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

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

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

2013-07-01

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

Risk management in the North sea offshore industry: History, status and challenges

NASA Astrophysics Data System (ADS)

Smith, E. J.

1995-10-01

There have been major changes in the UK and Norwegian offshore safety regimes in the last decade. On the basis of accumulated experience (including some major accidents), there has been a move away from a rigid, prescriptive approach to setting safety standards; it is now recognised that a more flexible, "goal-setting" approach is more suited to achieving cost-effective solutions to offshore safety. In order to adapt to this approach, offshore operators are increasingly using Quantitative Risk Assessment (QRA) techniques as part of their risk management programmes. Structured risk assessment can be used at all stages of a project life-cycle. In the design stages (concept and detailed design), these techniques are valuable tools in ensuring that money is wisely spent on safety-related systems. In the operational stage, QRA can aid the development of procedures. High quality Safety Management Systems (SMSs), covering issues such as training, inspection, and emergency planning, are crucial to maintain "asdesigned" levels of safety and reliability. Audits of SMSs should be carried out all through the operational phase to ensure that risky conditions do not accumulate.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

PubMed

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

Preliminary Framework for Human-Automation Collaboration

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

Oxstrand, Johanna Helene; Le Blanc, Katya Lee; Spielman, Zachary Alexander

The Department of Energy’s Advanced Reactor Technologies Program sponsors research, development and deployment activities through its Next Generation Nuclear Plant, Advanced Reactor Concepts, and Advanced Small Modular Reactor (aSMR) Programs to promote safety, technical, economical, and environmental advancements of innovative Generation IV nuclear energy technologies. The Human Automation Collaboration (HAC) Research Project is located under the aSMR Program, which identifies developing advanced instrumentation and controls and human-machine interfaces as one of four key research areas. It is expected that the new nuclear power plant designs will employ technology significantly more advanced than the analog systems in the existing reactor fleetmore » as well as utilizing automation to a greater extent. Moving towards more advanced technology and more automation does not necessary imply more efficient and safer operation of the plant. Instead, a number of concerns about how these technologies will affect human performance and the overall safety of the plant need to be addressed. More specifically, it is important to investigate how the operator and the automation work as a team to ensure effective and safe plant operation, also known as the human-automation collaboration (HAC). The focus of the HAC research is to understand how various characteristics of automation (such as its reliability, processes, and modes) effect an operator’s use and awareness of plant conditions. In other words, the research team investigates how to best design the collaboration between the operators and the automated systems in a manner that has the greatest positive impact on overall plant performance and reliability. This report addresses the Department of Energy milestone M4AT-15IN2302054, Complete Preliminary Framework for Human-Automation Collaboration, by discussing the two phased development of a preliminary HAC framework. The framework developed in the first phase was used as the basis for selecting topics to be investigated in more detail. The results and insights gained from the in-depth studies conducted during the second phase were used to revise the framework. This report describes the basis for the framework developed in phase 1, the changes made to the framework in phase 2, and the basis for the changes. Additional research needs are identified and presented in the last section of the report.« less

National Dam Safety Program. Bethany Hole Dam (NJ00798), Delaware River Basin, Tributary to Haynes Creek, Burlington County, New Jersey. Phase I Inspection Report.

DTIC Science & Technology

1981-07-01

performed on an "as needed" basis. Sediment and accumulated debris are frequently removed from the spillway since the dam is used for water supply. 4.3...Rugr Unvriy oi uvyo M.10 J n 19504. IVION OF ATE REOURESBETHANY ’d -HOLE DAM , M-23M-i Staiiddpoismsl f aieoii AR/Z Recet aluvi m V poite inporlydaie

A HISTORICAL PERSPECTIVE OF NUCLEAR THERMAL HYDRAULICS

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

D’Auria, F; Rohatgi, Upendra S.

The nuclear thermal-hydraulics discipline was developed following the needs for nuclear power plants (NPPs) and, to a more limited extent, research reactors (RR) design and safety. As in all other fields where analytical methods are involved, nuclear thermal-hydraulics took benefit of the development of computers. Thermodynamics, rather than fluid dynamics, is at the basis of the development of nuclear thermal-hydraulics together with the experiments in complex two-phase situations, namely, geometry, high thermal density, and pressure.

Nighttime approaches to offshore installations in Brazil: Safety shortcomings experienced by helicopter pilots.

PubMed

Nascimento, Felipe A C; Majumdar, Arnab; Jarvis, Steve

2012-07-01

Accident rates for night sorties by helicopters traveling to offshore oil and gas platforms are at least five times higher than those during the daytime. Because pilots need to transition from automated flight to a manually flown night visual segment during arrival, the approach and landing phases cause great concern. Despite this, in Brazil, regulatory changes have been sought to allow for the execution of offshore night flights because of the rapid expansion of the petroleum industry. This study explores the factors that affect safety during night visual segments in Brazil using 28 semi-structured interviews with offshore helicopter pilots, followed by a template analysis of the narratives. The relationships among the factors suggest that flawed safety oversights, caused by a combination of lack of infrastructure for night flights offshore and declining training, currently favor spatial disorientation on the approach and near misses when close to the destination. Safety initiatives can be derived on the basis of these results. Copyright © 2012 Elsevier Ltd. All rights reserved.

Toward a Safety Risk-Based Classification of Unmanned Aircraft

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2016-01-01

There is a trend of growing interest and demand for greater access of unmanned aircraft (UA) to the National Airspace System (NAS) as the ongoing development of UA technology has created the potential for significant economic benefits. However, the lack of a comprehensive and efficient UA regulatory framework has constrained the number and kinds of UA operations that can be performed. This report presents initial results of a study aimed at defining a safety-risk-based UA classification as a plausible basis for a regulatory framework for UA operating in the NAS. Much of the study up to this point has been at a conceptual high level. The report includes a survey of contextual topics, analysis of safety risk considerations, and initial recommendations for a risk-based approach to safe UA operations in the NAS. The next phase of the study will develop and leverage deeper clarity and insight into practical engineering and regulatory considerations for ensuring that UA operations have an acceptable level of safety.

Is mipomersen ready for clinical implementation? A transatlantic dilemma.

PubMed

Sjouke, Barbara; Balak, Deepak M W; Beuers, Ulrich; Ratziu, Vlad; Stroes, Erik S G

2013-08-01

Mipomersen has been approved by the US Food and Drug Administration as an orphan drug for patients with homozygous familial hypercholesterolemia (HoFH). In contrast, the European Medicines Agency advised negatively on the use of mipomersen. In this review, we discuss the efficacy and safety considerations for this discrepancy. On the basis of the results of clinical trials with mipomersen, safety concerns have been raised regarding cardiovascular risk reduction and development of hepatic steatosis. In addition, (long-term) tolerability concerns have been raised predominantly regarding injection site reactions. A pooled analysis of cardiovascular events in phase III trials with mipomersen did not provide evidence for either a positive or negative effect on cardiovascular disease. Although long-term studies with mipomersen are eagerly awaited, hepatic fat content appears to stabilize after 6-12 months notwithstanding continued mipomersen administration. HoFH is a disease with an unmet medical need for new lipid-lowering therapies. On the basis of a mean 2.9 mmol/l LDL-cholesterol reduction, mipomersen is expected to reduce cardiovascular risk in HoFH. Available evidence suggests that the fat accumulation associated with this treatment differs from steatohepatitis, which is a progressive and damaging liver disease. No evidence is available suggesting that injection site reactions because of mipomersen treatment will result in safety issues.

Design criteria for a self-actuated shutdown system to ensure limitation of core damage. [LMFBR

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

Deane, N.A.; Atcheson, D.B.

1981-09-01

Safety-based functional requirements and design criteria for a self-actuated shutdown system (SASS) are derived in accordance with LOA-2 success criteria and reliability goals. The design basis transients have been defined and evaluated for the CDS Phase II design, which is a 2550 MWt mixed oxide heterogeneous core reactor. A partial set of reactor responses for selected transients is provided as a function of SASS characteristics such as reactivity worth, trip points, and insertion times.

Antifoam degradation testing

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

Lambert, D. P.; Zamecnik, J. R.; Newell, D. D.

2015-08-20

This report describes the results of testing to quantify the degradation products resulting from the dilution and storage of Antifoam 747. Antifoam degradation is of concern to the Defense Waste Processing Facility (DWPF) due to flammable decomposition products in the vapor phase of the Chemical Process Cell vessels, as well as the collection of flammable and organic species in the offgas condensate. The discovery that hexamethyldisiloxane is formed from the antifoam decomposition was the basis for a Potential Inadequacy in the Safety Analysis declaration by the DWPF.

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

Class act: safety comparison of approved tyrosine kinase inhibitors for non-small-cell lung carcinoma.

PubMed

Burotto, Mauricio; Ali, Syed Abbas; O'Sullivan Coyne, Geraldine

2015-01-01

The past decade has seen the development and widespread use of tyrosine kinase inhibitors (TKIs) targeting a mutated EGFR (mEGFR) for the treatment of metastatic NSCLC. We discuss the main properties of the TKIs currently recommended for the treatment of mEGFR NSCLC: gefitinib, erlotinib and afatinib. The mechanism of action, pharmacodynamics and pharmacokinetics of these drugs, with emphasis on the historical context of their preclinical and clinical development, will be covered, including potential resistance mechanisms to these first-generation TKIs that has driven the trial design for second and third generations of EGFR inhibitors. Six Phase III clinical trials comparing these three TKIs with cisplatin-based chemotherapy upfront for mEGFR NSCLC provide the basis for the comparative safety and toxicity analysis between these agents. Class-related toxicity of these EGFR inhibitors, including life-threatening effects, will be discussed. Toxicity and safety analysis from the Phase III trials of these agents in mEGFR populations suggests that afatinib has more frequent and severe side effects. Given that an efficacy advantage has not yet been demonstrated for afatinib over erlotinib and gefitinib, the consistent class toxicity profile of these agents means that gefitinib and erlotinib are a safer first-line treatment recommendation.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

PubMed Central

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states. PMID:25569274

Identifying the most significant indicators of the total road safety performance index.

PubMed

Tešić, Milan; Hermans, Elke; Lipovac, Krsto; Pešić, Dalibor

2018-04-01

The review of the national and international literature dealing with the assessment of the road safety level has shown great efforts of the authors who tried to define the methodology for calculating the composite road safety index on a territory (region, state, etc.). The procedure for obtaining a road safety composite index of an area has been largely harmonized. The question that has not been fully resolved yet concerns the selection of indicators. There is a wide range of road safety indicators used to show a road safety situation on a territory. Road safety performance index (RSPI) obtained on the basis of a larger number of safety performance indicators (SPIs) enable decision makers to more precisely define the earlier goal- oriented actions. However, recording a broader comprehensive set of SPIs helps identify the strengths and weaknesses of a country's road safety system. Providing high quality national and international databases that would include comparable SPIs seems to be difficult since a larger number of countries dispose of a small number of identical indicators available for use. Therefore, there is a need for calculating a road safety performance index with a limited number of indicators (RSPI ln n ) which will provide a comparison of a sufficient quality, of as many countries as possible. The application of the Data Envelopment Analysis (DEA) method and correlative analysis has helped to check if the RSPI ln n is likely to be of sufficient quality. A strong correlation between the RSPI ln n and the RSPI has been identified using the proposed methodology. Based on this, the most contributing indicators and methodologies for gradual monitoring of SPIs, have been defined for each country analyzed. The indicator monitoring phases in the analyzed countries have been defined in the following way: Phase 1- the indicators relating to alcohol, speed and protective systems; Phase 2- the indicators relating to roads and Phase 3- the indicators relating to trauma management. This will help achieve the standardization of indicators including data collection procedures and selection of the key list of indicators that need to be monitored. Based on the results, it has been concluded that the use of the most contributing indicators will make it possible to assess the level of road safety on a territory, with an acceptable quality score by focusing on the low-ranked countries. A smaller set of significant indicators defined in this manner can serve for a fast and simple understanding of a road safety situation and assessment of effects of measures undertaken. Also, this universal index approach is applicable in cases when a broader comprehensive set of indicators is analyzed, which provides a more accurate identification of weaker points and rank the countries in a more meaningful way. Copyright © 2018 Elsevier Ltd. All rights reserved.

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 § 1975.2 Basis... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution...

Crack orientation and depth estimation in a low-pressure turbine disc using a phased array ultrasonic transducer and an artificial neural network.

PubMed

Yang, Xiaoxia; Chen, Shili; Jin, Shijiu; Chang, Wenshuang

2013-09-13

Stress corrosion cracks (SCC) in low-pressure steam turbine discs are serious hidden dangers to production safety in the power plants, and knowing the orientation and depth of the initial cracks is essential for the evaluation of the crack growth rate, propagation direction and working life of the turbine disc. In this paper, a method based on phased array ultrasonic transducer and artificial neural network (ANN), is proposed to estimate both the depth and orientation of initial cracks in the turbine discs. Echo signals from cracks with different depths and orientations were collected by a phased array ultrasonic transducer, and the feature vectors were extracted by wavelet packet, fractal technology and peak amplitude methods. The radial basis function (RBF) neural network was investigated and used in this application. The final results demonstrated that the method presented was efficient in crack estimation tasks.

Crack Orientation and Depth Estimation in a Low-Pressure Turbine Disc Using a Phased Array Ultrasonic Transducer and an Artificial Neural Network

PubMed Central

Yang, Xiaoxia; Chen, Shili; Jin, Shijiu; Chang, Wenshuang

2013-01-01

Stress corrosion cracks (SCC) in low-pressure steam turbine discs are serious hidden dangers to production safety in the power plants, and knowing the orientation and depth of the initial cracks is essential for the evaluation of the crack growth rate, propagation direction and working life of the turbine disc. In this paper, a method based on phased array ultrasonic transducer and artificial neural network (ANN), is proposed to estimate both the depth and orientation of initial cracks in the turbine discs. Echo signals from cracks with different depths and orientations were collected by a phased array ultrasonic transducer, and the feature vectors were extracted by wavelet packet, fractal technology and peak amplitude methods. The radial basis function (RBF) neural network was investigated and used in this application. The final results demonstrated that the method presented was efficient in crack estimation tasks. PMID:24064602

Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme.

PubMed

Reardon, David A; Fink, Karen L; Mikkelsen, Tom; Cloughesy, Timothy F; O'Neill, Alison; Plotkin, Scott; Glantz, Michael; Ravin, Paula; Raizer, Jeffrey J; Rich, Keith M; Schiff, David; Shapiro, William R; Burdette-Radoux, Susan; Dropcho, Edward J; Wittemer, Sabine M; Nippgen, Johannes; Picard, Martin; Nabors, L Burt

2008-12-01

Cilengitide, an inhibitor of alphavbeta3 and alphavbeta5 integrin receptors, demonstrated minimal toxicity and durable activity across a wide range of doses administered to adults with recurrent glioblastoma multiforme (GBM) in a prior phase I study. The current multicenter phase II study was conducted to evaluate the activity and safety of cilengitide in GBM patients at first recurrence. Eligible patients were randomly assigned to receive either 500 or 2,000 mg of cilengitide twice weekly on a continuous basis. Patients were assessed every 4 weeks. The primary end point was 6-month progression-free survival (PFS) rate. Secondary end points included PFS, overall survival (OS), and radiographic response, as well as quality-of-life and pharmacokinetic assessments. Eighty-one patients were enrolled, including 41 on the 500-mg arm and 40 on the 2,000-mg arm. The safety profile of cilengitide was excellent, with no significant reproducible toxicities observed on either arm. Antitumor activity was observed in both treatment cohorts but trended more favorably among patients treated with 2,000 mg, including a 6-month PFS of 15% and a median OS of 9.9 months. Cilengitide monotherapy is well tolerated and exhibits modest antitumor activity among recurrent GBM patients. Additional studies integrating cilengitide into combinatorial regimens for GBM are warranted.

Safety equipment list for the 241-SY-101 RAPID mitigation project

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

MORRIS, K.L.

1999-06-29

This document provides the safety classification for the safety (safety class and safety RAPID Mitigation Project. This document is being issued as the project SEL until the supporting authorization basis documentation, this document will be superseded by the TWRS SEL (LMHC 1999), documentation istlralized. Upon implementation of the authorization basis significant) structures, systems, and components (SSCS) associated with the 241-SY-1O1 which will be updated to include the information contained herein.

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

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

Meichle, R.H.

1994-10-10

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

10 CFR 830.201 - Performance of work.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Performance of work. 830.201 Section 830.201 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.201 Performance of work. A contractor must perform work in accordance with the safety basis for a hazard category 1, 2, or 3 DOE nuclear...

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.

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. 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/.

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

PubMed

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

2013-09-06

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

Single pilot IFR accident data analysis

NASA Technical Reports Server (NTRS)

Harris, D. F.

1983-01-01

The aircraft accident data recorded by the National Transportation and Safety Board (NTSR) for 1964-1979 were analyzed to determine what problems exist in the general aviation (GA) single pilot instrument flight rule (SPIFR) environment. A previous study conducted in 1978 for the years 1964-1975 provided a basis for comparison. This effort was generally limited to SPIFR pilot error landing phase accidents but includes some SPIFR takeoff and enroute accident analysis as well as some dual pilot IFR accident analysis for comparison. Analysis was performed for 554 accidents of which 39% (216) occurred during the years 1976-1979.

Safety analysis report for the Waste Storage Facility. Revision 2

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

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

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

Phase II trial of the association of a methionine-free diet with cystemustine therapy in melanoma and glioma.

PubMed

Thivat, Emilie; Farges, Marie-Chantal; Bacin, Franck; D'Incan, Michel; Mouret-Reynier, Marie-Ange; Cellarier, Eric; Madelmont, Jean-Claude; Vasson, Marie-Paule; Chollet, Philippe; Durando, Xavier

2009-12-01

In a previous phase I clinical trial of dietary methionine (MET) restriction with cystemustine treatment for melanoma or glioma, we determined the optimal MET-free diet duration to be 1 day. On this basis, a phase II clinical trial was initiated to evaluate safety and efficacy of this combination. Twenty-two patients (20 with metastatic melanoma and 2 with recurrent gloma) received a median of 4 cycles of the association of a 1-day MET-free diet with cystemustine (60 mg/m(2)) every two weeks. This association was well tolerated (toxicity and nutritional status). Toxicity remained mainly hematological and consisted of WHO grade 3-4 thrombocytopenia, leucopenia and neutropenia in 36, 27 and 27% of patients respectively. The median disease-free survival was 1.8 months and the median survival was 4.6 months, with 2 long-duration stabilizations. The plasmatic MET depletion obtained was of 40 + or - 31%.

[Peripheral venous catheter use in the emergency department: reducing adverse events in patients and biosafety problems for staff].

PubMed

Tomás Vecina, Santiago; Mozota Duarte, Julián; Ortega Marcos, Miguel; Gracia Ruiz Navarro, María; Borillo, Vicente; San Juan Gago, Leticia; Roqueta Egea, Fermin; Chanovas Borrás, Manuel

2016-01-01

To test a strategy to reduce the rate of adverse events in patients and safety problems for emergency department staff who insert peripheral venous catheters (PVCs). The strategy consisted of training, implementing a protocol, and introducing safety-engineered PVCs. Prospective, multicenter, observational, preauthorization study in patients requiring PVC placement in an emergency department. The study had 2 phases. The first consisted of training, implementing a protocol for using conventional PVCs, and monitoring practice. The second phase introduced safety-engineered PVC sets. The number of adverse events in patients and threats to safety for staff were compared between the 2 phases. A total of 520 patients were included, 180 in the first phase and 340 in the second. We detected breaches in aseptic technique, failure to maintain a sterile field, and improper management of safety equipment and devices. Some practices improved significantly during the second phase. Eighty-six adverse events occurred in the first phase and 52 (15.4%) in the second; the between-phase difference was not statistically significant. The incidence of postinfusion phlebitis was 50% lower in the second phase. Seven splash injuries and 1 accidental puncture occurred with conventional PVCs in the first phase; 2 splash injuries occurred with the safety-engineered PVCs in the second phase (36% decrease, P = .04). Differences were particularly noticeable for short-term PVC placements (P = .02). Combining training, a protocol, and the use of safety-engineered PVC sets offers an effective strategy for improving patient and staff safety.

Guidance on health effects of toxic chemicals. Safety Analysis Report Update Program

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

Foust, C.B.; Griffin, G.D.; Munro, N.B.

1994-02-01

Martin Marietta Energy Systems, Inc. (MMES), and Martin Marietta Utility Services, Inc. (MMUS), are engaged in phased programs to update the safety documentation for the existing US Department of Energy (DOE)-owned facilities. The safety analysis of potential toxic hazards requires a methodology for evaluating human health effects of predicted toxic exposures. This report provides a consistent set of health effects and documents toxicity estimates corresponding to these health effects for some of the more important chemicals found within MMES and MMUS. The estimates are based on published toxicity information and apply to acute exposures for an ``average`` individual. The healthmore » effects (toxicological endpoints) used in this report are (1) the detection threshold; (2) the no-observed adverse effect level; (3) the onset of irritation/reversible effects; (4) the onset of irreversible effects; and (5) a lethal exposure, defined to be the 50% lethal level. An irreversible effect is defined as a significant effect on a person`s quality of life, e.g., serious injury. Predicted consequences are evaluated on the basis of concentration and exposure time.« less

High dose rate brachytherapy for oral cancer

PubMed Central

YamazakI, Hideya; Yoshida, Ken; Yoshioka, Yasuo; Shimizutani, Kimishige; Furukawa, Souhei; Koizumi, Masahiko; Ogawa, Kazuhiko

2013-01-01

Brachytherapy results in better dose distribution compared with other treatments because of steep dose reduction in the surrounding normal tissues. Excellent local control rates and acceptable side effects have been demonstrated with brachytherapy as a sole treatment modality, a postoperative method, and a method of reirradiation. Low-dose-rate (LDR) brachytherapy has been employed worldwide for its superior outcome. With the advent of technology, high-dose-rate (HDR) brachytherapy has enabled health care providers to avoid radiation exposure. This therapy has been used for treating many types of cancer such as gynecological cancer, breast cancer, and prostate cancer. However, LDR and pulsed-dose-rate interstitial brachytherapies have been mainstays for head and neck cancer. HDR brachytherapy has not become widely used in the radiotherapy community for treating head and neck cancer because of lack of experience and biological concerns. On the other hand, because HDR brachytherapy is less time-consuming, treatment can occasionally be administered on an outpatient basis. For the convenience and safety of patients and medical staff, HDR brachytherapy should be explored. To enhance the role of this therapy in treatment of head and neck lesions, we have reviewed its outcomes with oral cancer, including Phase I/II to Phase III studies, evaluating this technique in terms of safety and efficacy. In particular, our studies have shown that superficial tumors can be treated using a non-invasive mold technique on an outpatient basis without adverse reactions. The next generation of image-guided brachytherapy using HDR has been discussed. In conclusion, although concrete evidence is yet to be produced with a sophisticated study in a reproducible manner, HDR brachytherapy remains an important option for treatment of oral cancer. PMID:23179377

High dose rate brachytherapy for oral cancer.

PubMed

Yamazaki, Hideya; Yoshida, Ken; Yoshioka, Yasuo; Shimizutani, Kimishige; Furukawa, Souhei; Koizumi, Masahiko; Ogawa, Kazuhiko

2013-01-01

Brachytherapy results in better dose distribution compared with other treatments because of steep dose reduction in the surrounding normal tissues. Excellent local control rates and acceptable side effects have been demonstrated with brachytherapy as a sole treatment modality, a postoperative method, and a method of reirradiation. Low-dose-rate (LDR) brachytherapy has been employed worldwide for its superior outcome. With the advent of technology, high-dose-rate (HDR) brachytherapy has enabled health care providers to avoid radiation exposure. This therapy has been used for treating many types of cancer such as gynecological cancer, breast cancer, and prostate cancer. However, LDR and pulsed-dose-rate interstitial brachytherapies have been mainstays for head and neck cancer. HDR brachytherapy has not become widely used in the radiotherapy community for treating head and neck cancer because of lack of experience and biological concerns. On the other hand, because HDR brachytherapy is less time-consuming, treatment can occasionally be administered on an outpatient basis. For the convenience and safety of patients and medical staff, HDR brachytherapy should be explored. To enhance the role of this therapy in treatment of head and neck lesions, we have reviewed its outcomes with oral cancer, including Phase I/II to Phase III studies, evaluating this technique in terms of safety and efficacy. In particular, our studies have shown that superficial tumors can be treated using a non-invasive mold technique on an outpatient basis without adverse reactions. The next generation of image-guided brachytherapy using HDR has been discussed. In conclusion, although concrete evidence is yet to be produced with a sophisticated study in a reproducible manner, HDR brachytherapy remains an important option for treatment of oral cancer.

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2011-10-01 2011-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2014-10-01 2014-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2013-10-01 2013-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2012-10-01 2012-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

Clinical Development of a Cytomegalovirus DNA Vaccine: From Product Concept to Pivotal Phase 3 Trial.

PubMed

Smith, Larry R; Wloch, Mary K; Chaplin, Jennifer A; Gerber, Michele; Rolland, Alain P

2013-09-25

2013 marks a milestone year for plasmid DNA vaccine development as a first-in-class cytomegalovirus (CMV) DNA vaccine enters pivotal phase 3 testing. This vaccine consists of two plasmids expressing CMV antigens glycoprotein B (gB) and phosphoprotein 65 (pp65) formulated with a CRL1005 poloxamer and benzalkonium chloride (BAK) delivery system designed to enhance plasmid expression. The vaccine's planned initial indication under investigation is for prevention of CMV reactivation in CMV-seropositive (CMV⁺) recipients of an allogeneic hematopoietic stem cell transplant (HCT). A randomized, double-blind placebo-controlled phase 2 proof-of-concept study provided initial evidence of the safety of this product in CMV⁺ HCT recipients who underwent immune ablation conditioning regimens. This study revealed a significant reduction in viral load endpoints and increased frequencies of pp65-specific interferon-γ-producing T cells in vaccine recipients compared to placebo recipients. The results of this endpoint-defining trial provided the basis for defining the primary and secondary endpoints of a global phase 3 trial in HCT recipients. A case study is presented here describing the development history of this vaccine from product concept to initiation of the phase 3 trial.

Decommissioning of the Iraq former nuclear complex

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

Abbas, Mohammed; Helou, Tuama; Ahmead, Bushra

2007-07-01

Available in abstract form only. Full text of publication follows: A number of sites in Iraq have some degree of radiological contamination and require decommissioning and remediation in order to ensure radiological safety. Many of these sites in Iraq are located at the nuclear research centre at Al Tuwaitha. The International Atomic Energy Agency (IAEA) Board of Governors has approved a project to assist the Government of Iraq in the evaluation and decommissioning of former facilities that used radioactive materials. The project is divided into three phases: Phase 1: collect and analyze all available data and conduct training of themore » Iraqi staff, Phase 2: develop a decommissioning and remediation plan, and Phase 3: implement field activities relating to decommissioning, remediation and site selection suitable for final disposal of waste. Four working groups have been established to complete the Phase 1 work and significant progress has been made in drafting a new nuclear law which will provide the legal basis for the licensing of the decommissioning of the former nuclear complex. Work is also underway to collect and analysis existing date, to prioritize future activities and to develop a waste management strategy. This will be a long-term and costly project. (authors)« less

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

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

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

Advanced Collaborative Emissions Study (ACES)

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

Greenbaum, Daniel; Costantini, Maria; Van Erp, Annemoon

2013-12-31

The objective of the Advanced Collaborative Emissions Study (ACES) was to determine before widespread commercial deployment whether or not the new, energy-efficient, heavy duty diesel engines (2007 and 2010 EPA Emissions Standards Compliant) may generate anticipated toxic emissions that could adversely affect the environment and human health. ACES was planned to take place in three phases. In Phase 1, extensive emissions characterization of four production-intent prototype engine and control systems designed to meet 2007 standards for nitrogen oxides (NOx) and particulate matter (PM) was conducted at an existing emissions characterization facility: Southwest Research Institute (SwRI). One of the tested enginesmore » was selected (at random, after careful comparison of results) for health testing in Phase 3. In Phase 2, extensive emission characterization of three production-intent prototype engine and control systems meeting the 2010 standards (including more advanced NOx controls to meet the more stringent 2010 NOx standards) was conducted at the same test facility. In Phase 3, one engine/aftertreatment system selected from Phase 1 was further characterized during health effects studies (at an existing inhalation toxicology laboratory: Lovelace Respiratory Research Institute, [LRRI]) to form the basis of the ACES safety assessment. The Department of Energy (DOE) award provided funding for emissions characterization in Phases 1 and 2 as well as exposure characterization in Phase 3. The main health analyses in Phase 3 were funded separately and are not reported here.« less

Variable dynamic testbed vehicle : safety plan

DOT National Transportation Integrated Search

1997-02-01

This safety document covers the entire safety process from inception to delivery of the Variable Dynamic Testbed Vehicle. In addition to addressing the process of safety on the vehicle , it should provide a basis on which to build future safety proce...

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2010-01-01 2010-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2011-01-01 2011-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

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

PubMed Central

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

2013-01-01

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety. PACS number: 87.55.Qr PMID:24036868

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

PubMed

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

2015-01-01

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

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-01-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-12-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

IMPLEMENTATION OF DEFENSE NUCLEAR FACILITY SAFETY BOARD RECOMMENDATION 2000-2 AT WIPP

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

Jackson, K.; Wu, C.

2002-02-26

The Defense Nuclear Safeties Board (DNFSB) issued Recommendation 2000-2 on March 8, 2000, concerning the degrading conditions of vital safety systems, or systems important to nuclear safety, at DOE sites across the nation. The Board recommended that the DOE take action to assess the condition of its nuclear systems to ensure continued operational readiness of vital safety systems that are important for safely accomplishing the DOE's mission. To verify the readiness of vital safety systems, a two-phased approach was established. Phase I consisted of a qualitative assessment to approved criteria of the defined vital safety systems by operating contractor personnel,more » overseen by Federal field office personnel. Based on Phase I Assessment results, vital safety systems with significant deficiencies would be further assessed in Phase II, a more extensive quantitative assessment, by a contractor and Federal team, using a second set of criteria. In addition, Defense Nuclear Facility Safety Board Recommendation 2000-2 concluded that the degradation of confinement ventilation systems was of major concern, and issued a separate set of criteria to perform a Phase II Assessment on confinement ventilation systems.« less

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

NASA Astrophysics Data System (ADS)

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

2012-01-01

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

Multiparameter thermo-mechanical OCT-based characterization of laser-induced cornea reshaping

NASA Astrophysics Data System (ADS)

Zaitsev, Vladimir Yu.; Matveyev, Alexandr L.; Matveev, Lev A.; Gelikonov, Grigory V.; Vitkin, Alex; Omelchenko, Alexander I.; Baum, Olga I.; Shabanov, Dmitry V.; Sovetsky, Alexander A.; Sobol, Emil N.

2017-02-01

Phase-sensitive optical coherence tomography (OCT) is used for visualizing dynamic and cumulative strains and corneashape changes during laser-produced tissue heating. Such non-destructive (non-ablative) cornea reshaping can be used as a basis of emerging technologies of laser vision correction. In experiments with cartilaginous samples, polyacrilamide phantoms and excised rabbit eyes we demonstrate ability of the developed OCT system to simultaneously characterize transient and cumulated strain distributions, surface displacements, scattering tissue properties and possibility of temperature estimation via thermal-expansion measurements. The proposed approach can be implemented in perspective real-time OCT systems for ensuring safety of new methods of laser reshaping of cornea.

Cardiovascular safety of antihistamines

PubMed Central

Olasiński, Jerzy; Grajek, Stefan

2014-01-01

Histamine is a mediator, which increases the permeability of capillaries during the early phase of allergic reaction, causes smooth muscle contraction of bronchi and stimulates mucous glands in the nasal cavity. Antihistamines are the basis of symptomatic treatment in the majority of allergic diseases, especially allergic rhinitis, allergic conjunctivitis, urticaria and anaphylaxis. The cardiotoxic effects of the two withdrawn drugs, terfenadine and astemizole, were manifested by prolonged QT intervals and triggering torsades de pointes (TdP) caused by blockade of the ‘rapid’ IKr potassium channels. These phenomena, however, are not a class effect. This review deals with a new generation of antihistamine drugs in the context of QT interval prolongation risk. PMID:25097491

Evaluation of Selected Chemical Processes for Production of Low-cost Silicon, Phase 3

NASA Technical Reports Server (NTRS)

Blocher, J. M.; Browning, M. F.

1979-01-01

Refinements of the design of the 50 MT/year Experimental Process System Development Unit were made and competitive bids were received from mechanical, electrical, and structural contractors. Bids on most of the equipment were received and cataloged. Emergency procedures were defined to counter a variety of contingencies disclosed in operations and safety reviews. Experimental work with an electrolytic cell for zinc chloride disclosed no significant increase in power efficiency by steps taken to increase electrolyte circulation. On the basis of materials compatibility and permeability tests, 310 stainless steel was chosen for the shell of the fluidized-bed reactor and SiC-coated graphite for the liner.

Statewide traffic safety study phase I : review of current traffic safety research, practice, analytical procedures and databases.

DOT National Transportation Integrated Search

2005-05-01

This report synthesized the research findings of Phase I of the Statewide Traffic Safety Study of Louisiana, sponsored by the Louisiana Department of Transportation and Development. The objective of Phase I was to provide a comprehensive review of th...

Progress of IRSN R&D on ITER Safety Assessment

NASA Astrophysics Data System (ADS)

Van Dorsselaere, J. P.; Perrault, D.; Barrachin, M.; Bentaib, A.; Gensdarmes, F.; Haeck, W.; Pouvreau, S.; Salat, E.; Seropian, C.; Vendel, J.

2012-08-01

The French "Institut de Radioprotection et de Sûreté Nucléaire" (IRSN), in support to the French "Autorité de Sûreté Nucléaire", is analysing the safety of ITER fusion installation on the basis of the ITER operator's safety file. IRSN set up a multi-year R&D program in 2007 to support this safety assessment process. Priority has been given to four technical issues and the main outcomes of the work done in 2010 and 2011 are summarized in this paper: for simulation of accident scenarios in the vacuum vessel, adaptation of the ASTEC system code; for risk of explosion of gas-dust mixtures in the vacuum vessel, adaptation of the TONUS-CFD code for gas distribution, development of DUST code for dust transport, and preparation of IRSN experiments on gas inerting, dust mobilization, and hydrogen-dust mixtures explosion; for evaluation of the efficiency of the detritiation systems, thermo-chemical calculations of tritium speciation during transport in the gas phase and preparation of future experiments to evaluate the most influent factors on detritiation; for material neutron activation, adaptation of the VESTA Monte Carlo depletion code. The first results of these tasks have been used in 2011 for the analysis of the ITER safety file. In the near future, this R&D global programme may be reoriented to account for the feedback of the latter analysis or for new knowledge.

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory

PubMed Central

Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim

2017-01-01

Background: Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Method: Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. Results: Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Conclusion: Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. PMID:28340232

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory.

PubMed

Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-Hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim; Dennis, Eslie

2017-05-01

Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. : Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. © American Society for Clinical Pathology 2017.

