, Matthew; Phipps, Denham L; Barber, Nicholas

2015-01-01

Identifying risk is an important facet of a safety practice in an organization. To identify risk, all components within a system of operation should be considered. In clinical safety practice, a team of people, technologies, procedures and protocols, management structure and environment have been identified as key components in a system of operation. To explore risks in relation to prescription dispensing in community pharmacies by taking into account relationships between key components that relate to the dispensing process. Fifteen community pharmacies in England with varied characteristics were identified, and data were collected using non-participant observations, shadowing and interviews. Approximately 360 hours of observations and 38 interviews were conducted by the team. Observation field notes from each pharmacy were written into case studies. Overall, 52,500 words from 15 case studies and interview transcripts were analyzed using thematic and line-by-line analyses. Validation techniques included multiple data collectors co-authoring each case study for consensus, review of case studies by members of the wider team including academic and practicing community pharmacists, and patient safety experts and two presentations (internally and externally) to review and discuss findings. Risks identified were related to relationships between people and other key components in dispensing. This included how different levels of staff communicated internally and externally, followed procedures, interacted with technical systems, worked with management, and engaged with the environment. In a dispensing journey, the following categories were identified which show how risks are inextricably linked through relationships between human components and other key components: 1) dispensing with divided attention; 2) dispensing under pressure; 3) dispensing in a restricted space or environment; and, 4) managing external influences. To identify and evaluate risks effectively, an approach that includes understanding relationships between key components in dispensing is required. Since teams of people in community pharmacies are a key dispensing component, and therefore part of the operational process, it is important to note how they relate to other components in the environment within which they operate. Pharmacies can take the opportunity to reflect on the organization of their systems and review in particular how they can improve on the four key categories identified. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Probabilistic assessment of dynamic system performance. Part 3

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

Belhadj, Mohamed

1993-01-01

Accurate prediction of dynamic system failure behavior can be important for the reliability and risk analyses of nuclear power plants, as well as for their backfitting to satisfy given constraints on overall system reliability, or optimization of system performance. Global analysis of dynamic systems through investigating the variations in the structure of the attractors of the system and the domains of attraction of these attractors as a function of the system parameters is also important for nuclear technology in order to understand the fault-tolerance as well as the safety margins of the system under consideration and to insure a safemore » operation of nuclear reactors. Such a global analysis would be particularly relevant to future reactors with inherent or passive safety features that are expected to rely on natural phenomena rather than active components to achieve and maintain safe shutdown. Conventionally, failure and global analysis of dynamic systems necessitate the utilization of different methodologies which have computational limitations on the system size that can be handled. Using a Chapman-Kolmogorov interpretation of system dynamics, a theoretical basis is developed that unifies these methodologies as special cases and which can be used for a comprehensive safety and reliability analysis of dynamic systems.« less

PROGRESS IN DESIGN OF THE INSTRUMENTATION AND CONTROL OF THE TOKAMAK COOLING WATER SYSTEM

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

Korsah, Kofi; DeVan, Bill; Ashburn, David

This paper discusses progress in the design of the control, interlock and safety systems of the Tokamak Cooling Water System (TCWS) for the ITER fusion reactor. The TCWS instrumentation and control (I&C) is one of approximately 200 separate plant I&C systems (e.g., vacuum system I&C, magnets system I&C) that interface to a common central I&C system through standardized networks. Several aspects of the I&C are similar to the I&C of fission-based power plants. However, some of the unique features of the ITER fusion reactor and the TCWS (e.g., high quasi-static magnetic field, need for baking and drying as well asmore » cooling operations), also demand some unique safety and qualification considerations. The paper compares the design strategy/guidelines of the TCWS I&C and the I&C of conventional nuclear power plants. Issues such as safety classifications, independence between control and safety systems, sensor sharing, redundancy, voting schemes, and qualification methodologies are discussed. It is concluded that independence and separation requirements are similar in both designs. However, the voting schemes for safety systems in nuclear power plants typically use 2oo4 (i.e., 4 divisions of safety I&C, any 2 of which is sufficient to trigger a safety action), while 2oo3 voting logic - within each of 2 independent trains - is used in the TCWS I&C. It is also noted that 2oo3 voting is also acceptable in nuclear power plants if adequate risk assessment and reliability is demonstrated. Finally, while qualification requirements provide similar guidance [e.g., both IEC 60780 (invoked in ITER-space), and IEEE 323 (invoked in fission power plant space) provide similar guidance], an important qualification consideration is the susceptibility of I&C to the magnetic fields of ITER. Also, the radiation environments are different. In the case of magnetic fields the paper discusses some options that are being considered.« less

Applications of teleworking based on a study of disabled workers.

PubMed

Nishina, Masahisa

2010-01-01

There are many problems involved in maintaining safety for different kinds of handicapped workers. One of the biggest problems is how these persons can commute to their workplace safely. One possible solution to this problem is using a teleworking system. This system is also good for saving money and the environment because it does not require commuting. The teleworking system has many other merits including enhanced safety and can be applied to many other aspects of life. For example, it can be used for the care of solitary elderly persons, watching small children in a two-income family, and working or providing medical treatment in remote and underpopulated areas. However, these applications are not yet common, and few reports have dealt with such merits. The case studies of disabled workers using teleworking reported here demonstrate the safety, financial and environmental benefits of teleworking.

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.

Revised Standard Rules Tender Governing Motor Carrier Transportation

DOT National Transportation Integrated Search

2002-05-10

The following case study provides an in-depth view of the deployment of the safety information exchange components of the Commercial Vehicle Information Systems and Networks (CVISN) technology program in Connecticut. It describes successful practices...

Thrombolysis with intravenous recombinant tissue plasminogen activator during early postpartum period: a review of the literature.

PubMed

Akazawa, Munetoshi; Nishida, Makoto

2017-05-01

Thromboembolic events are one of the leading causes of maternal death during the postpartum period. Postpartum thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) is controversial because the treatment may lead to massive bleeding. Data centralization may be beneficial for analyzing the safety and effectiveness of systemic thrombolysis during the early postpartum period. We performed a computerized MEDLINE and EMBASE search. We collected data for 13 cases of systemic thrombolytic therapy during the early postpartum period, when limiting the early postpartum period to 48 hours after delivery. Blood transfusion was necessary in all cases except for one (12/13; 92%). In seven cases (7/13; 54%), a large amount of blood was required for transfusion. Subsequent laparotomy to control bleeding was required in five cases (5/13; 38%), including three cases of hysterectomy and two cases of hematoma removal, all of which involved cesarean delivery. In cases of transvaginal delivery, there was no report of laparotomy. The occurrence of severe bleeding was high in relation to cesarean section, compared with vaginal deliveries. Using rt-PA in relation to cesarean section might be worth avoiding. However, the paucity of data in the literature makes it difficult to assess the ultimate outcomes and safety of this treatment. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

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.

Toward the modelling of safety violations in healthcare systems.

PubMed

Catchpole, Ken

2013-09-01

When frontline staff do not adhere to policies, protocols, or checklists, managers often regard these violations as indicating poor practice or even negligence. More often than not, however, these policy and protocol violations reflect the efforts of well intentioned professionals to carry out their work efficiently in the face of systems poorly designed to meet the diverse demands of patient care. Thus, non-compliance with institutional policies and protocols often signals a systems problem, rather than a people problem, and can be influenced among other things by training, competing goals, context, process, location, case complexity, individual beliefs, the direct or indirect influence of others, job pressure, flexibility, rule definition, and clinician-centred design. Three candidates are considered for developing a model of safety behaviour and decision making. The dynamic safety model helps to understand the relationship between systems designs and human performance. The theory of planned behaviour suggests that intention is a function of attitudes, social norms and perceived behavioural control. The naturalistic decision making paradigm posits that decisions are based on a wider view of multiple patients, expertise, systems complexity, behavioural intention, individual beliefs and current understanding of the system. Understanding and predicting behavioural safety decisions could help us to encourage compliance to current processes and to design better interventions.

An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies

PubMed Central

Yuksel, Mustafa; Gonul, Suat; Laleci Erturkmen, Gokce Banu; Sinaci, Ali Anil; Invernizzi, Paolo; Facchinetti, Sara; Migliavacca, Andrea; Bergvall, Tomas; Depraetere, Kristof; De Roo, Jos

2016-01-01

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information. PMID:27123451

People or systems? To blame is human. The fix is to engineer.

PubMed

Holden, Richard J

2009-12-01

Person-centered safety theories that place the burden of causality on human traits and actions have been largely dismissed in favor of systems-centered theories. Students and practitioners are now taught that accidents are caused by multiple factors and occur due to the complex interactions of numerous work system elements, human and non-human. Nevertheless, person-centered approaches to safety management still prevail. This paper explores the notion that attributing causality and blame to people persists because it is both a fundamental psychological tendency as well as an industry norm that remains strong in aviation, health care, and other industries. Consequences of that possibility are discussed and a case is made for continuing to invest in whole-system design and engineering solutions.

Influence of different safety shoes on gait and plantar pressure: a standardized examination of workers in the automotive industry

PubMed Central

Ochsmann, Elke; Noll, Ulrike; Ellegast, Rolf; Hermanns, Ingo; Kraus, Thomas

2016-01-01

Objective: Working conditions, such as walking and standing on hard surfaces, can increase the development of musculoskeletal complaints. At the interface between flooring and musculoskeletal system, safety shoes may play an important role in the well-being of employees. The aim of this study was to evaluate the effects of different safety shoes on gait and plantar pressure distributions on industrial flooring. Methods: Twenty automotive workers were individually fitted out with three different pairs of safety shoes ( "normal" shoes, cushioned shoes, and midfoot bearing shoes). They walked at a given speed of 1.5 m/s. The CUELA measuring system and shoe insoles were used for gait analysis and plantar pressure measurements, respectively. Statistical analysis was conducted by ANOVA analysis for repeated measures. Results: Walking with cushioned safety shoes or a midfoot bearing safety shoe led to a significant decrease of the average trunk inclination (p<0.005). Furthermore, the average hip flexion angle decreased for cushioned shoes as well as midfoot bearing shoes (p<0.002). The range of motion of the knee joint increased for cushioned shoes. As expected, plantar pressure distributions varied significantly between cushioned or midfoot bearing shoes and shoes without ergonomic components. Conclusion: The overall function of safety shoes is the avoidance of injury in case of an industrial accident, but in addition, safety shoes could be a long-term preventive instrument for maintaining health of the employees' musculoskeletal system, as they are able to affect gait parameters. Further research needs to focus on safety shoes in working situations. PMID:27488038

Influence of different safety shoes on gait and plantar pressure: a standardized examination of workers in the automotive industry.

PubMed

Ochsmann, Elke; Noll, Ulrike; Ellegast, Rolf; Hermanns, Ingo; Kraus, Thomas

2016-09-30

Working conditions, such as walking and standing on hard surfaces, can increase the development of musculoskeletal complaints. At the interface between flooring and musculoskeletal system, safety shoes may play an important role in the well-being of employees. The aim of this study was to evaluate the effects of different safety shoes on gait and plantar pressure distributions on industrial flooring. Twenty automotive workers were individually fitted out with three different pairs of safety shoes ( "normal" shoes, cushioned shoes, and midfoot bearing shoes). They walked at a given speed of 1.5 m/s. The CUELA measuring system and shoe insoles were used for gait analysis and plantar pressure measurements, respectively. Statistical analysis was conducted by ANOVA analysis for repeated measures. Walking with cushioned safety shoes or a midfoot bearing safety shoe led to a significant decrease of the average trunk inclination (p<0.005). Furthermore, the average hip flexion angle decreased for cushioned shoes as well as midfoot bearing shoes (p<0.002). The range of motion of the knee joint increased for cushioned shoes. As expected, plantar pressure distributions varied significantly between cushioned or midfoot bearing shoes and shoes without ergonomic components. The overall function of safety shoes is the avoidance of injury in case of an industrial accident, but in addition, safety shoes could be a long-term preventive instrument for maintaining health of the employees' musculoskeletal system, as they are able to affect gait parameters. Further research needs to focus on safety shoes in working situations.

Safe teleoperation based on flexible intraoperative planning for robot-assisted laser microsurgery.

PubMed

Mattos, Leonardo S; Caldwell, Darwin G

2012-01-01

This paper describes a new intraoperative planning system created to improve precision and safety in teleoperated laser microsurgeries. It addresses major safety issues related to real-time control of a surgical laser during teleoperated procedures, which are related to the reliability and robustness of the telecommunication channels. Here, a safe solution is presented, consisting in a new planning system architecture that maintains the flexibility and benefits of real-time teleoperation and keeps the surgeon in control of all surgical actions. The developed system is based on our virtual scalpel system for robot-assisted laser microsurgery, and allows the intuitive use of stylus to create surgical plans directly over live video of the surgical field. In this case, surgical plans are defined as graphic objects overlaid on the live video, which can be easily modified or replaced as needed, and which are transmitted to the main surgical system controller for subsequent safe execution. In the process of improving safety, this new planning system also resulted in improved laser aiming precision and improved capability for higher quality laser procedures, both due to the new surgical plan execution module, which allows very fast and precise laser aiming control. Experimental results presented herein show that, in addition to the safety improvements, the new planning system resulted in a 48% improvement in laser aiming precision when compared to the previous virtual scalpel system.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

PubMed

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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.

Proceedings of the Sixth NASA Langley Formal Methods (LFM) Workshop

NASA Technical Reports Server (NTRS)

Rozier, Kristin Yvonne (Editor)

2008-01-01

Today's verification techniques are hard-pressed to scale with the ever-increasing complexity of safety critical systems. Within the field of aeronautics alone, we find the need for verification of algorithms for separation assurance, air traffic control, auto-pilot, Unmanned Aerial Vehicles (UAVs), adaptive avionics, automated decision authority, and much more. Recent advances in formal methods have made verifying more of these problems realistic. Thus we need to continually re-assess what we can solve now and identify the next barriers to overcome. Only through an exchange of ideas between theoreticians and practitioners from academia to industry can we extend formal methods for the verification of ever more challenging problem domains. This volume contains the extended abstracts of the talks presented at LFM 2008: The Sixth NASA Langley Formal Methods Workshop held on April 30 - May 2, 2008 in Newport News, Virginia, USA. The topics of interest that were listed in the call for abstracts were: advances in formal verification techniques; formal models of distributed computing; planning and scheduling; automated air traffic management; fault tolerance; hybrid systems/hybrid automata; embedded systems; safety critical applications; safety cases; accident/safety analysis.

The effects of housing systems for laying hens on egg safety and quality

USDA-ARS?s Scientific Manuscript database

Transitions in laying hen management and housing systems have constantly occurred throughout the history of commercial egg production. Around the world, there has been a rapid shift in hen housing requirements since the turn of the current century. In most cases, the changes in hen housing require...

APT Blanket System Loss-of-Coolant Accident (LOCA) Based on Initial Conceptual Design - Case 4: External Pressurizer Surge Line Break Near Inlet Header

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

Hamm, L.L.

1998-10-07

This report is one of a series of reports documenting accident scenario simulations for the Accelerator Production of Tritium (APT) blanket heat removal systems. The simulations were performed in support of the Preliminary Safety Analysis Report (PSAR) for the APT.

APT Blanket System Loss-of-Coolant Accident (LOCA) Analysis Based on Initial Conceptual Design - Case 3: External HR Break at Pump Outlet without Pump Trip

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

Hamm, L.L.

1998-10-07

This report is one of a series of reports that document normal operation and accident simulations for the Accelerator Production of Tritium (APT) blanket heat removal (HR) system. These simulations were performed for the Preliminary Safety Analysis Report.

14 CFR 27.903 - Engines.

Code of Federal Regulations, 2014 CFR

2014-01-01

... usage. (b) Engine or drive system cooling fan blade protection. (1) If an engine or rotor drive system... fan blade fails. This must be shown by showing that— (i) The fan blades are contained in case of failure; (ii) Each fan is located so that a failure will not jeopardize safety; or (iii) Each fan blade...

14 CFR 27.903 - Engines.

Code of Federal Regulations, 2012 CFR

2012-01-01

... usage. (b) Engine or drive system cooling fan blade protection. (1) If an engine or rotor drive system... fan blade fails. This must be shown by showing that— (i) The fan blades are contained in case of failure; (ii) Each fan is located so that a failure will not jeopardize safety; or (iii) Each fan blade...

14 CFR 27.903 - Engines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... usage. (b) Engine or drive system cooling fan blade protection. (1) If an engine or rotor drive system... fan blade fails. This must be shown by showing that— (i) The fan blades are contained in case of failure; (ii) Each fan is located so that a failure will not jeopardize safety; or (iii) Each fan blade...

14 CFR 27.903 - Engines.

Code of Federal Regulations, 2011 CFR

2011-01-01

... usage. (b) Engine or drive system cooling fan blade protection. (1) If an engine or rotor drive system... fan blade fails. This must be shown by showing that— (i) The fan blades are contained in case of failure; (ii) Each fan is located so that a failure will not jeopardize safety; or (iii) Each fan blade...

14 CFR 27.903 - Engines.

Code of Federal Regulations, 2013 CFR

2013-01-01

... usage. (b) Engine or drive system cooling fan blade protection. (1) If an engine or rotor drive system... fan blade fails. This must be shown by showing that— (i) The fan blades are contained in case of failure; (ii) Each fan is located so that a failure will not jeopardize safety; or (iii) Each fan blade...

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.

A probabilistic technique for the assessment of complex dynamic system resilience

NASA Astrophysics Data System (ADS)

Balchanos, Michael Gregory

In the presence of operational uncertainty, one of the greatest challenges in systems engineering is to ensure system effectiveness, mission capability and survivability for large scale, complex system architectures. Historic events such as the 2003 Northeastern Blackout, and the 2005 Hurricane Katrina, have underlined the great importance of system safety, and survivability. With safety management currently applied on a reactive basis to emerging incidents and risk challenges, there is a paradigm shift from passive, reactive and diagnosis-based approaches to the development of architectures that will autonomously manage safety and survivability through active, proactive and prognosis-based engineering solutions. The shift aims to bring safety considerations early in the engineering design process, in order to reduce retrofitting and additional safety certification costs, increase flexibility in risk management, and essentially make safety be "built-in" the design. As a possible enabling research direction, resilience engineering is an emerging discipline, pertinent to safety management, which offers alternative insights on the design of more safe and survivable system architectures. Conceptually, resilience engineering brings new perspectives on the understanding of system safety, accidents, failures, performance degradations and risk. A resilient system can "absorb" the impact of change due to unexpected disturbances, while it "adapts" to change, in order to maintain the system's physical integrity and capability to carry on with its mission. The leading hypothesis advocates that if a complex dynamic system is more resilient, then it would be more survivable, thus more effective, despite the unexpected disturbances that could affect its normal operating conditions. For investigating the impact of more resilient systems on survivability and safety, a framework for theoretical resilience estimations has been formulated. It constitutes the basis for quantitative techniques for total system resilience evaluation, based on scenario-based, dynamic system simulations. Physics-based Modeling and Simulation (M&S) is applied for dynamical system behavior analysis, which includes system performance, health monitoring, damage propagation and overall mission capability. For the development of the assessment framework and testing of a resilience assessment technique, a small-scale canonical problem has been formulated, involving a computational model of a degradable and reconfigurable spring-mass-damper SDOF system, in a multiple main and redundant spring configuration. A rule-based feedback controller is responsible for system performance recovery, through the application of different reconfiguration strategies and strategic activation of the necessary main or redundant springs. Uncertainty effects on system operation are introduced through disturbance factors, such as external forces with varying magnitude, input frequency, event duration and occurrence time. Such factors are the basis for scenario formulation, in support of a Monte Carlo simulation analysis. Case studies with varying levels of damping and different reconfiguration strategies, involve the investigation of operational uncertainty effects on system performance, mission capability, and system survivability. These studies furthermore explore uncertainty effects on resilience functions that describe the system's capacities on "restoring" mission capability, on "absorbing" the effects of changing conditions, and on "adapting" to the occurring change. The proposed resilience assessment technique or the Topological Investigation for Resilient and Effective Systems, through Increased Architecture Survivability (TIRESIAS) is then applied and demonstrated for a naval system application, in the form of a reduced scale, reconfigurable cooling network of a naval combatant. Uncertainty effects are modeled through combinations of different number of network fluid leaks. The TIRESIAS approach on the system baseline (32-control valve configuration) has allowed for the investigation of leak effects on survival times, mission capability degradations, as well as the resilience function capacities. As part of the technique demonstration, case studies were conducted for different architecture configurations, which have been generated for different total number of control valves and valve locations on the topology.

An Investigation of Proposed Techniques for Quantifying Confidence in Assurance Arguments

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2016-01-01

The use of safety cases in certification raises the question of assurance argument sufficiency and the issue of confidence (or uncertainty) in the argument's claims. Some researchers propose to model confidence quantitatively and to calculate confidence in argument conclusions. We know of little evidence to suggest that any proposed technique would deliver trustworthy results when implemented by system safety practitioners. Proponents do not usually assess the efficacy of their techniques through controlled experiment or historical study. Instead, they present an illustrative example where the calculation delivers a plausible result. In this paper, we review current proposals, claims made about them, and evidence advanced in favor of them. We then show that proposed techniques can deliver implausible results in some cases. We conclude that quantitative confidence techniques require further validation before they should be recommended as part of the basis for deciding whether an assurance argument justifies fielding a critical system.

Improving Quality and Safety of Care Using “Technovigilance”: An Ethnographic Case Study of Secondary Use of Data from an Electronic Prescribing and Decision Support System

PubMed Central

Dixon-Woods, Mary; Redwood, Sabi; Leslie, Myles; Minion, Joel; Martin, Graham P; Coleman, Jamie J

2013-01-01

Context “Meaningful use” of electronic health records to improve quality of care has remained understudied. We evaluated an approach to improving patients’ safety and quality of care involving the secondary use of data from a hospital electronic prescribing and decision support system (ePDSS). Methods We conducted a case study of a large English acute care hospital with a well-established ePDSS. Our study was based on ethnographic observations of clinical settings (162 hours) and meetings (28 hours), informal conversations with clinical staff, semistructured interviews with ten senior executives, and the collection of relevant documents. Our data analysis was based on the constant comparative method. Findings This hospital's approach to quality and safety could be characterized as “technovigilance.” It involved treating the ePDSS as a warehouse of data on clinical activity and performance. The hospital converted the secondary data into intelligence about the performance of individuals, teams, and clinical services and used this as the basis of action for improvement. Through a combination of rapid audit, feedback to clinical teams, detailed and critical review of apparent omissions in executive-led meetings, a focus on personal professional responsibility for patients’ safety and quality care, and the correction of organizational or systems defects, technovigilance was—based on the hospital's own evidence—highly effective in improving specific indicators. Measures such as the rate of omitted doses of medication showed marked improvement. As do most interventions, however, technovigilance also had unintended consequences. These included the risk of focusing attention on aspects of patient safety made visible by the system at the expense of other, less measurable but nonetheless important, concerns. Conclusions The secondary use of electronic data can be effective for improving specific indicators of care if accompanied by a range of interventions to ensure proper interpretation and appropriate action. But care is needed to avoid unintended consequences. PMID:24028694

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.

One shot of carbon-ion radiotherapy cured a 6-cm chemo-resistant metastatic liver tumor: a case of breast cancer.

PubMed

Harada, Mayumi; Karasawa, Kumiko; Yasuda, Shigeo; Kamada, Tadashi; Nemoto, Kenji

2015-09-01

The standard treatment for metastatic liver tumor from breast cancer is systemic medical treatment, and there is controversy regarding the value of local treatment. However, there are some exceptional cases that do benefit from local therapy. We describe the case of a 54-year-old woman with systemic therapy-resistant liver metastasis from breast cancer successfully treated with a single shot of 36-GyE carbon-ion radiotherapy and surviving more than 8 years without local recurrence. This case represents a good example of the usefulness and safety of carbon-ion radiotherapy, and who might benefit from local therapy.

The Morality and Economics of Safety in Defence Procurement

NASA Astrophysics Data System (ADS)

Clement, Tim

Ministry of Defence policy is to conform as closely as possible to UK health and safety legislation in all its operations. We consider the implications of the law and the guidance provided by the Health and Safety Executive for the arguments we need to make for the safety of defence procurements, and extract four general principles to help in answering the questions that arise when considering the safety of systems with complex behaviour. One of these principles is analysed further to identify how case law and the guidance interpret the requirement for risks to be reduced so far as is reasonably practicable. We then apply the principles to answer some questions that have arisen in our work as Independent Safety Auditors, including the limits to the tolerability of risk to armed forces personnel and civilians in wartime, and the acceptability of the transfer of risk from one group to another when controls on risk are introduced.

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

Hospital safety climate surveys: measurement issues.

PubMed

Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

2010-12-01

Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

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.

Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study.

