TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements
DOE Office of Scientific and Technical Information (OSTI.GOV)
Alan Bond
2001-04-01
This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.
Evaluating safety and operation of high-speed signalized intersections : final report, March 2010.
DOT National Transportation Integrated Search
2010-03-01
This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...
75 FR 57302 - Advisory Committee on Reactor Safeguards; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-20
... Monday, October 14, 2009, (74 FR 52829-52830). Thursday, October 7, 2010, Conference Room T2-B1, Two....: Final Safety Evaluation Report Associated with the Economic Simplified Boiling Water Reactor (ESBWR..., Inc. regarding the final Safety Evaluation Report associated with the ESBWR design certification...
DOT National Transportation Integrated Search
2003-09-16
The objective of this Hazardous Material (HazMat) Transportation Safety and Security Field Operational Test (FOT) Final Detailed Test Plans evaluation is to measure the impact of technology solutions on the safety, security, and operational efficienc...
75 FR 70304 - Advisory Committee on Reactor Safeguards
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-17
..., Rockville, Maryland. Thursday, December 2, 2010, Conference Room T2-B1, Two White Flint North, Rockville... opening remarks regarding the conduct of the meeting. 8:35 a.m.-10 a.m.: Final Safety Evaluation Report... Kewaunee, Inc., regarding the final safety evaluation report associated with the License Renewal...
DOT National Transportation Integrated Search
1988-02-01
THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...
Independent evaluation of the transit retrofit package safety applications : final report.
DOT National Transportation Integrated Search
2015-02-01
This report presents the methodology and results of the independent evaluation of retrofit safety packages installed on transit vehicles in the : Safety Pilot Model Deploymentpart of the United States Department of Transportations Intelligent T...
Evaluating pedestrian safety improvements : final report.
DOT National Transportation Integrated Search
2012-12-01
The purpose of the study was to evaluate the impact of new pedestrian countermeasure installations on pedestrian safety to assist in informing future pedestrian safety initiatives. In order to address these objectives, the WMU team conducted a litera...
DOT National Transportation Integrated Search
2010-12-01
This project mainly focuses on exit ramp performance analysis of safety and operations. In addition, issues of advance guide sign for exit ramp are also mentioned. : Safety analysis evaluates safety performances of different exit ramps used in Florid...
Safety performance functions for intersections : final report, December 2009.
DOT National Transportation Integrated Search
2009-12-01
Road safety management activities include screening the network for sites with a potential for safety improvement (Network : Screening), diagnosing safety problems at specific sites, and evaluating the safety effectiveness of implemented : countermea...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-31
..., are described in the final safety analysis report (FSAR). The staff safety evaluation documents the acceptability of these analyses, and it is the combination of the FSAR analyses and the staff safety evaluation... analysis, maintain their capability to perform their safety functions. Technical Specification Operability...
A long-term plan for evaluating the FHWA's Office of Safety programs : final draft
DOT National Transportation Integrated Search
2006-01-01
The purpose of this report is to develop a generalized plan for evaluating and measuring the effectiveness of the major safety programs of the the FHWA Office of Safety. This report is organized into three sections in order to coincide with the state...
DOT National Transportation Integrated Search
2016-12-01
An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...
DOT National Transportation Integrated Search
2016-11-01
An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...
Evaluating safety and operations of high-speed signalized intersections.
DOT National Transportation Integrated Search
2010-03-01
This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...
Evaluating safety and operation of high-speed intersections.
DOT National Transportation Integrated Search
2010-03-01
This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-19
... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Final Written Re-Evaluation for... for Sikorsky Memorial Airport in Stratford, Connecticut. ADDRESSES: The Written Re-Evaluation document... Sikorsky Memorial Airport involving Runway Safety Areas and other airfield improvements. This Written Re...
Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J
2016-11-01
Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.
10 CFR 52.79 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2010 CFR
2010-01-01
... assurance program will be implemented; (26) The applicant's organizational structure, allocations or... presents a safety analysis of the structures, systems, and components of the facility as a whole. The final... contain an analysis and evaluation of the major structures, systems, and components of the facility that...
DOT National Transportation Integrated Search
2003-03-17
The purpose of this effort is to independently evaluate the Battelle Operational Test Team to test methods for leveraging technology and operations to improve HAZMAT transport security, safety, and operational efficiency. As such, the preceding techn...
Development and validation of a remote home safety protocol.
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.
DOT National Transportation Integrated Search
2017-06-01
The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...
Safety performance evaluation of converging chevron pavement markings : final report.
DOT National Transportation Integrated Search
2014-12-01
The objectives of this study were (1) to perform a detailed safety analysis of converging chevron : pavement markings, quantifying the potential safety benefits and developing an understanding of the : incident types addressed by the treatment, and (...
Characterization And Evaluation Of A Prototype Forward-Looking Automotive Radar (Flar), Final Report
DOT National Transportation Integrated Search
1997-03-01
This is the final report for a three-year Discretionary Cooperative Agreement with the National Highway Traffic Safety Administration (NHTSA Grant DTNH22-94-Y-17016), Characterization and Evaluation of a Forward-Looking automotive Radar Sensor....
75 FR 36779 - Qualification of Drivers; Exemption Renewals; Vision
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-28
... deficiency for 3 years. Recent driving performance is especially important in evaluating future safety... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-1999... AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of final disposition...
Evaluation of US 119 Pine Mountain safety improvements : final report.
DOT National Transportation Integrated Search
2007-09-01
The Transportation Center at the University of Kentucky was requested to perform an evaluation of the safety improvement project over a 7.1-mile section of US 119 on t he Whitesburg side of Pine Mountain in Letcher County to determine whether the typ...
Linking sustainable transportation in a university community : final report.
DOT National Transportation Integrated Search
2010-01-01
The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The purpose of the FHWA Low-Cost Safety Improvements Pooled Fund Study is to e...
Evaluation of New York state's mandatory occupant restraint law. Volume 6, Final summary report
DOT National Transportation Integrated Search
1987-02-01
This is the final report summarizing the evaluation of the first year of New York State's Mandatory Occupant Restraint Law. The results indicate that the major goals of the legislation were accomplished. Safety restraint use among front seat occupant...
76 FR 23340 - Advisory Committee on Reactor Safeguards; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-26
... Thursday, October 21, 2010 (75 FR 65038-65039). Thursday, May 12, 2011, Conference Room T2-B1, 11545... Safety Evaluation Report Associated with the License Renewal Application for the Hope Creek Generating... NRC staff and PSEG Nuclear, LLC regarding the final safety evaluation report (SER) associated with the...
2010-09-29
The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.
Wireless roadside inspection phase II evaluation final report.
DOT National Transportation Integrated Search
2011-06-01
The Federal Motor Carrier Safety Administration (FMCSA) Wireless Roadside Inspection (WRI) Program is demonstrating the feasibility and value of electronically assessing truck and coach driver and vehicle safety at least 25 times more often than is p...
Evaluation of safety and mobility of two-lane roundabouts : final report.
DOT National Transportation Integrated Search
2017-07-01
When looking at measures of fatal and severe-injury crashes, roundabouts have demonstrated improved safety performance compared to traditional signalized intersections. Despite this, when it comes to less severe crashes, multilane roundabouts fail to...
Final safety analysis report for the Galileo Mission: Volume 2: Summary
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The General Purpose Heat Source Radioisotope Thermoelectric Generator (GPHS-RTG) will be used as the prime source of electric power for the spacecraft on the Galileo mission. The use of radioactive material in these missions necessitates evaluations of the radiological risks that may be encountered by launch complex personnel and by the Earth's general population resulting from postulated malfunctions or failures occurring in the mission operations. The purpose of the Final Safety Analysis Report (FSAR) is to present the analyses and results of the latest evaluation of the nuclear safety potential of the GPHS-RTG as employed in the Galileo mission. Thismore » evaluation is an extension of earlier work that addressed the planned 1986 launch using the Space Shuttle Vehicle with the Centaur as the upper stage. This extended evaluation represents the launch by the Space Shuttle/IUS vehicle. The IUS stage has been selected as the vehicle to be used to boost the Galileo spacecraft into the Earth escape trajectory after the parking orbit is attained.« less
Evaluation of pedestrian safety campaigns : final report.
DOT National Transportation Integrated Search
2004-02-01
The objective of the study was to determine the efficacy and success of SHAs public service campaign : regarding pedestrian safety. Data collection issues forced a change in this focus as the project progressed. : The study contains two issues tha...
29 CFR 1952.154 - Final approval determination.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... determined that in operation the State of North Carolina's occupational safety and health program is at least...-State Integrated Management Information System, the Assistant Secretary evaluated actual operations...
ERIC Educational Resources Information Center
Wurbacher and Associates, Takoma Park, MD.
This report describes results and conclusions of a third-party evaluation of a 1-year demonstration project in Alexandria (Virginia) to develop "safety nets" for 12 people with disabilities who were either unemployed or with a history of unemployment. An Employment Security Specialist worked with these individuals and their families to:…
USDA-ARS?s Scientific Manuscript database
We have finally received funding for parts of a GLP compliant Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administered in feed to tilapia; we will again be working with the folks at AADAP on this study. A preliminary trial was completed in October/November to establi...
Evaluation of the Corridor Safety Improvement Program : phase 1 final report.
DOT National Transportation Integrated Search
1997-09-01
This project is an analysis of Oregon's Corridor Safety Improvement Programs implemented on Oregon Route 22 and Oregon Route 34. Improvements were : made along each corridor in 1993. : The project used a mail-out survey to determine the level of awar...
Hwang, Jee-In; Yoon, Tai-Young; Jin, Hyeon-Jeong; Park, Yikyun; Park, Ju-Young; Lee, Beom-Joon
2016-11-01
As final-year medical and nursing students will soon play key roles in frontline patient care, their preparedness for safe, reliable care provision is of special importance. We assessed patient safety competencies of final-year health profession students, and the effect of a 1-day patient safety education programme on these competencies. A cross-sectional survey was conducted with 233 students in three colleges of medicine, nursing, and traditional medicine in Seoul. A before-and-after study followed to evaluate the effectiveness of the curriculum. Patient safety competency was measured using the Health-Professional Education for Patients Safety Survey (H-PEPSS) and an objective patient safety knowledge test. The mean scores were 3.4 and 1.7 out of 5.0, respectively. The communication domain was rated the highest and the teamwork domain was rated the lowest. H-PEPSS scores significantly differed between the students from three colleges. The 1-day patient safety education curriculum significantly improved H-PEPSS and knowledge test scores. These results indicated that strengthening patient safety competencies, especially teamwork, of students is required in undergraduate healthcare curricula. A 1-day interprofessional patient safety education programme may be a promising strategy. The findings suggest that interprofessional patient safety education needs to be implemented as a core undergraduate course to improve students' safety competence.
Evaluating the potential safety benefits of electronic hours-of-service recorders final report.
DOT National Transportation Integrated Search
2014-04-01
The purpose of the current study was to assess the benefits of installed electronic hours-of-service recorders : (EHSRs) on safety and hours-of-service (HOS) violations related to Class 7 and 8 trucks as they operated during : normal revenue service....
Software for occupational health and safety risk analysis based on a fuzzy model.
Stefanovic, Miladin; Tadic, Danijela; Djapan, Marko; Macuzic, Ivan
2012-01-01
Risk and safety management are very important issues in healthcare systems. Those are complex systems with many entities, hazards and uncertainties. In such an environment, it is very hard to introduce a system for evaluating and simulating significant hazards. In this paper, we analyzed different types of hazards in healthcare systems and we introduced a new fuzzy model for evaluating and ranking hazards. Finally, we presented a developed software solution, based on the suggested fuzzy model for evaluating and monitoring risk.
DOT National Transportation Integrated Search
2008-12-08
The objective of this research is to develop a general methodological framework for planning and : evaluating the effectiveness of highway reconstruction strategies on the systems performance : measures, in particular safety, mobility, and the tot...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Ausherman, V.K.; Khadikar, A.V.; Syson, S.R.
1981-09-01
The objective of the RSV Program was to provide research and test data applicable to the automobile safety performance requirements for the mid-1980s, and to evaluate the compatibility of these requirements with environmental policies, efficient energy utilization, and consumer economic considerations.
30 CFR 18.61 - Final inspection of complete machine.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Final inspection of complete machine. 18.61 Section 18.61 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Inspections...
Evaluation of the effectiveness of pavement rumble strips : final report.
DOT National Transportation Integrated Search
2008-01-01
This report analyzes the effectiveness of continuous shoulder rumble strips (CSRS) and center line rumble strips (CLRS) on rural two lane roads in Kentucky. This study evaluates the safety benefits, and design details associated with the application ...
10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2010 CFR
2010-01-01
... analysis of the structures, systems, and components of the reactor to be manufactured, with emphasis upon... assumed for this evaluation should be based upon a major accident, hypothesized for purposes of site... structures, systems, and components with the objective of assessing the risk to public health and safety...
Markovic, Ingrid
2007-09-01
Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-26
... requirements with current health and safety standards. Finally, the NRC is proposing to revise, clarify, or... lung and liver diseases.\\2\\ Because of the potential for uranium and thorium to produce health effects... order to better evaluate potential impacts to public health and safety. \\1\\ U.S. Department of Health...
Schneider, Erika; Ruggieri, Paul; Fromwiller, Lauren; Underwood, Reginald; Gurland, Brooke; Yurkschatt, Cynthia; Kubiak, Kevin; Obuchowski, Nancy A
2013-12-01
Delays between order and magnetic resonance (MR) exam often result when using the conventional paper-based MR safety screening process. The impact of an electronic MR safety screening process imbedded in a computerized physician order entry (CPOE) system was evaluated. Retrospective chart review of 4 months of inpatient MR exam orders and reports was performed before and after implementation of electronic MR safety documentation. Time from order to MR exam completion, time from MR exam completion to final radiology report, and time from first order to final report were analyzed by exam anatomy. Length of stay (LOS) and date of service within the admission were also analyzed. We evaluated 1947 individual MR orders in 1549 patients under an institutional review board exemption and a waiver of informed consent. Implementation of the electronic safety screening process resulted in a significant decrease of 1.1 hours (95% confidence interval 1.0-1.3 hours) in the mean time between first order to final report and a nonsignificant decrease of 0.8 hour in the median time from first order to exam end. There was a 1-day reduction (P = .697) in the time from admission to the MR exam compared to the paper process. No significant change in LOS was found except in neurological intensive care patients imaged within the first 24 hours of their admission, where a mean 0.9-day decrease was found. Benefits of an electronic process for MR safety screening include enabling inpatients to have decreased time to MR exams, thus enabling earlier diagnosis and treatment and reduced LOS. Copyright © 2013 AUR. Published by Elsevier Inc. All rights reserved.
NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review
NASA Technical Reports Server (NTRS)
Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick
2003-01-01
The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.
ERIC Educational Resources Information Center
Walker, Bonnie L.
This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…
DOT National Transportation Integrated Search
2009-03-28
This study examines the safety effects of the improvements made on multi-lane arterials. The improvements were divided into two categories: 1) corridor level improvements, and 2) intersection improvements. Empirical Bayes method, which is one of the ...
Development and Piloting of a Food Safety Audit Tool for the Domestic Environment.
Borrusso, Patricia; Quinlan, Jennifer J
2013-12-04
Research suggests that consumers often mishandle food in the home based on survey and observation studies. There is a need for a standardized tool for researchers to objectively evaluate the prevalence and identify the nature of food safety risks in the domestic environment. An audit tool was developed to measure compliance with recommended sanitation, refrigeration and food storage conditions in the domestic kitchen. The tool was piloted by four researchers who independently completed the inspection in 22 homes. Audit tool questions were evaluated for reliability using the κ statistic. Questions that were not sufficiently reliable (κ < 0.5) or did not provide direct evidence of risk were revised or eliminated from the final tool. Piloting the audit tool found good reliability among 18 questions, 6 questions were revised and 28 eliminated, resulting in a final 24 question tool. The audit tool was able to identify potential food safety risks, including evidence of pest infestation (27%), incorrect refrigeration temperature (73%), and lack of hot water (>43 °C, 32%). The audit tool developed here provides an objective measure for researchers to observe and record the most prevalent food safety risks in consumer's kitchens and potentially compare risks among consumers of different demographics.
76 FR 5218 - Advisory Committee on Reactor Safeguards
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-28
..., October 21, 2010 (74 FR 65038-65039). Thursday, February 10, 2011, Conference Room T2-B1, 11545 Rockville... Evaluation Report Associated with the License Renewal Application for the Palo Verde Nuclear Generating... NRC staff and Arizona Public Service Company regarding the final Safety Evaluation Report associated...
Effect of state workplace safety laws on occupational injury rates.
Smitha, M W; Kirk, K A; Oestenstad, K R; Brown, K C; Lee, S D
2001-12-01
The purpose of this study was to evaluate the effect of four common types of mandatory state-level workplace safety regulations on injury severity rates during the period 1992 to 1997 for the manufacturing sector. The full Poisson regression model showed safety committee regulations to have a highly significant reducing effect on injury rates, chi 2 (1, n = 3286) = 10.1774, P = 0.0014. Safety program regulations were significant at the alpha = 0.10 level, chi 2 (1, n = 3286) = 3.5676, P = 0.0589. The effect of insurance carrier loss control regulations in the full model was nonsignificant. However, insurance carrier loss control regulations were highly significant (alpha = 0.01) in the final reduced model. Targeting initiatives were nonsignificant in both the full and reduced models (alpha = 0.05). The study results are important to state and federal agencies considering adopting workplace safety regulations that are similar to the four types evaluated in this study.
Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J
2008-06-01
This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.
Yang, Wei; Xie, Yanming; Zhuang, Yan
2011-10-01
There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-22
... of the comments. A document comparing the version of the ISG that went out for public comment and the final version of the ISG can be found under ADAMS Accession No. ML111170302. ADDRESSES: Publicly... its issued staff guidance in the agency external web page ( http://www.nrc.gov/reading-rm/doc...
Rollover Data Special Study : Final Report.
DOT National Transportation Integrated Search
2011-01-31
This report summarizes research results from the Rollover Data Special Study (RODSS) project. The research encompassed the : design of a RODSS database for the National Highway Traffic Safety Administration, review of the RODSS data to evaluate the :...
Miami regional advanced traveler information system project : final evaluation report
DOT National Transportation Integrated Search
2002-04-01
In 1999 the U.S. Congress earmarked funds for selected projects that were assessed as supporting the improvements of transportation efficiency, promoting safety, increasing traffic flow, reducing emissions, improving traveler information, enhancing a...
Riverside County transit : ITS demonstration project : phase II evaluation final report
DOT National Transportation Integrated Search
2001-12-24
In 1999, the U.S. Congress earmarked funds for selected projects that were assessed as supporting improvements in transportation efficiency, promoting safety, increasing traffic flow, reducing emissions, improving traveler information, enhancing alte...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Collins, E.K.
1979-08-01
Three separate reviews of the Turkey Point Units 3 and 4 were conducted by the FPLCO between 1972 and 1975. Initially, at the request of NBC in 1972, the FPLCO reviewed several water systems as sources of flooding. Subsequently, as a result of an abnormal occurrence, the drainage system was reviewed. Finally, the facilities were again reviewed at NRC's request and both the potential sources of flooding and safety-related equipment which could be damaged by flooding were identified. The sources of flooding and the appropriate safety equipment are discussed. An evaluation is presented of measures that were taken by FPLCOmore » to minimize the danger of flooding and to protect safety-related equipment.« less
SER assistant: An expert system for safety evaluation reports
DOE Office of Scientific and Technical Information (OSTI.GOV)
DeChaine, M.D.; Levine, S.H.; Feltus, M.A.
1993-01-01
The SER Assistant is an expert system that assists engineers to write safety evaluation reports (SERs). Section 50.59 of the Code of Federal Regulations allows modifications to be made to nuclear power plants without prior US Nuclear Regulatory Commission approval if two conditions are satisfied. First, the change must not affect the technical specifications of the plant. Second, the modification must not affect a part of the plant described in the final safety analysis report, or if it does, it must not create an unreviewed safety question. The purpose of an SER is to ensure that these conditions are satisfiedmore » for the proposed modification. The SER Assistant aids this process by providing relevant, but directed, questions and information as well as giving engineers an organized environment to document their thought processes.« less
75 FR 81317 - Advisory Committee on Reactor Safeguards; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-27
... Thursday, October 21, 2010 (74 FR 65038-65039). Thursday, January 13, 2011, Conference Room T2-B1, Two... Evaluation Report Associated With the Vogtle Units 3 and 4 Combined License Application (Open/Closed)-- The... Nuclear Company, and NuStar Energy regarding the Final Safety Evaluation Report associated with the Vogtle...
DOT National Transportation Integrated Search
1985-12-01
This is the final report on the results of three observational surveys of restraint use by front seat occupants conducted as part of the evaluation of New York's Mandatory Occupant Restraint Law. Observations were conducted at a probability sample of...
DOT National Transportation Integrated Search
2017-09-01
This project evaluated current nighttime work zone lighting practices for limited-access highways and primary routes in Virginia through (1) an on-site evaluation of lighting levels in work zones; (2) an illuminance characterization of various commer...
Modeling level-of-safety for bus stops in China.
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).
76 FR 17808 - Final Vehicle Safety Rulemaking and Research Priority Plan 2011-2013
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-31
... [Docket No. NHTSA-2009-0108] Final Vehicle Safety Rulemaking and Research Priority Plan 2011- 2013 AGENCY... availability. SUMMARY: This document announces the availability of the Final NHTSA Vehicle Safety and Fuel.... This Priority Plan is an update to the Final Vehicle Safety Rulemaking and Research Priority Plan 2009...
75 FR 61619 - Safety Zone; IJSBA World Finals, Lower Colorado River, Lake Havasu, AZ
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-06
...-AA00 Safety Zone; IJSBA World Finals, Lower Colorado River, Lake Havasu, AZ AGENCY: Coast Guard, DHS... Sports Boating Association (IJSBA) World Finals. This temporary safety zone is necessary to provide for... notice of proposed rulemaking (NPRM) entitled Safety Zone; IJSBA World Finals in the Federal Register (75...
2014-12-01
final page of the questionnaire instructed the participants to go to their designated seats in the aircraft seat mock-up. The research facilitator...confirmed their seats and reminded them that they would see a video of General Instructions (Appendix C), then the simulated passenger safety...water survival and passenger safety study. Our present concern is with determining how effectively different designs of life preservers can be
Development and Piloting of a Food Safety Audit Tool for the Domestic Environment
Borrusso, Patricia; Quinlan, Jennifer J.
2013-01-01
Research suggests that consumers often mishandle food in the home based on survey and observation studies. There is a need for a standardized tool for researchers to objectively evaluate the prevalence and identify the nature of food safety risks in the domestic environment. An audit tool was developed to measure compliance with recommended sanitation, refrigeration and food storage conditions in the domestic kitchen. The tool was piloted by four researchers who independently completed the inspection in 22 homes. Audit tool questions were evaluated for reliability using the κ statistic. Questions that were not sufficiently reliable (κ < 0.5) or did not provide direct evidence of risk were revised or eliminated from the final tool. Piloting the audit tool found good reliability among 18 questions, 6 questions were revised and 28 eliminated, resulting in a final 24 question tool. The audit tool was able to identify potential food safety risks, including evidence of pest infestation (27%), incorrect refrigeration temperature (73%), and lack of hot water (>43 °C, 32%). The audit tool developed here provides an objective measure for researchers to observe and record the most prevalent food safety risks in consumer’s kitchens and potentially compare risks among consumers of different demographics. PMID:28239139
A review on the benchmarking concept in Malaysian construction safety performance
NASA Astrophysics Data System (ADS)
Ishak, Nurfadzillah; Azizan, Muhammad Azizi
2018-02-01
Construction industry is one of the major industries that propels Malaysia's economy in highly contributes to our nation's GDP growth, yet the high fatality rates on construction sites have caused concern among safety practitioners and the stakeholders. Hence, there is a need of benchmarking in performance of Malaysia's construction industry especially in terms of safety. This concept can create a fertile ground for ideas, but only in a receptive environment, organization that share good practices and compare their safety performance against other benefit most to establish improvement in safety culture. This research was conducted to study the awareness important, evaluate current practice and improvement, and also identify the constraint in implement of benchmarking on safety performance in our industry. Additionally, interviews with construction professionals were come out with different views on this concept. Comparison has been done to show the different understanding of benchmarking approach and how safety performance can be benchmarked. But, it's viewed as one mission, which to evaluate objectives identified through benchmarking that will improve the organization's safety performance. Finally, the expected result from this research is to help Malaysia's construction industry implement best practice in safety performance management through the concept of benchmarking.
Chen, Yikai; Wang, Kai; Xu, Chengcheng; Shi, Qin; He, Jie; Li, Peiqing; Shi, Ting
2018-05-19
To overcome the limitations of previous highway alignment safety evaluation methods, this article presents a highway alignment safety evaluation method based on fault tree analysis (FTA) and the characteristics of vehicle safety boundaries, within the framework of dynamic modeling of the driver-vehicle-road system. Approaches for categorizing the vehicle failure modes while driving on highways and the corresponding safety boundaries were comprehensively investigated based on vehicle system dynamics theory. Then, an overall crash probability model was formulated based on FTA considering the risks of 3 failure modes: losing steering capability, losing track-holding capability, and rear-end collision. The proposed method was implemented on a highway segment between Bengbu and Nanjing in China. A driver-vehicle-road multibody dynamics model was developed based on the 3D alignments of the Bengbu to Nanjing section of Ning-Luo expressway using Carsim, and the dynamics indices, such as sideslip angle and, yaw rate were obtained. Then, the average crash probability of each road section was calculated with a fixed-length method. Finally, the average crash probability was validated against the crash frequency per kilometer to demonstrate the accuracy of the proposed method. The results of the regression analysis and correlation analysis indicated good consistency between the results of the safety evaluation and the crash data and that it outperformed the safety evaluation methods used in previous studies. The proposed method has the potential to be used in practical engineering applications to identify crash-prone locations and alignment deficiencies on highways in the planning and design phases, as well as those in service.
Quantification of the benefits of access management for Kentucky : final report.
DOT National Transportation Integrated Search
2006-07-01
This report describes the benefits quantification performed for the proposed access management plan for Kentucky. This study evaluates the capacity, safety and economic impacts associated with access management programs. The proposed Kentucky access ...
Evaluation and Countermeasures on sustainable development of nickel resources in China
NASA Astrophysics Data System (ADS)
Lin, Zhifeng
2017-08-01
Nickel is an important strategic resource in China. With the gradual reduction of nickel re-sources and the increasing competition of the global mineral resources market, the safety of nickel resources in China has been seriously threatened. Therefore, it is very important to evaluate the sustainable develop-ment of nickel resources in China and put forward the corresponding countermeasures. In this paper, the concept and research situation of sustainable development are analyzed. Based on the specific development of nickel resources in China, this paper uses AHP to evaluate the safety of nickel resources in china. Finally, it puts forward the concrete measures to implement the sustainable development strategy of nickel resources in China.
Ensuring the validity of calculated subcritical limits
DOE Office of Scientific and Technical Information (OSTI.GOV)
Clark, H.K.
1977-01-01
The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less
Evaluating vegetation management practices for woody and herbaceous vegetation : final report.
DOT National Transportation Integrated Search
2017-03-01
To determine vegetation management practices, ODOT Districts can implement to increase efficiency : and cost-effectiveness that contribute to worker safety and foster safe highway use by the traveling : public. ODOT would benefit from a Roadside Inte...
Overcoming barriers to ITS : lessons from other technologies : final report
DOT National Transportation Integrated Search
1999-12-08
The purpose of this study was to (1) identify from direct interaction with motorcoach owners, safety directors, operations managers, and drivers those fatigue-inducing stresses which they believe are unique to the motorcoach industry; (2) evaluate th...
Safety evaluation of the SCATS control system, final report.
DOT National Transportation Integrated Search
2010-09-01
Since 1992, traffic signals in Oakland County and a portion of Macomb and Wayne Counties of Michigan have been : converted to the Sydney Coordinated Adaptive Traffic System (SCATS). County traffic engineers have been : adjusting various SCATS paramet...
State Patrol Mobile Data Communications Network : final report and local evaluation
DOT National Transportation Integrated Search
2005-01-14
The Wisconsin Department of Transportation (WisDOT) has implemented a statewide digital microwave backbone infrastructure that is used to transport communications voice and data information for 161 public safety agencies throughout the State of Wisco...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-28
... Final Safety Evaluation Report (FSER) associated with the ESBWR design certification. The Subcommittee... from the website cited above or by contacting the identified DFO. Moreover, in view of the possibility...
Safety evaluation of red-light cameras
DOT National Transportation Integrated Search
2005-04-01
The objective of this final study was to determine the effectiveness of red-light-camera (RLC) systems in reducing crashes. The study used empirical Bayes before-and-after research using data from seven jurisdictions across the United States at 132 t...
DOT National Transportation Integrated Search
2017-03-01
This project explores the possibility of using high-resolution traffic signal data to evaluate intersection safety. : Traditional methods using historical crash data collected from infrequently and randomly occurring vehicle : collisions can require ...
On Some Methods in Safety Evaluation in Geotechnics
NASA Astrophysics Data System (ADS)
Puła, Wojciech; Zaskórski, Łukasz
2015-06-01
The paper demonstrates how the reliability methods can be utilised in order to evaluate safety in geotechnics. Special attention is paid to the so-called reliability based design that can play a useful and complementary role to Eurocode 7. In the first part, a brief review of first- and second-order reliability methods is given. Next, two examples of reliability-based design are demonstrated. The first one is focussed on bearing capacity calculation and is dedicated to comparison with EC7 requirements. The second one analyses a rigid pile subjected to lateral load and is oriented towards working stress design method. In the second part, applications of random field to safety evaluations in geotechnics are addressed. After a short review of the theory a Random Finite Element algorithm to reliability based design of shallow strip foundation is given. Finally, two illustrative examples for cohesive and cohesionless soils are demonstrated.
ERIC Educational Resources Information Center
Bologa, James F.; And Others
The study was conducted to measure variables related to safe driving and to designate factors predictive of success in driving safety of educable mentally retarded (EMR) students as compared to normal students. Subjects were 349 EMR and 443 intellectually normal students (ages 16-20), who were evaluated in the following areas: visual acuity,…
Rudolphi, Josie M; Donham, Kelley J
2015-01-01
ABSTRACT The University of Iowa began training health care professionals to care for farmers' occupational health needs since 1974. In order to geographically expand this training to practicing health and safety professionals, the "Building Capacity: A National Resource of Agricultural Medicine Professionals" program was developed and launched in 2006. The model began in 1987 as a program of Iowa's Center for Agricultural Safety and Health. In 2006, with funding from the National Institute for Occupational Safety and Health (NIOSH), Great Plains Center for Agricultural Health (GPCAH), the program was expanded beyond the Iowa borders. The principal component of the program, the 40-hour course, Agricultural Medicine: Occupational and Environmental Health for Rural Health Professionals-the Core Course (AMCC) is now being offered to health and safety professionals in nine states in the United States, in Australia, and a modified version presented in Turkey. An initial paper evaluated the first phase of the program, years 2007-2010. This paper compares the first phase (2007-2010) with the second phase (2011-2013), which has involved over 500 health and safety professionals. This paper also describes evaluation of the course and changes resulting from the evaluation. Finally, this paper describes best practices for operating this program and makes recommendations for future courses, as well as other trainings within the field.
State Patrol Mobile Data Communications Network : phase 2, final report and local evaluation
DOT National Transportation Integrated Search
2005-05-12
The Wisconsin Department of Transportation (WisDOT) has implemented a statewide digital microwave backbone infrastructure that is used to transport communications voice and data information for 161 public safety agencies throughout the State of Wisco...
Pedestrian safety impacts of curb extensions : a case study : final report.
DOT National Transportation Integrated Search
2005-07-01
This report documents a case study evaluating motorist yielding behavior at a crosswalk in Albany, Oregon. In 2003 the City of Albany installed curb extensions, continental markings and advance stop bars at several uncontrolled intersections along th...
Evaluation of Safety, Design, and Operation of Shared-Use Paths
DOT National Transportation Integrated Search
2006-03-01
This TechBrief summarizes the final report of the same title (FHWA-HRT-05-137). Shared-use paths are paved, off-street travelways that serve bicyclists, pedestrians, and other nonmotorized modes of travel. The Federal Highway Administration (FHWA) ha...
FHWA research and technology evaluation : gusset plates final report
DOT National Transportation Integrated Search
2016-01-01
On August 1, 2007, the I35W Mississippi River Bridge (I35W Bridge) in Minneapolis, MN, collapsed. The National Transportation Safety Board (NTSB) turned to the Federal Highway Administration (FHWA) to provide technical expertise during their in...
In-Vehicle Safety Advisory And Warning System (Ivsaws), Volume II: Final Report
DOT National Transportation Integrated Search
2001-04-01
Methods for determining the workability of freshly mixed portland-cement concrete with slumps less than 51 mm (2 in) were investigated. Four potential methods to determine the workability of concrete were proposed for evaluation and development. The ...
State Patrol Mobile Data Communications Network : final report and local evaluation, phase 3
DOT National Transportation Integrated Search
2006-04-07
The Wisconsin Department of Transportation (WisDOT) has implemented a statewide digital microwave backbone infrastructure that is used to transport communications voice and data information for 172 public safety agencies throughout the State of Wisco...