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Preliminary documented safety analysis. 830.206 Section 830.206 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.206 Preliminary documented safety analysis. If construction begins after December 11, 2000, the contractor...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Antiangiogenic treatment in hepatocellular carcinoma: the balance of efficacy and safety

PubMed Central

Welker, Martin-Walter; Trojan, Joerg

2013-01-01

Hepatocellular carcinoma (HCC) is a severe complication of advanced liver disease with a worldwide incidence of more than 600,000 patients per year. Liver function, clinical performance status, and tumor size are considered in the Barcelona Clinic Liver Cancer (BCLC) system. While curative treatment options are available for early stages, most patients present with intermediate- or advanced-stage HCC, burdened with a poor prognosis, substantially influenced by the degree of liver-function impairment. Hypervascularization is a major characteristic of HCC, and antiangiogenic treatments are the basis of treatment in noncurative stages, including interventional and pharmacological treatments. Currently, the tyrosine-kinase inhibitor sorafenib is still the only approved drug for HCC. Further improvements in survival in patients with intermediate- and advanced-stage HCC may be anticipated by both multimodal approaches, such as combination of interventional and systemic treatments, and new systemic treatment options. Until now, the Phase III development of other tyrosine-kinase inhibitors in patients with advanced HCC has failed due to minor efficacy and/or increased toxicity compared to sorafenib. However, promising Phase II data have been reported with MET inhibitors in this hard-to-treat population. This review gives a critical overview of antiangiogenic drugs and strategies in intermediate- and advanced-stage HCC, with a special focus on safety. PMID:24204170

Fusion energy

NASA Astrophysics Data System (ADS)

1990-09-01

The main purpose of the International Thermonuclear Experimental Reactor (ITER) is to develop an experimental fusion reactor through the united efforts of many technologically advanced countries. The ITER terms of reference, issued jointly by the European Community, Japan, the USSR, and the United States, call for an integrated international design activity and constitute the basis of current activities. Joint work on ITER is carried out under the auspices of the International Atomic Energy Agency (IAEA), according to the terms of quadripartite agreement reached between the European Community, Japan, the USSR, and the United States. The site for joint technical work sessions is at the Max Planck Institute of Plasma Physics. Garching, Federal Republic of Germany. The ITER activities have two phases: a definition phase performed in 1988 and the present design phase (1989 to 1990). During the definition phase, a set of ITER technical characteristics and supporting research and development (R and D) activities were developed and reported. The present conceptual design phase of ITER lasts until the end of 1990. The objectives of this phase are to develop the design of ITER, perform a safety and environmental analysis, develop site requirements, define future R and D needs, and estimate cost, manpower, and schedule for construction and operation. A final report will be submitted at the end of 1990. This paper summarizes progress in the ITER program during the 1989 design phase.

10 CFR 830.203 - Unreviewed safety question process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Unreviewed safety question process. 830.203 Section 830.203 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.203 Unreviewed safety question process. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE...

Effectiveness of high school safety belt instruction

DOT National Transportation Integrated Search

1982-12-01

The Effectiveness of High School Safety Belt Instruction was developed during a two-phased project. In Phase I, Focus Group Activities were conducted to determine whether audiovisual safety belt instructional materials assembled by the National Highw...

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

Early investigational tubulin inhibitors as novel cancer therapeutics.

PubMed

Nepali, Kunal; Ojha, Ritu; Lee, Hsueh-Yun; Liou, Jing-Ping

2016-08-01

Microtubules represent one of the most logical and strategic molecular targets amongst the current targets for chemotherapy, alongside DNA. In the past decade, tubulin inhibitors as cancer therapeutics have been an area of focus due to the improved understanding and biological relevance of microtubules in cellular functions. Fueled by the objective of developing novel chemotherapeutics and with the aim of establishing the benefits of tubulin inhibition, several clinical trials have been conducted with others ongoing. At present, the antitubulin development pipeline contains an armful of agents under clinical investigation. This review focuses on novel tubulin inhibitors as cancer therapeutics. The article covers the agents which have completed the phase II studies along with the agents demonstrating promising results in phase I studies. Countless clinical trials evaluating the efficacy, safety and pharmacokinetics of novel tubulin inhibitors highlights the scientific efforts being paid to establish their candidature as cancer therapeutics. Colchicine binding site inhibitors as vascular disrupting agents (VDAs) and new taxanes appear to be the most likely agents for future clinical interest. Numerous agents have demonstrated clinical benefits in terms of efficacy and survival in phase I and II studies. However conclusive benefits can only be ascertained on the basis of phase III studies.

Postirradiation Testing Laboratory (327 Building)

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

Kammenzind, D.E.

A Standards/Requirements Identification Document (S/RID) is the total list of the Environment, Safety and Health (ES and H) requirements to be implemented by a site, facility, or activity. These requirements are appropriate to the life cycle phase to achieve an adequate level of protection for worker and public health and safety, and the environment during design, construction, operation, decontamination and decommissioning, and environmental restoration. S/RlDs are living documents, to be revised appropriately based on change in the site`s or facility`s mission or configuration, a change in the facility`s life cycle phase, or a change to the applicable standards/requirements. S/RIDs encompassmore » health and safety, environmental, and safety related safeguards and security (S and S) standards/requirements related to the functional areas listed in the US Department of Energy (DOE) Environment, Safety and Health Configuration Guide. The Fluor Daniel Hanford (FDH) Contract S/RID contains standards/requirements, applicable to FDH and FDH subcontractors, necessary for safe operation of Project Hanford Management Contract (PHMC) facilities, that are not the direct responsibility of the facility manager (e.g., a site-wide fire department). Facility S/RIDs contain standards/requirements applicable to a specific facility that are the direct responsibility of the facility manager. S/RlDs are prepared by those responsible for managing the operation of facilities or the conduct of activities that present a potential threat to the health and safety of workers, public, or the environment, including: Hazard Category 1 and 2 nuclear facilities and activities, as defined in DOE 5480.23. Selected Hazard Category 3 nuclear, and Low Hazard non-nuclear facilities and activities, as agreed upon by RL. The Postirradiation Testing Laboratory (PTL) S/RID contains standards/ requirements that are necessary for safe operation of the PTL facility, and other building/areas that are the direct responsibility of the specific facility manager. The specific DOE Orders, regulations, industry codes/standards, guidance documents and good industry practices that serve as the basis for each element/subelement are identified and aligned with each subelement.« less

Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study.

PubMed

Ishida, Takashi; Jo, Tatsuro; Takemoto, Shigeki; Suzushima, Hitoshi; Uozumi, Kimiharu; Yamamoto, Kazuhito; Uike, Naokuni; Saburi, Yoshio; Nosaka, Kisato; Utsunomiya, Atae; Tobinai, Kensei; Fujiwara, Hiroshi; Ishitsuka, Kenji; Yoshida, Shinichiro; Taira, Naoya; Moriuchi, Yukiyoshi; Imada, Kazunori; Miyamoto, Toshihiro; Akinaga, Shiro; Tomonaga, Masao; Ueda, Ryuzo

2015-06-01

This multicentre, randomized, phase II study was conducted to examine whether the addition of mogamulizumab, a humanized anti-CC chemokine receptor 4 antibody, to mLSG15, a dose-intensified chemotherapy, further increases efficacy without compromising safety of patients with newly diagnosed aggressive adult T-cell leukaemia-lymphoma (ATL). Patients were assigned 1:1 to receive mLSG15 plus mogamulizumab or mLSG15 alone. The primary endpoint was the complete response rate (%CR); secondary endpoints included the overall response rate (ORR) and safety. The %CR and ORR in the mLSG15-plus-mogamulizumab arm (n = 29) were 52% [95% confidence interval (CI), 33-71%] and 86%, respectively; the corresponding values in the mLSG15 arm (n = 24) were 33% (95% CI, 16-55%) and 75%, respectively. Grade ≥ 3 treatment-emergent adverse events, including anaemia, thrombocytopenia, lymphopenia, leucopenia and decreased appetite, were observed more frequently (≥10% difference) in the mLSG15-plus-mogamulizumab arm. Several adverse events, including skin disorders, cytomegalovirus infection, pyrexia, hyperglycaemia and interstitial lung disease, were observed only in the mLSG15-plus-mogamulizumab arm. Although the combination strategy showed a potentially less favourable safety profile, a higher %CR was achieved, providing the basis for further investigation of this novel treatment for newly diagnosed aggressive ATL. This study was registered at ClinicalTrials.gov, identifier: NCT01173887. © 2015 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Phase I (Safety) Study of Autologous Tolerogenic Dendritic Cells in Type 1 Diabetic Patients

PubMed Central

Giannoukakis, Nick; Phillips, Brett; Finegold, David; Harnaha, Jo; Trucco, Massimo

2011-01-01

OBJECTIVE The safety of dendritic cells to selectively suppress autoimmunity, especially in type 1 diabetes, has never been ascertained. We investigated the safety of autologous dendritic cells, stabilized into an immunosuppressive state, in established adult type 1 diabetic patients. RESEARCH DESIGN AND METHODS A randomized, double-blind, phase I study was conducted. A total of 10, otherwise generally healthy, insulin-requiring type 1 diabetic patients between 18 and 60 years of age, without any other known or suspected health conditions, received autologous dendritic cells, unmanipulated or engineered ex vivo toward an immunosuppressive state. Ten million cells were administered intradermally in the abdomen once every 2 weeks for a total of four administrations. The primary end point determined the proportion of patients with adverse events on the basis of the physician’s global assessment, hematology, biochemistry, and immune monitoring for a period of 12 months. RESULTS The dendritic cells were safely tolerated. There were no discernible adverse events in any patient throughout the study. Other than a significant increase in the frequency of peripheral B220+ CD11c− B cells, mainly seen in the recipients of engineered dendritic cells during the dendritic cell administration period, there were no statistically relevant differences in other immune populations or biochemical, hematological, and immune biomarkers compared with baseline. CONCLUSIONS Treatment with autologous dendritic cells, in a native state or directed ex vivo toward a tolerogenic immunosuppressive state, is safe and well tolerated. Dendritic cells upregulated the frequency of a potentially beneficial B220+ CD11c− B-cell population, at least in type 1 diabetes autoimmunity. PMID:21680720

A strategic management model for evaluation of health, safety and environmental performance.

PubMed

Abbaspour, Majid; Toutounchian, Solmaz; Roayaei, Emad; Nassiri, Parvin

2012-05-01

Strategic health, safety, and environmental management system (HSE-MS) involves systematic and cooperative planning in each phase of the lifecycle of a project to ensure that interaction among the industry group, client, contractor, stakeholder, and host community exists with the highest level of health, safety, and environmental standard performances. Therefore, it seems necessary to assess the HSE-MS performance of contractor(s) by a comparative strategic management model with the aim of continuous improvement. The present Strategic Management Model (SMM) has been illustrated by a case study and the results show that the model is a suitable management tool for decision making in a contract environment, especially in oil and gas fields and based on accepted international standards within the framework of management deming cycle. To develop this model, a data bank has been created, which includes the statistical data calculated by converting the HSE performance qualitative data into quantitative values. Based on this fact, the structure of the model has been formed by defining HSE performance indicators according to the HSE-MS model. Therefore, 178 indicators have been selected which have been grouped into four attributes. Model output provides quantitative measures of HSE-MS performance as a percentage of an ideal level with maximum possible score for each attribute. Defining the strengths and weaknesses of the contractor(s) is another capability of this model. On the other hand, this model provides a ranking that could be used as the basis for decision making at the contractors' pre-qualification phase or during the execution of the project.

PHP-HT (VitaResc Biotech).

PubMed

Baldwin, A; Wiley, E

2001-04-01

VitaResc (formerly Apex) is developing PHP-HT, pyridoxalated hemoglobin polyoxyethylene conjugate, for the potential treatment of nitric oxide-induced shock (characterized by hypotension), associated with various etiologies, initially in septic shock. A phase I safety study and an initial phase I/II patient trial for NO-induced shock have been completed, and VitaResc has enrolled patients in three of five planned cohorts in a continuation of these trials to include a protocol of continuous infusion and dose escalation [330680,349187,390918]. The results from the dose escalation trials are expected to provide the basis for a randomized, controlled phase II/III pivotal trial of PHP-HT [390918]. VitaResc has licensed PHP-HT exclusively from Ajinomoto for all indications, worldwide, except Japan [275263]. Ajinomoto originally developed the human derived and chemically modified hemoglobin preparation as a blood substitute, but no development has been reported by the company since 1997 [275277,303577]. The other potential indications of PHP-HT include shock associated with burns, pancreatitis, hemodialysis and cytokine therapies [275277]. VitaResc expects the annual market potential of PHP-HT to exceed 1 billion dollars [330680].

Multiphase flow and transport in porous media

NASA Astrophysics Data System (ADS)

Parker, J. C.

1989-08-01

Multiphase flow and transport of compositionally complex fluids in geologic media is of importance in a number of applied problems which have major social and economic effects. In petroleum reservoir engineering, efficient recovery of energy reserves is the principal goal. Unfortunately, some of these hydrocarbons and other organic chemicals often find their way unwanted into the soils and groundwater supplies. Removal in the latter case is predicated on ensuring the public health and safety. In this paper, principles of modeling fluid flow in systems containing up to three fluid phases (namely, water, air, and organic liquid) are described. Solution of the governing equations for multiphase flow requires knowledge of functional relationships between fluid pressures, saturations, and permeabilities which may be formulated on the basis of conceptual models of fluid-porous media interactions. Mechanisms of transport in multicomponent multiphase systems in which species may partition between phases are also described, and the governing equations are presented for the case in which local phase equilibrium may be assumed. A number of hypothetical numerical problems are presented to illustrate the physical behavior of systems in which multiphase flow and transport arise.

Current Sports: Medicine Issues. Annual Safety Education Review--1973.

ERIC Educational Resources Information Center

Craig, Timothy T., Ed.

This document is a collection of papers whose theme is sports safety. Section one, "Government Interest in Sports Safety," includes an article on Washington, D.C.'s focus on sports safety. Section two, "Medical Aspects of Safety in Sports," includes articles regarding the medical basis of restriction from athletics, orthopaedic restrictions, and…

The Dread Factor: How Hazards and Safety Training Influence Learning and Performance

ERIC Educational Resources Information Center

Burke, Michael J.; Salvador, Rommel O.; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous…

Improving traffic safety culture in Iowa : phase II.

DOT National Transportation Integrated Search

2013-07-01

Phase II of Improving Traffic Safety Culture in Iowa focuses on producing actions that will improve the traffic safety culture across the state, and involves collaboration among the three large public universities in Iowa: Iowa State University, Univ...

Transportation Safety Information Report : Second Quarter 1984

DOT National Transportation Integrated Search

1984-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Transportation Safety Information Report : Second Quarter 1985

DOT National Transportation Integrated Search

1985-10-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Orbital transfer vehicle concept definition and systems analysis study. Volume 11: Study extension 2 results

NASA Technical Reports Server (NTRS)

Willcockson, W. H.

1988-01-01

Work conducted in the second extension of the Phase A Orbit Transfer Vehicle Concept Definition and Systems Analysis Study is summarized. Four major tasks were identified: (1) define an initial OTV program consistent with near term Civil Space Leadership Initiative missions; (2) develop program evolution to long term advanced missions; (3) investigate the implications of current STS safety policy on an Aft Cargo Carrier based OTV; and (4) expand the analysis of high entry velocity aeroassist. An increased emphasis on the breath of OTV applications was undertaken to show the need for the program on the basis of the expansion of the nation's capabilities in space.

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

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

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

Phase I Dose-Escalation Trial of PT2385, a First-in-Class Hypoxia-Inducible Factor-2α Antagonist in Patients With Previously Treated Advanced Clear Cell Renal Cell Carcinoma.

PubMed

Courtney, Kevin D; Infante, Jeffrey R; Lam, Elaine T; Figlin, Robert A; Rini, Brian I; Brugarolas, James; Zojwalla, Naseem J; Lowe, Ann M; Wang, Keshi; Wallace, Eli M; Josey, John A; Choueiri, Toni K

2018-03-20

Purpose The von Hippel-Lindau tumor suppressor is inactivated in the majority of clear cell renal cell carcinomas (ccRCCs), leading to inappropriate stabilization of hypoxia-inducible factor-2α (HIF-2α). PT2385 is a first-in-class HIF-2α antagonist. Objectives of this first-in-human study were to characterize the safety, pharmacokinetics, pharmacodynamics, and efficacy, and to identify the recommended phase II dose (RP2D) of PT2385. Patients and Methods Eligible patients had locally advanced or metastatic ccRCC that had progressed during one or more prior regimens that included a vascular endothelial growth factor inhibitor. PT2385 was administered orally at twice-per-day doses of 100 to 1,800 mg, according to a 3 + 3 dose-escalation design, followed by an expansion phase at the RP2D. Results The dose-escalation and expansion phases enrolled 26 and 25 patients, respectively. Patients were heavily pretreated, with a median of four (range, one to seven) prior therapies. No dose-limiting toxicity was observed at any dose. On the basis of safety, pharmacokinetic, and pharmacodynamic profiling, the RP2D was defined as 800 mg twice per day. PT2385 was well tolerated, with anemia (grade 1 to 2, 35%; grade 3, 10%), peripheral edema (grade 1 to 2, 37%; grade 3, 2%), and fatigue (grade 1 to 2, 37%; no grade 3 or 4) being the most common treatment-emergent adverse events. No patients discontinued treatment because of adverse events. Complete response, partial response, and stable disease as best response were achieved by 2%, 12%, and 52% of patients, respectively. At data cutoff, eight patients remained in the study, with 13 patients in the study for ≥ 1 year. Conclusion PT2385 has a favorable safety profile and is active in patients with heavily pretreated ccRCC, validating direct HIF-2α antagonism for the treatment of patients with ccRCC.

Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

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

Pugliese, S.M.

1977-02-01

In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

Safety and Activity of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study.

PubMed

Moore, Kathleen N; Martin, Lainie P; O'Malley, David M; Matulonis, Ursula A; Konner, Jason A; Perez, Raymond P; Bauer, Todd M; Ruiz-Soto, Rodrigo; Birrer, Michael J

2017-04-01

Purpose This phase I expansion cohort study evaluated the safety and clinical activity of mirvetuximab soravtansine (IMGN853), an antibody-drug conjugate consisting of a humanized anti-folate receptor alpha (FRα) monoclonal antibody linked to the tubulin-disrupting maytansinoid DM4, in a population of patients with FRα-positive and platinum-resistant ovarian cancer. Patients and Methods Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer received IMGN853 at 6.0 mg/kg (adjusted ideal body weight) once every 3 weeks. Eligibility included a minimum requirement of FRα positivity by immunohistochemistry (≥ 25% of tumor cells with at least 2+ staining intensity). Adverse events, tumor response (via Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), and progression-free survival (PFS) were determined. Results Forty-six patients were enrolled. Adverse events were generally mild (≤ grade 2), with diarrhea (44%), blurred vision (41%), nausea (37%), and fatigue (30%) being the most commonly observed treatment-related toxicities. Grade 3 fatigue and hypotension were reported in two patients each (4%). For all evaluable patients, the confirmed objective response rate was 26%, including one complete and 11 partial responses, and the median PFS was 4.8 months. The median duration of response was 19.1 weeks. Notably, in the subset of patients who had received three or fewer prior lines of therapy (n = 23), an objective response rate of 39%, PFS of 6.7 months, and duration of response of 19.6 weeks were observed. Conclusion IMGN853 exhibited a manageable safety profile and was active in platinum-resistant ovarian cancer, with the strongest signals of efficacy observed in less heavily pretreated individuals. On the basis of these findings, the dose, schedule, and target population were identified for a phase III trial of IMGN853 monotherapy in patients with platinum-resistant disease.

Safety and Activity of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha–Targeting Antibody–Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study

PubMed Central

Martin, Lainie P.; O’Malley, David M.; Matulonis, Ursula A.; Konner, Jason A.; Perez, Raymond P.; Bauer, Todd M.; Ruiz-Soto, Rodrigo; Birrer, Michael J.

2017-01-01

Purpose This phase I expansion cohort study evaluated the safety and clinical activity of mirvetuximab soravtansine (IMGN853), an antibody–drug conjugate consisting of a humanized anti–folate receptor alpha (FRα) monoclonal antibody linked to the tubulin-disrupting maytansinoid DM4, in a population of patients with FRα-positive and platinum-resistant ovarian cancer. Patients and Methods Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer received IMGN853 at 6.0 mg/kg (adjusted ideal body weight) once every 3 weeks. Eligibility included a minimum requirement of FRα positivity by immunohistochemistry (≥ 25% of tumor cells with at least 2+ staining intensity). Adverse events, tumor response (via Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), and progression-free survival (PFS) were determined. Results Forty-six patients were enrolled. Adverse events were generally mild (≤ grade 2), with diarrhea (44%), blurred vision (41%), nausea (37%), and fatigue (30%) being the most commonly observed treatment-related toxicities. Grade 3 fatigue and hypotension were reported in two patients each (4%). For all evaluable patients, the confirmed objective response rate was 26%, including one complete and 11 partial responses, and the median PFS was 4.8 months. The median duration of response was 19.1 weeks. Notably, in the subset of patients who had received three or fewer prior lines of therapy (n = 23), an objective response rate of 39%, PFS of 6.7 months, and duration of response of 19.6 weeks were observed. Conclusion IMGN853 exhibited a manageable safety profile and was active in platinum-resistant ovarian cancer, with the strongest signals of efficacy observed in less heavily pretreated individuals. On the basis of these findings, the dose, schedule, and target population were identified for a phase III trial of IMGN853 monotherapy in patients with platinum-resistant disease. PMID:28029313

Characterization of NiTi Shape Memory Damping Elements designed for Automotive Safety Systems

NASA Astrophysics Data System (ADS)

Strittmatter, Joachim; Clipa, Victor; Gheorghita, Viorel; Gümpel, Paul

2014-07-01

Actuator elements made of NiTi shape memory material are more and more known in industry because of their unique properties. Due to the martensitic phase change, they can revert to their original shape by heating when subjected to an appropriate treatment. This thermal shape memory effect (SME) can show a significant shape change combined with a considerable force. Therefore such elements can be used to solve many technical tasks in the field of actuating elements and mechatronics and will play an increasing role in the next years, especially within the automotive technology, energy management, power, and mechanical engineering as well as medical technology. Beside this thermal SME, these materials also show a mechanical SME, characterized by a superelastic plateau with reversible elongations in the range of 8%. This behavior is based on the building of stress-induced martensite of loaded austenite material at constant temperature and facilitates a lot of applications especially in the medical field. Both SMEs are attended by energy dissipation during the martensitic phase change. This paper describes the first results obtained on different actuator and superelastic NiTi wires concerning their use as damping elements in automotive safety systems. In a first step, the damping behavior of small NiTi wires up to 0.5 mm diameter was examined at testing speeds varying between 0.1 and 50 mm/s upon an adapted tensile testing machine. In order to realize higher testing speeds, a drop impact testing machine was designed, which allows testing speeds up to 4000 mm/s. After introducing this new type of testing machine, the first results of vertical-shock tests of superelastic and electrically activated actuator wires are presented. The characterization of these high dynamic phase change parameters represents the basis for new applications for shape memory damping elements, especially in automotive safety systems.

Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

PubMed

Novák, Zoltán; Yáñez, Anahí; Kiss, Ildikó; Kuna, Piotr; Tortajada-Girbés, Miguel; Valiente, Román

2016-08-01

Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria. © 2016 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

Establishing research priorities for patient safety in emergency medicine: a multidisciplinary consensus panel.

PubMed

Plint, Amy C; Stang, Antonia S; Calder, Lisa A

2015-01-01

Patient safety in the context of emergency medicine is a relatively new field of study. To date, no broad research agenda for patient safety in emergency medicine has been established. The objective of this study was to establish patient safety-related research priorities for emergency medicine. These priorities would provide a foundation for high-quality research, important direction to both researchers and health-care funders, and an essential step in improving health-care safety and patient outcomes in the high-risk emergency department (ED) setting. A four-phase consensus procedure with a multidisciplinary expert panel was organized to identify, assess, and agree on research priorities for patient safety in emergency medicine. The 19-member panel consisted of clinicians, administrators, and researchers from adult and pediatric emergency medicine, patient safety, pharmacy, and mental health; as well as representatives from patient safety organizations. In phase 1, we developed an initial list of potential research priorities by electronically surveying a purposeful and convenience sample of patient safety experts, ED clinicians, administrators, and researchers from across North America using contact lists from multiple organizations. We used simple content analysis to remove duplication and categorize the research priorities identified by survey respondents. Our expert panel reached consensus on a final list of research priorities through an in-person meeting (phase 3) and two rounds of a modified Delphi process (phases 2 and 4). After phases 1 and 2, 66 unique research priorities were identified for expert panel review. At the end of phase 4, consensus was reached for 15 research priorities. These priorities represent four themes: (1) methods to identify patient safety issues (five priorities), (2) understanding human and environmental factors related to patient safety (four priorities), (3) the patient perspective (one priority), and (4) interventions for improving patient safety (five priorities). This study established expert, consensus-based research priorities for patient safety in emergency medicine. This framework could be used by researchers and health-care funders and represents an essential guiding step towards enhancing quality of care and patient safety in the ED.

National Dam Safety Program. Brocton Reservoir (Inventory Number NY 785) , Lake Erie Basin, Chautauqua County, New York. Phase I Inspection Report

DTIC Science & Technology

1980-09-26

Inspection Report Brocton Reservoir National Dam Safety Program Lake Erie Basin, Chautauqua County, New York 6. PERFORMING ORG. REPORT NUMBER Inventory No...LAKE ERIE BASIN BROCTON RESERVOIR I ’CHAUTAUQUA COUNTY, NEW YORK I INVENTORY NO. N.Y. 785 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAMI. I...Drawings I I I I I I I I I I PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAIM NAME OF DAM: Brocton Reservoir Inventory No. N.Y. 785 I STATE LOCATED

Recent findings relating to firefighter safety zones

Treesearch

Bret Butler; Russ Parsons; William Mell

2015-01-01

Designation of safety zones is a primary duty of all wildland firefighters. Unfortunately, information regarding what constitutes an adequate safety zone is inadequately defined. Measurements of energy release from wildland fires have been used to develop an empirically based safety zone guideline. The basis for this work is described here.

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2011 CFR

2011-01-01

... occurrences, design basis accidents, external events, and natural phenomena for which the plant must be... important to safety, (2) protection of electric equipment important to safety against other natural phenomena and external events, and (3) environmental qualification of electric equipment important to safety...

A uniform transit safety records system for the Commonwealth of Virginia.

DOT National Transportation Integrated Search

1981-01-01

This study was conceived as the first phase of a three-phase program to develop a safety data base for intracity bus transit. It involved reviewing the state of the art of general transportation safety management, examining the current intracity bus ...

External Quality Assessment beyond the analytical phase: an Australian perspective.

PubMed

Badrick, Tony; Gay, Stephanie; McCaughey, Euan J; Georgiou, Andrew

2017-02-15

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion.

External Quality Assessment beyond the analytical phase: an Australian perspective

PubMed Central

Gay, Stephanie; McCaughey, Euan J.; Georgiou, Andrew

2017-01-01

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion. PMID:28392728

30 CFR 75.806 - Connection of single-phase loads.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Connection of single-phase loads. 75.806 Section 75.806 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Underground High-Voltage Distribution...

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

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

2005-01-01

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

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

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

2005-01-01

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

A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.

PubMed

André, F E; Foulkes, M A

1998-01-01

The overall intent of clinical testing is to establish, in a series of phased studies, the clinical tolerance and acceptable "safety" of the candidate vaccine, as well as the type, level and persistence of the immune response after its inoculation, to a representative target population, according to a convenient administration schedule. The final stages involve the direct or indirect demonstration of protective efficacy, if possible in the population(s) for which the vaccine is intended. In addition, consistency of production must be demonstrated. At all these stages, the amount of prior information from preclinical and other studies affects and informs the objectives and design of subsequent studies. Progression from one testing phase to the next is dependent upon attaining the pre-set objectives of each series of studies. The precise objectives to be met will be decided on a case-by-case basis. The earliest assessments in humans (Phase I) involve evaluation of short-term clinical tolerance as measured by local and general reactogenicity, and gross assessments of immunogenicity, in a small number of highly selected individuals in an idealised situation. The selection of "optimal" dose and schedule are the result of further dose-ranging investigations (Phase II), involving more volunteers, with longer, more detailed follow-up assessments. It is at this stage that the accumulated evidence on its immunogenicity profile should be sufficient to assess whether or not the vaccine is worthy of further development. The next level of investigation (Phase III) aims to measure with greater precision the vaccine protective efficacy in the intended target population(s) by comparison of infection and/or disease attack rates in vaccine and placebo recipients. In consistency studies different production lots, manufactured at commercial scale, are tested to demonstrate consistency of manufacture. Additional bridging studies to establish similarity of lots at different production scales, or studies of the duration of the immunity conferred, are conducted in parallel with the progression of the studies in the different phases mentioned above. These latter types of studies are usually carried out concurrently with Phase III studies. This progression continues into the post-marketing period (Phase IV) with surveillance of long term efficacy and observational studies of possible rare adverse events to establish "safety" with more confidence. This paper examines, in general, the aims and designs of studies in each phase as an introduction to the more specific publications that follow.

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2012 CFR

2012-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2014 CFR

2014-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2013 CFR

2013-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia.

PubMed

Carpiniello, Bernardo; Pinna, Federica

2016-01-01

Three-monthly injections of paliperidone palmitate (PP-3M) represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario. An analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs). The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores), in addition to reasonably good safety and tolerability profiles. PP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be conducted to confirm this expectation. In view of its efficacy, tolerability, and safety, together with the longer timespan between injections, PP-3M currently represents one of the best available options, and may contribute towards addressing the issue of poor adherence, even in early psychosis.

RMP-02/MTN-006: A Phase 1 Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Tenofovir 1% Gel Compared with Oral Tenofovir Disoproxil Fumarate

PubMed Central

Cranston, Ross D.; Kashuba, Angela; Hendrix, Craig W.; Bumpus, Namandjé N.; Richardson-Harman, Nicola; Elliott, Julie; Janocko, Laura; Khanukhova, Elena; Dennis, Robert; Cumberland, William G.; Ju, Chuan; Carballo-Diéguez, Alex; Mauck, Christine; McGowan, Ian

2012-01-01

Abstract This study was designed to assess the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic (PD) responses to rectal administration of tenofovir (TFV) 1% vaginally formulated gel and oral tenofovir disoproxil fumarate (TDF). This study was designed as a phase 1, randomized, two-site (United States), double-blind, placebo-controlled study of sexually abstinent men and women. Eighteen participants received a single 300-mg exposure of oral TDF and were then randomized 2:1 to receive a single and then seven daily exposures of rectal TFV or hydroxyethyl cellulose (HEC) placebo gel. Safety endpoints included clinical adverse events (AEs) and mucosal safety parameters. Blood and colonic biopsies were collected for PK analyses and ex vivo HIV-1 challenge. No serious AEs were reported. However, AEs were significantly increased with 7-day TFV gel use, most prominently with gastrointestinal AEs (p=0.002). Only 25% of participants liked the TFV gel. Likelihood of use “if somewhat protective” was ∼75% in both groups. Indices of mucosal damage showed minimal changes. Tissue TFV diphosphate (TFV-DP) Cmax 30 min after single rectal exposure was 6–10 times greater than single oral exposure; tissue TFV-DP was 5.7 times greater following 7-day versus single rectal exposure. In vivo exposure correlated with significant ex vivo tissue infectibility suppression [single-rectal: p=0.12, analysis of covariance (ANCOVA) p=0.006; 7-day rectal: p=0.02, ANCOVA p=0.005]. Tissue PK–PD was significantly correlated (p=0.002). We conclude that rectal dosing with TFV 1% gel resulted in greater TFV-DP tissue detection than oral dosing with reduced ex vivo biopsy infectibility, enabling PK–PD correlations. On the basis of increased gastrointestinal AEs, rectally applied, vaginally formulated TFV was not entirely safe or acceptable, suggesting the need for alternative rectal-specific formulations. PMID:22943559

Rationales for home safety promotion in the Iranian primary healthcare system: results from a pilot study.

PubMed

Mohammadi, R; Ekman, R; Svanström, L; Gooya, M M

2006-01-01

To analyse the prerequisites for a nationwide primary healthcare (PHC) home safety promotion programme in Iran. Injury is a major public health problem throughout the world, currently accounting for one-seventh of all premature deaths and disabilities. Within 20 years, it is estimated that the proportion will increase to one-fifth. The present healthcare system in Iran was started in 1979, with a major focus on easy access to services and prevention. The system is based on the 'health house', which is run by community health workers. A survey shows that 36% of injuries occur in the home environment. A pilot phase of the Home Safety Promotion Programme was initiated in 1994, and included safety checking at home for fences, kitchens, drugs and poisons, heaters, electricity, and stairs and ladders. The pilot study covered 478,551 households out of the 12 million (approximately) in Iran. Sixty-nine supervisors were involved individually, assembled into eight focus groups. Household safety increased by 10-20% over the 4 years of the study. The frequency of home visits changed from annual to seasonal, since all participants agreed that there were seasonal differences in safety problems. The supervisors showed a high level of knowledge of injury as a public health problem, and also positive attitudes towards doing something about safety on the basis of a PHC scheme. The role of a surveillance system was highlighted, and it was suggested that such a system should be added to the programme. Based on our preliminary findings, there were reasons to obtain a policy decision concerning a national programme for safety promotion before extending the pilot scheme to the whole country. A national safety programme was decided upon following completion of the pilot study. It includes a home-related-injury surveillance system that is mandatory in rural areas and voluntary in some cities.

Global Precipitation Measurement (GPM) Safety Inhibit Timeline Tool

NASA Technical Reports Server (NTRS)

Dion, Shirley

2012-01-01

The Global Precipitation Measurement (GPM) Observatory is a joint mission under the partnership by National Aeronautics and Space Administration (NASA) and the Japan Aerospace Exploration Agency (JAXA), Japan. The NASA Goddard Space Flight Center (GSFC) has the lead management responsibility for NASA on GPM. The GPM program will measure precipitation on a global basis with sufficient quality, Earth coverage, and sampling to improve prediction of the Earth's climate, weather, and specific components of the global water cycle. As part of the development process, NASA built the spacecraft (built in-house at GSFC) and provided one instrument (GPM Microwave Imager (GMI) developed by Ball Aerospace) JAXA provided the launch vehicle (H2-A by MHI) and provided one instrument (Dual-Frequency Precipitation Radar (DPR) developed by NTSpace). Each instrument developer provided a safety assessment which was incorporated into the NASA GPM Safety Hazard Assessment. Inhibit design was reviewed for hazardous subsystems which included the High Gain Antenna System (HGAS) deployment, solar array deployment, transmitter turn on, propulsion system release, GMI deployment, and DPR radar turn on. The safety inhibits for these listed hazards are controlled by software. GPM developed a "pathfinder" approach for reviewing software that controls the electrical inhibits. This is one of the first GSFC in-house programs that extensively used software controls. The GPM safety team developed a methodology to document software safety as part of the standard hazard report. As part of this process a new tool "safety inhibit time line" was created for management of inhibits and their controls during spacecraft buildup and testing during 1& Tat GSFC and at the Range in Japan. In addition to understanding inhibits and controls during 1& T the tool allows the safety analyst to better communicate with others the changes in inhibit states with each phase of hardware and software testing. The tool was very useful for communicating compliance with safety requirements especially when working with a foreign partner.

Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

PubMed

Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

2016-12-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

76 FR 10524 - Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 571 and 585 [Docket No. NHTSA-2011-0004] RIN 2127-AK23 Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements; Incorporation by Reference Correction In rule document 2011-547...

Users perspectives on interactive distance technology enabling home-based motor training for stroke patients.

PubMed

Ehn, Maria; Hansson, Pär; Sjölinder, Marie; Boman, Inga-Lill; Folke, Mia; Sommerfeld, Disa; Borg, Jörgen; Palmcrantz, Susanne

2015-01-01

The aim of this work has been to develop a technical support enabling home-based motor training after stroke. The basis for the work plan has been to develop an interactive technical solution supporting three different groups of stroke patients: (1) patients with stroke discharged from hospital with support from neuro team; (2) patients with stroke whose support from neuro team will be phased out and (3) patients living with impaired motor functions long-term. The technology has been developed in close collaboration with end-users using a method earlier evaluated and described [12]. This paper describes the main functions of the developed technology. Further, results from early user-tests with end-users, performed to identify needs for improvements to be carried out during further technical development. The developed technology will be tested further in a pilot study of the safety and, usefulness of the technology when applied as a support for motor training in three different phases of the post-stroke rehabilitation process.

Analyses in support of risk-informed natural gas vehicle maintenance facility codes and standards :

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

Ekoto, Isaac W.; Blaylock, Myra L.; LaFleur, Angela Christine

2014-03-01

Safety standards development for maintenance facilities of liquid and compressed gas fueled large-scale vehicles is required to ensure proper facility design and operation envelopes. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase I work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest. Finally, scenario analyses were performed using detailed simulations and modeling to estimate the overpressure hazardsmore » from HAZOP defined scenarios. The results from Phase I will be used to identify significant risk contributors at NGV maintenance facilities, and are expected to form the basis for follow-on quantitative risk analysis work to address specific code requirements and identify effective accident prevention and mitigation strategies.« less

Vehicle fires and fire safety in tunnels

DOT National Transportation Integrated Search

2002-09-20

Tunnels present what is arguably the most hazardous environment, from the point of view of fire safety, that members of the public ever experience. The fire safety design of tunnels is carried out by tunnel engineers on the basis of a potential fire ...

