Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

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

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

PubMed

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

2015-07-10

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

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.

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

NASA Astrophysics Data System (ADS)

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

2016-12-01

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

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

ERIC Educational Resources Information Center

Alberts, Caitlin M.; Stevenson, Clinton D.

2017-01-01

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

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

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

Safety Case Patterns: Theory and Applications

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.

2015-01-01

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

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

PubMed

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

2008-12-15

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

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.

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

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

Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

ERIC Educational Resources Information Center

Renfrew, Malcolm M., Ed.; Palladino, George F.

1980-01-01

Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

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)

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.

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

PubMed

Ahasan, M R; Partanen, T

2001-03-01

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

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

PubMed

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

2011-05-27

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

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

PubMed

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

2017-03-01

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

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

NASA Astrophysics Data System (ADS)

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

2012-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2008-01-01

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

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.

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.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Stephen B.

2010-01-01

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

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

PubMed Central

Etheridge, Kierstan; DeLellis, Teresa

2017-01-01

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

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

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.

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

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

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

PubMed

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

2017-12-01

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

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

Deep Borehole Disposal Safety Analysis.

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

Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

Lessons learnt from Dental Patient Safety Case Reports

PubMed Central

Obadan, Enihomo M.; Ramoni, Rachel B.; Kalenderian, Elsbeth

2015-01-01

Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety. PMID:25925524

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

PubMed

Tusé, Daniel

2011-03-01

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

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.

A Taxonomy of Fallacies in System Safety Arguments

NASA Technical Reports Server (NTRS)

Greenwell, William S.; Knight, John C.; Holloway, C. Michael; Pease, Jacob J.

2006-01-01

Safety cases are gaining acceptance as assurance vehicles for safety-related systems. A safety case documents the evidence and argument that a system is safe to operate; however, logical fallacies in the underlying argument may undermine a system s safety claims. Removing these fallacies is essential to reduce the risk of safety-related system failure. We present a taxonomy of common fallacies in safety arguments that is intended to assist safety professionals in avoiding and detecting fallacious reasoning in the arguments they develop and review. The taxonomy derives from a survey of general argument fallacies and a separate survey of fallacies in real-world safety arguments. Our taxonomy is specific to safety argumentation, and it is targeted at professionals who work with safety arguments but may lack formal training in logic or argumentation. We discuss the rationale for the selection and categorization of fallacies in the taxonomy. In addition to its applications to the development and review of safety cases, our taxonomy could also support the analysis of system failures and promote the development of more robust safety case patterns.

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

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

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

1997-07-01

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

Violence and School Safety. Case Citations, 2002.

ERIC Educational Resources Information Center

Russo, Charles J., Ed.; Mawdsley, Ralph D., Ed.

This publication highlights and explains some 400 court cases from 2002 involving issues of school violence and safety. It is divided into four sections, or topics: (1) "The Fourth Amendment: Search and Seizure" (R. Mawdsley); (2) "Negligence" (W. Evans, Jr.); (3) "Assault on School Personnel" (M. Yates); and (4) "Drugs and Weapons in Schools" (M.…

HSE's safety assessment principles for criticality safety.

PubMed

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

2008-06-01

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

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

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

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.

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.

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.

Collaborating with nurse leaders to develop patient safety practices.

PubMed

Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna

2017-07-03

Purpose The organisational level and leadership development are crucial elements in advancing patient safety, because patient safety weaknesses are often caused by system failures. However, little is known about how frontline leader and director teams can be supported to develop patient safety practices. The purpose of this study is to describe the patient safety development process carried out by nursing leaders and directors. The research questions were: how the chosen development areas progressed in six months' time and how nursing leaders view the participatory development process. Design/methodology/approach Participatory action research was used to engage frontline nursing leaders and directors into developing patient safety practices. Semi-structured group interviews ( N = 10) were used in data collection at the end of a six-month action cycle, and data were analysed using content analysis. Findings The participatory development process enhanced collaboration and gave leaders insights into patient safety as a part of the hospital system and their role in advancing it. The chosen development areas advanced to different extents, with the greatest improvements in those areas with simple guidelines to follow and in which the leaders were most participative. The features of high-reliability organisation were moderately identified in the nursing leaders' actions and views. For example, acting as a change agent to implement patient safety practices was challenging. Participatory methods can be used to support leaders into advancing patient safety. However, it is important that the participants are familiar with the method, and there are enough facilitators to steer development processes. Originality/value Research brings more knowledge of how leaders can increase their effectiveness in advancing patient safety and promoting high-reliability organisation features in the healthcare organisation.

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

NASA Technical Reports Server (NTRS)

Holloway, C. M.

2008-01-01

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

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

PubMed

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

2006-05-01

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

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.

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

PubMed

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

2007-05-01

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

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

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

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

DOT National Transportation Integrated Search

1981-09-01

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

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

PubMed

Koo, Otilia M Y; Varia, Sailesh A

2011-07-01

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

Generic health/safety/environment cases

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

Kelland, A.N.; Primrose, M.; Pickles, J.C.

1996-12-31

A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less

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

PubMed

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

2008-11-01

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

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

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

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

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

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2015-01-01

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

Global road safety online course development.

DOT National Transportation Integrated Search

2017-06-01

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

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

PubMed

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

2006-10-11

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

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

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

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

Science, safety, and trust: the case of transgenic food.

PubMed

Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

2013-02-01

Genetically modified (GM) food is discussed as an example of the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. On the whole, peer-reviewed studies on GM food safety do not note significant health risks, with a few exceptions, like the most renowned "Pusztai affair" and the recent "Seralini case." These latter studies have been disregarded by the scientific community, based on incorrect experimental designs and statistic analysis. Such contradictory results show the complexity of risk evaluation, and raise concerns in the citizen-consumers against the GM food. A thoughtful consideration by scientific community and decision makers of the moral values that are present in risk evaluation and risk management should be the most trustable answer to citizen-consumers to their claim for clear and definitive answers concerning safety/un-safety of GM food.

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

PubMed

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

2016-04-01

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

A systematic review of occupational safety and health business cases.

PubMed

Verbeek, Jos; Pulliainen, Marjo; Kankaanpää, Eila

2009-12-01

Business cases are commonly developed as means to rationalize investment. We systematically reviewed 26 reported cases on occupational safety and health (OSH) interventions to assess if health and productivity arguments make a good business case. To be included in the review, studies had to analyze the costs and benefits, including productivity, of an OSH intervention at the enterprise level. We searched Medline and Embase for studies and used Google search in addition. Two reviewers independently selected studies and extracted data. The intervention profitability was calculated in euros (euro in 2008) as the first year's benefits minus the total intervention costs per worker. The payback period was calculated as the intervention costs divided by the first year's benefits. We found three ex-ante and 23 ex-post cases. In 20 cases, the study design was a before-after comparison without a control group. Generally a 100% reduction of injuries or sickness absence was assumed. In two cases, productivity and quality increases were very large. The main benefit was avoided sick leave. Depreciation or discounting was applied only in a minority of cases. The intervention profitability was negative in seven studies, up to euro 500 per employee in 12 studies and more than euro 500 per employee in seven studies. The payback period was less than half a year for 19 studies. Only a few studies included sensitivity analyses. Few ex-ante business cases for management decisions on OSH are reported. Guidelines for reporting and evaluation are needed. Business cases need more sound assumptions on the effectiveness of interventions and should incorporate greater uncertainty into their design. Ex-post evaluation should be based preferably on study designs that control for trends at a time different from that of the intervention.

The reduction of a ""safety catastrophic'' potential hazard: A case history

NASA Technical Reports Server (NTRS)

Jones, J. P.

1971-01-01

A worst case analysis is reported on the safety of time watch movements for triggering explosive packages on the lunar surface in an experiment to investigate physical lunar structural characteristics through induced seismic energy waves. Considered are the combined effects of low pressure, low temperature, lunar gravity, gear train error, and position. Control measures constitute a seal control cavity and design requirements to prevent overbanking in the mainspring torque curve. Thus, the potential hazard is reduced to safety negligible.

Generalized implementation of software safety policies

NASA Technical Reports Server (NTRS)

Knight, John C.; Wika, Kevin G.

1994-01-01

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

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...

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

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

PubMed

Matsui, Yasuhiro; Oikawa, Shoko; Hitosugi, Masahito

2016-05-18

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

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

DOT National Transportation Integrated Search

2016-11-15

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

Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

PubMed

Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

2013-12-01

In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is

Safety Training--A Special Case?

ERIC Educational Resources Information Center

Cooper, Mark; Cotton, David

2000-01-01

Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

Safety in numbers: the development of Leapfrog's composite patient safety score for U.S. hospitals.