The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Nelson, R.C.; Gray, L.B.; Huff, D.A.
The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment ofmore » the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System.« less
10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2013 CFR
2013-01-01
...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...
10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2012 CFR
2012-01-01
...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...
10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2014 CFR
2014-01-01
...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...
10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.
Code of Federal Regulations, 2011 CFR
2011-01-01
...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...
Waterson, Patrick; Robertson, Michelle M; Cooke, Nancy J; Militello, Laura; Roth, Emilie; Stanton, Neville A
2015-01-01
An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a 'roadmap' for future work.
Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Yamamoto, Kazuhiko; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao
2018-04-27
We evaluated the long-term (52 weeks) safety and effectiveness of iguratimod (IGU) in patients with rheumatoid arthritis (RA). This multicenter, prospective, observational study included all evaluable RA patients who received IGU since its market launch in 2012. We evaluated adverse events (AEs); adverse drug reactions (ADRs); ADRs of special interest, including liver and renal dysfunctions, interstitial lung disease, gastrointestinal and blood disorders, and infection; and change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) at week 52. Safety and effectiveness were analyzed in 2666 and 1614 patients, respectively. The incidences of AEs, serious AEs, ADRs, and serious ADRs were 46.92, 7.35, 38.26, and 4.58%, respectively. The incidence of ADRs peaked at approximately 4 weeks of treatment. Subsequently, the ADR incidence did not increase over time. Improvement of RA activity was shown up to week 52. Long-term treatment with IGU in patients with RA resulted in a tolerable safety profile and an improvement in RA activity. IGU could be considered a useful treatment option for patients with RA.
DOT National Transportation Integrated Search
2008-02-02
The Wisconsin Department of Transportation (WisDOT) has implemented a statewide digital microwave backbone infrastructure that is used to transport communications voice and data information for 161 public safety agencies throughout the State of Wisco...
Commercial Motor Vehicle (CMV) Driver Restart Study: Final Report
DOT National Transportation Integrated Search
2017-03-01
A congressionally-mandated naturalistic study was conducted to evaluate the operational, safety, fatigue, and health impacts of the restart provisions in Sections 395.3(c) and 395.3(d) of Title 49, Code of Federal Regulations. A total of 235 commerci...
DOT National Transportation Integrated Search
2004-11-11
The catastrophic events of September 11, 2001 and the ongoing war on terrorism have heightened the level of concern from Federal government officials and the transportation industry regarding the secure transport of hazardous materials (HAZMAT). Secu...
DOT National Transportation Integrated Search
2002-03-01
The Commercial Vehicle Information Systems and Networks Model Deployment Initiative (CVISN MDI) is funded by the Intelligent Transportation Systems Joint Program Office (ITS JPO) and managed by the Federal Motor Carrier Safety Administration (FMCSA),...
Evaluation of j-turn intersection design performance in Missouri, final report.
DOT National Transportation Integrated Search
2013-12-01
Research shows that a high percentage of crashes that take place on high-speed rural expressways occur at intersections : with minor roads. One low-cost alternative design for improving the safety of at-grade intersections on such expressways is : th...
76 FR 53051 - Safety Zone; ISAF Nations Cup Grand Final Fireworks Display, Sheboygan, WI
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-25
...-AA00 Safety Zone; ISAF Nations Cup Grand Final Fireworks Display, Sheboygan, WI AGENCY: Coast Guard.... Background and Purpose The ISAF Nations Cup Grand Final fireworks are a City permitted fireworks display that.... 165.T09-0755 Safety Zone; ISAF Nations Cup Grand Final Fireworks Display, Sheboygan, Wisconsin. (a...
76 FR 61261 - Safety Zone; IJSBA World Finals; Lower Colorado River, Lake Havasu, AZ
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-04
...-AA00 Safety Zone; IJSBA World Finals; Lower Colorado River, Lake Havasu, AZ AGENCY: Coast Guard, DHS... Boating Association (IJSBA) World Finals. This temporary safety zone is necessary to provide for the... The International Jet Sports Boating Association is sponsoring the IJSBA World Finals. The event will...
Investigation of safety analysis methods using computer vision techniques
NASA Astrophysics Data System (ADS)
Shirazi, Mohammad Shokrolah; Morris, Brendan Tran
2017-09-01
This work investigates safety analysis methods using computer vision techniques. The vision-based tracking system is developed to provide the trajectory of road users including vehicles and pedestrians. Safety analysis methods are developed to estimate time to collision (TTC) and postencroachment time (PET) that are two important safety measurements. Corresponding algorithms are presented and their advantages and drawbacks are shown through their success in capturing the conflict events in real time. The performance of the tracking system is evaluated first, and probability density estimation of TTC and PET are shown for 1-h monitoring of a Las Vegas intersection. Finally, an idea of an intersection safety map is introduced, and TTC values of two different intersections are estimated for 1 day from 8:00 a.m. to 6:00 p.m.
2016-07-19
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.
Evaluation of the effect of MnPASS lane design on mobility and safety : final report.
DOT National Transportation Integrated Search
2014-06-01
Dynamically priced High Occupancy Toll (HOT) lanes have been recently added to the traffic operations arsenal in : an attempt to preserve infrastructure investment in the future by maintaining a control on demand. This study : focuses on the operatio...
Xiong, Zhenjie; Sun, Da-Wen; Pu, Hongbin; Gao, Wenhong; Dai, Qiong
2017-03-04
With improvement in people's living standards, many people nowadays pay more attention to quality and safety of meat. However, traditional methods for meat quality and safety detection and evaluation, such as manual inspection, mechanical methods, and chemical methods, are tedious, time-consuming, and destructive, which cannot meet the requirements of modern meat industry. Therefore, seeking out rapid, non-destructive, and accurate inspection techniques is important for the meat industry. In recent years, a number of novel and noninvasive imaging techniques, such as optical imaging, ultrasound imaging, tomographic imaging, thermal imaging, and odor imaging, have emerged and shown great potential in quality and safety assessment. In this paper, a detailed overview of advanced applications of these emerging imaging techniques for quality and safety assessment of different types of meat (pork, beef, lamb, chicken, and fish) is presented. In addition, advantages and disadvantages of each imaging technique are also summarized. Finally, future trends for these emerging imaging techniques are discussed, including integration of multiple imaging techniques, cost reduction, and developing powerful image-processing algorithms.
NASA Astrophysics Data System (ADS)
Taylor, Gabriel James
The failure of electrical cables exposed to severe thermal fire conditions are a safety concern for operating commercial nuclear power plants (NPPs). The Nuclear Regulatory Commission (NRC) has promoted the use of risk-informed and performance-based methods for fire protection which resulted in a need to develop realistic methods to quantify the risk of fire to NPP safety. Recent electrical cable testing has been conducted to provide empirical data on the failure modes and likelihood of fire-induced damage. This thesis evaluated numerous aspects of the data. Circuit characteristics affecting fire-induced electrical cable failure modes have been evaluated. In addition, thermal failure temperatures corresponding to cable functional failures have been evaluated to develop realistic single point thermal failure thresholds and probability distributions for specific cable insulation types. Finally, the data was used to evaluate the prediction capabilities of a one-dimension conductive heat transfer model used to predict cable failure.
DOT National Transportation Integrated Search
1989-01-01
When concrete deterioration begins to occur in highway pavement, : repairs become necessary to assure the rider safety, extend its : useful life and restore its riding qualities. One rehabilitation : technique used to restore the pavement to acceptab...
Assessment and evaluations of I-80 truck loads and their load effects : final report.
DOT National Transportation Integrated Search
2016-12-01
The research objective is to examine the safety of Wyoming bridges on the I-80 corridor considering the actual truck traffic on the : interstate based upon weigh in motion (WIM) data. This was accomplished by performing statistical analyses to determ...
Technical summary : Travtek operational test evaluation : final reports
DOT National Transportation Integrated Search
2009-01-01
This guide is packed with useful information. It focuses on some of the less well-known safety messages the road offers you. It is designed to be kept in your glove compartment after it has been read so that you will have its valuable information at ...
Accident analysis and control options in support of the sludge water system safety analysis
DOE Office of Scientific and Technical Information (OSTI.GOV)
HEY, B.E.
A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less
Development and weighting of a life cycle assessment screening model
NASA Astrophysics Data System (ADS)
Bates, Wayne E.; O'Shaughnessy, James; Johnson, Sharon A.; Sisson, Richard
2004-02-01
Nearly all life cycle assessment tools available today are high priced, comprehensive and quantitative models requiring a significant amount of data collection and data input. In addition, most of the available software packages require a great deal of training time to learn how to operate the model software. Even after this time investment, results are not guaranteed because of the number of estimations and assumptions often necessary to run the model. As a result, product development, design teams and environmental specialists need a simplified tool that will allow for the qualitative evaluation and "screening" of various design options. This paper presents the development and design of a generic, qualitative life cycle screening model and demonstrates its applicability and ease of use. The model uses qualitative environmental, health and safety factors, based on site or product-specific issues, to sensitize the overall results for a given set of conditions. The paper also evaluates the impact of different population input ranking values on model output. The final analysis is based on site or product-specific variables. The user can then evaluate various design changes and the apparent impact or improvement on the environment, health and safety, compliance cost and overall corporate liability. Major input parameters can be varied, and factors such as materials use, pollution prevention, waste minimization, worker safety, product life, environmental impacts, return of investment, and recycle are evaluated. The flexibility of the model format will be discussed in order to demonstrate the applicability and usefulness within nearly any industry sector. Finally, an example using audience input value scores will be compared to other population input results.
Road safety issues for bus transport management.
Cafiso, Salvatore; Di Graziano, Alessandro; Pappalardo, Giuseppina
2013-11-01
Because of the low percentage of crashes involving buses and the assumption that public transport improves road safety by reducing vehicular traffic, public interest in bus safety is not as great as that in the safety of other types of vehicles. It is possible that less attention is paid to the significance of crashes involving buses because the safety level of bus systems is considered to be adequate. The purpose of this study was to evaluate the knowledge and perceptions of bus managers with respect to safety issues and the potential effectiveness of various technologies in achieving higher safety standards. Bus managers were asked to give their opinions on safety issues related to drivers (training, skills, performance evaluation and behaviour), vehicles (maintenance and advanced devices) and roads (road and traffic safety issues) in response to a research survey. Kendall's algorithm was used to evaluate the level of concordance. The results showed that the majority of the proposed items were considered to have great potential for improving bus safety. The data indicated that in the experience of the participants, passenger unloading and pedestrians crossing near bus stops are the most dangerous actions with respect to vulnerable users. The final results of the investigation showed that start inhibition, automatic door opening, and the materials and internal architecture of buses were considered the items most strongly related to bus passenger safety. Brake assistance and vehicle monitoring systems were also considered to be very effective. With the exception of driver assistance systems for passenger and pedestrian safety, the perceptions of the importance of other driver assistance systems for vehicle monitoring and bus safety were not unanimous among the bus company managers who participated in this survey. The study results showed that the introduction of new technologies is perceived as an important factor in improving bus safety, but a better understanding of their actual effectiveness and related risk factor avoidance must be developed to permit their useful implementation in bus fleets. Copyright © 2013 Elsevier Ltd. All rights reserved.
Waterson, Patrick; Robertson, Michelle M.; Cooke, Nancy J.; Militello, Laura; Roth, Emilie; Stanton, Neville A.
2015-01-01
An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. Practitioner Summary: We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a ‘roadmap’ for future work. PMID:25832121
Sommer, Doron D; Arbab-Tafti, Sadaf; Farrokhyar, Forough; Tewfik, Marc; Vescan, Allan; Witterick, Ian J; Rotenberg, Brian; Chandra, Rakesh; Weitzel, Erik K; Wright, Erin; Ramakrishna, Jayant
2018-02-27
The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery-specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery. This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method. Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%). The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting. © 2018 ARS-AAOA, LLC.
Flight set 360L001 (STS-26) insulation component. Volume 3: Final release
NASA Technical Reports Server (NTRS)
Albrechtsen, K.; Passman, J.
1989-01-01
The postfire condition of the external and internal insulation for STS-26 is documented and the thermal safety factors of the RSRM-1A and RSRM-1B internal insulation are evaluated. The Insulation Component Program Team assessment of the observation is discussed.
75 FR 65497 - Science Board Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... for Food Safety and Applied Nutrition (CFSAN) will present its evaluation and review of the final... contact person on or before Monday, November 8, 2010. Oral presentations from the public will be scheduled...
FAST DASH: Safety Technology Evaluation Project #1 – Blindspot Warning, 2012
DOT National Transportation Integrated Search
2014-01-01
The objective of this research project was to examine the efficacy of the new restart rule promulgated as part of the Hours of Service of Drivers Final Rule, published on December 27, 2011, with a compliance date of July 1, 2013. Under the new restar...
DOT National Transportation Integrated Search
1975-02-01
This technical appendix presents an overview of the national pedestrian safety effort. The appendix also reports the results of a survey of 48 ongoing educational programs being conducted in eight U.S. urban centers. A final chapter suggests procedur...
77 FR 12985 - Proposed Revised Habitat for the Spotted Owl: Minimizing Regulatory Burdens
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-05
... protect public health, welfare, safety, and our environment while promoting economic growth, innovation... applicable law and science; (3) develop clear direction, as part of the final rule, for evaluating logging... science and economics, including those comments that suggest potential methods for minimizing regulatory...
DOT National Transportation Integrated Search
2017-01-01
Driver fatigue and drowsiness can have a profound impact on safety. Centerline and shoulder rumble strips (RS) are popular countermeasures designed to produce audible and tactile warning when vehicles deviate from the travel lane onto the RS. This re...
[Evaluating training programs on occupational health and safety: questionnaire development].
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.
2015-02-01
supply, sanitary sewage/wastewater, storm water handling, and communications systems. Solid waste TEAMS Final Environmental Assessment Kirtland...appropriately sanitized prior to being placed back into service. This will ensure safety of the water system. Sanitary Sewer/Wastewater System. Kirtland...AFB does not have its own sewage treatment plant. Instead, the sanitary sewer system of Kirtland AFB transports wastewater to the city of
Patient safety and infection control: bases for curricular integration.
Silva, Andréa Mara Bernardes da; Bim, Lucas Lazarini; Bim, Felipe Lazarini; Sousa, Alvaro Francisco Lopes; Domingues, Pedro Castania Amadio; Nicolussi, Adriana Cristina; Andrade, Denise de
2018-05-01
To analyze curricular integration between teaching of patient safety and good infection prevention and control practices. Integrative review, designed to answer the question: "How does curricular integration of content about 'patient safety teaching' and content about 'infection prevention and control practices' occur in undergraduate courses in the health field?". The following databases were searched for primary studies: CINAHL, LILACS, ScienceDirect, Web of Science, Scopus, Europe PMC and MEDLINE. The final sample consisted of 13 studies. After content analysis, primary studies were grouped into two subject categories: "Innovative teaching practices" and "Curricular evaluation. Patient safety related to infection prevention and control practices is present in the curriculum of health undergraduate courses, but is not coordinated with other themes, is taught sporadically, and focuses mainly on hand hygiene.
NASA Technical Reports Server (NTRS)
Borthwick, Dawn E.; Cronch, Daniel F.; Nixon, Glen R.
1991-01-01
The goal of this project is to design a reusable safety device for a waist tether which will absorb the kinetic energy of an astronaut drifting away from the Space Station. The safety device must limit the tension of the tether line in order to prevent damage to the astronaut's space suit or to the structure of the spacecraft. The tether currently used on shuttle missions must be replaced after the safety feature has been developed. A reusable tether for the Space Station would eliminate the need for replacement tethers, conserving space and mass. This report presents background information, scope and limitations, methods of research and development, alternative designs, a final design solution and its evaluation, and recommendations for further work.
DOE Office of Scientific and Technical Information (OSTI.GOV)
R. Camp
Over the past four years, the Electrical Safety Program at PPPL has evolved in addressing changing regulatory requirements and lessons learned from accident events, particularly in regards to arc flash hazards and implementing NFPA 70E requirements. This presentation will discuss PPPL's approaches to the areas of electrical hazards evaluation, both shock and arc flash; engineered solutions for hazards mitigation such as remote racking of medium voltage breakers, operational changes for hazards avoidance, targeted personnel training and hazard appropriate personal protective equipment. Practical solutions for nominal voltage identification and zero voltage checks for lockout/tagout will also be covered. Finally, we willmore » review the value of a comprehensive electrical drawing program, employee attitudes expressed as a personal safety work ethic, integrated safety management, and sustained management support for continuous safety improvement.« less
Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung
2016-08-01
The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.
Palavecino Prpich, Noelia Z; Castro, Marcela P; Cayré, María E; Garro, Oscar A; Vignolo, Graciela M
2015-01-01
Lactic acid bacteria (LAB) and coagulase negative cocci (CNC) were isolated from artisanal dry sausages sampled from the northeastern region of Chaco, Argentina. In order to evaluate their performance in situ and considering technological features of the isolated strains, two mixed selected autochthonous starter cultures (SAS) were designed: (i) SAS-1 (Lactobacillus sakei 487 + Staphylococcus vitulinus C2) and (ii) SAS-2 (L. sakei 442 + S. xylosus C8). Cultures were introduced into dry sausage manufacturing process at a local small-scale facility. Microbiological and physicochemical parameters were monitored throughout fermentation and ripening periods, while sensory attributes of the final products were evaluated by a trained panel. Lactic acid bacteria revealed their ability to colonize and adapt properly to the meat matrix, inhibiting the growth of spontaneous microflora and enhancing safety and hygienic profile of the products. Both SAS showed a beneficial effect on lipid oxidation and texture of the final products. Staphylococcus vitulinus C2, from SAS-1, promoted a better redness of the final product. Sensory profile revealed that SAS addition preserved typical sensory attributes. Introduction of these cultures could provide an additional tool to standardize manufacturing processes aiming to enhance safety and quality while keeping typical sensory attributes of regional dry fermented sausages.
Incident reporting: Its role in aviation safety and the acquisition of human error data
NASA Technical Reports Server (NTRS)
Reynard, W. D.
1983-01-01
The rationale for aviation incident reporting systems is presented and contrasted to some of the shortcomings of accident investigation procedures. The history of the United State's Aviation Safety Reporting System (ASRS) is outlined and the program's character explained. The planning elements that resulted in the ASRS program's voluntary, confidential, and non-punitive design are discussed. Immunity, from enforcement action and misuse of the volunteered data, is explained and evaluated. Report generation techniques and the ASRS data analysis process are described; in addition, examples of the ASRS program's output and accomplishments are detailed. Finally, the value of incident reporting for the acquisition of safety information, particularly human error data, is explored.
Setting an Agenda for Advancing Young Worker Safety in the U.S. and Canada
Runyan, Carol W.; Lewko, John; Rauscher, Kimberly
2012-01-01
Scholars and practitioners from multiple perspectives, including developmental science, sociology, business, medicine, and public health, have considered the implications of employment for young people. We summarize a series of meetings designed to synthesize information from these perspectives and derive recommendations to guide research, practice, and policy with a focus on young worker safety and health. During the first three meetings, participants from the United States and Canada considered invited white papers addressing developmental issues, public health data and findings, as well as programmatic advances and evaluation needs. At the final meeting, the participants recommended both research and policy directions to advance understanding and improve young worker safety. PMID:22547854
Canister Storage Building (CSB) Design Basis Accident Analysis Documentation
DOE Office of Scientific and Technical Information (OSTI.GOV)
CROWE, R.D.; PIEPHO, M.G.
2000-03-23
This document provided the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report''. All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.
[Preclinical evaluation of the safety of biotechnology products: specific aspects].
Descotes, Jacques; Ravel, Guillaume; Vial, Thierry
2003-01-01
Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.
77 FR 23159 - Locomotive Safety Standards; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-18
.... FRA-2009-0094 and FR-2009-0095, Notice No. 4] RIN 2130-AC16 Locomotive Safety Standards; Correction... notifying the public that the correct docket number for the Locomotive Safety Standards final rule is FRA... rule related to locomotive safety standards. See 77 FR 21312. The final rule established a public...
Flight set 360L007 (STS-33) insulation component. Volume 3: Final release
NASA Technical Reports Server (NTRS)
Hicken, Steve
1990-01-01
Volume 3 of this postfire report deals with the insulation component of the RSRM. The report is released twice for each flight set. The interim release contract date is on or before 60 days after the last field joint or nozzle to case joint is disassembled at KSC and contain the results of the KSC visual evaluation. The data contained in Volume 3 interim release supersedes the insulation data presented in the KSC 10 day report. The final release contract data is on or before 60 days after the last factory joint is disassembled at the Clearfield H-7 facility and contains the results of all visual evaluations and a thermal safety factor analysis. The data contained in the Volume 3 final release supersedes the interim release and the insulation data presented in the Clearfield 10 day report.
Final safety analysis report for the Galileo Mission: Volume 1, Reference design document
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Galileo mission uses nuclear power sources called Radioisotope Thermoelectric Generators (RTGs) to provide the spacecraft's primary electrical power. Because these generators contain nuclear material, a Safety Analysis Report (SAR) is required. A preliminary SAR and an updated SAR were previously issued that provided an evolving status report on the safety analysis. As a result of the Challenger accident, the launch dates for both Galileo and Ulysses missions were later rescheduled for November 1989 and October 1990, respectively. The decision was made by agreement between the DOE and the NASA to have a revised safety evaluation and report (FSAR) preparedmore » on the basis of these revised vehicle accidents and environments. The results of this latest revised safety evaluation are presented in this document (Galileo FSAR). Volume I, this document, provides the background design information required to understand the analyses presented in Volumes II and III. It contains descriptions of the RTGs, the Galileo spacecraft, the Space Shuttle, the Inertial Upper Stage (IUS), the trajectory and flight characteristics including flight contingency modes, and the launch site. There are two appendices in Volume I which provide detailed material properties for the RTG.« less
Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan
2015-01-01
Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.
The impact of red light cameras on safety in Arizona.
Shin, Kangwon; Washington, Simon
2007-11-01
Red light cameras (RLCs) have been used in a number of US cities to yield a demonstrable reduction in red light violations; however, evaluating their impact on safety (crashes) has been relatively more difficult. Accurately estimating the safety impacts of RLCs is challenging for several reasons. First, many safety related factors are uncontrolled and/or confounded during the periods of observation. Second, "spillover" effects caused by drivers reacting to non-RLC equipped intersections and approaches can make the selection of comparison sites difficult. Third, sites selected for RLC installation may not be selected randomly, and as a result may suffer from the regression to the mean bias. Finally, crash severity and resulting costs need to be considered in order to fully understand the safety impacts of RLCs. Recognizing these challenges, a study was conducted to estimate the safety impacts of RLCs on traffic crashes at signalized intersections in the cities of Phoenix and Scottsdale, Arizona. Twenty-four RLC equipped intersections in both cities are examined in detail and conclusions are drawn. Four different evaluation methodologies were employed to cope with the technical challenges described in this paper and to assess the sensitivity of results based on analytical assumptions. The evaluation results indicated that both Phoenix and Scottsdale are operating cost-effective installations of RLCs: however, the variability in RLC effectiveness within jurisdictions is larger in Phoenix. Consistent with findings in other regions, angle and left-turn crashes are reduced in general, while rear-end crashes tend to increase as a result of RLCs.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...
Analysis of Associate Degree Program for Traffic Safety Technicians. Final Report.
ERIC Educational Resources Information Center
Shimada, Jonathan K.
A study was conducted to evaluate the impact of the Associate Degree Program for Traffic Engineering Technicians (TET's) offered at three community colleges on students' subsequent job performance as technicians. Data were collected by means of personal interviews and telephone interviews with 81 students, their primary instructors, and their…
Complex Multi-Chamber Airbag Performance Simulation Final Report CRADA No. TSB-961-94
DOE Office of Scientific and Technical Information (OSTI.GOV)
Kay, Gregory; Kithil, Philip
The purpose of this small business CRADA was to evaluate the performance of new airbag concepts which were developed by the Advanced Safety Concepts, Inc. (ASCI). These new airbag concepts, if successful, could have major potential savings to society in terms of fewer injuries, lost time and lives.
Evaluation of earthquake and tsunami on JSFR
DOE Office of Scientific and Technical Information (OSTI.GOV)
Chikazawa, Y.; Enuma, Y.; Kisohara, N.
2012-07-01
Evaluation of earthquake and tsunami on JSFR has been analyzed. For seismic design, safety components are confirmed to maintain their functions even against recent strong earthquakes. As for Tsunami, some parts of reactor building might be submerged including component cooling water system whose final heat sink is sea water. However, in the JSFR design, safety grade components are independent from component cooling water system (CCWS). The JSFR emergency power supply adopts a gas turbine system with air cooling, since JSFR does not basically require quick start-up of the emergency power supply thanks to the natural convection DHRS. Even in casemore » of long station blackout, the DHRS could be activated by emergency batteries or manually and be operated continuously by natural convection. (authors)« less
Probiotic and synbiotic safety in infants under two years of age.
van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J
2014-03-01
In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.
[Development and validation of the Korean patient safety culture scale for nursing homes].
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.
Evaluation of Safety, Quality and Productivity in Construction
NASA Astrophysics Data System (ADS)
Usmen, M. A.; Vilnitis, M.
2015-11-01
This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.
Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj; Marioryad, Hossein
2015-10-01
Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead.
Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj
2015-01-01
Background Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. Aim This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. Materials and Methods First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Results Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Conclusion Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead. PMID:26557547
78 FR 63100 - Unified Registration System; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-23
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 390 [Docket... Carrier Safety Administration (FMCSA), DOT. ACTION: Final rule; correction. SUMMARY: FMCSA makes..., Organizational and Conforming Amendments to the Federal Motor Carrier Safety Regulations'' final rule published...
78 FR 23489 - Safety Zone; V.I. Carnival Finale, St. Thomas Harbor; St. Thomas, U.S.V.I.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-19
...-AA00 Safety Zone; V.I. Carnival Finale, St. Thomas Harbor; St. Thomas, U.S.V.I. AGENCY: Coast Guard... waters of St. Thomas Harbor in St. Thomas, U.S. Virgin Islands during the V.I. Carnival Finale, a... being positioned near the St. Thomas Harbor channel from which fireworks will be lit. The safety zone is...
78 FR 22778 - Safety Zone; Corp. Event Finale UHC, St. Thomas Harbor; St. Thomas, U.S.V.I.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-17
...-AA00 Safety Zone; Corp. Event Finale UHC, St. Thomas Harbor; St. Thomas, U.S.V.I. AGENCY: Coast Guard... waters of St. Thomas Harbor in St. Thomas, U.S. Virgin Islands during the Corp. Event Finale UHC, a... barge being positioned near the St. Thomas Harbor channel from which fireworks will be lit. The safety...
Lean manufacturing comes to China: a case study of its impact on workplace health and safety.
Brown, Garrett D; O'Rourke, Dara
2007-01-01
Lean manufacturing, which establishes small production "cells," or teams of workers, who complete an entire product from raw material processing through final assembly and shipment, increases health and safety hazards by mixing previously separated exposures to various chemicals (with possible additive and cumulative effects) and noise. The intensification of work leads to greater ergonomic and stress-related adverse health effects, as well as increased safety hazards. The standard industrial hygiene approach of anticipation, recognition, evaluation, and hazard control is applicable to lean operations. A focus on worker participation in identifying and solving problems is critical for reducing negative impacts. A key to worker safety in lean production operations is the development of informed, empowered, and active workers with the knowledge, skills, and opportunity to act in the workplace to eliminate or reduce hazards.
NASA Safety and Health (Short Form). Final rule
NASA Technical Reports Server (NTRS)
2001-01-01
This final rule adopts with changes the interim rule published in the Federal Register on April 5, 2001 (65 FR 18051-18053), which amended the NASA FAR Supplement to implement a Safety and Health (Short Form) clause to address safety and occupational health in all NASA contracts above the micro-purchase threshold where the existing Safety and Health clause did not apply, and amended other safety and health clauses to be consistent with the new NASA Safety and Health (Short Form) clause.
ERIC Educational Resources Information Center
McPherson, Kenard; And Others
Instructional modules for driver education programs were prepared to improve safe driving knowledge, attitudes, and performances of 16- to 18-year-old drivers. These modules were designed to provide supplementary instruction in five content areas critical to the safe and efficient operation of motor vehicles by young drivers--speed management,…
DOE Office of Scientific and Technical Information (OSTI.GOV)
Johnson, N.; Davis, S.
1979-07-01
Performance and handling tests on the Calspan RSV were performed in Italy by the Istituto Sperimentale Auto E Motori (ISAM) and in West Germany by Volkswagenwerk AG Wolfsburg. The ISAM tests evaluated the Calspan RSV in the areas of fuel economy, vehicle response, braking and handling, and driver environment. The Volkswagen tests evaluated the Calspan RSV in the areas of braking, steering, handling, and overturning immunity. The ISAM tests are unlike any previously used to evaluate American vehicles. Therefore, the Calspan RSV results are compared to those of ten European cars which had undergone identical tests. The Volkswagen test proceduresmore » were identical to those specified in the Research Safety Vehicle program. The Calspan RSV results are compared to the RSV specifications for these tests.« less
Safety Behaviors in Adults With Social Anxiety: Review and Future Directions.
Piccirillo, Marilyn L; Taylor Dryman, M; Heimberg, Richard G
2016-09-01
Safety behaviors are considered an important factor in the maintenance of social anxiety disorder (SAD). Safety behaviors are typically employed by socially anxious individuals to reduce anxiety in feared social situations. However, by preventing individuals with social anxiety from gathering evidence that would disconfirm their maladaptive beliefs about social situations, the use of safety behaviors ultimately maintains social anxiety over time. Twenty years ago, Wells and colleagues (1995) demonstrated that use of safety behaviors diminishes the efficacy of exposure treatment for SAD, suggesting that reduction in the use of safety behaviors during exposure can enhance treatment response. Research on safety behaviors has expanded considerably since Wells et al.'s seminal publication, and our understanding of the role safety behaviors may play in the maintenance of social anxiety has grown in breadth and depth. In this paper, we present a detailed review of the published research on safety behaviors relevant to social anxiety and social-anxiety-related processes. Finally, we evaluate the impact of safety behaviors on the outcome of treatment for SAD, and we look to the literature on safety behaviors in other anxiety disorders to inform our understanding of use of safety behaviors during exposure and to facilitate future research in SAD. Copyright © 2015. Published by Elsevier Ltd.
Aviation occupant survival factors: an empirical study of the SQ006 accident.
Chang, Yu-Hern; Yang, Hui-Hua
2010-03-01
We present an empirical study of Singapore Airline (SIA) flight SQ006 to illustrate the critical factors that influence airplane occupant survivability. The Fuzzy Delphi Method was used to identify and rank the survival factors that may reduce injury and fatality in potentially survivable accidents. This is the first attempt by a group from both the public and private sectors in Taiwan to focus on cabin-safety issues related to survival factors. We designed a comprehensive survey based on our discussions with aviation safety experts. We next designed an array of important cabin-safety dimensions and then investigated and selected the critical survival factors for each dimension. Our findings reveal important cabin safety and survivability information that should provide a valuable reference for developing and evaluating aviation safety programs. We also believe that the results will be practical for designing cabin-safety education material for air travelers. Finally, the major contribution of this research is that it has identified 47 critical factors that influence accident survivability; therefore, it may encourage improvements that will promote more successful cabin-safety management. Copyright 2009 Elsevier Ltd. All rights reserved.
Tritium glovebox stripper system seismic design evaluation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Grinnell, J. J.; Klein, J. E.
2015-09-01
The use of glovebox confinement at US Department of Energy (DOE) tritium facilities has been discussed in numerous publications. Glovebox confinement protects the workers from radioactive material (especially tritium oxide), provides an inert atmosphere for prevention of flammable gas mixtures and deflagrations, and allows recovery of tritium released from the process into the glovebox when a glovebox stripper system (GBSS) is part of the design. Tritium recovery from the glovebox atmosphere reduces emissions from the facility and the radiological dose to the public. Location of US DOE defense programs facilities away from public boundaries also aids in reducing radiological dosesmore » to the public. This is a study based upon design concepts to identify issues and considerations for design of a Seismic GBSS. Safety requirements and analysis should be considered preliminary. Safety requirements for design of GBSS should be developed and finalized as a part of the final design process.« less
Authorization basis supporting documentation for plutonium finishing plant
DOE Office of Scientific and Technical Information (OSTI.GOV)
King, J.P., Fluor Daniel Hanford
1997-03-05
The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysismore » Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.« less
77 FR 53164 - Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway Workers
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-31
...-0059, Notice No. 6] RIN 2130-AC37 Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway... complex issues raised in both the petitions for reconsideration of the final rule published November 30... issues. One of the Petitions included a request for a delay in the effective date of the final rule until...
DOT National Transportation Integrated Search
2016-12-01
This final report summarizes the methods, results, conclusions, and recommendations derived from a survey conducted to understand values, beliefs, and attitudes regarding engagement in behaviors that impact the traffic safety of others. Results of th...
Hazards, risks and safety of diagnostic ultrasound.