Identifying User Needs and the Participative Design Process

NASA Astrophysics Data System (ADS)

Meiland, Franka; Dröes, Rose-Marie; Sävenstedt, Stefan; Bergvall-Kåreborn, Birgitta; Andersson, Anna-Lena

As the number of persons with dementia increases and also the demands on care and support at home, additional solutions to support persons with dementia are needed. The COGKNOW project aims to develop an integrated, user-driven cognitive prosthetic device to help persons with dementia. The project focuses on support in the areas of memory, social contact, daily living activities and feelings of safety. The design process is user-participatory and consists of iterative cycles at three test sites across Europe. In the first cycle persons with dementia and their carers (n = 17) actively participated in the developmental process. Based on their priorities of needs and solutions, on their disabilities and after discussion between the team, a top four list of Information and Communication Technology (ICT) solutions was made and now serves as the basis for development: in the area of remembering - day and time orientation support, find mobile service and reminding service, in the area of social contact - telephone support by picture dialling, in the area of daily activities - media control support through a music playback and radio function, and finally, in the area of safety - a warning service to indicate when the front door is open and an emergency contact service to enhance feelings of safety. The results of this first project phase show that, in general, the people with mild dementia as well as their carers were able to express and prioritize their (unmet) needs, and the kind of technological assistance they preferred in the selected areas. In next phases it will be tested if the user-participatory design and multidisciplinary approach employed in the COGKNOW project result in a user-friendly, useful device that positively impacts the autonomy and quality of life of persons with dementia and their carers.

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Good practices on cost - effective road infrastructure safety investments.

PubMed

Yannis, George; Papadimitriou, Eleonora; Evgenikos, Petros; Dragomanovits, Anastasios

2016-12-01

The paper presents the findings of a research project aiming to quantify and subsequently classify several infrastructure-related road safety measures, based on the international experience attained through extensive and selected literature review and additionally on a full consultation process including questionnaire surveys addressed to experts and relevant workshops. Initially, a review of selected research reports was carried out and an exhaustive list of road safety infrastructure investments covering all types of infrastructure was compiled. Individual investments were classified according to the infrastructure investment area and the type of investment and were thereafter analysed on the basis of key safety components. These investments were subsequently ranked in relation to their safety effects and implementation costs and on the basis of this ranking, a set of five most promising investments was selected for an in-depth analysis. The results suggest that the overall cost effectiveness of a road safety infrastructure investment is not always in direct correlation with the safety effect and is recommended that cost-benefit ratios and safety effects are always examined in conjunction with each other in order to identify the optimum solution for a specific road safety problem in specific conditions and with specific objectives.

26 CFR 1.187-1 - Amortization of certain coal mine safety equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 3 2010-04-01 2010-04-01 false Amortization of certain coal mine safety... (continued) § 1.187-1 Amortization of certain coal mine safety equipment. (a) Allowance of deduction—(1) In... respect to the amortization of the adjusted basis (for determining gain) of any certified coal mine safety...

76 FR 22812 - Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

...-AA00 Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION... navigable waters of Mission Bay in support of the Sea World Fireworks. This safety zone is necessary to... impracticable, because immediate action is needed to ensure the public's safety. Basis and Purpose Sea World is...

Rational and irrational clinical strategies for collaborative medicine.

PubMed

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

A Method for Developing Standard Patient Education Program.

PubMed

Lura, Carolina Bryne; Hauch, Sophie Misser Pallesgaard; Gøeg, Kirstine Rosenbeck; Pape-Haugaard, Louise

2018-01-01

In Denmark, patients being treated on Haematology Outpatients Departments get instructed to self-manage their blood sample collection from Central Venous Catheter (CVC). However, this is a complex and risky procedure, which can jeopardize patient safety. The aim of the study was to suggest a method for developing standard digital patient education programs for patients in self-administration of blood samples drawn from CVC. The Design Science Research Paradigm was used to develop a digital patient education program, called PAVIOSY, to increase patient safety during execution of the blood sample collection procedure by using videos for teaching as well as procedural support. A step-by-step guide was developed and used as basis for making the videos. Quality assurance through evaluation with a nurse was conducted on both the step-by-step guide and the videos. The quality assurance evaluation of the videos showed; 1) Errors due to the order of the procedure can be determined by reviewing the videos despite that the guide was followed. 2) Videos can be used to identify errors - important for patient safety - in the procedure, which are not identifiable in a written script. To ensure correct clinical content of the educational patient system, health professionals must be engaged early in the development of content and design phase.

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial.

PubMed

Inoue, Nagamu; Kobayashi, Kiyonori; Naganuma, Makoto; Hirai, Fumihito; Ozawa, Morio; Arikan, Dilek; Huang, Bidan; Robinson, Anne M; Thakkar, Roopal B; Hibi, Toshifumi

2017-07-01

Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

PubMed

Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

A trial of an all-terrain vehicle safety education video in a community-based hunter education program.

PubMed

Williams, Robert S; Graham, James; Helmkamp, James C; Dick, Rhonda; Thompson, Tonya; Aitken, Mary E

2011-01-01

All-terrain vehicle (ATV) injury is an increasingly serious problem, particularly among rural youth. There have been repeated calls for ATV safety education, but little study regarding optimal methods or content for such education. The purpose of this study was to determine if an ATV safety video was effective in increasing ATV safety knowledge when used in a community-based statewide hunter education program. During the baseline phase, surveys focusing on ATV safety were distributed to students in the Arkansas hunter safety program in 2006. In the intervention phase a year later, an ATV safety video on DVD was provided for use in required hunter education courses across Arkansas. The same survey was administered to hunter education students before and after the course. In the baseline phase, 1,641 precourse and 1,374 postcourse surveys were returned and analyzed. In the intervention phase, 708 precourse and 694 postcourse surveys were completed. Student knowledge of ATV safety after watching the video was higher than in preintervention classes. Knowledge of appropriate helmet usage increased from 95% to 98.8% (P < .0001). Awareness of the importance of not carrying a passenger behind the driver increased from 59.5% to 91.1% (P < .0001). Awareness of importance of hands-on ATV rider training increased from 82.1% to 92.4% (P < .0001). A brief ATV safety video used in a hunter education course increased ATV safety knowledge on most measures. A statewide hunter education program appears to be a useful venue for ATV safety education. © 2010 National Rural Health Association.

RELAP-7 Closure Correlations

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

Zou, Ling; Berry, R. A.; Martineau, R. C.

The RELAP-7 code is the next generation nuclear reactor system safety analysis code being developed at the Idaho National Laboratory (INL). The code is based on the INL’s modern scientific software development framework, MOOSE (Multi-Physics Object Oriented Simulation Environment). The overall design goal of RELAP-7 is to take advantage of the previous thirty years of advancements in computer architecture, software design, numerical integration methods, and physical models. The end result will be a reactor systems analysis capability that retains and improves upon RELAP5’s and TRACE’s capabilities and extends their analysis capabilities for all reactor system simulation scenarios. The RELAP-7 codemore » utilizes the well-posed 7-equation two-phase flow model for compressible two-phase flow. Closure models used in the TRACE code has been reviewed and selected to reflect the progress made during the past decades and provide a basis for the colure correlations implemented in the RELAP-7 code. This document provides a summary on the closure correlations that are currently implemented in the RELAP-7 code. The closure correlations include sub-grid models that describe interactions between the fluids and the flow channel, and interactions between the two phases.« less

Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial.

PubMed

Mega, J L; Braunwald, E; Mohanavelu, S; Burton, P; Poulter, R; Misselwitz, F; Hricak, V; Barnathan, E S; Bordes, P; Witkowski, A; Markov, V; Oppenheimer, L; Gibson, C M

2009-07-04

Rivaroxaban is an oral direct factor Xa inhibitor that has been effective in prevention of venous thromboembolism in patients undergoing elective orthopaedic surgery. However, its use after acute coronary syndromes has not been investigated. In this setting, we assessed the safety and efficacy of rivaroxaban and aimed to select the most favourable dose and dosing regimen. In this double-blind, dose-escalation, phase II study, undertaken at 297 sites in 27 countries, 3491 patients stabilised after an acute coronary syndrome were stratified on the basis of investigator decision to use aspirin only (stratum 1, n=761) or aspirin plus a thienopyridine (stratum 2, n=2730). Participants were randomised within each strata and dose tier with a block randomisation method at 1:1:1 to receive either placebo or rivaroxaban (at doses 5-20 mg) given once daily or the same total daily dose given twice daily. The primary safety endpoint was clinically significant bleeding (TIMI major, TIMI minor, or requiring medical attention); the primary efficacy endpoint was death, myocardial infarction, stroke, or severe recurrent ischaemia requiring revascularisation during 6 months. Safety analyses included all participants who received at least one dose of study drug; efficacy analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00402597. Three patients in stratum 1 and 26 in stratum 2 never received the study drug. The risk of clinically significant bleeding with rivaroxaban versus placebo increased in a dose-dependent manner (hazard ratios [HRs] 2.21 [95% CI 1.25-3.91] for 5 mg, 3.35 [2.31-4.87] for 10 mg, 3.60 [2.32-5.58] for 15 mg, and 5.06 [3.45-7.42] for 20 mg doses; p<0.0001). Rates of the primary efficacy endpoint were 5.6% (126/2331) for rivaroxaban versus 7.0% (79/1160) for placebo (HR 0.79 [0.60-1.05], p=0.10). Rivaroxaban reduced the main secondary efficacy endpoint of death, myocardial infarction, or stroke compared with placebo (87/2331 [3.9%] vs 62/1160 [5.5%]; HR 0.69, [95% CI 0.50-0.96], p=0.0270). The most common adverse event in both groups was chest pain (248/2309 [10.7%] vs 118/1153 [10.2%]). The use of an oral factor Xa inhibitor in patients stabilised after an acute coronary syndrome increases bleeding in a dose-dependent manner and might reduce major ischaemic outcomes. On the basis of these observations, a phase III study of low-dose rivaroxaban as adjunctive therapy in these patients is underway. Johnson & Johnson Pharmaceutical Research & Development and Bayer Healthcare AG.

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.

PubMed

Reisinger, Keith S; Block, Stanley L; Izu, Allen; Groth, Nicola; Holmes, Sandra J

2009-09-15

This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

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

NASA Astrophysics Data System (ADS)

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

1995-03-01

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

Comparative safety assessment of plant-derived foods.

PubMed

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

2008-02-01

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

47 CFR 95.1400 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Basis and purpose. 95.1400 Section 95.1400 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Personal Locator Beacons (PLB). § 95.1400 Basis and purpose. The rules in this subpart are...

Occupational Safety. Hygiene Safety. Pre-Apprenticeship Phase 1 Training.

ERIC Educational Resources Information Center

Lane Community Coll., Eugene, OR.

This self-paced student training module on hygiene safety is one of a number of modules developed for Pre-apprenticeship Phase 1 Training. Purpose of the module is to familiarize students with the different types of airborne contaminants--including noise--which may be health hazards and with the proper hygienic measures for dealing with them. The…

Occupational Safety. Hand Tools. Pre-Apprenticeship Phase 1 Training.

ERIC Educational Resources Information Center

Lane Community Coll., Eugene, OR.

This self-paced student training module on safety when using hand tools is one of a number of modules developed for Pre-apprenticeship Phase 1 Training. Purpose of the module is to teach students the correct safety techniques for operating common hand- and arm-powered tools, including selection, maintenance, technique, and uses. The module may…

A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study).

PubMed

Holland, Thomas L; O'Riordan, William; McManus, Alison; Shin, Elliot; Borghei, Ali; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Lodise, Thomas; Oguri, Toyoko; Corey, G Ralph; McLeroth, Patrick; Shukla, Rajesh; Huang, David B

2018-05-01

Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global phase 3, double-blind, randomized, active-controlled trial. Six hundred thirteen adults with acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15 mg/kg of body weight), both of which were administered intravenously every 12 h for 5 to 14 days. The primary endpoint was a ≥20% reduction in lesion size compared with that at the baseline at 48 to 72 h after the start of administration of study drug in the intent-to-treat population. Among patients randomized to iclaprim, 78.3% (231 of 295) met this primary endpoint, whereas 76.7% (234 of 305) of those receiving vancomycin met this primary endpoint (difference, 1.58%; 95% confidence interval, -5.10% to 8.26%). This met the prespecified 10% noninferiority margin. Iclaprim was well tolerated, with most adverse events being categorized as mild. In conclusion, iclaprim was noninferior to vancomycin in this phase 3 clinical trial for the treatment of acute bacterial skin and skin structure infections. On the basis of these results, iclaprim may be an efficacious and safe treatment for skin infections suspected or confirmed to be due to Gram-positive pathogens. (This trial has been registered at ClinicalTrials.gov under identifier NCT02607618.). Copyright © 2018 American Society for Microbiology.

High-Pressure Transvenous Perfusion of the Upper Extremity in Human Muscular Dystrophy: A Safety Study with 0.9% Saline.

PubMed

Fan, Zheng; Kocis, Keith; Valley, Robert; Howard, James F; Chopra, Manisha; Chen, Yasheng; An, Hongyu; Lin, Weili; Muenzer, Joseph; Powers, William

2015-09-01

We evaluated safety and feasibility of high-pressure transvenous limb perfusion in an upper extremity of adult patients with muscular dystrophy, after completing a similar study in a lower extremity. A dose escalation study of single-limb perfusion with 0.9% saline was carried out in nine adults with muscular dystrophies under intravenous analgesia. Our study demonstrates that it is feasible and definitely safe to perform high-pressure transvenous perfusion with 0.9% saline up to 35% of limb volume in the upper extremities of young adults with muscular dystrophy. Perfusion at 40% limb volume is associated with short-lived physiological changes in peripheral nerves without clinical correlates in one subject. This study provides the basis for a phase 1/2 clinical trial using pressurized transvenous delivery into upper limbs of nonambulatory patients with Duchenne muscular dystrophy. Furthermore, our results are applicable to other conditions such as limb girdle muscular dystrophy as a method for delivering regional macromolecular therapeutics in high dose to skeletal muscles of the upper extremity.

77 FR 42638 - Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... 1625-AA00 Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA AGENCY: Coast Guard... navigable waters of Mission Bay in support of the Sea World San Diego Fireworks. This safety zone is..., since immediate action is needed to ensure the public's safety. B. Basis and Purpose Sea World is...

78 FR 54280 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... safety-related batteries would remain operable if all the inter-cell and terminal connections were at the... new acceptance criteria for total battery connection resistance to ensure that the safety-related batteries can perform their specified safety function. Basis for proposed no significant hazards...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.210 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... throughout the State. The plan defines the covered occupational safety and health issues on the basis of... Section 1952.210 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... standards will be considered by the State Occupational Safety and Health Advisory Board which will make...

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children.

PubMed

Tan, Tina P; Ba, Zhaoyong; Sanders, Mary E; D'Amico, Frank J; Roberts, Robert F; Smith, Keisha H; Merenstein, Daniel J

2017-02-01

Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12-supplemented yogurt on the gut microbiota of the children. Sixty children ages 1 to 5 years were randomly assigned to consume 4 ounces of either BB-12-supplemented yogurt or nonsupplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. A total of 186 nonserious adverse events were reported, with no significant differences between the control and BB-12 groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. BB-12-supplemented yogurt is safe and well-tolerated when consumed by healthy children. The present study will form the basis for future randomized clinical trials investigating the potential effects of BB-12-supplemented yogurt in different disease states.

Biosimilars: pharmacovigilance and risk management.

PubMed

Zuñiga, Leyre; Calvo, Begoña

2010-07-01

Biosimilars cannot be authorized based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorization clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk-benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit-risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialized with a brand name or the INN plus the manufacturer's name. (c) 2010 John Wiley & Sons, Ltd.

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products...

Review article: novel oral-targeted therapies in inflammatory bowel disease.

PubMed

White, J R; Phillips, F; Monaghan, T; Fateen, W; Samuel, S; Ghosh, S; Moran, G W

2018-06-01

There is a great unmet clinical need for efficacious, tolerable, economical and orally administrated drugs for the treatment of inflammatory bowel disease (IBD). New therapeutic avenues have become possible including the development of medications that target specific genetic pathways found to be relevant in other immune mediated diseases. To provide an overview of recent clinical trials for new generation oral targeted medications that may have a future role in IBD management. Pubmed and Medline searches were performed up to 1 March 2018 using keywords: "IBD", "UC", "CD", "inflammatory bowel disease" "ulcerative colitis", "Crohn's disease" in combination with "phase", "study", "trial" and "oral". A manual search of the clinical trial register, article reference lists, abstracts from meetings of Digestive Disease Week, United European Gastroenterology Week and ECCO congress were also conducted. In randomised controlled trials primary efficacy endpoints were met for tofacitinib (JAK 1/3 inhibitor-phase III), upadacitinib (JAK 1 inhibitor-phase II) and AJM300 (α4-integrin antagonist-phase II) in ulcerative colitis. Ozanimod (S1P receptor agonist-phase II) also demonstrated clinical remission. For Crohn's disease, filgotinib (JAK1 inhibitor-phase II) met primary endpoints and laquinimod (quinolone-3-carboxide small molecule-phase II) was also efficacious. Trials using mongersen (SMAD7 inhibitor) and vidofludimus (dihydroorotate dehydrogenase inhibitor) have been halted. This is potentially the start of an exciting new era in which multiple therapeutic options are at the disposal of physicians to treat IBD on an individualised basis. Head-to-head studies with existing treatments and longer term safety data are needed for this to be possible. © 2018 John Wiley & Sons Ltd.

A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528.

PubMed

Dy, Grace K; Mandrekar, Sumithra J; Nelson, Garth D; Meyers, Jeffrey P; Adjei, Araba A; Ross, Helen J; Ansari, Rafat H; Lyss, Alan P; Stella, Philip J; Schild, Steven E; Molina, Julian R; Adjei, Alex A

2013-01-01

The purpose of this study was to assess the safety and efficacy of gemcitabine and carboplatin with (arm A) or without (arm B) daily oral cediranib as first-line therapy for advanced non-small-cell lung cancer. A lead-in phase to determine the tolerability of gemcitabine 1000 mg/m on days 1 and 8, and carboplatin on day 1 at area under curve 5 administered every 21 days with cediranib 45 mg once daily was followed by a 2 (A):1 (B) randomized phase II study. The primary end point was confirmed overall response rate (ORR) with 6-month progression-free survival (PFS6) rate in arm A as secondary end point. Polymorphisms in genes encoding cediranib targets and transport were correlated with treatment outcome. On the basis of the safety assessment, cediranib 30 mg daily was used in the phase II portion. A total of 58 and 29 evaluable patients were accrued to arms A and B. Patients in A experienced more grade 3+ nonhematologic adverse events, 71% versus 45% (p = 0.01). The ORR was 19% (A) versus 20% (B) (p = 1.0). PFS6 in A was 48% (95% confidence interval: 35%-62%), thus meeting the protocol-specified threshold of at least 40%. The median overall survival was 12.0 versus 9.9 months (p = 0.10). FGFR1 rs7012413, FGFR2 rs2912791, and VEGFR3 rs11748431 polymorphisms were significantly associated with decreased overall survival (hazard ratio 2.78-5.01, p = 0.0002-0.0095). The trial did not meet its primary end point of ORR but met its secondary end point of PFS6. The combination with cediranib 30 mg daily resulted in increased toxicity. Pharmacogenetic analysis revealed an association of FGFR and VEGFR variants with survival.

A system safety model for developmental aircraft programs

NASA Technical Reports Server (NTRS)

Amberboy, E. J.; Stokeld, R. L.

1982-01-01

Basic tenets of safety as applied to developmental aircraft programs are presented. The integration of safety into the project management aspects of planning, organizing, directing and controlling is illustrated by examples. The basis for project management use of safety and the relationship of these management functions to 'real-world' situations is presented. The rationale which led to the safety-related project decision and the lessons learned as they may apply to future projects are presented.

Metabolites characterization of chamaechromone in vivo and in vitro by using ultra-performance liquid chromatography/Xevo G2 quadrupole time-of-flight tandem mass spectrometry.

PubMed

Lou, Yan; Zheng, Jinqi; Wang, Baohong; Zhang, Xingguo; Zhang, Xia; Zeng, Su

2014-01-01

Stellera chamaejasme L. (Thymelaeaceae) was a toxic perennial herb and widely used as pesticide and dermatological agents in China. Chamaechromone was a major component in the dried roots of Stellera chamaejasme with anti-HBV and insecticidal activity. Analysis of metabolic profile in vivo and in vitro plays a pivotal role to unravel how TCM works. And the metabolites of chamaechromone might influence the effects and toxicity of Stellera chamaejasme. Moreover, the metabolic routes of chamaechromone provide an important basis for toxicological safety evaluation. Until now, little is known about the metabolism of chamaechromone. The current study was designed to characterize the whole metabolic pathways of chamaechromone in vitro and in vivo. Twenty-four rats were randomly divided into four groups, including two oral administration groups (100mgkg(-1)), one intravenous injection group (5 mgkg(-1)), and one control group. The metabolites in rat urine and feces and bile were identified by UPLC/Q-TOF MS analysis and β-glucuronidase hydrolysis. Moreover, the possible metabolic mechanism was further confirmed by Phase I and Phase II metabolism and catechol-O-methyltransferase methylation in rat liver S9 fraction and degradation in rat intestinal bacteria. A total of 24 metabolites from chamaechromone were detected and identified in vivo and in vitro, 20 of which were novel. And the major metabolic processes were hydroxylation, methylation, glucuronation, acetylation, dehydroxylation and degradation. The present study revealed the whole metabolic pathways of chamaechromone in rat through both in vitro and in vivo experiments for the first time. And chamaechromone could undergo extensive phase I and phase II metabolism in rat. These findings would provide an important basis for the further study and clinical application of chamaechromone. In addition, the results of this work have showed the feasibility of the UPLC/Q-TOF-MS approach for rapid and reliable characterization of metabolites. © 2013 Elsevier Ireland Ltd. All rights reserved.

CSF1R inhibition with emactuzumab in locally advanced diffuse-type tenosynovial giant cell tumours of the soft tissue: a dose-escalation and dose-expansion phase 1 study.

PubMed

Cassier, Philippe A; Italiano, Antoine; Gomez-Roca, Carlos A; Le Tourneau, Christophe; Toulmonde, Maud; Cannarile, Michael A; Ries, Carola; Brillouet, Anne; Müller, Claudia; Jegg, Anna-Maria; Bröske, Ann-Marie; Dembowski, Markus; Bray-French, Katharine; Freilinger, Christine; Meneses-Lorente, Georgina; Baehner, Monika; Harding, Ross; Ratnayake, Jayantha; Abiraj, Keelara; Gass, Nathalie; Noh, Karen; Christen, Randolph D; Ukarma, Lidia; Bompas, Emmanuelle; Delord, Jean-Pierre; Blay, Jean-Yves; Rüttinger, Dominik

2015-08-01

Diffuse-type tenosynovial giant cell tumour (dt-GCT) of the soft tissue (alternatively known as pigmented villonodular synovitis), an orphan disease with unmet medical need, is characterised by an overexpression of colony-stimulating factor 1 (CSF1), and is usually caused by a chromosomal translocation involving CSF1. CSF1 receptor (CSF1R) activation leads to the recruitment of CSF1R-expressing cells of the mononuclear phagocyte lineage that constitute the tumor mass in dt-GCT. Emactuzumab (RG7155) is a novel monoclonal antibody that inhibits CSF1R activation. We have assessed the safety, tolerability and activity of emactuzumab in patients with Dt-GCT of the soft tissue. In this phase 1, first-in-human dose-escalation and dose-expansion study, eligible patients were aged 18 years or older with dt-GCT of the soft tissue with locally advanced disease or resectable tumours requiring extensive surgery, an Eastern Cooperative Oncology Group performance status of 1 or less, measurable disease according to Response Evaluation Criteria In Solid Tumors version 1.1, and adequate end-organ function. Patients with GCT of the bone were not eligible. Patients received intravenous emactuzumab at 900 mg, 1350 mg, or 2000 mg every 2 weeks in the dose-escalation phase and at the optimal biological dose in a dose-expansion phase. The primary objective was to evaluate the safety and tolerability of emactuzumab, and to determine the maximum tolerated dose or optimal biological dose. All treated patients were included in the analyses. Expansion cohorts are currently ongoing. This study is registered with ClinicalTrials.gov, number NCT01494688. Between July 26, 2012, and Oct 21, 2013, 12 patients were enrolled in the dose-escalation phase. No dose-limiting toxicities were noted in the dose-escalation cohort; on the basis of pharmacokinetic, pharmacodynamic, and safety information, we chose a dose of 1000 mg every 2 week for the dose-expansion cohort, into which 17 patients were enrolled. Owing to different cutoff dates for safety and efficacy readouts, the safety population comprised 25 patients. Common adverse events after emactuzumab treatment were facial oedema (16 [64%] of 25 patients), asthenia (14 [56%]), and pruritus (14 [56%]). Five serious adverse events (periorbital oedema, lupus erythematosus [occurring twice], erythema, and dermohypodermitis all experienced by one [4%] patient each) were reported in five patients. Three of the five serious adverse events-periorbital oedema (one [4%]), lupus erythematosus (one [4%]), and dermohypodermitis (one [4%])-were assessed as grade 3. Two other grade 3 events were reported: mucositis (one [4%]) and fatigue (one [4%]). 24 (86%) of 28 patients achieved an objective response; two (7%) patients achieved a complete response. Further study of dt-GCT is warranted and different possibilities, such as an international collaboration with cooperative groups to assure appropriate recruitment in this rare disease, are currently being assessed. F Hoffmann-La Roche. Copyright © 2015 Elsevier Ltd. All rights reserved.

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

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

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

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

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

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

2012-07-01

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

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

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

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

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

NASA Astrophysics Data System (ADS)

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

2012-01-01

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

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

PubMed

Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

2014-04-01

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

Safety and mobility impacts of winter weather : phase I.

DOT National Transportation Integrated Search

2011-08-01

Highway agencies spend millions of dollars to ensure safe and efficient winter travel. However, the effectiveness of winter weather maintenance practices on safety and mobility are somewhat difficult to quantify. : Phase I of this project investigate...

National Dam Safety Program. Lake Muskoday Dam (Inventory Number N.Y. 341) Delaware River Basin, Sullivan County, New York. Phase I Inspection Report,

DTIC Science & Technology

1981-09-14

DACW-51-81-C-0006 . PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT PROJECT. TASK AREA & WORK UNIT NUMBERS ~ Flaherty-Giauara Associates...olie It neceary and Idontily b block number) Dam Safety National Dam Safety Program Visual Inspection Lake Muskoday Dam Hydrology, Structural Stability...DELAWARE RIVER BASIN LAKE MUSKODAY DAM SULLIVAN COUNTY, NEW YORK INVENTORY No.NY341 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAM J T C NEW YORK

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

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

2010-01-01

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

Deep Borehole Disposal Safety Analysis.

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

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

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

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2011 CFR

2011-01-01

... for the design and construction of a new DOE nuclear facility or a major modification to an existing... acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a... mitigate hazards to workers, the public, or the environment. They include (1) physical, design, structural...

49 CFR Appendix A to Part 385 - Explanation of Safety Audit Evaluation Criteria

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety management controls in place, is included in Appendix B, VII. List of Acute and Critical... having similar characteristics are combined together into six regulatory areas called “factors.” The regulatory factors, evaluated on the basis of the adequacy of the carrier's safety management controls, are...

76 FR 4420 - OSRAM SYLVANIA Products, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... basis that this noncompliance is inconsequential to motor vehicle safety. This notice of receipt of... petition OSRAM SYLVANIA argues that the noncompliance is inconsequential to motor vehicle safety for the... conforming to all applicable Federal motor vehicle safety standards. Subject ``H11 C'' light sources are...

Safe Schools Report 2004-2005

ERIC Educational Resources Information Center

New Mexico Public Education Department, 2006

2006-01-01

Safety in New Mexico's schools is one of the most important issues facing our communities. Every school and school district in the state make it a priority to identify and implement ways to increase the safety, security and integrity of students, teachers, staff, parents and visitors at our schools on a daily basis. Safety is critical for…

76 FR 23708 - Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

...-AA00 Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East... the Regional Water Rescue Exercise. Basis and Purpose The Pierce County, Washington, Department of... to read as follows: Sec. 165.T13-0251 Safety Zone; Pierce County Department of Emergency Management...

ITS logical architecture : volume 3, data dictionary.

DOT National Transportation Integrated Search

1981-01-01

The objective of the research effort was to develop an empirically and experiencially based model pedestrian safety program which cities can use as guidelines for pedestrian safety program planning, implementation, and evaluation. The basis of these ...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2014 CFR

2014-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2013 CFR

2013-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

USDA-ARS?s Scientific Manuscript database

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...

28 CFR 32.16 - Payment.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) more than one individual, on the basis of being a public safety officer's parent as his mother, or on that basis as his father. If more than one parent qualifies as the officer's mother, or as his father...

Environmental Baseline Survey for Installation of Five New Hydrogeologic Groundwater Monitoring Wells

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

Catechis, Christopher S.

This Phase I Environmental Baseline Survey (EBS) provides the findings of a survey and assessment for termination of an existing easement granted to the Department of Energy (DOE) for the installation of 5 new hydrogeologic groundwater monitoring wells located on KAFB, New Mexico. The purpose of this EBS is to: Document the nature, magnitude, and extent of any environmental contamination of the property. Identify potential environmental contamination liabilities associated with the property. Develop sufficient information to assess the health and safety risks. Ensure adequate protection for human health and the environment related to a specific property. Determine possible effects ofmore » contamination on property valuation, and serve as the basis for notice of environmental condition for applicable federal or local real property disclosure requirements.« less

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase II: Final Report.

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…

Long Duration Head-Down Tilt Bed Rest Studies: Safety Considerations Regarding Vision Health

NASA Technical Reports Server (NTRS)

Cromwell, Ronita L.; Zanello, S. B.; Yarbough, P. O.; Ploutz-Snyder, Robert; Taibbi, G.; Vizzeri, G.

2012-01-01

Visual symptoms reported in astronauts returning from long duration missions in low Earth orbit, including hyperopic shift, choroidal folds, globe flattening and papilledema, are thought to be related to fluid shifts within the body due to microgravity exposure. Because of this possible relation to fluid shifts, safety considerations have been raised regarding the ocular health of head-down tilt (HDT) bed rest subjects. HDT is a widely used ground ]based analog that simulates physiological changes of spaceflight, including fluid shifts. Thus, vision monitoring has been performed in bed rest subjects in order to evaluate the safety of HDT with respect to vision health. Here we report ocular outcomes in 9 healthy subjects (age range: 27-48 years; Male/Female ratio: 8/1) completing bed rest Campaign 11, an integrated, multidisciplinary 70-day 6 degrees HDT bed rest study. Vision examinations were performed on a weekly basis, and consisted of office-based (2 pre- and 2 post-bed rest) and in-bed testing. The experimental design was a repeated measures design, with measurements for both eyes taken for each subject at each planned time point. Findings for the following tests were all reported as normal in each testing session for every subject: modified Amsler grid, red dot test, confrontational visual fields, color vision and fundus photography. Overall, no statistically significant differences were observed for any of the measures, except for both near and far visual acuity, which increased during the course of the study. This difference is not considered clinically relevant as may result from the effect of learning. Intraocular pressure results suggest a small increase at the beginning of the bed rest phase (p=0.059) and lesser increase at post-bed rest with respect to baseline (p=0.046). These preliminary results provide the basis for further analyses that will include correlations between intraocular pressure change pre- and post-bed rest, and optical coherence tomography measurements of the retina.

Safety and tolerance of ester-C compared with regular ascorbic acid.

PubMed

Gruenwald, Joerg; Graubaum, Hans-Joachim; Busch, Regina; Bentley, Christine

2006-01-01

The goal of this randomized, double-blind crossover clinical trial in 50 healthy volunteers sensitive to acidic foods was to evaluate whether Ester-C calcium ascorbate causes fewer epigastric adverse effects than are produced by regular ascorbic acid (AA). Volunteers were randomly separated into 2 groups of 25. The study comprised an observation period of 9 days (phase 1 medication for 3 consecutive days, washout phase for 3 consecutive days, phase 2 medication for 3 consecutive days). Participants took 1000 mg vitamin C as Ester-C during phase 1 of the study followed by 1000 mg of vitamin C as AA during phase 2, or vice versa. During the course of the study, 3 examinations for the evaluation of epigastric adverse effects were performed (on days 0, 3, and 9). Participants used a diary to record epigastric adverse effects on a daily basis. In total, 28 (56%) of 50 participants reported 88 epigastric adverse effects of mild to moderate intensity. Of these 88 adverse effects, 33 (37.5%) occurred after intake of Ester-C and 55 (62.5%) were noted after intake of AA. The tolerability of Ester-C was rated "very good" by 72% of participants, whereas AA was rated "very good" by only 54%. This difference is statistically significant (P<.05). Investigators concluded that Ester-C compared with AA caused significantly fewer epigastric adverse effects in participants sensitive to acidic foods and that Ester-C is much better tolerated.

Governing patient safety: lessons learned from a mixed methods evaluation of implementing a ward-level medication safety scorecard in two English NHS hospitals.

PubMed

Ramsay, Angus I G; Turner, Simon; Cavell, Gillian; Oborne, C Alice; Thomas, Rebecca E; Cookson, Graham; Fulop, Naomi J

2014-02-01

Relatively little is known about how scorecards presenting performance indicators influence medication safety. We evaluated the effects of implementing a ward-level medication safety scorecard piloted in two English NHS hospitals and factors influencing these. We used a mixed methods, controlled before and after design. At baseline, wards were audited on medication safety indicators; during the 'feedback' phase scorecard results were presented to intervention wards on a weekly basis over 7 weeks. We interviewed 49 staff, including clinicians and managers, about scorecard implementation. At baseline, 18.7% of patients (total n=630) had incomplete allergy documentation; 53.4% of patients (n=574) experienced a drug omission in the preceding 24 h; 22.5% of omitted doses were classified as 'critical'; 22.1% of patients (n=482) either had ID wristbands not reflecting their allergy status or no ID wristband; and 45.3% of patients (n=237) had drugs that were either unlabelled or labelled for another patient in their drug lockers. The quantitative analysis found no significant improvement in intervention wards following scorecard feedback. Interviews suggested staff were interested in scorecard feedback and described process and culture changes. Factors influencing scorecard implementation included 'normalisation' of errors, study duration, ward leadership, capacity to engage and learning preferences. Presenting evidence-based performance indicators may potentially influence staff behaviour. Several practical and cultural factors may limit feedback effectiveness and should be considered when developing improvement interventions. Quality scorecards should be designed with care, attending to evidence of indicators' effectiveness and how indicators and overall scorecard composition fit the intended audience.