PubMed

Austin, J Matthew; D'Andrea, Guy; Birkmeyer, John D; Leape, Lucian L; Milstein, Arnold; Pronovost, Peter J; Romano, Patrick S; Singer, Sara J; Vogus, Timothy J; Wachter, Robert M

2014-03-01

To develop a composite patient safety score that provides patients, health-care providers, and health-care purchasers with a standardized method to evaluate patient safety in general acute care hospitals in the United States. The Leapfrog Group sought guidance from a panel of national patient safety experts to develop the composite score. Candidate patient safety performance measures for inclusion in the score were identified from publicly reported national sources. Hospital performance on each measure was converted into a "z-score" and then aggregated using measure-specific weights. A reference mean score was set at 3, with scores interpreted in terms of standard deviations above or below the mean, with above reflecting better than average performance. Twenty-six measures were included in the score. The mean composite score for 2652 general acute care hospitals in the United States was 2.97 (range by hospital, 0.46-3.94). Safety scores were slightly lower for hospitals that were publicly owned, rural in location, or had a larger percentage of patients with Medicaid as their primary insurance. The Leapfrog patient safety composite provides a standardized method to evaluate patient safety in general acute care hospitals in the United States. While constrained by available data and publicly reported scores on patient safety measures, the composite score reflects the best available evidence regarding a hospital's efforts and outcomes in patient safety. Additional analyses are needed, but the score did not seem to have a strong bias against hospitals with specific characteristics. The composite score will continue to be refined over time as measures of patient safety evolve.

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

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

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

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

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.

Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies.

PubMed

Coloma, Preciosa M; Becker, Benedikt; Sturkenboom, Miriam C J M; van Mulligen, Erik M; Kors, Jan A

2015-10-01

There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following associations as case studies: (1) rosiglitazone and cardiovascular events (i.e. stroke and myocardial infarction); and (2) human papilloma virus (HPV) vaccine and infertility. We collected publicly accessible, English-language posts on Facebook, Google+, and Twitter until September 2014. Data were queried for co-occurrence of keywords related to the drug/vaccine and event of interest within a post. Messages were analysed with respect to geographical distribution, context, linking to other web content, and author's assertion regarding the supposed association. A total of 2537 posts related to rosiglitazone/cardiovascular events and 2236 posts related to HPV vaccine/infertility were retrieved, with the majority of posts representing data from Twitter (98 and 85%, respectively) and originating from users in the US. Approximately 21% of rosiglitazone-related posts and 84% of HPV vaccine-related posts referenced other web pages, mostly news items, law firms' websites, or blogs. Assertion analysis predominantly showed affirmation of the association of rosiglitazone/cardiovascular events (72%; n = 1821) and of HPV vaccine/infertility (79%; n = 1758). Only ten posts described personal accounts of rosiglitazone/cardiovascular adverse event experiences, and nine posts described HPV vaccine problems related to infertility. Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

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

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

PubMed

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

2017-03-01

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

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

PubMed

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

2013-08-30

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

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

PubMed

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

2016-09-01

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

Development of photovoltaic array and module safety requirements

NASA Technical Reports Server (NTRS)

1982-01-01

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

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

PubMed

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

2018-06-15

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

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.

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

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

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

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

DOT National Transportation Integrated Search

2011-03-01

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

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

PubMed

Wu, Connor Y H; Loo, Becky P Y

2016-01-01

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

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

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

NASA Technical Reports Server (NTRS)

Hansen, Frederick D.; Pitts, Donald

2005-01-01

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

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

Development of a safety management protocol.

DOT National Transportation Integrated Search

2008-09-01

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

Microbiological food safety: a dilemma of developing societies.

PubMed

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

2014-11-01

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

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.

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

System safety in Stirling engine development

NASA Technical Reports Server (NTRS)

Bankaitis, H.

1981-01-01

The DOE/NASA Stirling Engine Project Office has required that contractors make safety considerations an integral part of all phases of the Stirling engine development program. As an integral part of each engine design subtask, analyses are evolved to determine possible modes of failure. The accepted system safety analysis techniques (Fault Tree, FMEA, Hazards Analysis, etc.) are applied in various degrees of extent at the system, subsystem and component levels. The primary objectives are to identify critical failure areas, to enable removal of susceptibility to such failures or their effects from the system and to minimize risk.

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

PubMed

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

2018-02-05

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

The potential for further development of passive safety.

PubMed

Frampton, Richard; Lenard, James

2009-10-01

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

The Potential for Further Development of Passive Safety

PubMed Central

Frampton, Richard; Lenard, James

2009-01-01

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

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

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

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

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

PubMed

Glenn, Kevin C

2008-01-01

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

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.

Statin-Associated Polymyalgia Rheumatica. An Analysis Using WHO Global Individual Case Safety Database: A Case/Non-Case Approach

PubMed Central

de Jong, Hilda J. I.; Saldi, Siti R. F.; Klungel, Olaf H.; Vandebriel, Rob J.; Souverein, Patrick C.; Meyboom, Ronald H. B.; Passier, J. L. M. (Anneke); van Loveren, Henk; Tervaert, Jan Willem Cohen

2012-01-01

Objective To assess whether there is an association between statin use and the occurrence of polymyalgia rheumatic (PMR) in the spontaneous reporting database of the World Health Organisation (WHO). Methods We conducted a case/non-case study based on individual case safety reports (ICSR) in the WHO global ICSR database (VigiBase). Case reports containing the adverse event term polymyalgia rheumatica (WHOART or MedDRA Preferred Term) were defined as cases. Non-cases were all case reports containing other adverse event terms. Each case was matched to five non-cases by age, gender, and time of reporting. Case reports regarding a statin as suspected or concomitant drug were identified using the Anatomical Therapeutic Chemical (ATC) classification. Multivariate logistic regression was used to calculate reporting odds ratios (RORs) with 95% confidence intervals (CI). Results We identified 327 reports of PMR as cases and 1635 reports of other ADRs as non-cases. Among cases, statins were more frequently reported as suspected agent (29.4%) compared to non-cases (2.9%). After adjustment for several covariates, statins were significantly associated with reports of PMR (ROR 14.21; 95% CI 9.89–20.85). Conclusion The results of this study lends support to previous anecdotal case reports in the literature suggesting that the use of a statin may be associated with the occurrence of PMR. Further studies are needed to study the strength of the association in more detail and to elucidate the underlying mechanism. PMID:22844450

Comparative Case Studies Of Corridor Safety Improvement Efforts

DOT National Transportation Integrated Search

1999-12-01

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

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

PubMed

Bhatti, Junaid A; Ahmed, Aizaz

2014-01-01

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

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

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

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

Development of the safety control framework for shield tunneling in close proximity to the operational subway tunnels: case studies in mainland China.

PubMed

Li, Xinggao; Yuan, Dajun

2016-01-01

China's largest cities like Beijing and Shanghai have seen a sharp increase in subway network development as a result of the rapid urbanization in the last decade. The cities are still expanding their subway networks now, and many shield tunnels are being or will be constructed in close proximity to the existing operational subway tunnels. The execution plans for the new nearby shield tunnel construction calls for the development of a safety control framework-a set of control standards and best practices to help organizations manage the risks involved. Typical case studies and relevant key technical parameters are presented with a view to presenting the resulting safety control framework. The framework, created through collaboration among the relevant parties, addresses and manages the risks in a systematic way based on actual conditions of each tunnel crossing construction. The framework consists of six parts: (1) inspecting the operational subway tunnels; (2) deciding allowed movements of the existing tunnels and tracks; (3) simulating effects of the shield tunneling on the existing tunnels; (4) doing preparation work; (5) monitoring design and information management; and (6) measures and activation mechanism of the countermeasures. The six components are explained and demonstrated in detail. In the end, discussions made involve construction and post-construction settlement of the operational tunnel, application of the remedial grouting to rectify excessive settlements of the operational tunnel, and use of the innovative tool of the optical fiber measurement for tunnel movement monitoring. It is concluded that the construction movement of the tunnel can be controlled within 15 mm when the shield machine is <7 m in excavation diameter. The post-construction settlement of the tunnel buried in the very soft ground is much greater than its construction settlement, and last several years until reaching a final stable state. Two cases are outlined to demonstrate the

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

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

2011-01-01

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

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.

Implementing Stakeholders' Access to Expertise: Experimenting on Nuclear Installations' Safety Cases - 12160

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

Gilli, Ludivine; Charron, Sylvie

2012-07-01

In 2009 and 2010, the Institute for Nuclear Safety and Radiation Protection (IRSN) led two pilot actions dealing with nuclear installations' safety cases. One concerned the periodical review of the French 900 MWe nuclear reactors, the other concerned the decommissioning of a workshop located on the site of Areva's La Hague fuel-reprocessing plant site in Northwestern France. The purpose of both these programs was to test ways for IRSN and a small number of stakeholders (Non-Governmental Organizations (NGOs) members, local elected officials, etc.) to engage in technical discussions. The discussions were intended to enable the stakeholders to review future applicationsmore » and provide valuable input. The test cases confirmed there is a definite challenge in successfully opening a meaningful dialogue to discuss technical issues, in particular the fact that most expertise reports were not public and the conflict that exists between the contrary demands of transparency and confidentiality of information. The test case also confirmed there are ways to further improvement of stakeholders' involvement. (authors)« less

The Development of Laboratory Safety Questionnaire for Middle School Science Teachers

ERIC Educational Resources Information Center

Akpullukcu, Simge; Cavas, Bulent

2017-01-01

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

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.