Duck, Francis A
2008-12-01
The safety of exposure to diagnostic ultrasound is evaluated using a structured approach to risk assessment, based on the acoustic output of present ultrasound scanners. Thermal hazard is described, the magnitude and probability of temperature rise is reviewed, and the severity of harm from any outcome is reviewed. Similar assessments are made separately for acoustic cavitation and gas-body effects, which have previously been considered together. Finally, radiation pressure is considered in a similar manner. In each case, means to minimize the risk are suggested where appropriate. The highest risks are associated with the use of gas-bubble contrast agents. It is concluded that there is a medium risk associated with trans-cranial Doppler use, and that this use of ultrasound deserves more detailed safety review. The risks associated with the current practice of obstetric ultrasound are low. Whilst the severity of radiation pressure as a hazard is low, it is always present. Little is known about any associated cell responses and so the associated risk cannot be evaluated.
An early assessment of silicone hydrogel safety: pearls and pitfalls, and current status.
Keay, Lisa; Edwards, Katie; Stapleton, Fiona
2007-11-01
The contact lens industry has evolved and now provides many choices, including continuous wear, overnight orthokeratology, frequent-replacement lenses, daily-disposable lenses, and many alternatives in systems of care and maintenance. Epidemiologic studies to date have shown that how a lens is worn, particularly if worn overnight, can increase the risk of microbial keratitis. However, the risk of silicone hydrogel contact lenses worn on a continuous-wear basis has been evaluated only recently. This article summarizes the recent research data on extended-wear silicone hydrogel lenses and discusses the challenges of early evaluations of silicone hydrogel lens safety. Finally, the relevance of this information is discussed to practitioners and contact lens wearers making choices about the risks and benefits of different products and how they are used.
75 FR 38754 - Safety Zone; IJSBA World Finals; Lower Colorado River, Lake Havasu, AZ
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-06
...-AA00 Safety Zone; IJSBA World Finals; Lower Colorado River, Lake Havasu, AZ AGENCY: Coast Guard, DHS... navigable waters of Lake Havasu on the lower Colorado River in support of the IJSBA World Finals. This... International Jet Sports Boating Association is sponsoring the IJSBA World Finals. The event will consist of 300...
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.
Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji
2017-09-01
Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.
NASA Astrophysics Data System (ADS)
Moreira, Francisco; Silva, Nuno
2016-08-01
Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.
Evaluating #VetFinals: Can Twitter help students prepare for final examinations?
Kinnison, Tierney; Whiting, Martin; Magnier, Kirsty; Mossop, Liz
2017-04-01
Twitter is increasingly used in education. In this article, Twitter was evaluated for its potential to aid veterinary students in their preparation for final examinations. "#VetFinals" revision sessions were facilitated by experts on a variety of topics. The initiative was evaluated through consideration of potential participants, session content and student experiences. In analysis of nine sessions, 52 students participated from eight veterinary schools. During a session, the facilitator tweeted 66 times on average, primarily asking a general question. Students on average tweeted 84 times, mostly in response to facilitators. They also asked novel questions and responded to fellow students. Focus groups and interviews with 11 students suggested that: sessions are useful for preparation/self-testing to succeed in exams; the facilitator and session style impact on learning; the sessions feel like personalized learning; there are elements of safety and exposure leading to some fear of tweeting; peer-learning promotes competition; a community of learners was formed; Twitter has become a part of normal professional life. Whilst not all students will take part in this type of social media use, many found it beneficial. The importance of the facilitator suggests the need for faculty development.
Requirements Analysis for the Army Safety Management Information System (ASMIS)
1989-03-01
8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases
Unmanned aircraft system sense and avoid integrity and continuity
NASA Astrophysics Data System (ADS)
Jamoom, Michael B.
This thesis describes new methods to guarantee safety of sense and avoid (SAA) functions for Unmanned Aircraft Systems (UAS) by evaluating integrity and continuity risks. Previous SAA efforts focused on relative safety metrics, such as risk ratios, comparing the risk of using an SAA system versus not using it. The methods in this thesis evaluate integrity and continuity risks as absolute measures of safety, as is the established practice in commercial aircraft terminal area navigation applications. The main contribution of this thesis is a derivation of a new method, based on a standard intruder relative constant velocity assumption, that uses hazard state estimates and estimate error covariances to establish (1) the integrity risk of the SAA system not detecting imminent loss of '"well clear," which is the time and distance required to maintain safe separation from intruder aircraft, and (2) the probability of false alert, the continuity risk. Another contribution is applying these integrity and continuity risk evaluation methods to set quantifiable and certifiable safety requirements on sensors. A sensitivity analysis uses this methodology to evaluate the impact of sensor errors on integrity and continuity risks. The penultimate contribution is an integrity and continuity risk evaluation where the estimation model is refined to address realistic intruder relative linear accelerations, which goes beyond the current constant velocity standard. The final contribution is an integrity and continuity risk evaluation addressing multiple intruders. This evaluation is a new innovation-based method to determine the risk of mis-associating intruder measurements. A mis-association occurs when the SAA system incorrectly associates a measurement to the wrong intruder, causing large errors in the estimated intruder trajectories. The new methods described in this thesis can help ensure safe encounters between aircraft and enable SAA sensor certification for UAS integration into the National Airspace System.
Intravenous medication safety and smart infusion systems: lessons learned and future opportunities.
Keohane, Carol A; Hayes, Judy; Saniuk, Catherine; Rothschild, Jeffrey M; Bates, David W
2005-01-01
The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.
Weatherization Works: Final Report of the National Weatherization Evaluation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Brown, M.A.
2001-02-01
In 1990, the US Department of Energy (DOE) sponsored a comprehensive evaluation of its Weatherization Assistance Program, the nation's largest residential energy conservation program. Oak Ridge National Laboratory (ORNL) managed the five-part study. This document summarizes the findings of the evaluation. Its conclusions are based mainly on data from the 1989 program year. The evaluation concludes that the Program meets the objectives of its enabling legislation and fulfills its mission statement. Specifically, it saves energy, lowers fuel bills, and improves the health and safety of dwellings occupied by low-income people. In addition, the Program achieves its mission in a cost-effectivemore » manner based on each of three perspectives employed by the evaluators. Finally, the evaluation estimates that the investments made in 1989 will, over a 20-year lifetime, save the equivalent of 12 million barrels of oil, roughly the amount of oil added to the Strategic Petroleum Reserve in each of the past several years. The Program's mission is to reduce the heating and cooling costs for low-income families--particularly the elderly, persons with disabilities, and children by improving the energy efficiency of their homes and ensuring their health and safety. Substantial progress has been made, but the job is far from over. The Department of Health and Human Services (HHS) reports that the average low-income family spends 12 percent of its income on residential energy, compared to only 3% for the average-income family. Homes where low-income families live also have a greater need for energy efficiency improvements, but less money to pay for them.« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Darby, John L.
2011-05-01
As the nuclear weapon stockpile ages, there is increased concern about common degradation ultimately leading to common cause failure of multiple weapons that could significantly impact reliability or safety. Current acceptable limits for the reliability and safety of a weapon are based on upper limits on the probability of failure of an individual item, assuming that failures among items are independent. We expanded the current acceptable limits to apply to situations with common cause failure. Then, we developed a simple screening process to quickly assess the importance of observed common degradation for both reliability and safety to determine if furthermore » action is necessary. The screening process conservatively assumes that common degradation is common cause failure. For a population with between 100 and 5000 items we applied the screening process and conclude the following. In general, for a reliability requirement specified in the Military Characteristics (MCs) for a specific weapon system, common degradation is of concern if more than 100(1-x)% of the weapons are susceptible to common degradation, where x is the required reliability expressed as a fraction. Common degradation is of concern for the safety of a weapon subsystem if more than 0.1% of the population is susceptible to common degradation. Common degradation is of concern for the safety of a weapon component or overall weapon system if two or more components/weapons in the population are susceptible to degradation. Finally, we developed a technique for detailed evaluation of common degradation leading to common cause failure for situations that are determined to be of concern using the screening process. The detailed evaluation requires that best estimates of common cause and independent failure probabilities be produced. Using these techniques, observed common degradation can be evaluated for effects on reliability and safety.« less
Evaluation of the neighborhood environment walkability scale in Nigeria.
Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien
2013-03-21
The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.
78 FR 33754 - Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway Workers
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-05
... Workers AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Final... published November 30, 2011, and scheduled to take effect on July 1, 2013. The final rule mandates that roadway workers comply with specified on-track safety procedures that railroads must adopt to protect...
75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-29
... with the new requirements in the final rule entitled ``Investigational New Drug Safety Reporting...] Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New... the agency considers your comment on this draft guidance before it begins work on the final version of...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-22
... a final rule under section 104(d) of the Consumer Product Safety Improvement Act of 2008 (``CPSIA... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1130 Requirements for Consumer Registration of Durable Infant or Toddler Products; Correction AGENCY: Consumer Product Safety Commission. ACTION: Final...
1991-02-01
to adequately assess the health and environmental risks associated with the closure and transfer of the Annex forI other use; and 3) identification of...1990); Draft Final Technical Plan, Draft Final Sampling Design Plan and Draft Final Health and Safety Plan, USATHAMA, June 1990. 2.1.2 Draft Final...Final Technical Plan, Sampling Design Plan and Health and Safety Plan) supplied by USATHAMA. The estimate may be revised, with USATHAMA approval, as
[Patient safety in management contracts].
Campillo-Artero, C
2012-01-01
Patient safety is becoming commonplace in management contracts. Since our experience in patient safety still falls short of other clinical areas, it is advisable to review some of its characteristics in order to improve its inclusion in these contracts. In this paper opinions and recommendations concerning the design and review of contractual clauses on safety are given, as well as reflections drawn from methodological papers and informal opinions of clinicians, who are most familiar with the nuances of safe and unsafe practices. After reviewing some features of these contracts, criteria for prioritizing and including safety objectives and activities in them, and key points for their evaluation are described. The need to replace isolated activities by systemic and multifaceted ones is emphasized. Errors, limitations and improvement opportunities observed when contracts are linked to indicators, information and adverse event reporting systems are analysed. Finally, the influence of the rules of the game, and clinicians behaviour are emphasised. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.
2003-01-10
This final rule amends the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, ambulatory surgery centers, hospices that provide inpatient services, religious nonmedical health care institutions, critical access hospitals, and Programs of All-Inclusive Care for the Elderly facilities. Further, this final rule adopts the 2000 edition of the Life Safety Code and eliminates references in our regulations to all earlier editions.
Are Limits of Concern a useful concept to improve the environmental risk assessment of GM plants?
Dolezel, Marion; Miklau, Marianne; Heissenberger, Andreas; Reichenbecher, Wolfram
2017-01-01
The European Food Safety Authority (EFSA) has introduced a concept for the environmental risk assessment of genetically modified (GM) plants which foresees the definition of ecological threshold values defining acceptable adverse effects of the GM plant on the environment (Limits of Concern, LoC). We analysed the LoC concept by scrutinising its feasibility with regard to important aspects of the environmental risk assessment. We then considered its relationship with protection goals, the comparative safety assessment and the stepwise testing approach. We finally discussed its usefulness for assessing long-term effects, effects on non-target organisms and species of conservation concern. The LoC concept is a possible approach to introduce ecological thresholds into environmental risk assessment in order to evaluate environmental harm. However, the concept leaves many important aspects open. Thresholds for environmental harm for protection goals need spatial and temporal differentiation from LoCs used for ERA indicators. Regionalisation of LoCs must be provided for as biodiversity levels and protection goals vary across the EU. Further guidance is needed with respect to the consequences, in case LoCs are exceeded and a link needs to be established between environmentally relevant results from the comparative safety assessment and the LoC concept. LoCs for long-term effects have to be evaluated by long-term monitoring. LoCs for non-target organisms need to be discriminated according to the species and parameters assessed. The overall LoC concept is considered useful if LoCs are further specified and differentiated. Although LoCs will finally be determined by political decisions, they should be based on scientific grounds in order to increase confidence in the conclusions on the safety of GM plants.
Final postflight hardware evaluation report RSRM-28 (STS-53)
NASA Technical Reports Server (NTRS)
Starrett, William David, Jr.
1993-01-01
The final report for the Clearfield disassembly evaluation and a continuation of the KSC postflight assessment for the RSRM-28 (STS-53) RSRM flight set is presented. All observed hardware conditions were documented on PFOR's and are included in Appendices A through C. Appendices D and E contain the measurements and safety factor data for the nozzle and insulation components. This report, along with the KSC Ten-Day Postflight Hardware Evaluation Report (TWR-64215), represents a summary of the RSRM-28 hardware evaluation. The as-flown hardware configuration is documented in TWR-63638. Disassembly evaluation photograph numbers are logged in TWA-1989. The RSRM-28 flight set disassembly evaluations described were performed at the RSRM Refurbishment Facility in Clearfield, Utah. The final factory joint demate occurred on July 15, 1993. Additional time was required to perform the evaluation of the stiffener rings per special issue 4.1.5.2 because of the washout schedule. The release of this report was after completion of all special issues per program management direction. Detailed evaluations were performed in accordance with the Clearfield PEEP, TWR-50051, Revision A. All observations were compared against limits that are also defined in the PEEP. These limits outline the criteria for categorizing the observations as acceptable, reportable, or critical. Hardware conditions that were unexpected and/or determined to be reportable or critical were evaluated by the applicable team and tracked through the PFAR system.
Billy, T J; Wachsmuth, I K
1997-08-01
Recent outbreaks of foodborne illness and studies by expert groups have established the need for fundamental change in the United States meat and poultry inspection programme to reduce the risk of foodborne illness. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) has embarked on a broad effort to bring about such change, with particular emphasis on the reduction of pathogenic micro-organisms in raw meat and poultry products. The publication on 25 July 1996 of the Final Rule on pathogen reduction and hazard analysis and critical control point (HACCP) systems was a major milestone in the FSIS strategy for change. The Final Rule provides a framework for change and clarifies the respective roles of industry and government in ensuring the safety of meat and poultry products. With the implementation of this Final Rule underway, the FSIS has been exploring ways in which slaughter inspection carried out under an HACCP-based system can be changed so that food safety risks are addressed more adequately and the allocation of inspection resources is improved further. In addition, the FSIS is broadening the focus of food safety activities to extend beyond slaughter and processing plants by working with industry, academia and other government agencies. Such co-operation should lead to the development of measures to improve food safety before animals reach the slaughter plant and after products leave the inspected establishment for distribution to the retail level. For the future, the FSIS believes that quantitative risk assessments will be at the core of food safety activities. Risk assessments provide the most effective means of identifying how specific pathogens and other hazards may be encountered throughout the farm-to-table chain and of measuring the potential impact of various interventions. In addition, these assessments will be used in the development and evaluation of HACCP systems. The FSIS is currently conducting a quantitative risk assessment for eggs, and several surveys and studies are being performed to supply data needed to conduct other risk assessments. The FSIS has established a food safety research agenda which will fill data gaps.
49 CFR 389.29 - Adoption of final rules.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Adoption of final rules. 389.29 Section 389.29 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS Procedures for Adoption of Rules § 389.29 Adoption of final rules...
49 CFR 389.29 - Adoption of final rules.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Adoption of final rules. 389.29 Section 389.29 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS Procedures for Adoption of Rules § 389.29 Adoption of final rules...
2016-06-23
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
Hawaii State Plan for Occupational Safety and Health. Final rule.
2012-09-21
This document announces the Occupational Safety and Health Administration's (OSHA) decision to modify the Hawaii State Plan's ``final approval'' determination under Section 18(e) of the Occupational Safety and Health Act (the Act) and to transition to ``initial approval'' status. OSHA is reinstating concurrent federal enforcement authority over occupational safety and health issues in the private sector, which have been solely covered by the Hawaii State Plan since 1984.
Parental physical activity, safety perceptions and children’s independent mobility
2013-01-01
Background Parents are likely to be a basic influence on their children's behavior. There is an absence of information about the associations between parents' physical activity and perception of neighborhood environment with children’s independent mobility. The purpose of this study is to examine the contribution of parental physical activity and perception of neighborhood safety to children’s independent mobility. Methods In this cross-sectional study of 354 pupils and their parents, independent mobility, perceptions of neighborhood safety and physical activity were evaluated by questionnaire. Categorical principal components analyses were used to determine the underlying dimensions of both independent mobility and perceptions of neighborhood safety items. Results The strongest predictor of independent mobility was the parental perception of sidewalk and street safety (ß = 0.132). Parent’s physical activity was also a significant predictor. The final model accounted for 13.0% of the variance. Conclusions Parental perception of neighborhood safety and parents’ self reported physical activity might be associated with children’s independent mobility. Further research in this topic is needed to explore this possible association. PMID:23767778
77 FR 13978 - Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway Workers
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-08
... rule; delay of effective date and request for comments. SUMMARY: This document delays the effective date of the final rule published November 30, 2011, and scheduled to take effect on May 1, 2012. The final rule mandates that roadway workers comply with specified on-track safety procedures that railroads...
76 FR 44829 - Federal Motor Vehicle Safety Standards; Air Brake Systems
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-27
... [Docket No. NHTSA-2009-0175] RIN 2127-AK84 Federal Motor Vehicle Safety Standards; Air Brake Systems... final rule that amended the Federal motor vehicle safety standard for air brake systems by requiring... July 27, 2009, NHTSA published a final rule in the Federal Register amending Federal Motor Vehicle...
Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.
Dallas, Michael J
2008-01-01
Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.
NASA Technical Reports Server (NTRS)
Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)
1996-01-01
As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in-trail approaches. This research was performed under contract to NASA and in cooperation with the FAA's Safety Division (ASY).
Lee, Hyun Cheol; Yoo, Do Hyeon; Testa, Mauro; Shin, Wook-Geun; Choi, Hyun Joon; Ha, Wi-Ho; Yoo, Jaeryong; Yoon, Seokwon; Min, Chul Hee
2016-04-01
The aim of this study is to evaluate the potential hazard of naturally occurring radioactive material (NORM) added consumer products. Using the Monte Carlo method, the radioactive products were simulated with ICRP reference phantom and the organ doses were calculated with the usage scenario. Finally, the annual effective doses were evaluated as lower than the public dose limit of 1mSv y(-1) for 44 products. It was demonstrated that NORM-added consumer products could be quantitatively assessed for the safety regulation. Copyright © 2016 Elsevier Ltd. All rights reserved.
Umigai, Naofumi; Murakami, Katsura; Shimizu, Ryoma; Takeda, Ryuji; Azuma, Takayuki
2018-02-01
Paprika oleoresin is obtained by solvent extraction from Capsicum annuum L. fruits and contains multiple carotenoids, such as capsanthin, β-carotene, zeaxanthin, and β-cryptoxanthin, which are considered protective against various diseases. Herein, we investigated the effect of paprika oleoresin supplementation on plasma carotenoid accumulation and evaluated the safety of the oleoresin. We used a double-blinded, placebo-controlled comparative clinical study design and tested the effects of varying doses in healthy adult subjects. In total, 33 subjects were randomly divided into three groups to take capsules containing 0, 20, or 100 mg of paprika oleoresin daily for 12 consecutive weeks. Plasma carotenoid concentrations were measured at 0, 4, 8, and 12 weeks, and the safety of paprika oleoresin capsules was investigated using analyses of blood biochemistry, hematology, and urine contents. In these experiments, β-cryptoxanthin and zeaxanthin dose-dependently accumulated in plasma within the dose range of the study over 12 consecutive weeks of paprika oleoresin supplementation. Moreover, β-cryptoxanthin accumulated to higher levels than the other paprika oleoresin carotenoids. In contrast, capsanthin was not detected in plasma before or during the 12-week treatment period. Finally, no adverse events were associated with intake of paprika oleoresin (20 and 100 mg/day) in safety evaluations. Paprika oleoresin is a suitable source of carotenoids, especially β-cryptoxanthin.
Archer, David F; Kovalevsky, George; Ballagh, Susan A; Grubb, Gary S
2009-09-01
A continuous regimen of oral levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg was evaluated for inhibition of ovulation, time to return to ovulation after stopping treatment and safety. This open-label study was conducted in healthy women aged 18-35 years. Ovulation was documented before treatment, and then participants received oral tablets containing LNG 90 mcg/EE 20 mcg to be taken continuously for three 28-day intervals. Ovarian activity was assessed three times per week during the treatment period with transvaginal ultrasound scans and measurements of serum 17beta-estradiol, progesterone, follicle-stimulating hormone and luteinizing hormone concentrations. Safety assessments included physical examinations, laboratory evaluations and adverse event records. Thirty-seven of the 58 subjects who received treatment met predefined criteria for efficacy analysis. No on-treatment ovulations occurred in the efficacy or intent-to-treat population. There was evidence of ovulation within 37 days of stopping treatment for 46 (98%) of 47 subjects evaluated posttreatment. The final subject with a history of polycystic ovarian syndrome ovulated by Day 66. The safety profile observed during this 84-day continuous regimen was similar to that seen with other low-dose oral contraceptives administered in a cyclic regimen. The continuous LNG/EE regimen completely inhibited ovulation, with little evidence of follicular development and with rapid return of ovulatory capacity after stopping treatment.
A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems.
Silva, Lenardo C; Almeida, Hyggo O; Perkusich, Angelo; Perkusich, Mirko
2015-10-30
Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage.
A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems
Silva, Lenardo C.; Almeida, Hyggo O.; Perkusich, Angelo; Perkusich, Mirko
2015-01-01
Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage. PMID:26528982
Dynamic Resectorization and Coordination Technology: An Evaluation of Air Traffic Control Complexity
NASA Technical Reports Server (NTRS)
Brinton, Christopher R.
1996-01-01
The work described in this report is done under contract with the National Aeronautics and Space Administration (NASA) to support the Advanced Air Transportation Technology (AATR) program. The goal of this program is to contribute to and accelerate progress in Advanced Air Transportation Technologies. Wyndemere Incorporated is supporting this goal by studying the complexity of the Air Traffic Specialist's role in maintaining the safety of the Air Transportation system. It is envisioned that the implementation of Free Flight may significantly increase the complexity and difficulty of maintaining this safety. Wyndemere Incorporated is researching potential methods to reduce this complexity. This is the final report for the contract.
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).
2016-05-04
This final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions of the Life Safety Code. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
Safety Evaluation of a Novel Strain of Bacteroides fragilis.
Wang, Ye; Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao
2017-01-01
Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey's manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro , ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro . This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum.
Safety Evaluation of a Novel Strain of Bacteroides fragilis
Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao
2017-01-01
Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey’s manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro, ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro. This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum. PMID:28367145
Tefertiller, Candy; Hays, Kaitlin; Jones, Janell; Jayaraman, Arun; Hartigan, Clare; Bushnik, Tamara; Forrest, Gail F
2018-01-01
Objective: To assess safety and mobility outcomes utilizing the Indego powered exoskeleton in indoor and outdoor walking conditions with individuals previously diagnosed with a spinal cord injury (SCI). Methods: We conducted a multicenter prospective observational cohort study in outpatient clinics associated with 5 rehabilitation hospitals. A convenience sample of nonambulatory individuals with SCI ( N = 32) completed an 8-week training protocol consisting of walking training 3 times per week utilizing the Indego powered exoskeleton in indoor and outdoor conditions. Participants were also trained in donning/doffing the exoskeleton during each session. Safety measures such as adverse events (AEs) were monitored and reported. Time and independence with donning/doffing the exoskeleton as well as walking outcomes to include the 10-meter walk test (10MWT), 6-minute walk test (6MWT), Timed Up & Go test (TUG), and 600-meter walk test were evaluated from midpoint to final evaluations. Results: All 32 participants completed the training protocol with limited device-related AEs, which resulted in no interruption in training. The majority of participants in this trial were able to don and doff the Indego independently. Final walking speed ranged from 0.19 to 0.55 m/s. Final average indoor and outdoor walking speeds among all participants were 0.37 m/s ( SD = 0.08, 0.09, respectively), after 8 weeks of training. Significant ( p < .05) improvements were noted between midpoint and final gait speeds in both indoor and outdoor conditions. Average walking endurance also improved among participants after training. Conclusion: The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory. Improvements in speed and independence were noted with walking in indoor and outdoor conditions as well as with donning/doffing the exoskeleton.
Psychological safety and error reporting within Veterans Health Administration hospitals.
Derickson, Ryan; Fishman, Jonathan; Osatuke, Katerine; Teclaw, Robert; Ramsel, Dee
2015-03-01
In psychologically safe workplaces, employees feel comfortable taking interpersonal risks, such as pointing out errors. Previous research suggested that psychologically safe climate optimizes organizational outcomes. We evaluated psychological safety levels in Veterans Health Administration (VHA) hospitals and assessed their relationship to employee willingness of reporting medical errors. We conducted an ANOVA on psychological safety scores from a VHA employees census survey (n = 185,879), assessing variability of means across racial and supervisory levels. We examined organizational climate assessment interviews (n = 374) evaluating how many employees asserted willingness to report errors (or not) and their stated reasons. Finally, based on survey data, we identified 2 (psychologically safe versus unsafe) hospitals and compared their number of employees who would be willing/unwilling to report an error. Psychological safety increased with supervisory level (P < 0.001, η = 0.03) and was not meaningfully related to race (P < 0.001, η = 0.003). Twelve percent of employees would not report an error; retaliation fear was the most commonly mentioned deterrent. Furthermore, employees at the psychologically unsafe hospital (71% would report, 13% would not) were less willing to report an error than at the psychologically safe hospital (91% would, 0% would not). A substantial minority would not report an error and were willing to admit so in a private interview setting. Their stated reasons as well as higher psychological safety means for supervisory employees both suggest power as an important determinant. Intentions to report were associated with psychological safety, strongly suggesting this climate aspect as instrumental to improving patient safety and reducing costs.
Huang, Donghong; Sun, Zhenqiu; Hu, Jingxuan; Shen, Minxue; Peng, Zhen; Zeng, Na
2014-03-01
To evaluate the effect of nutrition and food safety education among middle school students in a poverty-stricken county in west China, and to explore the better education model for further education. Students of grade 7 to 9 were selected from 4 middle schools in the country through multi-stage cluster sampling for the questionnaire, and the schools were assigned into an intervention group or a control group. After students in the intervention schools completed one year nutrition and food safety education with the textbooks, students were chosen from the same 4 schools to finish the same questionnaire again. A total of 410 students from grade 7 to 9 were selected at the baseline study, and 474 students in the final study. The essential characteristics of the 2 groups were not statistically significant (P>0.05). In the baseline investigation, the differences in the scores on nutrition and food safety knowledge, attitude and practice between the 2 groups were not significant (P>0.05). In the final study, the scores on the knowledge, attitude of nutrition knowledge learning, and dietary habits among students in the intervention group were significantly higher than those in the control group (P<0.05). School-students mixed model demonstrated that the intervention was protective factor on scores of knowledge, in particular with nutrition related diseases and reasonable diet (P<0.05). But the intervention didn't affect the scores on attitude in both ways (P>0.05). Nutrition and food safety education can improve the nutrition and food safety knowledge effectively. The curriculum should be further standardized and different emphases should be set up to different grades to cultivate healthy diet behaviors.
Safety of probiotics and synbiotics in children under 18 years of age.
van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claassen, E
2015-01-01
This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.
9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
Code of Federal Regulations, 2013 CFR
2013-01-01
... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...
9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
Code of Federal Regulations, 2014 CFR
2014-01-01
... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...
9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
Code of Federal Regulations, 2012 CFR
2012-01-01
... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-14
... 1625-AA00 Safety Zone, Corp. Event Finale UHC, St. Thomas Harbor; St. Thomas, U.S. Virgin Islands... establish a temporary safety zone on the waters of St. Thomas Harbor in St. Thomas, U.S. Virgin Islands... near the St. Thomas Harbor channel from which fireworks will be lit. DATES: Comments and related...
NHS Blood Tracking Pilot: City University Evaluation Project
NASA Astrophysics Data System (ADS)
Goddard, Kate; Shabestari, Omid; Adriano, Juan; Kay, Jonathan; Roudsari, Abdul
Automation of healthcare processes is an emergent theme in the drive to increase patient safety. The Mayday Hospital has been chosen as the pilot site for the implementation of the Electronic Clinical Transfusion Management System to track blood from the point of ordering to the final transfusion. The Centre for Health Informatics at City University is carrying out an independent evaluation of the system implementation using a variety of methodologies to both formatively inform the implementation process and summatively provide an account of the lessons learned for future implementations.
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Ausherman, V.K.; Khadikar, A.V.; Syson, S.R.
1981-09-01
The objective of the RSV Program was to provide research and test data applicable to the automobile safety performance requirements for the mid-1980s, and to evaluate the compatibility of these requirements with environmental policies, efficient energy utilization, and consumer economic considerations. The RSV Program has demonstrated that it is possible to make cars much safer than they are presently. It has produced automobile designs that are consistent, at affordable cost, with the national objectives for fuel economy and environmental protection. It has indicated, at least to a limited degree, that the technological findings are applicable, at varying levels, to amore » variety of car designs. And it has provided evidence that these findings can be wrapped in a package of considerable appeal to the public. This Final Report is a comprehensive compilation of the findings of the Phase III efforts of Minicars, Inc. It describes the design and testing of the RSV systems, and the performance levels achieved.« less
Attitudes to teamwork and safety among Italian surgeons and operating room nurses.
Prati, Gabriele; Pietrantoni, Luca
2014-01-01
Previous studies have shown that surgical team members' attitudes about safety and teamwork in the operating theatre may play a role in patient safety. The aim of this study was to assess attitudes about teamwork and safety among Italian surgeons and operating room nurses. Fifty-five surgeons and 48 operating room nurses working in operating theatres at one hospital in Italy completed the Operating Room Management Attitudes Questionnaire (ORMAQ). Results showed several discrepancies in attitudes about teamwork and safety between surgeons and operating room nurses. Surgeons had more positive views on the quality of surgical leadership, communication, teamwork, and organizational climate in the theatre than operating room nurses. Operating room nurses reported that safety rules and procedures were more frequently disregarded than the surgeons. The results are only partially aligned with previous ORMAQ surveys of surgical teams in other countries. The differences emphasize the influence of national culture, as well as the particular healthcare system. This study shows discrepancies on many aspects in attitudes to teamwork and safety between surgeons and operating room nurses. The findings support implementation and use of team interventions and human factor training. Finally, attitude surveys provide a method for assessing safety culture in surgery, for evaluating the effectiveness of training initiatives, and for collecting data for a hospital's quality assurance programme.
Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej
2018-06-01
Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine traffic volumes, and speeds as a function of radii). The final models may help quantify the safety impact of different turbo-roundabout solutions. Copyright © 2018 Elsevier Ltd. All rights reserved.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F
2015-12-08
Despite the recognition that educating healthcare students in patient safety is essential, changing already full curricula can be challenging. Furthermore, institutions may lack the capacity and capability to deliver patient safety education, particularly from the start of professional practice studies. Using senior students as peer educators to deliver practice-based education can potentially overcome some of the contextual barriers in training junior students. Therefore, this study aimed to evaluate the effectiveness of a peer-led patient safety education programme for junior pharmacy students. A repeat cross-sectional design utilising a previously validated patient safety attitudinal survey was used to evaluate attitudes prior to, immediately after and 1 month after the delivery of a patient safety education programme. Latent growth curve (LGC) modelling was used to evaluate the change in attitudes of first-year students using second-year students as a comparator group. Undergraduate university students in Sydney, Australia. 175 first-year and 140 second-year students enrolled in the Bachelor of Pharmacy programme at the University of Sydney. An introductory patient safety programme was implemented into the first-year Bachelor of Pharmacy curriculum at the University of Sydney. The programme covered introductory patient safety topics including teamwork, communication skills, systems thinking and open disclosure. The programme consisted of 2 lectures, delivered by a senior academic, and a workshop delivered by trained final-year pharmacy students. A full LGC model was constructed including the intervention as a non-time-dependent predictor of change (χ(2) (51)=164.070, root mean square error of approximation=0.084, comparative fit index=0.913, standardised root mean square=0.056). First-year students' attitudes significantly improved as a result of the intervention, particularly in relation to internalising errors (p=0.010), questioning behaviours (p<0.001) and open disclosure (p=0.008). Peer-led education is an effective method that can be adopted to improve junior pharmacy students' attitudes towards patient safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
The optimization of wireless power transmission: design and realization.
Jia, Zhiwei; Yan, Guozheng; Liu, Hua; Wang, Zhiwu; Jiang, Pingping; Shi, Yu
2012-09-01
A wireless power transmission system is regarded as a practical way of solving power-shortage problems in multifunctional active capsule endoscopes. The uniformity of magnetic flux density, frequency stability and orientation stability are used to evaluate power transmission stability, taking into consideration size and safety constraints. Magnetic field safety and temperature rise are also considered. Test benches are designed to measure the relevent parameters. Finally, a mathematical programming model in which these constraints are considered is proposed to improve transmission efficiency. To verify the feasibility of the proposed method, various systems for a wireless active capsule endoscope are designed and evaluated. The optimal power transmission system has the capability to supply continuously at least 500 mW of power with a transmission efficiency of 4.08%. The example validates the feasibility of the proposed method. Introduction of novel designs enables further improvement of this method. Copyright © 2012 John Wiley & Sons, Ltd.
78 FR 16208 - Safety Zone; V. I. Carnival Finale; St. Thomas Harbor; St. Thomas, U.S. Virgin Islands
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-14
... 1625-AA00 Safety Zone; V. I. Carnival Finale; St. Thomas Harbor; St. Thomas, U.S. Virgin Islands AGENCY... establish a safety zone on the waters of St. Thomas Harbor in St. Thomas, U. S. Virgin Islands during the V..., 2013, and will entail a barge being positioned near the St. Thomas Harbor channel from which fireworks...