Governing patient safety: lessons learned from a mixed methods evaluation of implementing a ward-level medication safety scorecard in two English NHS hospitals

PubMed Central

Ramsay, Angus I G; Turner, Simon; Cavell, Gillian; Oborne, C Alice; Thomas, Rebecca E; Cookson, Graham; Fulop, Naomi J

2014-01-01

Background Relatively little is known about how scorecards presenting performance indicators influence medication safety. We evaluated the effects of implementing a ward-level medication safety scorecard piloted in two English NHS hospitals and factors influencing these. Methods We used a mixed methods, controlled before and after design. At baseline, wards were audited on medication safety indicators; during the ‘feedback’ phase scorecard results were presented to intervention wards on a weekly basis over 7 weeks. We interviewed 49 staff, including clinicians and managers, about scorecard implementation. Results At baseline, 18.7% of patients (total n=630) had incomplete allergy documentation; 53.4% of patients (n=574) experienced a drug omission in the preceding 24 h; 22.5% of omitted doses were classified as ‘critical’; 22.1% of patients (n=482) either had ID wristbands not reflecting their allergy status or no ID wristband; and 45.3% of patients (n=237) had drugs that were either unlabelled or labelled for another patient in their drug lockers. The quantitative analysis found no significant improvement in intervention wards following scorecard feedback. Interviews suggested staff were interested in scorecard feedback and described process and culture changes. Factors influencing scorecard implementation included ‘normalisation’ of errors, study duration, ward leadership, capacity to engage and learning preferences. Discussion Presenting evidence-based performance indicators may potentially influence staff behaviour. Several practical and cultural factors may limit feedback effectiveness and should be considered when developing improvement interventions. Quality scorecards should be designed with care, attending to evidence of indicators’ effectiveness and how indicators and overall scorecard composition fit the intended audience. PMID:24029440

Safety and Security Interface Technology Initiative

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

Dr. Michael A. Lehto; Kevin J. Carroll; Dr. Robert Lowrie

Safety and Security Interface Technology Initiative Mr. Kevin J. Carroll Dr. Robert Lowrie, Dr. Micheal Lehto BWXT Y12 NSC Oak Ridge, TN 37831 865-576-2289/865-241-2772 carrollkj@y12.doe.gov Work Objective. Earlier this year, the Energy Facility Contractors Group (EFCOG) was asked to assist in developing options related to acceleration deployment of new security-related technologies to assist meeting design base threat (DBT) needs while also addressing the requirements of 10 CFR 830. NNSA NA-70, one of the working group participants, designated this effort the Safety and Security Interface Technology Initiative (SSIT). Relationship to Workshop Theme. “Supporting Excellence in Operations Through Safety Analysis,” (workshop theme)more » includes security and safety personnel working together to ensure effective and efficient operations. One of the specific workshop elements listed in the call for papers is “Safeguards/Security Integration with Safety.” This paper speaks directly to this theme. Description of Work. The EFCOG Safety Analysis Working Group (SAWG) and the EFCOG Security Working Group formed a core team to develop an integrated process involving both safety basis and security needs allowing achievement of the DBT objectives while ensuring safety is appropriately considered. This effort garnered significant interest, starting with a two day breakout session of 30 experts at the 2006 Safety Basis Workshop. A core team was formed, and a series of meetings were held to develop that process, including safety and security professionals, both contractor and federal personnel. A pilot exercise held at Idaho National Laboratory (INL) in mid-July 2006 was conducted as a feasibility of concept review. Work Results. The SSIT efforts resulted in a topical report transmitted from EFCOG to DOE/NNSA in August 2006. Elements of the report included: Drivers and Endstate, Control Selections Alternative Analysis Process, Terminology Crosswalk, Safety Basis/Security Documentation Integration, Configuration Control, and development of a shared ‘tool box’ of information/successes. Specific Benefits. The expectation or end state resulting from the topical report and associated implementation plan includes: (1) A recommended process for handling the documentation of the security and safety disciplines, including an appropriate change control process and participation by all stakeholders. (2) A means to package security systems with sufficient information to help expedite the flow of that system through the process. In addition, a means to share successes among sites, to include information and safety basis to the extent such information is transportable. (3) Identification of key security systems and associated essential security elements being installed and an arrangement for the sites installing these systems to host an appropriate team to review a specific system and determine what information is exportable. (4) Identification of the security systems’ essential elements and appropriate controls required for testing of these essential elements in the facility. (5) The ability to help refine and improve an agreed to control set at the manufacture stage.« less

Evidence of organizational injustice in poultry processing plants: Possible effects on occupational health and safety among Latino workers in North Carolina.

PubMed

Marín, Antonio J; Grzywacz, Joseph G; Arcury, Thomas A; Carrillo, Lourdes; Coates, Michael L; Quandt, Sara A

2009-01-01

Over 250,000 workers are employed in poultry processing, one of the most dangerous industries in the US. These jobs are increasingly held by immigrant workers who are frequently undocumented, lack knowledge of workers' rights to workplace safety, and who are reluctant to pursue their rights. This situation creates the potential for organizational injustice, made visible through abusive supervisory practices, and leads to situations in which occupational illnesses and injuries are likely to occur. This paper draws on data collected during the research phases of a community-based participatory research and social justice project. Two hundred survey interviews and 26 in-depth interviews were collected in representative, community-based samples in western North Carolina. Analyses describe associations between one aspect of organizational injustice, abusive supervision, and worker injuries. Workers' reports of abusive supervision are associated with a variety of specific and summary health indicators. The associations are stronger for women than for men. These suggest that the use of relative power within the plant may be the basis for injuries and illnesses. Three types of power relations are described that form the basis for these abusive interactions in the plant: ethnicity (American vs. Latino), immigration status ("good papers" vs. undocumented), and rank (supervisor vs. worker). Two factors modify these relations: kinship (preferences and privileges for family members) and gender. Among Latino immigrants working in poultry plants, power differences reflecting organizational injustice in the form of abusive supervision may promote occupational illnesses and injuries, particularly for women. (c) 2008 Wiley-Liss, Inc.

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

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

Boyd D. Christensen; Annette L. Schafer

2013-11-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

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

Christensen, Boyd D.; Schafer, Annette L.

2014-02-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

Developing a patient-led electronic feedback system for quality and safety within Renal PatientView.

PubMed

Giles, Sally J; Reynolds, Caroline; Heyhoe, Jane; Armitage, Gerry

2017-03-01

It is increasingly acknowledged that patients can provide direct feedback about the quality and safety of their care through patient reporting systems. The aim of this study was to explore the feasibility of patients, healthcare professionals and researchers working in partnership to develop a patient-led quality and safety feedback system within an existing electronic health record (EHR), known as Renal PatientView (RPV). Phase 1 (inception) involved focus groups (n = 9) and phase 2 (requirements) involved cognitive walkthroughs (n = 34) and 1:1 qualitative interviews (n = 34) with patients and healthcare professionals. A Joint Services Expert Panel (JSP) was convened to review the findings from phase 1 and agree the core principles and components of the system prototype. Phase 1 data were analysed using a thematic approach. Data from phase 1 were used to inform the design of the initial system prototype. Phase 2 data were analysed using the components of heuristic evaluation, resulting in a list of core principles and components for the final system prototype. Phase 1 identified four main barriers and facilitators to patients feeding back on quality and safety concerns. In phase 2, the JSP agreed that the system should be based on seven core principles and components. Stakeholders were able to work together to identify core principles and components for an electronic patient quality and safety feedback system in renal services. Tensions arose due to competing priorities, particularly around anonymity and feedback. Careful consideration should be given to the feasibility of integrating a novel element with differing priorities into an established system with existing functions and objectives. © 2016 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Research safety vehicle, Phase II. Volume I. Executive summary. Final report jul 75-dec 76

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

Struble, D.

1976-12-01

Volume I summarizes the results of the Minicars Research Safety Vehicle Phase II program, as detailed in Volumes II and III. Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidentialmore » Task Force on Motor Vehicle Goals beyond 1980.« less

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

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

Medication safety.

PubMed

Keohane, Carol A; Bates, David W

2008-03-01

Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

77 FR 64411 - Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... 1625-AA00 Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL AGENCY: Coast Guard.... Smith Fireworks Event. Entry into, transiting or anchoring in this zone is prohibited to all vessels... safety hazards associated with a fireworks display. B. Basis and Purpose Cooper T. Smith Corp. has hired...

Monitoring pathogens from irradiated agriculture products

NASA Astrophysics Data System (ADS)

Butterweck, Joseph S.

The final food and environmental safety assessment of agriculture product irradiation can only be determined by product history. Product history will be used for future research and development, regulations, commercial practices and implementation of agriculture and food irradiation on a regional basis. The commercial irradiator treats large varieties and amounts of products that are used in various environments. It, in time, will generate a large data base of product history. Field product monitoring begins when food irradiation progresses from the pilot/demonstration phase to the commercial phase. At that time, it is important that there be in place a monitoring system to collect and analyze field data. The systems managers, public health authorities and exotic disease specialists will use this information to assess the reduction of food pathogens on the populace and the environment. The common sources of monitoring data are as follows: 1) Host Monitoring a) Medical Diagnosis b) Autopsy c) Serology Surveys 2) Environmental Monitoring a) Sentinel b) Pest Surveys/Microbial Counts c) Sanitary Inspections 3) Food Industries Quality Assurance Monitoring a) End Product Inspection b) Complaints c) Continual Use of the Product

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

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

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

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

Preventing back injuries in hospital settings: the effects of video modeling on safe patient lifting by nurses.

PubMed

Nielsen, Don; Sigurdsson, Sigurdur O; Austin, John

2009-01-01

This study evaluated video scoring and feedback about scoring as a safety intervention among 6 nursing staff. The dependent variable was safety behavior on one-person transfers. Following baseline, 5 nursing staff participated in an information phase. A video scoring phase was then introduced for all 6. A feedback phase was added for 2 participants. All participants experienced treatment withdrawal. Information resulted in improvements for all 5 participants who received it. Further improvements were observed during video scoring for the 5 participants who improved following information. No improvements were observed for the participant who received only video scoring. Safety feedback further improved safety for the 2 participants who received it. However, participants' behavior returned to video scoring levels during withdrawal.

PREVENTING BACK INJURIES IN HOSPITAL SETTINGS: THE EFFECTS OF VIDEO MODELING ON SAFE PATIENT LIFTING BY NURSES

PubMed Central

Nielsen, Don; Sigurdsson, Sigurdur O; Austin, John

2009-01-01

This study evaluated video scoring and feedback about scoring as a safety intervention among 6 nursing staff. The dependent variable was safety behavior on one-person transfers. Following baseline, 5 nursing staff participated in an information phase. A video scoring phase was then introduced for all 6. A feedback phase was added for 2 participants. All participants experienced treatment withdrawal. Information resulted in improvements for all 5 participants who received it. Further improvements were observed during video scoring for the 5 participants who improved following information. No improvements were observed for the participant who received only video scoring. Safety feedback further improved safety for the 2 participants who received it. However, participants' behavior returned to video scoring levels during withdrawal. PMID:20190918

Towards a Usability and Error "Safety Net": A Multi-Phased Multi-Method Approach to Ensuring System Usability and Safety.

PubMed

Kushniruk, Andre; Senathirajah, Yalini; Borycki, Elizabeth

2017-01-01

The usability and safety of health information systems have become major issues in the design and implementation of useful healthcare IT. In this paper we describe a multi-phased multi-method approach to integrating usability engineering methods into system testing to ensure both usability and safety of healthcare IT upon widespread deployment. The approach involves usability testing followed by clinical simulation (conducted in-situ) and "near-live" recording of user interactions with systems. At key stages in this process, usability problems are identified and rectified forming a usability and technology-induced error "safety net" that catches different types of usability and safety problems prior to releasing systems widely in healthcare settings.

Fire safety in transit systems fault tree analysis

DOT National Transportation Integrated Search

1981-09-01

Fire safety countermeasures applicable to transit vehicles are identified and evaluated. This document contains fault trees which illustrate the sequences of events which may lead to a transit-fire related casualty. A description of the basis for the...

Pilot Construction Project for Granular Shoulder Stabilization

DOT National Transportation Integrated Search

2013-09-30

Granular shoulders need to be maintained on a regular basis because edge ruts and potholes develop, posing a safety hazard to motorists. The successful mitigation of edge-rut issues for granular shoulders would increase safety and reduce the number o...

Long-term tolerability of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study.

PubMed

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-04-01

This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. In this Phase III, multicentre, open-label study, women (aged 18-35 years) were randomised to EE/DRSP in the following regimens: flexible(MIB) (24-120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexible(MIB) regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexible(MIB), conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives.

Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

PubMed

Würtzen, G

1993-01-01

The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

Simulation of data safety components for corporative systems

NASA Astrophysics Data System (ADS)

Yaremko, Svetlana A.; Kuzmina, Elena M.; Savchuk, Tamara O.; Krivonosov, Valeriy E.; Smolarz, Andrzej; Arman, Abenov; Smailova, Saule; Kalizhanova, Aliya

2017-08-01

The article deals with research of designing data safety components for corporations by means of mathematical simulations and modern information technologies. Simulation of threats ranks has been done which is based on definite values of data components. The rules of safety policy for corporative information systems have been presented. The ways of realization of safety policy rules have been proposed on the basis of taken conditions and appropriate class of valuable data protection.

Safety assessment tool for construction zone work phasing plans

DOT National Transportation Integrated Search

2016-05-01

The Highway Safety Manual (HSM) is the compilation of national safety research that provides quantitative methods for : analyzing highway safety. The HSM presents crash modification functions related to freeway work zone characteristics such as : wor...

Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study.

PubMed

McDermott, David F; Sosman, Jeffrey A; Sznol, Mario; Massard, Christophe; Gordon, Michael S; Hamid, Omid; Powderly, John D; Infante, Jeffrey R; Fassò, Marcella; Wang, Yan V; Zou, Wei; Hegde, Priti S; Fine, Gregg D; Powles, Thomas

2016-03-10

The objective was to determine the safety and clinical activity of atezolizumab (MPDL3280A), a humanized programmed death-ligand 1 (PD-L1) antibody, in renal cell carcinoma (RCC). Exploratory biomarkers were analyzed and associated with outcomes. Seventy patients with metastatic RCC, including clear cell (ccRCC; n = 63) and non-clear cell (ncc; n = 7) histologies, received atezolizumab intravenously every 3 weeks. PD-L1 expression was scored at four diagnostic levels (0/1/2/3) that were based on PD-L1 staining on tumor cells and tumor-infiltrating immune cells (IC) with the SP142 assay. Primary end points were safety and toxicity; secondary end points assessed clinical activity per Response Evaluation Criteria in Solid Tumors version 1.1 and immune-related response criteria. Plasma and tissue were analyzed for potential biomarkers of atezolizumab response. Grade 3 treatment-related and immune-mediated adverse events occurred in 17% and 4% of patients, respectively, and there were no grade 4 or 5 events. Sixty-three patients with ccRCC were evaluable for overall survival (median, 28.9 months; 95% CI, 20.0 months to not reached) and progression-free survival (median, 5.6 months; 95% CI, 3.9 to 8.2 months), and 62 patients were evaluable for objective response rate (ORR; 15%; 95% CI, 7% to 26%). ORR was evaluated on the basis of PD-L1 IC expression (IC1/2/3: n = 33; 18%; 95% CI, 7% to 35%; and IC0: n = 22; 9%; 95% CI, 1% to 29%). The ORR for patients with Fuhrman grade 4 and/or sarcomatoid histology was 22% (n = 18; 95% CI, 6% to 48%). Decreases in circulating plasma markers and acute-phase proteins and an increased baseline effector T-cell-to-regulatory T-cell gene expression ratio correlated with response to atezolizumab. Atezolizumab demonstrated a manageable safety profile and promising antitumor activity in patients with metastatic RCC. Correlative studies identified potential predictive and pharmacodynamic biomarkers. These results have guided ongoing studies and combinations with atezolizumab in RCC. © 2016 by American Society of Clinical Oncology.

Golden rice: scientific, regulatory and public information processes of a genetically modified organism.

PubMed

Moghissi, A Alan; Pei, Shiqian; Liu, Yinzuo

2016-01-01

Historically, agricultural development evolved in three phases. During the first phase the plants were selected on the basis of the availability of a plant with desirable properties at a specific location. The second phase provided the agricultural community with crossbreeding plants to achieve improvement in agricultural production. The evolution of biological knowledge has provided the ability to genetically engineer (GE) crops, one of the key processes within genetically modified organisms (GMO). This article uses golden rice, a species of transgenic Asian rice which contains a precursor of vitamin A in the edible part of the plant as an example of GE/GMO emphasizing Chinese experience in agricultural evolution. It includes a brief review of agricultural evolution to be followed by a description of golden rice development. Golden rice was created as a humanitarian project and has received positive comments by the scientific community and negative voices from certain environmental groups. In this article, we use the Best Available Science (BAS) Concept and Metrics for Evaluation of Scientific Claims (MESC) derived from it to evaluate claims and counter claims on scientific aspects of golden rice. This article concludes that opposition to golden rice is based on belief rather than any of its scientifically derived nutritional, safety or environmental properties.

Variations in population exposure and evacuation potential to multiple tsunami evacuation phases on Alameda and Bay Farm Islands, California

NASA Astrophysics Data System (ADS)

Peters, J.

2015-12-01

Planning for a tsunami evacuation is challenging for California communities due to the variety of earthquake sources that could generate a tsunami. A maximum tsunami inundation zone is currently the basis for all tsunami evacuations in California, although an Evacuation Playbook consisting of specific event-based evacuation phases relating to flooding severity is in development. We chose to investigate the Evacuation Playbook approach for the island community of Alameda, CA since past reports estimated a significant difference in numbers of residents in the maximum inundation zone when compared to an event-based inundation zone. In order to recognize variations in the types of residents and businesses within each phase, a population exposure analysis was conducted for each of the four Alameda evacuation phases. A pedestrian evacuation analysis using an anisotropic, path distance model was also conducted to understand the time it would take for populations to reach high ground by foot. Initial results suggest that the two islands of the City of Alameda have different situations when it comes to the four tsunami evacuation phases. Pedestrian evacuation results suggest that Bay Farm Island would have more success evacuating by vehicle due to limited nearby high ground for pedestrians to reach safety. Therefore, agent-based traffic simulation software was used to model vehicle evacuation off Bay Farm Island. Initial results show that Alameda Island could face challenges evacuating numerous boat docks and a large beach for phases 1 and 2, whereas Bay Farm Island is unaffected at these phases but might be challenged with evacuating by vehicle for phases 3 and maximum due to congestion on limited egress routes. A better understanding of the population exposure within each tsunami Evacuation Playbook phase and the time it would take to evacuate out of each phase by foot or vehicle will help emergency managers implement the evacuation phases during an actual tsunami event.

Individuals with severely impaired vision can learn useful orientation and mobility skills in virtual streets and can use them to improve real street safety.

PubMed

Bowman, Ellen Lambert; Liu, Lei

2017-01-01

Virtual reality has great potential in training road safety skills to individuals with low vision but the feasibility of such training has not been demonstrated. We tested the hypotheses that low vision individuals could learn useful skills in virtual streets and could apply them to improve real street safety. Twelve participants, whose vision was too poor to use the pedestrian signals were taught by a certified orientation and mobility specialist to determine the safest time to cross the street using the visual and auditory signals made by the start of previously stopped cars at a traffic-light controlled street intersection. Four participants were trained in real streets and eight in virtual streets presented on 3 projection screens. The crossing timing of all participants was evaluated in real streets before and after training. The participants were instructed to say "GO" at the time when they felt the safest to cross the street. A safety score was derived to quantify the GO calls based on its occurrence in the pedestrian phase (when the pedestrian sign did not show DON'T WALK). Before training, > 50% of the GO calls from all participants fell in the DON'T WALK phase of the traffic cycle and thus were totally unsafe. 20% of the GO calls fell in the latter half of the pedestrian phase. These calls were unsafe because one initiated crossing this late might not have sufficient time to walk across the street. After training, 90% of the GO calls fell in the early half of the pedestrian phase. These calls were safer because one initiated crossing in the pedestrian phase and had at least half of the pedestrian phase for walking across. Similar safety changes occurred in both virtual street and real street trained participants. An ANOVA showed a significant increase of the safety scores after training and there was no difference in this safety improvement between the virtual street and real street trained participants. This study demonstrated that virtual reality-based orientation and mobility training could be as efficient as real street training in improving street safety in individuals with severely impaired vision.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt in healthy children

PubMed Central

Tan, Tina P.; Ba, Zhaoyong; Sanders, Mary Ellen; D’Amico, Frank J.; Roberts, Robert F.; Smith, Keisha Herbin; Merenstein, Daniel J.

2016-01-01

Objectives Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration (FDA) has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12® (BB-12®)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12®-supplemented yogurt on the gut microbiota of the children. Methods Sixty children aged 1–5 years were randomly assigned to consume four ounces of either BB-12®-supplemented yogurt or non-supplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. Results A total of 186 non-serious adverse events were reported, with no significant differences between the control and BB-12® groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. Conclusions BB-12®-supplemented yogurt is safe and well-tolerated when consumed by healthy children. This study will form the basis for future randomized clinical trials investigating the potential effects of BB-12®-supplemented yogurt in different disease states. PMID:28114246

Rail Safety/Equipment Crashworthiness : Volume 1. A Systems Analysis of Injury Minimization in Rail Systems

DOT National Transportation Integrated Search

1978-07-01

The Department of Transportation, Transportation Systems Center (TSC), is providing technical assistance to the Federal Railroad Administration (FRA) in a program to improve railroad safety and efficiency by providing a technological basis for improv...

Safety Effectiveness of Regulatory Headlight Signs in Wyoming - Phase 1 : Interim Report - Phase 2

DOT National Transportation Integrated Search

2016-01-01

Although Daytime Running Lights (DRLs) may have a significant impact on increasing vehicle conspicuity during different times of the day, their effect on overall safety is still up for debate. A recent study by the U.S. Department of Transportation (...

75 FR 13336 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-19

... Approved for Collection at Key West International Airport (EYW) and Use at EYW: Runway safety area design. Runway safety area construction. Approach clearing--design. Runway obstruction clearing--design. Runway obstruction clearing, phase II--construction. Noise implementation plan, phase 6--design. Noise implementation...

76 FR 55796 - Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...-AA00 Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION.... Basis and Purpose Competitor Group is sponsoring the TriRock Triathlon, consisting of 2000 swimmers.... 165.T11-431 to read as follows: Sec. 165.T11-431 Safety Zone; TriRock Triathlon, San Diego Bay, San...

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

PubMed

Richert, Laura; Doussau, Adélaïde; Lelièvre, Jean-Daniel; Arnold, Vincent; Rieux, Véronique; Bouakane, Amel; Lévy, Yves; Chêne, Geneviève; Thiébaut, Rodolphe

2014-02-26

Many candidate vaccine strategies against human immunodeficiency virus (HIV) infection are under study, but their clinical development is lengthy and iterative. To accelerate HIV vaccine development optimised trial designs are needed. We propose a randomised multi-arm phase I/II design for early stage development of several vaccine strategies, aiming at rapidly discarding those that are unsafe or non-immunogenic. We explored early stage designs to evaluate both the safety and the immunogenicity of four heterologous prime-boost HIV vaccine strategies in parallel. One of the vaccines used as a prime and boost in the different strategies (vaccine 1) has yet to be tested in humans, thus requiring a phase I safety evaluation. However, its toxicity risk is considered minimal based on data from similar vaccines. We newly adapted a randomised phase II trial by integrating an early safety decision rule, emulating that of a phase I study. We evaluated the operating characteristics of the proposed design in simulation studies with either a fixed-sample frequentist or a continuous Bayesian safety decision rule and projected timelines for the trial. We propose a randomised four-arm phase I/II design with two independent binary endpoints for safety and immunogenicity. Immunogenicity evaluation at trial end is based on a single-stage Fleming design per arm, comparing the observed proportion of responders in an immunogenicity screening assay to an unacceptably low proportion, without direct comparisons between arms. Randomisation limits heterogeneity in volunteer characteristics between arms. To avoid exposure of additional participants to an unsafe vaccine during the vaccine boost phase, an early safety decision rule is imposed on the arm starting with vaccine 1 injections. In simulations of the design with either decision rule, the risks of erroneous conclusions were controlled <15%. Flexibility in trial conduct is greater with the continuous Bayesian rule. A 12-month gain in timelines is expected by this optimised design. Other existing designs such as bivariate or seamless phase I/II designs did not offer a clear-cut alternative. By combining phase I and phase II evaluations in a multi-arm trial, the proposed optimised design allows for accelerating early stage clinical development of HIV vaccine strategies.

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study.

PubMed

Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-02-16

The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. 34 elderly medical wards within a northern region of England, UK. Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced when conducting the first stage of the positive deviance approach. UK Clinical Research Network Portfolio (reference-18050). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study

PubMed Central

Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-01-01

Objective The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. Design A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. Setting 34 elderly medical wards within a northern region of England, UK. Participants Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Results Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. Conclusions This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced when conducting the first stage of the positive deviance approach. Trial registration number UK Clinical Research Network Portfolio (reference-18050). PMID:29453303

Professional conceptualisation and accomplishment of patient safety in mental healthcare: an ethnographic approach

PubMed Central

2011-01-01

Background This study seeks to broaden current understandings of what patient safety means in mental healthcare and how it is accomplished. We propose a qualitative observational study of how safety is produced or not produced in the complex context of everyday professional mental health practice. Such an approach intentionally contrasts with much patient safety research which assumes that safety is achieved and improved through top-down policy directives. We seek instead to understand and articulate the connections and dynamic interactions between people, materials, and organisational, legal, moral, professional and historical safety imperatives as they come together at particular times and places to perform safe or unsafe practice. As such we advocate an understanding of patient safety 'from the ground up'. Methods/Design The proposed project employs a six-phase data collection framework in two mental health settings: an inpatient unit and a community team. The first four phases comprise multiple modes of focussed, unobtrusive observation of professionals at work, to enable us to trace the conceptualisation and enactment of safety as revealed in dialogue and narrative, use of artefacts and space, bodily activity and patterns of movement, and in the accomplishment of specific work tasks. An interview phase and a social network analysis phase will subsequently be conducted to offer comparative perspectives on the observational data. This multi-modal and holistic approach to studying patient safety will complement existing research, which is dominated by instrumentalist approaches to discovering factors contributing to error, or developing interventions to prevent or manage adverse events. Discussion This ethnographic research framework, informed by the principles of practice theories and in particular actor-network ideas, provides a tool to aid the understanding of patient safety in mental healthcare. The approach is novel in that it seeks to articulate an 'anatomy of patient safety' as it actually occurs, in terms of the networks of elements coalescing to enable the conceptual and material performance of safety in mental health settings. By looking at how patient safety happens or does not happen, this study will enable us to better understand how we might in future productively tackle its improvement. PMID:21569572

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

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

Kot, C. A.

1998-02-10

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

Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.

PubMed

Weinreb, Robert N; Liebmann, Jeffrey M; Martin, Keith R; Kaufman, Paul L; Vittitow, Jason L

2018-01-01

To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12. Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P<0.001). A significantly greater proportion of LBN-treated subjects attained a mean IOP ≤18 mm Hg and IOP reduction ≥25% from baseline versus timolol-treated subjects (P<0.001). The IOP reduction with LBN was sustained through the safety phase; subjects crossed over from timolol to LBN experienced additional significant IOP lowering (P≤0.009). Both treatments were well tolerated, and there were no safety concerns with long-term LBN treatment. In this pooled analysis of subjects with OAG and OHT, LBN 0.024% qd provided greater IOP-lowering compared with timolol 0.5% bid and maintained lowered IOP through 12 months. LBN demonstrated a safety profile comparable to that of prostaglandin analogs.

Wireless Roadside Inspection Proof of Concept Test Final Report

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

Capps, Gary J; Franzese, Oscar; Knee, Helmut E

2009-03-01

The U.S. Department of Transportation (DOT) FMCSA commissioned the Wireless Roadside Inspection (WRI) Program to validate technologies and methodologies that can improve safety through inspections using wireless technologies that convey real-time identification of commercial vehicles, drivers, and carriers, as well as information about the condition of the vehicles and their drivers. It is hypothesized that these inspections will: -- Increase safety -- Decrease the number of unsafe commercial vehicles on the road; -- Increase efficiency -- Speed up the inspection process, enabling more inspections to occur, at least on par with the number of weight inspections; -- Improve effectiveness --more » Reduce the probability of drivers bypassing CMV inspection stations and increase the likelihood that fleets will attempt to meet the safety regulations; and -- Benefit industry -- Reduce fleet costs, provide good return-on-investment, minimize wait times, and level the playing field. The WRI Program is defined in three phases which are: Phase 1: Proof of Concept Test (POC) Testing of commercially available off-the-shelf (COTS) or near-COTS technology to validate the wireless inspection concept. Phase 2: Pilot Test Safety technology maturation and back office system integration Phase 3: Field Operational Test Multi-vehicle testing over a multi-state instrumented corridor This report focuses on Phase 1 efforts that were initiated in March, 2006. Technical efforts dealt with the ability of a Universal Wireless Inspection System (UWIS) to collect driver, vehicle, and carrier information; format a Safety Data Message Set from this information; and wirelessly transmit a Safety Data Message Set to a roadside receiver unit or mobile enforcement vehicle.« less

STS safety approval process for small self-contained payloads

NASA Technical Reports Server (NTRS)

Gum, Mary A.

1988-01-01

The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

Occupational Safety Review of High Technology Facilities

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

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

Study on the Rule of Super Strata Movement and Subsidence

NASA Astrophysics Data System (ADS)

Yao, Shunli; Yuan, Hongyong; Jiang, Fuxing; Chen, Tao; Wu, Peng

2018-01-01

The movement of key strata is related to the safety of the whole earth’s surface for coal mining under super strata. Based on the key strata theory, the paper comprehensively analyzes the characteristics of the subsidence before and after the instability of the super strata by studing through FLAC3D and microseismic dynamic monitoring of the surface rock movement observation. The stability of the super strata movement is analyzed according to the characteristic value of the subsidence. The subsidence law and quantitative indexes under the control of the super rock strata that provides basis for the prevention and control of surface risk, optimize mining area and face layout and reasonably set mining boundary around mining area. It provides basis for the even growth of mine safety production and regional public safety.

Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies.

PubMed

Burgos-Vargas, Ruben; Cardiel, Mario; Xibillé, Daniel; Pacheco-Tena, César; Pascual-Ramos, Virginia; Abud-Mendoza, Carlos; Mahgoub, Ehab; Rahman, Mahboob; Fan, Haiyun; Rojo, Ricardo; García, Erika; Santana, Karina

2017-05-25

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. 119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. In Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Investigational hormone receptor agonists as ongoing female contraception: a focus on selective progesterone receptor modulators in early clinical development.

PubMed

Nelson, Anita L

2015-01-01

As efforts are made to continue to increase the safety of contraceptive methods, those without estrogen have attracted new attention. Progestin-only options are available in many delivery systems, but most cause disturbed bleeding patterns. For gynecologic patients, selective progesterone receptor modulators (SPRMs) have been approved for medical abortion, for ovulation suppression in emergency contraception, and for the treatment of heavy menstrual bleeding due to leiomyoma. This article discusses the role of SPRMs in controlling fertility on an ongoing basis with particular emphasis on mifepristone and ulipristal acetate (UPA), since none of the other compounds has progressed out of early Phase I - II testing. It also discusses important information about the mechanisms of action and safety of these two SPRMs. Of all the investigational hormone agonist/antagonists, SPRMs have demonstrated the greatest potential as ongoing female contraceptives. They have the ability to suppress ovulation after initiation of the luteinizing hormone (LH) surge without affecting ovarian production of estrogen or inducing any significant metabolic changes. SPRMs may well be able to provide longer term contraception as oral agents, vaginal rings, and perhaps even intrauterine devices. UPA has the greatest promise. Current research needs to be expanded.

The EVA space suit development in Europe.

PubMed

Skoog, A I

1994-01-01

The progress of the European EVA space suit predevelopment activities has resulted in an improved technical reference concept, which will form the basis for a start of the Phase C/D development work in 1992. Technology development work over the last 2 years has resulted in a considerable amount of test data and a better understanding of the characteristics and behaviour of individual parts of the space suit system, in particular in the areas of suits' mobility and life support functions. This information has enabled a consolidation of certain design features on the one hand, but also led to the challenging of some of the design solutions on the other hand. While working towards an improved situation with respect to the main design drivers mass and cost, the technical concept has been improved with respect to functional safety and ease of handling, taking the evolving Hermes spaceplane requirements into consideration. Necessary hardware and functional redundancies have been implemented taking the operational scenario with Hermes and Columbus servicing into consideration. This paper presents the latest design status of the European EVA space suit concept, with particular emphasis on crew safety, comfort and productivity, in the frame of the predevelopment work for the European Space Agency.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

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

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

Egg processing plant sanitation, SSOPs, and GMPs.

USDA-ARS?s Scientific Manuscript database

The basis of food safety programs in processing facilities is prerequisite programs such as sanitation and good manufacturing practices. Thoughtful, thorough, and complete sanitation programs are necessary to enhance the food safety of products and reduce the likelihood of foodborne illness. Egg p...

Large trucks involved in fatal crashes : the North Carolina data 1993-1997

DOT National Transportation Integrated Search

1999-03-01

An analysis of large, truck-involved crash outcomes in North Carolina for the period 1993-1997 was conducted by the UNC Highway Safety Research Center (HSRC) for the purpose of establishing an empirical basis for subsequent Governor's Highway Safety ...

Further Analysis of Motorcycle Helmet Effectiveness Using CODES Linked Data

DOT National Transportation Integrated Search

1998-01-01

Linked data from the Crash Outcome Data Evaluation System (CODES) in seven : states was used by the National Highway Traffic Safety Administration as the : basis of a 1996 Report to Congress on the Benefits of Safety Belts and : Motorcycle Helmets (D...

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

47 CFR 101.1305 - Private internal service.

Code of Federal Regulations, 2010 CFR

2010-10-01

... business purposes or public safety communications and not on a for-hire or for-profit basis. ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Private internal service. 101.1305 Section 101.1305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES...

Trends in public information within the Fairfax Alcohol Safety Action Project, 1975.

DOT National Transportation Integrated Search

1976-01-01

To assess current trends in the effectiveness of the public information and education countermeasure of the Fairfax Alcohol Safety Action Project, two pieces of survey type research are conducted on a periodic basis. The roadside survey has been cond...

Materials Safety Data Sheets: the basis for control of toxic chemicals

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

Ketchen, E.E.; Porter, W.E.

1979-09-01

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

Materials Safety Data Sheets: the basis for control of toxic chemicals

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

Ketchen, E.E.; Porter, W.E.

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

The efficacy and safety of Baoji Tablets for treating common cold with summer-heat and dampness syndrome: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Despite the high incidence and the economic impact of the common cold, there are still no effective therapeutic options available. Although traditional Chinese medicine (TCM) is widely used in China to treat the common cold, there is still a lack of high-quality clinical trials. This article sets forth the protocol for a high-quality trial of a new TCM drug, Baoji Tablets, which is designed to treat the common cold with summer-heat and dampness syndrome (CCSDS). The trial is evaluating both the efficacy and safety of Baoji Tablets. Methods/design This study is designed as a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized and placebo-controlled trial. A total of 288 patients will be recruited from four centers. The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g. The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary and secondary symptoms, changes in primary and secondary symptom scores and cumulative symptom score at day 4, as well as an evaluation of treatment efficacy. Discussion This is the first multicenter, double-blind, double-dummy, randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China. It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS, and provide evidence for a phase III clinical trial. Trial registration This study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197. PMID:24359521

[Determination of aconitine, hypaconitine and mesaconitine in Shenfu injection].

PubMed

Zhang, Pan-Pan; Zhang, Jun-Zhen; Wang, Zhao-Hong; Lu, Yong-Jiang; Jiang, Ye

2013-05-01

To establish a method for the content determination of indexes for measuring aconitic compounds contained in Shenfu injection, in order to provide basis for the evaluation of the curative effect of monkshood in Shenfu injection. The sample were purified and enriched with HF-LPME. ACQUITY UPLC BEH C18 column (2.1 mm x 50 mm, 1.7 microm) was adopted and eluted with a gradient program, with acetonitrile-10 mmol x L(-1) NH4HCO3 (pH 10) as the mobile phases. The flow rate was 0.45 mL x min(-1). The content was determined with ESI and MRM. The results showed that aconitine, hypaconitine and mesaconitine showed a good linear relationship, with r > 0.999, within the range of 0.1-100 ng x L(-1). The recoveries were detected to be 100.1%, 97.4%, 97.5%, with RSD being 1.2%, 1.1%, 1.5%, respectively. This method was used to prove the safety of Shenfu injection, and provide scientific basis for correct evaluation of curative effect of monkshood, as well as a reliable, simple and practical means for quality control of monkshood-containing Chinese materia medica preparations.

Leveraging the Partnership for Patients' Initiative to Improve Patient Safety and Quality Within the Military Health System.