A conceptual framework to development of construction safety culture in Indonesia

NASA Astrophysics Data System (ADS)

Armyn Machfudiyanto, Rossy; Latief, Yusuf

2017-12-01

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

Developing and Testing the Health Care Safety Hotline

PubMed Central

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

2017-01-01

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

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.

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.

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

PubMed

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

2017-04-01

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

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

PubMed

Chen, Ching-Fu; Chen, Shu-Chuan

2012-07-01

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

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.

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

PubMed

Abdelrazik, Abeer Mohamed; Ezzat Ahmed, Ghada M

2016-02-01

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

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

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

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

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.

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

PubMed

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

2016-05-05

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

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

PubMed

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

2017-12-01

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

Development and Implementation of a Food Safety Knowledge Instrument

ERIC Educational Resources Information Center

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

2007-01-01

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

Understanding adolescent development: implications for driving safety.

PubMed

Keating, Daniel P

2007-01-01

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

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

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

Comparative safety assessment of plant-derived foods.

PubMed

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

2008-02-01

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

Development and validation of a remote home safety protocol.

PubMed

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

2018-02-01

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

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

PubMed

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

2015-01-01

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

Development and Validation of a Safety Climate Scale for Manufacturing Industry

PubMed Central

Ghahramani, Abolfazl; Khalkhali, Hamid R.

2015-01-01

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

Advanced Booster Composite Case/Polybenzimidazole Nitrile Butadiene Rubber Insulation Development

NASA Technical Reports Server (NTRS)

Gentz, Steve; Taylor, Robert; Nettles, Mindy

2015-01-01

The NASA Engineering and Safety Center (NESC) was requested to examine processing sensitivities (e.g., cure temperature control/variance, debonds, density variations) of polybenzimidazole nitrile butadiene rubber (PBI-NBR) insulation, case fiber, and resin systems and to evaluate nondestructive evaluation (NDE) and damage tolerance methods/models required to support human-rated composite motor cases. The proposed use of composite motor cases in Blocks IA and II was expected to increase performance capability through optimizing operating pressure and increasing propellant mass fraction. This assessment was to support the evaluation of risk reduction for large booster component development/fabrication, NDE of low mass-to-strength ratio material structures, and solid booster propellant formulation as requested in the Space Launch System NASA Research Announcement for Advanced Booster Engineering Demonstration and/or Risk Reduction. Composite case materials and high-energy propellants represent an enabling capability in the Agency's ability to provide affordable, high-performing advanced booster concepts. The NESC team was requested to provide an assessment of co- and multiple-cure processing of composite case and PBI-NBR insulation materials and evaluation of high-energy propellant formulations.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2014-04-01

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

System safety engineering in the development of advanced surface transportation vehicles

NASA Technical Reports Server (NTRS)

Arnzen, H. E.

1971-01-01

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

Occupational Safety and Health Programs in Career Education.

ERIC Educational Resources Information Center

DiCarlo, Robert D.; And Others

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

Development of Large-Scale Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

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

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

PubMed

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

2015-01-01

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

Interprofessional learning for medication safety.

PubMed

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

2014-07-01

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

Transit safety retrofit package development : final report.

DOT National Transportation Integrated Search

2014-07-01

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

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

PubMed

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

2018-01-01

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

Influence of professional drivers' personality traits on road traffic safety: case study.

PubMed

Živković, Snežana; Nikolić, Vesna; Markič, Mirko

2015-01-01

The purpose of this paper is to present basic elements of the research directed at identifying and determining the personality traits of professional drivers that affect safe, secure and enjoyable ride on public roads. A quantitative method has been used here, whereas data were acquired from a questionnaire based on a sample of 59 professional drivers. Determining personality traits of professional drivers that are in correlation with a safe and pleasant ride on the roads has been enabled by applying the five-factor model of personality ('Big Five') and the Personality Inventory NEO-PI. From these results it was concluded that safe operation of the vehicle in traffic involves the successful 'conduct' of oneself, which recognises the importance of certain personality traits of professional drivers for traffic safety and the need for appropriate professional selection in the case of employment of professional drivers. Research results implicate development of educational programmes aimed at achieving harmony of psychological, physical and sensory health, that is, programmes for permanent informing, educating and training professional drivers for defensive driving. The research opens the way for new research tasks that should help in creating a specific structure of curricula that can be used in a variety of transportation companies and enterprises to improve general and public safety.

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

PubMed

Stewart, Lee; Usher, Kim

2010-11-01

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

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

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

Crude versus case-mix-adjusted control charts for safety monitoring in thyroid surgery.

PubMed

Duclos, Antoine; Voirin, Nicolas; Touzet, Sandrine; Soardo, Pietro; Schott, Anne-Marie; Colin, Cyrille; Peix, Jean-Louis; Lifante, Jean-Christophe

2010-12-01

Patient-safety monitoring based on health-outcome indicators can lead to misinterpretation of changes in case mix. This study aimed to compare the detection of indicator variations between crude and case-mix-adjusted control charts using data from thyroid surgeries. The study population included each patient who underwent thyroid surgery in a teaching hospital from January 2006 to May 2008. Patient safety was monitored according to two indicators, which are immediately recognisable postoperative complications: recurrent laryngeal nerve palsy and hypocalcaemia. Each indicator was plotted monthly on a p-control chart using exact limits. The weighted κ statistic was calculated to measure the agreement between crude and case-mix-adjusted control charts. We evaluated the outcomes of 1405 thyroidectomies. The overall proportions of immediate recurrent laryngeal nerve palsy and hypocalcaemia were 7.4% and 20.5%, respectively. The proportion of agreement in the detection of indicator variations between the crude and case-mix-adjusted p-charts was 95% (95% CI 85% to 99%). The strength of the agreement was κ = 0.76 (95% CI 0.54 to 0.98). The single special cause of variation that occurred was only detected by the case-mix-adjusted p-chart. There was good agreement in the detection of indicator variations between crude and case-mix-adjusted p-charts. The joint use of crude and adjusted charts seems to be a reasonable approach to increase the accuracy of interpretation of variations in outcome indicators.

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

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.

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

DOT National Transportation Integrated Search

1995-01-01

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

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.

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

PubMed

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

2012-01-01

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

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

PubMed

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

2007-10-01

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

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

Code of Federal Regulations, 2011 CFR

2011-01-01

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

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

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

2007-01-01

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

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

PubMed

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

2014-07-01

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

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.

Development of instruction in hospital electrical safety for medical education.

PubMed

Yoo, J H; Broderick, W A

1978-01-01

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

Transit safety retrofit package development : applications requirements document.

DOT National Transportation Integrated Search

2014-05-01

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

Development of a British Road Safety Education Support Materials Curriculum.

ERIC Educational Resources Information Center

Bouck, Linda H.

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

The Development and Deployment of a Maintenance Operations Safety Survey.

PubMed

Langer, Marie; Braithwaite, Graham R

2016-11-01

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

The Development and Deployment of a Maintenance Operations Safety Survey

PubMed Central

Langer, Marie; Braithwaite, Graham R.

2016-01-01

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

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-03-28

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

Extending Safety Culture Development through Communication - 12366

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

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

2012-07-01

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

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

PubMed Central

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

2014-01-01

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

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

PubMed Central

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

2007-01-01

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

Developing an educational safety program for pharmacy employees.

PubMed

Hayman, J N

1980-02-01

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

Development of E-Learning Materials for Machining Safety Education

NASA Astrophysics Data System (ADS)

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

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

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

PubMed Central

2014-01-01

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

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

PubMed

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

2014-01-01

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

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

PubMed

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

2010-01-01

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

Supervisor Health and Safety Support: Scale Development and Validation

PubMed Central

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

2013-01-01

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

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

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

PubMed

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

2017-08-01

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

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

NASA Technical Reports Server (NTRS)

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

2008-01-01

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

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

PubMed

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

2018-02-01

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

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

PubMed

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

2010-12-01

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

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

PubMed Central

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

2015-01-01

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

Child Development Associate. Safety for Young Children.

ERIC Educational Resources Information Center

Oscar Rose Junior Coll., Midwest City, OK.

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

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.

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

PubMed

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

2016-01-01

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

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS

EPA Science Inventory

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

A multi-stakeholder series of discussions d...

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.

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

PubMed

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

2017-12-01

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

Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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

2017-06-01

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

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-11-08

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

Development of safety performance monitoring procedures.

DOT National Transportation Integrated Search

2010-02-01

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

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.

Development of safety performance functions for North Carolina.