NASA Astrophysics Data System (ADS)
Jin, Yang; Ciwei, Gao; Jing, Zhang; Min, Sun; Jie, Yu
2017-05-01
The selection and evaluation of priority domains in Global Energy Internet standard development will help to break through limits of national investment, thus priority will be given to standardizing technical areas with highest urgency and feasibility. Therefore, in this paper, the process of Delphi survey based on technology foresight is put forward, the evaluation index system of priority domains is established, and the index calculation method is determined. Afterwards, statistical method is used to evaluate the alternative domains. Finally the top four priority domains are determined as follows: Interconnected Network Planning and Simulation Analysis, Interconnected Network Safety Control and Protection, Intelligent Power Transmission and Transformation, and Internet of Things.
Safe surgery: validation of pre and postoperative checklists 1
Alpendre, Francine Taporosky; Cruz, Elaine Drehmer de Almeida; Dyniewicz, Ana Maria; Mantovani, Maria de Fátima; Silva, Ana Elisa Bauer de Camargo e; dos Santos, Gabriela de Souza
2017-01-01
ABSTRACT Objective: to develop, evaluate and validate a surgical safety checklist for patients in the pre and postoperative periods in surgical hospitalization units. Method: methodological research carried out in a large public teaching hospital in the South of Brazil, with application of the principles of the Safe Surgery Saves Lives Programme of the World Health Organization. The checklist was applied to 16 nurses of 8 surgical units and submitted for validation by a group of eight experts using the Delphi method online. Results: the instrument was validated and it was achieved a mean score ≥1, level of agreement ≥75% and Cronbach’s alpha >0.90. The final version included 97 safety indicators organized into six categories: identification, preoperative, immediate postoperative, immediate postoperative, other surgical complications, and hospital discharge. Conclusion: the Surgical Safety Checklist in the Pre and Postoperative periods is another strategy to promote patient safety, as it allows the monitoring of predictive signs and symptoms of surgical complications and the early detection of adverse events. PMID:28699994
Design and Performance Analysis of an Intrinsically Safe Ultrasonic Ranging Sensor
Zhang, Hongjuan; Wang, Yu; Zhang, Xu; Wang, Dong; Jin, Baoquan
2016-01-01
In flammable or explosive environments, an ultrasonic sensor for distance measurement poses an important engineering safety challenge, because the driving circuit uses an intermediate frequency transformer as an impedance transformation element, in which the produced heat or spark is available for ignition. In this paper, an intrinsically safe ultrasonic ranging sensor is designed and implemented. The waterproof piezoelectric transducer with integrated transceiver is chosen as an energy transducing element. Then a novel transducer driving circuit is designed based on an impedance matching method considering safety spark parameters to replace an intermediate frequency transformer. Then, an energy limiting circuit is developed to achieve dual levels of over-voltage and over-current protection. The detail calculation and evaluation are executed and the electrical characteristics are analyzed to verify the intrinsic safety of the driving circuit. Finally, an experimental platform of the ultrasonic ranging sensor system is constructed, which involves short-circuit protection. Experimental results show that the proposed ultrasonic ranging sensor is excellent in both ranging performance and intrinsic safety. PMID:27304958
Design and Performance Analysis of an Intrinsically Safe Ultrasonic Ranging Sensor.
Zhang, Hongjuan; Wang, Yu; Zhang, Xu; Wang, Dong; Jin, Baoquan
2016-06-13
In flammable or explosive environments, an ultrasonic sensor for distance measurement poses an important engineering safety challenge, because the driving circuit uses an intermediate frequency transformer as an impedance transformation element, in which the produced heat or spark is available for ignition. In this paper, an intrinsically safe ultrasonic ranging sensor is designed and implemented. The waterproof piezoelectric transducer with integrated transceiver is chosen as an energy transducing element. Then a novel transducer driving circuit is designed based on an impedance matching method considering safety spark parameters to replace an intermediate frequency transformer. Then, an energy limiting circuit is developed to achieve dual levels of over-voltage and over-current protection. The detail calculation and evaluation are executed and the electrical characteristics are analyzed to verify the intrinsic safety of the driving circuit. Finally, an experimental platform of the ultrasonic ranging sensor system is constructed, which involves short-circuit protection. Experimental results show that the proposed ultrasonic ranging sensor is excellent in both ranging performance and intrinsic safety.
Evaluation of Porous Silicon Oxide on Silicon Microcantilevers for Sensitive Detection of Gaseous HF
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wallace, Ryan A.; Sepaniak, Michael J.; Lavrik, Nickolay V.
Sensitive detection of harmful chemicals in industrial applications is pertinent to safety. In this paper, we demonstrate the use of a sensitive silicon microcantilever (MC) system with a porous silicon oxide layer deposited on the active side of the MCs that have been mechanically manipulated to increase sensitivity. Included is the evaluation of porous silicon oxide present on different geometries of MCs and exposed to varying concentrations of hydrogen fluoride in humid air. Finally, profilometry and the signal generated by the stress-induced porous silicon oxide (PSO) coating and bending of the MC were used as methods of evaluation.
Evaluation of Porous Silicon Oxide on Silicon Microcantilevers for Sensitive Detection of Gaseous HF
Wallace, Ryan A.; Sepaniak, Michael J.; Lavrik, Nickolay V.; ...
2017-05-10
Sensitive detection of harmful chemicals in industrial applications is pertinent to safety. In this paper, we demonstrate the use of a sensitive silicon microcantilever (MC) system with a porous silicon oxide layer deposited on the active side of the MCs that have been mechanically manipulated to increase sensitivity. Included is the evaluation of porous silicon oxide present on different geometries of MCs and exposed to varying concentrations of hydrogen fluoride in humid air. Finally, profilometry and the signal generated by the stress-induced porous silicon oxide (PSO) coating and bending of the MC were used as methods of evaluation.
Nuclear thermal propulsion transportation systems for lunar/Mars exploration
NASA Technical Reports Server (NTRS)
Clark, John S.; Borowski, Stanley K.; Mcilwain, Melvin C.; Pellaccio, Dennis G.
1992-01-01
Nuclear thermal propulsion technology development is underway at NASA and DoE for Space Exploration Initiative (SEI) missions to Mars, with initial near-earth flights to validate flight readiness. Several reactor concepts are being considered for these missions, and important selection criteria will be evaluated before final selection of a system. These criteria include: safety and reliability, technical risk, cost, and performance, in that order. Of the concepts evaluated to date, the Nuclear Engine for Rocket Vehicle Applications (NERVA) derivative (NDR) is the only concept that has demonstrated full power, life, and performance in actual reactor tests. Other concepts will require significant design work and must demonstrate proof-of-concept. Technical risk, and hence, development cost should therefore be lowest for the concept, and the NDR concept is currently being considered for the initial SEI missions. As lighter weight, higher performance systems are developed and validated, including appropriate safety and astronaut-rating requirements, they will be considered to support future SEI application. A space transportation system using a modular nuclear thermal rocket (NTR) system for lunar and Mars missions is expected to result in significant life cycle cost savings. Finally, several key issues remain for NTR's, including public acceptance and operational issues. Nonetheless, NTR's are believed to be the 'next generation' of space propulsion systems - the key to space exploration.
Gupta, S; Paichadze, N; Gritsenko, E; Klyavin, V; Yurasova, E; Hyder, A A
2017-03-01
Road traffic injuries are a leading cause of morbidity and mortality in the world. In Russia, a road safety program was implemented in Lipetskaya and Ivanovskaya oblasts (regions) as part of a 10-country effort funded by Bloomberg Philanthropies. The program was focused on increasing seat belt and child restraint use and reducing speeding. The primary goals of this monitoring and evaluation study are to assess trends in seat belt use, child restraint use, and speed compliance in the two oblasts over the 5 years and to explore the overall impact of the program on road traffic injury and death rates. Primary data via roadside observations and interviews, and secondary data from official government sources were collected and analyzed for this study. Our results indicate significant improvements in seat belt wearing and child seat use rates and in prevalence of speeding in both intervention oblasts. The observations were consistent with the results from the roadside interviews. In Lipetskaya, restraint use by all occupants increased from 52.4% (baseline, October 2010) to 77.4% (final round, October 2014) and child restraint use increased from 20.9% to 54.1% during the same period. In Ivanovskaya, restraint use by all occupants increased from 48% (baseline, April 2012) to 88.7% (final round, October 2014) and child restraint use increased from 20.6% to 89.4% during the same period. In Lipetskaya, the overall prevalence of speeding (vehicles driving above speed limit) declined from 47.0% (baseline, July 2011) to 30.4% (final round, October 2014) and a similar pattern was observed in Ivanovskaya where the prevalence of speeding decreased from 54.6% (baseline, March 2012) to 46.6% (final round, October 2014). Through 2010-2014, the road traffic crash and injury rates per 100,000 population decreased in Lipetskaya oblast (191.5 and 246.9 in 2010 and 170.4 and 208.6 in 2014, respectively) and slightly increased in Ivanovskaya oblast (184.4 and 236.0 in 2010 and 186.7 and 243.4 in 2014, respectively). These road safety improvements are associated with the program that enabled a combined focus on policy reform, legislation, enforcement, advocacy, education, and data collection and use. However, the existence of other road safety efforts, lack of data from comparable regions, and unavailability of risk factor-specific data make it difficult to attribute these changes to the program. Copyright © 2016. Published by Elsevier Ltd.
Fein, Henry G; Vaughan, T Brooks; Kushner, Harvey; Cram, David; Nguyen, Dat
2015-10-27
Overweight and obesity are common among patients with Cushing's syndrome (CS) and may persist in some patients even after ostensibly curative surgery, contributing to cardiometabolic dysfunction and increased cardiovascular risk. Mifepristone, a selective glucocorticoid receptor antagonist, was effective in controlling hyperglycemia in a 24-week trial of adults (N = 50) with endogenous CS and associated type 2 diabetes mellitus/impaired glucose tolerance or hypertension who had failed or were not candidates for surgery (SEISMIC, Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing's Syndrome). This analysis examines long-term weight change among patients who received mifepristone in SEISMIC and enrolled in a long-term safety extension (LTE) study. Patients completing the 24-week SEISMIC study and subsequent 6-week off-drug safety evaluation were invited to enroll in the LTE study. Mifepristone doses at the end of SEISMIC were the LTE starting doses. Body weight measures were reviewed at baseline and week 24 of SEISMIC and at LTE month 6, 12, 18, 24, and final visit (last observation collected during the LTE study). Of the 30 patients enrolled in the LTE, evaluable weight data were available for 29 (20/29 female; mean age of 44.7 ± 11.2 years). These patients received mifepristone for a median of 29.2 months (range 8.4-41.9). Mean ± SD weight from SEISMIC baseline to LTE final visit decreased by 10.3 ± 16.3 kg (mean 105.4 ± 34.3 kg to 95.1 ± 32.9 kg), a 9.3 % decrease from baseline weight (P = 0.0008). Of the 29 LTE patients, 18 (62.1 %) lost ≥ 5 % of body weight by the end of the initial 24-week treatment period; this ≥5 % weight loss persisted in 83.3 % (15/18) at LTE final visit. Ten patients (34.5 %) lost ≥ 10 % of initial body weight by week 24 of SEISMIC, which persisted in 80 % at LTE final visit. No new safety signals were detected with long-term mifepristone use. Clinically meaningful weight loss achieved during a 24-week study of mifepristone for CS persisted for two additional years in patients who remained on therapy. Long-term treatment with mifepristone appears to have a beneficial effect on weight in patients with endogenous CS. NCT00569582 (SEISMIC); NCT00936741 (Long-Term Extension).
Methods and strategies for future reactor safety goals
NASA Astrophysics Data System (ADS)
Arndt, Steven Andrew
There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.
Smith, Ian; Yardley, Denise; Burris, Howard; De Boer, Richard; Amadori, Dino; McIntyre, Kristi; Ejlertsen, Bent; Gnant, Michael; Jonat, Walter; Pritchard, Kathleen I; Dowsett, Mitch; Hart, Lowell; Poggio, Susan; Comarella, Lisa; Salomon, Herve; Wamil, Barbara; O'Shaughnessy, Joyce
2017-04-01
Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) -positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93; 95% CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similar DFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (> 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.
Ben Salah, N; El Borgi, W; Aounallah Skhiri, H; Ben Lakhal, F; Mouelhi, H; Zoueri, B; Gouider, E; Hafsia, R
2013-09-01
In Tunisia, red blood cells (RBC) transfusion joins in a statutory frame but remains subject to failures because of the misunderstanding of legislation and regulations. Our purpose is to estimate the knowledge of the medical staff in the immunological safety of RBC transfusion before and after reading an auto-education CD-ROM. It is a study of evaluation of an intervention. Eighty physicians participated to the study. The evaluation was done using an anonymous questionnaire, containing seven questions with multiple choices (QMC) relating to several items. The rate of good answers (RGA) calculated by questions and by items took into account the impact of the CD-ROM on the improvement of the answers after reading. The global average mark is 2.9/7. The RGA to questions varies from 22.5 % to 76.3%. All participants answered correctly to more than 50% of all items. Two answered correctly to all items. Among the participants, 31.3% answered to all "important" items, concerning ABO blood groups compatibility and ultimate bedside test. The rate of participation to the final evaluation was 83%. The impact of the CD-ROM was important and statistically significant. In the final evaluation, the global mark raised from 2.9 to 5.8/7, 31.5% (vs 2%) answered correctly all the questions and 95.5% (vs 31.3%) answered correctly all "important" items. This study revealed a misunderstanding of the doctors in immunological safety of RBC transfusions. Auto-teaching by CD-ROM was efficient. An improvement of the knowledge by continuous training is necessary in our country. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
OPERATION CASTLE. Radiological Safety. Volume 1
1985-09-01
OPERATION CASTLE Radiological Safety Final Report Volume I Headquarters Joint Task Force Seven Technical Branch, J-3 Division Washington, DC...Spring 1954 EXTRACTED VERSION DTIC -uECTE MAR031986 NOTICE: This is an extract of Operation CASTLE, Radiological Safety, Final Report, Volume I ...SYMBOL (If jpQiictbl») ■ i PROCUREMENT INSTRUMENT IDENTIFICATION NUMBER 8c AOORESS (G(y, SU(t tncl ZIRCod») 10 SOURCE OF FUNDING NUMBERS PROGRAM
Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety Final Report
DOT National Transportation Integrated Search
2008-02-01
This Final Report describes the process and product from the project, Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety (OBMS), in which a prototypical suite of hardware and software on a class 8 truck was developed and tested. The...
77 FR 74194 - Issuance of Final Guidance Publication
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... NIOSH-238] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC... Respiratory Disease from Exposures Caused by Dampness in Office Buildings, Schools, and Other Nonindustrial...
Yang, Y. Tony; Cheng, Xi; Bian, John; Bennett, Charles L.
2016-01-01
The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.” PMID:27171162
Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L
2016-01-01
The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."
Onboard Safety Technology Survey Synthesis - Final Report
DOT National Transportation Integrated Search
2008-01-01
The Federal Motor Carrier Safety Administration (FMCSA) funded this project to collect, merge, and conduct an assessment of onboard safety system surveys and resulting data sets that may benefit commercial vehicle operations safety and future researc...
76 FR 22019 - Safety Standard for Toddler Beds
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-20
... warnings should increase consumers' understanding of the connection between the relevant behaviors and... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1217 RIN 3041-AC79 Safety Standard for Toddler Beds AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: The Consumer Product Safety...
Postflight hardware evaluation 360T026 (RSRM-26, STS-47)
NASA Technical Reports Server (NTRS)
Nielson, Greg
1993-01-01
The final report for the Clearfield disassembly evaluation and a continuation of the KSC postflight assessment for the 360T026 (STS-47) Redesigned Solid Rocket Motor (RSRM) flight set is provided. All observed hardware conditions were documented on PFOR's and are included in Appendices A, B, and C. Appendices D and E contain the measurements and safety factor data for the nozzle and insulation components. This report, along with the KSC Ten-Day Postflight Hardware Evaluation Report (TWR-64203), represents a summary of the 360T026 hardware evaluation. The as-flown hardware configuration is documented in TWR-60472. Disassembly evaluation photograph numbers are logged in TWA-1987. The 360T026 flight set disassembly evaluations described were performed at the RSRM Refurbishment Facility in Clearfield, Utah. The final factory joint demate occurred on 12 April 1993. Detailed evaluations were performed in accordance with the Clearfield Postflight Engineering Evaluation Plan (PEEP), TWR-50051, Revision A. All observations were compared against limits that are also defined in the PEEP. These limits outline the criteria for categorizing the observations as acceptable, reportable, or critical. Hardware conditions that were unexpected and/or determined to be reportable or critical were evaluated by the applicable CPT and tracked through the PFAR system.
Taking a Concept to Commercialization: Designing Relevant Tests to Address Safety.
Ferrara, Lisa A
2016-04-01
Taking a product from concept to commercialization requires careful navigation of the regulatory pathway through a series of steps: (A) moving the idea through proof of concept and beyond; (B) evaluating new technologies that may provide added value to the idea; (C) designing appropriate test strategies and protocols; and (D) evaluating and mitigating risks. Moving an idea from the napkin stage of development to the final product requires a team effort. When finished, the product rarely resembles the original design, but careful steps throughout the product life cycle ensure that the product meets the vision.
Katagiri, Hideaki; Taketsuna, Masanori; Kondo, Shinpei; Kajimoto, Kenta; Aoi, Etsuko; Tanji, Yuka
2018-01-01
To assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM) in patients with acute agitation associated with schizophrenia in a real-world clinical setting. The postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study). Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration. Effectiveness and safety from initial RAIM administration were evaluated using the Positive and Negative Syndrome Scale-Excited Component score and treatment-emergent adverse events (TEAEs), respectively. The effectiveness and safety analysis set included a total of 521 and 522 patients, respectively. A majority of patients received 10 mg of RAIM (475/522 patients, 91.0%). The mean ± SD total Positive and Negative Syndrome Scale-Excited Component score was 23.6±6.2 (n=318) at baseline (before initial RAIM administration), 17.4±6.8 (n=280) at 2 hours after initial administration, 16.2±6.8 (n=246) 2 days after final administration, 14.9±6.2 (n=248) 3 days after final administration, 13.8±5.9 (n=242) 4 days after final administration, 13.2±5.8 (n=221) 7 days after initial administration, and 13.4±6.2 (n=351) at final observation (with the last observation carried forward approach), showing that reduction in agitation seen with RAIM was sustained with oral dose of olanzapine. The most common TEAEs were dyslalia and somnolence (each event occurred in four patients), and abnormal hepatic function and constipation (occurred in three patients). One serious adverse event of sudden cardiac death occurred after transitioned to oral olanzapine with many other antipsychotic drugs. In the treatment of acute agitation associated with schizophrenia, RAIM could be generally transitioned to oral olanzapine without exacerbating adverse events or losing treatment effect.
United States Air Force F-35A Operational Basing Environmental Impact Statement. Volume 1
2013-09-01
Evaluation (FDE) program and Weapons School (WS) beddown, the F-22 designator was used. Subsequent testing , development, and deployment resulted in...Initial F-35A Operational Basing EIS Final, September 2013 contract to develop the JSF ( designated the F-35 Lightning II). Since then, testing of F...of the aircraft even with system failures. Throughout the design and testing process, safety initiatives took previous best practices for single
76 FR 82179 - Drivers of CMVs: Restricting the Use of Cellular Phones
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-30
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 390 Drivers of CMVs: Restricting the Use of Cellular Phones AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Final rule; correction. SUMMARY: FMCSA is correcting a Final Rule that appeared in...
A novel framework to evaluate pedestrian safety at non-signalized locations.
Fu, Ting; Miranda-Moreno, Luis; Saunier, Nicolas
2018-02-01
This paper proposes a new framework to evaluate pedestrian safety at non-signalized crosswalk locations. In the proposed framework, the yielding maneuver of a driver in response to a pedestrian is split into the reaction and braking time. Hence, the relationship of the distance required for a yielding maneuver and the approaching vehicle speed depends on the reaction time of the driver and deceleration rate that the vehicle can achieve. The proposed framework is represented in the distance-velocity (DV) diagram and referred as the DV model. The interactions between approaching vehicles and pedestrians showing the intention to cross are divided in three categories: i) situations where the vehicle cannot make a complete stop, ii) situations where the vehicle's ability to stop depends on the driver reaction time, and iii) situations where the vehicle can make a complete stop. Based on these classifications, non-yielding maneuvers are classified as "non-infraction non-yielding" maneuvers, "uncertain non-yielding" maneuvers and "non-yielding" violations, respectively. From the pedestrian perspective, crossing decisions are classified as dangerous crossings, risky crossings and safe crossings accordingly. The yielding compliance and yielding rate, as measures of the yielding behavior, are redefined based on these categories. Time to crossing and deceleration rate required for the vehicle to stop are used to measure the probability of collision. Finally, the framework is demonstrated through a case study in evaluating pedestrian safety at three different types of non-signalized crossings: a painted crosswalk, an unprotected crosswalk, and a crosswalk controlled by stop signs. Results from the case study suggest that the proposed framework works well in describing pedestrian-vehicle interactions which helps in evaluating pedestrian safety at non-signalized crosswalk locations. Copyright © 2017 Elsevier Ltd. All rights reserved.
75 FR 16010 - Safety Zone; Red River, MN
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-31
...-AAOO Safety Zone; Red River, MN AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard Captain of the Port (COTP), Marine Safety Unit Duluth, MN is establishing a temporary safety zone on the waters of the Red River, MN. This safety zone is being established to ensure the safety of...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 5 2013-10-01 2013-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 5 2012-10-01 2012-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 5 2014-10-01 2014-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...
Bärgman, Jonas; Boda, Christian-Nils; Dozza, Marco
2017-05-01
As the development and deployment of in-vehicle intelligent safety systems (ISS) for crash avoidance and mitigation have rapidly increased in the last decades, the need to evaluate their prospective safety benefits before introduction has never been higher. Counterfactual simulations using relevant mathematical models (for vehicle dynamics, sensors, the environment, ISS algorithms, and models of driver behavior) have been identified as having high potential. However, although most of these models are relatively mature, models of driver behavior in the critical seconds before a crash are still relatively immature. There are also large conceptual differences between different driver models. The objective of this paper is, firstly, to demonstrate the importance of the choice of driver model when counterfactual simulations are used to evaluate two ISS: Forward collision warning (FCW), and autonomous emergency braking (AEB). Secondly, the paper demonstrates how counterfactual simulations can be used to perform sensitivity analyses on parameter settings, both for driver behavior and ISS algorithms. Finally, the paper evaluates the effect of the choice of glance distribution in the driver behavior model on the safety benefit estimation. The paper uses pre-crash kinematics and driver behavior from 34 rear-end crashes from the SHRP2 naturalistic driving study for the demonstrations. The results for FCW show a large difference in the percent of avoided crashes between conceptually different models of driver behavior, while differences were small for conceptually similar models. As expected, the choice of model of driver behavior did not affect AEB benefit much. Based on our results, researchers and others who aim to evaluate ISS with the driver in the loop through counterfactual simulations should be sure to make deliberate and well-grounded choices of driver models: the choice of model matters. Copyright © 2017 Elsevier Ltd. All rights reserved.
Bicycle and pedestrian safety in the highway safety manual : final report.
DOT National Transportation Integrated Search
2016-07-01
An accurate understanding of the expected effectiveness of bicycle and pedestrian safety : countermeasures is needed to support decisions about how to best allocate limited public : resources to increase safety for non-motorized users. However, the k...
9 CFR 113.110 - Clostridium Botulinum Type C Bacterin-Toxoid.
Code of Federal Regulations, 2012 CFR
2012-01-01
..., safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released. (a) Purity test. Final container samples of completed product from each serial... test. Bulk or final container samples of completed product from each serial shall be tested for safety...
9 CFR 113.110 - Clostridium Botulinum Type C Bacterin-Toxoid.
Code of Federal Regulations, 2010 CFR
2010-01-01
..., safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released. (a) Purity test. Final container samples of completed product from each serial... test. Bulk or final container samples of completed product from each serial shall be tested for safety...
29 CFR 1905.51 - Finality for purposes of judicial review.
Code of Federal Regulations, 2010 CFR
2010-07-01
... UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 Effect of Initial Decisions § 1905... 29 Labor 5 2010-07-01 2010-07-01 false Finality for purposes of judicial review. 1905.51 Section 1905.51 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...
Cultural differences in dealing with critical incidents.
Leonhardt, Jörg; Vogt, Joachim
2009-01-01
This article discusses the cultural aspects of High Reliability Organizations (HROs), such as air navigation services. HROs must maintain a highly professional safety culture and constantly be prepared to handle crises. The article begins with a general discussion of the concept of organizational culture. The special characteristics of HROs and their safety culture is then described. Finally the article illustrates how Critical Incident Stress Management (CISM) is becoming an ingrained feature of the organizational culture in air traffic control systems. Critical Incident Stress Management is a prevention program that can successfully guard against the negative effects of critical incidents. The CISM program of DFS (Deutsche Flugsicherung) was recently evaluated by the University of Copenhagen. This evaluation not only confirmed the successful prevention of negative effects at the operation's employee level (especially air traffic controllers), but also showed a sustained improvement of its safety culture and its overall organizational performance. The special aspects of cross-cultural crisis intervention and the challenges it faces, as well as the importance of prevention programs, such as CISM, are illustrated using the examples of two aircraft accidents: the crash landing of a calibration aircraft and the Lake Constance air disaster.
Evaluation of Neutron-induced Cross Sections and their Related Covariances with Physical Constraints
NASA Astrophysics Data System (ADS)
De Saint Jean, C.; Archier, P.; Privas, E.; Noguère, G.; Habert, B.; Tamagno, P.
2018-02-01
Nuclear data, along with numerical methods and the associated calculation schemes, continue to play a key role in reactor design, reactor core operating parameters calculations, fuel cycle management and criticality safety calculations. Due to the intensive use of Monte-Carlo calculations reducing numerical biases, the final accuracy of neutronic calculations increasingly depends on the quality of nuclear data used. This paper gives a broad picture of all ingredients treated by nuclear data evaluators during their analyses. After giving an introduction to nuclear data evaluation, we present implications of using the Bayesian inference to obtain evaluated cross sections and related uncertainties. In particular, a focus is made on systematic uncertainties appearing in the analysis of differential measurements as well as advantages and drawbacks one may encounter by analyzing integral experiments. The evaluation work is in general done independently in the resonance and in the continuum energy ranges giving rise to inconsistencies in evaluated files. For future evaluations on the whole energy range, we call attention to two innovative methods used to analyze several nuclear reaction models and impose constraints. Finally, we discuss suggestions for possible improvements in the evaluation process to master the quantification of uncertainties. These are associated with experiments (microscopic and integral), nuclear reaction theories and the Bayesian inference.
76 FR 34773 - Final Safety Culture Policy Statement
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-14
... Special Joint Session on Safety Culture at the Health Physics Society Annual Meeting, and presentations on... safety-first focus in nuclear work environments for public health and safety. The Commission's emphasis... operations, if attacked, could have an impact on public health and safety. During the early years of...
DOT National Transportation Integrated Search
1992-01-01
This report was prepared in response to a request from the Transportation Safety Administration of the Virginia Department ofMotor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virgin...
78 FR 48046 - Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-07
...-AA00 Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone on the navigable..., 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew...
78 FR 54578 - Safety Zone, Tiki Swim; Oceanside Harbor, Oceanside, CA
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-05
...-AA00 Safety Zone, Tiki Swim; Oceanside Harbor, Oceanside, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone on the navigable waters of..., 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Callan, J.R.; Kelly, R.T.; Quinn, M.L.
1995-05-01
Remote Afterloading Brachytherapy (RAB) is a medical process used in the treatment of cancer. RAB uses a computer-controlled device to remotely insert and remove radioactive sources close to a target (or tumor) in the body. Some RAB problems affecting the radiation dose to the patient have been reported and attributed to human error. To determine the root cause of human error in the RAB system, a human factors team visited 23 RAB treatment sites in the US The team observed RAB treatment planning and delivery, interviewed RAB personnel, and performed walk-throughs, during which staff demonstrated the procedures and practices usedmore » in performing RAB tasks. Factors leading to human error in the RAB system were identified. The impact of those factors on the performance of RAB was then evaluated and prioritized in terms of safety significance. Finally, the project identified and evaluated alternative approaches for resolving the safety significant problems related to human error.« less
Systematic strategies for the third industrial accident prevention plan in Korea.
Kang, Young-sig; Yang, Sung-hwan; Kim, Tae-gu; Kim, Day-sung
2012-01-01
To minimize industrial accidents, it's critical to evaluate a firm's priorities for prevention factors and strategies since such evaluation provides decisive information for preventing industrial accidents and maintaining safety management. Therefore, this paper proposes the evaluation of priorities through statistical testing of prevention factors with a cause analysis in a cause and effect model. A priority matrix criterion is proposed to apply the ranking and for the objectivity of questionnaire results. This paper used regression method (RA), exponential smoothing method (ESM), double exponential smoothing method (DESM), autoregressive integrated moving average (ARIMA) model and proposed analytical function method (PAFM) to analyze trends of accident data that will lead to an accurate prediction. This paper standardized the questionnaire results of workers and managers in manufacturing and construction companies with less than 300 employees, located in the central Korean metropolitan areas where fatal accidents have occurred. Finally, a strategy was provided to construct safety management for the third industrial accident prevention plan and a forecasting method for occupational accident rates and fatality rates for occupational accidents per 10,000 people.
DOT National Transportation Integrated Search
2005-03-01
The Crash Avoidance Metrics Partnership (CAMP) Vehicle Safety Communications Consortium (VSCC) comprised of BMW, DaimlerChrysler, Ford, GM, Nissan, Toyota, and Volkswagen, in partnership with USDOT, established the Vehicle Safety Communications (VSC)...
Review and evaluation of automotive fuel conservation technologies. Final report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Siegel, H.M.; Schwarz, R.; Andon, J.
1981-12-01
To support the Office of Research and Development of the National Highway Traffic Safety Administration with focused studies in areas affecting automotive fuel economy and related safety issues, a series of in-depth studies were carried out: Fuel Consumption Estimates of Stratified Charge Rotary Engines Installed in Five Vehicles; Oldsmobile Omega X Body Baseline Weight Data; GM X Body Material Substitution Weight Reduction/Cost Effectiveness Study; Calspan RSV Restraint System Cost Study; FMVSS No. 208 Extension to Light Trucks, Vans, and MPV's - Cost Lead Time Study; Multipiece Rims for Trucks, Buses, and Trailers; Identifying Design Changes, Cost Impacts and Manufacturing Leadmore » Times to Upgrade FMVSS 114 for Passenger Cars, Trucks, and MPV's; Ford Escort GL Baseline Weight Data.« less
14 CFR Appendix B of Part 415 - Safety Review Document Outline
Code of Federal Regulations, 2010 CFR
2010-01-01
... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...
14 CFR Appendix B of Part 415 - Safety Review Document Outline
Code of Federal Regulations, 2012 CFR
2012-01-01
... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...
14 CFR Appendix B of Part 415 - Safety Review Document Outline
Code of Federal Regulations, 2011 CFR
2011-01-01
... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...
Gotteland, Martin; Cires, Maria Jose; Carvallo, Claudia; Vega, Natalia; Ramirez, Maria Antonieta; Morales, Pamela; Rivas, Patricia; Astudillo, Fernanda; Navarrete, Paola; Dubos, Céline; Figueroa, Alvaro; Troncoso, Miriam; Ulloa, Carolina; Mizgier, Maria Luisa; Carrasco-Pozo, Catalina; Speisky, Hernan; Brunser, Oscar; Figueroa, Guillermo
2014-04-01
The aim of this study was to select autochthonous strains of Lactobacillus from stools of healthy infants and adults, human milk, artisanal goat cheese, and fruits and vegetables according to their probiotic properties and safety. From 421 strains of Lactobacillus isolated, 102 (24.2%) were shown to be tolerant to gastric pH and bile salts; they were used to determine their anti-Helicobacter pylori (agar diffusion assay), antioxidant (oxygen radical absorption capacity), and anti-inflammatory (inhibition of interleukin-8 release by tumor necrosis factor-α-stimulated HT-29 cells) activities as well as their ability to adhere to intestinal (Caco-2) and gastric (AGS) epithelial cells. Results obtained were compared with three commercial probiotic Lactobacillus rhamnosus GG, L. plantarum 299v, and L. johnsonii NCC533. The five strains most efficient according to these activities were subsequently identified by sequencing their 16S rRNA gene, their susceptibility to antibiotics was determined, and their safety evaluated in mice. One strain of L. plantarum was discarded due to the higher prevalence of liver bacterial translocation observed in the animals fed this strain. In conclusion, four autochthonous strains of L. rhamnosus were finally selected with probiotic properties and safety allowing their eventual use in human studies. These results contribute to increase the diversity of probiotic strains available for the development of nutraceuticals and functional foods.
Wu, Jun; Li, Chengbing; Huo, Yueying
2014-01-01
Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises. PMID:25477954
Wu, Jun; Li, Chengbing; Huo, Yueying
2014-01-01
Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises.
Monitoring road safety development at regional level: A case study in the ASEAN region.