PubMed

King, Heidi B; Kesling, Kimberly; Birk, Carmen; Walker, Theodore; Taylor, Heather; Datena, Michael; Burgess, Brittany; Bower, Lyndsay

2017-03-01

Partnership for Patients (PfP) was a national initiative sponsored by the Department of Health and Human Services, Centers for Medicare and Medicaid Services, to reduce preventable hospital acquired conditions (HACs) by 40% and readmissions (within 30 days) by 20%, by the end of 2013 (as compared to the baseline of CY2010). Along with partners across the nation, the Assistant Secretary of Defense for Health Affairs, Dr. Jonathan Woodson, pledged to support PfP in June 2011. Participation of the Military Health System (MHS) in PfP marked the implementation of the first enterprise-wide patient safety initiative. Three phases of the MHS initiative were developed to meet the aims of the national PfP initiative: (1) Planning and Design, (2) Implementation, and (3) Monitoring and Sustainment. The Planning and Design phase focused on the identification of evidence-based practices (Table III); the development of implementation guides; the implementation of various communication, education, and improvement strategies; and the development of methods by which to track progress and share successes. The implementation phase focused on identifying roles and responsibilities across all levels of care; creating, disseminating, and implementing evidence-based practices at participating military treatment facilities; and establishing a structured learning action network. Finally, during the monitoring and sustainment phase, per the guidance of the Agency for Healthcare Research and Quality, an overall HAC rate was developed for quarterly analysis. The HAC rate per 1,000 dispositions (i.e., discharges) was an aggregate of all PfP HACs. Using the HAC rate, the improvement rate was calculated by comparing the current quarter's HAC rate to the baseline (CY2010). This allowed the MHS to track the overall progress across the enterprise. The MHS achieved a number of accomplishments, including a 15.8% cumulative reduction in HACs by the end of 2013, an 11.1% reduction in readmissions, avoided nearly 500 harm events since PfP implementation, and approximately $13.5 million in cost avoidance (on the basis of national cost estimate data available at the beginning of the PfP initiative). The two most critical lessons learned for the MHS during the PfP initiative are (1) continuous leadership engagement and inspection is vital to ensure field workers are engaged with safety and quality expectations and (2) applying a "one-size-fits-all" approach to improve a large delivery system is not effective. In addition, it is most impactful when local military treatment facility-level teams are involved in determining strategies to implement evidence-based standard processes and protocols that reduce variation when integrating practice change into daily operations. The MHS will continue to integrate PfP efforts into improvement activities by leveraging lessons learned from this initiative and determining how they can be applied to other areas of care and/or patient safety and quality initiatives. The Patient Safety Improvement Collaborative has committed to oversee and support the establishment and implementation of ongoing, focused patient safety and quality initiatives across the MHS using a collaborative vision to engage all levels of leadership and staff, and to ensure sustained improvements. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

2013 CEF RUN - PHASE 1 DATA ANALYSIS AND MODEL VALIDATION

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

Choi, A.

2014-05-08

Phase 1 of the 2013 Cold cap Evaluation Furnace (CEF) test was completed on June 3, 2013 after a 5-day round-the-clock feeding and pouring operation. The main goal of the test was to characterize the CEF off-gas produced from a nitric-formic acid flowsheet feed and confirm whether the CEF platform is capable of producing scalable off-gas data necessary for the revision of the DWPF melter off-gas flammability model; the revised model will be used to define new safety controls on the key operating parameters for the nitric-glycolic acid flowsheet feeds including total organic carbon (TOC). Whether the CEF off-gas datamore » were scalable for the purpose of predicting the potential flammability of the DWPF melter exhaust was determined by comparing the predicted H{sub 2} and CO concentrations using the current DWPF melter off-gas flammability model to those measured during Phase 1; data were deemed scalable if the calculated fractional conversions of TOC-to-H{sub 2} and TOC-to-CO at varying melter vapor space temperatures were found to trend and further bound the respective measured data with some margin of safety. Being scalable thus means that for a given feed chemistry the instantaneous flow rates of H{sub 2} and CO in the DWPF melter exhaust can be estimated with some degree of conservatism by multiplying those of the respective gases from a pilot-scale melter by the feed rate ratio. This report documents the results of the Phase 1 data analysis and the necessary calculations performed to determine the scalability of the CEF off-gas data. A total of six steady state runs were made during Phase 1 under non-bubbled conditions by varying the CEF vapor space temperature from near 700 to below 300°C, as measured in a thermowell (T{sub tw}). At each steady state temperature, the off-gas composition was monitored continuously for two hours using MS, GC, and FTIR in order to track mainly H{sub 2}, CO, CO{sub 2}, NO{sub x}, and organic gases such as CH{sub 4}. The standard deviation of the average vapor space temperature during each steady state ranged from 2 to 6°C; however, those of the measured off-gas data were much larger due to the inherent cold cap instabilities in the slurry-fed melters. In order to predict the off-gas composition at the sampling location downstream of the film cooler, the measured feed composition was charge-reconciled and input into the DWPF melter off-gas flammability model, which was then run under the conditions for each of the six Phase 1 steady states. In doing so, it was necessary to perform an overall heat/mass balance calculation from the melter to the Off-Gas Condensate Tank (OGCT) in order to estimate the rate of air inleakage as well as the true gas temperature in the CEF vapor space (T{sub gas}) during each steady state by taking into account the effects of thermal radiation on the measured temperature (T{sub tw}). The results of Phase 1 data analysis and subsequent model runs showed that the predicted concentrations of H{sub 2} and CO by the DWPF model correctly trended and further bounded the respective measured data in the CEF off-gas by over predicting the TOC-to-H{sub 2} and TOC-to-CO conversion ratios by a factor of 2 to 5; an exception was the 7X over prediction of the latter at T{sub gas} = 371°C but the impact of CO on the off-gas flammability potential is only minor compared to that of H{sub 2}. More importantly, the seemingly-excessive over prediction of the TOC-to-H{sub 2} conversion by a factor of 4 or higher at T{sub gas} < ~350°C was attributed to the conservative antifoam decomposition scheme added recently to the model and therefore is considered a modeling issue and not a design issue. At T{sub gas} > ~350°C, the predicted TOC-to-H{sub 2} conversions were closer to but still higher than the measured data by a factor of 2, which may be regarded as adequate from the safety margin standpoint. The heat/mass balance calculations also showed that the correlation between T{sub tw} and T{sub gas} in the CEF vapor space was close to that of the ½ scale SGM, whose data were taken as directly applicable to the DWPF melter and thus used to set all the parameters of the original model. Based on these results of the CEF Phase 1 off-gas and thermal data analyses, it is concluded that: (1) The thermal characteristics of the CEF vapor space are prototypic thanks to its prototypic design; and (2) The CEF off-gas data are scalable in terms of predicting the flammability potential of the DWPF melter off-gas. These results also show that the existing DWPF safety controls on the TOC and antifoam as a function of nitrate are conservative by the same order of magnitude shown by the Phase 1 data at T{sub gas} < ~350°C, since they were set at T{sub gas} = 294°C, which falls into the region of excessive conservatism for the current DWPF model in terms of predicting the TOC-to-H{sub 2} conversion. In order to remedy the overly-conservative antifoam decomposition scheme used in the current DWPF model, the data from two recent tests will be analyzed in detail in order to gain additional insights into the antifoam decomposition chemistry in the cold cap. The first test was run in a temperature-programmed furnace using both normal and spiked feeds with fresh antifoam under inert and slightly oxidizing vapor space conditions. Phase 2 of the CEF test was run with the baseline nitric-glycolic acid flowsheet feeds that contained the “processed antifoam” and those spiked with fresh antifoam in order to study the effects of antifoam concentration as well as processing history on its decomposition chemistry under actual melter conditions. The goal is to develop an improved antifoam decomposition model from the analysis of these test data and incorporate it into a new multistage cold cap model to be developed concurrently for the nitric-glycolic acid flowsheet feeds. These activities will be documented in the Phase 2 report. Finally, it is recommended that some of the conservatism in the existing DWPF safety controls be removed by improving the existing measured-vs.-true gas temperature correlation used in the melter vapor space combustion calculations. The basis for this recommendation comes from the fact that the existing correlation was developed by linearly extrapolating the SGM data taken over a relatively narrow temperature range down to the safety basis minimum of 460°C, thereby under predicting the true gas temperature considerably, as documented in this report. Specifically, the task of improving the current temperature correlation will involve; (1) performing a similar heat/mass balance analysis used in this study on actual DWPF data, (2) validating the measured-vs.-true gas temperature correlation for the CEF developed in this study against the DWPF melter heat/mass balance results, and (3) making adjustments to the CEF correlation, if necessary, before incorporating it into the DWPF safety basis calculations. The steps described here can be completed with relatively minimum efforts.« less

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

The dread factor: how hazards and safety training influence learning and performance.

PubMed

Burke, Michael J; Salvador, Rommel O; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

Using an iterative eigensolver to compute vibrational energies with phase-spaced localized basis functions.

PubMed

Brown, James; Carrington, Tucker

2015-07-28

Although phase-space localized Gaussians are themselves poor basis functions, they can be used to effectively contract a discrete variable representation basis [A. Shimshovitz and D. J. Tannor, Phys. Rev. Lett. 109, 070402 (2012)]. This works despite the fact that elements of the Hamiltonian and overlap matrices labelled by discarded Gaussians are not small. By formulating the matrix problem as a regular (i.e., not a generalized) matrix eigenvalue problem, we show that it is possible to use an iterative eigensolver to compute vibrational energy levels in the Gaussian basis.

To Report or Not to Report: Exploring Healthy Volunteers' Rationales for Disclosing Adverse Events in Phase I Drug Trials.

PubMed

McManus, Lisa; Fisher, Jill A

2018-04-25

Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and, thereby, jeopardize the validity of the trial results. We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants' interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. Our findings demonstrate that participants' reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.

Applying U.S. EOP Analytical Justification Experience for VVER Plants in the Ukraine

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

Linn, Paul A.; Julian, Harold V.; Chapman, James R.

2002-07-01

The foundation for new Emergency Operating Instructions (EOIs) being developed at several plants in the Ukraine is the Westinghouse Owners Group (WOG) Emergency Response Guidelines (ERGs) developed in the U.S. The ERGs were chosen as a base for the new EOIs for several reasons. First the overall structure and format was adaptable to VVER Pressurized Water Reactor (PWR) designs. Second, the ERGs have served as a base for many plant EOIs in both the U.S. and internationally. Third, key information supporting the ERGs was available. This paper describes the method used at one of the Ukrainian plants to provide anmore » analytical justification for their EOIs. The method being employed by a second plant is very similar, differing only slightly in how it is implemented. The WOG ERG development program, which started shortly after the accident at Three Mile Island Unit 2, used many sources of technical information on plant and system transient response, which were available in support of the plant design and licensing efforts. In addition, operating experience from many operating PWR plants in the U.S. and around the world was used. For example, design basis accident (DBA) analyses, documented in a plant's Safety Analysis Report (SAR) and other design documents, had been performed by Nuclear Steam Supply System (NSSS) vendors, utilities, or the Architect/Engineer. All relevant sources were considered in the development of the ERGs. Limited Probabilistic Risk Assessment (PRA) analyses were available during that time period. When a technical basis for a recovery strategy and associated operator actions was not available, an analysis was defined and performed. In general, these analyses were performed on a generic basis, and addressed the different categories of design (e.g., number of reactor coolant loops and/or low/high pressure safety injection system design). U.S. Nuclear Power plants that were in the WOG program were responsible for implementing the generic ERGs. This required the utilities to review the generic analyses to ensure that they were applicable and to justify any deviations from the ERG methodology. Modern PRA analyses are similar to the analyses supporting the ERGs since they address multiple failures and assume better estimate or expected assumptions for equipment availability and operator performance. The process being employed by Ukrainian plants is similar to the WOG. That is, available analyses and operating experience are being reviewed and pertinent information extracted to assist in the analytical justification of the EOIs. This includes the use of recently updated PRA and DBA analyses, other 'original' design information and operating experience. A systematic review of the EOIs is being conducted to identify items requiring analytical justification. For each analysis identified, the specific purpose of the analysis is being documented. The analysis needs are then compared to the available analyses and operating experience. From this review, new analyses needed to justify the EOIs are developed, and a basis for using existing analyses is established. The work is being conducted in two phases. The first phase performs all of the reviews and assessments necessary to determine the new analyses required to justify the EOIs. In the second phase, these new analyses will be conducted and documented, and the EOI Analytical Justification (AJ) report will be written. (authors)« less

77 FR 29929 - Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... section of this notice. Basis and Purpose On July 4, 2012 the Town of Cape Charles will sponsor a...-AA00 Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA AGENCY: Coast... temporary safety zone on the waters of Cape Charles City Harbor in Cape Charles, VA in support of the Fourth...

76 FR 18672 - Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

...-AA00 Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC AGENCY: Coast Guard... Safety Zone for the ``Big Rock Blue Marlin Air Show'', an aerial demonstration to be held over the waters... Register. Basis and Purpose On June 11, 2011 from 7 p.m. to 8 p.m., the Big Rock Blue Marlin Tournament...

77 FR 35850 - Safety Zone; F/V Deep Sea, Penn Cove, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... 1625-AA00 Safety Zone; F/V Deep Sea, Penn Cove, WA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone around the Fishing Vessel (F/V) Deep Sea... with the sunken F/V Deep Sea. B. Basis and Purpose On the evening of May 13, 2012, the F/V Deep Sea...

School Safety, Severe Disciplinary Actions, and School Characteristics: A Secondary Analysis of the School Survey on Crime and Safety

ERIC Educational Resources Information Center

Han, Seunghee; Akiba, Motoko

2011-01-01

On the basis of a secondary analysis of survey data collected from 1,872 secondary school principals in the 2005-2006 School Survey on Crime and Safety, we examined the frequency of and reasons for severe disciplinary actions and the relationship between school characteristics and severe disciplinary actions. We found that severe disciplinary…

16 CFR 1034.110 - Self-evaluation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Self-evaluation. 1034.110 Section 1034.110 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER PRODUCT SAFETY COMMISSION § 1034.110...

Prediction of main factors’ values of air transportation system safety based on system dynamics

NASA Astrophysics Data System (ADS)

Spiridonov, A. Yu; Rezchikov, A. F.; Kushnikov, V. A.; Ivashchenko, V. A.; Bogomolov, A. S.; Filimonyuk, L. Yu; Dolinina, O. N.; Kushnikova, E. V.; Shulga, T. E.; Tverdokhlebov, V. A.; Kushnikov, O. V.; Fominykh, D. S.

2018-05-01

On the basis of the system-dynamic approach [1-8], a set of models has been developed that makes it possible to analyse and predict the values of the main safety indicators for the operation of aviation transport systems.

76 FR 53072 - Certification; Importation of Vehicles and Equipment Subject to Federal Safety, Bumper, and Theft...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-25

... used as a basis for the non-automatic suspension of an RI registration, deletes redundant text from... Part 592 as a Basis for the Non-Automatic Suspension or Revocation of an RI Registration B. Deletion of... violations of the regulations in part 592 as a basis for the non-automatic suspension or revocation of an RI...

Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials.

PubMed

Schoenfeld, P; Pimentel, M; Chang, L; Lembo, A; Chey, W D; Yu, J; Paterson, C; Bortey, E; Forbes, W P

2014-05-01

The efficacy of rifaximin, a nonsystemic, gut-targeted antibiotic for reducing non-constipation-predominant irritable bowel syndrome (non-C IBS) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double-blind, placebo-controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow-up periods are lacking. To assess and determine the frequency of rifaximin and placebo adverse events (AEs) in phase 2b and phase 3 non-C IBS trials. A post hoc pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three times daily for 2 weeks) studies was performed. Data on treatment and post-treatment AEs were collected. Patients were followed up for 12 weeks and 10 weeks post-treatment in the phase 2b and phase 3 trials, respectively. Patients receiving rifaximin (n = 1103) and placebo (n = 829) had a similar incidence of drug-related AEs (12.1% vs. 10.7%), serious AEs (1.5% vs. 2.2%), drug-related AEs resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal-associated AEs (12.2% vs. 12.2%) and infection-associated AEs (8.5% vs. 9.5%). There were no cases of Clostridium difficile colitis or deaths. The safety and tolerability profile of rifaximin during treatment and post-treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of C. difficile colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non-constipation-predominant irritable bowel syndrome (ClinicalTrials.gov: NCT00269412, NCT00731679, and NCT00724126). © 2014 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Effects of a multicentre teamwork and communication programme on patient outcomes: results from the Triad for Optimal Patient Safety (TOPS) project.

PubMed

Auerbach, Andrew D; Sehgal, Niraj L; Blegen, Mary A; Maselli, Judith; Alldredge, Brian K; Vittinghoff, Eric; Wachter, Robert M

2012-02-01

Improving communication between caregivers is an important approach to improving safety. To implement teamwork and communication interventions and evaluate their impact on patient outcomes. A prospective, interrupted time series of a three-phase a run-in period (phase 1), during which a training programme was given to providers and staff on each unit; phase 2, which focused on unit-based safety teams to identify and address care problems using skills from phase 1; and phase 3, which focused on engaging patients in communication efforts. General medical inpatient units at three northern California hospitals. Administrative data were collected from all adults admitted to the target units, and a convenience sample of patients interviewed during and after hospitalisation. Readmission, length of stay and patient reports of teamwork, problems with care, and overall satisfaction. 10 977 patients were admitted; 581 patients (5.3% of total sample) were interviewed in hospital, and 313 (2.9% overall, 53.8% of interviewed patients) completed 1-month surveys. No phase of the study was associated with adjusted differences in readmission or length of stay. The phase 2 intervention appeared to be associated with improvement in reports of whether physicians treated them with respect, whether nurses treated them with respect or understood their needs (p<0.05 for all). Interestingly, patients were more likely to perceive that an error took place with their care and agreed less that their caregivers worked well together as a team. No phase had a consistent impact on patient reports of care processes or overall satisfaction. Limitations The study lacks direct measures of patient safety. Efforts to simultaneously improve caregivers' ability to troubleshoot care and enhance communication may improve patients' perception of team functions, but may also increase patients' perception of safety gaps.

75 FR 11574 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... protection during plant operation and maintenance activities. For plants that have a design basis that... coatings be qualified and capable of surviving a design-basis accident without adversely affecting safety...

16 CFR 1034.130 - General prohibitions against discrimination.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1034.130 Section 1034.130 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER... handicapped person shall, on the basis of handicap, be excluded from participation in, be denied the benefits...

47 CFR 87.1 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES... purpose for which this part is issued. (a) Basis. The rules for the aviation services in this part are... Regulations). (3) The Convention on International Civil Aviation—(ICAO Convention). (b) Purpose. This part...

Multi-Criteria Approach in Multifunctional Building Design Process

NASA Astrophysics Data System (ADS)

Gerigk, Mateusz

2017-10-01

The paper presents new approach in multifunctional building design process. Publication defines problems related to the design of complex multifunctional buildings. Currently, contemporary urban areas are characterized by very intensive use of space. Today, buildings are being built bigger and contain more diverse functions to meet the needs of a large number of users in one capacity. The trends show the need for recognition of design objects in an organized structure, which must meet current design criteria. The design process in terms of the complex system is a theoretical model, which is the basis for optimization solutions for the entire life cycle of the building. From the concept phase through exploitation phase to disposal phase multipurpose spaces should guarantee aesthetics, functionality, system efficiency, system safety and environmental protection in the best possible way. The result of the analysis of the design process is presented as a theoretical model of the multifunctional structure. Recognition of multi-criteria model in the form of Cartesian product allows to create a holistic representation of the designed building in the form of a graph model. The proposed network is the theoretical base that can be used in the design process of complex engineering systems. The systematic multi-criteria approach makes possible to maintain control over the entire design process and to provide the best possible performance. With respect to current design requirements, there are no established design rules for multifunctional buildings in relation to their operating phase. Enrichment of the basic criteria with functional flexibility criterion makes it possible to extend the exploitation phase which brings advantages on many levels.

Laboratory safety and the WHO World Alliance for Patient Safety.

PubMed

McCay, Layla; Lemer, Claire; Wu, Albert W

2009-06-01

Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.

First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

PubMed

Baylis, Francoise; McLeod, Marcus

2017-01-01

A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for patients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptable to initiate such trials on the basis of safety and efficacy data obtained from pre-clinical studies. If the pre-clinical studies that inform trial design are themselves poorly designed - as a result of which the quality of pre-clinical evidence is deficient - then the ethical requirement of scientific validity for clinical research may not be satisfied. In turn, this could mean that the Phase 1 clinical trial will be unsafe and that trial participants will be exposed to risk for no potential benefit. To assist sponsors, researchers, clinical investigators and reviewers in deciding when it is ethically acceptable to initiate first-in-human Phase 1 CRISPR gene editing clinical trials, structured processes have been developed to assess and minimize translational distance between pre-clinical and clinical research. These processes draw attention to various features of internal validity, construct validity, and external validity. As well, the credibility of supporting evidence is to be critically assessed with particular attention to optimism bias, financial conflicts of interest and publication bias. We critically examine the pre-clinical evidence used to justify the first-inhuman Phase 1 CRISPR gene editing cancer trial in the United States using these tools. We conclude that the proposed trial cannot satisfy the ethical requirement of scientific validity because the supporting pre-clinical evidence used to inform trial design is deficient. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The SAS4A/SASSYS-1 Safety Analysis Code System, Version 5

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

Fanning, T. H.; Brunett, A. J.; Sumner, T.

The SAS4A/SASSYS-1 computer code is developed by Argonne National Laboratory for thermal, hydraulic, and neutronic analysis of power and flow transients in liquidmetal- cooled nuclear reactors (LMRs). SAS4A was developed to analyze severe core disruption accidents with coolant boiling and fuel melting and relocation, initiated by a very low probability coincidence of an accident precursor and failure of one or more safety systems. SASSYS-1, originally developed to address loss-of-decay-heat-removal accidents, has evolved into a tool for margin assessment in design basis accident (DBA) analysis and for consequence assessment in beyond-design-basis accident (BDBA) analysis. SAS4A contains detailed, mechanistic models of transientmore » thermal, hydraulic, neutronic, and mechanical phenomena to describe the response of the reactor core, its coolant, fuel elements, and structural members to accident conditions. The core channel models in SAS4A provide the capability to analyze the initial phase of core disruptive accidents, through coolant heat-up and boiling, fuel element failure, and fuel melting and relocation. Originally developed to analyze oxide fuel clad with stainless steel, the models in SAS4A have been extended and specialized to metallic fuel with advanced alloy cladding. SASSYS-1 provides the capability to perform a detailed thermal/hydraulic simulation of the primary and secondary sodium coolant circuits and the balance-ofplant steam/water circuit. These sodium and steam circuit models include component models for heat exchangers, pumps, valves, turbines, and condensers, and thermal/hydraulic models of pipes and plena. SASSYS-1 also contains a plant protection and control system modeling capability, which provides digital representations of reactor, pump, and valve controllers and their response to input signal changes.« less

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID:29691240

Space-Based Telemetry and Range Safety Project Ku-Band and Ka-Band Phased Array Antenna

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Birr, Richard B.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to increase data rates and flexibility and decrease costs by using space-based communications assets for telemetry during launches and landings. Phase 1 used standard S-band antennas with the Tracking and Data Relay Satellite System to obtain a baseline performance. The selection process and available resources for Phase 2 resulted in a Ku-band phased array antenna system. Several development efforts are under way for a Ka-band phased array antenna system for Phase 3. Each phase includes test flights to demonstrate performance and capabilities. Successful completion of this project will result in a set of communications requirements for the next generation of launch vehicles.

Ku- and Ka-Band Phased Array Antenna for the Space-Based Telemetry and Range Safety Project

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Birr, Richard B.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to increase data rates and flexibility and decrease costs by using space-based communications assets for telemetry during launches and landings. Phase 1 used standard S-band antennas with the Tracking and Data Relay Satellite System to obtain a baseline performance. The selection process and available resources for Phase 2 resulted in a Ku-band phased array antenna system. Several development efforts are under way for a Ka-band phased array antenna system for Phase 3. Each phase includes test flights to demonstrate performance and capabilities. Successful completion of this project will result in a set of communications requirements for the next generation of launch vehicles.

77 FR 48856 - Safety Zone; Superior Bay, Duluth, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... participants, event safety personnel, boaters and spectators during the Superior Man Triathlon. DATES: This..., spectators, and vessels from the hazards associated with the Superior Man Triathlon, which are discussed... interest. B. Basis and Purpose On August 26, 2012, the inaugural Superior Man Triathlon will occur along...

2007 motor vehicle occupant safety survey : use of and support for emergency medical services systems.

DOT National Transportation Integrated Search

2009-09-01

The Motor Vehicle Occupant Safety Survey (MVOSS) is a national telephone survey administered by NHTSA on a periodic basis to obtain data on attitudes, knowledge, and self-reported behavior primarily in areas of occupant protection. The sample is comp...

Equivalent Safety Basis for Evaluation of On-Site Packages for US DOE Facilities

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

Smith, A.C.

Packages for transport of radioactive material within the boundaries of a Department of Energy facility (on-site) must conform to the requirements for packages shipped in normal commerce, or must provide equivalent safety. Equivalence is achieved if the frequency of severe on-site accidents, which could result in a release of radioactive material, is less than or equal to the frequency of Beyond-HAC accidents for packages in commerce. This is shown to be achieved it the rate of on-site accident is 22 per 100 MVM or lower. For equivalence to Normal Conditions of Transport, for on-site packages, appropriate, defensible Design Basis Conditionsmore » can be established and the ability of the package to meet the reduced requirements shown in the On-site Safety Assessment.« less

Three flavor neutrino oscillations in matter: Flavor diagonal potentials, the adiabatic basis, and the CP phase

NASA Astrophysics Data System (ADS)

Kneller, James P.; McLaughlin, Gail C.

2009-09-01

We discuss the three neutrino flavor evolution problem with general, flavor-diagonal, matter potentials and a fully parametrized mixing matrix that includes CP violation, and derive expressions for the eigenvalues, mixing angles, and phases. We demonstrate that, in the limit that the mu and tau potentials are equal, the eigenvalues and matter mixing angles θ˜12 and θ˜13 are independent of the CP phase, although θ˜23 does have CP dependence. Since we are interested in developing a framework that can be used for S matrix calculations of neutrino flavor transformation, it is useful to work in a basis that contains only off-diagonal entries in the Hamiltonian. We derive the “nonadiabaticity” parameters that appear in the Hamiltonian in this basis. We then introduce the neutrino S matrix, derive its evolution equation and the integral solution. We find that this new Hamiltonian, and therefore the S matrix, in the limit that the μ and τ neutrino potentials are the same, is independent of both θ˜23 and the CP violating phase. In this limit, any CP violation in the flavor basis can only be introduced via the rotation matrices, and so effects which derive from the CP phase are then straightforward to determine. We then show explicitly that the electron neutrino and electron antineutrino survival probability is independent of the CP phase in this limit. Conversely, if the CP phase is nonzero and mu and tau matter potentials are not equal, then the electron neutrino survival probability cannot be independent of the CP phase.

Individuals with severely impaired vision can learn useful orientation and mobility skills in virtual streets and can use them to improve real street safety

PubMed Central

Liu, Lei

2017-01-01

Virtual reality has great potential in training road safety skills to individuals with low vision but the feasibility of such training has not been demonstrated. We tested the hypotheses that low vision individuals could learn useful skills in virtual streets and could apply them to improve real street safety. Twelve participants, whose vision was too poor to use the pedestrian signals were taught by a certified orientation and mobility specialist to determine the safest time to cross the street using the visual and auditory signals made by the start of previously stopped cars at a traffic-light controlled street intersection. Four participants were trained in real streets and eight in virtual streets presented on 3 projection screens. The crossing timing of all participants was evaluated in real streets before and after training. The participants were instructed to say “GO” at the time when they felt the safest to cross the street. A safety score was derived to quantify the GO calls based on its occurrence in the pedestrian phase (when the pedestrian sign did not show DON’T WALK). Before training, > 50% of the GO calls from all participants fell in the DON’T WALK phase of the traffic cycle and thus were totally unsafe. 20% of the GO calls fell in the latter half of the pedestrian phase. These calls were unsafe because one initiated crossing this late might not have sufficient time to walk across the street. After training, 90% of the GO calls fell in the early half of the pedestrian phase. These calls were safer because one initiated crossing in the pedestrian phase and had at least half of the pedestrian phase for walking across. Similar safety changes occurred in both virtual street and real street trained participants. An ANOVA showed a significant increase of the safety scores after training and there was no difference in this safety improvement between the virtual street and real street trained participants. This study demonstrated that virtual reality-based orientation and mobility training could be as efficient as real street training in improving street safety in individuals with severely impaired vision. PMID:28445540

42 CFR 485.701 - Basis and scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Therapy and Speech-Language Pathology Services § 485.701 Basis and scope. This subpart implements section 1861(p)(4) of the Act, which— (a) Defines outpatient physical therapy and speech pathology services; (b... records; and (c) Authorizes the Secretary to establish by regulation other health and safety requirements...

Long-term tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study

PubMed Central

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-01-01

Background This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. Study design In this Phase III, multicentre, open-label study, women (aged 18–35 years) were randomised to EE/DRSP in the following regimens: flexibleMIB (24–120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexibleMIB regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexibleMIB, conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. Conclusions EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives. PMID:22454004

School Safety Study: Phase I.

ERIC Educational Resources Information Center

Arora, Alka

This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

Safety through Education and Training.

ERIC Educational Resources Information Center

Thorburn, S.

1990-01-01

Addresses the need for safety education as a continuous process through elementary and secondary phases of education in the context of human risk within modern society. Discusses the teaching of safety subjects in civil engineering curriculum. (YP)

Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-12-01

Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS ® software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Criticality Safety Evaluation of the LLNL Inherently Safe Subcritical Assembly (ISSA)

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

Percher, Catherine

2012-06-19

The LLNL Nuclear Criticality Safety Division has developed a training center to illustrate criticality safety and reactor physics concepts through hands-on experimental training. The experimental assembly, the Inherently Safe Subcritical Assembly (ISSA), uses surplus highly enriched research reactor fuel configured in a water tank. The training activities will be conducted by LLNL following the requirements of an Integration Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of LLNL instructors. This report provides the technical criticality safety basis for instructional operations with the ISSA experimental assembly.

Estimating propagation velocity through a surface acoustic wave sensor

DOEpatents

Xu, Wenyuan; Huizinga, John S.

2010-03-16

Techniques are described for estimating the propagation velocity through a surface acoustic wave sensor. In particular, techniques which measure and exploit a proper segment of phase frequency response of the surface acoustic wave sensor are described for use as a basis of bacterial detection by the sensor. As described, use of velocity estimation based on a proper segment of phase frequency response has advantages over conventional techniques that use phase shift as the basis for detection.

PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform.

PubMed

Claes, Jomme; Buys, Roselien; Woods, Catherine; Briggs, Andrew; Geue, Claudia; Aitken, Moira; Moyna, Niall; Moran, Kieran; McCaffrey, Noel; Chouvarda, Ioanna; Walsh, Deirdre; Budts, Werner; Filos, Dimitris; Triantafyllidis, Andreas; Maglaveras, Nicos; Cornelissen, Véronique A

2017-06-30

Exercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%-30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy. In a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40-80 years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internet-enabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3 months and 6 months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure. Secondary outcomes include cardiopulmonary endurance capacity, muscle strength, body composition, cardiovascular risk factors, peripheral endothelial vascular function, patient satisfaction, health-related quality of life (HRQoL), well-being, mediators of behaviour change and safety. HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation. The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses and events. NCT02717806. This trial is currently in the pre-results stage. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A new procedure for the determination of distillation temperature distribution of high-boiling petroleum products and fractions.

PubMed

Boczkaj, Grzegorz; Przyjazny, Andrzej; Kamiński, Marian

2011-03-01

The distribution of distillation temperatures of liquid and semi-fluid products, including petroleum fractions and products, is an important process and practical parameter. It provides information on properties of crude oil and content of particular fractions, classified on the basis of their boiling points, as well as the optimum conditions of atmospheric or vacuum distillation. At present, the distribution of distillation temperatures is often investigated by simulated distillation (SIMDIS) using capillary gas chromatography (CGC) with a short capillary column with polydimethylsiloxane as the stationary phase. This paper presents the results of investigations on the possibility of replacing currently used CGC columns for SIMDIS with a deactivated fused silica capillary tube without any stationary phase. The SIMDIS technique making use of such an empty fused silica column allows a considerable lowering of elution temperature of the analytes, which results in a decrease of the final oven temperature while ensuring a complete separation of the mixture. This eliminates the possibility of decomposition of less thermally stable mixture components and bleeding of the stationary phase which would result in an increase of the detector signal. It also improves the stability of the baseline, which is especially important in the determination of the end point of elution, which is the basis for finding the final temperature of distillation. This is the key parameter for the safety process of hydrocracking, where an excessively high final temperature of distillation of a batch can result in serious damage to an expensive catalyst bed. This paper compares the distribution of distillation temperatures of the fraction from vacuum distillation of petroleum obtained using SIMDIS with that obtained by the proposed procedure. A good agreement between the two procedures was observed. In addition, typical values of elution temperatures of n-paraffin standards obtained by the two procedures were compared. Finally, the agreement between boiling points of polar compounds determined from their retention times and actual boiling points was investigated.

Large scale exact quantum dynamics calculations: Ten thousand quantum states of acetonitrile

NASA Astrophysics Data System (ADS)

Halverson, Thomas; Poirier, Bill

2015-03-01

'Exact' quantum dynamics (EQD) calculations of the vibrational spectrum of acetonitrile (CH3CN) are performed, using two different methods: (1) phase-space-truncated momentum-symmetrized Gaussian basis and (2) correlated truncated harmonic oscillator basis. In both cases, a simple classical phase space picture is used to optimize the selection of individual basis functions-leading to drastic reductions in basis size, in comparison with existing methods. Massive parallelization is also employed. Together, these tools-implemented into a single, easy-to-use computer code-enable a calculation of tens of thousands of vibrational states of CH3CN to an accuracy of 0.001-10 cm-1.

TA 55 Reinvestment Project II Phase C Update Project Status May 23, 2017

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

Giordano, Anthony P.

The TA-55 Reinvestment Project (TRP) II Phase C is a critical infrastructure project focused on improving safety and reliability of the Los Alamos National Laboratory (LANL) TA-55 Complex. The Project recapitalizes and revitalizes aging and obsolete facility and safety systems providing a sustainable nuclear facility for National Security Missions.

Reduction in pediatric identification band errors: a quality collaborative.

PubMed

Phillips, Shannon Connor; Saysana, Michele; Worley, Sarah; Hain, Paul D

2012-06-01

Accurate and consistent placement of a patient identification (ID) band is used in health care to reduce errors associated with patient misidentification. Multiple safety organizations have devoted time and energy to improving patient ID, but no multicenter improvement collaboratives have shown scalability of previously successful interventions. We hoped to reduce by half the pediatric patient ID band error rate, defined as absent, illegible, or inaccurate ID band, across a quality improvement learning collaborative of hospitals in 1 year. On the basis of a previously successful single-site intervention, we conducted a self-selected 6-site collaborative to reduce ID band errors in heterogeneous pediatric hospital settings. The collaborative had 3 phases: preparatory work and employee survey of current practice and barriers, data collection (ID band failure rate), and intervention driven by data and collaborative learning to accelerate change. The collaborative audited 11377 patients for ID band errors between September 2009 and September 2010. The ID band failure rate decreased from 17% to 4.1% (77% relative reduction). Interventions including education of frontline staff regarding correct ID bands as a safety strategy; a change to softer ID bands, including "luggage tag" type ID bands for some patients; and partnering with families and patients through education were applied at all institutions. Over 13 months, a collaborative of pediatric institutions significantly reduced the ID band failure rate. This quality improvement learning collaborative demonstrates that safety improvements tested in a single institution can be disseminated to improve quality of care across large populations of children.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

49 CFR 807.151 - Program accessibility: New construction and alterations.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) NATIONAL TRANSPORTATION SAFETY BOARD ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE NATIONAL TRANSPORTATION SAFETY BOARD § 807.151 Program accessibility... the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR 101-19.600 to 101-19...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2010 CFR

2010-10-01

... financial and operational information. The Public Safety Broadband Licensee shall submit, on a quarterly basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing Agreement, and as approved by the Commission. Such quarterly financial reports shall be filed with the...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

75 FR 39197 - Safety Zone; Fireworks Display, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

...-AA00 Safety Zone; Fireworks Display, Portland, OR AGENCY: Coast Guard, DHS. ACTION: Notice of proposed..., and the shoreline to the east and west in support of the Oregon Symphony Celebration Fireworks Display... Register. Basis and Purpose The Oregon Symphony Celebration Fireworks display is an annual event. The...

School Safety Project: Product Evaluation, 1990-1991.

ERIC Educational Resources Information Center

Saginaw Public Schools, MI. Dept. of Evaluation Services.

A districtwide school safety project implemented in Saginaw, Michigan, in 1990-91, the third year of its operation, is evaluated in this report. The project is evaluated on the basis of the following objectives: employment and training of home-school liaison officers; establishment of an advisory council; development and implementation of…

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2010 CFR

2010-01-01

... Analysis Reports for Nuclear Power Plants, or successor document. (2) A DOE nonreactor nuclear facility... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., the public and the environment from adverse consequences. These analyses and hazard controls...