PubMed

El-Chami, Mikhael; Kowal, Robert C; Soejima, Kyoko; Ritter, Philippe; Duray, Gabor Z; Neuzil, Petr; Mont, Lluis; Kypta, Alexander; Sagi, Venkata; Hudnall, John Harrison; Stromberg, Kurt; Reynolds, Dwight

2017-07-01

Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies. © 2017 Wiley Periodicals, Inc.

A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

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

Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.

Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entriesmore » in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care.« less

Orion GN&C Fault Management System Verification: Scope And Methodology

NASA Technical Reports Server (NTRS)

Brown, Denise; Weiler, David; Flanary, Ronald

2016-01-01

In order to ensure long-term ability to meet mission goals and to provide for the safety of the public, ground personnel, and any crew members, nearly all spacecraft include a fault management (FM) system. For a manned vehicle such as Orion, the safety of the crew is of paramount importance. The goal of the Orion Guidance, Navigation and Control (GN&C) fault management system is to detect, isolate, and respond to faults before they can result in harm to the human crew or loss of the spacecraft. Verification of fault management/fault protection capability is challenging due to the large number of possible faults in a complex spacecraft, the inherent unpredictability of faults, the complexity of interactions among the various spacecraft components, and the inability to easily quantify human reactions to failure scenarios. The Orion GN&C Fault Detection, Isolation, and Recovery (FDIR) team has developed a methodology for bounding the scope of FM system verification while ensuring sufficient coverage of the failure space and providing high confidence that the fault management system meets all safety requirements. The methodology utilizes a swarm search algorithm to identify failure cases that can result in catastrophic loss of the crew or the vehicle and rare event sequential Monte Carlo to verify safety and FDIR performance requirements.

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

PubMed Central

Sinaci, A. Anil; Laleci Erturkmen, Gokce B.; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H. Alper; Cicekli, Nihan Kesim

2015-01-01

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

Probabilistic Surface Characterization for Safe Landing Hazard Detection and Avoidance (HDA)

NASA Technical Reports Server (NTRS)

Johnson, Andrew E. (Inventor); Ivanov, Tonislav I. (Inventor); Huertas, Andres (Inventor)

2015-01-01

Apparatuses, systems, computer programs and methods for performing hazard detection and avoidance for landing vehicles are provided. Hazard assessment takes into consideration the geometry of the lander. Safety probabilities are computed for a plurality of pixels in a digital elevation map. The safety probabilities are combined for pixels associated with one or more aim points and orientations. A worst case probability value is assigned to each of the one or more aim points and orientations.

Quality and Safety Implications of Emergency Department Information Systems

PubMed Central

Farley, Heather L.; Baumlin, Kevin M.; Hamedani, Azita G.; Cheung, Dickson S.; Edwards, Michael R.; Fuller, Drew C.; Genes, Nicholas; Griffey, Richard T.; Kelly, John J.; McClay, James C.; Nielson, Jeff; Phelan, Michael P.; Shapiro, Jason S.; Stone-Griffith, Suzanne; Pines, Jesse M.

2013-01-01

The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services “meaningful use” incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals’ electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital’s or physician group’s approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system’s ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or enterprise systems. PMID:23796627

Shift in performance of food safety management systems in supply chains: case of green bean chain in Kenya versus hot pepper chain in Uganda.

PubMed

Nanyunja, Jessica; Jacxsens, Liesbeth; Kirezieva, Klementina; Kaaya, Archileo N; Uyttendaele, Mieke; Luning, Pieternel A

2016-08-01

This study investigates the level of design and operation of food safety management systems (FSMS) of farmers and export traders in Kenya and Uganda. FSMS diagnostic tools developed for the fresh produce chain were used to assess the levels of context riskiness, FSMS activities and system output in primary production (n = 60) and trade (n = 60). High-risk context characteristics combined with basic FSMS are expected to increase the risk on unsafe produce. In Uganda both farmers and export traders of hot peppers operate in a high- to moderate-risk context but have basic FSMS and low systems output. In Kenya, both farmers and export traders of green beans operate in a low- to moderate-risk context. The farmers have average performing FSMS, whereas export trade companies showed more advanced FSMS and system output scores ranging from satisfactory to good. Large retailers supplying the EU premium market play a crucial role in demanding compliance with strict voluntary food safety standards, which was reflected in the more advanced FSMS and good system output in Kenya, especially traders. In Kenya, a clear shift in more fit-for-purpose FSMS and higher system output was noticed between farms and trade companies. In the case of Uganda, traders commonly supply to the less demanding EU wholesale markets such as ethnic specialty shops. They only have to comply with the legal phytosanitary and pesticide residue requirements for export activities, which apparently resulted in basic FSMS and low system output present with both farmers and traders. © 2015 Society of Chemical Industry. © 2015 Society of Chemical Industry.

Critical features of an auditable management system for an ISO 9000-compatible occupational health and safety standard.

PubMed

Levine, S; Dyjack, D T

1997-04-01

An International Organization for Standardization (ISO) 9001: 1994-harmonized occupational health and safety (OHS) management system has been written at the University of Michigan, and reviewed, revised, and accepted under the direction of the American Industrial Hygiene Association (AIHA) Occupational Health and Safety Management Systems (OHSMS) Task Force and the Board of Directors. This system is easily adaptable to the ISO 14001 format and to both OHS and environmental management system applications. As was the case with ISO 9001: 1994, this system is expected to be compatible with current production quality and OHS quality systems and standards, have forward compatibility for new applications, and forward flexibility, with new features added as needed. Since ISO 9001: 1987 and 9001: 1994 have been applied worldwide, the incorporation of harmonized OHS and environmental management system components should be acceptable to business units already performing first-party (self-) auditing, and second-party (contract qualification) auditing. This article explains the basis of this OHS management system, its relationship to ISO 9001 and 14001 standards, the philosophy and methodology of an ISO-harmonized system audit, the relationship of these systems to traditional OHS audit systems, and the authors' vision of the future for application of such systems.

New Mexico’s comprehensive impaired-driving program : a case study.

DOT National Transportation Integrated Search

2014-03-01

In late 2004, the National Highway Traffic Safety Administration provided funds to the New Mexico Department of Transportation to demonstrate a process for implementing a comprehensive State impaired driving system. NHTSA also contracted with the Pac...

Understanding safety and production risks in rail engineering planning and protection.

PubMed

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

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.

Patient safety in otolaryngology: a descriptive review.

PubMed

Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

2017-03-01

Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within Otolaryngology, although patient safety has evolved along similar themes as other surgical specialties; there are several specific high-risk areas. Medical error is a common problem and its human cost is of immense importance. Steps to reduce such errors require the identification of high-risk practice within a complex healthcare system. The commitment to patient safety and quality improvement in medicine depend on personal responsibility and professional accountability.

Bias in benefit-risk appraisal in older products: the case of buflomedil for intermittent claudication.

PubMed

De Backer, Tine L M; Vander Stichele, Robert H; Van Bortel, Luc M

2009-01-01

Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards were not in place at the time these products were registered. This issue of bias in benefit-risk assessment of older products is illustrated here with an example: buflomedil in intermittent claudication. Data on efficacy were retrieved from a Cochrane systematic review. Data on safety were obtained by comparing the number of reports of serious adverse events and fatalities published in the literature with those reported in postmarketing surveillance databases. In the case of efficacy, the slim basis of evidence for the benefit of buflomedil is undermined by documented publication bias. In the case of safety, bias in reporting to international safety databases is illustrated by the discrepancy between the number of drug-related deaths published in the literature (20), the potentially drug-related deaths in the WHO database (20) and deaths attributed to buflomedil in the database of the international marketing authorization holder (11). In older products, efficacy cannot be evaluated without a thorough search for publication bias. For safety, case reporting of drug-related serious events and deaths in the literature remains a necessary instrument for risk appraisal of older medicines, despite the existence of postmarketing safety databases. The enforcement of efficient communication between healthcare workers, drug companies, national centres of pharmacovigilance, national poison centers and the WHO is necessary to ensure the validity of postmarketing surveillance reporting systems. Drugs considered obsolete because of unfavourable benefit-risk assessment should not be allowed to stay on the market.

Less than severe worst case accidents

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

Sanders, G.A.

1996-08-01

Many systems can provide tremendous benefit if operating correctly, produce only an inconvenience if they fail to operate, but have extreme consequences if they are only partially disabled such that they operate erratically or prematurely. In order to assure safety, systems are often tested against the most severe environments and accidents that are considered possible to ensure either safe operation or safe failure. However, it is often the less severe environments which result in the ``worst case accident`` since these are the conditions in which part of the system may be exposed or rendered unpredictable prior to total system failure.more » Some examples of less severe mechanical, thermal, and electrical environments which may actually be worst case are described as cautions for others in industries with high consequence operations or products.« less

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.

Feedback from incident reporting: information and action to improve patient safety.

PubMed

Benn, J; Koutantji, M; Wallace, L; Spurgeon, P; Rejman, M; Healey, A; Vincent, C

2009-02-01

Effective feedback from incident reporting systems in healthcare is essential if organisations are to learn from failures in the delivery of care. Despite the wide-scale development and implementation of incident reporting in healthcare, studies in the UK suggest that information concerning system vulnerabilities could be better applied to improve operational safety within organisations. In this article, the findings and implications of research to identify forms of effective feedback from incident reporting are discussed, to promote best practices in this area. The research comprised a mixed methods review to investigate mechanisms of effective feedback for healthcare, drawing upon experience within established reporting programmes in high-risk industry and transport domains. Systematic searches of published literature were undertaken, and 23 case studies describing incident reporting programmes with feedback were identified for analysis from the international healthcare literature. Semistructured interviews were undertaken with 19 subject matter experts across a range of domains, including: civil aviation, maritime, energy, rail, offshore production and healthcare. In analysis, qualitative information from several sources was synthesised into practical requirements for developing effective feedback in healthcare. Both action and information feedback mechanisms were identified, serving safety awareness, improvement and motivational functions. The provision of actionable feedback that visibly improved systems was highlighted as important in promoting future reporting. Fifteen requirements for the design of effective feedback systems were identified, concerning: the role of leadership, the credibility and content of information, effective dissemination channels, the capacity for rapid action and the need for feedback at all levels of the organisation, among others. Above all, the safety-feedback cycle must be closed by ensuring that reporting, analysis and investigation result in timely corrective actions that effectively address vulnerabilities in existing work systems. Limited research evidence exists concerning the issue of effective forms of safety feedback within healthcare. Much valuable operational knowledge resides in safety management communities within high-risk industries. Multiple means of feeding back recommended actions and safety information may be usefully employed to promote safety awareness, improve clinical processes and promote future reporting. Further work is needed to establish best practices for feedback systems in healthcare that effectively close the safety loop.

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.

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)

Policy analysis of the budget used in training program for reducing lower back pain among heavy equipment operators in the construction industry: System dynamics approach

NASA Astrophysics Data System (ADS)

Vitharana, V. H. P.; Chinda, T.

2018-04-01

Lower back pain (LBP), prevalence is high among the heavy equipment operators leading to high compensation cost in the construction industry. It is found that proper training program assists in reducing chances of having LBP. This study, therefore aims to examine different safety related budget available to support LBP related training program for different age group workers, utilizing system dynamics modeling approach. The simulation results show that at least 2.5% of the total budget must be allocated in the safety and health budget to reduce the chances of having LBP cases.

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

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

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

2013-07-01

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

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.

HSE inspector advises on 'common mistakes'.

PubMed

Baillie, Jonathan

2012-10-01

A recent IHEEM seminar on water hygiene and safety, 'The Invisible Threat', saw John Newbold, an HM specialist inspector at the Health and Safety Executive (HSE) with experience investigating Legionella cases and outbreaks, provide useful insight into how healthcare estates engineers and other 'responsible' personnel could ensure compliance with the law by properly 'managing and controlling' Legionella risk. He provided a first-hand view of what he dubbed 'some of the common mistakes' made by those responsible for managing water system safety, and gave useful advice and guidance on how to avoid them, and thus minimise the risk of falling foul of the HSE and other regulators. HEJ editor, Jonathan Baillie, reports.

Personnel safety with pressurized gas systems

DOE PAGES

Cadwallader, Lee C.; Zhao, Haihua

2016-09-08

In this study, selected accident case histories are described that illustrate the potential modes of injury from gas jets, pressure-driven missiles, and asphyxiants. Gas combustion hazards are also briefly mentioned. Using high-pressure helium and nitrogen, estimates of safe exclusion distances are calculated for differing pressures, temperatures, and breach sizes. Some sources for gas system reliability values are also cited.

Automation, decision support, and expert systems in nephrology.

PubMed

Soman, Sandeep; Zasuwa, Gerard; Yee, Jerry

2008-01-01

Increasing data suggest that errors in medicine occur frequently and result in substantial harm to the patient. The Institute of Medicine report described the magnitude of the problem, and public interest in this issue, which was already large, has grown. The traditional approach in medicine has been to identify the persons making the errors and recommend corrective strategies. However, it has become increasingly clear that it is more productive to focus on the systems and processes through which care is provided. If these systems are set up in ways that would both make errors less likely and identify those that do occur and, at the same time, improve efficiency, then safety and productivity would be substantially improved. Clinical decision support systems (CDSSs) are active knowledge systems that use 2 or more items of patient data to generate case specific recommendations. CDSSs are typically designed to integrate a medical knowledge base, patient data, and an inference engine to generate case specific advice. This article describes how automation, templating, and CDSS improve efficiency, patient care, and safety by reducing the frequency and consequences of medical errors in nephrology. We discuss practical applications of these in 3 settings: a computerized anemia-management program (CAMP, Henry Ford Health System, Detroit, MI), vascular access surveillance systems, and monthly capitation notes in the hemodialysis unit.

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.

Experiments with Geometric Non-Linear Coupling for Analytical Validation

DTIC Science & Technology

2010-03-01

maintaining a high safety factor. This is the primary constraint and is very important in keeping the end conditions of the experiment known. 3.1.4...the maximum load case while maintaining a safety factor of at least 2. Figure 3.14: Cable and Winch. The load is measured using a 3,000 lbf...the class and power of this laser, laser eyewear is required for safe use of the system. The Photon 80 can scan at various levels of detail. For

Validating the Danish adaptation of the World Health Organization's International Classification for Patient Safety classification of patient safety incident types

PubMed Central

Mikkelsen, Kim Lyngby; Thommesen, Jacob; Andersen, Henning Boje

2013-01-01

Objectives Validation of a Danish patient safety incident classification adapted from the World Health Organizaton's International Classification for Patient Safety (ICPS-WHO). Design Thirty-three hospital safety management experts classified 58 safety incident cases selected to represent all types and subtypes of the Danish adaptation of the ICPS (ICPS-DK). Outcome Measures Two measures of inter-rater agreement: kappa and intra-class correlation (ICC). Results An average number of incident types used per case per rater was 2.5. The mean ICC was 0.521 (range: 0.199–0.809) and the mean kappa was 0.513 (range: 0.193–0.804). Kappa and ICC showed high correlation (r = 0.99). An inverse correlation was found between the prevalence of type and inter-rater reliability. Results are discussed according to four factors known to determine the inter-rater agreement: skill and motivation of raters; clarity of case descriptions; clarity of the operational definitions of the types and the instructions guiding the coding process; adequacy of the underlying classification scheme. Conclusions The incident types of the ICPS-DK are adequate, exhaustive and well suited for classifying and structuring incident reports. With a mean kappa a little above 0.5 the inter-rater agreement of the classification system is considered ‘fair’ to ‘good’. The wide variation in the inter-rater reliability and low reliability and poor discrimination among the highly prevalent incident types suggest that for these types, precisely defined incident sub-types may be preferred. This evaluation of the reliability and usability of WHO's ICPS should be useful for healthcare administrations that consider or are in the process of adapting the ICPS. PMID:23287641

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven 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, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

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.

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.

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

PubMed

Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

2014-10-07

Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. Copyright © 2014 Elsevier Ltd. All rights reserved.

Assessing the Relative Influence and Efficacy of Public and Private Food Safety Regulation Regimes: Comparing Codex and Global G.A.P. Standards.

PubMed

Halabi, Sam F; Lin, Ching-Fu

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization jointly run by the Food and Agricultural Organization and the World Health Organization and GlobalG.A.P., a farm assurance program created in the late 1990s by supermarket chains and their major suppliers which has now expanded into a global certifying coalition. While Codex standards are adopted, often as written, by national food safety regulators who are principal drivers of the standard setting process, customers for agricultural products in many countries now demand evidence of GlobalG.A.P. certification as a prerequisite for doing business This article tests not only the durability and strength of private sector standard setting in the food safety system, but also the desirability of that system as an alternative to formal, governmental processes embodied, for our purposes, in the standards adopted by Codex. In many cases, official standards and GlobalG.A.P. standards clash in ways that implicate not only food safety but the flow of agricultural products in the global trading system. The article analyzes current weaknesses in both regimes and possibilities for change that will better reconcile the two competing systems.

Deriving Safety Cases from Machine-Generated Proofs

NASA Technical Reports Server (NTRS)

Basir, Nurlida; Fischer, Bernd; Denney, Ewen

2009-01-01

Proofs provide detailed justification for the validity of claims and are widely used in formal software development methods. However, they are often complex and difficult to understand, because they use machine-oriented formalisms; they may also be based on assumptions that are not justified. This causes concerns about the trustworthiness of using formal proofs as arguments in safety-critical applications. Here, we present an approach to develop safety cases that correspond to formal proofs found by automated theorem provers and reveal the underlying argumentation structure and top-level assumptions. We concentrate on natural deduction proofs and show how to construct the safety cases by covering the proof tree with corresponding safety case fragments.

Chemical technology for the toxic gas flow control through process water system.

PubMed

Broussard, G; Bramanti, O; Salvatore, A; Marchese, F M

2001-01-01

The aim of this work is focused on the safety and toxicological aspects due to under-pressure industrial plant management, above all in the case which the gas is very dangerous for human health and environment. Here is illustrated the safe method of control of risks through specific choices of engineering devices and chemical process: in this way we have shown the mathematical calculation regarding the case of ammonia flow gas running in the piping and plant under-pressure. In this paper the Authors show the assessment of the technological solution for falling down of a toxic gas as NH3, which lets off from safety values facilities. The under pressure industrial plants with ammonia are protected through the safety valves, settled at 20 bar pressure. The out-let gas flow is capted by a tank of a water bulk of five time theoretical water amount necessary to the complete absorption of gas. In order to prevent any health risk and carry out a safety management, it needs to verify two basic aspects, with connected specific techniques: 1. The safety valves technology through the mathematical calculation of operating device; 2. The absorption process of the toxic agent for controlling of dangerous runaway of gas.

Safety Assessment of Probiotics

NASA Astrophysics Data System (ADS)

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

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

Nonminimal hints for asymptotic safety

NASA Astrophysics Data System (ADS)

Eichhorn, Astrid; Lippoldt, Stefan; Skrinjar, Vedran

2018-01-01

In the asymptotic-safety scenario for gravity, nonzero interactions are present in the ultraviolet. This property should also percolate into the matter sector. Symmetry-based arguments suggest that nonminimal derivative interactions of scalars with curvature tensors should therefore be present in the ultraviolet regime. We perform a nonminimal test of the viability of the asymptotic-safety scenario by working in a truncation of the renormalization group flow, where we discover the existence of an interacting fixed point for a corresponding nonminimal coupling. The back-coupling of such nonminimal interactions could in turn destroy the asymptotically safe fixed point in the gravity sector. As a key finding, we observe nontrivial indications of stability of the fixed-point properties under the impact of nonminimal derivative interactions, further strengthening the case for asymptotic safety in gravity-matter systems.

Safety improvements through Intelligent Transport Systems: a South African case study based on microscopic simulation modelling.

PubMed

Vanderschuren, Marianne

2008-03-01

Intelligent Transport Systems (ITS) can facilitate the delivery of a wide range of policy objectives. There are six main objectives/benefits identified in the international literature: Safety (reduction of (potential) crashes), mobility (reduction of delays and travel times), efficiency (optimise the use of existing infrastructure), productivity (cost saving), energy/environment and customer satisfaction [Mitretek Systems, 2001. Intelligent Transport System Benefits: 2001 update, Under Contract to the Federal Highway Administration, US Department of Transportation, Washington, DC, US]. In the South African context, there is an interest for measures that can reduce (potential) crashes. In South Africa the number of year on year traffic related fatalities is still increasing. In 2005 the number of fatalities was 15393 (from 14135 in 2004) while the estimated costs for the same period increased from R8.89-billion to R9.99-billion [RTMC, 2007. Interim Road Traffic and Fatal Crash Report 2006, Road Traffic Management Corporation, Pretoria, SA]. Given the extent of the road safety problem and the potential benefits of ITS, the need for further research is apparent. A study with regards to the potential of different types of models (macroscopic, mesoscopic and miscroscopic simulation models) led to the use of Paramics. Two corridors and three types of ITS measures were investigated and safety benefits were estimated.

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

PubMed

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

2017-01-01

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

A Real-Time Construction Safety Monitoring System for Hazardous Gas Integrating Wireless Sensor Network and Building Information Modeling Technologies.

PubMed

Cheung, Weng-Fong; Lin, Tzu-Hsuan; Lin, Yu-Cheng

2018-02-02

In recent years, many studies have focused on the application of advanced technology as a way to improve management of construction safety management. A Wireless Sensor Network (WSN), one of the key technologies in Internet of Things (IoT) development, enables objects and devices to sense and communicate environmental conditions; Building Information Modeling (BIM), a revolutionary technology in construction, integrates database and geometry into a digital model which provides a visualized way in all construction lifecycle management. This paper integrates BIM and WSN into a unique system which enables the construction site to visually monitor the safety status via a spatial, colored interface and remove any hazardous gas automatically. Many wireless sensor nodes were placed on an underground construction site and to collect hazardous gas level and environmental condition (temperature and humidity) data, and in any region where an abnormal status is detected, the BIM model will alert the region and an alarm and ventilator on site will start automatically for warning and removing the hazard. The proposed system can greatly enhance the efficiency in construction safety management and provide an important reference information in rescue tasks. Finally, a case study demonstrates the applicability of the proposed system and the practical benefits, limitations, conclusions, and suggestions are summarized for further applications.

Guide for Oxygen Component Qualification Tests

NASA Technical Reports Server (NTRS)

Bamford, Larry J.; Rucker, Michelle A.; Dobbin, Douglas

1996-01-01

Although oxygen is a chemically stable element, it is not shock sensitive, will not decompose, and is not flammable. Oxygen use therefore carries a risk that should never be overlooked, because oxygen is a strong oxidizer that vigorously supports combustion. Safety is of primary concern in oxygen service. To promote safety in oxygen systems, the flammability of materials used in them should be analyzed. At the NASA White Sands Test Facility (WSTF), we have performed configurational tests of components specifically engineered for oxygen service. These tests follow a detailed WSTF oxygen hazards analysis. The stated objective of the tests was to provide performance test data for customer use as part of a qualification plan for a particular component in a particular configuration, and under worst-case conditions. In this document - the 'Guide for Oxygen Component Qualification Tests' - we outline recommended test systems, and cleaning, handling, and test procedures that address worst-case conditions. It should be noted that test results apply specifically to: manual valves, remotely operated valves, check valves, relief valves, filters, regulators, flexible hoses, and intensifiers. Component systems are not covered.

Gymnastics Safety and The Law.

ERIC Educational Resources Information Center

Dailey, Bob

Data collected from the National Electronic Injury Surveillance System (NEISS) and 26 tort liability cases are examined as a basis for recommendations for gymnastics instructors, supervisors, and administrators. Tables supply supportive statistics for a discussion of gymnastics injuries classified by sex, body part injured, severity, and…

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

PubMed

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

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

Safety illusion and error trap in a collectively-operated machine accident.

PubMed

de Almeida, Ildeberto Muniz; Nobre, Hildeberto; do Amaral Dias, Maria Dionísia; Vilela, Rodolfo Andrade Gouveia

2012-01-01

Workplace accidents involving machines are relevant for their magnitude and their impacts on worker health. Despite consolidated critical statements, explanation centered on errors of operators remains predominant with industry professionals, hampering preventive measures and the improvement of production-system reliability. Several initiatives were adopted by enforcement agencies in partnership with universities to stimulate production and diffusion of analysis methodologies with a systemic approach. Starting from one accident case that occurred with a worker who operated a brake-clutch type mechanical press, the article explores cognitive aspects and the existence of traps in the operation of this machine. It deals with a large-sized press that, despite being endowed with a light curtain in areas of access to the pressing zone, did not meet legal requirements. The safety devices gave rise to an illusion of safety, permitting activation of the machine when a worker was still found within the operational zone. Preventive interventions must stimulate the tailoring of systems to the characteristics of workers, minimizing the creation of traps and encouraging safety policies and practices that replace judgments of behaviors that participate in accidents by analyses of reasons that lead workers to act in that manner.

An Assessment of Reduced Crew and Single Pilot Operations in Commercial Transport Aircraft Operations

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Kramer, Lynda J.; Kennedy, Kellie D.; Stephens, Chad L.; Etherington, Timothy J.