Chen, Faan; Wang, Jianjun; Wu, Jiaorong; Chen, Xiaohong; Zegras, P Christopher
2017-09-01
Persistent monitoring of progress, evaluating the results of interventions and recalibrating to achieve continuous improvement over time is widely recognized as being crucial towards the successful development of road safety. In the ASEAN (Association of Southeast Asian Nations) region there is a lack of well-resourced teams that contain multidisciplinary safety professionals, and specialists in individual countries, who are able to carry out this work effectively. In this context, not only must the monitoring framework be effective, it must also be easy to use and adapt. This paper provides a case study that can be easily reproduced; based on an updated and refined Road Safety Development Index (RSDI), by means of the RSR (Rank-sum ratio)-based model, for monitoring/reporting road safety development at regional level. The case study was focused on the road safety achievements in eleven Southeast Asian countries; identifying the areas of poor performance, potential problems and delays. These countries are finally grouped into several classes based on an overview of their progress and achievements regarding to road safety. The results allow the policymakers to better understand their own road safety progress toward their desired impact; more importantly, these results enable necessary interventions to be made in a quick and timely manner. Keeping action plans on schedule if things are not progressing as desired. This would avoid 'reinventing the wheel' and trial and error approaches to road safety, making the implementation of action plans more effective. Copyright © 2017 Elsevier Ltd. All rights reserved.
Berteau, Cecile; Schwarzenbach, Florence; Donazzolo, Yves; Latreille, Mathilde; Berube, Julie; Abry, Herve; Cotten, Joël; Feger, Celine; Laurent, Philippe E
2010-10-05
A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects' preferred system for a final study injection or future treatment. A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.
DOT National Transportation Integrated Search
2016-07-01
To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...
DOT National Transportation Integrated Search
2016-05-01
Collisions in the work zone have always been a contributing factor to compromising safety on urban roadways. The National Highway Traffic Safety Administration (NHTSA) and the State Transportation Authorities have implemented many safety countermeasu...
Design, Construction and Testing of an In-Pile Loop for PWR (Pressurized Water Reactor) Simulation.
1987-06-01
computer modeling remains at best semiempirical (C-i), this large variation in scaling factor makes extrapolation of data impossible. The DIDO Water...in a full scale PWR are not practical. The reactor plant is not controlled to tolerances necessary for research, and utilities are reluctant to vary...MIT Reactor Safeguards Committee, in revision 1 to the PCCL Safety Evaluation Report (SER), for final approval to begin in-pile testing and
2009-09-01
evaluate specific system equipment func- tions, performance, operations, and safety in the field environment. The planned test procedures require free space...emission of radiofrequency (RF) electromagnetic energy within a limited spectral region and controlled power spec- tral density. There would be...for personnel. The applicable DoD standard that provides required guidelines for permissible exposure limits of DoD personnel is DoD Instruction
76 FR 72823 - Voluntary Mergers of Federal Home Loan Banks
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-28
..., Senior Financial Analyst, Policy and Program Development, [email protected] , (202) 408-2828 (this is... Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act).\\6\\ \\6\\ See 12 U... final rule. A definition for the term ``Financial Statements'' has been added to the final rule to refer...
76 FR 21253 - Safety Zone; M/V DAVY CROCKETT, Columbia River
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-15
...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending and expanding the emergency safety zone established on... January 28, 2011. The safety zone is necessary to help ensure the safety of the response workers and...
Preliminary hazards analysis -- vitrification process
DOE Office of Scientific and Technical Information (OSTI.GOV)
Coordes, D.; Ruggieri, M.; Russell, J.
1994-06-01
This paper presents a Preliminary Hazards Analysis (PHA) for mixed waste vitrification by joule heating. The purpose of performing a PHA is to establish an initial hazard categorization for a DOE nuclear facility and to identify those processes and structures which may have an impact on or be important to safety. The PHA is typically performed during and provides input to project conceptual design. The PHA is then followed by a Preliminary Safety Analysis Report (PSAR) performed during Title 1 and 2 design. The PSAR then leads to performance of the Final Safety Analysis Report performed during the facility`s constructionmore » and testing. It should be completed before routine operation of the facility commences. This PHA addresses the first four chapters of the safety analysis process, in accordance with the requirements of DOE Safety Guidelines in SG 830.110. The hazards associated with vitrification processes are evaluated using standard safety analysis methods which include: identification of credible potential hazardous energy sources; identification of preventative features of the facility or system; identification of mitigative features; and analyses of credible hazards. Maximal facility inventories of radioactive and hazardous materials are postulated to evaluate worst case accident consequences. These inventories were based on DOE-STD-1027-92 guidance and the surrogate waste streams defined by Mayberry, et al. Radiological assessments indicate that a facility, depending on the radioactive material inventory, may be an exempt, Category 3, or Category 2 facility. The calculated impacts would result in no significant impact to offsite personnel or the environment. Hazardous materials assessment indicates that a Mixed Waste Vitrification facility will be a Low Hazard facility having minimal impacts to offsite personnel and the environment.« less
Stomski, Norman; Gluyas, Heather; Andrus, Prue; Williams, Anne; Hopkins, Martin; Walters, Jennifer; Sandy, Martinique; Morrison, Paul
2018-04-01
Several studies report that patient safety skills, especially non-technical skills, receive scant attention in nursing curricula. Hence, there is a compelling reason to incorporate material that enhances non-technical skills, such as situation awareness, in nursing curricula in order to assist in the reduction of healthcare related adverse events. The objectives of this study were to: 1) understand final year nursing students' confidence in their patient safety skills; and 2) examine the impact of situation awareness training on final year nursing students' confidence in their patient safety skills. Participants were enrolled from a convenience sample comprising final year nursing students at a Western Australia university. Self-reported confidence in patient safety skills was assessed with the Health Professional in Patient Safety Survey before and after the delivery of a situation awareness educational intervention. Pre/post educational intervention differences were examined by repeated measures ANOVA. No significant differences in confidence about patient safety skills were identified within settings (class/clinical). However, confidence in patient safety skills significantly decreased between settings i.e. nursing students lost confidence after clinical placements. The educational intervention delivered in this study did not seem to improve confidence in patient safety skills, but substantial ceiling effects may have confounded the identification of such improvement. Further studies are required to establish whether the findings of this study can be generalised to other university nursing cohorts. Copyright © 2018 Elsevier Ltd. All rights reserved.
Safety of railroad passenger vehicle dynamics : final summary report
DOT National Transportation Integrated Search
2002-07-01
This report is a summary of all the work done by Foster-Miller on the passenger rail vehicle dynamic safety under the contract awarded by the FRA. The report presents key issues and findings in the safety assessments and a safety assessment methodolo...
Petschonek, Sarah; Burlison, Jonathan; Cross, Carl; Martin, Kathy; Laver, Joseph; Landis, Ronald S; Hoffman, James M
2013-12-01
Given the growing support for establishing a just patient safety culture in health-care settings, a valid tool is needed to assess and improve just patient safety culture. The purpose of this study was to develop a measure of individual perceptions of just culture for a hospital setting. The 27-item survey was administered to 998 members of a health-care staff in a pediatric research hospital as part of the hospital's ongoing patient safety culture assessment process. Subscales included balancing a blame-free approach with accountability, feedback and communication, openness of communication, quality of the event reporting process, continuous improvement, and trust. The final sample of 404 participants (40% response rate) included nurses, physicians, pharmacists, and other hospital staff members involved in patient care. Confirmatory factor analysis was used to test the internal structure of the measure and reliability analyses were conducted on the subscales. Moderate support for the factor structure was established with confirmatory factor analysis. After modifications were made to improve statistical fit, the final version of the measure included 6 subscales loading onto one higher-order dimension. Additionally, Cronbach α reliability scores for the subscales were positive, with each dimension being above 0.7 with the exception of one. The instrument designed and tested in this study demonstrated adequate structure and reliability. Given the uniqueness of the current sample, further verification of the JCAT is needed from hospitals that serve broader populations. A validated tool could also be used to evaluate the relation between just culture and patient safety outcomes.
Petschonek, Sarah; Burlison, Jonathan; Cross, Carl; Martin, Kathy; Laver, Joseph; Landis, Ronald S.; Hoffman, James M.
2014-01-01
Objectives Given the growing support for establishing a just patient safety culture in healthcare settings, a valid tool is needed to assess and improve just patient safety culture. The purpose of this study was to develop a measure of individual perceptions of just culture for a hospital setting. Methods The 27 item survey was administered to 998 members of a healthcare staff in a pediatric research hospital as part of the hospital's ongoing patient safety culture assessment process. Subscales included balancing a blame-free approach with accountability, feedback and communication, openness of communication, quality of the event reporting process, continuous improvement, and trust. The final sample of 404 participants (40% response rate) included nurses, physicians, pharmacists and other hospital staff members involved in patient care. Confirmatory factor analysis was used to test the internal structure of the measure and reliability analyses were conducted on the subscales. Results Moderate support for the factor structure was established with confirmatory factor analysis. After modifications were made to improve statistical fit, the final version of the measure included six subscales loading onto one higher-order dimension. Additionally, Cronbach's alpha reliability scores for the subscales were positive, with each dimension being above 0.7 with the exception of one. Conclusions The instrument designed and tested in this study demonstrated adequate structure and reliability. Given the uniqueness of the current sample, further verification of the JCAT is needed from hospitals that serve broader populations. A validated tool could also be used to evaluate the relation between just culture and patient safety outcomes. PMID:24263549
Jónsson, Ásbjörn; Backi, Christoph Josef; Lunestad, Bjørn Tore; Karlsdóttir, Magnea G
2017-01-01
Abstract BACKGROUND The catch of marine whitefish is typically seasonal, whereas the land‐based processing industry has a need for all‐year stable supply of raw materials. This challenge can be met by applying fish frozen at sea. When using frozen fish, the methods employed for thawing may influence the safety and quality of the final product. This study aimed to investigate the applicability of novel thawing strategies in order to provide an all‐year supply of high‐quality and safe cod products. RESULTS Comparative investigations of quality and safety factors after thawing in water, with and without air circulation, and contact thawing were performed. The parameters included water‐holding capacity, thawing loss, drip loss, cooking yield, sensory evaluation and microbiological analyses (including total volatile bases nitrogen). Water thawing with air circulation provided faster thawing than water thawing without air circulation and contact thawing. For all three methods, the quality of the thawed fish was acceptable and the shelf life of the fillets during chilled storage was between 10 and 14 days post‐filleting. CONCLUSION The results show that controlled freezing of cod, followed by appropriate thawing, may provide the processing industry with an all‐year delivery of raw materials, without compromising quality and safety of the final product. © 2017 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. PMID:28862323
DOE Office of Scientific and Technical Information (OSTI.GOV)
Larry G. Hoffman; Kenneth Alvar; Thomas Buhl
1999-06-01
This progress report presents the results of 10 projects funded ($504K) in FY98 by the Technology Development, Evaluation, and Application (TDEA) Committee of the Environment, Safety, and Health Division. Nine projects are new for this year; two projects were completed in their third and final TDEA-funded year. As a result of their TDEA-funded projects, investigators have published 19 papers in professional journals, proceedings, or Los Alamos reports and presented their work at professional meetings. Supplemental funds and in-kind contributions, such as staff time, instrument use, and work space were also provided to the TDEA-funded projects by organizations external to ESHmore » Division. Products generated from the projects funded in FY98 included a new extremity dosimeter that replaced the previously used finger-ring dosimeters, a light and easy-to-use detector to measure energy deposited by neutron interactions, and a device that will allow workers to determine the severity of a hazard.« less
Evaluation of safety profile of black shilajit after 91 days repeated administration in rats
Velmurugan, C; Vivek, B; Wilson, E; Bharathi, T; Sundaram, T
2012-01-01
Objective To evaluate the safety of shilajit by 91 days repeated administration in different dose levels in rats. Methods In this study the albino rats were divided into four groups. Group I received vehicle and group II, III and IV received 500, 2 500 and 5 000 mg/kg of shilajit, respectively. Finally animals were sacrificed and subjected to histopathology and iron was estimated by flame atomic absorption spectroscopy and graphite furnace. Results The result showed that there were no significant changes in iron level of treated groups when compared with control except liver (5 000 mg/kg) and histological slides of all organs revealed normal except negligible changes in liver and intestine with the highest dose of shilajit. The weight of all organs was normal when compared with control. Conclusions The result suggests that black shilajit, an Ayurvedic formulation, is safe for long term use as a dietary supplement for a number of disorders like iron deficiency anaemia. PMID:23569899
Evaluation of safety profile of black shilajit after 91 days repeated administration in rats.
Velmurugan, C; Vivek, B; Wilson, E; Bharathi, T; Sundaram, T
2012-03-01
To evaluate the safety of shilajit by 91 days repeated administration in different dose levels in rats. In this study the albino rats were divided into four groups. Group I received vehicle and group II, III and IV received 500, 2 500 and 5 000 mg/kg of shilajit, respectively. Finally animals were sacrificed and subjected to histopathology and iron was estimated by flame atomic absorption spectroscopy and graphite furnace. The result showed that there were no significant changes in iron level of treated groups when compared with control except liver (5 000 mg/kg) and histological slides of all organs revealed normal except negligible changes in liver and intestine with the highest dose of shilajit. The weight of all organs was normal when compared with control. The result suggests that black shilajit, an Ayurvedic formulation, is safe for long term use as a dietary supplement for a number of disorders like iron deficiency anaemia.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Monteleone, S.
1998-03-01
This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following: (1) human reliability analysis and human performance evaluation; (2) technical issues relatedmore » to rulemakings; (3) risk-informed, performance-based initiatives; and (4) high burn-up fuel research. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database.« less
Collapse Mechanisms Of Masonry Structures
NASA Astrophysics Data System (ADS)
Zuccaro, G.; Rauci, M.
2008-07-01
The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of one of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.
Collapse Mechanisms Of Masonry Structures
DOE Office of Scientific and Technical Information (OSTI.GOV)
Zuccaro, G.; Rauci, M.
2008-07-08
The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of onemore » of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.« less
Urban and suburban arterial safety performance functions : final report.
DOT National Transportation Integrated Search
2016-06-30
This report documents findings from a comprehensive set of safety performance functions developed for the entire urban-suburban : arterial road segment system on the state highway system in Washington. Conventional urban suburban safety performance :...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-13
... Natural Gas Operators AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No...: ``Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting Requirements.'' The final rule...
Clarke, Christina M; Persaud, Drepaul David
2011-03-01
Many contemporary acute care facilities lack safe and effective clinical handover practices resulting in patient transitions that are vulnerable to discontinuities in care, medical errors, and adverse patient safety events. This article is intended to supplement existing handover improvement literature by providing practical guidance for leaders and managers who are seeking to improve the safety and the effectiveness of clinical handovers in the acute care setting. A 4-stage change model has been applied to guide the application of strategies for handover improvement. Change management and quality improvement principles, as well as concepts drawn from safety science and high-reliability organizations, were applied to inform strategies. A model for handover improvement respecting handover complexity is presented. Strategies targeted to stages of change include the following: 1. Enhancing awareness of handover problems and opportunities with the support of strategic directions, accountability, end user involvement, and problem complexity recognition. 2. Identifying solutions by applying and adapting best practices in local contexts. 3. Implementing locally adapted best practices supported by communication, documentation, and training. 4. Institutionalizing practice changes through integration, monitoring, and active dissemination. Finally, continued evaluation at every stage is essential. Although gaps in handover process and function knowledge remain, efforts to improve handover safety and effectiveness are still possible. Continued evaluation is critical in building this understanding and to ensure that practice changes lead to improvements in patient safety, organizational effectiveness, and patient and provider satisfaction. Through handover knowledge building, fundamental changes in handover policies and practices may be possible.
Poster - 28: Shielding of X-ray Rooms in Ontario in the Absence of Best Practice
DOE Office of Scientific and Technical Information (OSTI.GOV)
Frimeth, Jeff; Richer, Jeff; Nesbitt, James
This poster will be strictly based on the Healing Arts Radiation Protection (HARP) Act, Regulation 543 under this Act (X-ray Safety Code), and personal communication the presenting author has had. In Ontario, the process of approval of an X-ray machine installation by the Director of the X-ray Inspection Service (XRIS) follows a certain protocol. Initially, the applicant submits a series of forms, including recommended shielding amounts, in order to satisfy the law. This documentation is then transferred to a third-party vendor (i.e. a professional engineer – P.Eng.) outsourced by the Ministry of Health and Long-term Care (MOHLTC). The P.Eng. thenmore » evaluates the submitted documentation for appropriate fulfillment of the HARP Act and Reg. 543 requirements. If the P.Eng.’s evaluation of the documentation is to their satisfaction, the XRIS is then notified. Finally, the Director will then issue a letter of approval to install the equipment at the facility. The methodology required to be used by the P.Eng. in order to determine the required amounts of protective barriers, and recommended to be used by the applicant, is contained within Safety Code 20A. However, Safety Code 35 has replaced the obsolete Safety Code 20A document and employs best practices in shielding design. This talk will focus further on specific intentions and limitations of Safety Code 20A. Furthermore, this talk will discuss the definition of the “practice of professional engineering” in Ontario. COMP members who are involved in shielding design are strongly encouraged to attend.« less
Colorectal Cancer Safety Net: Is It Catching Patients Appropriately?
Althans, Alison R; Brady, Justin T; Times, Melissa L; Keller, Deborah S; Harvey, Alexis R; Kelly, Molly E; Patel, Nilam D; Steele, Scott R
2018-01-01
Disparities in access to colorectal cancer care are multifactorial and are affected by socioeconomic elements. Uninsured and Medicaid patients present with advanced stage disease and have worse outcomes compared with similar privately insured patients. Safety net hospitals are a major care provider to this vulnerable population. Few studies have evaluated outcomes for safety net hospitals compared with private institutions in colorectal cancer. The purpose of this study was to compare demographics, screening rates, presentation stage, and survival rates between a safety net hospital and a tertiary care center. Comparative review of patients at 2 institutions in the same metropolitan area were conducted. The study included colorectal cancer care delivered either at 1 safety net hospital or 1 private tertiary care center in the same city from 2010 to 2016. A total of 350 patients with colorectal cancer from each hospital were evaluated. Overall survival across hospital systems was measured. The safety net hospital had significantly more uninsured and Medicaid patients (46% vs 13%; p < 0.001) and a significantly lower median household income than the tertiary care center ($39,299 vs $49,741; p < 0.0001). At initial presentation, a similar percentage of patients at each hospital presented with stage IV disease (26% vs 20%; p = 0.06). For those undergoing resection, final pathologic stage distribution was similar across groups (p = 0.10). After a comparable median follow-up period (26.6 mo for safety net hospital vs 29.2 mo for tertiary care center), log-rank test for overall survival favored the safety net hospital (p = 0.05); disease-free survival was similar between hospitals (p = 0.40). This was a retrospective review, reporting from medical charts. Our results support the value of safety net hospitals for providing quality colorectal cancer care, with survival and recurrence outcomes equivalent or improved compared with a local tertiary care center. Because safety net hospitals can provide equivalent outcomes despite socioeconomic inequalities and financial constraints, emphasis should be focused on ensuring that adequate funding for these institutions continues. See Video Abstract at http://links.lww.com/DCR/A454.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-26
... Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety Standards... effectiveness of information collection requirements contained in the final rule on Examinations of Work Areas... requirements in MSHA's final rule on Examinations of Work Areas in Underground Coal Mines for Violations of...
NASA Technical Reports Server (NTRS)
Stough, Roger
2004-01-01
The purpose of this workshop was to survey existing health and safety policies as well as processes and practices for various extreme environments; to identify strengths and shortcomings of these processes; and to recommend parameters for inclusion in a generic approach to policy formulation, applicable to the broadest categories of extreme environments. It was anticipated that two additional workshops would follow. The November 7, 2003 workshop would be devoted to the evaluation of different model(s) and a concluding expert evaluation of the usefulness of the model using a policy formulation example. The final workshop was planned for March 2004.
76 FR 11339 - Update to NFPA 101, Life Safety Code, for State Home Facilities
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-02
... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 51 RIN 2900-AN59 Update to NFPA 101, Life Safety Code..., Life Safety Code. The change is designed to assure that State Home facilities meet current industry- wide standards regarding life safety and fire safety. DATES: Effective Date: This final rule is...
ERIC Educational Resources Information Center
Chorness, Maury H.; And Others
To examine the feasibility of establishing Highway Safety Manpower Development and Research (HSMDR) Centers at university-level institutions which would produce three types of manpower--safety specialists, safety professionals, and research manpower, previous National Highway Safety Bureau research studies and approximately 50 federally funded…
76 FR 34862 - Safety Zone; M/V DAVY CROCKETT, Columbia River
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-15
...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement of a safety zone established on the... original safety zone was established on January 28, 2011. The safety zone is necessary to help ensure the...
78 FR 9623 - Federal Motor Vehicle Safety Standards; Air Brake Systems
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... [Docket No. NHTSA-2013-0011] RIN 2127-AL11 Federal Motor Vehicle Safety Standards; Air Brake Systems... rule that amended the Federal motor vehicle safety standard for air brake systems by requiring... published a final rule in the Federal Register amending Federal Motor Vehicle Safety Standard (FMVSS) No...
DOT National Transportation Integrated Search
2015-07-01
In 2002, the Federal Motor Carrier Safety Administration (FMCSA) issued the New Entrant Program Interim Final Rule in response to the requirement in the Motor Carrier Safety Improvement Act of 1999. The requirement in the Act was based on research fi...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-17
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR 191... Reports AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Issuance of... Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on November 26, 2010...
The role of quantitative safety evaluation in regulatory decision making of drugs.
Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat
2016-01-01
Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.
2006-09-22
This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.
78 FR 70415 - Federal Motor Vehicle Safety Standards; Occupant Crash Protection
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-25
...Completing the first initiative of NHTSA's 2007 ``NHTSA's Approach to Motorcoach Safety'' plan and one of the principal undertakings of DOT's 2009 Motorcoach Safety Action Plan, and fulfilling a statutory mandate of the Motorcoach Enhanced Safety Act of 2012, incorporated into the Moving Ahead for Progress in the 21st Century Act, this final rule amends the Federal motor vehicle safety standard (FMVSS) on occupant crash protection to require lap/shoulder seat belts for each passenger seating position in all new over-the-road buses, and in new buses other than over-the-road buses with a gross vehicle weight rating (GVWR) greater than 11,793 kilograms (kg) (26,000 pounds (lb), with certain exclusions. By requiring the passenger lap/ shoulder seat belts, this final rule significantly reduces the risk of fatality and serious injury in frontal crashes and the risk of occupant ejection in rollovers, thus considerably enhancing the safety of these vehicles.
Methods and benefits of experimental seismic evaluation of nuclear power plants. Final report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1979-07-01
This study reviews experimental techniques, instrumentation requirements, safety considerations, and benefits of performing vibration tests on nuclear power plant containments and internal components. The emphasis is on testing to improve seismic structural models. Techniques for identification of resonant frequencies, damping, and mode shapes, are discussed. The benefits of testing with regard to increased damping and more accurate computer models are oulined. A test plan, schedule and budget are presented for a typical PWR nuclear power plant.
2005-07-06
C95.1-1991, American National Standard Safety Levels With Respect to Human Exposure to Radiofrequency Electromagnetic Fields , 300 kHz to 100 GHz. New...Site 4) were evaluated for possible siting of the ASR- 11. All three sites are situated in undeveloped fields on base. Site 2 is located between the...alternative ASR-1 1 sites. 3.12 ELECTROMAGNETIC ENERGY 3.12.1 Existing Conditions Electrical currents and components generate electrical fields and
EPA/NASA/USAF Depainting Effort Concludes
NASA Technical Reports Server (NTRS)
Finckenor, Miria M.; Clark-Ingram, Marceia
2000-01-01
The final report contains strip rate data from all of the methods, lessons learned during processing, metallurgical evaluations of the panels, and summaries of corrosion and hydrogen embrittlement studies. Any changes in surface roughness, fatigue and tensile properties, and crack detectability are noted in the report. No process was singled out above the others, as companies should consider equipment and operational costs when complying with the Aerospace NESHAP (National Emission Standards for Hazardous Air Pollutants) and new OSHA (Occupational Safety and Health Administration) regulations.
Migration limits for children's toys are nothing to play with.
Krätke, Renate; Beausoleil, Claire; Carroquino, Maria José; Duarte-Davidson, Raquel; Fernandes, Teresa; Schoeters, Greet
2016-10-01
The European Commission and its independent Scientific Committee on Health and Environmental Risks (SCHER) published their final Opinion on estimates of the amount of toy materials ingested by children. The SCHER was asked to review available data on the ingestion of the following three types of toy material by children, and evaluate whether the ingestion amounts which formed the basis for the migration limits of 19 elements in the Toy Safety Directive are still appropriate or whether they should be changed. In the final Opinion the SCHER considers the ingestion amounts mentioned above to be appropriate, and that these ingestion amounts should remain classified as daily amounts rather than weekly. Copyright © 2016 Elsevier Inc. All rights reserved.
Inhaled chemotherapy in lung cancer: future concept of nanomedicine
Zarogoulidis, Paul; Chatzaki, Ekaterini; Porpodis, Konstantinos; Domvri, Kalliopi; Hohenforst-Schmidt, Wolfgang; Goldberg, Eugene P; Karamanos, Nikos; Zarogoulidis, Konstantinos
2012-01-01
Regional chemotherapy was first used for lung cancer 30 years ago. Since then, new methods of drug delivery and pharmaceuticals have been investigated in vitro, and in animals and humans. An extensive review of drug delivery systems, pharmaceuticals, patient monitoring, methods of enhancing inhaled drug deposition, safety and efficacy, and also additional applications of inhaled chemotherapy and its advantages and disadvantages are presented. Regional chemotherapy to the lung parenchyma for lung cancer is feasible and efficient. Safety depends on the chemotherapy agent delivered to the lungs and is dose-dependent and time-dependent. Further evaluation is needed to provide data regarding early lung cancer stages, and whether regional chemotherapy can be used as neoadjuvant or adjuvant treatment. Finally, inhaled chemotherapy could one day be administered at home with fewer systemic adverse effects. PMID:22619512
Factor Analysis of Traffic Safety in Urban Roads Based on FTA-LEC
NASA Astrophysics Data System (ADS)
Shuicheng, TIAN; Xingbo, YANG; Xiaoqing, SHEN; Detao, ZHANG
2018-05-01
In order to reduce the number and the loss of urban road traffic accidents in our country, improve the safety of road traffic, a statistical analysis of the research report on major road traffic accidents in 2016 was conducted. The risk factors affecting urban road traffic in China were analyzed by using FTA to find the basic hidden events. Secondly, the risk value of the identified hidden danger events were calculated and classified into four levels I, II, III and IV through the LEC evaluation method. Finally, the graded results of risk factors are verified through a case of specific accidents in Beijing. The results show that: the case verified the scientificalness and effectiveness of hazard classification and provided guidance for urban road traffic management.
Mosberger, Rafael; Andreasson, Henrik; Lilienthal, Achim J
2014-09-26
This article presents a novel approach for vision-based detection and tracking of humans wearing high-visibility clothing with retro-reflective markers. Addressing industrial applications where heavy vehicles operate in the vicinity of humans, we deploy a customized stereo camera setup with active illumination that allows for efficient detection of the reflective patterns created by the worker's safety garments. After segmenting reflective objects from the image background, the interest regions are described with local image feature descriptors and classified in order to discriminate safety garments from other reflective objects in the scene. In a final step, the trajectories of the detected humans are estimated in 3D space relative to the camera. We evaluate our tracking system in two industrial real-world work environments on several challenging video sequences. The experimental results indicate accurate tracking performance and good robustness towards partial occlusions, body pose variation, and a wide range of different illumination conditions.
Mosberger, Rafael; Andreasson, Henrik; Lilienthal, Achim J.
2014-01-01
This article presents a novel approach for vision-based detection and tracking of humans wearing high-visibility clothing with retro-reflective markers. Addressing industrial applications where heavy vehicles operate in the vicinity of humans, we deploy a customized stereo camera setup with active illumination that allows for efficient detection of the reflective patterns created by the worker's safety garments. After segmenting reflective objects from the image background, the interest regions are described with local image feature descriptors and classified in order to discriminate safety garments from other reflective objects in the scene. In a final step, the trajectories of the detected humans are estimated in 3D space relative to the camera. We evaluate our tracking system in two industrial real-world work environments on several challenging video sequences. The experimental results indicate accurate tracking performance and good robustness towards partial occlusions, body pose variation, and a wide range of different illumination conditions. PMID:25264956
NASA Astrophysics Data System (ADS)
Wolfhope, J.
2017-12-01
This presentation will focus on the history, development, and best practices for evaluating the risks associated with the portfolio of water infrastructure in the United States. These practices have evolved from the early development of the Federal Guidelines for Dam Safety and the establishment of the National Dam Safety Program, to the most recent update of the Best Practices for Dam and Levee Risk Analysis jointly published by the U.S. Department of Interior Bureau of Reclamation and the U.S. Army Corps of Engineers. Since President Obama signed the Water Infrastructure Improvements for the Nation Act (WIIN) Act, on December 16, 2016, adding a new grant program under FEMA's National Dam Safety Program, the focus has been on establishing a risk-based priority system for use in identifying eligible high hazard potential dams for which grants may be made. Finally, the presentation provides thoughts on the future direction and priorities for managing the risk of dams and levees in the United States.
New geometric design consistency model based on operating speed profiles for road safety evaluation.
Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo
2013-12-01
To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment. Copyright © 2012 Elsevier Ltd. All rights reserved.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mueller, Don; Rearden, Bradley T; Reed, Davis Allan
2010-01-01
One of the challenges associated with implementation of burnup credit is the validation of criticality calculations used in the safety evaluation; in particular the availability and use of applicable critical experiment data. The purpose of the validation is to quantify the relationship between reality and calculated results. Validation and determination of bias and bias uncertainty require the identification of sets of critical experiments that are similar to the criticality safety models. A principal challenge for crediting fission products (FP) in a burnup credit safety evaluation is the limited availability of relevant FP critical experiments for bias and bias uncertainty determination.more » This paper provides an evaluation of the available critical experiments that include FPs, along with bounding, burnup-dependent estimates of FP biases generated by combining energy dependent sensitivity data for a typical burnup credit application with the nuclear data uncertainty information distributed with SCALE 6. A method for determining separate bias and bias uncertainty values for individual FPs and illustrative results is presented. Finally, a FP bias calculation method based on data adjustment techniques and reactivity sensitivity coefficients calculated with the SCALE sensitivity/uncertainty tools and some typical results is presented. Using the methods described in this paper, the cross-section bias for a representative high-capacity spent fuel cask associated with the ENDF/B-VII nuclear data for 16 most important stable or near stable FPs is predicted to be no greater than 2% of the total worth of the 16 FPs, or less than 0.13 % k/k.« less
77 FR 42179 - Safety Zone; Fireworks Display, Potomac River, Charles County, Newburg, MD
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-18
...]30[sec] W, located at Newburg in Charles County, Maryland (NAD 1983). The temporary safety zone will... 1625-AA00 Safety Zone; Fireworks Display, Potomac River, Charles County, Newburg, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard will establish a safety zone upon...
77 FR 24838 - Safety Zone; Magothy River, Sillery Bay, MD
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-26
...-AA00 Safety Zone; Magothy River, Sillery Bay, MD AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a safety zone in certain waters of the Magothy River, in Sillery Bay... a notice of proposed rulemaking (NPRM) entitled ``Safety Zone; Magothy River, Sillery Bay, MD'' in...
75 FR 35299 - Safety Zone; Ship Repair in Penobscot Bay, ME
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-22
... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2010-0519] RIN 1625-AA00 Safety Zone; Ship Repair in Penobscot Bay, ME AGENCY: Coast Guard, DHS. ACTION: Temporary final... Safety zone; Ship repair in Penobscot Bay, ME. (a) Location. The following area is a safety zone: All...
78 FR 43064 - Safety Zone; Maritime Heritage Festival Fireworks, St. Helens, OR
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-19
...-AA00 Safety Zone; Maritime Heritage Festival Fireworks, St. Helens, OR AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone in St. Helens, OR. This safety... associated with fireworks displays. As part of the Maritime Heritage Festival Fireworks in St. Helens, OR...
76 FR 73511 - Safety Zone; M/V DAVY CROCKETT, Columbia River
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-29
...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement period of a safety zone established on... sight at approximate river mile 117. The original safety zone was established on January 28, 2011. The...
76 FR 23485 - Safety Zone; Red River
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-27
...-AA00 Safety Zone; Red River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for all waters of the Red River in the State of North..., extending the entire width of the river. This safety zone is needed to protect persons and vessels from...
75 FR 19250 - Safety Zone; BWRC Spring Classic, Parker, AZ
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-14
...-AA00 Safety Zone; BWRC Spring Classic, Parker, AZ AGENCY: Coast Guard, DHS. ACTION: Temporary final... Spring Classic. This temporary safety zone is necessary to provide for the safety of the participants... Water Resort and Casino Spring Classic, which is held on the Lake Moolvalya region on the Colorado River...
75 FR 52463 - Safety Zone; Raccoon Creek, Bridgeport, NJ
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-26
... comment period would be contrary to the rule's objectives of ensuring safety of life on the navigable... required. This rule involves a limited-in-duration safety zone intended to protect life and property on the...-AA00 Safety Zone; Raccoon Creek, Bridgeport, NJ AGENCY: Coast Guard, DHS. ACTION: Temporary final rule...