A Daily Diary Approach to the Examination of Chronic Stress, Daily Hassles and Safety Perceptions in Hospital Nursing.

PubMed

Louch, Gemma; O'Hara, Jane; Gardner, Peter; O'Connor, Daryl B

2017-12-01

Stress is a significant concern for individuals and organisations. Few studies have explored stress, burnout and patient safety in hospital nursing on a daily basis at the individual level. This study aimed to examine the effects of chronic stress and daily hassles on safety perceptions, the effect of chronic stress on daily hassles experienced and chronic stress as a potential moderator. Utilising a daily diary design, 83 UK hospital nurses completed three end-of-shift diaries, yielding 324 person days. Hassles, safety perceptions and workplace cognitive failure were measured daily, and a baseline questionnaire included a measure of chronic stress. Hierarchical multivariate linear modelling was used to analyse the data. Higher chronic stress was associated with more daily hassles, poorer perceptions of safety and being less able to practise safely, but not more workplace cognitive failure. Reporting more daily hassles was associated with poorer perceptions of safety, being less able to practise safely and more workplace cognitive failure. Chronic stress did not moderate daily associations. The hassles reported illustrate the wide-ranging hassles nurses experienced. The findings demonstrate, in addition to chronic stress, the importance of daily hassles for nurses' perceptions of safety and the hassles experienced by hospital nurses on a daily basis. Nurses perceive chronic stress and daily hassles to contribute to their perceptions of safety. Measuring the number of daily hassles experienced could proactively highlight when patient safety threats may arise, and as a result, interventions could usefully focus on the management of daily hassles.

Safety and mobility impacts of winter weather - phase 3.

DOT National Transportation Integrated Search

2014-09-01

Highway agencies spend millions of dollars to ensure safe and efficient winter travel. However, the effectiveness of winter-weather : maintenance practices on safety and mobility are somewhat difficult to quantify. Safety and Mobility Impacts of Wint...

NASA/Navy Benchmarking Exchange (NNBE). Volume 1. Interim Report. Navy Submarine Program Safety Assurance

NASA Technical Reports Server (NTRS)

2002-01-01

The NASA/Navy Benchmarking Exchange (NNBE) was undertaken to identify practices and procedures and to share lessons learned in the Navy's submarine and NASA's human space flight programs. The NNBE focus is on safety and mission assurance policies, processes, accountability, and control measures. This report is an interim summary of activity conducted through October 2002, and it coincides with completion of the first phase of a two-phase fact-finding effort.In August 2002, a team was formed, co-chaired by senior representatives from the NASA Office of Safety and Mission Assurance and the NAVSEA 92Q Submarine Safety and Quality Assurance Division. The team closely examined the two elements of submarine safety (SUBSAFE) certification: (1) new design/construction (initial certification) and (2) maintenance and modernization (sustaining certification), with a focus on: (1) Management and Organization, (2) Safety Requirements (technical and administrative), (3) Implementation Processes, (4) Compliance Verification Processes, and (5) Certification Processes.

49 CFR 195.452 - Pipeline integrity management in high consequence areas.

Code of Federal Regulations, 2011 CFR

2011-10-01

... engineering evaluation and provides an equivalent level of public safety and environmental protection. (c... situations—(i) Engineering basis. An operator may be able to justify an engineering basis for a longer assessment interval on a segment of line pipe. The justification must be supported by a reliable engineering...

Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study.

PubMed

Pinter, M M; Pogarell, O; Oertel, W H

1999-04-01

Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance. Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings. There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%--resulting in 1.7 more hours "on" time a day--compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams. Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications.

Everolimus for Advanced Pancreatic Neuroendocrine Tumours: A Subgroup Analysis Evaluating Japanese Patients in the RADIANT-3 Trial

PubMed Central

Ito, Tetsuhide; Okusaka, Takuji; Ikeda, Masafumi; Igarashi, Hisato; Morizane, Chigusa; Nakachi, Kohei; Tajima, Takeshi; Kasuga, Akio; Fujita, Yoshie; Furuse, Junji

2012-01-01

Objective Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65% risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95% confidence interval, 8.31–not available) with everolimus vs 2.83 months (95% confidence interval, 2.46–8.34) with placebo, resulting in an 81% risk reduction in progression (hazard ratio, 0.19; 95% confidence interval, 0.08–0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100%) Japanese patients receiving everolimus and in 13 (77%) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87%), stomatitis (n = 17; 74%), infections (n = 15; 65%), nail disorders (n = 12; 52%), epistaxis (n = 10; 44%) and pneumonitis (n = 10; 44%). Conclusions These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours. PMID:22859827

One-year safety and efficacy study of bilastine treatment in Japanese patients with chronic spontaneous urticaria or pruritus associated with skin diseases.

PubMed

Yagami, Akiko; Furue, Masutaka; Togawa, Michinori; Saito, Akihiro; Hide, Michihiro

2017-04-01

A number of second-generation non-sedating antihistamines are used in clinical practices over the world. However, long-term safety and efficacy have not been proved high level evidence based medicine. We have performed an open-label, multicenter, phase III study to evaluate the long-term safety and efficacy of bilastine, a novel non-sedating H 1 -antihistamine for patients with chronic spontaneous urticaria (CSU) or pruritus associated with skin diseases (trial registration no. JapicCTI-142528). Patients aged 18-74 years were treated with bilastine 20 mg once daily for up to 52 weeks. Safety and tolerability were assessed on the basis of adverse events (AE), bilastine-related AE, laboratory tests and vital signs. Efficacy was assessed based on rash score, itch score, overall improvement and quality of life. One hundred and ninety-eight patients enrolled, 122 of whom (61.6%) completed the 52-week treatment period. AE were reported in 64.5% and bilastine-related AE in 2.5% of patients throughout the 52-week treatment period. All AE were mild to moderate in severity. AE associated with the nervous system occurred in 10 patients (5.1%) including seven patients (3.6%) with headache. Somnolence reported in two of these patients (1.0%) was related to bilastine. All efficacy variables improved during treatment with bilastine. In conclusion, long-term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with CSU or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment. © 2016 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

To make or buy patient safety solutions: a resource dependence and transaction cost economics perspective.

PubMed

Fareed, Naleef; Mick, Stephen S

2011-01-01

For almost a decade, public and private organizations have pressured hospitals to improve their patient safety records. Since 2008, the Centers for Medicare & Medicaid Services has no longer been reimbursing hospitals for secondary diagnoses not reported during the point of admission. This ruling has motivated some hospitals to engage in safety-oriented programs to decrease adverse events. This study examined which hospitals may engage in patient safety solutions and whether they create these patient safety solutions within their structures or use suppliers in the market. We used a theoretical model that incorporates the key constructs of resource dependence theory and transaction cost economics theory to predict a hospital's reaction to Centers for Medicare & Medicaid Services "never event" regulations. We present propositions that speculate on how forces conceptualized from the resource dependence theory may affect adoption of patient safety innovations and, when they do, whether the adopting hospitals will do so internally or externally according to the transaction cost economics theory. On the basis of forces identified by the resource dependence theory, we predict that larger, teaching, safety net, horizontally integrated, highly interdependent, and public hospitals in concentrated, high public payer presence, competitive, and resource-rich environments will be more likely to engage in patient safety innovations. Following the logic of the transaction cost economics theory, we predict that of the hospitals that react positively to the never event regulation, most will internalize their innovations in patient safety solutions rather than approach the market, a choice that helps hospitals economize on transaction costs. This study helps hospital managers in their strategic thinking and planning in relation to current and future regulations related to patient safety. For researchers and policy analysts, our propositions provide the basis for empirical testing.

Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.

PubMed

Lovell, Daniel J; Ruperto, Nicolino; Mouy, Richard; Paz, Eliana; Rubio-Pérez, Nadina; Silva, Clovis A; Abud-Mendoza, Carlos; Burgos-Vargas, Ruben; Gerloni, Valeria; Melo-Gomes, Jose A; Saad-Magalhaes, Claudia; Chavez-Corrales, J; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J; Foeldvari, Ivan; Hofer, Michael; Huppertz, Hans-Iko; Job Deslandre, Chantal; Minden, Kirsten; Punaro, Marilynn; Block, Alan J; Giannini, Edward H; Martini, Alberto

2015-10-01

The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease-modifying antirheumatic drugs were previously established in a phase III study that included a 4-month open-label lead-in period, a 6-month double-blind withdrawal period, and a long-term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient-reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. Patients enrolled in the phase III trial could enter the open-label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double-blind period. One hundred fifty-three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient-years) of adverse events decreased during the LTE phase (433.61 events during the short-term phase [combined lead-in and double-blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time. Long-term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality-of-life benefits in patients with JIA. © 2015 The Authors. Arthritis & Rheumatology is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Development of the Sanofi Pasteur tetravalent dengue vaccine: One more step forward.

PubMed

Guy, Bruno; Briand, Olivier; Lang, Jean; Saville, Melanie; Jackson, Nicholas

2015-12-10

Sanofi Pasteur has developed a recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) that is in late-stage development. The present review summarizes the different steps in the development of this dengue vaccine, with a particular focus on the clinical data from three efficacy trials, which includes one proof-of-concept phase IIb (NCT00842530) and two pivotal phase III efficacy trials (NCT01373281 and NCT01374516). Earlier studies showed that the CYD-TDV candidate had a satisfactory safety profile and was immunogenic across the four vaccine serotypes in both in vitro and in vivo preclinical tests, as well as in initial phase I to phase II clinical trials in both flavivirus-naïve and seropositive individuals. Data from the 25 months (after the first injection) active phase of the two pivotal phase III efficacy studies shows that CYD-TDV (administered at 0, 6, and 12 months) is efficacious against virologically-confirmed disease (primary endpoint) and has a good safety profile. Secondary analyses also showed efficacy against all four dengue serotypes and protection against severe disease and hospitalization. The end of the active phases in these studies completes more than a decade of development of CYD-TDV, but considerable activities and efforts remain to address outstanding scientific, clinical, and immunological questions, while preparing for the introduction and use of CYD-TDV. Additional safety observations were recently reported from the first complete year of hospital phase longer term surveillance for two phase 3 studies and the first and second completed years for one phase 2b study, demonstrating the optimal age for intervention from 9 years. Dengue is a complex disease, and both short-term and long-term safety and efficacy will continue to be addressed by ongoing long-term follow-up and future post-licensure studies. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Long‐Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years

PubMed Central

Ruperto, Nicolino; Mouy, Richard; Paz, Eliana; Rubio‐Pérez, Nadina; Silva, Clovis A.; Abud‐Mendoza, Carlos; Burgos‐Vargas, Ruben; Gerloni, Valeria; Melo‐Gomes, Jose A.; Saad‐Magalhaes, Claudia; Chavez‐Corrales, J.; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J.; Foeldvari, Ivan; Hofer, Michael; Huppertz, Hans‐Iko; Job Deslandre, Chantal; Minden, Kirsten; Punaro, Marilynn; Block, Alan J.; Giannini, Edward H.; Martini, Alberto

2015-01-01

Objective The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease‐modifying antirheumatic drugs were previously established in a phase III study that included a 4‐month open‐label lead‐in period, a 6‐month double‐blind withdrawal period, and a long‐term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient‐reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. Methods Patients enrolled in the phase III trial could enter the open‐label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double‐blind period. Results One hundred fifty‐three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient‐years) of adverse events decreased during the LTE phase (433.61 events during the short‐term phase [combined lead‐in and double‐blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time. Conclusion Long‐term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality‐of‐life benefits in patients with JIA. PMID:26097215

Findings From the National Machine Guarding Program

PubMed Central

Parker, David L.; Yamin, Samuel; Xi, Min; Gordon, Robert; Most, Ivan; Stanley, Rod

2017-01-01

Objectives: This manuscript assesses safety climate data from the National Machine Guarding Program (NMGP)—a nationwide intervention to improve machine safety. Methods: Baseline safety climate surveys were completed by 2161 employees and 341 owners or managers at 115 businesses. A separate onsite audit of safety management practices and machine guarding equipment was conducted at each business. Results: Safety climate measures were not correlated with machine guarding or safety management practices. The presence of a safety committee was correlated with higher scores on the safety management audit when contrasted with those without one. Conclusions: The presence of a safety committee is easily assessed and provides a basis on which to make recommendations with regard to how it functions. Measures of safety climate fail to provide actionable information. Future research on small manufacturing firms should emphasize the presence of an employee-management safety committee. PMID:28930801

USDOT guidance summary for connected vehicle deployments : safety management.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to safety management plan for the CV Pilots DeploymentConcept Development Phase. This guidance provides key concepts and references in developing the SafetyManagement Plan in Task 4, lists relevant ...

Quieter Cars and the Safety of Blind Pedestrians: Phase 1.

DOT National Transportation Integrated Search

2010-04-01

The National Highway Traffic Safety Administration recognizes that quieter cars such as hybrid-electric vehicles in low-speed operation using their : electric motors, may introduce a safety issue for pedestrians who are blind. This study documents th...

National child safety seat distribution program evaluation

DOT National Transportation Integrated Search

1999-03-01

The National Child Safety Seat Distribution Program (NCSS) was a multi-year, multi-phase program intended to distribute $8 million in child safety seats to low-income and special needs children in all fifty states. Non-profit organizations that recei...

Software reliability through fault-avoidance and fault-tolerance

NASA Technical Reports Server (NTRS)

Vouk, Mladen A.; Mcallister, David F.

1993-01-01

Strategies and tools for the testing, risk assessment and risk control of dependable software-based systems were developed. Part of this project consists of studies to enable the transfer of technology to industry, for example the risk management techniques for safety-concious systems. Theoretical investigations of Boolean and Relational Operator (BRO) testing strategy were conducted for condition-based testing. The Basic Graph Generation and Analysis tool (BGG) was extended to fully incorporate several variants of the BRO metric. Single- and multi-phase risk, coverage and time-based models are being developed to provide additional theoretical and empirical basis for estimation of the reliability and availability of large, highly dependable software. A model for software process and risk management was developed. The use of cause-effect graphing for software specification and validation was investigated. Lastly, advanced software fault-tolerance models were studied to provide alternatives and improvements in situations where simple software fault-tolerance strategies break down.

The presence of anti-Tat antibodies is predictive of long-term nonprogression to AIDS or severe immunodeficiency: findings in a cohort of HIV-1 seroconverters.

PubMed

Rezza, Giovanni; Fiorelli, Valeria; Dorrucci, Maria; Ciccozzi, Massimo; Tripiciano, Antonella; Scoglio, Arianna; Collacchi, Barbara; Ruiz-Alvarez, Maria; Giannetto, Concettina; Caputo, Antonella; Tomasoni, Lina; Castelli, Francesco; Sciandra, Mauro; Sinicco, Alessandro; Ensoli, Fabrizio; Buttò, Stefano; Ensoli, Barbara

2005-04-15

The human immunodeficiency virus (HIV) type 1 Tat protein plays a key role in the life cycle of the virus and in pathogenesis and is highly conserved among HIV subtypes. On the basis of this and of safety, immunogenicity, and efficacy findings in monkeys, Tat is being tested as a vaccine in phase 1 trials. Here, we evaluated the incidence and risk of progression to advanced HIV disease by anti-Tat serostatus in a cohort of 252 HIV-1 seroconverters. The risk of progression was lower in the anti-Tat-positive subjects than in the anti-Tat-negative subjects. Progression was faster in the persistently anti-Tat-negative subjects than in the transiently anti-Tat-positive subjects, and no progression was observed in the persistently anti-Tat-positive subjects.

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase I: Final Report.

ERIC Educational Resources Information Center

Walker, Bonnie L.

This report describes the development and pilot testing of a fire safety certification system for board and care operators and staff who serve clients with developmental disabilities. During Phase 1, training materials were developed, including a trainer's manual, a participant's coursebook a videotape, an audiotape, and a pre-/post test which was…

Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

NASA Technical Reports Server (NTRS)

1972-01-01

Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

Wyoming freight movement system vulnerabilities and ITS.

DOT National Transportation Integrated Search

2013-12-01

This report summarizes the work performed during the second phase of a two-phase : research project. The first phase focused on two main areas: freight safety and wind : vulnerability, and the identification of critical infrastructure. Phase I also t...

Usability Methods for Ensuring Health Information Technology Safety: Evidence-Based Approaches. Contribution of the IMIA Working Group Health Informatics for Patient Safety.

PubMed

Borycki, E; Kushniruk, A; Nohr, C; Takeda, H; Kuwata, S; Carvalho, C; Bainbridge, M; Kannry, J

2013-01-01

Issues related to lack of system usability and potential safety hazards continue to be reported in the health information technology (HIT) literature. Usability engineering methods are increasingly used to ensure improved system usability and they are also beginning to be applied more widely for ensuring the safety of HIT applications. These methods are being used in the design and implementation of many HIT systems. In this paper we describe evidence-based approaches to applying usability engineering methods. A multi-phased approach to ensuring system usability and safety in healthcare is described. Usability inspection methods are first described including the development of evidence-based safety heuristics for HIT. Laboratory-based usability testing is then conducted under artificial conditions to test if a system has any base level usability problems that need to be corrected. Usability problems that are detected are corrected and then a new phase is initiated where the system is tested under more realistic conditions using clinical simulations. This phase may involve testing the system with simulated patients. Finally, an additional phase may be conducted, involving a naturalistic study of system use under real-world clinical conditions. The methods described have been employed in the analysis of the usability and safety of a wide range of HIT applications, including electronic health record systems, decision support systems and consumer health applications. It has been found that at least usability inspection and usability testing should be applied prior to the widespread release of HIT. However, wherever possible, additional layers of testing involving clinical simulations and a naturalistic evaluation will likely detect usability and safety issues that may not otherwise be detected prior to widespread system release. The framework presented in the paper can be applied in order to develop more usable and safer HIT, based on multiple layers of evidence.

75 FR 38716 - Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

...-AA00 Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR AGENCY: Coast Guard, DHS... waters of Pelican Bay and the Pacific Ocean for the Vietnam Veterans of America Fireworks Display near... period will have passed. Basis and Purpose The Vietnam Veterans of America are holding a fireworks...

Developing a Model on Improving Maritime English Training for Maritime Transportation Safety

ERIC Educational Resources Information Center

Yercan, Funda; Fricke, Donna; Stone, Laurie

2005-01-01

Maritime services form an integral part of what regulatory agencies requires for the safe navigation and operation of vessels. Therefore, the maritime industry's compliance with governmental regulations and international protocols has been essential for maritime safety management. As a basis to this aspect, the preparation of maritime students as…

75 FR 37720 - Safety Zone; New Bern Air Show, Neuse River, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... would be contrary to public interest, since immediate action is needed to ensure the safety of human life and property from the hazards associated with air show operations. Basis and Purpose Coast Guard... effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g...

76 FR 38568 - Safety Zone; Bullhead City Regatta, Bullhead City, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

...-AA00 Safety Zone; Bullhead City Regatta, Bullhead City, AZ AGENCY: Coast Guard, DHS. ACTION: Temporary... the Colorado River in Bullhead City, Arizona for the Bullhead City Regatta on August 13, 2011. This... the waterway during the Regatta event. Basis and Purpose The City of Bullhead is sponsoring the...

Safety recommendation component of mobile information assistant of the tourist

NASA Astrophysics Data System (ADS)

Savchuk, Valeriya V.; Kunanec, Natalia E.; Pasichnyk, Volodymyr V.; Popiel, Piotr; Weryńska-Bieniasz, RóŻa; Kashaganova, Gulzhamal; Kalizhanova, Aliya

2017-08-01

The goal of article is to introduce and justify the need for the safety system components of Mobile Information of the tourist (MIAT). One of the objectives of the system is to determine the level of risk in a particular tourist destination on the basis of available information in the knowledge base.

Safety in the Air: A Curriculum About Flight and Air Traffic Control Designed for Middle School Students

DOT National Transportation Integrated Search

1983-01-01

Safety in the Air is designed to be taught as a six-lesson unit to middle school : students, preferably sixth, seventh, or eighth grade level. : This curriculum is designed first of all to familiarize both the teacher and the : student with some basi...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2012 CFR

2012-10-01

... basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing... Commission, with a copy to the Chiefs of the Wireless Telecommunications and the Public Safety and Homeland Security Bureaus. [72 FR 48860, Aug. 24, 2007, as amended at 74 FR 8879, Feb. 27, 2009] ...

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

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

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Constructing a modern cytology laboratory: A toolkit for planning and design.

PubMed

Roberson, Janie; Wrenn, Allison; Poole, John; Jaeger, Andrew; Eltoum, Isam A

2013-01-01

Constructing or renovating a laboratory can be both challenging and rewarding. UAB Cytology (UAB CY) recently undertook a project to relocate from a building constructed in 1928 to new space. UAB CY is part of an academic center that provides service to a large set of patients, support training of one cytotechnology program and one cytopathology fellowship training program and involve actively in research and scholarly activity. Our objectives were to provide a safe, aesthetically pleasing space and gain efficiencies through lean processes. The phases of any laboratory design project are Planning, Schematic Design (SD), Design Development (DD), Construction Documents (CD) and Construction. Lab personnel are most critical in the Planning phase. During this time stakeholders, relationships, budget, square footage and equipment were identified. Equipment lists, including what would be relocated, purchased new and projected for future growth ensure that utilities were matched to expected need. A chemical inventory was prepared and adequate storage space was planned. Regulatory and safety requirements were discussed. Tours and high level process flow diagrams helped architects and engineers understand the laboratory daily work. Future needs were addressed through a questionnaire which identified potential areas of growth and technological change. Throughout the project, decisions were driven by data from the planning phase. During the SD phase, objective information from the first phase was used by architects and planners to create a general floor plan. This was the basis of a series of meetings to brainstorm and suggest modifications. DD brings more detail to the plans with engineering, casework, equipment specifics, finishes. Design changes should be completed at this phase. The next phase, CD took the project from the lab purview into purely technical mode. Construction documents were used by the contractor for the bidding process and ultimately the Construction phase. The project fitted out a total of 9,000 square feet; 4,000 laboratory and 5,000 office/support. Lab space includes areas for Prep, CT screening, sign out and Imaging. Adjacent space houses faculty offices and conferencing facilities. Transportation time was reduced (waste removal) by a Pneumatic Tube System, specimen drop window to Prep Lab and a pass thru window to the screening area. Open screening and prep areas allow visual management control. Efficiencies were gained by ergonomically placing CT Manual and Imaging microscopes and computers in close proximity, also facilitating a paperless workflow for additional savings. Logistically, closer proximity to Surgical Pathology maximized the natural synergies between the areas. Lab construction should be a systematic process based on sound principles for safety, high quality testing, and finance. Our detailed planning and design process can be a model for others undertaking similar projects.

Constructing a modern cytology laboratory: A toolkit for planning and design

PubMed Central

Roberson, Janie; Wrenn, Allison; Poole, John; Jaeger, Andrew; Eltoum, Isam A.

2013-01-01

Introduction: Constructing or renovating a laboratory can be both challenging and rewarding. UAB Cytology (UAB CY) recently undertook a project to relocate from a building constructed in 1928 to new space. UAB CY is part of an academic center that provides service to a large set of patients, support training of one cytotechnology program and one cytopathology fellowship training program and involve actively in research and scholarly activity. Our objectives were to provide a safe, aesthetically pleasing space and gain efficiencies through lean processes. Methods: The phases of any laboratory design project are Planning, Schematic Design (SD), Design Development (DD), Construction Documents (CD) and Construction. Lab personnel are most critical in the Planning phase. During this time stakeholders, relationships, budget, square footage and equipment were identified. Equipment lists, including what would be relocated, purchased new and projected for future growth ensure that utilities were matched to expected need. A chemical inventory was prepared and adequate storage space was planned. Regulatory and safety requirements were discussed. Tours and high level process flow diagrams helped architects and engineers understand the laboratory daily work. Future needs were addressed through a questionnaire which identified potential areas of growth and technological change. Throughout the project, decisions were driven by data from the planning phase. During the SD phase, objective information from the first phase was used by architects and planners to create a general floor plan. This was the basis of a series of meetings to brainstorm and suggest modifications. DD brings more detail to the plans with engineering, casework, equipment specifics, finishes. Design changes should be completed at this phase. The next phase, CD took the project from the lab purview into purely technical mode. Construction documents were used by the contractor for the bidding process and ultimately the Construction phase. Results: The project fitted out a total of 9,000 square feet; 4,000 laboratory and 5,000 office/support. Lab space includes areas for Prep, CT screening, sign out and Imaging. Adjacent space houses faculty offices and conferencing facilities. Transportation time was reduced (waste removal) by a Pneumatic Tube System, specimen drop window to Prep Lab and a pass thru window to the screening area. Open screening and prep areas allow visual management control. Efficiencies were gained by ergonomically placing CT Manual and Imaging microscopes and computers in close proximity, also facilitating a paperless workflow for additional savings. Logistically, closer proximity to Surgical Pathology maximized the natural synergies between the areas. Conclusions: Lab construction should be a systematic process based on sound principles for safety, high quality testing, and finance. Our detailed planning and design process can be a model for others undertaking similar projects PMID:23599722

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

9 CFR 307.6 - Basis of billing for overtime and holiday services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of billing for overtime and holiday services. 307.6 Section 307.6 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION...

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 2A: Accident model document, appendix

NASA Technical Reports Server (NTRS)

1972-01-01

The detailed abort sequence trees for the reference zirconium hydride (ZrH) reactor power module that have been generated for each phase of the reference Space Base program mission are presented. The trees are graphical representations of causal sequences. Each tree begins with the phase identification and the dichotomy between success and failure. The success branch shows the mission phase objective as being achieved. The failure branch is subdivided, as conditions require, into various primary initiating abort conditions.

Phase diagram of nanoscale alloy particles used for vapor-liquid-solid growth of semiconductor nanowires.

PubMed

Sutter, Eli; Sutter, Peter

2008-02-01

We use transmission electron microscopy observations to establish the parts of the phase diagram of nanometer sized Au-Ge alloy drops at the tips of Ge nanowires (NWs) that determine their temperature-dependent equilibrium composition and, hence, their exchange of semiconductor material with the NWs. We find that the phase diagram of the nanoscale drop deviates significantly from that of the bulk alloy, which explains discrepancies between actual growth results and predictions on the basis of the bulk-phase equilibria. Our findings provide the basis for tailoring vapor-liquid-solid growth to achieve complex one-dimensional materials geometries.

Molecular quantum control landscapes in von Neumann time-frequency phase space

NASA Astrophysics Data System (ADS)

Ruetzel, Stefan; Stolzenberger, Christoph; Fechner, Susanne; Dimler, Frank; Brixner, Tobias; Tannor, David J.

2010-10-01

Recently we introduced the von Neumann representation as a joint time-frequency description for femtosecond laser pulses and suggested its use as a basis for pulse shaping experiments. Here we use the von Neumann basis to represent multidimensional molecular control landscapes, providing insight into the molecular dynamics. We present three kinds of time-frequency phase space scanning procedures based on the von Neumann formalism: variation of intensity, time-frequency phase space position, and/or the relative phase of single subpulses. The shaped pulses produced are characterized via Fourier-transform spectral interferometry. Quantum control is demonstrated on the laser dye IR140 elucidating a time-frequency pump-dump mechanism.

Molecular quantum control landscapes in von Neumann time-frequency phase space.

PubMed

Ruetzel, Stefan; Stolzenberger, Christoph; Fechner, Susanne; Dimler, Frank; Brixner, Tobias; Tannor, David J

2010-10-28

Recently we introduced the von Neumann representation as a joint time-frequency description for femtosecond laser pulses and suggested its use as a basis for pulse shaping experiments. Here we use the von Neumann basis to represent multidimensional molecular control landscapes, providing insight into the molecular dynamics. We present three kinds of time-frequency phase space scanning procedures based on the von Neumann formalism: variation of intensity, time-frequency phase space position, and/or the relative phase of single subpulses. The shaped pulses produced are characterized via Fourier-transform spectral interferometry. Quantum control is demonstrated on the laser dye IR140 elucidating a time-frequency pump-dump mechanism.

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

Nicholson, J. C.

Performance metrics for evaluating commercial fixatives are often not readily available for important parameters that must be considered per the facility safety basis and the facility Basis for Interim Operations (BIO). One such parameter is the behavior of such materials in varied, “non-ideal” conditions where ideal is defined as 75 °F, 40% RH. Coupled with the inherent flammable nature of the fixative materials that can act to propagate flame along surfaces that are otherwise fireproof (concrete, sheet metal), much is left unknown when considering the safety basis implications for introducing these materials into nuclear facilities. Through SRNL’s efforts, three (3)more » fixatives, one (1) decontamination gel, and six (6) intumescent coatings were examined for their responses to environmental conditions to determine whether these materials were impervious to non-nominal temperatures and humidities that may be found in nuclear facilities. Characteristics that were examined included set-to-touch time, dust free time, and adhesion testing of the fully cured compounds. Of these ten materials, three were two-part epoxy materials while the other seven consisted of only one constituent. The results show that the epoxies tested are unable to cure in sub-freezing temperatures, with the low temperatures inhibiting crosslinking to a very significant degree. These efforts show significant inhibiting of performance for non-nominal environmental conditions, something that must be addressed both in the decision process for a fixative material to apply and per the safety basis to ensure the accurate flammability and material at risk is calculated.« less

Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial.

PubMed

Hacke, Werner; Schellinger, Peter D; Albers, Gregory W; Bornstein, Natan M; Dahlof, Bjorn L; Fulton, Rachael; Kasner, Scott E; Shuaib, Ashfaq; Richieri, Steven P; Dilly, Stephen G; Zivin, Justin; Lees, Kennedy R

2014-11-01

On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke. We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated ≤24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included. The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0-2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705-1.488). Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset. http://www.clinicaltrials.gov. Unique identifier: NCT01120301. © 2014 American Heart Association, Inc.

Acute And Long-Term Bioeffects And Lamp Safety

NASA Astrophysics Data System (ADS)

Andersen, F. Alan

1980-10-01

Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

Probabilistic margin evaluation on accidental transients for the ASTRID reactor project

NASA Astrophysics Data System (ADS)

Marquès, Michel

2014-06-01

ASTRID is a technological demonstrator of Sodium cooled Fast Reactor (SFR) under development. The conceptual design studies are being conducted in accordance with the Generation IV reactor objectives, particularly in terms of improving safety. For the hypothetical events, belonging to the accidental category "severe accident prevention situations" having a very low frequency of occurrence, the safety demonstration is no more based on a deterministic demonstration with conservative assumptions on models and parameters but on a "Best-Estimate Plus Uncertainty" (BEPU) approach. This BEPU approach ispresented in this paper for an Unprotected Loss-of-Flow (ULOF) event. The Best-Estimate (BE) analysis of this ULOFt ransient is performed with the CATHARE2 code, which is the French reference system code for SFR applications. The objective of the BEPU analysis is twofold: first evaluate the safety margin to sodium boiling in taking into account the uncertainties on the input parameters of the CATHARE2 code (twenty-two uncertain input parameters have been identified, which can be classified into five groups: reactor power, accident management, pumps characteristics, reactivity coefficients, thermal parameters and head losses); secondly quantify the contribution of each input uncertainty to the overall uncertainty of the safety margins, in order to refocusing R&D efforts on the most influential factors. This paper focuses on the methodological aspects of the evaluation of the safety margin. At least for the preliminary phase of the project (conceptual design), a probabilistic criterion has been fixed in the context of this BEPU analysis; this criterion is the value of the margin to sodium boiling, which has a probability 95% to be exceeded, obtained with a confidence level of 95% (i.e. the M5,95percentile of the margin distribution). This paper presents two methods used to assess this percentile: the Wilks method and the Bootstrap method ; the effectiveness of the two methods is compared on the basis of 500 simulations performed with theCATHARE2 code. We conclude that, with only 100 simulations performed with the CATHARE2 code, which is a number of simulations workable in the conceptual design phase of the ASTRID project where the models and the hypothesis are often modified, it is best in order to evaluate the percentile M5,95 of the margin to sodium boiling to use the bootstrap method, which will provide a slightly conservative result. On the other hand, in order to obtain an accurate estimation of the percentileM5,95, for the safety report for example, it will be necessary to perform at least 300 simulations with the CATHARE2 code. In this case, both methods (Wilks and Bootstrap) would give equivalent results.

Clinical Evaluation of a Novel Intrarectal Device for Management of Fecal Incontinence in Bedridden Patients.

PubMed

Singh, Sandeep; Bhargava, Balram; Vasantha, Padma; Bhatia, Rohit; Sharma, Hanish; Pal, Sujoy; Sahni, Peush; Makharia, Govind K

The primary objective of the study was to evaluate the safety and efficacy of a stool management kit (SMK) for containment of fecal incontinence in hospitalized bedridden patients. A single-group quasi-experimental study. Twenty bedridden adults who had at least 1 episode of fecal incontinence in the prior 24 hours participated in the study. The study setting was the neurological unit of the All India Institute of Medical Sciences in New Delhi, India. The study was carried out in 2 phases. The device was placed in situ for up to 24 hours in 10 patients during phase I of the study and up to 120 hours in an additional 10 patients during phase II. Participants were assessed for anorectal injury and peripheral device leakage on a 4- to 6-hourly basis. Sigmoidoscopy was performed to evaluate for any mucosal trauma or alteration of anorectal pathology after retrieval of the device. The device was successfully placed in all patients following the first attempt to place the device; 80% of patients retained the device until planned removal. The SMK diverted fecal matter without anal leakage in 174 (93.5%) out of 186 assessment points in a group of 20 patients. The devices remained in situ for 21 ± 0.2 and 84.5 ± 38.9 hours during phase I and phase II, respectively. None experienced anorectal bleeding, sphincter injury, or mucosal ulceration with device usage. Post-device sigmoidoscopy revealed erythema at the site of diverter placement in 2 participants. Study findings suggest that the SMK successfully diverted liquid to semiformed fecal exudate without peripheral device leakage in 93.5% of bedridden patients. No serious adverse events occurred. Additional research is needed to compare its effectiveness with that of currently available intrarectal balloon devices.

Synthesis and characterization of barium silicide (BaSi2) nanowire arrays for potential solar applications.

PubMed

Pokhrel, Ankit; Samad, Leith; Meng, Fei; Jin, Song

2015-11-07

In order to utilize nanostructured materials for potential solar and other energy-harvesting applications, scalable synthetic techniques for these materials must be developed. Herein we use a vapor phase conversion approach to synthesize nanowire (NW) arrays of semiconducting barium silicide (BaSi2) in high yield for the first time for potential solar applications. Dense arrays of silicon NWs obtained by metal-assisted chemical etching were converted to single-crystalline BaSi2 NW arrays by reacting with Ba vapor at about 930 °C. Structural characterization by X-ray diffraction and high-resolution transmission electron microscopy confirm that the converted NWs are single-crystalline BaSi2. The optimal conversion reaction conditions allow the phase-pure synthesis of BaSi2 NWs that maintain the original NW morphology, and tuning the reaction parameters led to a controllable synthesis of BaSi2 films on silicon substrates. The optical bandgap and electrochemical measurements of these BaSi2 NWs reveal a bandgap and carrier concentrations comparable to previously reported values for BaSi2 thin films.

Multi-criteria decision model for retrofitting existing buildings

NASA Astrophysics Data System (ADS)

Bostenaru Dan, M. D.

2004-08-01

Decision is an element in the risk management process. In this paper the way how science can help in decision making and implementation for retrofitting buildings in earthquake prone urban areas is investigated. In such interventions actors from various spheres are involved. Their interests range among minimising the intervention for maximal preservation or increasing it for seismic safety. Research was conducted to see how to facilitate collaboration between these actors. A particular attention was given to the role of time in actors' preferences. For this reason, on decision level, both the processural and the personal dimension of risk management, the later seen as a task, were considered. A systematic approach was employed to determine the functional structure of a participative decision model. Three layers on which actors implied in this multi-criteria decision problem interact were identified: town, building and element. So-called 'retrofit elements' are characteristic bearers in the architectural survey, engineering simulations, costs estimation and define the realms perceived by the inhabitants. This way they represent an interaction basis for the interest groups considered in a deeper study. Such orientation means for actors' interaction were designed on other levels of intervention as well. Finally, an 'experiment' for the implementation of the decision model is presented: a strategic plan for an urban intervention towards reduction of earthquake hazard impact through retrofitting. A systematic approach proves thus to be a very good communication basis among the participants in the seismic risk management process. Nevertheless, it can only be applied in later phases (decision, implementation, control) only, since it serves verifying and improving solution and not developing the concept. The 'retrofit elements' are a typical example of the detailing degree reached in the retrofit design plans in these phases.