2017-01-01

Future reduced crew operations or even single pilot operations for commercial airline and on-demand mobility applications are an active area of research. These changes would reduce the human element and thus, threaten the precept that "a well-trained and well-qualified pilot is the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system." NASA recently completed a pilot-in-the-loop high fidelity motion simulation study in partnership with the Federal Aviation Administration (FAA) attempting to quantify the pilot's contribution to flight safety during normal flight and in response to aircraft system failures. Crew complement was used as the experiment independent variable in a between-subjects design. These data show significant increases in workload for single pilot operations, compared to two-crew, with subjective assessments of safety and performance being significantly degraded as well. Nonetheless, in all cases, the pilots were able to overcome the failure mode effects in all crew configurations. These data reflect current-day flight deck equipage and help identify the technologies that may improve two-crew operations and/or possibly enable future reduced crew and/or single pilot operations.

NASA Accident Precursor Analysis Handbook, Version 1.0

NASA Technical Reports Server (NTRS)

Groen, Frank; Everett, Chris; Hall, Anthony; Insley, Scott

2011-01-01

Catastrophic accidents are usually preceded by precursory events that, although observable, are not recognized as harbingers of a tragedy until after the fact. In the nuclear industry, the Three Mile Island accident was preceded by at least two events portending the potential for severe consequences from an underappreciated causal mechanism. Anomalies whose failure mechanisms were integral to the losses of Space Transportation Systems (STS) Challenger and Columbia had been occurring within the STS fleet prior to those accidents. Both the Rogers Commission Report and the Columbia Accident Investigation Board report found that processes in place at the time did not respond to the prior anomalies in a way that shed light on their true risk implications. This includes the concern that, in the words of the NASA Aerospace Safety Advisory Panel (ASAP), "no process addresses the need to update a hazard analysis when anomalies occur" At a broader level, the ASAP noted in 2007 that NASA "could better gauge the likelihood of losses by developing leading indicators, rather than continue to depend on lagging indicators". These observations suggest a need to revalidate prior assumptions and conclusions of existing safety (and reliability) analyses, as well as to consider the potential for previously unrecognized accident scenarios, when unexpected or otherwise undesired behaviors of the system are observed. This need is also discussed in NASA's system safety handbook, which advocates a view of safety assurance as driving a program to take steps that are necessary to establish and maintain a valid and credible argument for the safety of its missions. It is the premise of this handbook that making cases for safety more experience-based allows NASA to be better informed about the safety performance of its systems, and will ultimately help it to manage safety in a more effective manner. The APA process described in this handbook provides a systematic means of analyzing candidate accident precursors by evaluating anomaly occurrences for their system safety implications and, through both analytical and deliberative methods used to project to other circumstances, identifying those that portend more serious consequences to come if effective corrective action is not taken. APA builds upon existing safety analysis processes currently in practice within NASA, leveraging their results to provide an improved understanding of overall system risk. As such, APA represents an important dimension of safety evaluation; as operational experience is acquired, precursor information is generated such that it can be fed back into system safety analyses to risk-inform safety improvements. Importantly, APA utilizes anomaly data to predict risk whereas standard reliability and PRA approaches utilize failure data which often is limited and rare.

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.

Verified compilation of Concurrent Managed Languages

DTIC Science & Technology

2017-11-01

designs for compiler intermediate representations that facilitate mechanized proofs and verification; and (d) a realistic case study that combines these...ideas to prove the correctness of a state-of- the-art concurrent garbage collector. 15. SUBJECT TERMS Program verification, compiler design ...Even though concurrency is a pervasive part of modern software and hardware systems, it has often been ignored in safety-critical system designs . A

Surveillance of work-related amputations in Michigan using multiple data sources: results for 2006-2012.

PubMed

Largo, Thomas W; Rosenman, Kenneth D

2015-03-01

An amputation is one of the most serious injuries an employee can sustain and may result in lost time from work and permanent limitations that restrict future activity. A multidata source system has been shown to identify twice as many acute traumatic fatalities as one relying only on employer reporting. This study demonstrates the value of a multidata source approach for non-fatal occupational injuries. Data were abstracted from medical records of patients treated for work-related amputations at Michigan hospitals and emergency departments and were linked to workers' compensation claims data. Safety inspections were conducted by the Michigan Occupational Safety and Health Administration for selected cases. From 2006 through 2012, 4140 Michigan residents had a work-related amputation. In contrast, the Survey of Occupational Injury and Illness conducted by the Bureau of Labor Statistics (BLS) estimated that there were 1770 cases during this period. During the 7-year period, work-related amputation rates decreased by 26%. The work-related amputation rate for men was more than six times that for women. Industries with the highest work-related amputation rates were Wood Product Manufacturing and Paper Manufacturing. Power saws and presses were the leading causes of injury. One hundred and seventy-three safety inspections were conducted as a result of referrals from the system. These inspections identified 1566 violations and assessed $652 755 in penalties. The system was fairly simple to maintain, identified more than twice as many cases than either BLS or workers' compensation alone, and was useful for initiating inspection of high-risk worksites. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Deriving Safety Cases from Automatically Constructed Proofs

NASA Technical Reports Server (NTRS)

Basir, Nurlida; Denney, Ewen; Fischer, Bernd

2009-01-01

Formal proofs provide detailed justification for the validity of claims and are widely used in formal software development methods. However, they are often complex and difficult to understand, because the formalism in which they are constructed and encoded is usually machine-oriented, and they may also be based on assumptions that are not justified. This causes concerns about the trustworthiness of using formal proofs as arguments in safety-critical applications. Here, we present an approach to develop safety cases that correspond to formal proofs found by automated theorem provers and reveal the underlying argumentation structure and top-level assumptions. We concentrate on natural deduction style proofs, which are closer to human reasoning than resolution proofs, and show how to construct the safety cases by covering the natural deduction proof tree with corresponding safety case fragments. We also abstract away logical book-keeping steps, which reduces the size of the constructed safety cases. We show how the approach can be applied to the proofs found by the Muscadet prover.

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).

Health, safety, and environmental management system operation in contracting companies: A case study.

PubMed

Nassiri, Parvin; Yarahmadi, Rasoul; Gholami, Pari Shafaei; Hamidi, Abdolamir; Mirkazemi, Roksana

2016-05-03

Systematic and cooperative interactions among parent industry and contractors are necessary for a successful health, safety, and environmental management system (HSE-MS). This study was conducted to evaluate the HSE-MS performance in contracting companies in one of the petrochemical industries in Iran during 2013. Managers of parent and contracting companies participated in this study. The data collection forms included 7 elements of an integrated HSE-MS (leadership and commitment; policy and strategic objectives; organization, resources, and documentation; evaluation and risk management; planning; implementation and monitoring; auditing and reviewing). The results showed that mean percentage of the total scores in seven elements of HSE-MS was 85.7% and 87.0% based on self-report and report of parent company, respectively. In conclusion, this study showed that HSE-MS was desirably functioning; however, improvement to ensure health and safety of workers is still required.

Relief, restoration and reform: economic upturn yields modest and uneven health returns.

PubMed

Hurley, Robert; Katz, Aaron; Felland, Laurie

2008-01-01

The sensitivity of state budgets to economic cycles contributes to fluctuations in health coverage, eligibility, benefits and provider payment levels in public programs, as well as support for safety net hospitals and community health centers (CHCs). The aftershocks of the 2001 recession on state budgets were felt well into 2004. More recently, the economic recovery allowed many states to restore cuts and, in some cases, expand health services for low-income people, according to findings from the Center for Studying Health System Change's (HSC) 2007 site visits to 12 nationally representative metropolitan communities. Along with bolstering support of safety net providers and raising Medicaid payments for private physicians, some states advanced even more ambitious health reform proposals. Yet across communities, safety net systems face mounting challenges of caring for more uninsured patients, and these pressures will likely increase given the current economic downturn.

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.

Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

PubMed

Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

2014-08-01

To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors. It supports the safety of SFI for clinical, research,and production uses based on objective, reliable, and scientific information to provide safe medication.

Multiple Kernel Learning for Heterogeneous Anomaly Detection: Algorithm and Aviation Safety Case Study

NASA Technical Reports Server (NTRS)

Das, Santanu; Srivastava, Ashok N.; Matthews, Bryan L.; Oza, Nikunj C.

2010-01-01

The world-wide aviation system is one of the most complex dynamical systems ever developed and is generating data at an extremely rapid rate. Most modern commercial aircraft record several hundred flight parameters including information from the guidance, navigation, and control systems, the avionics and propulsion systems, and the pilot inputs into the aircraft. These parameters may be continuous measurements or binary or categorical measurements recorded in one second intervals for the duration of the flight. Currently, most approaches to aviation safety are reactive, meaning that they are designed to react to an aviation safety incident or accident. In this paper, we discuss a novel approach based on the theory of multiple kernel learning to detect potential safety anomalies in very large data bases of discrete and continuous data from world-wide operations of commercial fleets. We pose a general anomaly detection problem which includes both discrete and continuous data streams, where we assume that the discrete streams have a causal influence on the continuous streams. We also assume that atypical sequence of events in the discrete streams can lead to off-nominal system performance. We discuss the application domain, novel algorithms, and also discuss results on real-world data sets. Our algorithm uncovers operationally significant events in high dimensional data streams in the aviation industry which are not detectable using state of the art methods

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.

Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus.

PubMed

Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F

2016-11-01

We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.

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.

European Train Control System: A Case Study in Formal Verification

NASA Astrophysics Data System (ADS)

Platzer, André; Quesel, Jan-David

Complex physical systems have several degrees of freedom. They only work correctly when their control parameters obey corresponding constraints. Based on the informal specification of the European Train Control System (ETCS), we design a controller for its cooperation protocol. For its free parameters, we successively identify constraints that are required to ensure collision freedom. We formally prove the parameter constraints to be sharp by characterizing them equivalently in terms of reachability properties of the hybrid system dynamics. Using our deductive verification tool KeYmaera, we formally verify controllability, safety, liveness, and reactivity properties of the ETCS protocol that entail collision freedom. We prove that the ETCS protocol remains correct even in the presence of perturbation by disturbances in the dynamics. We verify that safety is preserved when a PI controlled speed supervision is used.

Operational Performance Risk Assessment in Support of A Supervisory Control System

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

Denning, Richard S.; Muhlheim, Michael David; Cetiner, Sacit M.

Supervisory control system (SCS) is developed for multi-unit advanced small modular reactors to minimize human interventions in both normal and abnormal operations. In SCS, control action decisions made based on probabilistic risk assessment approach via Event Trees/Fault Trees. Although traditional PRA tools are implemented, their scope is extended to normal operations and application is reversed; success of non-safety related system instead failure of safety systems this extended PRA approach called as operational performance risk assessment (OPRA). OPRA helps to identify success paths, combination of control actions for transients and to quantify these success paths to provide possible actions without activatingmore » plant protection system. In this paper, a case study of the OPRA in supervisory control system is demonstrated within the context of the ALMR PRISM design, specifically power conversion system. The scenario investigated involved a condition that the feed water control valve is observed to be drifting to the closed position. Alternative plant configurations were identified via OPRA that would allow the plant to continue to operate at full or reduced power. Dynamic analyses were performed with a thermal-hydraulic model of the ALMR PRISM system using Modelica to evaluate remained safety margins. Successful recovery paths for the selected scenario are identified and quantified via SCS.« less

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.

Enhancing Nursing Staffing Forecasting With Safety Stock Over Lead Time Modeling.

PubMed

McNair, Douglas S

2015-01-01

In balancing competing priorities, it is essential that nursing staffing provide enough nurses to safely and effectively care for the patients. Mathematical models to predict optimal "safety stocks" have been routine in supply chain management for many years but have up to now not been applied in nursing workforce management. There are various aspects that exhibit similarities between the 2 disciplines, such as an evolving demand forecast according to acuity and the fact that provisioning "stock" to meet demand in a future period has nonzero variable lead time. Under assumptions about the forecasts (eg, the demand process is well fit as an autoregressive process) and about the labor supply process (≥1 shifts' lead time), we show that safety stock over lead time for such systems is effectively equivalent to the corresponding well-studied problem for systems with stationary demand bounds and base stock policies. Hence, we can apply existing models from supply chain analytics to find the optimal safety levels of nurse staffing. We use a case study with real data to demonstrate that there are significant benefits from the inclusion of the forecast process when determining the optimal safety stocks.

Pulsed Laser-induced Liquid Jet System for Treatment of Sellar and Parasellar Tumors: Safety Evaluation.

PubMed

Nakagawa, Atsuhiro; Ogawa, Yoshikazu; Amano, Kosaku; Ishii, Yudo; Tahara, Shigeshi; Horiguchi, Kentaro; Kawamata, Takakazu; Yano, Shigetoshi; Arafune, Tatsuhiko; Washio, Toshikatsu; Kuratsu, Jun-Ichi; Saeki, Naokatsu; Okada, Yoshikazu; Teramoto, Akira; Tominaga, Teiji

2015-11-01

The pulsed laser-induced liquid jet (LILJ) system is an emerging surgical instrument intended to assist both maximal removal of the lesion and functional maintenance through preservation of fine vessels and minimal damage to the surrounding tissue. The system ejects the minimum required amount of pulsed water through a handy bayonet-shaped catheter. We have already shown a significant increase in removal rate, in addition to a noteworthy reduction of intraoperative blood loss and procedure time in the treatment of large pituitary and skull base tumors in a single-institution series. The present study evaluated the safety of the system in multiple institutions. The study included 46 patients, 29 men and 17 women (mean age: 59.1 years) who underwent microsurgical/endoscopic resection of lesions in or in the vicinity of the pituitary fossa through the transsphenoidal approach between October 2011 and June 2012 at six institutions. The histologic diagnoses were pituitary adenoma (31 cases), meningioma (4), craniopharyngioma (3), cavernous angioma (2), and Rathke cyst cleft (1). Lesion volume ranged from 2.0 to 30.4 cm³ (mean: 3.7 cm³). Cavernous sinus invasion was observed in 11 cases and suprasellar extension in 29 cases. Preservation of intralesional arteries (diameter: 150 µm) was achieved in all situations in > 80% of cases. Intended surgical steps were achieved except for some restrictions in motion due to the use of an optical quartz fiber. No complications occurred directly related to the use of the device. The LILJ system can be used for safe removal of lesions in or in the vicinity of the pituitary fossa. Georg Thieme Verlag KG Stuttgart · New York.

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.

Improvement of a Chemical Storage Room Ventilation System

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

Yousif, Emad; Al-Dahhan, Wedad; Abed, Rashed Nema

Scientists at universities across Iraq are actively working to report actual incidents and accidents occurring in their laboratories, as well as structural improvements made to improve safety and security, to raise awareness and encourage openness, leading to widespread adoption of robust Chemical Safety and Security (CSS) practices. This manuscript is the third in a series of five case studies describing laboratory incidents, accidents, and laboratory improvements. We summarize an improvement to the chemical storage room ventilation system at Al-Nahrain University to create and maintain a safe working atmosphere in an area where chemicals are stored and handled, using US andmore » European design practices, standards, and regulations.« less

Chlamydia trachomatis infection: the efficacy and safety of a fast-track referral and treatment system.

PubMed

Sethupathi, M; Blackwell, A

2009-03-01

We introduced a Nurse/Health Advisor-led fast-track service for treating patients diagnosed with chlamydia outside a genitourinary medicine setting and contacts of chlamydia/non-specific urethritis/cervicitis wherever diagnosed. Asymptomatic patients were treated without initial testing and asked to return for full screening at four to six weeks. We assessed the efficacy and safety of the system and need for follow-up after treatment. Case-notes of 226 patients (121 men and 105 women) were analysed, of whom 140 attended follow-up. With the exception of one case of gonorrhoea, no other serious sexually transmitted infection was detected. Twenty-seven (19.2%) patients were re-treated for either chlamydia (six patients, 4.4%) or non-specific genital infection or because of having unprotected intercourse with untreated or partially treated partners. We conclude that in our relatively low-risk population, our fast-track service is safe and effective. Test of cure for chlamydia seems essential because of the high percentage of patients requiring re-treatment.

Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-08-01

Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities associated with sampling locations showing poor performance.

Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

2012-01-01

Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

Optimizing medication safety in the home.

PubMed

LeBlanc, Raeanne Genevieve; Choi, Jeungok

2015-06-01

Medication safety among community-dwelling older adults in the United States is an ongoing health issue impacting health outcomes, chronic disease management, and aging in place at home. This article describes a medication safety improvement project that aimed to: (1) Increase the ability of participants to manage medications, (2) Identify and make necessary medication changes, (3) Create an accurate up-to-date medication list to be available in the home, and (4) Provide communication between the primary care provider, participant, and case manager. An in-home medication assessment was completed for 25 participants using an evidence-based medication management software system. This process was used to review medications; identify medication-related problems; create a shared medication list; and convey this information to the primary care provider, case manager, and client while addressing needed medication changes. Educational interventions on management and understanding of medications were provided to participants to emphasize the correct use of medications and use of a personal medication record. Outcome improvements included provision of an accurate medication list, early identification of medication-related problems, identification of drug duplication, and identification of medication self-management challenges that can be useful for optimizing medication safety-related home healthcare and inform future interventions.

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

PubMed

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

2017-02-01

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

Clinical use of closed-system safety peripheral intravenous cannulas.

PubMed

Barton, Andrew

2018-04-26

Peripheral intravenous (IV) cannulas are the quickest and most effective way of gaining venous vascular access and administering IV therapy. Closed-system peripheral IV cannulas have been shown to be safe and more reliable than open, non-valved peripheral cannulas in clinical practice. This article introduces the Smiths Medical DeltaVen closed-system peripheral IV cannula and includes three case studies describing its use in clinical practice and associated patient outcomes.

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.

Command and Control Software Development Memory Management

NASA Technical Reports Server (NTRS)

Joseph, Austin Pope

2017-01-01

This internship was initially meant to cover the implementation of unit test automation for a NASA ground control project. As is often the case with large development projects, the scope and breadth of the internship changed. Instead, the internship focused on finding and correcting memory leaks and errors as reported by a COTS software product meant to track such issues. Memory leaks come in many different flavors and some of them are more benign than others. On the extreme end a program might be dynamically allocating memory and not correctly deallocating it when it is no longer in use. This is called a direct memory leak and in the worst case can use all the available memory and crash the program. If the leaks are small they may simply slow the program down which, in a safety critical system (a system for which a failure or design error can cause a risk to human life), is still unacceptable. The ground control system is managed in smaller sub-teams, referred to as CSCIs. The CSCI that this internship focused on is responsible for monitoring the health and status of the system. This team's software had several methods/modules that were leaking significant amounts of memory. Since most of the code in this system is safety-critical, correcting memory leaks is a necessity.

Impact of software and hardware technologies on occupational health and safety policies in Saudi Arabian oil refineries.

PubMed

Idreis, Hany M; Siqueira, Carlos E; Levenstein, Charles C

2006-01-01

This article seeks to examine the impact of technology importation on occupational health and safety in both Saudi Arabian and U.S. oil refining industries. Technologies imported to the Saudi oil industry take two forms: hardware (sophisticated equipment to run oil facilities) and software (policies and regulations pertaining to workers' health and safety, and employment rights installed by Aramco's founding multinational companies). This study utilizes qualitative, historically oriented, cross-national case studies to compare and assess workers' health, safety, and rights in Saudi Aramco with its U.S. counterpart, Motiva Enterprises. Two facilities were chosen to conduct field research: the Saudi Aramco oil refinery at Jeddah and Motiva's refinery at Port Arthur, Texas. The Jeddah refinery is fully owned by Saudi Aramco, thus, representing Aramco's health and safety policies and regulations. The Port Arthur refinery serves as a reference case study for U.S. oil refining facilities. The aspects of occupational health and safety in Saudi Aramco--ExxonMobil's joint ventures SAMREF and LUBREF--also are discussed to examine workers' health policies in both companies. The American oil industry made a significant contribution in establishing the Saudi oil industry, with the cooperation of the Saudi government. Despite having outstanding employment benefits schemes in Saudi Aramco, the presence of an organized work force better serves employee participation in Motiva than in Aramco. Safety systems such as Process Safety Management (PSM)--applied in Motiva--partially exist in Aramco to operate hardware technologies safely. Motiva training systems are better through PACE's Triangle of Prevention (TOP). Both companies follow the same pattern of handling occupational injuries and diseases; however, Saudi government agencies (GOSI) are responsible for compensating and treating injured workers. Saudi workers expressed conditional support for the worker committee program proposed by the Ministry of Labor. American and Saudi workers are concerned about the quality and sufficiency of health and safety training, employment promotion, work pressure, and job uncertainty due to continuous downsizing. This article recommends that Saudi social actors increase safety and health awareness in the work environment by providing intensive occupational safety training to the employees (as demanded by Saudi and American workers), improve labor-management relations through establishing strong cooperative contacts with regional and international trade unions, and establish uniform and standard occupational health and safety regulations for Saudi Aramco and its subsidiaries in order to provide an equal level of protection for Saudi workers.

Translating Health Services Research into Practice in the Safety Net.

PubMed

Moore, Susan L; Fischer, Ilana; Havranek, Edward P

2016-02-01

To summarize research relating to health services research translation in the safety net through analysis of the literature and case study of a safety net system. Literature review and key informant interviews at an integrated safety net hospital. This paper describes the results of a comprehensive literature review of translational science literature as applied to health care paired with qualitative analysis of five key informant interviews conducted with senior-level management at Denver Health and Hospital Authority. Results from the literature suggest that implementing innovation may be more difficult in the safety net due to multiple factors, including financial and organizational constraints. Results from key informant interviews confirmed the reality of financial barriers to innovation implementation but also implied that factors, including institutional respect for data, organizational attitudes, and leadership support, could compensate for disadvantages. Translating research into practice is of critical importance to safety net providers, which are under increased pressure to improve patient care and satisfaction. Results suggest that translational research done in the safety net can better illuminate the special challenges of this setting; more such research is needed. © Health Research and Educational Trust.

The AP1000{sup R} nuclear power plant innovative features for extended station blackout mitigation

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

Vereb, F.; Winters, J.; Schulz, T.

2012-07-01

Station Blackout (SBO) is defined as 'a condition wherein a nuclear power plant sustains a loss of all offsite electric power system concurrent with turbine trip and unavailability of all onsite emergency alternating current (AC) power system. Station blackout does not include the loss of available AC power to buses fed by station batteries through inverters or by alternate AC sources as defined in this section, nor does it assume a concurrent single failure or design basis accident...' in accordance with Reference 1. In this paper, the innovative features of the AP1000 plant design are described with their operation inmore » the scenario of an extended station blackout event. General operation of the passive safety systems are described as well as the unique features which allow the AP1000 plant to cope for at least 7 days during station blackout. Points of emphasis will include: - Passive safety system operation during SBO - 'Fail-safe' nature of key passive safety system valves; automatically places the valve in a conservatively safe alignment even in case of multiple failures in all power supply systems, including normal AC and battery backup - Passive Spent Fuel Pool cooling and makeup water supply during SBO - Robustness of AP1000 plant due to the location of key systems, structures and components required for Safe Shutdown - Diverse means of supplying makeup water to the Passive Containment Cooling System (PCS) and the Spent Fuel Pool (SFP) through use of an engineered, safety-related piping interface and portable equipment, as well as with permanently installed onsite ancillary equipment. (authors)« less

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

29 CFR 1904.29 - Forms.

Code of Federal Regulations, 2012 CFR

2012-07-01

... to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND... reproductive system; (ii) An injury or illness resulting from a sexual assault; (iii) Mental illnesses; (iv... example, a sexual assault case could be described as “injury from assault,” or an injury to a reproductive...

29 CFR 1904.29 - Forms.

Code of Federal Regulations, 2013 CFR

2013-07-01

... to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND... reproductive system; (ii) An injury or illness resulting from a sexual assault; (iii) Mental illnesses; (iv... example, a sexual assault case could be described as “injury from assault,” or an injury to a reproductive...

Evaluation of Education and Outreach Methods and Strategies - A Case Study of a Web-Based Rail Safety Education Initiative

DOT National Transportation Integrated Search

2014-04-01

The U. S. Department of Transportations (U.S. DOT) Research and Innovative Technology Administrations (RITA) John A. Volpe National Transportation Systems Center (Volpe Center), under the direction of the U.S. DOT Federal Railroad Administratio...

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.

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

Feasibility Study of Alternative Fabrication Methods.

DTIC Science & Technology

1979-08-01

must comply with the I requirements of the latest edition of the National Electrical Code. The Body and Liner Assembly System will comply with I the...latest edition of the National Electrical Code per AMCR 385 (Army Material Command Safety Manual). Also, OSHA’s 1 Occupational Safety and Health...the top of the elevator. On the top and at the rear of * A-4 50 UD( AISA 6 --7 G OVe CASE THOMS ’ON J .7O37IA (PLACES) _ _ -- 3. BAL - 1N-TOS10 12N

Bureaucracy, Safety and Software: a Potentially Lethal Cocktail

NASA Astrophysics Data System (ADS)

Hatton, Les

This position paper identifies a potential problem with the evolution of software controlled safety critical systems. It observes that the rapid growth of bureaucracy in society quickly spills over into rules for behaviour. Whether the need for the rules comes first or there is simple anticipation of the need for a rule by a bureaucrat is unclear in many cases. Many such rules lead to draconian restrictions and often make the existing situation worse due to the presence of unintended consequences as will be shown with a number of examples.