DOT National Transportation Integrated Search

2011-12-06

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

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.

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

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

[Cardiac safety of electroconvulsive therapy in an elderly patient--a case report].

PubMed

Karakuła-Juchnowicz, Hanna; Próchnicki, Michał; Kiciński, Paweł; Olajossy, Marcin; Pelczarska-Jamroga, Agnieszka; Dzikowski, Michał; Jaroszyński, Andrzej

2015-10-01

Since electroconvulsive therapy (ECT) was introduced as treatment for psychiatric disorders in 1938, it has remained one of the most effective therapeutic methods. ECT is often used as a "treatment of last resort" when other methods fail, and a life-saving procedure in acute clinical states when a rapid therapeutic effect is needed. Mortality associated with ECT is lower, compared to the treatment with tricyclic antidepressants, and comparable to that observed in so-called minor surgery. In the literature, cases of effective and safe electroconvulsive therapy have been described in patients of advanced age, with a burden of many somatic disorders. However, cases of acute cardiac episodes have also been reported during ECT. The qualification of patients for ECT and the selection of a group of patients at the highest risk of cardiovascular complications remains a serious clinical problem. An assessment of the predictive value of parameters of standard electrocardiogram (ECG), which is a simple, cheap and easily available procedure, deserves special attention. This paper reports a case of a 74-year-old male patient treated with ECT for a severe depressive episode, in the context of cardiologic safety. Both every single ECT session and the full course were assessed to examine their impact on levels of troponin T, which is a basic marker of cardiac damage, and selected ECG parameters (QTc, QRS). In the presented case ECT demonstrated its high general and cardiac safety with no negative effect on cardiac troponin (TnT) levels, corrected QT interval (QTc) duration, or other measured ECG parameters despite initially increased troponin levels, the patient's advanced age, the burden of a severe somatic disease and its treatment (anticancer therapy). © 2015 MEDPRESS.

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

PubMed

Habbema, Louis

2009-11-01

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

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

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

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

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

PubMed

Twyman, Stephanie; Fahey, Erin; Lehna, Carlee

2014-01-01

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

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.

Nuclear-safety institution in France: emergence and development

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

Vallet, B.M.

1986-01-01

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

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

NASA Astrophysics Data System (ADS)

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

2016-03-01

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

The development and efficacy of safety training for commercial fishermen.

PubMed

Dzugan, Jerry

2010-10-01

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

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

PubMed

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

2014-05-01

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

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

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

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

2012-11-15

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

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

PubMed

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

2018-01-01

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

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

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

2004-01-01

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

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

PubMed

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

2018-01-01

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

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

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.

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

PubMed

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

2004-11-01

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

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 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.

Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

PubMed

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; De Maeyer, J H; Stanghellini, V

2012-04-01

The nonselective 5-HT(4) receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT(4) agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006-2008 and DDW 2008-2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT(4) agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT(4) agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT(1) receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT(4) agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT(4) agonists with no hERG or 5-HT(1) affinity (renzapride, clebopride, mosapride). 5-HT(4) agonists for GI disorders differ in chemical structure and selectivity for 5-HT(4) receptors. Selectivity for 5-HT(4) over non-5-HT(4) receptors may influence the agent's safety and overall risk-benefit profile. Based on available evidence, highly selective 5-HT(4) agonists may offer improved safety to treat patients with impaired GI motility. © 2012 Blackwell Publishing Ltd.

Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

PubMed Central

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

2012-01-01

Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

The Exposure Index: Developing firefighter safety performance measures

Treesearch

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

2011-01-01

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

The development of an inherent safety approach to the prevention of domino accidents.

PubMed

Cozzani, Valerio; Tugnoli, Alessandro; Salzano, Ernesto

2009-11-01

The severity of industrial accidents in which a domino effect takes place is well known in the chemical and process industry. The application of an inherent safety approach for the prevention of escalation events leading to domino accidents was explored in the present study. Reference primary scenarios were analyzed and escalation vectors were defined. Inherent safety distances were defined and proposed as a metric to express the intensity of the escalation vectors. Simple rules of thumb were presented for a preliminary screening of these distances. Swift reference indices for layout screening with respect to escalation hazard were also defined. Two case studies derived from existing layouts of oil refineries were selected to understand the potentialities coming from the application in the methodology. The results evidenced that the approach allows a first comparative assessment of the actual domino hazard in a layout, and the identification of critical primary units with respect to escalation events. The methodology developed also represents a useful screening tool to identify were to dedicate major efforts in the design of add-on measures, optimizing conventional passive and active measures for the prevention of severe domino accidents.

Ready to Respond: Case Studies in Campus Safety and Security

ERIC Educational Resources Information Center

Hyatt, James A.

2010-01-01

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

Safety analysis in test facility design

NASA Astrophysics Data System (ADS)

Valk, A.; Jonker, R. J.

1990-09-01

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

Framework Development Supporting the Safety Portal

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

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

2015-07-01

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

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

PubMed Central

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

2011-01-01

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

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

DOT National Transportation Integrated Search

2012-03-01

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

Railway safety climate: a study on organizational development.

PubMed

Cheng, Yung-Hsiang

2017-09-07

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

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

PubMed Central

RADOVIĆ, Vesela; KEKOVIĆ, Zoran; AGIĆ, Samir

2014-01-01

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

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

[Agricultural biotechnology safety assessment].

PubMed

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

2015-01-01

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

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

PubMed

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

2017-12-22

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

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

PubMed Central

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

2017-01-01

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

Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases.

PubMed

Gershman, Evgeni; Fruchter, Oren; Benjamin, Fox; Nader, Abed Rahman; Rosengarten, Dror; Rusanov, Victoria; Fridel, Ludmila; Kramer, Mordechai R

2015-01-01

Transbronchial biopsy (TBB) which is performed with metal forceps (forceps TBB) has been accepted as a useful technique in establishing diagnoses of diffuse lung diseases (DLDs). The use of cryoprobes to obtain alveolar tissue (cryo-TBB) is a new method which is currently used by our institute as well as others with excellent results. To assess the safety of cryo-TBB compared with conventional forceps TBB. We performed a retrospective data evaluation of 300 consecutive patients who underwent cryo-TBB between January 2012 and April 2014 and compared them with historical cases treated with forceps TBB between 2010 and 2012. The results of both diagnostic modalities were compared based on pathological reports. The major complications (significant bleeding and pneumothorax) were compared, along with postprocedural hospitalization. Pneumothorax was observed in 15 cases (4.95%) treated with cryo-TBB versus 9 cases (3.15%) treated with forceps TBB, with no significant difference (p = 0.303). The insertion of a chest tube was necessary in 6 (2%) and 4 (1.3%) of the cases having undergone cryo-TBB or forceps TBB, respectively (p = 0.8). In the cryo-TBB group, bleeding was encountered in 16 cases (5.2%), and it occurred in 13 cases (4.5%) of the forceps TBB group, with no significant difference in rates (p = 0.706). Also, there was no significant difference in hospital admission rates between the groups [cryo-TBB: 10 (3.3%); forceps TBB: 4 (1.44%); p = 0.181]. The safety profile of cryo- and forceps TBB remained the same even when stratified according to indications for TBB, i.e. immunocompromised hosts, patients after lung transplantation and those with DLDs. In patients with DLDs, cryo-TBB is as safe as forceps TBB.

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

PubMed

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

2016-10-28

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

'Geo'chemical research: a key building block for nuclear waste disposal safety cases.

PubMed

Altmann, Scott

2008-12-12

Disposal of high level radioactive waste in deep underground repositories has been chosen as solution by several countries. Because of the special status this type waste has in the public mind, national implementation programs typically mobilize massive R&D efforts, last decades and are subject to extremely detailed and critical social-political scrutiny. The culminating argument of each program is a 'Safety Case' for a specific disposal concept containing, among other elements, the results of performance assessment simulations whose object is to model the release of radionuclides to the biosphere. Public and political confidence in performance assessment results (which generally show that radionuclide release will always be at acceptable levels) is based on their confidence in the quality of the scientific understanding in the processes included in the performance assessment model, in particular those governing radionuclide speciation and mass transport in the geological host formation. Geochemistry constitutes a core area of research in this regard. Clay-mineral rich formations are the subjects of advanced radwaste programs in several countries (France, Belgium, Switzerland...), principally because of their very low permeabilities and demonstrated capacities to retard by sorption most radionuclides. Among the key processes which must be represented in performance assessment models are (i) radioelement speciation (redox state, speciation, reactions determining radionuclide solid-solution partitioning) and (ii) diffusion-driven transport. The safety case must therefore demonstrate a detailed understanding of the physical-chemical phenomena governing the effects of these two aspects, for each radionuclide, within the geological barrier system. A wide range of coordinated (and internationally collaborated) research has been, and is being, carried out in order to gain the detailed scientific understanding needed for constructing those parts of the Safety Case

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.