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

Sarkaria, Jann N., E-mail: sarkaria.jann@mayo.edu; Galanis, Evanthia; Wu Wenting

Background: The mammalian target of rapamycin (mTOR) functions within the PI3K/Akt signaling pathway as a critical modulator of cell survival. On the basis of promising preclinical data, the safety and tolerability of therapy with the mTOR inhibitor RAD001 in combination with radiation (RT) and temozolomide (TMZ) was evaluated in this Phase I study. Methods and Materials: All patients received weekly oral RAD001 in combination with standard chemoradiotherapy, followed by RAD001 in combination with standard adjuvant temozolomide. RAD001 was dose escalated in cohorts of 6 patients. Dose-limiting toxicities were defined during RAD001 combination therapy with TMZ/RT. Results: Eighteen patients were enrolled,more » with a median follow-up of 8.4 months. Combined therapy was well tolerated at all dose levels, with 1 patient on each dose level experiencing a dose-limiting toxicity: Grade 3 fatigue, Grade 4 hematologic toxicity, and Grade 4 liver dysfunction. Throughout therapy, there were no Grade 5 events, 3 patients experienced Grade 4 toxicities, and 6 patients had Grade 3 toxicities attributable to treatment. On the basis of these results, the recommended Phase II dosage currently being tested is RAD001 70 mg/week in combination with standard chemoradiotherapy. Fluorodeoxyglucose (FDG) positron emission tomography scans also were obtained at baseline and after the second RAD001 dose before the initiation of TMZ/RT; the change in FDG uptake between scans was calculated for each patient. Fourteen patients had stable metabolic disease, and 4 patients had a partial metabolic response. Conclusions: RAD001 in combination with RT/TMZ and adjuvant TMZ was reasonably well tolerated. Changes in tumor metabolism can be detected by FDG positron emission tomography in a subset of patients within days of initiating RAD001 therapy.« less

National Dam Safety Program. Manalapan Lake Dam (NJ00293), Raritan River Basin, Manalapan Brook, Middlesex County, New Jersey. Phase I Inspection Report.

DTIC Science & Technology

1979-04-01

NJ00293 1. OOVT ACCESSION NO. 4. TITLE (and Submit) Phase I Inspection Report National Dan Safety Program Manalapan Lake Dam Middlesea County...ssthoriistioa of set, Fsblic Lsw M- Ss7 . k brlsf assasaasat of ths ssa’s csssltlss is giwaa is ths frost of ths rsaort. oa wlsssl iaasostlaa, svallsbla

National Dam Safety Program. Steeger Lake Dam (MO 11098), Upper Mississippi - Kaskaskia - St. Louis Basin, Jefferson County, Missouri. Phase 1 Inspection Report

DTIC Science & Technology

1980-11-01

MISSOURPI 6 311-0 FOR: U. S. ARMY ENGINEER DISTRICT, ST. LOUIS CORPS OF ENGGINEERS -, NOVE4BER 1980 HS-8011 PHASE I REPORT NATIONAL DAM SAFETY...if the dam should fail, there may be loss of life, serious damage to homes, or extensive damage to agricultural, industrial and commercial facilities

Safety assessment for the postictal confusional phase following complex partial seizure.

PubMed

Tucker, C

1985-06-01

Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

Reactor Design and Decommissioning - An Overview of International Activities in Post Fukushima Era1 - 12396

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

Devgun, Jas S.; Laraia, Michele; Pescatore, Claudio

Accidents at the Fukushima Dai-ichi reactors as a result of the devastating earthquake and tsunami of March 11, 2011 have not only dampened the nuclear renaissance but have also initiated a re-examination of the design and safety features for the existing and planned nuclear reactors. Even though failures of some of the key site features at Fukushima can be attributed to events that in the past would have been considered as beyond the design basis, the industry as well as the regulatory authorities are analyzing what features, especially passive features, should be designed into the new reactor designs to minimizemore » the potential for catastrophic failures. It is also recognized that since the design of the Fukushima BWR reactors which were commissioned in 1971, many advanced safety features are now a part of the newer reactor designs. As the recovery efforts at the Fukushima site are still underway, decisions with respect to the dismantlement and decommissioning of the damaged reactors and structures have not yet been finalized. As it was with Three Mile Island, it could take several decades for dismantlement, decommissioning and clean up, and the project poses especially tough challenges. Near-term assessments have been issued by several organizations, including the IAEA, the USNRC and others. Results of such investigations will lead to additional improvements in system and site design measures including strengthening of the anti-tsunami defenses, more defense-in-depth features in reactor design, and better response planning and preparation involving reactor sites. The question also arises what would the effect be on the decommissioning scene worldwide, and what would the effect be on the new reactors when they are eventually retired and dismantled. This paper provides an overview of the US and international activities related to recovery and decommissioning including the decommissioning features in the reactor design process and examines these from a new perspective in the post Fukushima -accident era. Accidents at the Fukushima Daiichi reactors in the aftermath of the devastating earthquake and tsunami of March 11, 2011 have slowed down the nuclear renaissance world-wide and may have accelerated decommissioning either because some countries have decided to halt or reduce nuclear, or because the new safety requirements may reduce life-time extensions. Even in countries such as the UK and France that favor nuclear energy production existing nuclear sites are more likely to be chosen as sites for future NPPs. Even as the site recovery efforts continue at Fukushima and any decommissioning decisions are farther into the future, the accidents have focused attention on the reactor designs in general and specifically on the Fukushima type BWRs. The regulatory authorities in many countries have initiated a re-examination of the design of the systems, structures and components and considerations of the capability of the station to cope with beyond-design basis events. Enhancements to SSCs and site features for the existing reactors and the reactors that will be built will also impact the decommissioning phase activities. The newer reactor designs of today not only have enhanced safety features but also take into consideration the features that will facilitate future decommissioning. Lessons learned from past management and operation of reactors as well as the lessons from decommissioning are incorporated into the new designs. However, in the post-Fukushima era, the emphasis on beyond-design-basis capability may lead to significant changes in SSCs, which eventually will also have impact on the decommissioning phase. Additionally, where some countries decide to phase out the nuclear power, many reactors may enter the decommissioning phase in the coming decade. While the formal updating and expanding of existing guidance documents for accident cleanup and decommissioning would benefit by waiting until the Fukushima project has progressed sufficiently for that experience to be reliably interpreted, the development of structured on-line sharing of information and especially the creation of an on-line compendium of methods, tools, and techniques by which damaged fuel and other unique situations have been addressed can be addressed sooner and maintained as new problems and solutions arise and are resolved. The IAEA's new 'WEB 2.0 tool' CONNECT is expected to play a significant role in this and related information-sharing activities. The trend in some countries such as the United States has been to re-license the existing reactors for additional twenty years, beyond the original design life. Given the advances in technology over the past four decades, and considering that the newer designs incorporate significant improvements in safety systems, it may not be economical or technically feasible to retrofit enhancements into some of the older reactors. In such cases, the reactors may be retired from service and decommissioned. Overall, the energy demand in the world continues to rise, with sharp increases in the Asian countries, and nuclear power's role in the world's energy supply is expected to continue. Events at Fukushima have led to a re-examination on many fronts, including reactor design and regulatory requirements. Further changes may occur in these areas in the post-Fukushima era. These changes in turn will also impact the world-wide decommissioning scene and the decommissioning phase of the future reactors. (authors)« less

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

PubMed Central

2012-01-01

Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

Drug development: from concept to marketing!

PubMed

Tamimi, Nihad A M; Ellis, Peter

2009-01-01

Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for advancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safety and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product's safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright 2009 S. Karger AG, Basel.

Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data.

PubMed

D'Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D'Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

2015-01-01

Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. The overall safety profile of glycopyrronium was similar to its comparators indicating no increase in the overall risk for any of the investigated safety end points.

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

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

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

Enforcing Job Safety; A Union View of OSHA

ERIC Educational Resources Information Center

Wood, Michael

1975-01-01

A primary shortcoming of the Occupational Safety and Health Act of 1970 is that it provides the employer with too many phases of postponement of responsibility. However, positive administrative action has included organized labor's entry into all levels of job safety and health activities. (MW)

Technical Guidance from the International Safety Framework for Nuclear Power Source Applications in Outer Space for Design and Development Phases

NASA Astrophysics Data System (ADS)

Summerer, Leopold

2014-08-01

In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space [1] has been adopted, following a multi-year process that involved all major space faring nations in the frame of the International Atomic Energy Agency and the UN Committee on the Peaceful Uses of Outer Space. The safety framework reflects an international consensus on best practices. After the older 1992 Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second document at UN level dedicated entirely to space nuclear power sources.This paper analyses aspects of the safety framework relevant for the design and development phases of space nuclear power sources. While early publications have started analysing the legal aspects of the safety framework, its technical guidance has not yet been subject to scholarly articles. The present paper therefore focuses on the technical guidance provided in the safety framework, in an attempt to assist engineers and practitioners to benefit from these.

Dynamics of Cohering and Decohering Power under Markovian Channels

NASA Astrophysics Data System (ADS)

Chen, Ming-Ming; Luo, Yu; Shao, Lian-He; Li, Yong-Ming

2017-11-01

In this paper, we investigate the cohering and decohering power of the one-qubit Markovian channels with respect to coherence measures based on the l 1-norm, the Rényi α-relative entropy and the Tsallis α-relative entropy of coherence, respectively. The amplitude damping channel, phase damping channel, depolarizing channel, and flip channels are analytically calculated. It shows that the decohering power of the amplitude damping channel on the x,y , and z basis is equal to each other. The same phenomenon can be seen for the phase damping channel and the flip channels. The cohering power for the phase damping channel and the flip channels on the x,y basis also equals to that on the z basis. However, the cohering and decohering power of the depolarizing channel is independent to the reference basises. And the cohering power of the amplitude damping channel on the x,y basis is different to that on the z basis. Supported by the National Natural Science Foundation of China under Grant Nos. 11271237, 11671244, the Higher School Doctoral Subject Foundation of Ministry of Education of China under Grant No. 20130202110001, and Fundamental Research Funds for the Central Universities under Grants Nos. 2016TS060 and 2016CBY003

California Guide for Pedestrian Safety Education. Volumes I-III.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento.

This guide is designed to serve as the basis for a pedestrian safety education program for pupils in kindergarten through grade two. The basic printed materials for use in the program are provided in three volumes, each of which is intended for a different audience. Volume I, directed to school administrators and teachers, contains information for…

Study on Safety Monitoring System for Submarine Power Cable on the Basis of AIS and Radar Technology

NASA Astrophysics Data System (ADS)

Jie, Wang; Yao-Tian, Fan

Through analyzing the risks of submarine power cable, the highest risk to damage the cable identified is from ship. Based on concept of Vessel Traffic Management Information Systems, the three core sub-systems of safety monitoring system for submarine power cable were studied and described, also some suggestions were given.

78 FR 78362 - National Institute for Occupational Safety and Health Personal; Notice of public meeting in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... public commenter has spoken, whichever occurs first. ADDRESSES: First United Methodist Church, 53..., first served basis. The meeting will end at 8:30PM EST or after the last public commenter has spoken... Institute for Occupational Safety and Health Personal; Notice of public meeting in Endicott, New York AGENCY...

Shuttle: forever young?

PubMed

Sietzen, Frank

2002-01-01

NASA has started a 4-phase program of upgrades designed to increase safety and extend use of the space shuttles through the year 2020. Phase I is aimed at improving vehicle safety and supporting the space station. Phase II is aimed at combating obsolescence and includes a checkout launch and control system and protection from micrometeoroids and orbital debris. Phase III is designed to expand or enhance the capabilities of the shuttle and includes development of an auxiliary power unit, avionics, a channel-wall nozzle, extended nose landing gear, long-life fuel cells, a nontoxic orbital maneuvering system/reaction control system, and a water membrane evaporator. Phase IV is aimed at design of system changes that would alter the shuttle mold line and configuration; projects include a five-segment solid rocket booster, liquid flyback boosters, and a crew escape module.

Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia.

PubMed

von Stackelberg, Arend; Locatelli, Franco; Zugmaier, Gerhard; Handgretinger, Rupert; Trippett, Tanya M; Rizzari, Carmelo; Bader, Peter; O'Brien, Maureen M; Brethon, Benoît; Bhojwani, Deepa; Schlegel, Paul Gerhardt; Borkhardt, Arndt; Rheingold, Susan R; Cooper, Todd Michael; Zwaan, Christian M; Barnette, Phillip; Messina, Chiara; Michel, Gérard; DuBois, Steven G; Hu, Kuolung; Zhu, Min; Whitlock, James A; Gore, Lia

2016-12-20

Purpose Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19 on B-cell lymphoblasts. We evaluated the safety, pharmacokinetics, recommended dosage, and potential for efficacy of blinatumomab in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). Methods This open-label study enrolled children < 18 years old with relapsed/refractory BCP-ALL in a phase I dosage-escalation part and a phase II part, using 6-week treatment cycles. Primary end points were maximum-tolerated dosage (phase I) and complete remission rate within the first two cycles (phase II). Results We treated 49 patients in phase I and 44 patients in phase II. Four patients had dose-limiting toxicities in cycle 1 (phase I). Three experienced grade 4 cytokine-release syndrome (one attributed to grade 5 cardiac failure); one had fatal respiratory failure. The maximum-tolerated dosage was 15 µg/m 2 /d. Blinatumomab pharmacokinetics was linear across dosage levels and consistent among age groups. On the basis of the phase I data, the recommended blinatumomab dosage for children with relapsed/refractory ALL was 5 µg/m 2 /d for the first 7 days, followed by 15 µg/m 2 /d thereafter. Among the 70 patients who received the recommended dosage, 27 (39%; 95% CI, 27% to 51%) achieved complete remission within the first two cycles, 14 (52%) of whom achieved complete minimal residual disease response. The most frequent grade ≥ 3 adverse events were anemia (36%), thrombocytopenia (21%), and hypokalemia (17%). Three patients (4%) and one patient (1%) had cytokine-release syndrome of grade 3 and 4, respectively. Two patients (3%) interrupted treatment after grade 2 seizures. Conclusion This trial, which to the best of our knowledge was the first such trial in pediatrics, demonstrated antileukemic activity of single-agent blinatumomab with complete minimal residual disease response in children with relapsed/refractory BCP-ALL. Blinatumomab may represent an important new treatment option in this setting, requiring further investigation in curative indications.

Safety profile: fifteen years of clinical experience with ibuprofen.

PubMed

Royer, G L; Seckman, C E; Welshman, I R

1984-07-13

Since its introduction in the United States in 1974, ibuprofen (Motrin, Upjohn) has been shown to be safe and effective for the treatment of pain, dysmenorrhea, inflammation, and fever. A careful review of pre-registration and postmarketing data from both patients and normal subjects clearly indicates ibuprofen's remarkable safety profile compared with that of aspirin and other commonly prescribed nonsteroidal anti-inflammatory agents. Continued safety can be anticipated on the basis of the past 15 years of review experience.

Increasing the number of trained health and safety professionals in agricultural medicine: evaluation of the "building capacity" program, 2007-2013.

PubMed

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.

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

DOT National Transportation Integrated Search

2012-03-01

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

Motivation of employers to encourage their employees to use safety belts (Phase 1)

DOT National Transportation Integrated Search

1982-05-01

For the purpose of motivating employers to encourage their employees to use safety belts, a manual for employers, "The Profit in Safety Belts: A View for Employers", is developed. The manual brings to the attention of employers the various cost eleme...

Validation and application of Highway Safety Manual (Part D) and developing Florida CMF Manual, phase 2.

DOT National Transportation Integrated Search

2016-05-01

The Highway Safety Manual (HSM) Part D provides a comprehensive list of the effects of safety treatments : (countermeasures). These effects are quantified by crash modification factors (CMF) which are based on compilation : from past studies of the e...

Revenue sources for financing transportation safety activities in Virginia : phase two, state sources.

DOT National Transportation Integrated Search

1980-01-01

Senate Bill 85, an action of the 1978 General Assembly, amended the Code of Virginia to provide, in part, that the Division of Highway Safety be succeeded by the newly created Department of Transportation Safety effective July 1, 1978. In its Declara...

Nuclear safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Dix, Terry E.

1991-01-01

The results of a study to identify potential hazards arising from nuclear reactor power systems for use on the lunar and Martian surfaces, related safety issues, and resolutions of such issues by system design changes, operating procedures, and other means are presented. All safety aspects of nuclear reactor power systems from prelaunch ground handling to eventual disposal were examined consistent with the level of detail for SP-100 reactor design at the 1988 System Design Review and for launch vehicle and space transport vehicle designs and mission descriptions as defined in the 90-day Space Exploration Initiative (SEI) study. Information from previous aerospace nuclear safety studies was used where appropriate. Safety requirements for the SP-100 space nuclear reactor system were compiled. Mission profiles were defined with emphasis on activities after low earth orbit insertion. Accident scenarios were then qualitatively defined for each mission phase. Safety issues were identified for all mission phases with the aid of simplified event trees. Safety issue resolution approaches of the SP-100 program were compiled. Resolution approaches for those safety issues not covered by the SP-100 program were identified. Additionally, the resolution approaches of the SP-100 program were examined in light of the moon and Mars missions.

Safety and tolerability review of lorcaserin in clinical trials.

PubMed

Greenway, F L; Shanahan, W; Fain, R; Ma, T; Rubino, D

2016-10-01

Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations. © 2016 World Obesity.

Long-term efficacy and safety of lamotrigine monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures: An open-label extension study.

PubMed

Yasumoto, Sawa; Ohtsuka, Yoko; Sato, Katsuaki; Kurata, Atsuyo; Numachi, Yotaro; Shimizu, Masahiro

2018-05-31

To investigate the efficacy and safety of long-term lamotrigine (LTG) monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures. Six Japanese patients and one South Korean patient were enrolled in the extension phase of the study after completing the 12-week maintenance phase of an open-label clinical study of LTG monotherapy. During the extension phase, patients underwent efficacy and safety evaluation every 12 weeks. Of the seven patients, six patients completed the extension phase. The seizure-free rate confirmed by hyperventilation (HV)-electroencephalography ranged from 71.4% to 100.0% at each visit up to Week 168 of the extension phase. Similar effects were confirmed by HV-clinical signs and seizure diaries. Although no unexpected adverse events were observed, one Japanese patient was withdrawn from the extension phase due to mild drug-related rash developed 842 days after the start of LTG. Although the number of patients is limited, long-term LTG monotherapy appeared to be effective and generally well tolerated in Japanese and South Korean pediatric patients with typical absence seizures. Copyright © 2018 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

PubMed

Takahashi, Fumihiro; Morita, Satoshi

2018-02-08

Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

Generation III reactors safety requirements and the design solutions

NASA Astrophysics Data System (ADS)

Felten, P.

2009-03-01

Nuclear energy's public acceptance, and hence its development, depends on its safety. As a reactor designer, we will first briefly remind the basic safety principles of nuclear reactors' design. We will then show how the industry, and in particular Areva with its EPR, made design evolution in the wake of the Three Miles Island accident in 1979. In particular, for this new generation of reactors, severe accidents are taken into account beyond the standard design basis accidents. Today, Areva's EPR meets all so-called "generation III" safety requirements and was licensed by several nuclear safety authorities in the world. Many innovative solutions are integrated in the EPR, some of which will be introduced here.

Research safety vehicle. Phase II. Volume II. comprehensive technical results. Final report July 1975--December 1976

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

DiNapoli, N.; Fitzpatrick, M.; Strother, C.

1977-11-01

Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidential Task Force on Motor Vehicle Goals beyond 1980.

A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants.

PubMed

Martinon-Torres, Federico; Gimenez-Sanchez, Francisco; Bernaola-Iturbe, Enrique; Diez-Domingo, Javier; Jiang, Qin; Perez, John L

2014-09-08

Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in infants. A conserved, surface-exposed lipoprotein, LP2086 (a factor H-binding protein [fHBP]), is a promising MnB vaccine target. A bivalent, recombinant vaccine targeting the fHBP (rLP2086) of MnB was developed. This phase 1/2 clinical study was designed to assess the immunogenicity, safety, and tolerability of a 4-dose series of the rLP2086 vaccine at 20-, 60-, 120-, or 200-μg dose levels in vaccine-naive infants when given with routine childhood vaccines. The study was to consist of two phases: a single-blind sentinel phase and an open-label full enrollment phase. During the sentinel phase, randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort. The full enrollment phase was to occur after completion of the sentinel phase. Local reactions were generally mild and adverse events infrequent; however, after only 46 infants were randomized into the study, fever rates were 64% and 90% in subjects receiving one 20- or 60-μg rLP2086 dose, respectively. Most fevers were <39.0°C. Only 2 subjects in the 20-μg group and 1 subject in the 60-μg group experienced fevers >39.0°C; no fevers were >40.0°C. Due to these high fever rates, the study was terminated early. No immunogenicity data were collected. This report discusses the safety and acceptability of rLP2086 in infants after one 20- or 60-μg dose. Due to the high fever rate experienced in the 20- and 60-μg groups, rLP2086 in the current formulation may not be acceptable for infants. Copyright © 2014. Published by Elsevier Ltd.

Trauma-focused CBT for youth with complex trauma

PubMed Central

Mannarino, Anthony P.; Kliethermes, Matthew; Murray, Laura A.

2013-01-01

Objectives Many youth develop complex trauma, which includes regulation problems in the domains of affect, attachment, behavior, biology, cognition, and perception. Therapists often request strategies for using evidence-based treatments (EBTs) for this population. This article describes practical strategies for applying Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for youth with complex trauma. Methods TF-CBT treatment phases are described and modifications of timing, proportionality and application are described for youth with complex trauma. Practical applications include a) dedicating proportionally more of the model to the TF-CBT coping skills phase; b) implementing the TF-CBT Safety component early and often as needed throughout treatment; c) titrating gradual exposure more slowly as needed by individual youth; d) incorporating unifying trauma themes throughout treatment; and e) when indicated, extending the TF-CBT treatment consolidation and closure phase to include traumatic grief components and to generalize ongoing safety and trust. Results Recent data from youth with complex trauma support the use of the above TF-CBT strategies to successfully treat these youth. Conclusions The above practical strategies can be incorporated into TF-CBT to effectively treat youth with complex trauma. Practice implications Practical strategies include providing a longer coping skills phase which incorporates safety and appropriate gradual exposure; including relevant unifying themes; and allowing for an adequate treatment closure phase to enhance ongoing trust and safety. Through these strategies therapists can successfully apply TF-CBT for youth with complex trauma. PMID:22749612

System principles, mathematical models and methods to ensure high reliability of safety systems

NASA Astrophysics Data System (ADS)

Zaslavskyi, V.

2017-04-01

Modern safety and security systems are composed of a large number of various components designed for detection, localization, tracking, collecting, and processing of information from the systems of monitoring, telemetry, control, etc. They are required to be highly reliable in a view to correctly perform data aggregation, processing and analysis for subsequent decision making support. On design and construction phases of the manufacturing of such systems a various types of components (elements, devices, and subsystems) are considered and used to ensure high reliability of signals detection, noise isolation, and erroneous commands reduction. When generating design solutions for highly reliable systems a number of restrictions and conditions such as types of components and various constrains on resources should be considered. Various types of components perform identical functions; however, they are implemented using diverse principles, approaches and have distinct technical and economic indicators such as cost or power consumption. The systematic use of different component types increases the probability of tasks performing and eliminates the common cause failure. We consider type-variety principle as an engineering principle of system analysis, mathematical models based on this principle, and algorithms for solving optimization problems of highly reliable safety and security systems design. Mathematical models are formalized in a class of two-level discrete optimization problems of large dimension. The proposed approach, mathematical models, algorithms can be used for problem solving of optimal redundancy on the basis of a variety of methods and control devices for fault and defects detection in technical systems, telecommunication networks, and energy systems.

MEDICAL SPORTS INJURIES IN THE YOUTH ATHLETE: EMERGENCY MANAGEMENT

PubMed Central

Molony Jr, Joseph T.

2012-01-01

As the number of youth sports participants continues to rise over the past decade, so too have sports related injuries and emergency department visits. With low levels of oversight and regulation observed in youth sports, the responsibility for safety education of coaches, parents, law makers, organizations and institutions falls largely on the sports medicine practitioner. The highly publicized catastrophic events of concussion, sudden cardiac death, and heat related illness have moved these topics to the forefront of sports medicine discussions. Updated guidelines for concussion in youth athletes call for a more conservative approach to management in both the acute and return to sport phases. Athletes younger than eighteen suspected of having a concussion are no longer allowed to return to play on the same day. Reducing the risk of sudden cardiac death in the young athlete is a multi‐factorial process encompassing pre‐participation screenings, proper use of safety equipment, proper rules and regulations, and immediate access to Automated External Defibrillators (AED) as corner stones. Susceptibility to heat related illness for youth athletes is no longer viewed as rooted in physiologic variations from adults, but instead, as the result of various situations and conditions in which participation takes place. Hydration before, during and after strenuous exercise in a high heat stress environment is of significant importance. Knowledge of identification, management and risk reduction in emergency medical conditions of the young athlete positions the sports physical therapist as an effective provider, advocate and resource for safety in youth sports participation. This manuscript provides the basis for management of 3 major youth emergency sports medicine conditions. PMID:22530197

Identifying black swans in NextGen: predicting human performance in off-nominal conditions.

PubMed

Wickens, Christopher D; Hooey, Becky L; Gore, Brian F; Sebok, Angelia; Koenicke, Corey S

2009-10-01

The objective is to validate a computational model of visual attention against empirical data--derived from a meta-analysis--of pilots' failure to notice safety-critical unexpected events. Many aircraft accidents have resulted, in part, because of failure to notice nonsalient unexpected events outside of foveal vision, illustrating the phenomenon of change blindness. A model of visual noticing, N-SEEV (noticing-salience, expectancy, effort, and value), was developed to predict these failures. First, 25 studies that reported objective data on miss rate for unexpected events in high-fidelity cockpit simulations were identified, and their miss rate data pooled across five variables (phase of flight, event expectancy, event location, presence of a head-up display, and presence of a highway-in-the-sky display). Second, the parameters of the N-SEEV model were tailored to mimic these dichotomies. The N-SEEV model output predicted variance in the obtained miss rate (r = .73). The individual miss rates of all six dichotomous conditions were predicted within 14%, and four of these were predicted within 7%. The N-SEEV model, developed on the basis of an independent data set, was able to successfully predict variance in this safety-critical measure of pilot response to abnormal circumstances, as collected from the literature. As new technology and procedures are envisioned for the future airspace, it is important to predict if these may compromise safety in terms of pilots' failing to notice unexpected events. Computational models such as N-SEEV support cost-effective means of making such predictions.

A review of the efficacy and safety of canagliflozin in elderly patients with type 2 diabetes.

PubMed

Elmore, Lindsey K; Baggett, Sara; Kyle, Jeffrey A; Skelley, Jessica W

2014-01-01

To review the efficacy and safety of canagliflozin (CAN) in elderly patients with type 2 diabetes mellitus (T2DM). Studies were identified using PubMed, International Pharmaceutical Abstracts, MEDLINE, Academic Search Premier, SCOPUS, and Google Scholar from 2011 to August 2013. The following key words were reviewed: canagliflozin, canagliflozin elderly, canagliflozin geriatrics, dapagliflozin, sodium glucose cotransporter 2 (SGLT2) inhibitors, and SGLT2 receptor inhibitors. Articles evaluating CAN for diabetes that were published in English and used human subjects were selected. Fifteen clinical trials were identified and evaluated. Of 15 identified articles, 2 articles, 2 published posters, and unpublished information from the manufacturer were chosen based on the mean age of the study subjects. Evidence that elderly patients with T2DM have less A1C reduction with CAN is presented; the benefit on A1C is significant. Systolic blood pressure (SBP) and body weight reduction in the elderly were consistent with younger patients. Adverse effects such as increased urinary frequency, genital mycotic infections, and urinary tract infections may discourage the use of CAN in the elderly patient. Treatment with CAN improves A1C levels, reduces SBP and body weight, and is overall well tolerated in older subjects with T2DM. Risks and benefits of treatment with CAN should be assessed in geriatric patients on a case-by-case basis. Safety in elderly patients was consistent with that of other phase 3 trials in the general population. Additional longterm cardiovascular studies are needed.

Evaluation of Current Practice for Illumination at Roundabouts : Safety and Illumination of Roundabouts (Phase I)

DOT National Transportation Integrated Search

2016-03-01

This report is for the first phase of a two-phase research program to develop recommended practices for GDOT for lighting rural roundabouts. Phase I of the study was designed to improve our understanding of the relationship between roundabout illumin...

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

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

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

Toward a national core course in agricultural medicine and curriculum in agricultural safety and health: the "building capacity" consensus process.

PubMed

Rudolphi, Josie M; Donham, Kelley J

2015-01-01

ABSTRACT The agricultural industry poses specific hazards and risks to its workers. Since the 1970s, the University of Iowa has been establishing programs to educate rural health care and safety professionals who in turn provide education and occupational health and safety services to farm families and farm workers. This program has been well established in the state of Iowa as a program of Iowa's Center for Agricultural Safety and Health (I-CASH). However, the National 1989 Agriculture at Risk Report indicated there was a great need for agricultural medicine training beyond Iowa's borders. In order to help meet this need, Building Capacity: A National Resource of Agricultural Medicine Professionals was initiated as a project of the National Institute for Occupational Safety and Health (NIOSH)-funded Great Plains Center for Agricultural Health in 2006. Before the first phase of this project, a consensus process was conducted with a group of safety and health professionals to determine topics and learning objectives for the course. Over 300 students attended and matriculated the agricultural medicine course during first phase of the project (2007-2010). Beginning the second phase of the project (2012-2016), an expanded advisory committee (38 internationally recognized health and safety professionals) was convened to review the progress of the first phase, make recommendations for revisions to the required topics and competencies, and discuss updates to the second edition of the course textbook (Agricultural Medicine: Occupational and Environmental Health for the Health Professions). A formal consensus process was held and included an online survey and also a face-to-face meeting. The group was charged with the responsibility of developing the next version of this course by establishing best practices and setting an agenda with the long-term goal of developing a national course in agricultural medicine.

Ultrasound beam transmission using a discretely orthogonal Gaussian aperture basis

NASA Astrophysics Data System (ADS)

Roberts, R. A.

2018-04-01

Work is reported on development of a computational model for ultrasound beam transmission at an arbitrary geometry transmission interface for generally anisotropic materials. The work addresses problems encountered when the fundamental assumptions of ray theory do not hold, thereby introducing errors into ray-theory-based transmission models. Specifically, problems occur when the asymptotic integral analysis underlying ray theory encounters multiple stationary phase points in close proximity, due to focusing caused by concavity on either the entry surface or a material slowness surface. The approach presented here projects integrands over both the transducer aperture and the entry surface beam footprint onto a Gaussian-derived basis set, thereby distributing the integral over a summation of second-order phase integrals which are amenable to single stationary phase point analysis. Significantly, convergence is assured provided a sufficiently fine distribution of basis functions is used.

Teriflunomide: a once-daily oral medication for the treatment of relapsing forms of multiple sclerosis.

PubMed

Miller, Aaron E

2015-10-01

The purpose was to summarize US prescribing information for teriflunomide in the treatment of patients with relapsing forms of multiple sclerosis (RMS), with reference to clinical efficacy and safety outcomes. In September 2012, the US Food and Drug Administration granted approval for the use of teriflunomide, 14 mg and 7 mg once daily, to treat RMS on the basis of the results of a Phase II study and the Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) trial. After recent updates to the prescribing information (October 2014), key findings from these and 2 other Phase III clinical trials, TOWER (Teriflunomide Oral in People With Relapsing Multiple Sclerosis) and TOPIC (Oral Teriflunomide for Patients with a First Clinical Episode Suggestive of Multiple Sclerosis), and practical considerations for physicians are summarized. Teriflunomide, 14 mg and 7 mg, significantly reduced mean number of unique active lesions on magnetic resonance imaging (MRI; P < 0.05 for both doses) in the Phase II study. In the TEMSO and TOWER studies, the 14-mg dose of teriflunomide significantly reduced annualized relapse rate (31% and 36% relative risk reduction compared with placebo, respectively; both P < 0.001) and risk of disability progression sustained for 12 weeks (hazard ratio vs placebo 0.70 and 0.69, respectively; both P < 0.05). The 7-mg dose significantly (P < 0.02) reduced annualized relapse rate in both studies, although the reduction in risk of disability progression was not statistically significant. Teriflunomide treatment was also associated with significant efficacy on MRI measures of disease activity in TEMSO; both doses significantly reduced total lesion volume and number of gadolinium-enhancing T1 lesions. TOPIC evaluated patients with a first clinical event consistent with acute demyelination and brain MRI lesions characteristic of multiple sclerosis. More patients were free of relapse in the teriflunomide 14-mg and 7-mg groups than in the placebo group (P < 0.05 for both comparisons). In safety data pooled from the 4 studies, adverse events occurring in ≥2% of patients and ≥2% higher than in the placebo group were headache, alanine aminotransferase increase, diarrhea, alopecia (hair thinning), nausea, paresthesia, arthralgia, neutropenia, and hypertension. Routine monitoring procedures before and on treatment are recommended to assess potential safety issues. Women of childbearing potential must use effective contraception and, in the event of pregnancy, undergo an accelerated elimination procedure to reduce plasma concentrations of teriflunomide. Clinical evidence suggests that teriflunomide is an effective therapeutic choice for patients with RMS, both as an initial treatment and as an alternative for patients who may have experienced intolerance or inadequate response to a previous or current disease-modifying therapy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Timing of Formal Phase Safety Reviews for Large-Scale Integrated Hazard Analysis

NASA Technical Reports Server (NTRS)

Massie, Michael J.; Morris, A. Terry

2010-01-01

Integrated hazard analysis (IHA) is a process used to identify and control unacceptable risk. As such, it does not occur in a vacuum. IHA approaches must be tailored to fit the system being analyzed. Physical, resource, organizational and temporal constraints on large-scale integrated systems impose additional direct or derived requirements on the IHA. The timing and interaction between engineering and safety organizations can provide either benefits or hindrances to the overall end product. The traditional approach for formal phase safety review timing and content, which generally works well for small- to moderate-scale systems, does not work well for very large-scale integrated systems. This paper proposes a modified approach to timing and content of formal phase safety reviews for IHA. Details of the tailoring process for IHA will describe how to avoid temporary disconnects in major milestone reviews and how to maintain a cohesive end-to-end integration story particularly for systems where the integrator inherently has little to no insight into lower level systems. The proposal has the advantage of allowing the hazard analysis development process to occur as technical data normally matures.

A Safety Index and Method for Flightdeck Evaluation

NASA Technical Reports Server (NTRS)

Latorella, Kara A.

2000-01-01

If our goal is to improve safety through machine, interface, and training design, then we must define a metric of flightdeck safety that is usable in the design process. Current measures associated with our notions of "good" pilot performance and ultimate safety of flightdeck performance fail to provide an adequate index of safe flightdeck performance for design evaluation purposes. The goal of this research effort is to devise a safety index and method that allows us to evaluate flightdeck performance holistically and in a naturalistic experiment. This paper uses Reason's model of accident causation (1990) as a basis for measuring safety, and proposes a relational database system and method for 1) defining a safety index of flightdeck performance, and 2) evaluating the "safety" afforded by flightdeck performance for the purpose of design iteration. Methodological considerations, limitations, and benefits are discussed as well as extensions to this work.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Treatment using oxaliplatin and S-1 adjuvant chemotherapy for pathological stage III gastric cancer: a multicenter phase II study (TOSA trial) protocol.