Problems of collaborative work of the automated process control system (APCS) and the its information security and solutions.

NASA Astrophysics Data System (ADS)

Arakelyan, E. K.; Andryushin, A. V.; Mezin, S. V.; Kosoy, A. A.; Kalinina, Ya V.; Khokhlov, I. S.

2017-11-01

The principle of interaction of the specified systems of technological protections by the Automated process control system (APCS) and information safety in case of incorrect execution of the algorithm of technological protection is offered. - checking the correctness of the operation of technological protection in each specific situation using the functional relationship between the monitored parameters. The methodology for assessing the economic feasibility of developing and implementing an information security system.

Supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons.

PubMed

Ichikawa, Nobuki; Homma, Shigenori; Yoshida, Tadashi; Ohno, Yosuke; Kawamura, Hideki; Kamiizumi, You; Iijima, Hiroaki; Taketomi, Akinobu

2018-01-01

The use of laparoscopic colectomy is becoming widespread and acquisition of its technique is challenging. In this study, we investigated whether supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons. The outcomes of 23 right colectomies and 19 high anterior resections for colon cancers performed by five novice surgeons (experience level of <10 cases) between 2014 and 2016 were assessed. A laparoscopic surgeon qualified by the Endoscopic Surgical Skill Qualification System (Japan Society for Endoscopic Surgery) participated in surgeries as the teaching assistant. In the right colectomy group, one patient (4.3%) required conversion to open surgery and postoperative morbidities occurred in two cases (8.6%). The operative time moving average gradually decreased from 216 to 150 min, and the blood loss decreased from 128 to 28 mL. In the CUSUM charts, the values for operative time decreased continuously after the 18th case, as compared to the Japanese standard. The values for blood loss also plateaued after the 18th case. In the high anterior resection group, one patient (5.2%) required conversion to open surgery and no postoperative complication occurred in any patient. The operative time moving average gradually decreased from 258 to 228 min, and the blood loss decreased from 33 to 18 mL. The CUSUM charts showed that the values of operative time plateaued after the 18th case, as compared to the Japanese standard. In the CUSUM chart for blood loss, no distinguishing peak or trend was noted. Supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons. The trainee's learning curve in this study represents successful mentoring by the laparoscopic surgeon qualified by the Endoscopic Surgical Skill Qualification System.

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.

Effectiveness of child safety seats vs seat belts in reducing risk for death in children in passenger vehicle crashes.

PubMed

Elliott, Michael R; Kallan, Michael J; Durbin, Dennis R; Winston, Flaura K

2006-06-01

To provide an estimate of benefit, if any, of child restraint systems over seat belts alone for children aged from 2 through 6 years. Cohort study. A sample of children in US passenger vehicle crashes was obtained from the National Highway Transportation Safety Administration by combining cases involving a fatality from the US Department of Transportation Fatality Analysis Reporting System with a probability sample of cases without a fatality from the National Automotive Sampling System. Children in tow-away [corrected] crashes occurring between 1998 and 2003. Use of child restraint systems (rear-facing and forward-facing car seats, and shield and belt-positioning booster seats) vs seat belts. Potentially confounding variables included seating position, vehicle type, model year, driver and passenger ages, and driver survival status. Death of child passengers from injuries incurred during the crash. Compared with seat belts, child restraints, when not seriously misused (eg, unattached restraint, child restraint system harness not used, 2 children restrained with 1 seat belt) were associated with a 28% reduction in risk for death (relative risk, 0.72; 95% confidence interval, 0.54-0.97) in children aged 2 through 6 years after adjusting for seating position, vehicle type, model year, driver and passenger ages, and driver survival status. When including cases of serious misuse, the effectiveness estimate was slightly lower (21%) (relative risk, 0.79; 95% confidence interval, 0.59-1.05). Based on these findings as well as previous epidemiological and biomechanical evidence for child restraint system effectiveness in reducing nonfatal injury risk, efforts should continue to promote use of child restraint systems through improved laws and with education and disbursement programs.

Temporal Precedence Checking for Switched Models and its Application to a Parallel Landing Protocol

NASA Technical Reports Server (NTRS)

Duggirala, Parasara Sridhar; Wang, Le; Mitra, Sayan; Viswanathan, Mahesh; Munoz, Cesar A.

2014-01-01

This paper presents an algorithm for checking temporal precedence properties of nonlinear switched systems. This class of properties subsume bounded safety and capture requirements about visiting a sequence of predicates within given time intervals. The algorithm handles nonlinear predicates that arise from dynamics-based predictions used in alerting protocols for state-of-the-art transportation systems. It is sound and complete for nonlinear switch systems that robustly satisfy the given property. The algorithm is implemented in the Compare Execute Check Engine (C2E2) using validated simulations. As a case study, a simplified model of an alerting system for closely spaced parallel runways is considered. The proposed approach is applied to this model to check safety properties of the alerting logic for different operating conditions such as initial velocities, bank angles, aircraft longitudinal separation, and runway separation.

Information Extraction for System-Software Safety Analysis: Calendar Year 2007 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2008-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis on the models to identify possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations; 4) perform discrete-time-based simulation on the models to investigate scenarios where these paths may play a role in failures and mishaps; and 5) identify resulting candidate scenarios for software integration testing. This paper describes new challenges in a NASA abort system case, and enhancements made to develop the integrated tool set.

Effect of Neutron Absorbers Mixed in or Coating the Fuel of a 1-MWt Lithium-Cooled Space Reactor

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

Amiri, Benjamin W.; Los Alamos National Laboratory, Los Alamos, NM 87545; Poston, David I.

2005-02-06

The goal of this study was to determine the effect of various neutron poisons (boron, dysprosium, erbium, and gadolinium) on a 1-MWt, lithium-cooled liquid-metal reactor. The isotopes were considered to be in-fuel poisons, as well as poisons coating the fuel. One way to quantify the effectiveness of a poison in meeting accident-condition requirements is by defining the safety margin as the difference between keff at the beginning of life and keff during the accident scenarios. The isotope that showed the most potential in increasing the safety margin for the wet-sand/water case was 157Gd. The safety margin was 10%-20% greater usingmore » 157Gd as an in-fuel poison as opposed to a coating, depending on the poison quantity. However, the most limiting condition (i.e., the accident scenario with the highest keff, thus the lowest safety margin) is when the reactor is submerged in wet sand. None of the isotopes considered significantly affected the safety margin for the dry-sand case. However, the poison isotopes considered may have applicability for meeting the wet-sand/water keff requirements or as burnable poisons in a moderated system. The views expressed in this document are those of the author and do not necessarily reflect agreement by the government.« less

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.

A Real-Time Construction Safety Monitoring System for Hazardous Gas Integrating Wireless Sensor Network and Building Information Modeling Technologies

PubMed Central

Cheung, Weng-Fong; Lin, Tzu-Hsuan; Lin, Yu-Cheng

2018-01-01

In recent years, many studies have focused on the application of advanced technology as a way to improve management of construction safety management. A Wireless Sensor Network (WSN), one of the key technologies in Internet of Things (IoT) development, enables objects and devices to sense and communicate environmental conditions; Building Information Modeling (BIM), a revolutionary technology in construction, integrates database and geometry into a digital model which provides a visualized way in all construction lifecycle management. This paper integrates BIM and WSN into a unique system which enables the construction site to visually monitor the safety status via a spatial, colored interface and remove any hazardous gas automatically. Many wireless sensor nodes were placed on an underground construction site and to collect hazardous gas level and environmental condition (temperature and humidity) data, and in any region where an abnormal status is detected, the BIM model will alert the region and an alarm and ventilator on site will start automatically for warning and removing the hazard. The proposed system can greatly enhance the efficiency in construction safety management and provide an important reference information in rescue tasks. Finally, a case study demonstrates the applicability of the proposed system and the practical benefits, limitations, conclusions, and suggestions are summarized for further applications. PMID:29393887

A literature review of transmission effectiveness and electromagnetic compatibility in home telemedicine environments to evaluate safety and security.

PubMed

Carranza, Noemí; Ramos, Victoria; Lizana, Francisca G; García, Jorge; del Pozo, Alejando; Monteagudo, José Luis

2010-09-01

The objective of this study was to determine already reported cases of transmission/reception failure and interferences to evaluate the safety and security of the new mobile home telemedicine systems. The literature published in the last 10 years (1998-2009) has been reviewed, by searching in several databases. Searches on transmission effectiveness and electromagnetic compatibility were made manually through journals, conference proceedings, and also the healthcare technology assessment agencies' Web pages. Search strategies developed through electronic databases and manual search identified a total of 886 references, with 44 finally being included in the results. They have been divided by technology in the transmission/reception effectiveness studies, and according to the type of medical device in the case of electromagnetic interferences studies. The study reveals that there are numerous publications on telemedicine and home-monitoring systems using wireless networks. However, literature on effectiveness in terms of connectivity and transmission problems and electromagnetic interferences is limited. From the collected studies, it can be concluded that there are transmission failures, low-coverage areas, errors in the transmission of packets, and so on. Moreover, cases of serious interferences in medical instruments have also been reported. These facts highlight the lack of studies and specific recommendations to be followed in the implementation of biomonitoring systems in domestic environments using wireless networks.

75 FR 5997 - Privacy Act of 1974; Systems of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... proposed action will be effective without further notice on March 8, 2010, unless comments are received... entry and replace with ``Employee's name; Social Security Number (SSN) or foreign national number; title..., Social Security Number (SSN), or safety, health, injury, and accident records case number (if known...

Home Energy Saver

Science.gov Websites

up zip code Case Studies Weatherization: Improving Home Safety and Reducing Your Energy Bill home energy efficient? Your House is a System Living Off The Sun, Or, No Electricity Bill Kermit was Cottage Energy Blogs 5 Most Effective Ways to Save on Your Energy Bill Updating Guest Bathroom With Energy

Chemical Safety Alert: Emergency Isolation for Hazardous Material Fluid Transfer Systems - Application and Limitations of Excess Flow Valves

EPA Pesticide Factsheets

While excess flow valves (EFV) are in extensive service and have prevented numerous pipe or hose breaks from becoming much more serious incidents, experience shows that in some cases the EFV did not perform as intended, usually because of misapplication.

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.

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.

Simulation of Range Safety for the NASA Space Shuttle

NASA Technical Reports Server (NTRS)

Rabelo, Luis; Sepulveda, Jose; Compton, Jeppie; Turner, Robert

2005-01-01

This paper describes a simulation environment that seamlessly combines a number of safety and environmental models for the launch phase of a NASA Space Shuttle mission. The components of this simulation environment represent the different systems that must interact in order to determine the Expectation of casualties (E(sub c)) resulting from the toxic effects of the gas dispersion that occurs after a disaster affecting a Space Shuttle within 120 seconds of lift-off. The utilization of the Space Shuttle reliability models, trajectory models, weather dissemination systems, population models, amount and type of toxicants, gas dispersion models, human response functions to toxicants, and a geographical information system are all integrated to create this environment. This simulation environment can help safety managers estimate the population at risk in order to plan evacuation, make sheltering decisions, determine the resources required to provide aid and comfort, and mitigate damages in case of a disaster. This simulation environment may also be modified and used for the landing phase of a space vehicle but will not be discussed in this paper.

Occupational health and safety in China: the case of state-managed enterprises.

PubMed

Chen, Meei-Shia; Chan, Anita

2010-01-01

The widely held image, inside and outside China, of the total absence of an occupational health and safety (OHS) system in that country is not an accurate picture. This article argues that the unsafe working conditions and prevalent occupational diseases and injuries widely reported in the Chinese and foreign media occur mostly in private mines and in the Asian foreign-funded and domestic private manufacturing sectors. In contrast, the capital-intensive, larger state-owned enterprises and enterprises that have been transformed from state enterprises generally have better OHS systems. An in-depth study of two such enterprises reveals viable OHS systems, worker-management OHS committees, regular health and safety inspections, and trade unions' and workers congresses' oversight and supervision. Above all, there is an enterprise culture that regards accidents as avoidable, and both workers and management feel distressed and guilty when accidents happen. The authors believe it is important to acknowledge and champion these positive examples of "best practices" that can be emulated in workplaces throughout China, which is under great pressure from competitive domestic and global forces to relax its OHS standards.

Healthcare system-wide implementation of opioid-safety guideline recommendations: the case of urine drug screening and opioid-patient suicide- and overdose-related events in the Veterans Health Administration.

PubMed

Brennan, Penny L; Del Re, Aaron C; Henderson, Patricia T; Trafton, Jodie A

2016-12-01

This study provides an example of how healthcare system-wide progress in implementation of opioid-therapy guideline recommendations can be longitudinally assessed and then related to subsequent opioid-prescribed patient health and safety outcomes. Using longitudinal linear mixed effects analyses, we determined that in the Department of Veterans Affairs (VA) healthcare system (n = 141 facilities), over the 4-year interval from 2010 to 2013, a key opioid therapy guideline recommendation, urine drug screening (UDS), increased from 29 to 42 %, with an average within-facility increase rate of 4.5 % per year. Higher levels of UDS implementation from 2010 to 2013 were associated with lower risk of suicide and drug overdose events among VA opioid-prescribed patients in 2013, even after adjusting for patients' 2012 demographic characteristics and medical and mental health comorbidities. Findings suggest that VA clinicians and healthcare policymakers have been responsive to the 2010 VA/Department of Defense (DOD) UDS treatment guideline recommendation, resulting in improved patient safety for VA opioid-prescribed patients.

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.

A strategy for systemic toxicity assessment based on non-animal approaches: The Cosmetics Europe Long Range Science Strategy programme.

PubMed

Desprez, Bertrand; Dent, Matt; Keller, Detlef; Klaric, Martina; Ouédraogo, Gladys; Cubberley, Richard; Duplan, Hélène; Eilstein, Joan; Ellison, Corie; Grégoire, Sébastien; Hewitt, Nicola J; Jacques-Jamin, Carine; Lange, Daniela; Roe, Amy; Rothe, Helga; Blaauboer, Bas J; Schepky, Andreas; Mahony, Catherine

2018-08-01

When performing safety assessment of chemicals, the evaluation of their systemic toxicity based only on non-animal approaches is a challenging objective. The Safety Evaluation Ultimately Replacing Animal Test programme (SEURAT-1) addressed this question from 2011 to 2015 and showed that further research and development of adequate tools in toxicokinetic and toxicodynamic are required for performing non-animal safety assessments. It also showed how to implement tools like thresholds of toxicological concern (TTCs) and read-across in this context. This paper shows a tiered scientific workflow and how each tier addresses the four steps of the risk assessment paradigm. Cosmetics Europe established its Long Range Science Strategy (LRSS) programme, running from 2016 to 2020, based on the outcomes of SEURAT-1 to implement this workflow. Dedicated specific projects address each step of this workflow, which is introduced here. It tackles the question of evaluating the internal dose when systemic exposure happens. The applicability of the workflow will be shown through a series of case studies, which will be published separately. Even if the LRSS puts the emphasis on safety assessment of cosmetic relevant chemicals, it remains applicable to any type of chemical. Copyright © 2018. Published by Elsevier Ltd.

AP1000{sup R} nuclear power plant safety overview for spent fuel cooling

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

Gorgemans, J.; Mulhollem, L.; Glavin, J.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe class pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and costs. The AP1000 design uses passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems such as AC power, component cooling water, service water or HVAC. Furthermore, these passive features 'fail safe' during a non-LOCA event such that DC power and instrumentation are not required. The AP1000 also has simple, active, defense-in-depth systems to support normal plant operations. These active systems provide the first levelmore » of defense against more probable events and they provide investment protection, reduce the demands on the passive features and support the probabilistic risk assessment. The AP1000 passive safety approach allows the plant to achieve and maintain safe shutdown in case of an accident for 72 hours without operator action, meeting the expectations provided in the U.S. Utility Requirement Document and the European Utility Requirements for passive plants. Limited operator actions are required to maintain safe conditions in the spent fuel pool via passive means. In line with the AP1000 approach to safety described above, the AP1000 plant design features multiple, diverse lines of defense to ensure spent fuel cooling can be maintained for design-basis events and beyond design-basis accidents. During normal and abnormal conditions, defense-in-depth and other systems provide highly reliable spent fuel pool cooling. They rely on off-site AC power or the on-site standby diesel generators. For unlikely design basis events with an extended loss of AC power (i.e., station blackout) or loss of heat sink or both, spent fuel cooling can still be provided indefinitely: - Passive systems, requiring minimal or no operator actions, are sufficient for at least 72 hours under all possible pool heat load conditions. - After 3 days, several different means are provided to continue spent fuel cooling using installed plant equipment as well as off-site equipment with built-in connections. Even for beyond design basis accidents with postulated pool damage and multiple failures in the passive safety-related systems and in the defense-in-depth active systems, the AP1000 multiple spent fuel pool spray and fill systems provide additional lines of defense to prevent spent fuel damage. (authors)« less

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...

Catheter radiofrequency ablation for arrhythmias under the guidance of the Carto 3 three-dimensional mapping system in an operating room without digital subtraction angiography.

PubMed

Huang, Xingfu; Chen, Yanjia; Huang, Zheng; He, Liwei; Liu, Shenrong; Deng, Xiaojiang; Wang, Yongsheng; Li, Rucheng; Xu, Dingli; Peng, Jian

2018-06-01

Several studies have reported the efficacy of a zero-fluoroscopy approach for catheter radiofrequency ablation of arrhythmias in a digital subtraction angiography (DSA) room. However, no reports are available on the ablation of arrhythmias in the absence of DSA in the operating room. To investigate the efficacy and safety of catheter radiofrequency ablation for arrhythmias under the guidance of a Carto 3 three-dimensional (3D) mapping system in an operating room without DSA. Patients were enrolled according to the type of arrhythmia. The Carto 3 mapping system was used to reconstruct heart models and guide the electrophysiologic examination, mapping, and ablation. The total procedure, reconstruction, electrophysiologic examination, and mapping times were recorded. Furthermore, immediate success rates and complications were also recorded. A total of 20 patients were enrolled, including 12 males. The average age was 51.3 ± 17.2 (19-76) years. Nine cases of atrioventricular nodal re-entrant tachycardia, 7 cases of frequent ventricular premature contractions, 3 cases of Wolff-Parkinson-White syndrome, and 1 case of typical atrial flutter were included. All arrhythmias were successfully ablated. The procedure time was 127.0 ± 21.0 (99-177) minutes, the reconstruction time was 6.5 ± 2.9 (3-14) minutes, the electrophysiologic study time was 10.4 ± 3.4 (6-20) minutes, and the mapping time was 11.7 ± 8.3 (3-36) minutes. No complications occurred. Radiofrequency ablation of arrhythmias without DSA is effective and feasible under the guidance of the Carto 3 mapping system. However, the electrophysiology physician must have sufficient experience, and related emergency measures must be present to ensure safety.

The natural lifespan of a safety policy: violations and system migration in anaesthesia.

PubMed

de Saint Maurice, Guillaume; Auroy, Yves; Vincent, Charles; Amalberti, René

2010-08-01

Safety rules continue growing rapidly, as if constraining human behaviour was the unique avenue for reaching ultimate safety. Safety rules are essential for a safe system, but their multiplication can have counterproductive effects. To monitor, in an anaesthesia ward, compliance with a process-oriented safety rule, and understand barriers and facilitators which help and hinder physicians from following guidelines. The rule stipulated that the day before surgery anaesthetists had to record in the patient's file the drugs to be used for the anaesthesia (induction, maintenance, airway control). Compliance was assessed before introduction of the rule, immediately after, at 6 months and at 12 months. All medical staff were blinded to the protocol. 717 patient records were included. The results showed an initial compliance with policy, reaching 86% for some items (never 100%). Reduction began within 6 months and returned almost to initial levels within a year. One individual showed poor compliance throughout the study but even initially compliant doctors experienced a reduction. Compliance was higher for complex surgery but lower for unscheduled surgery and when job pressure was greater. Compliance eroded over time. A major trigger of erosion seemed to be lack of continued compliance by a senior member of staff. Rules and procedures constitute fragile safety barriers, and it may be better to forego introducing a new safety rule if it is not considered as a priority by staff and is therefore vulnerable to sacrifice in case of conflict with competitive demands.

The World Trade Center bombing: injury prevention strategies for high-rise building fires.

PubMed

Quenemoen, L E; Davis, Y M; Malilay, J; Sinks, T; Noji, E K; Klitzman, S

1996-06-01

The WTC disaster provided an opportunity to look for ways to prevent morbidity among occupants of high-rise buildings during fires. This paper first describes the overall morbidity resulting from the explosion and fire, and second, presents the results of a case-control study carried out to identify risk factors for smoke-related morbidity. The main ones include: increased age, presence of a pre-existing cardio-pulmonary condition, entrapment in a lift and prolonged evacuation time. Study results point to the importance of the following safety systems during high-rise building fires: smoke-control systems with separate emergency power sources; lift-cars, lift-car position-monitoring systems, and lift-car communication systems with separate emergency power sources; two-way emergency communication systems on all floors and in stairwells; stairwells with emergency lighting and designed for the rapid egress of crowds; evacuation systems/equipment to assist in the evacuation of vulnerable people (elderly, infirm). Also important are evacuation plans that include regularly scheduled safety training and evacuation drills.

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.

An evaluation of learning clinical decision-making for early rehabilitation in the ICU via interactive education with audience response system.

PubMed

Toonstra, Amy L; Nelliot, Archana; Aronson Friedman, Lisa; Zanni, Jennifer M; Hodgson, Carol; Needham, Dale M

2017-06-01

Knowledge-related barriers to safely implement early rehabilitation programs in intensive care units (ICUs) may be overcome via targeted education. The purpose of this study was to evaluate the effectiveness of an interactive educational session on short-term knowledge of clinical decision-making for safe rehabilitation of patients in ICUs. A case-based teaching approach, drawing from published safety recommendations for initiation of rehabilitation in ICUs, was used with a multidisciplinary audience. An audience response system was incorporated to promote interaction and evaluate knowledge before vs. after the educational session. Up to 175 audience members, of 271 in attendance (129 (48%) physical therapists, 51 (19%) occupational therapists, 31 (11%) nursing, 14 (5%) physician, 46 (17%) other), completed both the pre- and post-test questions for each of the six unique patient cases. In four of six patient cases, there was a significant (p< 0.001) increase in identifying the correct answer regarding initiation of rehabilitation activities. This learning effect was similar irrespective of participants' years of experience and clinical discipline. An interactive, case-based, educational session may be effective for increasing short-term knowledge, and identifying knowledge gaps, regarding clinical decision-making for safe rehabilitation of patients in ICUs. Implications for Rehabilitation Lack of knowledge regarding the safety considerations for early rehabilitation of ICU patients is a barrier to implementing early rehabilitation. Interactive educational formats, such as the use of audience response systems, offer a new method of teaching and instantly assessing learning of clinically important information. In a small study, we have shown that an interactive, case-based educational format may be used to effectively teach clinical decision-making for the safe rehabilitation of ICU patients to a diverse audience of clinicians.

Electromagnetic compatibility and safety design of a patient compliance-free, inductive implant charger.

PubMed

Theodoridis, Michael P; Mollov, Stefan V

2014-10-01

This article presents the design of a domestic, radiofrequency induction charger for implants toward compliance with the Federal Communications Commission safety and electromagnetic compatibility regulations. The suggested arrangement does not impose any patient compliance requirements other than the use of a designated bed for night sleep, and therefore can find a domestic use. The method can be applied to a number of applications; a rechargeable pacemaker is considered as a case study. The presented work has proven that it is possible to realize a fully compliant inductive charging system with minimal patient interaction, and has generated important information for consideration by the designers of inductive charging systems. Experimental results have verified the validity of the theoretical findings.

Lightning threat extent of a small thunderstorm

NASA Technical Reports Server (NTRS)

Nicholson, James R.; Maier, Launa M.; Weems, John

1988-01-01

The concern for safety of the personnel at the Kennedy Space Center (KSC) has caused NASA to promulgate strict safety procedures requiring either termination or substantial curtailment when ground lightning threat is believed to exist within 9.3 km of a covered operation. In cases where the threat is overestimated, in either space or time, an opportunity cost is accrued. This paper describes a small thunderstorm initiated over the KSC by terrain effects, that serves to exemplify the impact such an event may have on ground operations at the Center. Data from the Air Force Lightning Location and Protection System, the AF/NASA Launch Pad Lightning Warning System field mill network, radar, and satellite imagery are used to describe the thunderstorm and to discuss its impact.