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

DOT National Transportation Integrated Search

2015-06-01

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

Development of a conceptual integrated traffic safety problem identification database

DOT National Transportation Integrated Search

1999-12-01

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

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…

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

PubMed

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

2017-04-01

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

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

ERIC Educational Resources Information Center

Dyrenfurth, Michael; Linhardt, Richard

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

Advancing the hydrogen safety knowledge base

DOE PAGES

Weiner, S. C.

2014-08-29

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

A framework for the development of patient safety education and training guidelines.

PubMed

Zikos, Dimitrios; Diomidous, Marianna; Mantas, John

2010-01-01

Patient Safety (PS) is a major concern that involves a wide range of roles in healthcare, including those who are directly and indirectly involved, and patients as well. In order to succeed into developing a safety culture among healthcare providers, carers and patients, there should be given great attention into building appropriate education and training tools, especially addressing those who plan patient safety activities. The framework described in this policy paper is based on the results of the European Network for Patient Safety (EUNetPaS) project and analyses the principles and elements of the guidance that should be provided to those who design and implement Patient Safety Education and training activities. The main principles that it should be based on and the core teaching objectives-expected outcomes are addressed. Once the main context and considerations are properly set, the guidance should define the general schema of the content that should be included in the Education and Training activities, as well as how these activities would be delivered. It is also important that the different roles of the recipients are clearly distinguished and linked to their role-specific methods, proper delivery platforms and success stories. Setting these principles into practice when planning and implementing interventions, primarily aims to enlighten and support those who are enrolled to design and implement Patient Safety education and training teaching activities. This is achieved by providing them with a framework to build upon, succeeding to build a collaborative, safety conscious and competent environment, in terms of PS. A guidelines web platform has been developed to support this process.

The need for strategic development of safety sciences.

PubMed

Busquet, Francois; Hartung, Thomas

2017-01-01

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

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

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

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

PubMed

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

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

School Bus Fleet Safety: Planning and Development.

ERIC Educational Resources Information Center

Bieber, Robert M.

1984-01-01

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

Stories from the Sharp End: Case Studies in Safety Improvement

PubMed Central

McCarthy, Douglas; Blumenthal, David

2006-01-01

Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

Development of a large truck safety data needs study plan. Vol. 1, Summary

DOT National Transportation Integrated Search

1986-02-01

This report discusses the results of a study to determine the data needs necessary to address truck safety issues and to develop a data collection and analysis plan. Priority truck safety issues that are amenable to truck accident data analyses were ...

Organizational Effectiveness Case Development Manual

DTIC Science & Technology

1980-10-01

Target audience Legal issues UAmographic information Sanctions Write-up format L eaching case Pay-off s The manual is a guide for developing...most efficient and effective way. The manual is divided into three main sections: (1) on the issues of client system sanction, confidentiality, and...CASE DEVELOPMENT MANUAL James Bedoian, Larry E. Greiner, Charles P. Schaefer, Warren H. Schmidt, Stanley R. Weingart System Development Corporation

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

PubMed

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

2014-04-01

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

Reducing medication errors and increasing patient safety: case studies in clinical pharmacology.

PubMed

Benjamin, David M

2003-07-01

Today, reducing medication errors and improving patient safety have become common topics of discussion for the president of the United States, federal and state legislators, the insurance industry, pharmaceutical companies, health care professionals, and patients. But this is not news to clinical pharmacologists. Improving the judicious use of medications and minimizing adverse drug reactions have always been key areas of research and study for those working in clinical pharmacology. However, added to the older terms of adverse drug reactions and rational therapeutics, the now politically correct expression of medication error has emerged. Focusing on the word error has drawn attention to "prevention" and what can be done to minimize mistakes and improve patient safety. Webster's New Collegiate Dictionary has several definitions of error, but the one that seems to be most appropriate in the context of medication errors is "an act that through ingnorance, deficiency, or accident departs from or fails to achieve what should be done." What should be done is generally known as "the five rights": the right drug, right dose, right route, right time, and right patient. One can make an error of omission (failure to act correctly) or an error of commission (acted incorrectly). This article now summarizes what is currently known about medication errors and translates the information into case studies illustrating common scenarios leading to medication errors. Each case is analyzed to provide insight into how the medication error could have been prevented. "System errors" are described, and the application of failure mode effect analysis (FMEA) is presented to determine the part of the "safety net" that failed. Examples of reengineering the system to make it more "error proof" are presented. An error can be prevented. However, the practice of medicine, pharmacy, and nursing in the hospital setting is very complicated, and so many steps occur from "pen to patient" that there

Development of safety information materials and media plans for elderly pedestrians

DOT National Transportation Integrated Search

1993-06-01

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

Understanding procedural violations using Safety-I and Safety-II: The case of community pharmacies.

PubMed

Jones, Christian E L; Phipps, Denham L; Ashcroft, Darren M

2018-06-01

Procedural violations are known to occur in a range of work settings, and are an important topic of interest with regard to safety management. A Safety-I perspective sees violations as undesirable digressions from standardised procedures, while a Safety-II perspective sees violations as adaptations to a complex work system. This study aimed to apply both perspectives to the examination of violations in community pharmacies. Twenty-four participants (13 pharmacists and 11 pharmacy support staff) were purposively sampled to participate in semi-structured interviews using the critical incident technique. Participants described violations they made during the course of their work. Interviews were digitally recorded, transcribed verbatim and analysed using template analysis. Community pharmacies located in England and Wales. 31 procedural violations were described during the interviews revealing multiple reasons for violations in this setting. Our findings suggest that from a Safety-II perspective, staff violated to adapt to situations and to manage safety. However, participants also violated procedures in order to maintain productivity which was found to increase risk in some, but not all situations. Procedural violations often relied on the context in which staff were working, resulting in the violation being deemed rational to the individual making the violation, yet the behaviour may be difficult to justify from an outside perspective. Combining Safety-I and Safety-II perspectives provided a detailed understanding of the underlying reasons for procedural violations. Our findings identify aspects of practice that could benefit from targeted interventions to help support staff in providing safe patient care.

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

PubMed

Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

2017-06-01

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

A medication safety model: a case study in Thai hospital.

PubMed

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-06-12

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital.

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

PubMed

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

2011-05-01

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

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

PubMed Central

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

2016-01-01

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

Developing the radiation protection safety culture in the UK.

PubMed

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

2014-06-01

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

Allopurinol use in pregnancy in three women with inflammatory bowel disease: safety and outcomes: a case series

PubMed Central

2013-01-01

Background Allopurinol is a frequently prescribed drug. In inflammatory bowel disease patients who shunt thiopurine metabolism towards more toxic and less desirable pathways, allopurinol is proving to be an effective add on therapy with good resultant disease control and less treatment side effects. As many such patients are young, the potential for pregnant women to be exposed to allopurinol is increasing. The safety of allopurinol in pregnancy is not known however. Case presentation We report three cases of safe use of allopurinol in pregnancy for women with inflammatory bowel disease. This included 2 patients with ulcerative colitis and 1 patient with fistulising Crohn’s disease. Allopurinol was used throughout pregnancy in all patients. All 3 pregnancies resulted in normal healthy babies born at term by Caesarean section. Conclusion It is important to evaluate and document the safety of allopurinol during pregnancy, as it is finding new roles in young patients. These three cases add significantly to the very limited data on allopurinol use in pregnancy. We encourage reporting of all cases of allopurinol use in pregnant patients and suggest an allopurinol pregnancy registry to document drug exposures and outcomes. PMID:24345189

Federal and tribal lands road safety audits : case studies

DOT National Transportation Integrated Search

2009-12-01

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

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

PubMed

Cairnduff, Victoria; Dean, Moira; Koidis, Anastasios

2016-09-01

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

Development of a Nevada Statewide Database for Safety Analyst Software

DOT National Transportation Integrated Search

2017-02-02

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

Safety distance assessment of industrial toxic releases based on frequency and consequence: a case study in Shanghai, China.

PubMed

Yu, Q; Zhang, Y; Wang, X; Ma, W C; Chen, L M

2009-09-15

A case study on the safety distance assessment of a chemical industry park in Shanghai, China, is presented in this paper. Toxic releases were taken into consideration. A safety criterion based on frequency and consequence of major hazard accidents was set up for consequence analysis. The exposure limits for the accidents with the frequency of more than 10(-4), 10(-5)-10(-4) and 10(-6)-10(-5) per year were mortalities of 1% (or SLOT), 50% (SLOD) and 75% (twice of SLOD) respectively. Accidents with the frequency of less than 10(-6) per year were considered incredible and ignored in the consequence analysis. Taking the safety distance of all the hazard installations in a chemical plant into consideration, the results based on the new criterion were almost smaller than those based on LC50 or SLOD. The combination of the consequence and risk based results indicated that the hazard installations in two of the chemical plants may be dangerous to the protection targets and measurements had to be taken to reduce the risk. The case study showed that taking account of the frequency of occurrence in the consequence analysis would give more feasible safety distances for major hazard accidents and the results were more comparable to those calculated by risk assessment.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

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

Patient safety in phlebology: The ACP Phlebology Safety Checklist.