78 FR 45059 - Safety Zone; Sherman Private Party Fireworks, Lake Michigan, Winnetka, IL
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-26
...-AA00 Safety Zone; Sherman Private Party Fireworks, Lake Michigan, Winnetka, IL AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Michigan near Winnetka, IL. This safety zone is intended to restrict vessels from a portion of Lake...
77 FR 41686 - Safety Zone; Sheffield Lake Fireworks, Lake Erie, Sheffield Lake, OH
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-16
...-AA00 Safety Zone; Sheffield Lake Fireworks, Lake Erie, Sheffield Lake, OH AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Sheffield Lake, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie...
78 FR 21260 - Safety Zone; Lubbers Cup Regatta; Spring Lake, MI
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-10
...-AA00 Safety Zone; Lubbers Cup Regatta; Spring Lake, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Spring Lake in Spring Lake, Michigan. This safety zone is intended to restrict vessels from a portion of Spring Lake due to...
76 FR 38018 - Safety Zone, Newport River; Morehead City, NC
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-29
...-AA00 Safety Zone, Newport River; Morehead City, NC AGENCY: Coast Guard, DHS. ACTION: Temporary final... the main span US 70/Morehead City-Newport River high rise bridge in Carteret County, NC. This safety...) entitled Safety Zone, Newport River; Morehead City, North Carolina in the Federal Register (33 FR 165). We...
A cloud medication safety support system using QR code and Web services for elderly outpatients.
Tseng, Ming-Hseng; Wu, Hui-Ching
2014-01-01
Drug is an important part of disease treatment, but medication errors happen frequently and have significant clinical and financial consequences. The prevalence of prescription medication use among the ambulatory adult population increases with advancing age. Because of the global aging society, outpatients need to improve medication safety more than inpatients. The elderly with multiple chronic conditions face the complex task of medication management. To reduce the medication errors for the elder outpatients with chronic diseases, a cloud medication safety supporting system is designed, demonstrated and evaluated. The proposed system is composed of a three-tier architecture: the front-end tier, the mobile tier and the cloud tier. The mobile tier will host the personalized medication safety supporting application on Android platforms that provides some primary functions including reminders for medication, assistance with pill-dispensing, recording of medications, position of medications and notices of forgotten medications for elderly outpatients. Finally, the hybrid technology acceptance model is employed to understand the intention and satisfaction level of the potential users to use this mobile medication safety support application system. The result of the system acceptance testing indicates that this developed system, implementing patient-centered services, is highly accepted by the elderly. This proposed M-health system could assist elderly outpatients' homecare in preventing medication errors and improving their medication safety.
Safety-related requirements for photovoltaic modules and arrays. Final report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Levins, A.
1984-03-01
Underwriters Laboratories has conducted a study to identify and develop safety requirements for photovoltaic module and panel designs and configurations for residential, intermediate, and large scale applications. Concepts for safety systems, where each system is a collection of subsystems which together address the total anticipated hazard situation, are described. Descriptions of hardware, and system usefulness and viability are included. This discussion of safety systems recognizes that there is little history on which to base the expected safety related performance of a photovoltaic system. A comparison of these systems, as against the provisions of the 1984 National Electrical Code covering photovoltaicmore » systems is made. A discussion of the UL investigation of the photovoltaic module evaluated to the provisions of the Proposed UL Standard for Flat-Plate Photovoltaic Modules and Panels is included. Grounding systems, their basis and nature, and the advantages and disadvantages of each are described. The meaning of frame grounding, circuit grounding, and the type of circuit ground are covered. The development of the Standard for Flat-Plate Photovoltaic Modules and Panels has continued, and with both industry comment and a product submittal and listing, the Standard has been refined to a viable document allowing an objective safety review of photovoltaic modules and panels. How this document, and other UL documents would cover investigations of certain other photovoltaic system components is described.« less
Safety belt and motorcycle helmet use in Virginia : the Summer 2003 update.
DOT National Transportation Integrated Search
2004-01-01
The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...
Safety belt and motorcycle helmet use in Virginia : the Summer 2005 update.
DOT National Transportation Integrated Search
2005-01-01
The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration ( NHTSA) published the final guidelines for conducting surveys of belt and helme...
Safety belt and motorcycle helmet use in Virginia : the Summer 2007 update.
DOT National Transportation Integrated Search
2007-01-01
The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...
Safety belt and motorcycle helmet use in Virginia : the Summer 2004 update.
DOT National Transportation Integrated Search
2004-01-01
The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...
Safety belt and motorcycle helmet use in Virginia : the Summer 2006 update.
DOT National Transportation Integrated Search
2006-01-01
The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...
Connected commercial vehicles — retrofit safety device kit project : final report.
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...
76 FR 10500 - Nationally Recognized Testing Laboratories Fees
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-25
... Administration (OSHA), Labor. ACTION: Final rule. SUMMARY: The Occupational Safety and Health Administration... Signature I. Introduction The Occupational Safety and Health Administration (OSHA) is adjusting the approach... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1910 [Docket No...
Roadway safety analysis methodology for Utah : final report.
DOT National Transportation Integrated Search
2016-12-01
This research focuses on the creation of a three-part Roadway Safety Analysis methodology that applies and automates the cumulative work of recently-completed roadway safety research. The first part is to prepare the roadway and crash data for analys...
29 CFR 1952.104 - Final approval determination.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Assistant Secretary determined that, in operation, Oregon's occupational safety and health program (with the... accordance with 29 CFR part 1953; to allocate sufficient safety and health enforcement staff to meet the...
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 the addition of an additional ML ICSR detector. On a blind test set of 2500 posts, the final model demonstrated a gKappa of 78% and an accuracy of 83%. In the time test, it took the final model 48 h to complete a task that would have taken an estimated 44,000 h for human experts to perform. The results of this study indicate that an effective and scalable solution to the challenge of ICSR detection in SDM includes a workflow using an automated ML classifier to identify likely ICSRs for further human SME review.
Evaluation of Portable Multi-Gas Analyzers for use by Safety Personnel
NASA Technical Reports Server (NTRS)
Lueck, D. E.; Meneghelli, B. J.; Bardel, D. N.
1998-01-01
During confined space entry operations as well as Shuttle-safing operations, United Space Alliance (USA)/National Aeronautics and Space Administration (NASA) safety personnel use a variety of portable instrumentation to monitor for hazardous levels of compounds such as nitrogen dioxide (N%), monomethylhydrazine (NMM), FREON 21, ammonia (NH3), oxygen (O2), and combustibles (as hydrogen (H2)). Except for O2 and H2, each compound is monitored using a single analyzer. In many cases these analyzers are 5 to 10 years old and require frequent maintenance. In addition, they are cumbersome to carry and tend to make the job of personnel monitoring physically taxing. As part of an effort to upgrade the sensor technology background information was requested from a total of 27 manufacturers of portable multi-gas instruments. A set of criteria was established to determine which vendors would be selected for laboratory evaluation. These criteria were based on requests made by USA/NASA Safety personnel in order to meet requirements within their respective areas for confined-space and Shuttle-safing operations. Each of the 27 manufacturers of multi-gas analyzers was sent a copy of the criteria and asked to fill in the appropriate information pertaining to their instrumentation. Based on the results of the sensor criteria worksheets, a total of 9 vendors out of 27 surveyed manufacturers were chosen for evaluation. Each vendor included in the final evaluation process was requested to configure each of two analyzers with NO2, NH3, O2, and combustible sensors. A set of lab tests was designed in order to determine which of the multi-gas instruments under evaluation was best suited for use in both shuttle and confined space operations. These tests included linearity/repeatability, zero/span drift response/recovery, humidity, interference, and maintenance. At the conclusion of lab testing three vendors were selected for additional field testing. Based on the results of both the lab and field evaluations a single vendor was recommended for use by NASA/IJSA Safety personnel. Vendor selection criteria, as well as the results from both laboratory and field testing of the multi-gas analyzers, are presented as part of this paper.
Botsis, Taxiarchis; Foster, Matthew; Arya, Nina; Kreimeyer, Kory; Pandey, Abhishek; Arya, Deepa
2017-04-26
To evaluate the feasibility of automated dose and adverse event information retrieval in supporting the identification of safety patterns. We extracted all rabbit Anti-Thymocyte Globulin (rATG) reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) from the product's initial licensure in April 16, 1984 through February 8, 2016. We processed the narratives using the Medication Extraction (MedEx) and the Event-based Text-mining of Health Electronic Records (ETHER) systems and retrieved the appropriate medication, clinical, and temporal information. When necessary, the extracted information was manually curated. This process resulted in a high quality dataset that was analyzed with the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA) to explore the association of rATG dosing with post-transplant lymphoproliferative disorder (PTLD). Although manual curation was necessary to improve the data quality, MedEx and ETHER supported the extraction of the appropriate information. We created a final dataset of 1,380 cases with complete information for rATG dosing and date of administration. Analysis in PANACEA found that PTLD was associated with cumulative doses of rATG >8 mg/kg, even in periods where most of the submissions to FAERS reported low doses of rATG. We demonstrated the feasibility of investigating a dose-related safety pattern for a particular product in FAERS using a set of automated tools.
ICSBEP Benchmarks For Nuclear Data Applications
DOE Office of Scientific and Technical Information (OSTI.GOV)
Briggs, J. Blair
2005-05-24
The International Criticality Safety Benchmark Evaluation Project (ICSBEP) was initiated in 1992 by the United States Department of Energy. The ICSBEP became an official activity of the Organization for Economic Cooperation and Development (OECD) -- Nuclear Energy Agency (NEA) in 1995. Representatives from the United States, United Kingdom, France, Japan, the Russian Federation, Hungary, Republic of Korea, Slovenia, Serbia and Montenegro (formerly Yugoslavia), Kazakhstan, Spain, Israel, Brazil, Poland, and the Czech Republic are now participating. South Africa, India, China, and Germany are considering participation. The purpose of the ICSBEP is to identify, evaluate, verify, and formally document a comprehensive andmore » internationally peer-reviewed set of criticality safety benchmark data. The work of the ICSBEP is published as an OECD handbook entitled ''International Handbook of Evaluated Criticality Safety Benchmark Experiments.'' The 2004 Edition of the Handbook contains benchmark specifications for 3331 critical or subcritical configurations that are intended for use in validation efforts and for testing basic nuclear data. New to the 2004 Edition of the Handbook is a draft criticality alarm / shielding type benchmark that should be finalized in 2005 along with two other similar benchmarks. The Handbook is being used extensively for nuclear data testing and is expected to be a valuable resource for code and data validation and improvement efforts for decades to come. Specific benchmarks that are useful for testing structural materials such as iron, chromium, nickel, and manganese; beryllium; lead; thorium; and 238U are highlighted.« less
29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.
Code of Federal Regulations, 2013 CFR
2013-07-01
... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...
29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.
Code of Federal Regulations, 2011 CFR
2011-07-01
... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...
29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.
Code of Federal Regulations, 2012 CFR
2012-07-01
... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...
29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.
Code of Federal Regulations, 2014 CFR
2014-07-01
... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...
29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.
Code of Federal Regulations, 2010 CFR
2010-07-01
... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...
Chronic beryllium disease prevention program; worker safety and health program. Final rule.
2006-02-09
The Department of Energy (DOE) is today publishing a final rule to implement the statutory mandate of section 3173 of the Bob Stump National Defense Authorization Act (NDAA) for Fiscal Year 2003 to establish worker safety and health regulations to govern contractor activities at DOE sites. This program codifies and enhances the worker protection program in operation when the NDAA was enacted.
Miyamura, Koichi; Miyamoto, Toshihiro; Tanimoto, Mitsune; Yamamoto, Kazuhito; Kimura, Shinya; Kawaguchi, Tatsuya; Matsumura, Itaru; Hata, Tomoko; Tsurumi, Hisashi; Saito, Shigeki; Hino, Masayuki; Tadokoro, Seiji; Meguro, Kuniaki; Hyodo, Hideo; Yamamoto, Masahide; Kubo, Kohmei; Tsukada, Junichi; Kondo, Midori; Aoki, Makoto; Okada, Hikaru; Yanada, Masamitsu; Ohyashiki, Kazuma; Taniwaki, Masafumi
2016-12-01
Optimal management of patients with chronic myeloid leukemia in chronic phase with suboptimal molecular response (MR) to frontline imatinib is undefined. We report final results from SENSOR, which evaluated efficacy/safety of nilotinib in this setting. A substudy assessed whether BIM polymorphisms impacted response to nilotinib. In this single-arm, multicenter study, Japanese patients with suboptimal MR per European LeukemiaNet 2009 criteria (complete cytogenetic response, but not major MR [MMR]) after ≥18 months of frontline imatinib received nilotinib 400mg twice daily for 24 months. MR, BCR-ABL1 mutations/variants, and BIM polymorphisms were evaluated in a central laboratory. Primary endpoint was the MMR rate at 12 months (null hypothesis of 40%). Of 45 patients (median exposure, 22.08 months), 39 completed the study and six discontinued. At 12 and 24 months, 51.1% (95% CI, 35.8%-66.3%) and 66.7% (95% CI, 51.0%-80.0%) achieved MMR, respectively. Cumulative MMR incidence by 24 months was 75.6%. Of 40 patients analyzed, 10 of 12 (83.3%) with and 17 of 28 (60.7%) without BIM polymorphisms achieved MMR at 24 months. The safety profile was manageable with dose reductions and interruptions. Nilotinib provided clinical benefit for patients with suboptimal response to imatinib, and BIM polymorphisms did not influence MMR achievement. ClinicalTrials.gov: NCT01043874. Copyright © 2016 Elsevier Ltd. All rights reserved.
29 CFR 1952.105 - Level of Federal enforcement.
Code of Federal Regulations, 2011 CFR
2011-07-01
...), final approval relinquishes Federal OSHA authority with regard to occupational safety and health issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under Section 6 of the Act (with the exception of...
[How safe is the recombinant human growth hormone?
Calzada-León, Raúl
2017-01-01
In this paper, several aspects related to the safety of the use of biosynthetic human growth hormone are reviewed. For example, its classification as a biosynthetic drug, the phases that need to be performed in Mexico to verify its safety (obtaining, purification, preclinical studies, clinical trials, and finally observational clinical studies), as well as the evidence that exists in relation to the association of intracranial hypertension, muscular events, scoliosis, slipped capital femoral epiphysis, obstructive sleep apnea, pancreatitis, alterations in cortisol, thyroid hormones alterations, cardiovascular disease, metabolic risk, mortality and cancer, adverse events not related to its use, and finally dosing and safety.
A novel method for deriving thresholds of toxicological concern for vaccine constituents.
White, Jennifer; Wrzesinski, Claudia; Green, Martin; Johnson, Giffe T; McCluskey, James D; Abritis, Alison; Harbison, Raymond D
2016-05-01
Safety assessment evaluating the presence of impurities, residual materials, and contaminants in vaccines is a focus of current research. Thresholds of toxicological concern (TTCs) are mathematically modeled levels used for assessing the safety of many food and medication constituents. In this study, six algorithms are selected from the open-access ToxTree software program to derive a method for calculating TTCs for vaccine constituents: In Vivo Rodent Micronucleus assay/LD50, Benigni-Bossa/LD50, Cramer Extended/LD50, In Vivo Rodent Micronucleus assay/TDLo, Benigni-Bossa/TDLo, and the Cramer Extended/TDLo. Using an initial dataset (n = 197) taken from INCHEM, RepDose, RTECS, and TOXNET, the chemicals were divided into two families: "positive" - based on the presence of structures associated with adverse outcomes, or "negative" - no such structures or having structures that appear to be protective of health. The final validation indicated that the Benigni-Bossa/LD50 method is the most appropriate for calculating TTCs for vaccine constituents. Final TTCs were designated as 18.06 μg/person and 20.61 μg/person for the Benigni-Bossa/LD50 positive and negative structural families, respectively.
Ciuti, Gastone; Ricotti, Leonardo; Menciassi, Arianna; Dario, Paolo
2015-03-17
Over the past few decades the increased level of public awareness concerning healthcare, physical activities, safety and environmental sensing has created an emerging need for smart sensor technologies and monitoring devices able to sense, classify, and provide feedbacks to users' health status and physical activities, as well as to evaluate environmental and safety conditions in a pervasive, accurate and reliable fashion. Monitoring and precisely quantifying users' physical activity with inertial measurement unit-based devices, for instance, has also proven to be important in health management of patients affected by chronic diseases, e.g., Parkinson's disease, many of which are becoming highly prevalent in Italy and in the Western world. This review paper will focus on MEMS sensor technologies developed in Italy in the last three years describing research achievements for healthcare and physical activity, safety and environmental sensing, in addition to smart systems integration. Innovative and smart integrated solutions for sensing devices, pursued and implemented in Italian research centres, will be highlighted, together with specific applications of such technologies. Finally, the paper will depict the future perspective of sensor technologies and corresponding exploitation opportunities, again with a specific focus on Italy.
A human reliability based usability evaluation method for safety-critical software
DOE Office of Scientific and Technical Information (OSTI.GOV)
Boring, R. L.; Tran, T. Q.; Gertman, D. I.
2006-07-01
Boring and Gertman (2005) introduced a novel method that augments heuristic usability evaluation methods with that of the human reliability analysis method of SPAR-H. By assigning probabilistic modifiers to individual heuristics, it is possible to arrive at the usability error probability (UEP). Although this UEP is not a literal probability of error, it nonetheless provides a quantitative basis to heuristic evaluation. This method allows one to seamlessly prioritize and identify usability issues (i.e., a higher UEP requires more immediate fixes). However, the original version of this method required the usability evaluator to assign priority weights to the final UEP, thusmore » allowing the priority of a usability issue to differ among usability evaluators. The purpose of this paper is to explore an alternative approach to standardize the priority weighting of the UEP in an effort to improve the method's reliability. (authors)« less
Post-approval safety issues with innovative drugs: a European cohort study.
Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M
2013-11-01
At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having a first serious safety issue was statistically significant, log-rank (Mantel-Cox) p = 0.036. In the final adjusted Cox proportional hazard model there was no statistically significant difference in occurrence of a first serious safety issue for important, moderate and modest innovations versus non-innovative drugs; hazard ratios 1.76 (95 % CI 0.82-3.77), 1.61 (95 % CI 0.76-3.41)], and 1.25 (95 % CI 0.51-3.06), respectively. A higher level of innovation was not clearly related to an increased risk of serious safety issues identified after approval.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-16
...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago..., DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent safety zone from Brandon... Safety Zones; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary...
76 FR 20530 - Safety Zone; Boom Days, Buffalo Outer Harbor, Buffalo, NY
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
...[deg]51'47.61'' W (NAD 83). (b) Effective period. This regulation will be effective and the safety zone...-AA00 Safety Zone; Boom Days, Buffalo Outer Harbor, Buffalo, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone in the Buffalo Outer...
76 FR 22342 - National Standard 10 Guidelines
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-21
... safety of human life at sea.'' NMFS published final guidelines for NS10 in 1998 (63 FR 24212; May 1, 1998... of human life at sea, including whether and to what extent such measures may affect the safety of...; and an explanation that the phrase ``safety of human life at sea'' refers to both the safety of a...
78 FR 36662 - Safety Zone; Fairport Harbor Mardi Gras, Lake Erie, Fairport, OH
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-19
...-AA00 Safety Zone; Fairport Harbor Mardi Gras, Lake Erie, Fairport, OH AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Fairport Harbor, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie during...
77 FR 39638 - Safety Zone; Barbara Harder Wedding Fireworks, Lake Erie, Lake View, NY
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-05
...-AA00 Safety Zone; Barbara Harder Wedding Fireworks, Lake Erie, Lake View, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Lake View, NY. This safety zone is intended to restrict vessels from a portion of Lake Erie...
Sacchi, Emanuele; Sayed, Tarek; El-Basyouny, Karim
2016-09-01
Recently, important advances in road safety statistics have been brought about by methods able to address issues other than the choice of the best error structure for modeling crash data. In particular, accounting for spatial and temporal interdependence, i.e., the notion that the collision occurrence of a site or unit times depend on those of others, has become an important issue that needs further research. Overall, autoregressive models can be used for this purpose as they can specify that the output variable depends on its own previous values and on a stochastic term. Spatial effects have been investigated and applied mostly in the context of developing safety performance functions (SPFs) to relate crash occurrence to highway characteristics. Hence, there is a need for studies that attempt to estimate the effectiveness of safety countermeasures by including the spatial interdependence of road sites within the context of an observational before-after (BA) study. Moreover, the combination of temporal dynamics and spatial effects on crash frequency has not been explored in depth for SPF development. Therefore, the main goal of this research was to carry out a BA study accounting for spatial effects and temporal dynamics in evaluating the effectiveness of a road safety treatment. The countermeasure analyzed was the installation of traffic signals at unsignalized urban/suburban intersections in British Columbia (Canada). The full Bayes approach was selected as the statistical framework to develop the models. The results demonstrated that zone variation was a major component of total crash variability and that spatial effects were alleviated by clustering intersections together. Finally, the methodology used also allowed estimation of the treatment's effectiveness in the form of crash modification factors and functions with time trends. Copyright © 2016 Elsevier Ltd. All rights reserved.
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.
Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lee, Chang Jae; Han, Seung; Yun, Jae Hee
2015-07-01
Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less
Privalle, Laura S; Chen, Jingwen; Clapper, Gina; Hunst, Penny; Spiegelhalter, Frank; Zhong, Cathy X
2012-10-17
"Genetically modified" (GM) or "biotech" crops have been the most rapidly adopted agricultural technology in recent years. The development of a GM crop encompasses trait identification, gene isolation, plant cell transformation, plant regeneration, efficacy evaluation, commercial event identification, safety evaluation, and finally commercial authorization. This is a lengthy, complex, and resource-intensive process. Crops produced through biotechnology are the most highly studied food or food component consumed. Before commercialization, these products are shown to be as safe as conventional crops with respect to feed, food, and the environment. This paper describes this global process and the various analytical tests that must accompany the product during the course of development, throughout its market life, and beyond.
Operational and safety characteristics of lane widths : final report.
DOT National Transportation Integrated Search
2015-01-15
The primary goal of this study was to investigate and assess the effect of lane widths on the safety and : operation of highways in South Carolina. Because of the many site conditions that affect safety and : operations on roadways, this type of rese...
DOT National Transportation Integrated Search
1978-01-01
In October 1977, the Highway Safety Division of Virginia sponsored a statewide public opinion poll conducted by the Virginia Highway and Transportation Research Council. From the first through the twenty-second of October, approximately 1,700 randoml...
DOT National Transportation Integrated Search
1979-01-01
In October and November of 1978, the Virginia Department of Transportation Safety sponsored a statewide public opinion poll conducted by the Virginia Highway and Transportation Research Council. From the first of October through the fifteenth of Nove...
76 FR 34890 - Track Safety Standards; Concrete Crossties
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-15
...-0007, Notice No. 3] RIN 2130-AC01 Track Safety Standards; Concrete Crossties AGENCY: Federal Railroad... effective concrete crossties, for rail fastening systems connected to concrete crossties, and for automated inspections of track constructed with concrete crossties. The Track Safety Standards were amended via final...
Space Station crew safety alternatives study. Volume 5: Space Station safety plan
NASA Technical Reports Server (NTRS)
Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.
1985-01-01
The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.
Innovative safety valve selection techniques and data.
Miller, Curt; Bredemyer, Lindsey
2007-04-11
The new valve data resources and modeling tools that are available today are instrumental in verifying that that safety levels are being met in both current installations and project designs. If the new ISA 84 functional safety practices are followed closely, good industry validated data used, and a user's maintenance integrity program strictly enforced, plants should feel confident that their design has been quantitatively reinforced. After 2 years of exhaustive reliability studies, there are now techniques and data available to support this safety system component deficiency. Everyone who has gone through the process of safety integrity level (SIL) verification (i.e. reliability math) will appreciate the progress made in this area. The benefits of these advancements are improved safety with lower lifecycle costs such as lower capital investment and/or longer testing intervals. This discussion will start with a review of the different valve, actuator, and solenoid/positioner combinations that can be used and their associated application restraints. Failure rate reliability studies (i.e. FMEDA) and data associated with the final combinations will then discussed. Finally, the impact of the selections on each safety system's SIL verification will be reviewed.
From the traditional concept of safety management to safety integrated with quality.
García Herrero, Susana; Mariscal Saldaña, Miguel Angel; Manzanedo del Campo, Miguel Angel; Ritzel, Dale O
2002-01-01
This editorial reviews the evolution of the concepts of safety and quality that have been used in the traditional workplace. The traditional programs of safety are explored showing strengths and weaknesses. The concept of quality management is also viewed. Safety management and quality management principles, stages, and measurement are highlighted. The concepts of quality and safety guarantee are assessed. Total Quality Management concepts are reviewed and applied to safety quality. Total safety management principles are discussed. Finally, an analysis of the relationship between quality and safety from data collected from a company in Spain is presented.
29 CFR 1955.44 - Final decision.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 29 Labor 9 2010-07-01 2010-07-01 false Final decision. 1955.44 Section 1955.44 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED..., the Secretary shall issue a final decision ruling upon each exception and objection filed. The final...
Updating fire safety standards. Final rule; affirmation.
2011-11-16
This document affirms as final, without changes, a provision included in a final rule with request for comments that amended the Department of Veterans Affairs (VA) regulations concerning community residential care facilities, contract facilities for certain outpatient and residential services, and State home facilities. That provision established a five-year period within which all covered buildings with nursing home facilities existing as of June 25, 2001, must conform to the automatic sprinkler requirement of the 2009 edition of the National Fire Protection Association (NFPA) 101. This rule helps ensure the safety of veterans in the affected facilities.
Use of child safety seats in metropolitan areas of Virginia during summer 1994 : final report.
DOT National Transportation Integrated Search
1994-01-01
The Transportation Safety Administration of the Department of Motor Vehicles has, for a number of years, requested observational surveys of child safety seat use in the Commonwealth. The present survey was conducted in the summer of 1994 in the four ...
77 FR 9522 - Requirements for Consumer Registration of Durable Infant or Toddler Products
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-17
... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1130 Requirements for Consumer Registration of Durable Infant or Toddler Products AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: In accordance with the Consumer Product Safety Improvement Act of 2008 (``CPSIA''), the Consumer...
Thermal-hydraulic analysis capabilities and methods development at NYPA
DOE Office of Scientific and Technical Information (OSTI.GOV)
Feltus, M.A.
1987-01-01
The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Disney, R.K.
1994-10-01
The methodology for handling bias and uncertainty when calculational methods are used in criticality safety evaluations (CSE`s) is a rapidly evolving technology. The changes in the methodology are driven by a number of factors. One factor responsible for changes in the methodology for handling bias and uncertainty in CSE`s within the overview of the US Department of Energy (DOE) is a shift in the overview function from a ``site`` perception to a more uniform or ``national`` perception. Other causes for change or improvement in the methodology for handling calculational bias and uncertainty are; (1) an increased demand for benchmark criticalsmore » data to expand the area (range) of applicability of existing data, (2) a demand for new data to supplement existing benchmark criticals data, (3) the increased reliance on (or need for) computational benchmarks which supplement (or replace) experimental measurements in critical assemblies, and (4) an increased demand for benchmark data applicable to the expanded range of conditions and configurations encountered in DOE site restoration and remediation.« less
NASA Astrophysics Data System (ADS)
Ekedebe, Nnanna; Yu, Wei; Song, Houbing; Lu, Chao
2015-05-01
An intelligent transportation system (ITS) is one typical cyber-physical system (CPS) that aims to provide efficient, effective, reliable, and safe driving experiences with minimal congestion and effective traffic flow management. In order to achieve these goals, various ITS technologies need to work synergistically. Nonetheless, ITS's reliance on wireless connectivity makes it vulnerable to cyber threats. Thus, it is critical to understand the impact of cyber threats on ITS. In this paper, using real-world transportation dataset, we evaluated the consequences of cyber threats - attacks against service availability by jamming the communication channel of ITS. In this way, we can have a better understanding of the importance of ensuring adequate security respecting safety and life-critical ITS applications before full and expensive real-world deployments. Our experimental data shows that cyber threats against service availability could adversely affect traffic efficiency and safety performances evidenced by exacerbated travel time, fuel consumed, and other evaluated performance metrics as the communication network is compromised. Finally, we discuss a framework to make ITS secure and more resilient against cyber threats.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Brunett, A. J.; Fei, T.; Strons, P. S.
The Transient Reactor Test Facility (TREAT), located at Idaho National Laboratory (INL), is a test facility designed to evaluate the performance of reactor fuels and materials under transient accident conditions. The facility, an air-cooled, graphite-moderated reactor designed to utilize fuel containing high-enriched uranium (HEU), has been in non-operational standby status since 1994. Currently, in support of the missions of the Department of Energy (DOE) National Nuclear Security Administration (NNSA) Material Management and Minimization (M3) Reactor Conversion Program, a new core design is being developed for TREAT that will utilize low-enriched uranium (LEU). The primary objective of this conversion effort ismore » to design an LEU core that is capable of meeting the performance characteristics of the existing HEU core. Minimal, if any, changes are anticipated for the supporting systems (e.g. reactor trip system, filtration/cooling system, etc.); therefore, the LEU core must also be able to function with the existing supporting systems, and must also satisfy acceptable safety limits. In support of the LEU conversion effort, a range of ancillary safety analyses are required to evaluate the LEU core operation relative to that of the existing facility. These analyses cover neutronics, shielding, and thermal hydraulic topics that have been identified as having the potential to have reduced safety margins due to conversion to LEU fuel, or are required to support the required safety analyses documentation. The majority of these ancillary tasks have been identified in [1] and [2]. The purpose of this report is to document the ancillary safety analyses that have been performed at Argonne National Laboratory during the early stages of the LEU design effort, and to describe ongoing and anticipated analyses. For all analyses presented in this report, methodologies are utilized that are consistent with, or improved from, those used in analyses for the HEU Final Safety Analysis Report (FSAR) [3]. Depending on the availability of historical data derived from HEU TREAT operation, results calculated for the LEU core are compared to measurements obtained from HEU TREAT operation. While all analyses in this report are largely considered complete and have been reviewed for technical content, it is important to note that all topics will be revisited once the LEU design approaches its final stages of maturity. For most safety significant issues, it is expected that the analyses presented here will be bounding, but additional calculations will be performed as necessary to support safety analyses and safety documentation. It should also be noted that these analyses were completed as the LEU design evolved, and therefore utilized different LEU reference designs. Preliminary shielding, neutronic, and thermal hydraulic analyses have been completed and have generally demonstrated that the various LEU core designs will satisfy existing safety limits and standards also satisfied by the existing HEU core. These analyses include the assessment of the dose rate in the hodoscope room, near a loaded fuel transfer cask, above the fuel storage area, and near the HEPA filters. The potential change in the concentration of tramp uranium and change in neutron flux reaching instrumentation has also been assessed. Safety-significant thermal hydraulic items addressed in this report include thermally-induced mechanical distortion of the grid plate, and heating in the radial reflector.« less
NASA Technical Reports Server (NTRS)
Kammerer, Catherine C.; Jacoby, Joseph A.; Lomness, Janice K.; Hintze, Paul E.; Russell, Richard W.
2007-01-01
The United States Space Operational Space Shuttle Fleet Consists of three shuttles with an average age of 19.7 years. Shuttles are exposed to corrosive conditions while undergoing final closeout for missions at the launch pad and extreme conditions during ascent, orbit, and descent that may accelerate the corrosion process. Structural corrosion under TPS could progress undetected (without tile removal) and eventually result in reduction in structural capability sufficient to create negative margins of . safety and ultimate loss of local structural capability.
Independent Assessment of Instrumentation for ISS On-Orbit NDE. Volume 2; Appendices
NASA Technical Reports Server (NTRS)
Madaras, Eric I.
2013-01-01
International Space Station (ISS) Structural and Mechanical Systems Manager, requested that the NASA Engineering and Safety Center (NESC) provide a quantitative assessment of commercially available nondestructive evaluation (NDE) instruments for potential application to the ISS. This work supports risk mitigation as outlined in the ISS Integrated Risk Management Application (IRMA) Watch Item #4669, which addresses the requirement for structural integrity after an ISS pressure wall leak in the event of a penetration due to micrometeoroid or debris (MMOD) impact. This document contains the appendices the final report.
Harvey, Harold D; Fleming, Paul; Patterson, Michael
2002-09-01
One of the key challenges in managing the Health Promoting Workplace is the development of an effective policy for the control of environmental tobacco smoke (ETS). This paper explores the ethical consequences raised when the implementation of such a policy was evaluated in a large multi-campus university. In a three-stage evaluation, the first stage involved a qualitative enquiry with the Health and Safety Committee to obtain the management perspective on the working of the policy. A survey of the perception of the ETS policy and smoking behaviours with a representative sample of staff and students constituted the second stage. In the final stage the Health and Safety Committee was engaged with the findings of stages 1 and 2 to develop a response to the evaluation. The ethical implications which arise from this evaluation centre, firstly, on the underlying reasons for undertaking an evaluation. Secondly, consideration is given to the consequences of applying utilitarian principles to smoking policy for the minority who smoke and thus find their work or study patterns affected by a smoking ban. Such a ban limits their autonomy and while it may be helpful (beneficent) in terms of their longer-term physical health, it may have harmful (maleficent) effects on their psychological wellbeing and the potential for negative consequences if they choose to contravene the ban on smoking. The implications of addressing this situation are explored.