UAS Conflict-Avoidance Using Multiagent RL with Abstract Strategy Type Communication

NASA Technical Reports Server (NTRS)

Rebhuhn, Carrie; Knudson, Matt; Tumer, Kagan

2014-01-01

The use of unmanned aerial systems (UAS) in the national airspace is of growing interest to the research community. Safety and scalability of control algorithms are key to the successful integration of autonomous system into a human-populated airspace. In order to ensure safety while still maintaining efficient paths of travel, these algorithms must also accommodate heterogeneity of path strategies of its neighbors. We show that, using multiagent RL, we can improve the speed with which conflicts are resolved in cases with up to 80 aircraft within a section of the airspace. In addition, we show that the introduction of abstract agent strategy types to partition the state space is helpful in resolving conflicts, particularly in high congestion.

Announced Strategy Types in Multiagent RL for Conflict-Avoidance in the National Airspace

NASA Technical Reports Server (NTRS)

Rebhuhn, Carrie; Knudson, Matthew D.; Tumer, Kagan

2014-01-01

The use of unmanned aerial systems (UAS) in the national airspace is of growing interest to the research community. Safety and scalability of control algorithms are key to the successful integration of autonomous system into a human-populated airspace. In order to ensure safety while still maintaining efficient paths of travel, these algorithms must also accommodate heterogeneity of path strategies of its neighbors. We show that, using multiagent RL, we can improve the speed with which conflicts are resolved in cases with up to 80 aircraft within a section of the airspace. In addition, we show that the introduction of abstract agent strategy types to partition the state space is helpful in resolving conflicts, particularly in high congestion.

The electromagnetic environment of Magnetic Resonance Imaging systems. Occupational exposure assessment reveals RF harmonics

NASA Astrophysics Data System (ADS)

Gourzoulidis, G.; Karabetsos, E.; Skamnakis, N.; Kappas, C.; Theodorou, K.; Tsougos, I.; Maris, T. G.

2015-09-01

Magnetic Resonance Imaging (MRI) systems played a crucial role in the postponement of the former occupational electromagnetic fields (EMF) European Directive (2004/40/EC) and in the formation of the latest exposure limits adopted in the new one (2013/35/EU). Moreover, the complex MRI environment will be finally excluded from the implementation of the new occupational limits, leading to an increased demand for Occupational Health and Safety (OHS) surveillance. The gradient function of MRI systems and the application of the RF excitation frequency result in low and high frequency exposures, respectively. This electromagnetic field exposure, in combination with the increased static magnetic field exposure, makes the MRI environment a unique case of combined EMF exposure. The electromagnetic field levels in close proximity of different MRI systems have been assessed at various frequencies. Quality Assurance (QA) & safety issues were also faced. Preliminary results show initial compliance with the forthcoming limits in each different frequency band, but also revealed peculiar RF harmonic components, of no safety concern, to the whole range detected (20-1000MHz). Further work is needed in order to clarify their origin and characteristics.

A quantitative risk-assessment system (QR-AS) evaluating operation safety of Organic Rankine Cycle using flammable mixture working fluid.

PubMed

Tian, Hua; Wang, Xueying; Shu, Gequn; Wu, Mingqiang; Yan, Nanhua; Ma, Xiaonan

2017-09-15

Mixture of hydrocarbon and carbon dioxide shows excellent cycle performance in Organic Rankine Cycle (ORC) used for engine waste heat recovery, but the unavoidable leakage in practical application is a threat for safety due to its flammability. In this work, a quantitative risk assessment system (QR-AS) is established aiming at providing a general method of risk assessment for flammable working fluid leakage. The QR-AS covers three main aspects: analysis of concentration distribution based on CFD simulations, explosive risk assessment based on the TNT equivalent method and risk mitigation based on evaluation results. A typical case of propane/carbon dioxide mixture leaking from ORC is investigated to illustrate the application of QR-AS. According to the assessment results, proper ventilation speed, safe mixture ratio and location of gas-detecting devices have been proposed to guarantee the security in case of leakage. The results revealed that this presented QR-AS was reliable for the practical application and the evaluation results could provide valuable guidance for the design of mitigation measures to improve the safe performance of ORC system. Copyright © 2017 Elsevier B.V. All rights reserved.

Impact of revising the National Nosocomial Infection Surveillance System definition for catheter-related bloodstream infection in ICU: reproducibility of the National Healthcare Safety Network case definition in an Australian cohort of infection control professionals.

PubMed

Worth, Leon J; Brett, Judy; Bull, Ann L; McBryde, Emma S; Russo, Philip L; Richards, Michael J

2009-10-01

Effective and comparable surveillance for central venous catheter-related bloodstream infections (CLABSIs) in the intensive care unit requires a reproducible case definition that can be readily applied by infection control professionals. Using a questionnaire containing clinical cases, reproducibility of the National Nosocomial Infection Surveillance System (NNIS) surveillance definition for CLABSI was assessed in an Australian cohort of infection control professionals participating in the Victorian Hospital Acquired Infection Surveillance System (VICNISS). The same questionnaire was then used to evaluate the reproducibility of the National Healthcare Safety Network (NHSN) surveillance definition for CLABSI. Target hospitals were defined as large metropolitan (1A) or other large hospitals (non-1A), according to the Victorian Department of Human Services. Questionnaire responses of Centers for Disease Control and Prevention NHSN surveillance experts were used as gold standard comparator. Eighteen of 21 eligible VICNISS centers participated in the survey. Overall concordance with the gold standard was 57.1%, and agreement was highest for 1A hospitals (60.6%). The proportion of congruently classified cases varied according to NNIS criteria: criterion 1 (recognized pathogen), 52.8%; criterion 2a (skin contaminant in 2 or more blood cultures), 83.3%; criterion 2b (skin contaminant in 1 blood culture and appropriate antimicrobial therapy instituted), 58.3%; non-CLABSI cases, 51.4%. When survey questions regarding identification of cases of CLABSI criterion 2b were removed (consistent with the current NHSN definition), overall percentage concordance increased to 62.5% (72.2% for 1A centers). Further educational interventions are required to improve the discrimination of primary and secondary causes of bloodstream infection in Victorian intensive care units. Although reproducibility of the CLABSI case definition is relatively poor, adoption of the revised NHSN definition for CLABSI is likely to improve the concordance of Victorian data with international centers.

Human factors in command and control for the Los Angeles Fire Department.

PubMed

Harper, W R

1974-03-01

Ergonomics owes much of its operations and systems heritage to military research. Since public safety systems such as police, fire departments and civil defence organisations are quasi-military in nature, one may reasonably use the findings from military ergonomics research to extrapolate design data for use in a decision-making system. This article discusses a case study concerning Human Factors in command and control for the Los Angeles Fire Department. The case involved transfer from a manual dispatch system involving three geographic areas of metropolitan Los Angeles to one central computer-aided command and control system. Comments are made on console mock-ups, environmental factors in the Control Centre placement of the consoles. Because of extreme delays in procurement of the recommended hardware it is doubtful that empirical testing of the ergonomics aspect of the system will take place.

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

PubMed

Li, Zhaojian; Kolmanovsky, Ilya; Atkins, Ella; Lu, Jianbo; Filev, Dimitar P; Michelini, John

2016-11-01

This paper presents a safety-based route planner that exploits vehicle-to-cloud-to-vehicle (V2C2V) connectivity. Time and road risk index (RRI) are considered as metrics to be balanced based on user preference. To evaluate road segment risk, a road and accident database from the highway safety information system is mined with a hybrid neural network model to predict RRI. Real-time factors such as time of day, day of the week, and weather are included as correction factors to the static RRI prediction. With real-time RRI and expected travel time, route planning is formulated as a multiobjective network flow problem and further reduced to a mixed-integer programming problem. A V2C2V implementation of our safety-based route planning approach is proposed to facilitate access to real-time information and computing resources. A real-world case study, route planning through the city of Columbus, Ohio, is presented. Several scenarios illustrate how the "best" route can be adjusted to favor time versus safety metrics.

Safe use of electronic health records and health information technology systems: trust but verify.

PubMed

Denham, Charles R; Classen, David C; Swenson, Stephen J; Henderson, Michael J; Zeltner, Thomas; Bates, David W

2013-12-01

We will provide a context to health information technology systems (HIT) safety hazards discussions, describe how electronic health record-computer prescriber order entry (EHR-CPOE) simulation has already identified unrecognized hazards in HIT on a national scale, helping make EHR-CPOE systems safer, and we make the case for all stakeholders to leverage proven methods and teams in HIT performance verification. A national poll of safety, quality improvement, and health-care administrative leaders identified health information technology safety as the hazard of greatest concern for 2013. Quality, HIT, and safety leaders are very concerned about technology performance risks as addressed in the Health Information Technology and Patient Safety report of the Institute of Medicine; and these are being addressed by the Office of the National Coordinator of HIT of the U.S. Dept. of Human Services in their proposed plans. We describe the evolution of postdeployment testing of HIT performance, including the results of national deployment of Texas Medical Institute of Technology's electronic health record computer prescriber order entry (TMIT EHR-CPOE) Flight Simulator verification test that is addressed in these 2 reports, and the safety hazards of concern to leaders. A global webinar for health-care leaders addressed the top patient safety hazards in the areas of leadership, practices, and technologies. A poll of 76 of the 221 organizations participating in the webinar revealed that HIT hazards were the participants' greatest concern of all 30 hazards presented. Of those polled, 89% rated HIT patient/data mismatches in EHRs and HIT systems as a 9 or 10 on a scale of 1 to 10 as a hazard of great concern. Review of a key study of postdeployment testing of the safety performance of operational EHR systems with CPOE implemented in 62 hospitals, using the TMIT EHR-CPOE simulation tool, showed that only 53% of the medication orders that could have resulted in fatalities were detected. The study also showed significant variability in the performance of specific EHR vendor systems, with the same vendor product scoring as high as a 75% detection score in one health-care organization, and the same vendor system scoring below 10% in another health-care organization. HIT safety hazards should be taken very seriously, and the need for proven, robust, and regular postdeployment performance verification measurement of EHR system operations in every health-care organization is critical to ensure that these systems are safe for every patient. The TMIT EHR-CPOE flight simulator is a well-tested and scalable tool that can be used to identify performance gaps in EHR and other HIT systems. It is critical that suppliers, providers, and purchasers of health-care partner with HIT stakeholders and leverage the existing body of work, as well as expert teams and collaborative networks to make care safer; and public-private partnerships to accelerate safety in HIT. A global collaborative is already underway incorporating a "trust but verify" philosophy.

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

PubMed

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

2012-06-01

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

Using Smart Pumps to Understand and Evaluate Clinician Practice Patterns to Ensure Patient Safety

PubMed Central

Mansfield, Jennifer; Jarrett, Steven

2013-01-01

Background: Safety software installed on intravenous (IV) infusion pumps has been shown to positively impact the quality of patient care through avoidance of medication errors. The data derived from the use of smart pumps are often overlooked, although these data provide helpful insight into the delivery of quality patient care. Objective: The objectives of this report are to describe the value of implementing IV infusion safety software and analyzing the data and reports generated by this system. Case study: Based on experience at the Carolinas HealthCare System (CHS), executive score cards provide an aggregate view of compliance rate, number of alerts, overrides, and edits. The report of serious errors averted (ie, critical catches) supplies the location, date, and time of the critical catch, thereby enabling management to pinpoint the end-user for educational purposes. By examining the number of critical catches, a return on investment may be calculated. Assuming 3,328 of these events each year, an estimated cost avoidance would be $29,120,000 per year for CHS. Other reports allow benchmarking between institutions. Conclusion: A review of the data about medication safety across CHS has helped garner support for a medication safety officer position with the goal of ultimately creating a safer environment for the patient. PMID:24474836

Ionospheric threats to the integrity of airborne GPS users

NASA Astrophysics Data System (ADS)

Datta-Barua, Seebany

The Global Positioning System (GPS) has both revolutionized and entwined the worlds of aviation and atmospheric science. As the largest and most unpredictable source of GPS positioning error, the ionospheric layer of the atmosphere, if left unchecked, can endanger the safety, or "integrity," of the single frequency airborne user. An augmentation system is a differential-GPS-based navigation system that provides integrity through independent ionospheric monitoring by reference stations. However, the monitor stations are not in general colocated with the user's GPS receiver. The augmentation system must protect users from possible ionosphere density variations occurring between its measurements and the user's. This study analyzes observations from ionospherically active periods to identify what types of ionospheric disturbances may cause threats to user safety if left unmitigated. This work identifies when such disturbances may occur using a geomagnetic measure of activity and then considers two disturbances as case studies. The first case study indicates the need for a non-trivial threat model for the Federal Aviation Administration's Local Area Augmentation System (LAAS) that was not known prior to the work. The second case study uses ground- and space-based data to model an ionospheric disturbance of interest to the Federal Aviation Administration's Wide Area Augmentation System (WAAS). This work is a step in the justification for, and possible future refinement of, one of the WAAS integrity algorithms. For both WAAS and LAAS, integrity threats are basically caused by events that may be occurring but are unobservable. Prior to the data available in this solar cycle, events of such magnitude were not known to be possible. This work serves as evidence that the ionospheric threat models developed for WARS and LAAS are warranted and that they are sufficiently conservative to maintain user integrity even under extreme ionospheric behavior.

The Food Safety Modernization Act: a barrier to trade? Only if the science says so.

PubMed

McNeill, Naomi

2012-01-01

The Food Safety Modernization Act improves oversight of America's food safety system. Title III, which regulates imported food, may create extra burdens for importers and therefore act as a barrier to trade. What will be on trial before the World Trade Organization (WTO), however, is not the law's content, but the science supporting it. Under the WTO regime, food safety laws that could restrict the free movement of food commodities must be sufficiently justified by scientific evidence. Member states must engage in risk assessments and regulate food imports in a manner that is "no more restrictive than necessary" to protect against the health risks identified by scientific evidence. This article examines the requirements of the WTO to evaluate the FSMA's legality under WTO rules. It analyzes the case law of the WTO Panel and Appellate Body and compares the FMSA to the EU's General Food Law.

A COMPARATIVE ANALYSIS BETWEEN FRANCE AND JAPAN ON LOCAL GOVERNMENTS' INVOLVEMENT IN NUCLEAR SAFETY GOVERNANCE

NASA Astrophysics Data System (ADS)

Sugawara, Shin-Etsu; Shiroyama, Hideaki

This paper shows a comparative analysis between France and Japan on the way of the local governments' involvement in nuclear safety governance through some interviews. In France, a law came into force that requires related local governments to establish "Commision Locale d'Information" (CLI), which means the local governments officially involve in nuclear regulatory activity. Meanwhile, in Japan, related local governments substantially involve in the operation of nuclear facilities through the "safety agreements" in spite of the lack of legal authority. As a result of comparative analysis, we can point out some institutional input from French cases as follows: to clarify the local governments' roles in the nuclear regulation system, to establish the official channels of communication among nuclear utilities, national regulatory authorities and local governments, and to stipulate explicitly the transparency as a purpose of safety regulation.

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.

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

PubMed

Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

2010-03-01

Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population. To assess the feasibility of using proactive monitoring of an electronic medical record system, in combination with an independent endpoint adjudication committee, to detect adverse events among users of selected drugs. UK General Practice Research Database (GPRD) information was used to detect acute liver disorder associated with the use of amoxicillin/clavulanic acid (hepatotoxic) or low-dose aspirin (acetylsalicylic acid [non-hepatotoxic]). Individuals newly prescribed these drugs between 1 October 2005 and 31 March 2006 were identified. Acute liver disorder cases were assessed using GPRD computer records in combination with case validation by an independent endpoint adjudication committee. Signal generation thresholds were based on the background rate of acute liver disorder in the general population. Over a 6-month period, 8148 patients newly prescribed amoxicillin/clavulanic acid and 5577 patients newly prescribed low-dose aspirin were identified. Within this cohort, searches identified 11 potential liver disorder cases from computerized records: six for amoxicillin/clavulanic acid and five for low-dose aspirin. The independent endpoint adjudication committee refined this to four potential acute liver disorder cases for whom paper-based information was requested for final case assessment. Final case assessments confirmed no cases of acute liver disorder. The time taken for this study was 18 months (6 months for recruitment and 12 months for data management and case validation). To reach the estimated target exposure necessary to raise or rule out a signal of concern to public health, we determined that a recruitment period 2-3 times longer than that used in this study would be required. Based on the real market uptake of six commonly used medicinal products launched between 2001 and 2006 in the UK (budesonide/eformoterol [fixed-dose combination], duloxetine, ezetimibe, metformin/rosiglitazone [fixed-dose combination], tiotropium bromide and tadalafil) the target exposure would not have been reached until the fifth year of marketing using a single database. It is feasible to set up a system that actively monitors drug safety using a healthcare database and an independent endpoint adjudication committee. However, future successful implementation will require multiple databases to be queried so that larger study populations are included. This requires further development and harmonization of international healthcare databases.

Diffusing aviation innovations in a hospital in The Netherlands.

PubMed

de Korne, Dirk F; van Wijngaarden, Jeroen D H; Hiddema, U Frans; Bleeker, Fred G; Pronovost, Peter J; Klazinga, Niek S

2010-08-01

Many authors have advocated the diffusion of innovations from other high-risk industries into health care to improve safety. The aviation industry is comparable to health care because of its similarities in (a) the use of technology, (b) the requirement of highly specialized professional teams, and (c) the existence of risk and uncertainties. For almost 20 years, The Rotterdam Eye Hospital (Rotterdam, the Netherlands) has been engaged in diffusing several innovations adapted from aviation. A case-study methodology was used to assess the application of innovations in the hospital, with a focus on the context and the detailed mechanism for each innovation. Data on hospital performance outcomes were abstracted from the hospital information data management system, quality and safety reports, and the incident reporting system. Information on the innovations was obtained from a document search; observations; and semistructured, face-to-face interviews. Aviation industry-based innovations diffused into patient care processes were as follows: patient planning and booking system, taxi service/valet parking, risk analysis (as applied to wrong-site surgery), time-out procedure (also for wrong-site surgery), Crew Resource Management training, and black box. Observations indicated that the innovations had a positive effect on quality and safety in the hospital: Waiting times were reduced, work processes became more standardized, the number of wrong-site surgeries decreased, and awareness of patient safety was heightened. A near-20-year experience with aviation-based innovation suggests that hospitals start with relatively simple innovations and use a systematic approach toward the goal of improving safety.

Multi-Center Pilot Study to Evaluate the Safety Pro le of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis.

PubMed

Cohen, Joel L; Weiner, Steven F; Pozner, Jason N; Ibrahimi, Omar A; Vasily, David B; Ross, E Victor; Gabriel, Zena

2016-11-01

In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime. J Drugs Dermatol. 2016;15(11):1308-1312..

Nasogastric feeding tube located in the lung. SENSAR case of the trimester.

PubMed

2017-01-01

A clinical case is presented that was communicated to Spanish Notification System on Safety in Anaesthesia and Recovery (SENSAR). Using this communication and its analysis, a strategy is obtained in order to reduce the risks associated with the insertion of a nasogastric tube (NST) for enteral nutrition in adult patients in the post-surgical recovery unit. A description of the incident is presented, an analysis of its causes, and the measures that were introduced in order to avoid similar incidents in the future, as well as to promote a safety culture in the organisation. A description of associated incidents registered in SENSAR is also given. The aim of this work is to describe, analyse and introduce safety measures arising from incidents notified to SENSAR, associated with the insertion and checking of the nutrition NST in adult patients in the post-surgical recovery unit. Copyright © 2016 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

PubMed

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.

Safety inspections in construction sites: A systems thinking perspective.

PubMed

Saurin, Tarcisio Abreu

2016-08-01

Although safety inspections carried out by government officers are important for the prevention of accidents, there is little in-depth knowledge on their outcomes and processes leading to these. This research deals with this gap by using systems thinking (ST) as a lens for obtaining insights into safety inspections in construction sites. Thirteen case studies of sites with prohibited works were carried out, discussing how four attributes of ST were used in the inspections. The studies were undertaken over 6 years, and sources of evidence involved participant observation, direct observations, analysis of documents and interviews. Two complementary ways for obtaining insights into inspections, based on ST, were identified: (i) the design of the study itself needs to be in line with ST; and (ii) data collection and analysis should focus on the agents involved in the inspections, the interactions between agents, the constraints and opportunities faced by agents, the outcomes of interactions, and the recommendations for influencing interactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Use of 1540nm fractionated erbium:glass laser for split skin graft resurfacing: a case study.

PubMed

Narinesingh, S; Lewis, S; Nayak, B S

2013-09-01

The field of laser skin resurfacing has evolved rapidly over the past two decades from ablative lasers, to nonablative systems using near-infrared, intense-pulsed light and radio-frequency systems, and most recently fractional laser resurfacing. Although fractional thermolysis is still in its infancy, its efficacy in in the treatment of skin disorders have been clearly demonstrated. Here we present a case report on the safety and efficacy of a 1540nm erbium:glass laser in the treatment of the waffle pattern of a meshed skin graft in a 38-year-old patient with type V skin in the Caribbean.

SFTYCHEF: A Consultative, Diagnostic Expert System for Trench Excavation Safety Analysis on Light Commercial Construction Projects.

DTIC Science & Technology

1987-03-30

Safe Trench Excavation ...... 2 Applicability to Solution via Expert System. 3 Background: Expert Systems ..................... 4 Definition of an...trench, drownings in the trench, and other mishaps which are the result of a lack of S C- proper consideration for safe construction practices. Although...the problem is not a new one, there is as yet no *" obvious method that will guarantee a safe trench. In addition, the expertise needed to provide case

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.

Investigations on optimization of accident management measures following a station blackout accident in a VVER-1000 pressurized water reactor

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

Tusheva, P.; Schaefer, F.; Kliem, S.

2012-07-01

The reactor safety issues are of primary importance for preserving the health of the population and ensuring no release of radioactivity and fission products into the environment. A part of the nuclear research focuses on improvement of the safety of existing nuclear power plants. Studies, research and efforts are a continuing process at improving the safety and reliability of existing and newly developed nuclear power plants at prevention of a core melt accident. Station blackout (loss of AC power supply) is one of the dominant accidents taken into consideration at performing accident analysis. In case of multiple failures of safetymore » systems it leads to a severe accident. To prevent an accident to turn into a severe one or to mitigate the consequences, accident management measures must be performed. The present paper outlines possibilities for application and optimization of accident management measures following a station blackout accident. Assessed is the behaviour of the nuclear power plant during a station blackout accident without accident management measures and with application of primary/secondary side oriented accident management measures. Discussed are the possibilities for operators ' intervention and the influence of the performed accident management measures on the course of the accident. Special attention has been paid to the effectiveness of the passive feeding and physical phenomena having an influence on the system behaviour. The performed simulations show that the effectiveness of the secondary side feeding procedure can be limited due to an early evaporation or flashing effects in the feed water system. The analyzed cases show that the effectiveness of the accident management measures strongly depends on the initiation criteria applied for depressurization of the reactor coolant system. (authors)« less

Evidence-based analysis of field testing of medical electrical equipment.

PubMed

Taktak, A G; Brown, M C

2006-01-01

Field testing of medical electrical equipment remains a topic of debate amongst biomedical engineers. A questionnaire was circulated among members of the main professional body for Medical Engineering Departments in the UK and Ireland and in the Medical Physics and Engineering Mailbase Server. The aim of the questionnaire was to establish consensus on common practice on the frequency and type of safety tests carried out in the field and common sources of hazards and risk management. Twenty-six replies were received in total. A clear majority of 54% of the respondents reported that they carried out safety tests on hospital-based medical equipment on a yearly basis. For other equipment, regular tests were carried out by 58% on loan equipment and by 69% on medical electrical systems. Laboratory equipment on the other hand were not tested in 42% of the cases. Domiciliary and research equipment were only tested in 11% and 15% of the cases respectively. A clear majority of 93% said that they label equipment after tests, 34% said that they always record the actual values (as opposed to pass or fail) and 54% said they carry out functional test as part of the safety test. Although 61% of failures were attributed to the mains lead, only 50% of the respondents said that they had a management system in place for detachable mains leads.

NASA's Spaceliner 100 Investment Area Technology Activities

NASA Technical Reports Server (NTRS)

Hueter, Uwe; Lyles, Garry M. (Technical Monitor)

2001-01-01

NASA's has established long term goals for access-to-space. The third generation launch systems are to be fully reusable and operational around 2025. The goals for the third generation launch system are to reduce cost by a factor of 100 and improve safety by a factor of 10,000 over current conditions. The Advanced Space Transportation Program Office (ASTP) at the NASA's Marshall Space Flight Center in Huntsville, AL has the agency lead to develop space transportation technologies. Within ASTP, under the Spaceliner100 Investment Area, third generation technologies are being pursued in the areas of propulsion, airframes, integrated vehicle health management (IVHM), launch systems, and operations and range. The ASTP program will mature these technologies through ground system testing. Flight testing where required, will be advocated on a case by case basis.

Physics-of-Failure Approach to Prognostics

NASA Technical Reports Server (NTRS)

Kulkarni, Chetan S.