PubMed

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

2018-05-01

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

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.

Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

PubMed

Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

2014-01-01

A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

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

PubMed

Delaney, Bryan

2015-12-01

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

ASRM case insulation design and development

NASA Astrophysics Data System (ADS)

Bell, Matthew S.; Tam, William F. S.

1992-10-01

This paper describes the achievements made on the Advanced Solid Rocket Motor (ASRM) case insulation design and development program. The ASRM case insulation system described herein protects the metal case and joints from direct radiation and hot gas impingement. Critical failure of solid rocket systems is often traceable to failure of the insulation design. The wide ranging accomplishments included the development of a nonasbestos insulation material for ASRM that replaced the existing Redesigned Solid Rocket Motor (RSRM) asbestos-filled nitrile butadiene rubber (NBR) along with a performance gain of 300 pounds, and improved reliability of all the insulation joint designs, i.e., segmented case joint, case-to-nozzle and case-to-igniter joint. The insulation process development program included the internal stripwinding process. This process advancement allowed Aerojet to match to exceed the capability of other propulsion companies.

ASRM case insulation design and development

NASA Technical Reports Server (NTRS)

Bell, Matthew S.; Tam, William F. S.

1992-01-01

This paper describes the achievements made on the Advanced Solid Rocket Motor (ASRM) case insulation design and development program. The ASRM case insulation system described herein protects the metal case and joints from direct radiation and hot gas impingement. Critical failure of solid rocket systems is often traceable to failure of the insulation design. The wide ranging accomplishments included the development of a nonasbestos insulation material for ASRM that replaced the existing Redesigned Solid Rocket Motor (RSRM) asbestos-filled nitrile butadiene rubber (NBR) along with a performance gain of 300 pounds, and improved reliability of all the insulation joint designs, i.e., segmented case joint, case-to-nozzle and case-to-igniter joint. The insulation process development program included the internal stripwinding process. This process advancement allowed Aerojet to match to exceed the capability of other propulsion companies.

The development and validation of a psychological contract of safety scale.

PubMed

Walker, Arlene

2010-08-01

This paper builds on previous research by the author and describes the development and validation of a new measure of the psychological contract of safety. The psychological contract of safety is defined as the beliefs of individuals about reciprocal safety obligations inferred from implicit and explicit promises. A psychological contract is established when an individual believes that perceived employer and employee safety obligations are contingent on each other. A pilot test of the measure is first undertaken with participants from three different occupations: nurses, construction workers, and meat processing workers (N=99). Item analysis is used to refine the measure and provide initial validation of the scale. A larger validation study is then conducted with a participant sample of health care workers (N=424) to further refine the measure and to determine the psychometric properties of the scale. Item and correlational analyses produced the final employer and employee obligations scales, consisting of 21 and 17 items, respectively. Factor analyses identified two underlying dimensions in each scale comparable to that previously established in the organizational literature. These transactional and relational-type obligations provided construct validity of the scale. Internal consistency ratings using Cronbach's alpha found the components of the psychological contract of safety measure to be reliable. The refined and validated psychological contract of safety measure will allow investigation of the positive and negative outcomes associated with fulfilment and breach of the psychological contract of safety in future research. 2010 Elsevier Ltd. All rights reserved.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

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.

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

PubMed

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

2006-03-01

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

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

PubMed

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

2014-12-01

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

Latest developments in cryogenic safety

NASA Astrophysics Data System (ADS)

Webster, T. J.

1983-03-01

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

Latest developments in cryogenic safety

NASA Technical Reports Server (NTRS)

Webster, T. J.

1983-01-01

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

Developing safety performance functions incorporating reliability-based risk measures.

PubMed

Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

2011-11-01

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

[Patient safety and errors in medicine: development, prevention and analyses of incidents].

PubMed

Rall, M; Manser, T; Guggenberger, H; Gaba, D M; Unertl, K

2001-06-01

"Patient safety" and "errors in medicine" are issues gaining more and more prominence in the eyes of the public. According to newer studies, errors in medicine are among the ten major causes of death in association with the whole area of health care. A new era has begun incorporating attention to a "systems" approach to deal with errors and their causes in the health system. In other high-risk domains with a high demand for safety (such as the nuclear power industry and aviation) many strategies to enhance safety have been established. It is time to study these strategies, to adapt them if necessary and apply them to the field of medicine. These strategies include: to teach people how errors evolve in complex working domains and how types of errors are classified; the introduction of critical incident reporting systems that are free of negative consequences for the reporters; the promotion of continuous medical education; and the development of generic problem-solving skills incorporating the extensive use of realistic simulators wherever possible. Interestingly, the field of anesthesiology--within which realistic simulators were developed--is referred to as a model for the new patient safety movement. Despite this proud track record in recent times though, there is still much to be done even in the field of anesthesiology. Overall though, the most important strategy towards a long-term improvement in patient safety will be a change of "culture" throughout the entire health care system. The "culture of blame" focused on individuals should be replaced by a "safety culture", that sees errors and critical incidents as a problem of the whole organization. The acceptance of human fallability and an open-minded non-punitive analysis of errors in the sense of a "preventive and proactive safety culture" should lead to solutions at the systemic level. This change in culture can only be achieved with a strong commitment from the highest levels of an organization. Patient

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

PubMed

Haslberger, Alexander G

2006-05-03

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

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

PubMed

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

2012-06-01

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

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

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

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.

Development of Food Safety Psychosocial Questionnaires for Young Adults

ERIC Educational Resources Information Center

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

2007-01-01

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

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

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

Curtis Smith; Diego Mandelli

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

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

PubMed Central

2017-01-01

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

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

PubMed

Misbah, Samreen; Mahboob, Usman

2017-01-01

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

DFN Modeling for the Safety Case of the Final Disposal of Spent Nuclear Fuel in Olkiluoto, Finland

NASA Astrophysics Data System (ADS)

Vanhanarkaus, O.

2017-12-01

Olkiluoto Island is a site in SW Finland chosen to host a deep geological repository for high-level nuclear waste generated by nuclear power plants of power companies TVO and Fortum. Posiva, a nuclear waste management organization, submitted a construction license application for the Olkiluoto repository to the Finnish government in 2012. A key component of the license application was an integrated geological, hydrological and biological description of the Olkiluoto site. After the safety case was reviewed in 2015 by the Radiation and Nuclear Safety Authority in Finland, Posiva was granted a construction license. Posiva is now preparing an updated safety case for the operating license application to be submitted in 2022, and an update of the discrete fracture network (DFN) model used for site characterization is part of that. The first step describing and modelling the network of fractures in the Olkiluoto bedrock was DFN model version 1 (2009), which presented an initial understanding of the relationships between rock fracturing and geology at the site and identified the important primary controls on fracturing. DFN model version 2 (2012) utilized new subsurface data from additional drillholes, tunnels and excavated underground facilities in ONKALO to better understand spatial variability of the geological controls on geological and hydrogeological fracture properties. DFN version 2 connected fracture geometric and hydraulic properties to distinct tectonic domains and to larger-scale hydraulically conductive fault zones. In the version 2 DFN model, geological and hydrogeological models were developed along separate parallel tracks. The version 3 (2017) DFN model for the Olkiluoto site integrates geological and hydrogeological elements into a single consistent model used for geological, rock mechanical, hydrogeological and hydrogeochemical studies. New elements in the version 3 DFN model include a stochastic description of fractures within Brittle Fault Zones (BFZ

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

PubMed

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

2012-08-30

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

A Medication Safety Model: A Case Study in Thai Hospital

PubMed Central

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-01-01

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

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

PubMed

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

2018-04-01

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

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

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

PubMed

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

Safety of escitalopram in pregnancy: a case series.

PubMed

Bellantuono, Cesario; Bozzi, Francesca; Orsolini, Laura

2013-01-01

The aim of this paper is to report maternal and neonatal outcomes in pregnant women treated with escitalopram during pregnancy and breastfeeding. Women enrolled in the DEGRA Database at the Clinic of Affective Disorders in Pregnancy and Postpartum in Italy, treated during pregnancy with escitalopram and followed up throughout pregnancy, were included in this study. All patients provided written informed consent and the study was approved by the local ethics committee. Psychiatric diagnoses were assessed using the Structured Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) Axis I Disorders and symptoms were assessed using the Hamilton Rating Scale for Depression (17 items) and Hamilton Rating Scale for Anxiety (14 items). Clinical and sociodemographic characteristics as well as maternal and neonatal outcomes were recorded. The case histories of seven pregnant women treated for depression and/or anxiety disorders with escitalopram were reported. Four women were also treated with benzodiazepines. All pregnancies were full-term and all newborns had normal Apgar scores. There were no major malformations or miscarriages following exposure to escitalopram. Mild withdrawal syndrome was reported only in a newborn who was also exposed to a benzodiazepine. Two infants exposed to escitalopram during breastfeeding did not show any health problems. Our experience with use of escitalopram in pregnant women did not reveal any maternal or neonatal concerns. However, considering the few cases analyzed and the paucity of published literature, no conclusions can be drawn on its safety profile in pregnancy and breastfeeding.