78 FR 63381 - Safety Zones; Hawaiian Island Commercial Harbors, HI
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-24
... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2013-0021] RIN 1625-AA00 Safety Zones; Hawaiian Island Commercial Harbors, HI AGENCY: Coast Guard, DHS. ACTION: Final rule... as follows: Sec. 165. 14-1414 Safety Zones; Hawaiian Islands Commercial Harbors; HI. (a) Location...
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...
75 FR 71344 - Uniform Compliance Date for Food Labeling Regulations
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-23
... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317 and 381 [Docket No. FSIS-2010-0031] RIN 0583-AD Uniform Compliance Date for Food Labeling Regulations AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service...
14 CFR 415.204-415.400 - [Reserved
Code of Federal Regulations, 2011 CFR
2011-01-01
... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...
14 CFR 415.204-415.400 - [Reserved
Code of Federal Regulations, 2012 CFR
2012-01-01
... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...
14 CFR 415.204-415.400 - [Reserved
Code of Federal Regulations, 2010 CFR
2010-01-01
... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID... Impact for the Longhorn Pipeline Reversal Project AGENCY: Pipeline and Hazardous Materials Safety... regulations, 40 CFR parts 1500-1508, the Pipeline and Hazardous Materials Safety Administration (PHMSA) is...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-12
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2007-0039... Recognition AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice. SUMMARY: This notice announces the Occupational Safety and Health Administration's final decision expanding the scope...
DOT National Transportation Integrated Search
1994-01-01
Observational surveys of child safety seat use were conducted at the request of the Transportation Safety Administration of the Department of Motor Vehicles. The present survey was conducted in the four areas of the state with the largest populations...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-31
... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2011-0013... Equipment in Federally Inspected Establishments AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of availability. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing the...
DOT National Transportation Integrated Search
1992-01-01
Fearful that inflation and the gradual erosion of federal support for highway safety programs were undermining Virginia's historic position of national leadership in highway safety; management directed a study of potential sources of new revenue for ...
77 FR 51471 - Safety Zone; Swim Around Charleston, Charleston, SC
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-24
...-AA00 Safety Zone; Swim Around Charleston, Charleston, SC AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary moving safety zone during the Swim Around Charleston, a swimming race occurring on waters of the Wando River, the Cooper River, Charleston...
75 FR 35968 - Safety Zone; Fireworks Display in Stevenson, WA
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-24
...-AA00 Safety Zone; Fireworks Display in Stevenson, WA AGENCY: Coast Guard, DHS. ACTION: Temporary final... safety of the maritime public during the fireworks display and will do so by prohibiting all persons and... with fireworks displays on navigable waters. Such hazards include premature detonations, dangerous...
Educational Alternatives for Boating Safety Programs. Final Report.
ERIC Educational Resources Information Center
Sager, E.; And Others
The Coast Guard, in efforts to improve the safety of recreational boating, undertook research to identify educational alternatives in boating safety programs. Background research was done to assess materials from areas of boating education and education in comparable recreational areas. Research was also conducted to review educational and mass…
77 FR 22495 - Safety Zone; Lake Pontchartrain, New Orleans, LA
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-16
...-AA00 Safety Zone; Lake Pontchartrain, New Orleans, LA AGENCY: Coast Guard, DHS. ACTION: Temporary final... from the South shores of Lake Pontchartrain adjacent to the East bank of the Lakefront Airport runways... proposed rulemaking (NPRM) entitled Safety Zone, Lake Pontchartrain, New Orleans, LA in the Federal...
78 FR 59821 - Safety Zone, Delaware River; Wilmington, DE
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-30
... 1625-AA00 Safety Zone, Delaware River; Wilmington, DE AGENCY: Coast Guard, DHS. ACTION: Temporary final... safety zone will encompass all waters of Deepwater Anchorage No. 6, Delaware River, Wilmington, DE from... navigable waters of Deepwater Point Anchorage No. 6, Delaware River, Wilmington, DE, the effect of this...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-25
... will be test-driving Daimler vehicles on U.S. roads in order to meet future vehicle safety and... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2012... Application AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of final...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...
Gore, M E; Szczylik, C; Porta, C; Bracarda, S; Bjarnason, G A; Oudard, S; Lee, S-H; Haanen, J; Castellano, D; Vrdoljak, E; Schöffski, P; Mainwaring, P; Hawkins, R E; Crinò, L; Kim, T M; Carteni, G; Eberhardt, W E E; Zhang, K; Fly, K; Matczak, E; Lechuga, M J; Hariharan, S; Bukowski, R
2015-06-30
We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%). Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.
2000-04-18
This document amends OSHA's regulations to reflect the Assistant Secretary's decision granting final approval to the Nevada State plan. As a result of this affirmative determination under section 18(e) of the Occupational Safety and Health Act of 1970, Federal OSHA's standards and enforcement authority no longer apply to occupational safety and health issues covered by the Nevada plan, and authority for Federal concurrent jurisdiction is relinquished. Federal enforcement jurisdiction is retained over any private sector maritime employment, private sector employers on Indian land, and any contractors or subcontractors on any Federal establishment where the land is exclusive Federal jurisdiction. Federal jurisdiction remains in effect with respect to Federal government employers and employees. Federal OSHA will also retain authority for coverage of the United States Postal Service (USPS), including USPS employees, contract employees, and contractor-operated facilities engaged in USPS mail operations.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hu, T.A.
This is the final sample analysis report for tank 241-BX-104 (BX-104), cores 126 and 127. Two segments from each core yielded a total of 11 samples which were analyzed. The data quality objectives (DQOs) applicable to this sampling event were the Safety Screening DQO (Dukelow et al. 1995) and the Organic Safety DQO (Turner et al. 1995). The samples were received, extruded and analyzed at PNNL 325 Analytical Chemistry Laboratory (ACL). The analyses were performed in accordance with the Sample Analysis Plan (Gretsinger 1996) and indicated that the tank is safe with respect to the criteria in the Safety Screeningmore » and Organic DQO. Detailed analytical results were described in the analytical laboratory 45-day Report (Attachment 1, WHC-SD-WM-DP-171, REV. 0) and final report (Attachment 2, PNL-BX-104 REV.1) prepared by PNNL, 325 Laboratory. Corrections and/or exceptions to the PNNL final report are provided.« less
Catheter Ablation of Focal Atrial Tachycardia Using Remote Magnetic Navigation.
Webster, Mark; Pasupati, Sanjeevan; Lever, Nigel; Stiles, Martin
2018-05-01
This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support. Eligible patients required temporary pacing for TAVR, BAV, or electrophysiology (EP) procedures. Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Safety was defined as freedom from pericardial effusion requiring intervention or evidence of tamponade. Technical feasibility involved successful intracardiac delivery and pace capture. Additional evaluations included pacing threshold (PCT), rapid pacing, dislodgment, or sustained ventricular arrhythmias. Follow-up was to 30 days. Twenty-five patients (60% female; mean age, 64 ± 19 years) underwent 13 TAVRs (7 Sapien 3 valves [Edwards Lifesciences], 4 CoreValves [Medtronic], and 2 Lotus valves [Boston Scientific]), 11 EP procedures, and 1 BAV at two New Zealand centers from January 2016 to June 2016. Safety was met in all patients, with no device-related adverse events. Technical feasibility was achieved in 23 cases (92%); 2 patients had unsuitable anatomy. No patient had lead dislodgment or sustained ventricular arrhythmias, and the final procedural PCT was 0.7 ± 0.5 mA. Rapid pacing was successful in all cases. Five patients had successful postprocedural use up to 5 days. This first-in-human study demonstrates the safety and technical feasibility of the Tempo lead, providing stable periprocedural temporary pacing support.
Note on evaluating safety performance of road infrastructure to motivate safety competition.
Han, Sangjin
2016-01-01
Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.
21 CFR 315.6 - Evaluation of safety.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...
Impact of OSHA final rule--recording hearing loss: an analysis of an industrial audiometric dataset.
Rabinowitz, Peter M; Slade, Martin; Dixon-Ernst, Christine; Sircar, Kanta; Cullen, Mark
2003-12-01
The 2003 Occupational Safety and Health Administration (OSHA) Occupational Injury and Illness Recording and Reporting Final Rule changed the definition of recordable work-related hearing loss. We performed a study of the Alcoa Inc. audiometric database to evaluate the impact of this new rule. The 2003 rule increased the rate of potentially recordable hearing loss events from 0.2% to 1.6% per year. A total of 68.6% of potentially recordable cases had American Academy of Audiology/American Medical Association (AAO/AMA) hearing impairment at the time of recordability. On average, recordable loss occurred after onset of impairment, whereas the non-age-corrected 10-dB standard threshold shift (STS) usually preceded impairment. The OSHA Final Rule will significantly increase recordable cases of occupational hearing loss. The new case definition is usually accompanied by AAO/AMA hearing impairment. Other, more sensitive metrics should therefore be used for early detection and prevention of hearing loss.
Impact of OSHA Final Rule—Recording Hearing Loss: An Analysis of an Industrial Audiometric Dataset
Rabinowitz, Peter M.; Slade, Martin; Dixon-Ernst, Christine; Sircar, Kanta; Cullen, Mark
2013-01-01
The 2003 Occupational Safety and Health Administration (OSHA) Occupational Injury and Illness Recording and Reporting Final Rule changed the definition of recordable work-related hearing loss. We performed a study of the Alcoa Inc. audiometric database to evaluate the impact of this new rule. The 2003 rule increased the rate of potentially recordable hearing loss events from 0.2% to 1.6% per year. A total of 68.6% of potentially recordable cases had American Academy of Audiology/American Medical Association (AAO/AMA) hearing impairment at the time of recordability. On average, recordable loss occurred after onset of impairment, whereas the non-age-corrected 10-dB standard threshold shift (STS) usually preceded impairment. The OSHA Final Rule will significantly increase recordable cases of occupational hearing loss. The new case definition is usually accompanied by AAO/AMA hearing impairment. Other, more sensitive metrics should therefore be used for early detection and prevention of hearing loss. PMID:14665813
DOE Office of Scientific and Technical Information (OSTI.GOV)
Benson, Steven; Palo, Daniel; Srinivasachar, Srivats
2014-12-01
Under contract DE-FE0007603, the University of North Dakota conducted the project Evaluation of Carbon Dioxide Capture from Existing Coal Fired Plants by Hybrid Sorption Using Solid Sorbents. As an important element of this effort, an Environmental Health and Safety (EH&S) Assessment was conducted by Barr Engineering Co. (Barr) in association with the University of North Dakota. The assessment addressed air and particulate emissions as well as solid and liquid waste streams. The magnitude of the emissions and waste streams was estimated for evaluation purposes. EH&S characteristics of materials used in the system are also described. This document contains data basedmore » on the mass balances from both the 40 kJ/mol CO2 and 80 kJ/mol CO2 desorption energy cases evaluated in the Final Technical and Economic Feasibility study also conducted by Barr Engineering.« less
Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E
2017-12-01
This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.
78 FR 39608 - Safety Zone; Summer in the City Water Ski Show; Fox River, Green Bay, WI
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
...-AA00 Safety Zone; Summer in the City Water Ski Show; Fox River, Green Bay, WI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the Fox River in Green Bay, WI. This safety zone is intended to restrict vessels from a portion of the Fox River...
78 FR 9054 - Issuance of Final Guidance Publication
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-07
... NIOSH-144] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard...
Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.
ERIC Educational Resources Information Center
Bresler, B.; And Others
This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…
2015-05-22
The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
Recent Updates on the Systemic and Local Safety of Intranasal Steroids.
Jang, Tae Young; Kim, Young Hyo
2016-01-01
Allergic rhinitis is a global health problem, and its prevalence rate and socioeconomic burden continue to increase. Intranasal steroid (INS) is the first treatment choice in the majority of patients, because of its ability to effectively control allergic symptoms. However, patients and clinicians are concerned about the potential adverse effects of prolonged INS use. We performed to review for evaluating systemic and local safety of INS use, by searching MEDLINE, EMBASE, and Cochrane Library database for identification of relevant articles. In the present study, the systemic bioavailabilities of several commercially available INSs were researched, and then systemic safeties were reviewed with focus on suppression of the hypothalamus-pituitary-adrenal axis and their effects on pediatric growth. In addition, local adverse effects, such as, epistaxis and nasal septal perforation, were investigated. Finally, the authors proposed some techniques in order to avoid these complications. INSs offer a safe, effective means of treating allergic rhinitis in the short- and long-term with no or minimal adverse systemic and local effects. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
Kim, Jung-Ju; Ben Amara, Heithem; Schwarz, Frank; Kim, Hae-Young; Lee, Jung-Won; Wikesjö, Ulf M E; Koo, Ki-Tae
2017-10-01
This study aimed to evaluate the safety of ridge preservation/augmentation procedures when performed at compromised extraction sockets. Patients subject to ridge preservation/augmentation at periodontally compromised sockets at Seoul National University Dental Hospital (SNUDH) were evaluated in a chart review. Tooth extractions due to acute infection were not included in our study as chronically formed lesions are the only lesions that can be detected from radiographic images. If inflammatory symptoms persisted following ridge preservation/augmentation and antimicrobial and anti-inflammatory therapy, the patient was categorized as a re-infection case and implanted biomaterial removed. Of 10,060 patients subject to tooth extractions at SNUDH, 2011 through 2015, 297 cases meeting inclusion criteria were reviewed. The severity and type of lesions were not specific because extracting data was only done by radiographic images and chart records. The review identified eight patients exhibiting inflammatory symptoms that required additional antimicrobial and anti-inflammatory therapy. Within this group, re-infection occurred in two patients requiring biomaterials removal. The final safety rate for the ridge preservation/augmentation was 99.3%. None of the demographic factors, systemic conditions or choice of biomaterial affected the safety of ridge preservation/augmentation. Alveolar ridge preservation/augmentation at periodontally compromised sockets appears safe following thorough removal of infectious source. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Food Safety Crisis Management-A Comparison between Germany and the Netherlands.
van Asselt, E D; van der Fels-Klerx, H J; Breuer, O; Helsloot, I
2017-02-01
In order to prevent food safety incidents from becoming a crisis, a good crisis management structure is essential. The aim of the current study was to compare and evaluate the national food incident response plans of 2 neighboring EU Member States: Germany and the Netherlands. This revealed that the structure of these plans is comparable, starting with initial alerting, assessment of the problem, upscaling, an execution phase and finally an evaluation of the crisis management. However, the German communication structure is more complex than the Dutch one and cross-border communication between both countries is currently limited. In general, the presence of national response plans does not guarantee a good and swift response to a food safety incident as this is often hampered by difficulties in tracing the source of the problem as well as difficulties in communication between organizations involved in crisis management. A timely detection can be improved through the development of fast screening and detecting systems and through combining various data sources using computer software systems. Mutual cooperation and communication can be improved through joint exercises or projects. This will help to streamline communication toward consumers and trade partners. Such communication should be transparent relaying not only the facts but also the uncertainties in a crisis in order to gain consumer trust and safeguard international trade. © 2017 Institute of Food Technologists®.
Rousseau, Jacqueline; Kaegi, Christine; Boudreault, Renée; Nadeau, Sylvie
2008-01-01
Purpose: The GEM scale is an objective assessment tool, specifically developed for older adults, to evaluate walking safety using standardized tasks. The purpose of this study was to estimate the interrater and test–retest agreement of the GEM scale. Method: Participants (n = 41; ≥ 65 years) were recruited from geriatric units and assessed independently and simultaneously by three raters on two occasions using the GEM scale. Kappa coefficients and percentage agreement were calculated for each item of the scale. Results: A majority of walking items (n = 22) showed fair to substantial interrater agreement (κ ≥ 0.25) and substantial to almost perfect test–retest agreement (κ ≥ 0.60). Mean percentage agreement was high for both interrater and test–retest agreement (79% ± 15% and 83% ± 16% respectively). Moreover, detailed analyses demonstrated that the relatively low agreement of some items resulted from changes in the performance of some participants and the low variability of scores. Although some walking items showed less agreement, the final decision regarding the participants’ ability to walk safely resulted in moderate to substantial interrater and test–retest agreement. Conclusion: The GEM scale is a new assessment tool that can now be used with estimated interrater and test–retest properties to allow therapists to objectively evaluate walking safety among the elderly. PMID:20145760
Microbiological performance of a food safety management system in a food service operation.
Lahou, E; Jacxsens, L; Daelman, J; Van Landeghem, F; Uyttendaele, M
2012-04-01
The microbiological performance of a food safety management system in a food service operation was measured using a microbiological assessment scheme as a vertical sampling plan throughout the production process, from raw materials to final product. The assessment scheme can give insight into the microbiological contamination and the variability of a production process and pinpoint bottlenecks in the food safety management system. Three production processes were evaluated: a high-risk sandwich production process (involving raw meat preparation), a medium-risk hot meal production process (starting from undercooked raw materials), and a low-risk hot meal production process (reheating in a bag). Microbial quality parameters, hygiene indicators, and relevant pathogens (Listeria monocytogenes, Salmonella, Bacillus cereus, and Escherichia coli O157) were in accordance with legal criteria and/or microbiological guidelines, suggesting that the food safety management system was effective. High levels of total aerobic bacteria (>3.9 log CFU/50 cm(2)) were noted occasionally on gloves of food handlers and on food contact surfaces, especially in high contamination areas (e.g., during handling of raw material, preparation room). Core control activities such as hand hygiene of personnel and cleaning and disinfection (especially in highly contaminated areas) were considered points of attention. The present sampling plan was used to produce an overall microbiological profile (snapshot) to validate the food safety management system in place.
Indicators of safety compromise in gastrointestinal endoscopy.
Borgaonkar, Mark Ram; Hookey, Lawrence; Hollingworth, Roger; Kuipers, Ernst J; Forster, Alan; Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dube, Catherine; Enns, Robert; Macintosh, Donald; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Valori, Roland
2012-02-01
The importance of quality indicators has become increasingly recognized in gastrointestinal endoscopy. Patient safety requires the identification and monitoring of occurrences associated with harm or the potential for harm. The identification of relevant indicators of safety compromise is, therefore, a critical element that is key to the effective implementation of endoscopy quality improvement programs. To identify key indicators of safety compromise in gastrointestinal endoscopy. The Canadian Association of Gastroenterology Safety and Quality Indicators in Endoscopy Consensus Group was formed to address issues of quality in endoscopy. A subcommittee was formed to identify key safety indicators. A systematic literature review was undertaken, and articles pertinent to safety in endoscopy were identified and reviewed. All complications and measures used to document safety were recorded. From this, a preliminary list of 16 indicators was compiled and presented to the 35-person consensus group during a three-day meeting. A revised list of 20 items was subsequently put to the consensus group for vote for inclusion on the final list of safety indicators. Items were retained only if the consensus group highly agreed on their importance. A total of 19 indicators of safety compromise were retained and grouped into the three following categories: medication-related - the need for CPR, use of reversal agents, hypoxia, hypotension, hypertension, sedation doses in patients older than 70 years of age, allergic reactions and laryngospasm⁄bronchospasm; procedure-related early - perforation, immediate postpolypectomy bleeding, need for hospital admission or transfer to emergency department from the gastroenterology unit, instrument impaction, severe persistent abdominal pain requiring evaluation proven to not be perforation; and procedure-related delayed - death within 30 days of procedure, 14-day unplanned hospitalization, 14-day unplanned contact with a health provider, gastrointestinal bleeding within 14 days of procedure, infection or symptomatic metabolic complications. The 19 indicators of safety compromise in endoscopy, identified by a rigorous, evidence-based consensus process, provide clear outcomes to be recorded by all facilities as part of their continuing quality improvement programs.
Wireless roadside inspection phase II : final report : [technology brief].
DOT National Transportation Integrated Search
2014-04-01
The Federal Motor Carrier Safety Administration (FMCSA) Wireless Roadside Inspection (WRI) Program is demonstrating the feasibility and value of electronically assessing truck and motorcoach driver and vehicle safety. Electronic assessments (or WRIs)...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-17
...] Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA AGENCY: Coast... regulation and temporary safety zone proposed for those portions of the ``America's Cup World Series,'' the ``Louis Vuitton Cup'' challenger selection series, and the ``America's Cup Finals Match'' sailing regattas...
GAO’s Views on DOE’s 1991 Budget for Addressing Problems at the Nuclear Weapons Complex
1990-03-02
management, and efforts by DOE to make its contractors more accountable. Also, the Defense Nuclear Facilities Safety Board mandated by the Congress became...and safety matters. 6 Finally, the Defense Nuclear Facilities Safety Board was established. Although not a DOE action, its establishment, nevertheless
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-16
... of the Sarbanes-Oxley Act of 2002, as Amended; Correction AGENCY: Occupational Safety and Health Administration, Labor. ACTION: Interim final rule; correction. SUMMARY: The Occupational Safety and Health... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1980 [Docket Number...
San Antonio Creek Restoration, Vandenberg Air Force Base, California
2008-06-27
Management (Section 4.5), Human Health and Safety (Section 4.6), Land Use and Aesthetics (Section 4.7), 1 FINAL DRAFT and Transportation...Environmental Assessment for the San Antonio Creek Restoration at Vandenberg Air Force Base, California Environmental, Safety , and Occupational Health...Environmental, Safety , and Occupational Health Council Vandenberg AFB, CA MAJCOM Approval
DOT National Transportation Integrated Search
2011-09-01
The aim of this research was to develop a comprehensive inattention mitigation component of a behavior-based safety program (IM-BBS) in commercial motor vehicle operations that increases road safety. A key focus was on the use of real-time inattentio...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
... the contractor's or subcontractor's gross negligence or with reckless disregard for the safety of... that jeopardize the health and safety of Government personnel, through gross negligence or reckless... injury through gross negligence or with reckless disregard for the safety of such personnel, this final...
76 FR 30018 - Safety Zone; Marysville Days Fireworks, St. Clair River, Marysville, MI
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
...-AA00 Safety Zone; Marysville Days Fireworks, St. Clair River, Marysville, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on St. Clair River, Marysville, MI. This zone is intended to restrict vessels from a portion of St. Clair River...
77 FR 29901 - Safety Zone; Marysville Days Fireworks, St. Clair River, Marysville, MI
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-21
...-AA00 Safety Zone; Marysville Days Fireworks, St. Clair River, Marysville, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the St. Clair River, Marysville, Michigan. This zone is intended to restrict vessels from a portion of the St...
75 FR 6123 - Federal Motor Vehicle Safety Standards; Occupant Crash Protection
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-08
... motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a... [Docket No. NHTSA-2009-0156] RIN 2127-AK57 Federal Motor Vehicle Safety Standards; Occupant Crash...'s response to petitions for reconsideration of a November 12, 2008 final rule that amended the child...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-04
... [Docket No. NHTSA-2012-0174] RIN 2127-Al27 Federal Motor Vehicle Safety Standards; Lamps, Reflective... less than 30 feet in overall length, to the Federal motor vehicle safety standard (FMVSS) on lamps... final rule reorganizing the standard on December 4, 2007. DATES: Comments to this proposal must be...
Concept Paper on Health and Safety Issues in Day Care. Final Manuscript.
ERIC Educational Resources Information Center
Pizzo, Peggy; Aronson, Susan S.
This report discusses the existence and prevention of major health and safety risks for children in day care and makes recommendations for the Federal Interagency Day Care requirements (FIDCR) concerning health and safety. Section I describes varying concepts of risk related to probability and to possibility of adverse events, and discusses…
19 CFR 122.187 - Revocation or suspension of access.
Code of Federal Regulations, 2010 CFR
2010-04-01
... that continued access might pose an unacceptable risk to public health, interest or safety, national security, aviation safety, the revenue, or the security of the area. In this case the port director will... health, safety, or security is involved and, in such a case, a final notice of revocation or suspension...
The Washington State Task Force on Student Transportation Safety. Final Report.
ERIC Educational Resources Information Center
Washington State Legislature, Olympia.
Findings of a study conducted by the Washington State Task Force on Student Transportation Safety are presented in this report. The data-collection process involved four phases: meetings with experts in student transportation and pedestrian safety; public meetings, informational work sessions, and tours of problems areas; task force meetings; and…
Training Course for Compliance Safety and Health Officers. Final Report.
ERIC Educational Resources Information Center
McKnight, A. James; And Others
The report describes revision of the Compliance Safety and Health Officers (CSHO) course for the Department of Labor, Occupational Safety and Health Administration (OSHA). The CSHO's job was analyzed in depth, in accord with OSHA standards, policies, and procedures. A listing of over 1,700 violations of OSHA standards was prepared, and specialists…
Skills Conversion Project: Chapter 17, Occupational Safety and Health. Final Report.
ERIC Educational Resources Information Center
National Society of Professional Engineers, Washington, DC.
The greatest employment opportunity for safety professionals at the present time is with the Department of Labor for enforcement of the Williams-Steiger Act, which establishes the Occupational Safety and Health Administration (OSHA). As part of a federal study of job possibilities for displaced aerospace and defense technical professionals, it was…
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…
75 FR 18056 - Safety Zone; Fireworks Display, Patuxent River, Solomons Island Harbor, MD
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-09
..., DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone... necessary to provide for the safety of life on navigable waters during a fireworks display launched from... protect the maritime public in a portion of Solomons Island Harbor. DATES: This rule is effective from 7...
77 FR 62440 - Safety Zone; Wounded Warriors Benefit, Lake Erie, Huron, OH
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-15
...-AA00 Safety Zone; Wounded Warriors Benefit, Lake Erie, Huron, OH AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the waters of Lake Erie, East Huron, Ohio. This regulation is intended to restrict vessels from portions of Lake Erie...
75 FR 51099 - Final Supplementary Rules for Public Land in Oregon and Washington
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-18
... must not operate a motorcycle or ATV/OHV without a safety flag on Peterson Road, Juniper Road, Smith Canyon Road, and/or Wilderness Road. Safety flags are not required for street-legal, four- wheeled... the public's health and safety. They provide needed guidance in the areas of special forest products...
76 FR 29645 - Safety Zone, Newport River; Morehead City, NC
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-23
...-AA00 Safety Zone, Newport River; Morehead City, NC AGENCY: Coast Guard, DHS. ACTION: Temporary final... the main span US 70/Morehead City--Newport River high rise bridge in Carteret County, NC. This safety... Zone, Newport River; Morehead City, North Carolina in the Federal Register (33 FR 165). We received no...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... days aggregating at least 250 work days, occurring either solely under this employment or in...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... aggregating at least 250 work days, occurring either solely under this employment, or in combination with work...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... number of work days aggregating at least 250 work days, occurring either solely under this employment or...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-19
...-AA00 Safety Zone: Gilmerton Bridge Center Span Float-in, Elizabeth River; Norfolk, Portsmouth, and... final rule establishing a safety zone around the Gilmerton Bridge center span barge. Inadvertently, this... Gilmerton Bridge center span barge (77 FR 73541). Inadvertently, this rule included an error in the...
77 FR 42644 - Safety Zone; Canal Fest of the Tonawandas, Erie Canal, Tonawanda, NY
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-20
.... ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the... Canal during the Canal Fest of the Tonawandas Fireworks display. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with a fireworks display. DATES: This...
Manios, Stavros G; Grivokostopoulos, Nikolaos C; Bikouli, Vasiliki C; Doultsos, Dimitrios A; Zilelidou, Evangelia A; Gialitaki, Maria A; Skandamis, Panagiotis N
2015-09-16
A systematic approach in monitoring the hygiene of a meat processing plant using classical microbiological analyses combined with molecular characterization tools may assist in the safety of the final products. This study aimed: (i) to evaluate the total hygiene level and, (ii) to monitor and characterize the occurrence and spread of Salmonella spp. and Listeria monocytogenes in the environment and the final products of a meat industry that processes meat of global origin. In total, 2541 samples from the processing environment, the raw materials, and the final products were collected from a Greek meat industry in the period 2011-2013. All samples were subjected to enumeration of total viable counts (TVC), Escherichia coli (EC) and total coliforms (TCC) and the detection of Salmonella spp., while 709 of these samples were also analyzed for the presence L. monocytogenes. Pathogen isolates were serotyped and further characterized for their antibiotic resistance and subtyped by PFGE. Raw materials were identified as the primary source of contamination, while improper handling might have also favored the proliferation of the initial microbial load. The occurrence of Salmonella spp. and L. monocytogenes reached 5.5% and 26.9%, respectively. Various (apparent) cross-contamination or persistence trends were deduced based on PFGE analysis results. Salmonella isolates showed wide variation in their innate antibiotic resistance, contrary to L. monocytogenes ones, which were found susceptible to all antibiotics except for cefotaxime. The results emphasize the biodiversity of foodborne pathogens in a meat industry and may be used by meat processors to understand the spread of pathogens in the processing environment, as well as to assist the Food Business Operator (FBO) in establishing effective criteria for selection of raw materials and in improving meat safety and quality. This approach can limit the increase of microbial contamination during the processing steps observed in our study as well as the cross contamination of meat products. Copyright © 2014 Elsevier B.V. All rights reserved.
76 FR 22106 - Issuance of Final Guidance Publication
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-20
... NIOSH-033] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Health and Human Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The... (CDC) announces the availability of the following publication: NIOSH Current Intelligence Bulletin 63...
Rethinking impact evaluation and carbon reduction analysis on electric bus vehicles in China
NASA Astrophysics Data System (ADS)
Li, Zhenyu; Li, Chao; Liao, Kai; Yin, Zhifang
2018-02-01
New energy bus vehicles (NEBVs) are expanding in China, but they have some problems such as technology, high cost and safety etc., thus NEBVs should be comprehensively evaluated from costs, technologies, environment, and based on the evaluation results, some changes should be improved. This paper firstly analyses the current status of both vehicle development and existing policies, identifies the main characteristics and the main problems in term of the economic, standard, policy, etc., by scenario analysis, forecasts the future growth from now to 2030 and calculates the emission reduction in low level scenario and high level scenario. In 2020 and 2030, 6 million and 24 million ton of CO2 emission will be reduced respectively. Finally, the paper makes a conclusion of Chinese experiences and gives some measures for the future development.
Implementation of the Single European Code in a Multi-Tissue Bank.
Schroeter, Jan; Schulz, Tino; Schroeter, Bernard; Fleischhauer, Katrin; Pruß, Axel
2017-11-01
The traceability of tissue and cells transplants is important to ensure a high level of safety for the recipients. With the final introduction of the Single European Code (SEC) in April 2017 in the EU a consistent system among all member states became mandatory. The regulations for the SEC on EU and national level were evaluated. An overview on the different parts of the SEC with detailed explanations is given. Our own experiences with the implementation of the SEC in our multi-tissue bank are reported in addition. The implementation of the SEC in our multi-tissue bank could be successfully realized. However, it revealed a number of difficulties, especially the sterile labeling of certain tissue transplants and the complex update of the existing database. The introduction of the SEC has made a contribution to the safety of recipients of tissue and cells transplants through a system of comprehensive and transparent traceability.
Development of Safe and Effective Botanical Dietary Supplements
2015-01-01
Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082
Processing and filtrating of driver fatigue characteristic parameters based on rough set
NASA Astrophysics Data System (ADS)
Ye, Wenwu; Zhao, Xuyang
2018-05-01
With the rapid development of economy, people become increasingly rich, and cars have become a common means of transportation in daily life. However, the problem of traffic safety is becoming more and more serious. And fatigue driving is one of the main causes of traffic accidents. Therefore, it is of great importance for us to study the detection of fatigue driving to improve traffic safety. In the cause of determining whether the driver is tired, the characteristic quantity related to the steering angle of the steering wheel and the characteristic quantity of the driver's pulse are all important indicators. The fuzzy c-means clustering is used to discretize the above indexes. Because the characteristic parameters are too miscellaneous, rough set is used to filtrate these characteristics. Finally, this paper finds out the highest correlation with fatigue driving. It is proved that these selected characteristics are of great significance to the evaluation of fatigue driving.
Human Factors Checklist: Think Human Factors - Focus on the People
NASA Technical Reports Server (NTRS)
Miller, Darcy; Stelges, Katrine; Barth, Timothy; Stambolian, Damon; Henderson, Gena; Dischinger, Charles; Kanki, Barbara; Kramer, Ian
2016-01-01
A quick-look Human Factors (HF) Checklist condenses industry and NASA Agency standards consisting of thousands of requirements into 14 main categories. With support from contractor HF and Safety Practitioners, NASA developed a means to share key HF messages with Design, Engineering, Safety, Project Management, and others. It is often difficult to complete timely assessments due to the large volume of HF information. The HF Checklist evolved over time into a simple way to consider the most important concepts. A wide audience can apply the checklist early in design or through planning phases, even before hardware or processes are finalized or implemented. The checklist is a good place to start to supplement formal HF evaluation. The HF Checklist was based on many Space Shuttle processing experiences and lessons learned. It is now being applied to ground processing of new space vehicles and adjusted for new facilities and systems.
Nelson, B B; Goodrich, L R; Barrett, M F; Grinstaff, M W; Kawcak, C E
2017-07-01
The use of contrast media in computed tomography (CT) and magnetic resonance imaging (MRI) is increasing in horses. These contrast-enhanced imaging techniques provide improved tissue delineation and evaluation, thereby expanding diagnostic capabilities. While generally considered safe, not all contrast media exhibit the same safety profiles. The safety of contrast media use and descriptions of adverse events occurring in horses are sparsely reported. This review summarises the reported evidence of contrast media use and adverse events that occur in horses, with added contribution from other veterinary species and studies in man for comparison. This comprehensive data set empowers equine clinicians to develop use and monitoring strategies when working with contrast media. Finally, it summarises the current state-of-the-art and highlights the potential applications of contrast-enhanced CT and MRI for assessment of diseased or injured equine tissues, as well as (patho)physiological processes. © 2017 EVJ Ltd.