2017-01-01

As more and more electric vehicles emerge in our daily operation progressively, a very critical challenge lies in accurate prediction of the electrical components present in the system. In case of electric vehicles, computing remaining battery charge is safety-critical. In order to tackle and solve the prediction problem, it is essential to have awareness of the current state and health of the system, especially since it is necessary to perform condition-based predictions. To be able to predict the future state of the system, it is also required to possess knowledge of the current and future operations of the vehicle. In this presentation our approach to develop a system level health monitoring safety indicator for different electronic components is presented which runs estimation and prediction algorithms to determine state-of-charge and estimate remaining useful life of respective components. Given models of the current and future system behavior, the general approach of model-based prognostics can be employed as a solution to the prediction problem and further for decision making.

Range Systems Simulation for the NASA Shuttle: Emphasis on Disaster and Prevention Management During Lift-Off

NASA Technical Reports Server (NTRS)

Rabelo, Lisa; Sepulveda, Jose; Moraga, Reinaldo; Compton, Jeppie; Turner, Robert

2005-01-01

This article describes a decision-making system composed of a number of safety and environmental models for the launch phase of a NASA Space Shuttle mission. The components of this distributed simulation environment represent the different systems that must collaborate to establish the Expectation of Casualties (E(sub c)) caused by a failed Space Shuttle launch and subsequent explosion (accidental or instructed) of the spacecraft shortly after liftoff. This decision-making tool employs Space Shuttle reliability models, trajectory models, a blast model, weather dissemination systems, population models, amount and type of toxicants, gas dispersion models, human response functions to toxicants, and a geographical information system. Since one of the important features of this proposed simulation environment is to measure blast, toxic, and debris effects, the clear benefits is that it can help safety managers not only estimate the population at risk, but also to help plan evacuations, make sheltering decisions, establish the resources required to provide aid and comfort, and mitigate damages in case of a disaster.

An Assessment of Civil Tiltrotor Concept of Operations in the Next Generation Air Transportation System

NASA Technical Reports Server (NTRS)

Chung, William W.; Salvano, Dan; Rinehart, David; Young, Ray; Cheng, Victor; Lindsey, James

2012-01-01

Based on a previous Civil Tiltrotor (CTR) National Airspace System (NAS) performance analysis study, CTR operations were evaluated over selected routes and terminal airspace configurations assuming noninterference operations (NIO) and runway-independent operations (RIO). This assessment aims to further identify issues associated with these concepts of operations (ConOps), and their dependency on the airspace configuration and interaction with conventional fixed-wing traffic. Safety analysis following a traditional Safety Management System (SMS) methodology was applied to CTR-unique departure and arrival failures in the selected airspace to identify any operational and certification issues. Additional CTR operational cases were then developed to get a broader understanding of issues and gaps that will need to be addressed in future CTR operational studies. Finally, needed enhancements to National Airspace System performance analysis tools were reviewed, and recommendations were made on improvements in these tools that are likely to be required to support future progress toward CTR fleet operations in the Next Generation Air Transportation System (NextGen).

Emotions at work: what is the link to patient and staff safety? Implications for nurse managers in the NHS.

PubMed

Smith, Pam; Pearson, Pauline H; Ross, Fiona

2009-03-01

This paper sets the discussion of emotions at work within the modern NHS and the current prioritisation of creating a safety culture within the service. The paper focuses on the work of students, frontline nurses and their managers drawing on recent studies of patient safety in the curriculum, and governance and incentives in the care of patients with complex long term conditions. The primary research featured in the paper combined a case study design with focus groups, interviews and observation. In the patient safety research the importance of physical and emotional safety emerged as a key finding both for users and professionals. In the governance and incentives research, risk emerged as a key concern for managers, frontline workers and users. The recognition of emotions and the importance of emotional labour at an individual and organizational level managed by emotionally intelligent leaders played an important role in promoting worker and patient safety and reducing workplace risk. Nurse managers need to be aware of the emotional complexities of their organizations in order to set up systems to support the emotional wellbeing of professionals and users which in turn ensures safety and reduces risk.

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

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.

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.

[Serious product accidents due to the chemical substances used in household products in fiscal years 2007 and 2008].

PubMed

Isama, Kazuo

2009-01-01

The revised consumer product safety law was enforced in 2007. Then, the collection and publication system of the information of product accidents was newly included. Serious product accidents due to the chemical substances used in household products had 32 cases in fiscal years 2007 and 2008. These household products were a desk mat, a sectional bed, a spray-type adhesive, a paint and an adhesive for table tennis rackets. The safety measure of the household product was explained based on the law for the control of household products containing harmful substances.

27. The top of a typical pile, F Reactor in ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

27. The top of a typical pile, F Reactor in February 1945 in this case, showing the vertical safety rods (VSRs) and the cables that support them. The rods could be dropped into the pile to effect a rapid shutdown. The four silvered-colored drums on the left contained boron solution and are part of the last ditch safety system. Should the VSRs channels become blocked by an occurrence such as an earthquake, the solution could be dumped into the VSR channels to help shut down the reactor. D-8334 - B Reactor, Richland, Benton County, WA

78 FR 53494 - Dam Safety Modifications at Cherokee, Fort Loudoun, Tellico, and Watts Bar Dams

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... fundamental part of this mission was the construction and operation of an integrated system of dams and... by the Federal Emergency Management Agency, TVA prepares for the worst case flooding event in order... appropriate best management practices during all phases of construction and maintenance associated with the...

49 CFR 195.428 - Overpressure safety devices and overfill protection systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... months, but at least twice each calendar year, inspect and test each pressure limiting device, relief... reliability of operation for the service in which it is used. (b) In the case of relief valves on pressure breakout tanks containing highly volatile liquids, each operator shall test each valve at intervals not...

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...

Fire and the Design of Educational Buildings. Building Bulletin 7. Sixth Edition.

ERIC Educational Resources Information Center

Department of Education and Science, London (England).

This bulletin offers guidance on English school premises regulations applying to safety protection against fires in the following general areas: means of escape in case of fire; precautionary measures to prevent fire; fire warning systems and fire fighting; fire spreading speed; structures and materials resistant to fires; and damage control. It…

Microbial profiling, neural network and semantic web: an integrated information system for human pathogen risk management, prevention and surveillance in food safety

USDA-ARS?s Scientific Manuscript database

It is estimated that food-borne pathogens cause approximately 76 million cases of gastrointestinal illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States annually. Genomic, proteomic, and metabolomic studies, particularly, genome sequencing projects are providing valuable inform...

Health protection and risks for rescuers in cases of floods.

PubMed

Janev Holcer, Nataša; Jeličić, Pavle; Grba Bujević, Maja; Važanić, Damir

2015-03-01

Floods can pose a number of safety and health hazards for flood-affected populations and rescuers and bring risk of injuries, infections, and diseases due to exposure to pathogenic microorganisms and different biological and chemical contaminants. The risk factors and possible health consequences for the rescuers involved in evacuation and rescuing operations during the May 2014 flood crisis in Croatia are shown, as well as measures for the prevention of injuries and illnesses. In cases of extreme floods, divers play a particularly important role in rescuing and first-response activities. Rescuing in contaminated floodwaters means that the used equipment such as diving suits should be disinfected afterwards. The need for securing the implementation of minimal health and safety measures for involved rescuers is paramount. Data regarding injuries and disease occurrences among rescuers are relatively scarce, indicating the need for medical surveillance systems that would monitor and record all injuries and disease occurrences among rescuers in order to ensure sound epidemiological data. The harmful effects of flooding can be reduced by legislation, improvement of flood forecasting, establishing early warning systems, and appropriate planning and education.

"Defense-in-Depth" Laser Safety and the National Ignition Facility

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

King, J J

The National Ignition Facility (NIF) is the largest and most energetic laser in the world contained in a complex the size of a football stadium. From the initial laser pulse, provided by telecommunication style infrared nanoJoule pulsed lasers, to the final 192 laser beams (1.8 Mega Joules total energy in the ultraviolet) converging on a target the size of a pencil eraser, laser safety is of paramount concern. In addition to this, there are numerous high-powered (Class 3B and 4) diagnostic lasers in use that can potentially send their laser radiation travelling throughout the facility. With individual beam paths ofmore » up to 1500 meters and a workforce of more than one thousand, the potential for exposure is significant. Simple laser safety practices utilized in typical laser labs just don't apply. To mitigate these hazards, NIF incorporates a multi layered approach to laser safety or 'Defense in Depth.' Most typical high-powered laser operations are contained and controlled within a single room using relatively simplistic controls to protect both the worker and the public. Laser workers are trained, use a standard operating procedure, and are required to wear Personal Protective Equipment (PPE) such as Laser Protective Eyewear (LPE) if the system is not fully enclosed. Non-workers are protected by means of posting the room with a warning sign and a flashing light. In the best of cases, a Safety Interlock System (SIS) will be employed which will 'safe' the laser in the case of unauthorized access. This type of laser operation is relatively easy to employ and manage. As the operation becomes more complex, higher levels of control are required to ensure personnel safety. Examples requiring enhanced controls are outdoor and multi-room laser operations. At the NIF there are 192 beam lines and numerous other Class 4 diagnostic lasers that can potentially deliver their hazardous energy to locations far from the laser source. This presents a serious and complex potential hazard to personnel. Because of this, a multilayered approach to safety is taken. This paper presents the philosophy and approach taken at the NIF in the multi-layered 'defense-in-depth' approach to laser safety.« less

Multiple-function multi-input/multi-output digital control and on-line analysis

NASA Technical Reports Server (NTRS)

Hoadley, Sherwood T.; Wieseman, Carol D.; Mcgraw, Sandra M.

1992-01-01

The design and capabilities of two digital controller systems for aeroelastic wind-tunnel models are described. The first allowed control of flutter while performing roll maneuvers with wing load control as well as coordinating the acquisition, storage, and transfer of data for on-line analysis. This system, which employs several digital signal multi-processor (DSP) boards programmed in high-level software languages, is housed in a SUN Workstation environment. A second DCS provides a measure of wind-tunnel safety by functioning as a trip system during testing in the case of high model dynamic response or in case the first DCS fails. The second DCS uses National Instruments LabVIEW Software and Hardware within a Macintosh environment.

Cattle traceability system in Japan for bovine spongiform encephalopathy.

PubMed

Sugiura, Katsuaki; Onodera, Takashi

2008-01-01

To promote consumer confidence in the safety of beef and to ensure the proper implementation of eradication measures against bovine spongiform encephalopathy (BSE), the Cattle Traceability Law was approved by the Diet in June 2003 and a cattle traceability system has been in operation in Japan since December 2003. The system enables tracing the cohort and offspring animals of a BSE case within 24 h of its detection. The traceability database system also provides distributors, restaurants and consumers with information on the cattle from which the beef that they sell, serve and consume, originate.

Reaching out to clinicians: implementation of a computerized alert system.

PubMed

Degnan, Dan; Merryfield, Dave; Hultgren, Steve

2004-01-01

Several published articles have identified that providing automated, computer-generated clinical alerts about potentially critical clinical situations should result in better quality of care. In 1999, the pharmacy department at a community hospital network implemented and refined a commercially available, computerized clinical alert system. This case report discusses the implementation process, gives examples of how the system is used, and describes results following implementation. The use of the clinical alert system in this hospital network resulted in improved patient safety as well as in greater efficiency and decreased costs.

Operating room sound level hazards for patients and physicians.

PubMed

Fritsch, Michael H; Chacko, Chris E; Patterson, Emily B

2010-07-01

Exposure to certain new surgical instruments and operating room devices during procedures could cause hearing damage to patients and personnel. Surgical instruments and related equipment generate significant sound levels during routine usage. Both patients and physicians are exposed to these levels during the operative cases, many of which can last for hours. The noise loads during cases are cumulative. Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH) standards are inconsistent in their appraisals of potential damage. Implications of the newer power instruments are not widely recognized. Bruel and Kjaer sound meter spectral recordings for 20 major instruments from 5 surgical specialties were obtained at the ear levels for the patient and the surgeon between 32 and 20 kHz. Routinely used instruments generated sound levels as high as 131 dB. Patient and operator exposures differed. There were unilateral dominant exposures. Many instruments had levels that became hazardous well within the length of an average surgical procedure. The OSHA and NIOSH systems gave contradicting results when applied to individual instruments and types of cases. Background noise, especially in its intermittent form, was also of significant nature. Some patients and personnel have additional predisposing physiologic factors. Instrument noise levels for average length surgical cases may exceed OSHA and NIOSH recommendations for hearing safety. Specialties such as Otolaryngology, Orthopedics, and Neurosurgery use instruments that regularly exceed limits. General operating room noise also contributes to overall personnel exposures. Innovative countermeasures are suggested.

A sequential-move game for enhancing safety and security cooperation within chemical clusters.

PubMed

Pavlova, Yulia; Reniers, Genserik

2011-02-15

The present paper provides a game theoretic analysis of strategic cooperation on safety and security among chemical companies within a chemical industrial cluster. We suggest a two-stage sequential move game between adjacent chemical plants and the so-called Multi-Plant Council (MPC). The MPC is considered in the game as a leader player who makes the first move, and the individual chemical companies are the followers. The MPC's objective is to achieve full cooperation among players through establishing a subsidy system at minimum expense. The rest of the players rationally react to the subsidies proposed by the MPC and play Nash equilibrium. We show that such a case of conflict between safety and security, and social cooperation, belongs to the 'coordination with assurance' class of games, and we explore the role of cluster governance (fulfilled by the MPC) in achieving a full cooperative outcome in domino effects prevention negotiations. The paper proposes an algorithm that can be used by the MPC to develop the subsidy system. Furthermore, a stepwise plan to improve cross-company safety and security management in a chemical industrial cluster is suggested and an illustrative example is provided. Copyright © 2010 Elsevier B.V. All rights reserved.

Design of the Electronic Brake Pressure Modulator Using a Direct Adaptive Fuzzy Controller in Commercial Vehicles for the Safety of Braking in Fail

NASA Astrophysics Data System (ADS)

Kim, Hunmo

In the brake systems, it is important to reduce the rear brake pressure in order to secure the safety of the vehicle in braking. So, there was some research that reduced and controlled the rear brake pressure exactly like a L. S. P. V and a E. L. S. P. V. However, the previous research has some weaknesses: the L. S. P. V is a mechanical system and its brake efficiency is lower than the efficiency of E. L. S. P. V. But, the cost of E. L. S. P. V is very higher so its application to the vehicle is very difficult. Additionally, when a fail appears in the circuit which controls the valves, the fail results in some wrong operation of the valves. But, the previous researchers didn't take the effect of fail into account. Hence, the efficiency of them is low and the safety of the vehicle is not confirmed. So, in this paper we develop a new economical pressure modulator that exactly controls brake pressure and confirms the safety of the vehicle in any case using a direct adaptive fuzzy controller.

An integrated quality function deployment and capital budgeting methodology for occupational safety and health as a systems thinking approach: the case of the construction industry.

PubMed

Bas, Esra

2014-07-01

In this paper, an integrated methodology for Quality Function Deployment (QFD) and a 0-1 knapsack model is proposed for occupational safety and health as a systems thinking approach. The House of Quality (HoQ) in QFD methodology is a systematic tool to consider the inter-relationships between two factors. In this paper, three HoQs are used to consider the interrelationships between tasks and hazards, hazards and events, and events and preventive/protective measures. The final priority weights of events are defined by considering their project-specific preliminary weights, probability of occurrence, and effects on the victim and the company. The priority weights of the preventive/protective measures obtained in the last HoQ are fed into a 0-1 knapsack model for the investment decision. Then, the selected preventive/protective measures can be adapted to the task design. The proposed step-by-step methodology can be applied to any stage of a project to design the workplace for occupational safety and health, and continuous improvement for safety is endorsed by the closed loop characteristic of the integrated methodology. Copyright © 2013 Elsevier Ltd. All rights reserved.

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...

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.

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.

Constructing a safety and security system by medical applications of a fast face recognition optical parallel correlator

NASA Astrophysics Data System (ADS)

Watanabe, Eriko; Ishikawa, Mami; Ohta, Maiko; Murakami, Yasuo; Kodate, Kashiko

2006-01-01

Medical errors and patient safety have always received a great deal of attention, as they can be critically life-threatening and significant matters. Hospitals and medical personnel are trying their utmost to avoid these errors. Currently in the medical field, patients' record is identified through their PIN numbers and ID cards. However, for patients who cannot speak or move, or who suffer from memory disturbances, alternative methods would be more desirable, and necessary in some cases. The authors previously proposed and fabricated a specially-designed correlator called FARCO (Fast Face Recognition Optical Correlator) based on the Vanderlugt Correlator1, which operates at the speed of 1000 faces/s 2,3,4. Combined with high-speed display devices, the four-channel processing could achieve such high operational speed as 4000 faces/s. Running trial experiments on a 1-to-N identification basis using the optical parallel correlator, we succeeded in acquiring low error rates of 1 % FMR and 2.3 % FNMR. In this paper, we propose a robust face recognition system using the FARCO for focusing on the safety and security of the medical field. We apply our face recognition system to registration of inpatients, in particular children and infants, before and after medical treatments or operations. The proposed system has recorded a higher recognition rate by multiplexing both input and database facial images from moving images. The system was also tested and evaluated for further practical use, leaving excellent results. Hence, our face recognition system could function effectively as an integral part of medical system, meeting these essential requirements of safety, security and privacy.

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.

Towards a Formal Basis for Modular Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

Pressure Safety Program Implementation at ORNL

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

Lower, Mark; Etheridge, Tom; Oland, C. Barry

2013-01-01

The Oak Ridge National Laboratory (ORNL) is a US Department of Energy (DOE) facility that is managed by UT-Battelle, LLC. In February 2006, DOE promulgated worker safety and health regulations to govern contractor activities at DOE sites. These regulations, which are provided in 10 CFR 851, Worker Safety and Health Program, establish requirements for worker safety and health program that reduce or prevent occupational injuries, illnesses, and accidental losses by providing DOE contractors and their workers with safe and healthful workplaces at DOE sites. The regulations state that contractors must achieve compliance no later than May 25, 2007. According tomore » 10 CFR 851, Subpart C, Specific Program Requirements, contractors must have a structured approach to their worker safety and health programs that at a minimum includes provisions for pressure safety. In implementing the structured approach for pressure safety, contractors must establish safety policies and procedures to ensure that pressure systems are designed, fabricated, tested, inspected, maintained, repaired, and operated by trained, qualified personnel in accordance with applicable sound engineering principles. In addition, contractors must ensure that all pressure vessels, boilers, air receivers, and supporting piping systems conform to (1) applicable American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (2004) Sections I through XII, including applicable code cases; (2) applicable ASME B31 piping codes; and (3) the strictest applicable state and local codes. When national consensus codes are not applicable because of pressure range, vessel geometry, use of special materials, etc., contractors must implement measures to provide equivalent protection and ensure a level of safety greater than or equal to the level of protection afforded by the ASME or applicable state or local codes. This report documents the work performed to address legacy pressure vessel deficiencies and comply with pressure safety requirements in 10 CFR 851. It also describes actions taken to develop and implement ORNL’s Pressure Safety Program.« less

Can We Do That Here? Establishing the Scope of Surgical Practice at a New Safety-Net Community Hospital Through a Transparent, Collaborative Review of Physician Privileges.

PubMed

O'Neill, Sean M; Seresinghe, Sarah; Sharma, Arun; Russell, Tara A; Crawford, L'Orangerie; Frencher, Stanley K

2018-01-01

Stewarding of physician privileges wisely is imperative, but no guidelines exist for how to incorporate system-level factors in privileging decisions. A newly opened, safety-net community hospital tailored the scope of surgical practice through review of physician privileges. Martin Luther King, Jr. Community Hospital is a public-private partnership, safety-net institution in South Los Angeles that opened in July 2015. It has 131 beds, including a 28-bed emergency department, a 20-bed ICU, and 5 operating rooms. Staff privileging decisions were initially based only on physicians' training and experience, but this resulted in several cases that tested the boundaries of what a small community hospital was prepared to handle. A collaborative, transparent process to review physician privileges was developed. This began with physician-only review of procedure lists, followed by a larger, multidisciplinary group to assess system-level factors. Specific questions were used to guide discussion, and unanimous approval from all stakeholders was required to include a procedure. An initial list of 558 procedures across 11 specialties was reduced to 321 (57.5%). No new cases that fall outside these new boundaries have arisen. An inclusive process was crucial for obtaining buy-in and establishing cultural norms. Arranging transfer agreements remains a significant challenge. Accumulation of institutional experience continues through regular performance reviews. As this hospital's capabilities mature, a blueprint has been established for expanding surgical scope of practice based explicitly on system-level factors. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

WE-G-BRA-01: Patient Safety and Treatment Quality Improvement Through Incident Learning: Experience of a Non-Academic Proton Therapy Center

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

Zheng, Y; Johnson, R; Zhao, L

2015-06-15

Purpose: Incident learning has been proven to improve patient safety and treatment quality in conventional radiation therapy. However, its application in proton therapy has not been reported yet to our knowledge. In this study, we report our experience in developing and implementation of an in-house incident learning system. Methods: An incident learning system was developed based on published principles and tailored for our clinical practice and available resource about 18 months ago. The system includes four layers of error detection and report: 1) dosimetry peer review; 2) physicist plan quality assurance (QA); 3) treatment delivery issue on call and record;more » and 4) other incident report. The first two layers of QA and report were mandatory for each treatment plan through easy-to-use spreadsheets that are only accessible by the dosimetry and physicist departments. The treatment delivery issues were recorded case by case by the on call physicist. All other incidents were reported through an online incident report system, which can be anonymous. The incident report includes near misses on planning and delivery, process deviation, machine issues, work flow and documentation. Periodic incident reviews were performed. Results: In total, about 116 errors were reported through dosimetry review, 137 errors through plan QA, 83 treatment issues through physics on call record, and 30 through the online incident report. Only 8 incidents (2.2%) were considered to have a clinical impact to patients, and the rest of errors were either detected before reaching patients or had negligible dosimetric impact (<5% dose variance). Personnel training & process improvements were implemented upon periodic incident review. Conclusion: An incident learning system can be helpful in personnel training, error reduction, and patient safety and treatment quality improvement. The system needs to be catered for each clinic’s practice and available resources. Incident and knowledge sharing among proton centers are encouraged.« less

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

A decline in reports concerning small aircraft was noted; more reports involved transport aircraft, professional pilots, instrument meteorological conditions, and weather problems. A study of 136 reports of operational problems in terminal radar service areas was made. Pilot, controller, and system factors were found to be associated with these occurrences. Information transfer difficulties were prominent. Misunderstandings by pilots, and in some cases by controllers, of the policies and limitations of terminal radar programs were observed.

Business Case Analysis: Reconfiguration of the Frederick Memorial Healthcare System Courier Service

DTIC Science & Technology

2008-05-13

from each specimen. This figure alone clearly supports the existence of the FMH courier service. The problem , rather, lies in the efficiency and...investigated, to include the Hyundai Accent, Chevrolet Aveo, and the Honda Fit. Each vehicle was evaluated on cost, fuel efficiency, predicted reliability...P175/65R14 Tires Temporary Spare Tire SAFETY Driver Front Airbag and Front Passenger Airbag with Advanced Airbag System 3 Point Driver & Fr Pass

Clinical trial aims to improve outcomes for children and young adults with primary brain tumors | Center for Cancer Research

Cancer.gov

Central nervous system (CNS) tumors are the most common solid tumors among children and account for up to 25 percent of all childhood cancer cases. With few treatment options available at the time of recurrence or progression, this multicenter study will test the safety and efficacy of a drug that boosts the function of the immune system to fight tumors. Read more…

Development of a framework for the assessment of capacity and throughput technologies within the National Airspace System

NASA Astrophysics Data System (ADS)

Garcia, Elena

The demand for air travel is expanding beyond the capacity of the existing National Airspace System. Excess traffic results in delays and compromised safety. Thus, a number of initiatives to improve airspace capacity have been proposed. To assess the impact of these technologies on air traffic one must move beyond the vehicle to a system-of-systems point of view. This top-level perspective must include consideration of the aircraft, airports, air traffic control and airlines that make up the airspace system. In addition to these components and their interactions economics, safety and government regulations must also be considered. Furthermore, the air transportation system is inherently variable with changes in everything from fuel prices to the weather. The development of a modeling environment that enables a comprehensive probabilistic evaluation of technological impacts was the subject of this thesis. The final modeling environment developed used economics as the thread to tie the airspace components together. Airport capacities and delays were calculated explicitly with due consideration to the impacts of air traffic control. The delay costs were then calculated for an entire fleet, and an airline economic analysis, considering the impact of these costs, was carried out. Airline return on investment was considered the metric of choice since it brings together all costs and revenues, including the cost of delays, landing fees for airport use and aircraft financing costs. Safety was found to require a level of detail unsuitable for a system-of-systems approach and was relegated to future airspace studies. Environmental concerns were considered to be incorporated into airport regulations and procedures and were not explicitly modeled. A deterministic case study was developed to test this modeling environment. The Atlanta airport operations for the year 2000 were used for validation purposes. A 2005 baseline was used as a basis for comparing the four technologies considered: a very large aircraft, Terminal Area Productivity air traffic control technologies, smoothing of an airline schedule, and the addition of a runway. A case including all four technologies simultaneously was also considered. Unfortunately, the complexity of the system prevented full exploration of the probabilistic aspects of the National Airspace System.