Safety of escitalopram in pregnancy: a case series

PubMed Central

Bellantuono, Cesario; Bozzi, Francesca; Orsolini, Laura

2013-01-01

Background The aim of this paper is to report maternal and neonatal outcomes in pregnant women treated with escitalopram during pregnancy and breastfeeding. Methods Women enrolled in the DEGRA Database at the Clinic of Affective Disorders in Pregnancy and Postpartum in Italy, treated during pregnancy with escitalopram and followed up throughout pregnancy, were included in this study. All patients provided written informed consent and the study was approved by the local ethics committee. Psychiatric diagnoses were assessed using the Structured Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) Axis I Disorders and symptoms were assessed using the Hamilton Rating Scale for Depression (17 items) and Hamilton Rating Scale for Anxiety (14 items). Clinical and sociodemographic characteristics as well as maternal and neonatal outcomes were recorded. Results The case histories of seven pregnant women treated for depression and/or anxiety disorders with escitalopram were reported. Four women were also treated with benzodiazepines. All pregnancies were full-term and all newborns had normal Apgar scores. There were no major malformations or miscarriages following exposure to escitalopram. Mild withdrawal syndrome was reported only in a newborn who was also exposed to a benzodiazepine. Two infants exposed to escitalopram during breastfeeding did not show any health problems. Conclusion Our experience with use of escitalopram in pregnant women did not reveal any maternal or neonatal concerns. However, considering the few cases analyzed and the paucity of published literature, no conclusions can be drawn on its safety profile in pregnancy and breastfeeding. PMID:24043940

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

NASA Technical Reports Server (NTRS)

Zee, Stacey; Murray, D.

2009-01-01

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

Safety of Gadobutrol

PubMed Central

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

2016-01-01

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

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

PubMed

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

2012-06-01

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

Assessment of cognitive safety in clinical drug development

PubMed Central

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

2016-01-01

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

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

DOT National Transportation Integrated Search

1998-02-01

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

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

PubMed

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

2017-04-01

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

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

PubMed

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

2018-01-01

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

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

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

2017-01-01

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

Allopurinol use in pregnancy in three women with inflammatory bowel disease: safety and outcomes: a case series.

PubMed

Fazal, Muhammad W; Doogue, Matt P; Leong, Rupert W; Bampton, Peter A; Andrews, Jane M

2013-12-17

Allopurinol is a frequently prescribed drug. In inflammatory bowel disease patients who shunt thiopurine metabolism towards more toxic and less desirable pathways, allopurinol is proving to be an effective add on therapy with good resultant disease control and less treatment side effects. As many such patients are young, the potential for pregnant women to be exposed to allopurinol is increasing. The safety of allopurinol in pregnancy is not known however. We report three cases of safe use of allopurinol in pregnancy for women with inflammatory bowel disease. This included 2 patients with ulcerative colitis and 1 patient with fistulising Crohn's disease. Allopurinol was used throughout pregnancy in all patients. All 3 pregnancies resulted in normal healthy babies born at term by Caesarean section. It is important to evaluate and document the safety of allopurinol during pregnancy, as it is finding new roles in young patients. These three cases add significantly to the very limited data on allopurinol use in pregnancy. We encourage reporting of all cases of allopurinol use in pregnant patients and suggest an allopurinol pregnancy registry to document drug exposures and outcomes.

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

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

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

2006-07-01

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

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.

The development and test of urban and rural pedestrian safety messages

DOT National Transportation Integrated Search

1985-01-01

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

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

PubMed

Lauterberg, Jörg

2009-01-01

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

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

PubMed

Morrato, Elaine H; Ling, Sarah B

2012-11-01

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

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.

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

DOT National Transportation Integrated Search

2016-06-30

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

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

PubMed

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

2012-10-01

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

Occupational safety and health criteria for responsible development of nanotechnology

NASA Astrophysics Data System (ADS)

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

2014-01-01

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

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

PubMed

Qummouh, Rana; Rose, Vanessa; Hall, Pat

2012-12-01

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

Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media.

PubMed

Comfort, Shaun; Perera, Sujan; Hudson, Zoe; Dorrell, Darren; Meireis, Shawman; Nagarajan, Meenakshi; Ramakrishnan, Cartic; Fine, Jennifer

2018-06-01

There is increasing interest in social digital media (SDM) as a data source for pharmacovigilance activities; however, SDM is considered a low information content data source for safety data. Given that pharmacovigilance itself operates in a high-noise, lower-validity environment without objective 'gold standards' beyond process definitions, the introduction of large volumes of SDM into the pharmacovigilance workflow has the potential to exacerbate issues with limited manual resources to perform adverse event identification and processing. Recent advances in medical informatics have resulted in methods for developing programs which can assist human experts in the detection of valid individual case safety reports (ICSRs) within SDM. In this study, we developed rule-based and machine learning (ML) models for classifying ICSRs from SDM and compared their performance with that of human pharmacovigilance experts. We used a random sampling from a collection of 311,189 SDM posts that mentioned Roche products and brands in combination with common medical and scientific terms sourced from Twitter, Tumblr, Facebook, and a spectrum of news media blogs to develop and evaluate three iterations of an automated ICSR classifier. The ICSR classifier models consisted of sub-components to annotate the relevant ICSR elements and a component to make the final decision on the validity of the ICSR. Agreement with human pharmacovigilance experts was chosen as the preferred performance metric and was evaluated by calculating the Gwet AC1 statistic (gKappa). The best performing model was tested against the Roche global pharmacovigilance expert using a blind dataset and put through a time test of the full 311,189-post dataset. During this effort, the initial strict rule-based approach to ICSR classification resulted in a model with an accuracy of 65% and a gKappa of 46%. Adding an ML-based adverse event annotator improved the accuracy to 74% and gKappa to 60%. This was further improved by

SafetyAnalyst

DOT National Transportation Integrated Search

2009-01-01

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

Engineering and Development Program Plan, Aircraft Cabin Fire Safety.

DTIC Science & Technology

1980-06-01

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

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.

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

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

Time Safety Margin: Theory and Practice

DTIC Science & Technology

2016-09-01

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

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

PubMed

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

2018-01-01

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

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.

Development and application of a safety assessment methodology for waste disposals

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

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

1996-12-31

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

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

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

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

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

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

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

PubMed

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

2009-01-01

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

Safety of gentamicin bladder irrigations in complex urological cases.

PubMed

Defoor, William; Ferguson, Denise; Mashni, Susan; Creelman, Lisa; Reeves, Deborah; Minevich, Eugene; Reddy, Pramod; Sheldon, Curtis

2006-05-01

Recurrent urinary tract infections are common in complex pediatric urological cases, particularly those requiring clean intermittent catheterization. At our institution gentamicin bladder irrigations have been used for antimicrobial prophylaxis and to treat symptomatic bacteriuria, particularly when the infection does not involve the upper urinary tract. The purpose of this study was to assess the safety of this therapy. A retrospective study was performed of all children treated with gentamicin bladder irrigations from 1999 to 2004. The dose was 14 mg gentamicin in 30 ml saline instilled via catheter once or twice daily. Serum creatinine and random gentamicin levels were obtained according to a protocol based on risk of gentamicin toxicity. Patient demographics, laboratory results and outcomes were abstracted from the medical records. A total of 80 patients (38 males and 42 females) were identified. Median patient age was 10 years and median duration of treatment was 90 days. No patient had detectable serum gentamicin levels greater than 0.4 mg/dl. Small increases in serum creatinine were seen in 3 patients, all of whom had chronic renal insufficiency. A total of 21 patients (26%) had breakthrough UTIs, of which 5 (24%) were gentamicin resistant. No adverse events were documented. Gentamicin bladder irrigations are a helpful adjunct in the management of complex pediatric urological cases involving recurrent symptomatic bacteriuria. We no longer require intensive laboratory monitoring of low risk patients at our institution.

Development of a highway safety fundamental course.

DOT National Transportation Integrated Search

2015-05-01

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

Rocketdyne Safety Algorithm: Space Shuttle Main Engine Fault Detection

NASA Technical Reports Server (NTRS)

Norman, Arnold M., Jr.

1994-01-01

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

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

Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

PubMed Central

Ackerman, Janet M.; Dairkee, Shanaz H.; Fenton, Suzanne E.; Johnson, Dale; Navarro, Kathleen M.; Osborne, Gwendolyn; Rudel, Ruthann A.; Solomon, Gina M.; Zeise, Lauren; Janssen, Sarah

2015-01-01

Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015

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.