NASA Astrophysics Data System (ADS)
Epackachi, S.; Esmaili, O.; Mirghaderi, S. R.; Taheri, A. A.
2008-07-01
Tehran tower is a 56 story reinforced concrete tall building consisting of three wings with identical plan dimensions each approximately 48 meters by 22 meters. The three wings are at 120 degree from each other and have no expansions/seismic Joints. This paper contains the consideration of the retrofitting of the Tehran tower based on the findings of an exhaustive investigation of the nonlinear performance evaluation efforts. It has tried to show the procedure followed, methodologies utilized, and the results obtained for life-safety and collapse-prevention evaluation of the building. More over the weak zones of the structure due to analysis results are introduced and appropriate retrofit technique for satisfaction related life-safety and collapse-prevention criteria is presented. Actually in this project to improve the local behavior of coupling panels which are located regularly in main walls and definitely have been recognized as the most vulnerable structural elements, making use of steel plates which are connected to concrete members by chemical anchors has been used as the best retrofitting method for this case. Therefore in the final section of this paper it has been tried to explain the professional practical method utilized to perform the mentioned retrofitting project.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Gelinas, C.G.
1978-08-01
This report reviews potential air pollutant emission reductions which could be achieved by various strategies to control airfield operations at Los Angeles and San Francisco International Airports, and examines safety problems, cost impacts, potential fuel savings, time frame for strategy implementation, and potential regulatory and jurisdictional conflicts associated with each strategy. Airfield emission sources studied included aircraft operation in the idle, taxi, takeoff, and landing modes; ground service vehicles; fuel handling and storage; and aircraft engine maintenance. Nineteen potential strategies were identified, and seven strategies were selected for detailed analysis and examination after a preliminary evaluation. Two strategies, aircraft towingmore » and reducing the number of operating engines on the ground, appear to provide the most significant emission reduction. Both of these strategies offer potential reductions in the range of 20 to 40 percent of the carbon monoxide and nitrogen oxides which are currently emitted by ground operations. The aircraft towing strategy also offers a comparable improvement in suspended particulate matter emissions. When the overall feasibility of each strategy is evaluated, the strategy to reduce the number of operating engines appears to be the most viable since its implementation would result in fuel savings, no apparent safety problems, and it can be implemented immediately.« less
A hospital-based child protection programme evaluation instrument: a modified Delphi study.
Wilson, Denise; Koziol-McLain, Jane; Garrett, Nick; Sharma, Pritika
2010-08-01
Refine instrument for auditing hospital-based child abuse and neglect violence intervention programmes prior to field-testing. A modified Delphi study to identify and rate items and domains indicative of an effective and quality child abuse and neglect intervention programme. Experts participated in four Delphi rounds: two surveys, a one-day workshop and the opportunity to comment on the penultimate instrument. New Zealand. Twenty-four experts in the field of care and protection of children. Items with panel agreement >or=85% and mean importance rating >or=4.0 (scale from 1 (not important) to 5 (very important)). There was high-level consensus on items across Rounds 1 and 2 (89% and 85%, respectively). In Round 3 an additional domain (safety and security) was agreed upon and cultural issues, alert systems for children at risk, and collaboration among primary care, community, non-government and government agencies were discussed. The final instrument included nine domains ('policies and procedures', 'safety and security', 'collaboration', 'cultural environment', 'training of providers', 'intervention services', 'documentation' 'evaluation' and 'physical environment') and 64 items. The refined instrument represents the hallmarks of an ideal child abuse and neglect programme given current knowledge and experience. The instrument enables rigorous evaluations of hospital-based child abuse and neglect intervention programmes for quality improvement and benchmarking with other programmes.
2001-01-19
The Occupational Safety and Health Administration (OSHA) is revising its rule addressing the recording and reporting of occupational injuries and illnesses (29 CFR parts 1904 and 1952), including the forms employers use to record those injuries and illnesses. The revisions to the final rule will produce more useful injury and illness records, collect better information about the incidence of occupational injuries and illnesses on a national basis, promote improved employee awareness and involvement in the recording and reporting of job-related injuries and illnesses, simplify the injury and illness recordkeeping system for employers, and permit increased use of computers and telecommunications technology for OSHA recordkeeping purposes. This rulemaking completes a larger overall effort to revise Part 1904 of Title 29 of the Code of Federal Regulations. Two sections of Part 1904 have already been revised in earlier rulemakings. A rule titled Reporting fatalities and multiple hospitalization incidents to OSHA, became effective May 2, 1994 and has been incorporated into this final rule as Section 1904.39. A second rule entitled Annual OSHA injury and illness survey of ten or more employers became effective on March 13, 1997 and has been incorporated into this final rule as Section 1904.41. The final rule being published today also revises 29 CFR 1952.4, Injury and Illness Recording and Reporting Requirements, which prescribes the recordkeeping and reporting requirements for States that have an occupational safety and health program approved by OSHA under Section 18 of the Occupational Safety and Health Act (the "Act" or "OSH Act").
NASA Technical Reports Server (NTRS)
Bithell, R. A.; Pence, W. A., Jr.
1972-01-01
The effect of two sets of performance requirements, commercial and military, on the design and operation of the space shuttle booster is evaluated. Critical thrust levels are established according to both sets of operating rules for the takeoff, cruise, and go-around flight modes, and the effect on engine requirements determined. Both flyback and ferry operations are considered. The impact of landing rules on potential shuttle flyback and ferry bases is evaluated. Factors affecting reserves are discussed, including winds, temperature, and nonstandard flight operations. Finally, a recommended set of operating rules is proposed for both flyback and ferry operations that allows adequate performance capability and safety margins without compromising design requirements for either flight phase.
CERT tribal internship program. Final intern report: Lewis Yellowrobe, 1995
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1998-09-01
The purpose of this internship was to present state legislators with the history and an overview of the Department of Energy`s policies towards occupational health and safety during cleanup of nuclear weapons production facilities. The approach used library research and phone and personal interviews to acquire information on DOE policies. This intern report contains the final report to legislators entitled ``Environmental restoration and waste management: Worker health and safety concerns during nuclear facility cleanup.`` It presents the current status of DOE occupational health and safety at production facilities, Congressional intent, past DOE occupational policies, and options for state legislators tomore » use to get involved with DOE policy direction.« less
Review of APR+ Level 2 PSA. Revision 2
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lehner, John R.; Mubayi, Vinod; Pratt, W. Trevor
2012-02-17
Brookhaven National Laboratory (BNL) assisted the Korea Institute of Nuclear Safety (KINS) in reviewing the Level 2 Probabilistic Safety Assessment (PSA) of the APR+ Advanced Pressurized Water Reactor (PWR) prepared by the Korea Hydro & Nuclear Power Co., Ltd (KHNP) and KEPCO Engineering & Construction Co., Inc. (KEPCO-E&C). The work described in this report involves a review of the APR+ Level 2 PSA submittal [Ref. 1]. The PSA and, therefore, the review is limited to consideration of accidents initiated by internal events. As part of the review process, the review team also developed three sets of Requests for Additional Informationmore » (RAIs). These RAIs were provided to KHNP and KEPCO-E&C for their evaluation and response. This final detailed report documents the review findings for each technical element of the PSA and includes consideration of all of the RAIs made by the reviewers as well as the associated responses. This final report was preceded by an interim report [Ref. 2] that focused on identifying important issues regarding the PSA. In addition, a final meeting on the project was held at BNL on November 21-22, 2011, where BNL and KINS reviewers discussed their preliminary review findings with KHNP and KEPCO-E&C staffs. Additional information obtained during this final meeting was also used to inform the review findings of this final report. The review focused not only on the robustness of the APR+ design to withstand severe accidents, but also on the capability and acceptability of the Level 2 PSA in terms of level of detail and completeness. The Korean nuclear regulatory authorities will decide whether the PSA is acceptable and the BNL review team is providing its comments for KINS consideration. Section 2.0 provides the basis for the BNL review. Section 3.0 presents the review of each technical element of the PSA. Conclusions and a summary are presented in Section 4.0. Section 5.0 contains the references.« less
Final safety analysis report for the Galileo Mission: Volume 2: Book 1, Accident model document
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Accident Model Document (AMD) is the second volume of the three volume Final Safety Analysis Report (FSAR) for the Galileo outer planetary space science mission. This mission employs Radioisotope Thermoelectric Generators (RTGs) as the prime electrical power sources for the spacecraft. Galileo will be launched into Earth orbit using the Space Shuttle and will use the Inertial Upper Stage (IUS) booster to place the spacecraft into an Earth escape trajectory. The RTG's employ silicon-germanium thermoelectric couples to produce electricity from the heat energy that results from the decay of the radioisotope fuel, Plutonium-238, used in the RTG heat source.more » The heat source configuration used in the RTG's is termed General Purpose Heat Source (GPHS), and the RTG's are designated GPHS-RTGs. The use of radioactive material in these missions necessitates evaluations of the radiological risks that may be encountered by launch complex personnel as well as by the Earth's general population resulting from postulated malfunctions or failures occurring in the mission operations. The FSAR presents the results of a rigorous safety assessment, including substantial analyses and testing, of the launch and deployment of the RTGs for the Galileo mission. This AMD is a summary of the potential accident and failure sequences which might result in fuel release, the analysis and testing methods employed, and the predicted source terms. Each source term consists of a quantity of fuel released, the location of release and the physical characteristics of the fuel released. Each source term has an associated probability of occurrence. 27 figs., 11 tabs.« less
Shamaii, Azin; Omidvari, Manouchehr; Lotfi, Farhad Hosseinzadeh
2017-01-01
Performance assessment is a critical objective of management systems. As a result of the non-deterministic and qualitative nature of performance indicators, assessments are likely to be influenced by evaluators' personal judgments. Furthermore, in developing countries, performance assessments by the Health, Safety and Environment (HSE) department are based solely on the number of accidents. A questionnaire is used to conduct the study in one of the largest steel production companies in Iran. With respect to health, safety, and environment, the results revealed that control of disease, fire hazards, and air pollution are of paramount importance, with coefficients of 0.057, 0.062, and 0.054, respectively. Furthermore, health and environment indicators were found to be the most common causes of poor performance. Finally, it was shown that HSE management systems can affect the majority of performance safety indicators in the short run, whereas health and environment indicators require longer periods of time. The objective of this study is to present an HSE-MS unit performance assessment model in steel industries. Moreover, we seek to answer the following question: what are the factors that affect HSE unit system in the steel industry? Also, for each factor, the extent of impact on the performance of the HSE management system in the organization is determined.
The volume-viscosity swallow test for clinical screening of dysphagia and aspiration.
Rofes, Laia; Arreola, Viridiana; Clavé, Pere
2012-01-01
Oropharyngeal dysphagia (OD) is a major complaint among many patients with neurological diseases and in the elderly, but is often underdiagnosed. The volume-viscosity swallow test (V-VST) is a bedside method to screen patients for dysphagia. The V-VST was designed to identify clinical signs of impaired efficacy (labial seal, oral and pharyngeal residue, and piecemeal deglutition) and impaired safety of swallow (voice changes, cough and decrease in oxygen saturation ≥3%). It starts with nectar viscosity and increasing bolus volume, then liquid and finally pudding viscosity in a progression of increasing difficulty to protect patients from aspiration. The V-VST allows quick, safe and accurate screening for OD in hospitalized and independently living patients with multiple etiologies. The V-VST presents a sensitivity of 88.2% and a specificity of 64.7% to detect clinical signs of impaired safety of swallow (aspiration or penetration). The test takes 5-10 min to complete. The V-VST is an excellent tool to screen patients for OD. It combines good psychometric properties, a detailed and easy protocol designed to protect safety of patients, and valid end points to evaluate safety and efficacy of swallowing and detect silent aspirations. Copyright © 2012 S. Karger AG, Basel.
Ciuti, Gastone; Ricotti, Leonardo; Menciassi, Arianna; Dario, Paolo
2015-01-01
Over the past few decades the increased level of public awareness concerning healthcare, physical activities, safety and environmental sensing has created an emerging need for smart sensor technologies and monitoring devices able to sense, classify, and provide feedbacks to users’ health status and physical activities, as well as to evaluate environmental and safety conditions in a pervasive, accurate and reliable fashion. Monitoring and precisely quantifying users’ physical activity with inertial measurement unit-based devices, for instance, has also proven to be important in health management of patients affected by chronic diseases, e.g., Parkinson’s disease, many of which are becoming highly prevalent in Italy and in the Western world. This review paper will focus on MEMS sensor technologies developed in Italy in the last three years describing research achievements for healthcare and physical activity, safety and environmental sensing, in addition to smart systems integration. Innovative and smart integrated solutions for sensing devices, pursued and implemented in Italian research centres, will be highlighted, together with specific applications of such technologies. Finally, the paper will depict the future perspective of sensor technologies and corresponding exploitation opportunities, again with a specific focus on Italy. PMID:25808763
Safety by design of printed multilayer materials intended for food packaging.
Domeño, Celia; Aznar, Margarita; Nerín, Cristina; Isella, Francesca; Fedeli, Mauro; Bosetti, Osvaldo
2017-07-01
Printing inks are commonly used in multilayer plastics materials used for food packaging, and compounds present in inks can migrate to the food either by diffusion through the multilayers or because of set-off phenomena. To avoid this problem, the right design of the packaging is crucial. This paper studies the safety by design of multilayer materials. First, the migration from four different multilayers manufactured using polyethylene terephthalate (PET), aluminium (Al) and polyethylene (PE) was determined. The structural differences among materials such as the presence of inks or lacquer coatings as well as the differences in layers position allowed the study of a safety-by-design approach. Sixty-nine different compounds were detected and identified; 49 of them were not included in the positive list of Regulation EU/10/2011 or in Swiss legislation and 15 belong to Cramer class III, which means that they have a theoretical high toxicity. Some of the compounds related to ink composition were pyrene, a compound commercially used to make dyes and dye precursors and the antioxidant Irganox 1300. The application of external lacquers decreased the concentration of some migrants but also brought the potential for new migrants coming from its composition. A final risk assessment of the material allowed evaluating food safety for different food simulants and confirm it.
Security in Intelligent Transport Systems for Smart Cities: From Theory to Practice.
Javed, Muhammad Awais; Ben Hamida, Elyes; Znaidi, Wassim
2016-06-15
Connecting vehicles securely and reliably is pivotal to the implementation of next generation ITS applications of smart cities. With continuously growing security threats, vehicles could be exposed to a number of service attacks that could put their safety at stake. To address this concern, both US and European ITS standards have selected Elliptic Curve Cryptography (ECC) algorithms to secure vehicular communications. However, there is still a lack of benchmarking studies on existing security standards in real-world settings. In this paper, we first analyze the security architecture of the ETSI ITS standard. We then implement the ECC based digital signature and encryption procedures using an experimental test-bed and conduct an extensive benchmark study to assess their performance which depends on factors such as payload size, processor speed and security levels. Using network simulation models, we further evaluate the impact of standard compliant security procedures in dense and realistic smart cities scenarios. Obtained results suggest that existing security solutions directly impact the achieved quality of service (QoS) and safety awareness of vehicular applications, in terms of increased packet inter-arrival delays, packet and cryptographic losses, and reduced safety awareness in safety applications. Finally, we summarize the insights gained from the simulation results and discuss open research challenges for efficient working of security in ITS applications of smart cities.
Comparative physicochemical evaluation of a marketed herbomineral formulation: naga bhasma.
Garg, M; Das, S; Singh, G
2012-11-01
In the practice of Ayurveda, where herbomineral formulations are said to be made biocompatible through specific processes like Shodhana and Marana, the western medical science on the contrary has raised the safety concerns of these formulations in the recent past. In the present study, comparative physico-chemical analysis of Naga bhasma, a herbo-mineral preparation having a reputation of miraculous drug commonly used to treat several health disorders, was carried out using five marketed formulations through analytical methods like differential scanning calorimetry, X-ray difraction, thermogravimetric analysis, Fourier Transform infrared spectroscopy and also subjected for particle size analysis and estimation of trace and heavy metals to access the safety of these formulation. The results revealed variable observations regarding particle size, metal form and content of lead. The presence of free lead in five different formulations indicated towards the possible risk of severe side effects to the consumer. Present findings certainly put doubt over the safety of this formulation but at the same time, variation in the results with all five formulations also indicated that these formulations were not prepared as per the mentioned Ayurvedic text. Hence, enforcement of strict regulatory guidelines is strongly warranted before launching into the market. Further, a series of biological studies need to be conducted before taking any final verdict on the safety of this formulation.
ERIC Educational Resources Information Center
Lowry, Carlee S.
Designed to assist Bureau of Indian Affairs school officials in the identification of safety education program needs, this evaluation guide focuses upon the basic operational components in a safety education program. The means for establishing an evaluation design for safety education are presented via a flexible model appropriate for most…
2008-08-13
This final rule requires all long term care facilities to be equipped with sprinkler systems by August 13, 2013. Additionally, this final rule requires affected facilities to maintain their automatic sprinkler systems once they are installed.
49 CFR 389.39 - Direct final rulemaking procedures
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Direct final rulemaking procedures 389.39 Section 389.39 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER... PROCEDURES-FEDERAL MOTOR CARRIER SAFETY REGULATIONS Procedures for Adoption of Rules § 389.39 Direct final...
49 CFR 389.39 - Direct final rulemaking procedures
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Direct final rulemaking procedures 389.39 Section 389.39 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER... PROCEDURES-FEDERAL MOTOR CARRIER SAFETY REGULATIONS Procedures for Adoption of Rules § 389.39 Direct final...
Wireless roadside inspection phase II : final report.
DOT National Transportation Integrated Search
2014-03-01
The Federal Motor Carrier Safety Administration (FMCSA) Wireless Roadside Inspection (WRI) Program is demonstrating the feasibility and value of electronically assessing truck and motorcoach driver and vehicle safety at least 25 times more often than...
75 FR 15621 - Federal Motor Vehicle Safety Standards; Theft Protection and Rollaway Prevention
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-30
... Transportation (DOT). ACTION: Final rule. SUMMARY: Pursuant to a statutory mandate in the Cameron Gulbransen Kids.... Statutory Mandate and Background On February 28, 2008, the ``Cameron Gulbransen Kids Transportation Safety...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Chambers, Mark S.; Posner, Marshall; Jones, Christopher Uwe
Purpose: To study the efficacy and safety of cevimeline in two double-blind trials (Studies 003 and 004) enrolling patients with head and neck cancer in whom xerostomia developed after radiotherapy. Methods and Materials: Subjects were randomly assigned to receive cevimeline, 30 mg three times daily, or placebo for 12 weeks, with the possibility of dose escalation to 45 mg three times daily at 6 weeks. The primary efficacy endpoint was the patient's final global evaluation of oral dryness; change in unstimulated salivary flow was a secondary endpoint. Results: Five hundred seventy subjects (284 in Study 003 and 286 in Studymore » 004) were randomized. Significantly more cevimeline-treated subjects than placebo recipients (47.4% vs. 33.3%, p = 0.0162) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness. No significant difference between groups in the final global evaluation was seen in Study 004, in which a high placebo response rate of 47.6% was observed. In both studies, cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placebo recipients (p 0.0093 [Study 003] and p = 0.0215 [Study 004]), whereas no significant differences in stimulated salivary flow were observed. The most frequent adverse event was increased sweating. Conclusion: Cevimeline was well tolerated by patients with xerostomia after radiotherapy for head and neck cancer, and oral administration of 30-45 mg of cevimeline three times daily increased unstimulated salivary flow.« less
Cevimeline for the treatment of postirradiation xerostomia in patients with head and neck cancer.
Chambers, Mark S; Posner, Marshall; Jones, Christopher Uwe; Biel, Merrill A; Hodge, Kenneth M; Vitti, Robert; Armstrong, Ingrid; Yen, Cindy; Weber, Randal S
2007-07-15
To study the efficacy and safety of cevimeline in two double-blind trials (Studies 003 and 004) enrolling patients with head and neck cancer in whom xerostomia developed after radiotherapy. Subjects were randomly assigned to receive cevimeline, 30 mg three times daily, or placebo for 12 weeks, with the possibility of dose escalation to 45 mg three times daily at 6 weeks. The primary efficacy endpoint was the patient's final global evaluation of oral dryness; change in unstimulated salivary flow was a secondary endpoint. Five hundred seventy subjects (284 in Study 003 and 286 in Study 004) were randomized. Significantly more cevimeline-treated subjects than placebo recipients (47.4% vs. 33.3%, p = 0.0162) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness. No significant difference between groups in the final global evaluation was seen in Study 004, in which a high placebo response rate of 47.6% was observed. In both studies, cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placebo recipients (p = 0.0093 [Study 003] and p = 0.0215 [Study 004]), whereas no significant differences in stimulated salivary flow were observed. The most frequent adverse event was increased sweating. Cevimeline was well tolerated by patients with xerostomia after radiotherapy for head and neck cancer, and oral administration of 30-45 mg of cevimeline three times daily increased unstimulated salivary flow.
A cooperative positioning algorithm for DSRC enabled vehicular networks
NASA Astrophysics Data System (ADS)
Efatmaneshnik, M.; Kealy, A.; Alam, N.; Dempster, A. G.
2011-12-01
Many of the safety related applications that can be facilitated by Dedicated Short Range Communications (DSRC), such as vehicle proximity warnings, automated braking (e.g. at level crossings), speed advisories, pedestrian alerts etc., rely on a robust vehicle positioning capability such as that provided by a Global Navigation Satellite System (GNSS). Vehicles in remote areas, entering tunnels, high rise areas or any high multipath/ weak signal environment will challenge the integrity of GNSS position solutions, and ultimately the safety application it underpins. To address this challenge, this paper presents an innovative application of Cooperative Positioning techniques within vehicular networks. CP refers to any method of integrating measurements from different positioning systems and sensors in order to improve the overall quality (accuracy and reliability) of the final position solution. This paper investigates the potential of the DSRC infrastructure itself to provide an inter-vehicular ranging signal that can be used as a measurement within the CP algorithm. In this paper, time-based techniques of ranging are introduced and bandwidth requirements are investigated and presented. The robustness of the CP algorithm to inter-vehicle connection failure as well as GNSS dropouts is also demonstrated using simulation studies. Finally, the performance of the Constrained Kalman Filter used to integrate GNSS measurements with DSRC derived range estimates within a typical VANET is described and evaluated.
Predictive procedure for compensatory hyperhidrosis before sympathectomy: preliminary findings.
Jeong, Jin Yong; Park, Hyung Joo; Park, Jae Kil; Jo, Keon Hyeon; Wang, Young Pil; Lee, Jongho; Shin, Jae Seong
2014-08-01
Compensatory hyperhidrosis is one of the most common and serious adverse effects following sympathectomy. We performed a local anesthetic procedure that predicts the occurrence and severity of compensatory hyperhidrosis, and evaluated the feasibility, safety, and efficacy of the procedure. From July 2009 to July 2010, 20 patients with severe primary palmar hyperhidrosis underwent predictive procedures. A sympathetic nerve block was obtained via thoracoscopic approach under local anesthesia. The patients were evaluated for compensatory hyperhidrosis 1 week after the procedure before deciding whether to proceed with sympathectomy. Of the 20 patients, 17 patients proceeded with sympathectomy and 3 refused the final procedure. Following sympathectomy, the occurrence and severity of compensatory hyperhidrosis in the remaining 17 patients were statistically analyzed with two tailed paired t test, and there is no significant difference between the predictive and final procedures (t = 1.69, df = 16, p > 0.1). Predictive procedure using local anesthesia to detect compensatory hyperhidrosis before sympathectomy may be useful for helping patients to decide whether to undergo the operation. Georg Thieme Verlag KG Stuttgart · New York.
30 CFR 75.386 - Final mining of pillars.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Final mining of pillars. 75.386 Section 75.386... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.386 Final mining of pillars. When only one mine opening is available due to final mining of pillars, no more than 20 miners at a time shall...
2013-08-05
OSHA is issuing a final rule amending the Basic Program Elements to require Federal agencies to submit their occupational injury and illness recordkeeping information to the Bureau of Labor Statistics (BLS) and OSHA on an annual basis. The information, which is already required to be created and maintained by Federal agencies, will be used by BLS to aggregate injury and illness information throughout the Federal government. OSHA will use the information to identify Federal establishments with high incidence rates for targeted inspection, and assist in determining the most effective safety and health training for Federal employees. The final rule also interprets several existing basic program elements in our regulations to clarify requirements applicable to Federal agencies, amends the date when Federal agencies must submit to the Secretary of Labor their annual report on occupational safety and health programs, amends the date when the Secretary of Labor must submit to the President the annual report on Federal agency safety and health, and clarifies that Federal agencies must include uncompensated volunteers when reporting and recording occupational injuries and illnesses.
Virtual testing of speed reduction schemes on urban collector roads.
Domenichini, Lorenzo; Branzi, Valentina; Meocci, Monica
2018-01-01
Urban collector roads are complex driving environments often encompassing both the mobility and the access road functions. In these conditions motorized traffic and vulnerable road users compete continually. Speed reduction measures may play a relevant role in these contexts, provided that such measures are also designed in compliance with the driver's capabilities and expectations. The paper describes a test procedure using driving simulation experiments, designed to evaluate the reconfiguration project of Via Pistoiese, an urban road collector located in Florence (Italy). The road improvement design consisted of several engineering treatments aimed to reduce and homogenize the driving speed, as well as to manage the co-existence of the different road users and mainly to protect pedestrians. The main focus of the research was to understand if the drivers' behaviour was according to the design hypothesis before the safety treatments are implemented in the real world. Due to the multiple engineering treatments included in the reconfiguration project, the evaluation of the overall safety effectiveness of the project rather than the single treatment safety impact was the main concern of the research study. In addition, the study aimed to assess the usefulness of the considered testing method to understand how to integrate road design with drivers' performances, especially in heterogeneous traffic environments where drivers' behaviour plays a decisive role in the success of the proposed design solutions. Fifty-eight participants drove through two immersive virtual environments, reproducing the existing configuration and the project reconfiguration, while data relating to different driving aspects were collected. Two analyses were performed. The first was focused on the analysis of the mean speed profiles and revealed that the considered engineering treatments are able to control the speeding behaviour without providing a too high discomfort to the drivers. The second analysis was finalized to evaluate the driver's behaviour approaching zebra crossing, evaluating the impact of countermeasures allowing the drivers to perceive in advance a critical situation (a pedestrian that suddenly crossed the street) and consequently to perform a smoother and safer manoeuvre. The experiments confirmed the validity of the considered engineering treatments, allowing expecting the improvement of the traffic safety in via Pistoiese, and support the usefulness of virtual reality experimentations to predict of the safety effectiveness of design solutions, taking into account the drivers' behaviour. Copyright © 2017 Elsevier Ltd. All rights reserved.
Verstraelen, Hans; Vervaet, Chris; Remon, Jean-Paul
2016-01-01
Bacterial vaginosis is a prevalent state of dysbiosis of the vaginal microbiota with wide-ranging impact on human reproductive health. Based on recent insights in community ecology of the vaginal microbiome, we hypothesize that sustained vaginal DL-lactic acid enrichment will enhance the recruitment of lactobacilli, while counteracting bacterial vaginosis-associated bacteria. We therefore aimed to develop an intravaginal device that would be easy to insert and remove, while providing sustained DL-lactic acid release into the vaginal lumen. The final prototype selected is a vaginal ring matrix system consisting of a mixture of ethylene vinyl acetate and methacrylic acid-methyl methacrylate copolymer loaded with 150 mg DL-lactic acid with an L/D-lactic acid ratio of 1:1. Preclinical safety assessment was performed by use of the Slug Mucosal Irritation test, a non-vertebrate assay to evaluate vaginal mucosal irritation, which revealed no irritation. Clinical safety was evaluated in a phase I trial with six healthy nulliparous premenopausal volunteering women, with the investigational drug left in place for 7 days. Colposcopic monitoring according to the WHO/CONRAD guidelines for the evaluation of vaginal products, revealed no visible cervicovaginal mucosal changes. No adverse events related to the investigational product occurred. Total release from the intravaginal ring over 7 days was estimated through high performance liquid chromatography at 37.1 (standard deviation 0.9) mg DL-lactic acid. Semisolid lactic acid formulations have been studied to a limited extent in the past and typically consist of a large volume of excipients and very high doses of lactic acid, which is of major concern to mucosal safety. We have documented the feasability of enriching the vaginal environment with pure DL-lactic acid with a prototype intravaginal ring. Though the efficacy of this platform remains to be established possibly requiring further development, this approach may offer a novel avenue to modulate and protect the vaginal microbiota.
Zhang, Longhao; Zhao, Pujing; Chen, Ying; Zhang, Mingming
2015-01-01
Background From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. Objective To evaluate the effectiveness of HFE interventions in improving health care workers’ outcomes and patient safety and to assess the quality of the available evidence. Methods We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. Results For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers’ quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers’ attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. Conclusion The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need for scientific and standardized guidelines regarding how HFE should be implemented in health care. PMID:26067774
Patient safety and quality improvement: civil money penalty inflation adjustment. Direct final rule.
2009-08-25
The Department of Health and Human Services amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are amending the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990. We are using direct final rulemaking for this action because we expect that there will be no significant adverse comment on the rule.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1980-11-01
The Application for Certification for the construction of a 55 MW geothermal power plant and related facilities in Lake County was approved subject to terms identified in the Final Decision. The following are covered: findings on compliance with statutory site-certification requirements; final environmental impact report; procedural steps; evidentiary bases; need, environmental resources; public health and safety; plant and site safety and reliability; socioeconomic, land use, and cultural concerns, and transmission tap line. (MHR)
77 FR 56549 - Safety Zone; Blue Angels at Kaneohe Bay Air Show, Oahu, HI
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-13
... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2012-0739] RIN 1625-AA00 Safety Zone; Blue Angels at Kaneohe Bay Air Show, Oahu, HI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone while the U.S. Navy...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-28
... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2012-0767] RIN 1625-AA00 Safety Zone, Changes to Original Rule; Boston Harbor's Rock Removal Project, Boston Inner Harbor... original provisions of that temporary final rule, but adds two additional safety zones necessary for the...
75 FR 34929 - Safety Zones: Neptune Deep Water Port, Atlantic Ocean, Boston, MA
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-21
...-AA00 Safety Zones: Neptune Deep Water Port, Atlantic Ocean, Boston, MA AGENCY: Coast Guard, DHS. ACTION..., Boston, MA; Final Rule (USCG-2009-0589), to protect vessels from the hazard posed by the presence of the... read as follows: Sec. 165.T01-0542 Safety Zones: Neptune Deepwater Port, Atlantic Ocean, Boston, MA. (a...
77 FR 42649 - Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-20
... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2012-0497] RIN 1625-AA00 Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on...
DOT National Transportation Integrated Search
2016-10-01
Rural roads account for 90.3% of the 140,476 total centerline miles of roadways in Kansas. In recent years, rural fatal crashes have accounted for about 66% of all fatal crashes. The Highway Safety Manual (HSM) provides models and methodologies for a...
78 FR 48609 - Safety Zone; James River; Newport News, VA
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-09
...-AA00 Safety Zone; James River; Newport News, VA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule...-0670 to read as follows: Sec. 165.T05-0670 Safety Zone, James River, Newport News, VA. (a) Definitions...'11'' N longitude 076[deg]38'40'' W, located near Fort Eustis in Newport News, VA. (c) Regulations. (1...
49 CFR 238.229 - Safety appliances-general.
Code of Federal Regulations, 2014 CFR
2014-10-01
... support meets all of the conditions contained in § 238.230(b)(1) for being considered part of the car body... disassembly of a car is necessary to visually inspect the involved safety appliance bracket or support, the... for a final determination. No car with a defect in the weld of a safety appliance or its attachment...
49 CFR 238.229 - Safety appliances-general.
Code of Federal Regulations, 2013 CFR
2013-10-01
... support meets all of the conditions contained in § 238.230(b)(1) for being considered part of the car body... disassembly of a car is necessary to visually inspect the involved safety appliance bracket or support, the... for a final determination. No car with a defect in the weld of a safety appliance or its attachment...
49 CFR 238.229 - Safety appliances-general.
Code of Federal Regulations, 2012 CFR
2012-10-01
... support meets all of the conditions contained in § 238.230(b)(1) for being considered part of the car body... disassembly of a car is necessary to visually inspect the involved safety appliance bracket or support, the... for a final determination. No car with a defect in the weld of a safety appliance or its attachment...
76 FR 30020 - Safety Zone; Wicomico Community Fireworks, Great Wicomico River, Mila, VA
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
.... ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the.... This action is necessary to provide for the safety of life on navigable waters during the Wicomico... rule is effective from 9 p.m. on July 2, 2011, until 10 p.m. on July 3, 2011. ADDRESSES: Documents...
75 FR 42608 - Safety Zone; Lyme Community Days, Chaumont Bay, NY
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-22
... final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for Lyme Community Days... intended to ensure safety of life on navigable waters immediately prior to, during, and immediately after the fireworks event. DATES: This rule is effective from 9:30 p.m. to 10 p.m. on July 24, 2010...