[Preclinical evaluation of the safety of biotechnology products: specific aspects].

PubMed

Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

2003-01-01

Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.

Statechart Analysis with Symbolic PathFinder

NASA Technical Reports Server (NTRS)

Pasareanu, Corina S.

2012-01-01

We report here on our on-going work that addresses the automated analysis and test case generation for software systems modeled using multiple Statechart formalisms. The work is motivated by large programs such as NASA Exploration, that involve multiple systems that interact via safety-critical protocols and are designed with different Statechart variants. To verify these safety-critical systems, we have developed Polyglot, a framework for modeling and analysis of model-based software written using different Statechart formalisms. Polyglot uses a common intermediate representation with customizable Statechart semantics and leverages the analysis and test generation capabilities of the Symbolic PathFinder tool. Polyglot is used as follows: First, the structure of the Statechart model (expressed in Matlab Stateflow or Rational Rhapsody) is translated into a common intermediate representation (IR). The IR is then translated into Java code that represents the structure of the model. The semantics are provided as "pluggable" modules.

Health policy making through operative actions: a case study of provider capacity reduction in a public safety-net system.

PubMed

Tataw, David B

2014-01-01

This article describes and assesses the implications of policy decisions affecting health provider capacity in the Los Angeles County municipal safety-net health system from 1980 to 2000. Although never articulated in law or a county ordinance, the county pursued a sustained and discernable policy of cost reductions that affected capacity at King/Drew Medical Center from 1980 to 2000 without the input of beneficiaries or their advocates. Year after year, the county reduced personnel, supplies, and available beds either by reducing formal budgets or through operative actions of facility administrators that prevented the implementation of formally approved expenditures. This policy appears to have undermined the hospital system's mission of providing health services to at-risk populations with nowhere else to go. Decision making during the two decades under study revealed a decision-making pattern that challenged traditional models of policy decision making.

Determination of UAV pre-flight Checklist for flight test purpose using qualitative failure analysis

NASA Astrophysics Data System (ADS)

Hendarko; Indriyanto, T.; Syardianto; Maulana, F. A.

2018-05-01

Safety aspects are of paramount importance in flight, especially in flight test phase. Before performing any flight tests of either manned or unmanned aircraft, one should include pre-flight checklists as a required safety document in the flight test plan. This paper reports on the development of a new approach for determination of pre-flight checklists for UAV flight test based on aircraft’s failure analysis. The Lapan’s LSA (Light Surveillance Aircraft) is used as a study case, assuming this aircraft has been transformed into the unmanned version. Failure analysis is performed on LSA using fault tree analysis (FTA) method. Analysis is focused on propulsion system and flight control system, which fail of these systems will lead to catastrophic events. Pre-flight checklist of the UAV is then constructed based on the basic causes obtained from failure analysis.

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

Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy.

PubMed

Broggi, Sara; Cantone, Marie Claire; Chiara, Anna; Di Muzio, Nadia; Longobardi, Barbara; Mangili, Paola; Veronese, Ivan

2013-09-06

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety.

Description and Yield of Current Quality and Safety Review in Selected US Academic Emergency Departments.

PubMed

Griffey, Richard Thomas; Schneider, Ryan M; Sharp, Brian R; Pothof, Jeffrey J; Hodkins, Sheridan; Capp, Roberta; Wiler, Jennifer L; Sreshta, Neil; Sather, John E; Sampson, Christopher S; Powell, Jonathan T; Groner, Kathryn Y; Adler, Lee M

2017-06-29

Quality and safety review for performance improvement is important for systems of care and is required for US academic emergency departments (EDs). Assessment of the impact of patient safety initiatives in the context of increasing burdens of quality measurement compels standardized, meaningful, high-yield approaches for performance review. Limited data describe how quality and safety reviews are currently conducted and how well they perform in detecting patient harm and areas for improvement. We hypothesized that decades-old approaches used in many academic EDs are inefficient and low yield for identifying patient harm. We conducted a prospective observational study to evaluate the efficiency and yield of current quality review processes at five academic EDs for a 12-month period. Sites provided descriptions of their current practice and collected summary data on the number and severity of events identified in their reviews and the referral sources that led to their capture. Categories of common referral sources were established at the beginning of the study. Sites used the Institute for Healthcare Improvement's definition in defining an adverse event and a modified National Coordinating Council for Medication Error Reporting and Prevention (MERP) Index for grading severity of events. Participating sites had similar processes for quality review, including a two-level review process, monthly reviews and conferences, similar screening criteria, and a grading system for evaluating cases. In 60 months of data collection, we reviewed a total of 4735 cases and identified 381 events. This included 287 near-misses, errors/events (MERP A-I) and 94 adverse events (AEs) (MERP E-I). The overall AE rate (event rate with harm) was 1.99 (95% confidence interval = 1.62%-2.43%), ranging from 1.24% to 3.47% across sites. The overall rate of quality concerns (events without harm) was 6.06% (5.42%-6.78%), ranging from 2.96% to 10.95% across sites. Seventy-two-hour returns were the most frequent referral source used, accounting for 47% of the cases reviewed but with a yield of only 0.81% in identifying harm. Other referral sources similarly had very low yields. External referrals were the highest yield referral source, with 14.34% (10.64%-19.03%) identifying AEs. As a percentage of the 94 AEs identified, external referrals also accounted for 41.49% of cases. With an overall adverse event rate of 1.99%, commonly used referral sources seem to be low yield and inefficient for detecting patient harm. Approximately 6% of the cases identified by these criteria yielded a near miss or quality concern. New approaches to quality and safety review in the ED are needed to optimize their yield and efficiency for identifying harm and areas for improvement.

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.

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.

A review of national policies and strategies to improve quality of health care and patient safety: a case study from Lebanon and Jordan.

PubMed

El-Jardali, Fadi; Fadlallah, Racha

2017-08-16

Improving quality of care and patient safety practices can strengthen health care delivery systems, improve health sector performance, and accelerate attainment of health-related Sustainability Development Goals. Although quality improvement is now prominent on the health policy agendas of governments in low- and middle-income countries (LMICs), including countries of the Eastern Mediterranean Region (EMR), progress to date has not been optimal. The objective of this study is to comprehensively review existing quality improvement and patient safety policies and strategies in two selected countries of the EMR (Lebanon and Jordan) to determine the extent to which these have been institutionalized within existing health systems. We used a mixed methods approach that combined documentation review, stakeholder surveys and key informant interviews. Existing quality improvement and patient safety initiatives were assessed across five components of an analytical framework for assessing health care quality and patient safety: health systems context; national policies and legislation; organizations and institutions; methods, techniques and tools; and health care infrastructure and resources. Both Lebanon and Jordan have made important progress in terms of increased attention to quality and accreditation in national health plans and strategies, licensing requirements for health care professionals and organizations (albeit to varying extents), and investments in health information systems. A key deficiency in both countries is the absence of an explicit national policy for quality improvement and patient safety across the health system. Instead, there is a spread of several (disjointed) pieces of legal measures and national plans leading to fragmentation and lack of clear articulation of responsibilities across the entire continuum of care. Moreover, both countries lack national sets of standardized and applicable quality indicators for performance measurement and benchmarking. Importantly, incentive systems that link contractual agreement, regulations, accreditation, and performance indicators are underutilized in Lebanon and absent in Jordan. At the healthcare organizational level, there is a need to instill a culture of continuous quality improvement and promote professional training in quality improvement and patient safety. Study findings highlight the importance of aligning policies, organizations, methods, capacities and resources in order to institutionalize quality improvement and patient safety practices in health systems. Gaps and dysfunctions identified can help inform national deliberations and dialogues among key stakeholders in each study country. Findings can also inform future quality improvement efforts in the EMR and beyond, with a particular emphasis on LMICs.

Case management helps prevent criminal justice recidivism for people with serious mental illness.

PubMed

Leutwyler, Heather; Hubbard, Erin; Zahnd, Elaine

2017-09-11

Purpose The purpose of this paper is to discuss how case management can decrease recidivism for people with serious mental illness (SMI) because people with SMI are at high risk for incarceration and recidivism. Design/methodology/approach Examples of successful case management models for formerly incarcerated individuals with SMI found through a secondary analysis of qualitative data and an analysis of the literature are presented. Findings Currently, no international, national, or statewide guidelines exist to ensure that formerly incarcerated individuals with SMI receive case management upon community reentry despite evidence that such services can prevent further criminal justice involvement. Recommendations include establishment of and evaluation of best practices for case management. In addition, the authors recommend additional funding for case management with the goal of greatly increasing the number of individuals with SMI leaving the criminal justice system in their ability to access adequate case management. Originality/value Providing effective case management tailored to the needs of formerly incarcerated people with SMI improves their quality of life and reduces their involvement in the criminal justice system with clear positive outcomes for public safety and public health.

Flexible Control of Safety Margins for Action Based on Environmental Variability.

PubMed

Hadjiosif, Alkis M; Smith, Maurice A

2015-06-17

To reduce the risk of slip, grip force (GF) control includes a safety margin above the force level ordinarily sufficient for the expected load force (LF) dynamics. The current view is that this safety margin is based on the expected LF dynamics, amounting to a static safety factor like that often used in engineering design. More efficient control could be achieved, however, if the motor system reduces the safety margin when LF variability is low and increases it when this variability is high. Here we show that this is indeed the case by demonstrating that the human motor system sizes the GF safety margin in proportion to an internal estimate of LF variability to maintain a fixed statistical confidence against slip. In contrast to current models of GF control that neglect the variability of LF dynamics, we demonstrate that GF is threefold more sensitive to the SD than the expected value of LF dynamics, in line with the maintenance of a 3-sigma confidence level. We then show that a computational model of GF control that includes a variability-driven safety margin predicts highly asymmetric GF adaptation between increases versus decreases in load. We find clear experimental evidence for this asymmetry and show that it explains previously reported differences in how rapidly GFs and manipulatory forces adapt. This model further predicts bizarre nonmonotonic shapes for GF learning curves, which are faithfully borne out in our experimental data. Our findings establish a new role for environmental variability in the control of action. Copyright © 2015 the authors 0270-6474/15/359106-16$15.00/0.

Accident diagnosis system based on real-time decision tree expert system

NASA Astrophysics Data System (ADS)

Nicolau, Andressa dos S.; Augusto, João P. da S. C.; Schirru, Roberto

2017-06-01

Safety is one of the most studied topics when referring to power stations. For that reason, sensors and alarms develop an important role in environmental and human protection. When abnormal event happens, it triggers a chain of alarms that must be, somehow, checked by the control room operators. In this case, diagnosis support system can help operators to accurately identify the possible root-cause of the problem in short time. In this article, we present a computational model of a generic diagnose support system based on artificial intelligence, that was applied on the dataset of two real power stations: Angra1 Nuclear Power Plant and Santo Antônio Hydroelectric Plant. The proposed system processes all the information logged in the sequence of events before a shutdown signal using the expert's knowledge inputted into an expert system indicating the chain of events, from the shutdown signal to its root-cause. The results of both applications showed that the support system is a potential tool to help the control room operators identify abnormal events, as accidents and consequently increase the safety.

How SEIPS can be used as a model for macroergonomic approach in subunit healthcare (Case study: The nurse perception of fatigue in surgery ward unit)

NASA Astrophysics Data System (ADS)

Iftadi, Irwan; Astuti, Rahmaniyah Dwi; Pristiyana, Ardian Ade

2017-11-01

Occupational fatigue in healthcare nurses, which has multifaceted issues, is associated with decreased patient safety and the quality of nursing care. The aim of this study was to investigate the nurses fatigue problem in sub-unit healthcare based on their perceptual experience. Interviews were conducted and analyzed utilizing a direct qualitative content analysis approach using NVivo Software and guided by Model of System Engineering Initiative for Patient Safety (SEIPS). The findings of this research were a steering on what nurses perceive as contributing and preventing to fatigue which are likewise arranged in SEIPS model. It was shown that a macro ergonomic approach is valuable for understanding complexities of work systems, even though it is a small unit organization.

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.

A case-control study of forklift and other powered industrial vehicle incidents.

PubMed

Collins, J W; Smith, G S; Baker, S P; Landsittel, D P; Warner, M

1999-11-01

This study examined risk factors associated with forklift and other powered industrial vehicle (PIV) collision injuries with an emphasis on the design of factory traffic systems, the loading and safety features of PIVs, and the characteristics of the drivers. A case-control study examined risk factors for circumstances of injury-producing PIV incidents at eight automotive manufacturing plants between July 1992 and March 1995. A computerized safety and health surveillance system identified 171 incidents where a PIV (forklift 70%, personnel carriers 15%, other 15%) was involved in a collision incident. Site visits were conducted to collect data regarding the factory environment at the collision site, the PIVs involved in the incidents, and driver characteristics. These data were compared with information collected from a random sample of comparison worksites, PIVs, and PIV drivers who had not been involved in a PIV-related incident in the prior 3 years. In half of the cases (86 of 171), an employee (pedestrian) was struck by a PIV or an object being carried by the PIV. The presence of an obstruction that restricted the aisle width increased the odds of a collision incident 1.89 times (95% CI=1.22, 2.86). The presence of overhead mirrors at intersections and blind corners with limited visibility reduced the odds of a PIV collision incident by a third (OR=0.33, 95% CI=0.16, 0.68). When carrying a load, the odds of a PIV being involved in a collision was 1.58 (95% CI=1.03, 2.41) times greater than an unloaded one. Changes in the factory environment, vehicle safety features, and driver and pedestrian training are suggested to reduce the risk of PIV incidents. Am. J. Ind. Med. 36:522-531, 1999. Published 1999 Wiley-Liss, Inc.

Improving food safety within the dairy chain: an application of conjoint analysis.

PubMed

Valeeva, N I; Meuwissen, M P M; Lansink, A G J M Oude; Huirne, R B M

2005-04-01

This study determined the relative importance of attributes of food safety improvement in the production chain of fluid pasteurized milk. The chain was divided into 4 blocks: "feed" (compound feed production and its transport), "farm" (dairy farm), "dairy processing" (transport and processing of raw milk, delivery of pasteurized milk), and "consumer" (retailer/catering establishment and pasteurized milk consumption). The concept of food safety improvement focused on 2 main groups of hazards: chemical (antibiotics and dioxin) and microbiological (Salmonella, Escherichia coli, Mycobacterium paratuberculosis, and Staphylococcus aureus). Adaptive conjoint analysis was used to investigate food safety experts' perceptions of the attributes' importance. Preference data from individual experts (n = 24) on 101 attributes along the chain were collected in a computer-interactive mode. Experts perceived the attributes from the "feed" and "farm" blocks as being more vital for controlling the chemical hazards; whereas the attributes from the "farm" and "dairy processing" were considered more vital for controlling the microbiological hazards. For the chemical hazards, "identification of treated cows" and "quality assurance system of compound feed manufacturers" were considered the most important attributes. For the microbiological hazards, these were "manure supply source" and "action in salmonellosis and M. paratuberculosis cases". The rather high importance of attributes relating to quality assurance and traceability systems of the chain participants indicates that participants look for food safety assurance from the preceding participants. This information has substantial decision-making implications for private businesses along the chain and for the government regarding the food safety improvement of fluid pasteurized milk.

Lessons Learned from the Fukushima Nuclear Accident due to Tohoku Region Pacific Coast Earthquake

NASA Astrophysics Data System (ADS)

Miki, M.; Wada, M.; Takeuchi, N.

2012-01-01

On March 11 2011, Great Eastern Japan Earthquake hit Japan and caused the devastating damage. Fukushima Nuclear Power Station (NPS) also suffered damages and provided the environmental effect with radioactive products. The situation has been settled to some extent about two months after the accidents, and currently, the cooling of reactor is continuing towards settling the situation. Japanese NPSs are designed based on safety requirements and have multiple-folds of hazard controls. However, according to publicly available information, due to the lager-than-anticipated Tsunami, all the power supply were lost, which resulted in loss of hazard controls. Also, although nuclear power plants are equipped with system/procedure in case of loss of all controls, recovery was not made as planned in Fukushima NPSs because assumptions for hazard controls became impractical or found insufficient. In consequence, a state of emergency was declared. Through this accident, many lessons learned have been obtained from the several perspectives. There are many commonality between nuclear safety and space safety. Both industries perform thorough hazard assessments because hazards in both industries can result in loss of life. Therefore, space industry must learn from this accident and reconsider more robust space safety. This paper will introduce lessons learned from Fukushima nuclear accident described in the "Report of the Japanese Government to the IAEA Ministerial Conference on Nuclear Safety" [1], and discuss the considerations to establish more robust safety in the space systems. Detailed information of Fukushima Dai-ichi NPS are referred to this report.

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.

Gas House Autonomous System Monitoring

NASA Technical Reports Server (NTRS)

Miller, Luke; Edsall, Ashley

2015-01-01

Gas House Autonomous System Monitoring (GHASM) will employ Integrated System Health Monitoring (ISHM) of cryogenic fluids in the High Pressure Gas Facility at Stennis Space Center. The preliminary focus of development incorporates the passive monitoring and eventual commanding of the Nitrogen System. ISHM offers generic system awareness, adept at using concepts rather than specific error cases. As an enabler for autonomy, ISHM provides capabilities inclusive of anomaly detection, diagnosis, and abnormality prediction. Advancing ISHM and Autonomous Operation functional capabilities enhances quality of data, optimizes safety, improves cost effectiveness, and has direct benefits to a wide spectrum of aerospace applications.

Large-Scale Wireless Temperature Monitoring System for Liquefied Petroleum Gas Storage Tanks.

PubMed

Fan, Guangwen; Shen, Yu; Hao, Xiaowei; Yuan, Zongming; Zhou, Zhi

2015-09-18

Temperature distribution is a critical indicator of the health condition for Liquefied Petroleum Gas (LPG) storage tanks. In this paper, we present a large-scale wireless temperature monitoring system to evaluate the safety of LPG storage tanks. The system includes wireless sensors networks, high temperature fiber-optic sensors, and monitoring software. Finally, a case study on real-world LPG storage tanks proves the feasibility of the system. The unique features of wireless transmission, automatic data acquisition and management, local and remote access make the developed system a good alternative for temperature monitoring of LPG storage tanks in practical applications.

Under-reporting of work-related disorders in the workplace: a case study and review of the literature.

PubMed

Pransky, G; Snyder, T; Dembe, A; Himmelstein, J

1999-01-01

Accurate reporting of work-related conditions is necessary to monitor workplace health and safety, and to identify the interventions that are most needed. Reporting systems may be designed primarily for external agencies (OSHA or workers' compensation) or for the employer's own use. Under-reporting of workplace injuries and illnesses is common due to a variety of causes and influences. Based on previous reports, the authors were especially interested in the role of safety incentive programmes on under-reporting. Safety incentive programmes typically reward supervisors and employees for reducing workplace injury rates, and thus may unintentionally inhibit proper reporting. The authors describe a case study of several industrial facilities in order to illustrate the extent of under-reporting and the reasons for its occurrence. A questionnaire and interview survey was administered to 110 workers performing similar tasks and several managers, health, and safety personnel at each of three industrial facilities. Although less than 5% of workers had officially reported a work-related injury or illness during the past year, over 85% experienced work-related symptoms, 50% had persistent work-related problems, and 30% reported either lost time from work or work restrictions because of their ailment. Workers described several reasons for not reporting their injuries, including fear of reprisal, a belief that pain was an ordinary consequence of work activity or ageing, lack of management responsiveness after prior reports, and a desire not to lose their usual job. Interviews with management representatives revealed administrative and other barriers to reporting, stemming from their desire to attain a goal of no reported injuries, and misconceptions about requirements for recordability. The corporate and facility safety incentives appeared to have an indirect, but significant negative influence on the proper reporting of workplace injuries by workers. A variety of influences may contribute to under-reporting; because of under-reporting, worker surveys and symptom reports may provide more valuable and timely information on risks than recordable injury logs. Safety incentive programmes should be carefully designed to ensure that they provide a stimulus for safety-related changes, and to discourage under-reporting. A case-control study of similar establishments, or data before and after instituting safety incentives, would be required to more clearly establish the role of these programmes in under-reporting.

Sociology, systems and (patient) safety: knowledge translations in healthcare policy.

PubMed

Jensen, Casper Bruun

2008-03-01

In 2000 the American Institute of Medicine, adviser to the federal government on policy matters relating to the health of the public, published the report To Err is Human: Building a Safer Health System, which was to become a call to arms for improving patient safety across the Western world. By re-conceiving healthcare as a system, it was argued that it was possible to transform the current culture of blame, which made individuals take defensive precautions against being assigned responsibility for error - notably by not reporting adverse events, into a culture of safety. The IOM report draws on several prominent social scientists in accomplishing this re-conceptualisation. But the analyses of these authors are not immediately relevant for health policy. It requires knowledge translation to make them so. This paper analyses the process of translation. The discussion is especially pertinent due to a certain looping effect between social science research and policy concerns. The case here presented is thus doubly illustrative: exemplifying first how social science is translated into health policy and secondly how the transformation required for this to function is taken as an analytical improvement that can in turn be redeployed in social research.

Understanding and managing the effects of battery charger and inverter aging

NASA Astrophysics Data System (ADS)

Gunther, W.; Aggarwal, S.

An aging assessment of battery chargers and inverters was conducted under the auspices of the NRC's Nuclear Plant Aging Research (NPAR) Program. The intentions of this program are to resolve issues related to the aging and service wear of equipment and systems at operating reactor facilities and to assess their impact on safety. Inverters and battery chargers are used in nuclear power plants to perform significant functions related to plant safety and availability. The specific impact of a battery charger or inverter failure varies with plant configuration. Operating experience data have demonstrated that reactor trips, safety injection system actuations, and inoperable emergency core cooling systems have resulted from inverter failures; and dc bus degradation leading to diesel generator inoperability or loss of control room annunication and indication have resulted from battery and battery charger failures. For the battery charger and inverter, the aging and service wear of subcomponents have contributed significantly to equipment failures. This paper summarizes the data and then describes methods that can be used to detect battery charger and inverter degradation prior to failure, as well as methods to minimize the failure effects. In both cases, the managing of battery charger and inverter aging is emphasized.

Primary care quality and safety systems in the English National Health Service: a case study of a new type of primary care provider.

PubMed

Baker, Richard; Willars, Janet; McNicol, Sarah; Dixon-Woods, Mary; McKee, Lorna

2014-01-01

Although the predominant model of general practice in the UK National Health Service (NHS) remains the small partnership owned and run by general practitioners (GPs), new types of provider are emerging. We sought to characterize the quality and safety systems and processes used in one large, privately owned company providing primary care through a chain of over 50 general practices in England. Senior staff with responsibility for policy on quality and safety were interviewed. We also undertook ethnographic observation in non-clinical areas and interviews with staff in three practices. A small senior executive team set policy and strategy on quality and safety, including a systematic incident reporting and investigation system and processes for disseminating learning with a strong emphasis on customer focus. Standardization of systems was possible because of the large number of practices. Policies appeared generally well implemented at practice level. However, there was some evidence of high staff turnover, particularly of GPs. This caused problems for continuity of care and challenges in inducting new GPs in the company's systems and procedures. A model of primary care delivery based on a corporate chain may be useful in standardizing policies and procedures, facilitating implementation of systems, and relieving clinical staff of administrative duties. However, the model also poses some risks, including those relating to stability. Provider forms that retain the long term, personal commitment of staff to their practices, such as federations or networks, should also be investigated; they may offer the benefits of a corporate chain combined with the greater continuity and stability of the more traditional general practice.

Design and implementation of an identification system in construction site safety for proactive accident prevention.

PubMed

Yang, Huanjia; Chew, David A S; Wu, Weiwei; Zhou, Zhipeng; Li, Qiming

2012-09-01

Identifying accident precursors using real-time identity information has great potential to improve safety performance in construction industry, which is still suffering from day to day records of accident fatality and injury. Based on the requirements analysis for identifying precursor and the discussion of enabling technology solutions for acquiring and sharing real-time automatic identification information on construction site, this paper proposes an identification system design for proactive accident prevention to improve construction site safety. Firstly, a case study is conducted to analyze the automatic identification requirements for identifying accident precursors in construction site. Results show that it mainly consists of three aspects, namely access control, training and inspection information and operation authority. The system is then designed to fulfill these requirements based on ZigBee enabled wireless sensor network (WSN), radio frequency identification (RFID) technology and an integrated ZigBee RFID sensor network structure. At the same time, an information database is also designed and implemented, which includes 15 tables, 54 queries and several reports and forms. In the end, a demonstration system based on the proposed system design is developed as a proof of concept prototype. The contributions of this study include the requirement analysis and technical design of a real-time identity information tracking solution for proactive accident prevention on construction sites. The technical solution proposed in this paper has a significant importance in improving safety performance on construction sites. Moreover, this study can serve as a reference design for future system integrations where more functions, such as environment monitoring and location tracking, can be added. Copyright © 2011 Elsevier Ltd. All rights reserved.