MRI Evaluation and Safety in the Developing Brain

PubMed Central

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

2015-01-01

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

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.

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

PubMed

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

2017-02-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

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

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

PubMed

Wu, Tsung-Chih

2011-10-01

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

Leadership development and succession planning in case management.

PubMed

Miodonski, Kathleen; Hines, Patricia

2013-01-01

The director of case management is one of health care's leadership positions most frequently in demand. The lack of qualified and effective case management leaders will continue to be an issue for organizations for years to come, influenced by increasing pressures on health care reimbursement and the aging case management workforce. Organizations have an opportunity to create a program to develop future case management leaders from their internal talent. The proposed strategies are designed for the acute care hospital but also have applicability in other health care settings where there are case managers and a need for case management leadership. The business community offers leadership research and leadership development models with relevance to case management. Identifying and developing internal talent for leadership roles has been proven to be effective in preparation for advanced responsibilities, has a positive effect on staff morale, and minimizes the impact of vacant leadership positions during recruitment and onboarding activities. Creating a case management leadership development program for an organization can be an alternative to the process of external recruitment for case management department leaders. Such a program can be undertaken even in today's budget conscious environment by accessing existing resources in an organization in a creative and organized manner. The authors outline an approach for case management leaders to accept responsibility for succession planning and for case managers to accept responsibility for promoting their own career development through creation of a leadership development program.

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

PubMed Central

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

2014-01-01

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

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.

[Case-control study on accuracy and safety of patient-specific drill-guide templates used in scoliosis cases].

PubMed

Zhang, Yu-peng; Shi, Ya-min; Wang, Hua-dong; Hou, Shu-xun

2015-10-01

To evaluate the accuracy and safety of pedicle screw insertion with the aid of novel patient-specific drill-guide templates in scoliosis cases. Ten patients with scoliosis were selected to participate in the research (the observation group) from December 2013 to December 2014. The data was obtained from CT scanning, and put into the computer to perform reconstruction of spine, simulation of pedicle screw insertion, and design of patient-specific drill-guide templates with software. The templates were made with rapid prototyping technique. After sterilization, the templates were used to aid the pedicle screw insertion intraoperatively. The blood loss, operation duration, change of creatinine level pre- and post-operation, and complications related to pedicle screw insertion were recorded. The location of pedicle screws were graded so as to evaluate the accuracy. A comparative study was then performed with the data of ten scoliosis cases operated with free-hand method during the same period (control group). There were 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the observation group, including 3 males and 7 females. Their average age was 11.9 years old (ranged, 4 to 18 years old), and the average Cobb angle of main curve was 54.9° (ranged, 42.1° to 78.4°). There were also 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the control group,including 2 males and 8 females. Their average age was 12.6 years old (ranged, 6 to 17 years old), and the average Cobb angle of main curve was 56.6° (ranged, 38.2° to 93.4°). A total of 167 pedicle screws were inserted intraoperatively, with 138 screws (82.6%) in grade I, 26 screws (15.0%) in grade II, 4 screws in grade III (2.4%), but no screws in grade IV according to the CT image. There were 29 (17.4%) screws perforated, and 163 (97.6%) screws could be accepted. In the control group, a total of 165 pedicle screws were inserted intraoperatively, with 98 screws (59.4%) in grade

Development of a patient safety climate survey for Chinese hospitals: cross-national adaptation and psychometric evaluation.

PubMed

Zhu, Junya; Li, Liping; Zhao, Hailei; Han, Guangshu; Wu, Albert W; Weingart, Saul N

2014-10-01

Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries. To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals. Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety. The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items. The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

PubMed

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

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

PubMed

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

2018-06-22

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

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

PubMed

Park, Hyeoun-Ae

2016-11-10

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

Using Space Syntax to Assess Safety in Public Areas - Case Study of Tarbiat Pedestrian Area, Tabriz-Iran

NASA Astrophysics Data System (ADS)

Cihangir Çamur, Kübra; Roshani, Mehdi; Pirouzi, Sania

2017-10-01

In studying the urban complex issues, simulation and modelling of public space use considerably helps in determining and measuring factors such as urban safety. Depth map software for determining parameters of the spatial layout techniques; and Statistical Package for Social Sciences (SPSS) software for analysing and evaluating the views of the pedestrians on public safety were used in this study. Connectivity, integration, and depth of the area in the Tarbiat city blocks were measured using the Space Syntax Method, and these parameters are presented as graphical and mathematical data. The combination of the results obtained from the questionnaire and statistical analysis with the results of spatial arrangement technique represents the appropriate and inappropriate spaces for pedestrians. This method provides a useful and effective instrument for decision makers, planners, urban designers and programmers in order to evaluate public spaces in the city. Prior to physical modification of urban public spaces, space syntax simulates the pedestrian safety to be used as an analytical tool by the city management. Finally, regarding the modelled parameters and identification of different characteristics of the case, this study represents the strategies and policies in order to increase the safety of the pedestrians of Tarbiat in Tabriz.

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

PubMed

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

2010-02-01

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

Radioactive waste management in France: safety demonstration fundamentals.

PubMed

Ouzounian, G; Voinis, S; Boissier, F

2012-01-01

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

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

PubMed

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

2016-08-17

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

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

PubMed

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

2017-08-31

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

Lift truck safety review

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

Cadwallader, L.C.

1997-03-01

This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

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

PubMed Central

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

2012-01-01

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

Case for real-time systems development - Quo vadis?

NASA Technical Reports Server (NTRS)

Erb, Dona M.

1991-01-01

The paper focuses on the distinctive issues of computer-aided software engineering (CASE) products for the development of real-time systems. CASE technologies and associated standardization efforts are evolving from sets of conflicting interests. The majority of case products are intended for use in the development of management information systems. CASE products to support the development of large, complex real-time systems must provide additional capabilities. Generic concerns include the quality of the implementation of the required method for the phase of the system's development and whether the vendor is stable and committed to evolving the products in parallel with nonproprietary standards. The CASE market is undergoing considerable consolidation. The paper describes the major forces, cooperating entities, and remaining uncertainties that need to be weighed in near-term CASE procurements to limit risk of loss of investment in project time, trianing, and money.

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

PubMed

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

2015-05-01

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

Development and Validation of Career Development Guidelines by Task/Activity Analysis of Occupational Safety and Health Professions: Industrial Hygiene and Safety Professional. Final Report. Technical Report XII.

ERIC Educational Resources Information Center

Vernon, Ralph J.; And Others

This report summarizes research findings which resulted in development of curricula for occupational safety and health professions based on task/activity analyses and related performance objectives. The first seven chapters focus on the seven objectives. Chapter 1, Literature Review and Selection of Employers, concerns tasks required for…

MRI evaluation and safety in the developing brain.

PubMed

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

2015-03-01

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

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

DOT National Transportation Integrated Search

2014-03-01

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

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

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

Biological safety cabinetry.

PubMed Central

Kruse, R H; Puckett, W H; Richardson, J H

1991-01-01

The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents. Images PMID:2070345

ASRM Case Insulation development

NASA Technical Reports Server (NTRS)

Tam, W. F. S.; Bell, M.

1993-01-01

The ASRM Case Insulation Program used design of experiments to develop a high performance case insulation. The program traded-off more than thirty properties in areas of ablation performance, material properties, processibility, bonding/aging. Kevlar pulp was found to be the most significant factor. The low-molecular weight ethylene propylene diene monomer, EPDM was the second most significant factor. The curative was the third most significant factor. The tackifier was the fourth most significant factor. The stripwinding process for applying the insulation onto the case inner surfaces was also studied. The parameters selected for experiment were extruder speed, upper roller temperature and extruder nozzle temperature. The extrudability results showed that non-Kevlar filled formulations displayed optimum edges but poor thickness continuity. High Kevlar filled formulations displayed optimum thickness continuity but poor strip edge ratings.

ASRM Case Insulation development

NASA Astrophysics Data System (ADS)

Tam, W. F. S.; Bell, M.

1993-06-01

The ASRM Case Insulation Program used design of experiments to develop a high performance case insulation. The program traded-off more than thirty properties in areas of ablation performance, material properties, processibility, bonding/aging. Kevlar pulp was found to be the most significant factor. The low-molecular weight ethylene propylene diene monomer, EPDM was the second most significant factor. The curative was the third most significant factor. The tackifier was the fourth most significant factor. The stripwinding process for applying the insulation onto the case inner surfaces was also studied. The parameters selected for experiment were extruder speed, upper roller temperature and extruder nozzle temperature. The extrudability results showed that non-Kevlar filled formulations displayed optimum edges but poor thickness continuity. High Kevlar filled formulations displayed optimum thickness continuity but poor strip edge ratings.

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

PubMed

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

2013-03-01

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

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

PubMed

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

2013-06-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-10-01

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

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

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

PubMed

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

2012-01-01

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

The occupational safety and health scorecard--a business case example for strategic management.

PubMed