2013 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2013-01-01

Welcome to the 2013 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides an Agency overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various activities performed during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be conducted in the future. Specific topics discussed in the 2013 NASA Range Safety Annual Report include a program overview and 2013 highlights, Range Safety Training, Independent Assessments, support to Program Operations at all ranges conducting NASA launch/flight operations, a continuing overview of emerging range safety-related technologies, and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. As is the case each year, we had a wide variety of contributors to this report from across our NASA Centers and the national range safety community at large, and I wish to thank them all. On a sad note, we lost one of our close colleagues, Dr. Jim Simpson, due to his sudden passing in December. His work advancing the envelope of autonomous flight safety systems software/hardware development leaves a lasting impression on our community. Such systems are being flight tested today and may one day be considered routine in the range safety business. The NASA family has lost a pioneer in our field, and he will surely be missed. In conclusion, it has been a very busy and productive year, and I look forward to working with all of you in NASA Centers/Programs/Projects and with the national Range Safety community in making Flight/Space activities as safe as they can be in the upcoming year.

A predictive control framework for torque-based steering assistance to improve safety in highway driving

NASA Astrophysics Data System (ADS)

Ercan, Ziya; Carvalho, Ashwin; Tseng, H. Eric; Gökaşan, Metin; Borrelli, Francesco

2018-05-01

Haptic shared control framework opens up new perspectives on the design and implementation of the driver steering assistance systems which provide torque feedback to the driver in order to improve safety. While designing such a system, it is important to account for the human-machine interactions since the driver feels the feedback torque through the hand wheel. The controller should consider the driver's impact on the steering dynamics to achieve a better performance in terms of driver's acceptance and comfort. In this paper we present a predictive control framework which uses a model of driver-in-the-loop steering dynamics to optimise the torque intervention with respect to the driver's neuromuscular response. We first validate the system in simulations to compare the performance of the controller in nominal and model mismatch cases. Then we implement the controller in a test vehicle and perform experiments with a human driver. The results show the effectiveness of the proposed system in avoiding hazardous situations under different driver behaviours.

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

Systemic safety project selection tool.

DOT National Transportation Integrated Search

2013-07-01

"The Systemic Safety Project Selection Tool presents a process for incorporating systemic safety planning into traditional safety management processes. The Systemic Tool provides a step-by-step process for conducting systemic safety analysis; conside...

Surveillance of traumatic firefighter fatalities: an assessment of four systems.

PubMed

Estes, Chris R; Marsh, Suzanne M; Castillo, Dawn N

2011-01-01

Firefighters regularly respond to hazardous situations that put them at risk for fatal occupational injuries. Traumatic occupational fatality surveillance is a foundation for understanding the problem and developing prevention strategies. We assessed four surveillance systems for their utility in characterizing firefighter fatalities and informing prevention measures. We examined three population-based systems (the Bureau of Labor Statistics' Census of Fatal Occupational Injuries and systems maintained by the United States Fire Administration and the National Fire Protection Association) and one case-based system (data collected through the National Institute for Occupational Safety and Health Fire Fighter Fatality Investigation and Prevention Program). From each system, we selected traumatic fatalities among firefighters for 2003-2006. Then we compared case definitions, methods for case ascertainment, variables collected, and rate calculation methods. Overall magnitude of fatalities differed among systems. The population-based systems were effective in characterizing the circumstances of traumatic firefighter fatalities. The case-based surveillance system was effective in formulating detailed prevention recommendations, which could not be made based on the population-based data alone. Methods for estimating risk were disparate and limited fatality rate comparisons between firefighters and other workers. The systems included in this study contribute toward a greater understanding of firefighter fatalities. Areas of improvement for these systems should continue to be identified as they are used to direct research and prevention efforts.

Challenges in Achieving Trajectory-Based Operations

NASA Technical Reports Server (NTRS)

Cate, Karen Tung

2012-01-01

In the past few years much of the global ATM research community has proposed advanced systems based on Trajectory-Based Operations (TBO). The concept of TBO uses four-dimensional aircraft trajectories as the base information for managing safety and capacity. Both the US and European advanced ATM programs call for the sharing of trajectory data across different decision support tools for successful operations. However, the actual integration of TBO systems presents many challenges. Trajectory predictors are built to meet the specific needs of a particular system and are not always compatible with others. Two case studies are presented which examine the challenges of introducing a new concept into two legacy systems in regards to their trajectory prediction software. The first case describes the issues with integrating a new decision support tool with a legacy operational system which overlap in domain space. These tools perform similar functions but are driven by different requirements. The difference in the resulting trajectories can lead to conflicting advisories. The second case looks at integrating this same new tool with a legacy system originally developed as an integrated system, but diverged many years ago. Both cases illustrate how the lack of common architecture concepts for the trajectory predictors added cost and complexity to the integration efforts.

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

Developing a national framework for safe drinking water--case study from Iceland.

PubMed

Gunnarsdottir, Maria J; Gardarsson, Sigurdur M; Bartram, Jamie

2015-03-01

Safe drinking water is one of the fundaments of society and experience has shown that a holistic national framework is needed for its effective provision. A national framework should include legal requirements on water protection, surveillance on drinking water quality and performance of the water supply system, and systematic preventive management. Iceland has implemented these requirements into legislation. This case study analyzes the success and challenges encountered in implementing the legislation and provide recommendations on the main shortcomings identified through the Icelandic experience. The results of the analysis show that the national framework for safe drinking water is mostly in place in Iceland. The shortcomings include the need for both improved guidance and control by the central government; and for improved surveillance of the water supply system and implementation of the water safety plan by the Local Competent Authorities. Communication to the public and between stakeholders is also insufficient. There is also a deficiency in the national framework regarding small water supply systems that needs to be addressed. Other elements are largely in place or on track. Most of the lessons learned are transferable to other European countries where the legal system around water safety is built on a common foundation from EU directives. The lessons can also provide valuable insights into how to develop a national framework elsewhere. Copyright © 2014 Elsevier GmbH. All rights reserved.

Safety evaluation of traces of nickel and chrome in cosmetics: The case of Dead Sea mud.

PubMed

Ma'or, Ze'evi; Halicz, Ludwik; Portugal-Cohen, Meital; Russo, Matteo Zanotti; Robino, Federica; Vanhaecke, Tamara; Rogiers, Vera

2015-12-01

Metal impurities such as nickel and chrome are present in natural ingredients-containing cosmetic products. These traces are unavoidable due to the ubiquitous nature of these elements. Dead Sea mud is a popular natural ingredient of cosmetic products in which nickel and chrome residues are likely to occur. To analyze the potential systemic and local toxicity of Dead Sea mud taking into consideration Dead Sea muds' natural content of nickel and chrome. The following endpoints were evaluated: (Regulation No. 1223/20, 21/12/2009) systemic and (SCCS's Notes of Guidance) local toxicity of topical application of Dead Sea mud; health reports during the last five years of commercial marketing of Dead Sea mud. Following exposure to Dead Sea mud, MoS (margin of safety) calculations for nickel and chrome indicate no toxicological concern for systemic toxicity. Skin sensitization is also not to be expected by exposure of normal healthy skin to Dead Sea mud. Topical application, however, is not recommended for already nickel-or chrome-sensitized persons. As risk assessment of impurities present in cosmetics may be a difficult exercise, the case of Dead Sea mud is taken here as an example of a natural material that may contain traces of unavoidable metals. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Mission-Oriented Sensor Arrays and UAVs - a Case Study on Environmental Monitoring

NASA Astrophysics Data System (ADS)

Figueira, N. M.; Freire, I. L.; Trindade, O.; Simões, E.

2015-08-01

This paper presents a new concept of UAV mission design in geomatics, applied to the generation of thematic maps for a multitude of civilian and military applications. We discuss the architecture of Mission-Oriented Sensors Arrays (MOSA), proposed in Figueira et Al. (2013), aimed at splitting and decoupling the mission-oriented part of the system (non safety-critical hardware and software) from the aircraft control systems (safety-critical). As a case study, we present an environmental monitoring application for the automatic generation of thematic maps to track gunshot activity in conservation areas. The MOSA modeled for this application integrates information from a thermal camera and an on-the-ground microphone array. The use of microphone arrays technology is of particular interest in this paper. These arrays allow estimation of the direction-of-arrival (DOA) of the incoming sound waves. Information about events of interest is obtained by the fusion of the data provided by the microphone array, captured by the UAV, fused with information from the termal image processing. Preliminary results show the feasibility of the on-the-ground sound processing array and the simulation of the main processing module, to be embedded into an UAV in a future work. The main contributions of this paper are the proposed MOSA system, including concepts, models and architecture.

Developing and deploying a patient safety program in a large health care delivery system: you can't fix what you don't know about.

PubMed

Bagian, J P; Lee, C; Gosbee, J; DeRosier, J; Stalhandske, E; Eldridge, N; Williams, R; Burkhardt, M

2001-10-01

The Veterans Administration (VA) identified patient safety as a high-priority issue in 1997 and implemented the Patient Safety Improvement (PSI) initiative throughout its entire health care system. In spring 1998 the External Panel on Patient Safety System Design recommended alternative methods to enhance reporting and thereby improve patient safety. REDESIGNING THE PSI INITIATIVE: The VA began redesigning the PSI initiative in late 1998. The dedicated National Center for Patient Safety (NCPS) was established. Using the panel's recommendations as a jumping-off point, NCPS began to identify known and suspected obstacles to implementation (such as possible punitive consequences and additional workload). NCPS adopted a prioritization scoring method, the Safety Assessment Code (SAC) Matrix, for close calls and adverse events, which requires assessing the event's actual or potential severity and the probability of occurrence. The SAC Matrix specifies actions that must be taken for given scores. Use of the SAC score permits a consistent handling of reports throughout the VA system and a rational selection of cases to be considered. A system for performing a root cause analysis (RCA) was developed to guide caregivers at the frontline. This system includes a computer-aided tool, a flipbook containing a series of six questions, and reporting of the findings back to the reporter. The final step requires that the facility's chief executive officer "concur" or "nonconcur" on each recommended corrective action. The RCA team outlines how the effectiveness of the corrective action will be evaluated to verify that the action has had the intended effect, and it ascertains that there were no unintended negative consequences. Based on successful implementation in two pilots, full-scale national rollout to the 173 facilities began in April 2000 and was concluded by the end of August 2000. NCPS supplied 3 days of training for individuals at each facility. The training included didactic components, an introduction to human factors engineering concepts, and small- and large-group simulation exercises. Facility leaders were reminded of the necessity to reinforce the point that assignment to an RCA team was considered an important duty. It is essential to design and implement a system that takes into account the concerns of the frontline personnel and is aimed at being a tool for learning and not accountability. The system must have as its primary focus the dissemination of positive actions that reduce or eliminate vulnerabilities that have been identified, not a counting exercise of the number of reports.

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

Serving up food safety: who wants a piece of the pie?

PubMed

Schmidt, C W

2001-07-01

A total of 12 federal agencies, plus their state counterparts, contribute to the regulatory snarl that governs the safety of the American food supply. With so much federal oversight, one might expect U.S. foods to be virtually risk-free. But this is hardly the case; contaminated food is responsible for 75 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. Recent reports from the General Accounting Office and the National Research Council claim that creation of a single agency with centralized authority is the best solution to U.S. food safety problems. Some experts agree that regulatory gaps in food safety highlight the need for centralized leadership, and that more money is necessary to fund the number of inspectors needed to adequately inspect the food supply before it reaches consumers. The single-agency concept has garnered congressional, industry, and scientific support, but the idea isn't without its skeptics, who believe that consolidating food safety under a single agency eliminates checks and balances offered by the current system and, more importantly, runs the risk of politicizing the agency.

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.

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The safety management system must document the responsible person's— (1) Safety and pollution prevention...

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…

Westinghouse Small Modular Reactor passive safety system response to postulated events

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

Smith, M. C.; Wright, R. F.

2012-07-01

The Westinghouse Small Modular Reactor (SMR) is an 800 MWt (>225 MWe) integral pressurized water reactor. This paper is part of a series of four describing the design and safety features of the Westinghouse SMR. This paper focuses in particular upon the passive safety features and the safety system response of the Westinghouse SMR. The Westinghouse SMR design incorporates many features to minimize the effects of, and in some cases eliminates the possibility of postulated accidents. The small size of the reactor and the low power density limits the potential consequences of an accident relative to a large plant. Themore » integral design eliminates large loop piping, which significantly reduces the flow area of postulated loss of coolant accidents (LOCAs). The Westinghouse SMR containment is a high-pressure, compact design that normally operates at a partial vacuum. This facilitates heat removal from the containment during LOCA events. The containment is submerged in water which also aides the heat removal and provides an additional radionuclide filter. The Westinghouse SMR safety system design is passive, is based largely on the passive safety systems used in the AP1000{sup R} reactor, and provides mitigation of all design basis accidents without the need for AC electrical power for a period of seven days. Frequent faults, such as reactivity insertion events and loss of power events, are protected by first shutting down the nuclear reaction by inserting control rods, then providing cold, borated water through a passive, buoyancy-driven flow. Decay heat removal is provided using a layered approach that includes the passive removal of heat by the steam drum and independent passive heat removal system that transfers heat from the primary system to the environment. Less frequent faults such as loss of coolant accidents are mitigated by passive injection of a large quantity of water that is readily available inside containment. An automatic depressurization system is used to reduce the reactor pressure in a controlled manner to facilitate the passive injection. Long-term decay heat removal is accomplished using the passive heat removal systems augmented by heat transfer through the containment vessel to the environment. The passive injection systems are designed so that the fuel remains covered and effectively cooled throughout the event. Like during the frequent faults, the passive systems provide effective cooling without the need for ac power for seven days following the accident. Connections are available to add additional water to indefinitely cool the plant. The response of the safety systems of the Westinghouse SMR to various initiating faults has been examined. Among them, two accidents; an extended station blackout event, and a LOCA event have been evaluated to demonstrate how the plant will remain safe in the unlikely event that either should occur. (authors)« less

[Accelerated desensitization for hymenoptera venom allergy in 30 hours: efficacy and safety in 150 cases].

PubMed

van der Brempt, X; Ledent, C; Mairesse, M

1997-06-01

In this study, we performed 150 desensitizations in 139 Hymenoptera venom allergic patients (109 Yellow jacket allergic patients, 19 Honey bee allergic patients and 11 patients sensitized to both insects, who received a dual desensitization). We used a rush protocol, allowing injection of a total cumulated dose of 125,1 (Honey bee) to 175,1 (Yellow jacket) microgram of venom in 30 hours. Patients were hospitalized, with all emergency precautions for treating systemic reactions. The protocol was well tolerated in 147/150 cases; 3 patients had a benign systemic reaction. Patients received monthly maintenance doses of 100 micrograms venom. 39 patients experienced a field sting during immunotherapy; 2 of them (5%) had a benign systemic reaction. Thus, our rush desensitization protocol seems to be safe and effective.

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.

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.

Seeking perfection in healthcare. A case study in adopting Toyota Production System methods.

PubMed

Kaplan, Gary S; Patterson, Sarah H

2008-01-01

Virginia Mason Health System's vision to be the quality leader in healthcare means continually adopting new ways of thinking. One change has been shifting from believing defects are to be expected to believing zero defects in healthcare is not only possible, but also necessary. Generally, healthcare has advanced in technology and understanding of disease, but its business and management systems have changed little since the 1950s. Virginia Mason realized it needed a management method to help make real and measurable improvements in safety, quality, service and staff satisfaction.

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.

APT Blanket System Loss-of-Coolant Accident (LOCA) Based on Initial Conceptual Design - Case 2: with Beam Shutdown Only

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

Hamm, L.L.

1998-10-07

This report is one of a series of reports that document normal operation and accident simulations for the Accelerator Production of Tritium (APT) blanket heat removal system. These simulations were performed for the Preliminary Safety Analysis Report. This report documents the results of simulations of a Loss-of-Flow Accident (LOFA) where power is lost to all of the pumps that circulate water in the blanket region, the accelerator beam is shut off and neither the residual heat removal nor cavity flood systems operate.

Fatal and non-fatal injuries from vessels under air pressure in construction.

PubMed

Welch, L S; Weeks, J; Hunting, K L

1999-02-01

Using a surveillance system that captures data on construction workers treated in an urban emergency department, we identified a series of injuries caused by vessels and tools under air pressure. We describe those six cases, as well as similar cases found in the Census of Fatal Occupational Injuries; we also review data from the National Surveillance for Traumatic Occupational Fatalities database and data from the Bureau of Labor Statistics. Among the injuries and deaths for which we had good case descriptions, the majority would have been prevented by adherence to existing Occupational Safety and Health Administration standards in the construction industry.

Trans-arterial Onyx Embolization of a Functional Thoracic Paraganglioma

PubMed Central

Chacón-Quesada, Tatiana; Maud, Alberto; Ramos-Duran, Luis; Torabi, Alireza; Fitzgerald, Tamara; Akle, Nassim; Cruz Flores, Salvador; Trier, Todd

2015-01-01

Paragangliomas are rare tumors of the endocrine system. They are highly vascular and in some cases hormonally active, making their management challenging. Although there is strong evidence of the safety and effectiveness of preoperative embolization in the management of spinal tumors, only five cases have been reported in the setting of thoracic paragangliomas. We present the case of a 19-year-old man with a large, primary, functional, malignant paraganglioma of the thoracic spine causing a vertebral fracture and spinal cord compression. To our knowledge this is the first report of preoperative trans-arterial balloon augmented Onyx embolization of a thoracic paraganglioma. PMID:25763296

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.

Safer Systems: A NextGen Aviation Safety Strategic Goal

NASA Technical Reports Server (NTRS)

Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

2008-01-01

The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment Network (CISA) 2004-2009

PubMed Central

Williams, S Elizabeth; Klein, Nicola P; Halsey, Neal; Dekker, Cornelia L; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Sparks, Robert C; Tokars, Jerome I; Pahud, Barbara A; Aukes, Laurie; Jakob, Kathleen; Coronel, Silvia; Choi, Howard; Slade, Barbara A; Edwards, Kathryn M

2016-01-01

Background In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. PMID:21801776

[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.

Systematic Development of Intelligent Systems for Public Road Transport.

PubMed

García, Carmelo R; Quesada-Arencibia, Alexis; Cristóbal, Teresa; Padrón, Gabino; Alayón, Francisco

2016-07-16

This paper presents an architecture model for the development of intelligent systems for public passenger transport by road. The main objective of our proposal is to provide a framework for the systematic development and deployment of telematics systems to improve various aspects of this type of transport, such as efficiency, accessibility and safety. The architecture model presented herein is based on international standards on intelligent transport system architectures, ubiquitous computing and service-oriented architecture for distributed systems. To illustrate the utility of the model, we also present a use case of a monitoring system for stops on a public passenger road transport network.

Systematic Development of Intelligent Systems for Public Road Transport

PubMed Central

García, Carmelo R.; Quesada-Arencibia, Alexis; Cristóbal, Teresa; Padrón, Gabino; Alayón, Francisco

2016-01-01

This paper presents an architecture model for the development of intelligent systems for public passenger transport by road. The main objective of our proposal is to provide a framework for the systematic development and deployment of telematics systems to improve various aspects of this type of transport, such as efficiency, accessibility and safety. The architecture model presented herein is based on international standards on intelligent transport system architectures, ubiquitous computing and service-oriented architecture for distributed systems. To illustrate the utility of the model, we also present a use case of a monitoring system for stops on a public passenger road transport network. PMID:27438836

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

PubMed

Berends, B R; van Knapen, F

1999-10-01

Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences are that two parallel flows of meat and meat products may come to existence. One flow will exist of meat produced according to the new, and with respect to safety assurance, superior system. The other flow will consist of meat produced and inspected in the traditional way. However, this meat will contain all the flaws that required a revision of the system in the first place. This, and the fact that EU policy ordains that part-taking in an alternative meat inspection system should be voluntary, may very well result in a very slow start-up of the new system. One of the easiest solutions, however, would be to implement a decontamination step in the slaughtering process, provided that this is accompanied by strict codes of hygienic practices and good manufacturing practices. Not only would this lead to safer meat, but also result in the two separate flows of meat becoming one flow again as well as an easier to organize livestock production according to HACCP-principles.

Parental vaccine refusal in Wisconsin: a case-control study.

PubMed

Salmon, Daniel A; Sotir, Mark J; Pan, William K; Berg, Jeffrey L; Omer, Saad B; Stokley, Shannon; Hopfensperger, Daniel J; Davis, Jeffrey P; Halsey, Neal A

2009-02-01

Successful immunization programs have diminished parental fear of diseases and increased fear of vaccines. Children with nonmedical exemptions to school immunization requirements are at increased risk of acquiring and transmitting disease. We explored differences in vaccine attitudes, beliefs, and information sources among parents of exempt and vaccinated children. Self-administered surveys were mailed to 780 parents of children with nonmedical exemptions (cases) and 1491 parents of fully-vaccinated children (controls). Vaccines most often refused by exempt children were varicella (49%) and hepatitis B (30%). The most common reason for claiming exemptions was vaccine might cause harm (57%). Parents of vaccinated children were less likely than parents of exempt children to report concern about vaccine safety, question the need for immunization, and oppose immunization requirements. Nearly 25% of parents of vaccinated children reported that children get more immunizations than are good for them and 34% expressed concern that children's immune systems could be weakened by too many immunizations. Both groups received information from health care professionals; parents of exempt children were more likely to also consult other sources. Our findings support the need for improved methods to communicate vaccine safety information. Further studies to explore vaccine safety concerns among parents are needed.

The role of paediatric nurses in medication safety prior to the implementation of electronic prescribing: a qualitative case study.

PubMed

Farre, Albert; Heath, Gemma; Shaw, Karen; Jordan, Teresa; Cummins, Carole

2017-04-01

Objectives To explore paediatric nurses' experiences and perspectives of their role in the medication process and how this role is enacted in everyday practice. Methods A qualitative case study on a general surgical ward of a paediatric hospital in England, one year prior to the planned implementation of ePrescribing. Three focus groups and six individual semi-structured interviews were conducted, involving 24 nurses. Focus groups and interviews were audio-recorded, transcribed, anonymized and subjected to thematic analysis. Results Two overarching analytical themes were identified: the centrality of risk management in nurses' role in the medication process and the distributed nature of nurses' medication risk management practices. Nurses' contribution to medication safety was seen as an intrinsic feature of a role that extended beyond just preparing and administering medications as prescribed and placed nurses at the heart of a dynamic set of interactions, practices and situations through which medication risks were managed. These findings also illustrate the collective nature of patient safety. Conclusions Both the recognized and the unrecognized contributions of nurses to the management of medications needs to be considered in the design and implementation of ePrescribing systems.

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.

Drug safety in pregnancy--monitoring congenital anomalies.

PubMed

Morgan, Margery; De Jong-van den Berg, Lolkje T W; Jordan, Sue

2011-04-01

This paper outlines research into the causes of congenital anomalies, and introduces a pan-European study. The potential roles of nurses and midwives in this area are illustrated by a case report. Since the thalidomide disaster, use of drugs in pregnancy has been carefully monitored to prevent anything similar happening again. However, monitoring is incomplete and questions remain unanswered. Many medicines are essential for the health of pregnant women. However, drug use in pregnancy requires surveillance. Methods include spontaneous reporting of adverse events, cohort studies and case control studies. It is hoped that a Europe-wide study, combining data from several congenital anomaly registers, will provide a sufficiently large population to assess the impact of selected drugs on congenital anomalies. However, this work depends on the consistency of reporting by nurses and midwives. Drug safety in pregnancy remains undetermined. Collaboration across Europe has the potential to provide a framework for safety evaluation. Prescribers should consider the possibility of pregnancy in women of child-bearing age. Careful review of maternal drug use in early pregnancy is essential. Midwives and nurses should be aware of adverse event drug reporting systems, including congenital anomaly registers. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

Evaluation of the safety of mobile units for the conditioning of radioactive waste

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

Filss, Martin; Wallner, Christian

2013-07-01

In Germany mobile units are used to treat and condition radioactive waste. On behalf of the relevant authorities TUV SUD Industrie Service GmbH evaluates their safety. In this paper we outline the general procedure we apply and point out typical results. Generally, a generic safety case evaluates the effects of incidents and accidents and its consequences for the workers and the public. Special care is necessary to define the radioactive inventory, the nuclide composition and the mobility of the radioactive substances. A systems analysis is carried out. Typical aspects to be considered are the handling procedures, the measurement devices andmore » automatic actions. From the various possible malfunctions the critical ones have to be identified. Generally one or only a few scenarios have to be considered in detail. (authors)« less