PubMed

Namikawa, Tsutomu; Maeda, Hiromichi; Kitagawa, Hiroyuki; Oba, Koji; Tsuji, Akihito; Yoshikawa, Takaki; Kobayashi, Michiya; Hanazaki, Kazuhiro

2018-02-13

Recent studies demonstrated the efficacy of S-1-based adjuvant chemotherapy administered for six months after curative surgery for stage III gastric cancer; however, it is unproven whether this type of combination chemotherapy is more effective than the standard adjuvant chemotherapy of S-1 for one year. This multicenter phase II study evaluate the efficacy and safety of adjuvant chemotherapy using S-1 plus oxaliplatin followed by S-1 for up to one year for curatively resected stage III gastric cancer in patients aged over 20 years. Treatment initially comprises oral fluoropyrimidine S-1 (80 mg/m 2 ) administered twice daily for the first 2 weeks of a 3-week cycle. On day 1 of a second 3-week cycle, patients will receive 100 mg/m 2 of intravenous oxaliplatin followed by 80 mg/m 2 of S-1 (maximum 8 cycles). Then, the patients will receive 80 mg/m 2 of S-1 daily for 4 weeks, followed by 2 weeks of no chemotherapy. This 6-week cycle will be repeated during the first year after surgery. The primary endpoint is relapse-free survival for 3 years and secondary endpoints are safety, including the incidence of adverse events, and grading of neuropathy with each treatment cycle. The planned sample size of 75 patients is appropriate for this trial. The data will be analyzed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance. In contrast to previous trials, the current study involves administration of S-1 until one year after surgery in addition to prior S-1 plus oxaliplatin, and is the first study to evaluate the safety and efficacy of S-1 plus oxaliplatin followed by S-1 for up to one year in patients with curatively resected stage III gastric cancer. This trial is registered in the University Hospital Medical Information Network's Clinical Trials Registry (UMIN-CTR) registration number, R000029656  ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656 ). Registered January 24, 2017.

Site Safety and Health Plan (Phase 3) for the treatability study for in situ vitrification at Seepage Pit 1 in Waste Area Grouping 7, Oak Ridge National Laboratory, Oak Ridge, TN

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

Spalding, B.P.; Naney, M.T.

1995-06-01

This plan is to be implemented for Phase III ISV operations and post operations sampling. Two previous project phases involving site characterization have been completed and required their own site specific health and safety plans. Project activities will take place at Seepage Pit 1 in Waste Area Grouping 7 at ORNL, Oak Ridge, Tennessee. Purpose of this document is to establish standard health and safety procedures for ORNL project personnel and contractor employees in performance of this work. Site activities shall be performed in accordance with Energy Systems safety and health policies and procedures, DOE orders, Occupational Safety and Healthmore » Administration Standards 29 CFR Part 1910 and 1926; applicable United States Environmental Protection Agency requirements; and consensus standards. Where the word ``shall`` is used, the provisions of this plan are mandatory. Specific requirements of regulations and orders have been incorporated into this plan in accordance with applicability. Included from 29 CFR are 1910.120 Hazardous Waste Operations and Emergency Response; 1910.146, Permit Required - Confined Space; 1910.1200, Hazard Communication; DOE Orders requirements of 5480.4, Environmental Protection, Safety and Health Protection Standards; 5480.11, Radiation Protection; and N5480.6, Radiological Control Manual. In addition, guidance and policy will be followed as described in the Environmental Restoration Program Health and Safety Plan. The levels of personal protection and the procedures specified in this plan are based on the best information available from reference documents and site characterization data. Therefore, these recommendations represent the minimum health and safety requirements to be observed by all personnel engaged in this project.« less

Literature Review. Aquatic Resources Investigation, Rocky Mountain Arsenal. Phase I

DTIC Science & Technology

1987-08-26

COMPOSITION , AND PAST MANAGEMENT RESOURCES 2. ASSESS THE CONTAMINATION HISTORY OF THOSE RESOURCES 3. PROVIDE A BASIS FOR DESIGNING MORE DETAILED PHASE II...terms of habitat, species composition , and past management practices, (2) assess the contamination history of those resources, and (3) provide a basis for...governmental documents from the Rocky Mountain Arsenal, U.S. Fish and Wildlife Service, and Army Corps of Engineers; Shell Oil Company documents; and

30 CFR 75.905 - Connection of single-phase loads.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Alternating Current Circuits § 75.905 Connection of single-phase loads. [Statutory Provisions] Single-phase... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Connection of single-phase loads. 75.905 Section 75.905 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE...

30 CFR 75.905 - Connection of single-phase loads.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Alternating Current Circuits § 75.905 Connection of single-phase loads. [Statutory Provisions] Single-phase... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Connection of single-phase loads. 75.905 Section 75.905 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE...

49 CFR 585.2 - Phase-in reports.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Phase-in reports. 585.2 Section 585.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS General § 585.2 Phase-in reports. Each report submitted to NHTSA...

Evaluation of Environmental Conditions on the Curing Of Commercial Fixative and Intumescent Coatings

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

Nicholson, J. C.

2016-09-26

Performance metrics for evaluating commercial fixatives are often not readily available for important parameters that must be considered per the facility safety basis and the facility Basis for Interim Operations (BIO). One such parameter is the behavior of such materials in varied, “non-ideal” conditions where ideal is defined as 75 °F, 40% RH. Coupled with the inherent flammable nature of the fixative materials that can act to propagate flame along surfaces that are otherwise fireproof (concrete, sheet metal), much is left unknown when considering the safety basis implications for introducing these materials into nuclear facilities. Through SRNL’s efforts, three (3)more » fixatives, one (1) decontamination gel, and six (6) intumescent coatings were examined for their responses to environmental conditions to determine whether these materials were impervious to non-nominal temperatures and humidities that may be found in nuclear facilities. Characteristics that were examined included set-to-touch time, dust free time, and adhesion testing of the fully cured compounds. Of these ten materials, three were two-part epoxy materials while the other seven consisted of only one constituent. The results show that the epoxies tested are unable to cure in sub-freezing temperatures, with the low temperatures inhibiting crosslinking to a very significant degree. These efforts show significant inhibiting of performance for non-nominal environmental conditions, something that must be addressed both in the decision process for a fixative material to apply and per the safety basis to ensure the accurate flammability and material at risk is calculated.« less

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Phase transformations in an ascending adiabatic mixed-phase cloud volume

NASA Astrophysics Data System (ADS)

Pinsky, M.; Khain, A.; Korolev, A.

2015-04-01

Regimes of liquid-ice coexistence that may form in an adiabatic parcel ascending at constant velocity at freezing temperatures are investigated. Four zones with different microphysical structures succeeding one another along the vertical direction have been established. On the basis of a novel balance equation, analytical expressions are derived to determine the conditions specific for each of these zones. In particular, the necessary and sufficient conditions for formation of liquid water phase within an ascending parcel containing only ice particles are determined. The results are compared to findings reported in earlier studies. The role of the Wegener-Bergeron-Findeisen mechanism in the phase transformation is analyzed. The dependence of the phase relaxation time on height in the four zones is investigated on the basis of a novel analytical expression. The results obtained in the study can be instrumental for analysis and interpretation of observed mixed-phase clouds.

National Dam Safety Program. Lipps Lake Dam (MO 30214). Mississippi - Kaskaskia - St. Louis Basin, Cape Girardeau County, Missouri. Phase I Inspection Report.

DTIC Science & Technology

1980-10-01

AD-A105 988 HOSKINSEWESTERN-SONOER EGGER INC LINCOLN NEM F/S 13/13 NATIONAL DA -M SAFETY PROGRAM. LI PS LAKE DAM (MO 3021 ). MISS! SS7 - TC(U...COMPLETING FORM i. REPORT NUMBER 12. GOVT ACCESSION NO. 3. RECIPIENT’S CATALOG NIOMBER 4. TITLE (and Subtitle) 5. TYPE OF REPORT & PERIOD COVERED Phase I Dam

National Highway Safety Administration. Automatic collision notice field test summary.

PubMed

2001-10-01

From 1995 to 2000, the National Highway Traffic Safety Administration (NHTSA) sponsored an initiative to create and operate an Automatic Collision Notification (ACN) system on a demonstration basis in a rural area to provide faster and smarter emergency medical responses and in an attempt to save lives and reduce disabilities from injuries. This article is a brief summary of that demonstration.

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

Reaping the Benefits of Task Conflict in Teams: The Critical Role of Team Psychological Safety Climate

ERIC Educational Resources Information Center

Bradley, Bret H.; Postlethwaite, Bennett E.; Klotz, Anthony C.; Hamdani, Maria R.; Brown, Kenneth G.

2012-01-01

Past research suggests that task conflict may improve team performance under certain conditions; however, we know little about these specific conditions. On the basis of prior theory and research on conflict in teams, we argue that a climate of psychological safety is one specific context under which task conflict will improve team performance.…

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

PubMed

Friedman, A J; Wheeler, J

1991-04-01

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

Environmental, health, and safety issues of fuel cells in transportation. Volume 1: Phosphoric acid fuel-cell buses

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

Ring, S

1994-12-01

The U.S. Department of Energy (DOE) chartered the Phosphoric Acid Fuel-Cell (PAFC) Bus Program to demonstrate the feasibility of fuel cells in heavy-duty transportation systems. As part of this program, PAFC- powered buses are being built to meet transit industry design and performance standards. Test-bed bus-1 (TBB-1) was designed in 1993 and integrated in March 1994. TBB-2 and TBB-3 are under construction and should be integrated in early 1995. In 1987 Phase I of the program began with the development and testing of two conceptual system designs- liquid- and air-cooled systems. The liquid-cooled PAFC system was chosen to continue, throughmore » a competitive award, into Phase H, beginning in 1991. Three hybrid buses, which combine fuel-cell and battery technologies, were designed during Phase III. After completing Phase II, DOE plans a comprehensive performance testing program (Phase HI) to verify that the buses meet stringent transit industry requirements. The Phase III study will evaluate the PAFC bus and compare it to a conventional diesel bus. This NREL study assesses the environmental, health, and safety (EH&S) issues that may affect the commercialization of the PAFC bus. Because safety is a critical factor for consumer acceptance of new transportation-based technologies the study focuses on these issues. The study examines health and safety together because they are integrally related. In addition, this report briefly discusses two environmental issues that are of concern to the Environmental Protection Agency (EPA). The first issue involves a surge battery used by the PAFC bus that contains hazardous constituents. The second issue concerns the regulated air emissions produced during operation of the PAFC bus.« less

TITLE: Environmental, health, and safety issues offuel cells in transportation. Volume 1: Phosphoricacid fuel-cell buses

NASA Astrophysics Data System (ADS)

Ring, Shan

1994-12-01

The U.S. Department of Energy (DOE) chartered the Phosphoric Acid Fuel-Cell (PAFC) Bus Program to demonstrate the feasibility of fuel cells in heavy-duty transportation systems. As part of this program, PAFC- powered buses are being built to meet transit industry design and performance standards. Test-bed bus-1 (TBB-1) was designed in 1993 and integrated in March 1994. TBB-2 and TBB-3 are under construction and should be integrated in early 1995. In 1987 Phase 1 of the program began with the development and testing of two conceptual system designs- liquid- and air-cooled systems. The liquid-cooled PAFC system was chosen to continue, through a competitive award, into Phase H, beginning in 1991. Three hybrid buses, which combine fuel-cell and battery technologies, were designed during Phase 3. After completing Phase 2, DOE plans a comprehensive performance testing program (Phase H1) to verify that the buses meet stringent transit industry requirements. The Phase 3 study will evaluate the PAFC bus and compare it to a conventional diesel bus. This NREL study assesses the environmental, health, and safety (EH&S) issues that may affect the commercialization of the PAFC bus. Because safety is a critical factor for consumer acceptance of new transportation-based technologies the study focuses on these issues. The study examines health and safety together because they are integrally related. In addition, this report briefly discusses two environmental issues that are of concern to the Environmental Protection Agency (EPA). The first issue involves a surge battery used by the PAFC bus that contains hazardous constituents. The second issue concerns the regulated air emissions produced during operation of the PAFC bus.

Large-Scale Cubic-Scaling Random Phase Approximation Correlation Energy Calculations Using a Gaussian Basis.

PubMed

Wilhelm, Jan; Seewald, Patrick; Del Ben, Mauro; Hutter, Jürg

2016-12-13

We present an algorithm for computing the correlation energy in the random phase approximation (RPA) in a Gaussian basis requiring [Formula: see text] operations and [Formula: see text] memory. The method is based on the resolution of the identity (RI) with the overlap metric, a reformulation of RI-RPA in the Gaussian basis, imaginary time, and imaginary frequency integration techniques, and the use of sparse linear algebra. Additional memory reduction without extra computations can be achieved by an iterative scheme that overcomes the memory bottleneck of canonical RPA implementations. We report a massively parallel implementation that is the key for the application to large systems. Finally, cubic-scaling RPA is applied to a thousand water molecules using a correlation-consistent triple-ζ quality basis.

[Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

PubMed

Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

2011-10-01

The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

Quantitative phase imaging of platelets in patients with chronic renal failure treated with hemodialysis

NASA Astrophysics Data System (ADS)

Vasilenko, Irina; Vlasova, Elizaveta; Metelin, Vladislav; Kardasheva, Ziver

2018-02-01

The development of robust non-invasive laboratory screening methods for early diagnosis on the out-patient basis seems quite relevant for practical medicine. It is known, that platelet is an original biosensor, a detector of early changes in hemostasis condition. The aim of this study was to assess a potential of the quantitative phase imaging (QPI) technique for real time evaluation the influence of low-molecular weight and unfractionated heparin on platelets in patients with the end-stage of chronic renal failure, who were treated with program hemodialysis (PHD). The main group consisted of 21 patients who were administered a low-molecular weight heparin for hypocoagulation during the procedure of hemodialysis. The control group (15 patients) received unfractionated heparin. Morphodensitometric state of living platelets we evaluated by QPI using computer phase-interference microscope MIM (Moscow, Russia). We analyzed the optical-geometrical parameters and the morphological features of living platelets which reflected the degree of their activation at the beginning of PHD (before administration of heparin), in 15 minutes after it and at the end of the procedure. The results allow us to conclude that the use of low-molecular weight heparin provides better ratio of efficacy/safety and causes a reduction of the platelet activation during the hemodialysis procedure. Practical implementation of QPI for clinical monitoring of platelets makes it possible to obtain important information on hemostasis cell. It opens new opportunities to assess the efficacy of treatment, as well as for early diagnosis of complications for disease.

Usability and safety of ventricular assist devices: human factors and design aspects.

PubMed

Geidl, Lorenz; Zrunek, Philipp; Deckert, Zeno; Zimpfer, Daniel; Sandner, Sigrid; Wieselthaler, Georg; Schima, Heinrich

2009-09-01

The purpose of this study was the investigation of the usability and ergonomics of ventricular assist devices (VADs) in everyday usage. Patients with four different VAD types were observed. After implantation, instruction, and discharge from the hospital, the patients returned on a regular basis to the outpatient clinic, where the investigation took place. Data collection took place in two phases. In phase I home-released VAD patients were asked about perceived problems with the system at home. Additionally health-care professionals were interviewed to gather information on frequent VAD inconveniences and shortcomings. This inquiry resulted in a standardized self-assessment questionnaire and a manual skill test, which were performed in phase II by the whole collective (16 patients and ongoing). As a result, 38% of the patients disconnected parts of their system unintentionally at least once. All of them ascribed this problem to their own carelessness. Thirty-eight percent had to replace a cable. Seventy-five percent desired an additional cable strain relief. Thirty-eight percent suffered from rubbing of parts on the body. Sixty-three percent used a separate repository aside from the factory-provided transportation systems. The overall noise emission (pump, ventilators, and alarms) annoyed 56%; however, for 32% the alarm signals were too quiet to wake them up. No correlation between the assessed manual skills and the number of adverse events was found. To conclude, this preliminary study revealed considerable potential for improvements in the usability of ventricular assist systems.

The influence of pedestrian countdown signals on children's crossing behavior at school intersections.

PubMed

Fu, Lianning; Zou, Nan

2016-09-01

Previous studies have shown that pedestrian countdown signals had different influences on pedestrian crossing behavior. The purpose of this study was to examine the effects of the installation of countdown signals at school intersections on children's crossing behavior. A comparison analysis was carried out on the basis of observations at two different school intersections with or without pedestrian countdown signals in the city of Jinan, China. Four types of children's crossing behavior and child pedestrian-vehicle conflicts were analyzed in detail. The analysis results showed that using pedestrian countdown timers during the Red Man phase led to more children's violation and running behavior. Theses violators created more conflicts with vehicles. However, pedestrian countdown signals were effective at helping child pedestrian to complete crossing before the red light onset, avoid getting caught in the middle of crosswalk. No significant difference was found in children who started crossing during Flashing Green Man phase between the two types of pedestrian signals. Moreover, analysis results indicated that children who crossed the road alone had more violation and adventure crossing behavior than those had companions. Boys were found more likely to run crossing than girls, but there was no significant gender difference in other crossing behavior. Finally, it's recommended to remove countdown at the end of the Red Man phase to improve children's crossing behavior and reduce the conflicts with vehicles. Meanwhile other measures are proposed to improve children safety at school intersections. Copyright © 2016 Elsevier Ltd. All rights reserved.

Impact of economic incentives on costs and benefits of occupational health and safety.

PubMed

Pawłowska, Z; Rzepecki, J

2000-01-01

The most common type of economic incentive used in the field of health and safety is experience rating of insurance premiums. The impact of this incentive on occupational health and safety (OHS) costs in the company was analysed by comparing insurance costs with other OHS costs associated with inadequate working conditions, such as accident costs borne by a company. Accident costs were estimated on the basis of research carried out in 10 companies. Insurance costs and their adjustments according to the health and safety level in a company were calculated according to an experience rating model developed in the Central Institute for Labour Protection.

[Chemical safety, health, and environment: prospects for governance in the Brazilian context].

PubMed

Freitas, Carlos Machado de; Porto, Marcelo Firpo S; Moreira, Josino Costa; Pivetta, Fatima; Machado, Jorge M Huet; Freitas, Nilton B B de; Arcuri, Arline S

2002-01-01

Chemical safety is acknowledged by Agenda 21 as one of the most serious problems worldwide, involving governance at the national and international levels. In Brazil, chemical safety problems have increased in intensity and extent, far beyond the capacity to deal with them. The problems are all the more serious in Brazil because issues of democracy, security, sustainability, and equity, all fundamental to governance, are still incipient and still far from being solved. New societal arrangements and a new, contextualized and more participatory science form the basis for developing and expanding strategies for governance to deal with the problem of chemical safety.

Research on station management in subway operation safety

NASA Astrophysics Data System (ADS)

Li, Yiman

2017-10-01

The management of subway station is an important part of the safe operation of urban subway. In order to ensure the safety of subway operation, it is necessary to study the relevant factors that affect station management. In the protection of subway safety operations on the basis of improving the quality of service, to promote the sustained and healthy development of subway stations. This paper discusses the influencing factors of subway operation accident and station management, and analyzes the specific contents of station management security for subway operation, and develops effective suppression measures. It is desirable to improve the operational quality and safety factor for subway operations.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

Effectiveness of safety belt warning and interlock systems

DOT National Transportation Integrated Search

1973-04-01

Rental cars in Fayetteville, N.C., were equipped with four seat belt and warning systems: (Phase I) detachable shoulder and lap belt, no warning system; (Phase II) detachable shoulder and lap belt, warning system (January 1, 1972 standard); (Phase II...

Revenue sources for financing transportation safety activities in Virginia : phase three, feasibility of a surcharge on traffic fines.

DOT National Transportation Integrated Search

1981-01-01

Senate Bill 85, an action of the 1978 General Assembly, amended the Code of Virginia to provide, in part, that the Division of Highway Safety be succeeded by the newly created Department of Transportation Safety effective July 1, 1978. In its Declara...

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…

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

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

U18 : Traffic signal safety (phase B).

DOT National Transportation Integrated Search

2009-08-01

Efficiently scheduling traffic, particularly heavy vehicles, remains a key challenge in transportation engineering. This project has focused on the development of a novel trafficsignal-control methodology to improve the safety of heavy vehicles on...

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)...

Quantum phase space with a basis of Wannier functions

NASA Astrophysics Data System (ADS)

Fang, Yuan; Wu, Fan; Wu, Biao

2018-02-01

A quantum phase space with Wannier basis is constructed: (i) classical phase space is divided into Planck cells; (ii) a complete set of Wannier functions are constructed with the combination of Kohn’s method and Löwdin method such that each Wannier function is localized at a Planck cell. With these Wannier functions one can map a wave function unitarily onto phase space. Various examples are used to illustrate our method and compare it to Wigner function. The advantage of our method is that it can smooth out the oscillations in wave functions without losing any information and is potentially a better tool in studying quantum-classical correspondence. In addition, we point out that our method can be used for time-frequency analysis of signals.

Reaping the benefits of task conflict in teams: the critical role of team psychological safety climate.

PubMed

Bradley, Bret H; Postlethwaite, Bennett E; Klotz, Anthony C; Hamdani, Maria R; Brown, Kenneth G

2012-01-01

Past research suggests that task conflict may improve team performance under certain conditions; however, we know little about these specific conditions. On the basis of prior theory and research on conflict in teams, we argue that a climate of psychological safety is one specific context under which task conflict will improve team performance. Using evidence from 117 project teams, the present research found that psychological safety climate moderates the relationship between task conflict and performance. Specifically, task conflict and team performance were positively associated under conditions of high psychological safety. The results support the conclusion that psychological safety facilitates the performance benefits of task conflict in teams. Theoretical implications and suggestions for future research are discussed.

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Ferrell, Bob; Santuro, Steve; Simpson, James; Zoerner, Roger; Bull, Barton; Lanzi, Jim

2004-01-01

Autonomous Flight Safety System (AFSS) is an independent flight safety system designed for small to medium sized expendable launch vehicles launching from or needing range safety protection while overlying relatively remote locations. AFSS replaces the need for a man-in-the-loop to make decisions for flight termination. AFSS could also serve as the prototype for an autonomous manned flight crew escape advisory system. AFSS utilizes onboard sensors and processors to emulate the human decision-making process using rule-based software logic and can dramatically reduce safety response time during critical launch phases. The Range Safety flight path nominal trajectory, its deviation allowances, limit zones and other flight safety rules are stored in the onboard computers. Position, velocity and attitude data obtained from onboard global positioning system (GPS) and inertial navigation system (INS) sensors are compared with these rules to determine the appropriate action to ensure that people and property are not jeopardized. The final system will be fully redundant and independent with multiple processors, sensors, and dead man switches to prevent inadvertent flight termination. AFSS is currently in Phase III which includes updated algorithms, integrated GPS/INS sensors, large scale simulation testing and initial aircraft flight testing.

49 CFR 585.12 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS Advanced Air Bag Phase-in Reporting... Traffic Safety Administration in determining whether a manufacturer has complied with the advanced air bag...

49 CFR 585.12 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS Advanced Air Bag Phase-in Reporting... Traffic Safety Administration in determining whether a manufacturer has complied with the advanced air bag...

49 CFR 585.12 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS Advanced Air Bag Phase-in Reporting... Traffic Safety Administration in determining whether a manufacturer has complied with the advanced air bag...

49 CFR 585.12 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS Advanced Air Bag Phase-in Reporting... Traffic Safety Administration in determining whether a manufacturer has complied with the advanced air bag...

49 CFR 585.12 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS Advanced Air Bag Phase-in Reporting... Traffic Safety Administration in determining whether a manufacturer has complied with the advanced air bag...

Fifty Years of Research in ARDS. Cell-based Therapy for Acute Respiratory Distress Syndrome. Biology and Potential Therapeutic Value.

PubMed

Laffey, John G; Matthay, Michael A

2017-08-01

On the basis of several preclinical studies, cell-based therapy has emerged as a potential new therapeutic for acute respiratory distress syndrome (ARDS). Of the various cell-based therapy options, mesenchymal stem/stromal cells (MSCs) from bone marrow, adipose tissue, and umbilical cord have the most experimental data to support their potential efficacy for lung injury from both infectious and noninfectious causes. Mechanistically, MSCs exert their beneficial effects by release of paracrine factors, microvesicles, and transfer of mitochondria, all of which have antiinflammatory and pro-resolving effects on injured lung endothelium and alveolar epithelium, including enhancing the resolution of pulmonary edema by up-regulating sodium-dependent alveolar fluid clearance. MSCs also have antimicrobial effects mediated by release of antimicrobial factors and by up-regulating monocyte/macrophage phagocytosis. Phase 2a clinical trials to establish safety in ARDS are in progress, and two phase 1 trials did not report any serious adverse events. Several issues need further study, including: determining the optimal methods for large-scale production, reconstitution of cryopreserved cells for clinical use, defining cell potency assays, and determining the therapeutic potential of conditioned media derived from MSCs. Because ARDS is a heterogeneous syndrome, targeting MSCs to patients with ARDS with a more hyperinflammatory endotype may further enhance their potential for efficacy.

Analyses in Support of Risk-Informed Natural Gas Vehicle Maintenance Facility Codes and Standards: Phase II.

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

Blaylock, Myra L.; LaFleur, Chris Bensdotter; Muna, Alice Baca

Safety standards development for maintenance facilities of liquid and compressed natural gas fueled vehicles is required to ensure proper facility design and operating procedures. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase II work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest using risk ranking. Detailed simulations and modeling were performed to estimate the location and behaviormore » of natural gas releases based on these scenarios. Specific code conflicts were identified, and ineffective code requirements were highlighted and resolutions proposed. These include ventilation rate basis on area or volume, as well as a ceiling offset which seems ineffective at protecting against flammable gas concentrations. ACKNOWLEDGEMENTS The authors gratefully acknowledge Bill Houf (SNL -- Retired) for his assistance with the set-up and post-processing of the numerical simulations. The authors also acknowledge Doug Horne (retired) for his helpful discussions. We would also like to acknowledge the support from the Clean Cities program of DOE's Vehicle Technology Office.« less

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Safety Needs Mediate Stressful Events Induced Mental Disorders.

PubMed

Zheng, Zheng; Gu, Simeng; Lei, Yu; Lu, Shanshan; Wang, Wei; Li, Yang; Wang, Fushun

2016-01-01

"Safety first," we say these words almost every day, but we all take this for granted for what Maslow proposed in his famous theory of Hierarchy of Needs : safety needs come second to physiological needs. Here we propose that safety needs come before physiological needs. Safety needs are personal security, financial security, and health and well-being, which are more fundamental than physiological needs. Safety worrying is the major reason for mental disorders, such as anxiety, phobia, depression, and PTSD. The neural basis for safety is amygdala, LC/NE system, and corticotrophin-releasing hormone system, which can be regarded as a "safety circuitry," whose major behavior function is "fight or flight" and "fear and anger" emotions. This is similar to the Appraisal theory for emotions: fear is due to the primary appraisal, which is related to safety of individual, while anger is due to secondary appraisal, which is related to coping with the unsafe situations. If coping is good, the individual will be happy; if coping failed, the individual will be sad or depressed.

Validation of the group nuclear safety climate questionnaire.

PubMed

Navarro, M Felisa Latorre; Gracia Lerín, Francisco J; Tomás, Inés; Peiró Silla, José María

2013-09-01

Group safety climate is a leading indicator of safety performance in high reliability organizations. Zohar and Luria (2005) developed a Group Safety Climate scale (ZGSC) and found it to have a single factor. The ZGSC scale was used as a basis in this study with the researchers rewording almost half of the items on this scale, changing the referents from the leader to the group, and trying to validate a two-factor scale. The sample was composed of 566 employees in 50 groups from a Spanish nuclear power plant. Item analysis, reliability, correlations, aggregation indexes and CFA were performed. Results revealed that the construct was shared by each unit, and our reworded Group Safety Climate (GSC) scale showed a one-factor structure and correlated to organizational safety climate, formalized procedures, safety behavior, and time pressure. This validation of the one-factor structure of the Zohar and Luria (2005) scale could strengthen and spread this scale and measure group safety climate more effectively. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Infliximab is superior to other biological agents for treatment of active ulcerative colitis: A meta-analysis.

PubMed

Mei, Wei-Qun; Hu, Hui-Zhen; Liu, Ying; Li, Zhi-Chen; Wang, Wei-Guo

2015-05-21

To compare the efficacy and safety of biological agents for the treatment of active ulcerative colitis (UC). PubMed, MEDLINE, EMBASE and the Cochrane library were searched to screen relevant articles from January 1996 to August 2014. The mixed treatment comparison meta-analysis within a Bayesian framework was performed using WinBUGS14 software. The proportions of patients reaching clinical response, clinical remission and mucosal healing in induction and maintenance phases were analyzed as efficacy indicators. Serious adverse events in maintenance phase were analyzed as safety indicators. The meta-analysis results showed that biological agents achieved better clinical response, clinical remission and mucosal healing than placebo. Indirect comparison indicated that in induction phase, infliximab was more effective than adalimumab in inducing clinical response (OR = 0.41, 95%CI: 0.29-0.57), clinical remission (OR = 0.33, 95%CI: 0.19-0.56) and mucosal healing (OR = 0.33, 95%CI: 0.19-0.56), and golimumab in inducing clinical response (OR = 0.66, 95%CI: 0.39-2.33) and mucosal healing (OR = 2.15, 95%CI: 1.18-4.22). No significant difference was found between placebo and biological agents regarding their safety. All biological agents were superior to placebo for UC treatment in both induction and maintenance phases with a similar safety profile, and infliximab had a better clinical effect than the other biological agents.

Expanding AirSTAR Capability for Flight Research in an Existing Avionics Design

NASA Technical Reports Server (NTRS)

Laughter, Sean A.

2012-01-01

The NASA Airborne Subscale Transport Aircraft Research (AirSTAR) project is an Unmanned Aerial Systems (UAS) test bed for experimental flight control laws and vehicle dynamics research. During its development, the test bed has gone through a number of system permutations, each meant to add functionality to the concept of operations of the system. This enabled the build-up of not only the system itself, but also the support infrastructure and processes necessary to support flight operations. These permutations were grouped into project phases and the move from Phase-III to Phase-IV was marked by a significant increase in research capability and necessary safety systems due to the integration of an Internal Pilot into the control system chain already established for the External Pilot. The major system changes in Phase-IV operations necessitated a new safety and failsafe system to properly integrate both the Internal and External Pilots and to meet acceptable project safety margins. This work involved retrofitting an existing data system into the evolved concept of operations. Moving from the first Phase-IV aircraft to the dynamically scaled aircraft further involved restructuring the system to better guard against electromagnetic interference (EMI), and the entire avionics wiring harness was redesigned in order to facilitate better maintenance and access to onboard electronics. This retrofit and harness re-design will be explored and how it integrates with the evolved Phase-IV operations.

Review of phase III trial data on IL-23 inhibitors tildrakizumab and guselkumab for psoriasis.

PubMed

Amin, M; Darji, K; No, D J; Wu, J J

2017-10-01

The development of monoclonal antibodies targeting IL-12 and IL-23 has enhanced the therapeutic options available for psoriasis patients. Recent research suggests that IL-23 alone plays a role in the pathogenesis of psoriasis. The objective was to review the phase III clinical trial data for the anti-IL-23 agents to evaluate the safety and efficacy profile of each agent. We reviewed the results of the phase III clinical trials for the anti-IL-23 agents tildrakizumab and guselkumab. The results of phase III trials on risankizumab have not yet been reported. By week 12, the proportion of patients reaching Psoriasis Area and Severity Index (PASI 75) was >60% among the most efficacious dose of each agent. The percentage of patients achieving PASI 90 at week 16 was the primary endpoint for the phase III trials for guselkumab, which was above 70%. The safety profiles of the agents were comparable, with the most commonly reported adverse events of nasopharyngitis and upper respiratory tract infections. The anti-IL-23 agents demonstrated a rapid clinical improvement that is similar or superior to the improvement seen with currently marketed IL-17 inhibitors with a favourable short-term safety profile. The results of the phase III trials support the notion that IL-23 is a potential target in psoriasis treatment. © 2017 European Academy of Dermatology and Venereology.

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

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

Smith, Curtis; Rabiti, Cristian; Martineau, Richard

Safety is central to the design, licensing, operation, and economics of Nuclear Power Plants (NPPs). As the current Light Water Reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of Systems, Structures, and Components (SSCs) degradations or failures that initiate safety-significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very high degreemore » of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated, primarily based on “engineering judgment.”« less

[Patient safety in education and training of healthcare professionals in Germany].

PubMed

Hoffmann, Barbara; Siebert, H; Euteneier, A

2015-01-01

In order to improve patient safety, healthcare professionals who care for patients directly or indirectly are required to possess specific knowledge and skills. Patient safety education is not or only poorly represented in education and examination regulations of healthcare professionals in Germany; therefore, it is only practiced rarely and on a voluntary basis. Meanwhile, several training curricula and concepts have been developed in the past 10 years internationally and recently in Germany, too. Based on these concepts the German Coalition for Patient Safety developed a catalogue of core competencies required for safety in patient care. This catalogue will serve as an important orientation when patient safety is to be implemented as a subject of professional education in Germany in the future. Moreover, teaching staff has to be trained and educational and training activities have to be evaluated. Patient safety education and training for (undergraduate) healthcare professional will require capital investment.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 3: Nuclear Safety Analysis Document (NSAD)

NASA Technical Reports Server (NTRS)

1972-01-01

Nuclear safety analysis as applied to a space base mission is presented. The nuclear safety analysis document summarizes the mission and the credible accidents/events which may lead to nuclear hazards to the general public. The radiological effects and associated consequences of the hazards are discussed in detail. The probability of occurrence is combined with the potential number of individuals exposed to or above guideline values to provide a measure of accident and total mission risk. The overall mission risk has been determined to be low with the potential exposure to or above 25 rem limited to less than 4 individuals per every 1000 missions performed. No radiological risk to the general public occurs during the prelaunch phase at KSC. The most significant risks occur from prolonged exposure to reactor debris following land impact generally associated with the disposal phase of the mission where fission product inventories can be high.

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

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

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

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

Novel licensure pathways for expeditious introduction of new tuberculosis vaccines: a discussion of the adaptive licensure concept.

PubMed

Rustomjee, Roxana; Lockhart, Stephen; Shea, Jacqueline; Fourie, P Bernard; Hindle, Zoë; Steel, Gavin; Hussey, Gregory; Ginsberg, Ann; Brennan, Michael J

2014-03-01

The ultimate goal of vaccine development is licensure of a safe and efficacious product that has a well-defined manufacturing process resulting in a high quality product. In general, clinical development and regulatory approval occurs in a linear, sequential manner: Phase 1 - safety, immunogenicity; Phase 2 - immunogenicity, safety, dose ranging and preliminary efficacy; Phase 3 - definitive efficacy, safety, lot consistency; and, following regulatory approval, Phase 4 - post-marketing safety and effectiveness. For candidate TB vaccines, where correlates of protection are not yet identified, phase 2 and 3 efficacy of disease prevention trials are, by necessity, very large. Each trial would span 2-5 years, with full licensure expected only after 1 or even 2 decades of development. Given the urgent unmet need for a new TB vaccine, a satellite discussion was held at the International African Vaccinology Conference in Cape Town, South Africa in November 2012, to explore the possibility of expediting licensure by use of an "adaptive licensure" process, based on a risk/benefit assessment that is specific to regional needs informed by epidemiology. This may be appropriate for diseases such as TB, where high rates of morbidity, mortality, particularly in high disease burden countries, impose an urgent need for disease prevention. The discussion focused on two contexts: licensure within the South African regulatory environment - a high burden country where TB vaccine efficacy trials are on-going, and licensure by the United States FDA --a well-resourced regulatory agency where approval could facilitate global licensure of a novel TB vaccine. Copyright © 2013. Published by Elsevier Ltd.

78 FR 32412 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

...) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic...

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

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Contract Work Hours and Safety Standards Act. 2543... laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is... pay for all hours worked in excess of 40 hours in the work week. Section 107 of the Act is applicable...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false May a carrier require a passenger with a disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false May a carrier require a passenger with a disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

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...

Phase Misalignment between Suprachiasmatic Neuronal Oscillators Impairs Photic Behavioral Phase Shifts but not Photic Induction of Gene Expression

PubMed Central

Schwartz, Michael D.; Congdon, Seth; de la Iglesia, Horacio O.

2010-01-01

The ability of the circadian pacemaker within the suprachiasmatic nucleus (SCN) to respond to light stimulation in a phase-specific manner constitutes the basis for photic entrainment of circadian rhythms. The neural basis for this phase-specificity is unclear. We asked whether a lack of synchrony between SCN neurons, as reflected in phase misalignment between dorsomedial (dmSCN) and ventrolateral (vlSCN) neuronal oscillators in the rat, would impact the pacemaker’s ability to respond to phase-resetting light pulses. Light pulses delivered at maximal phase-misalignment between the vl-and dmSCN oscillators increased expression of Per1 mRNA, irrespective of the circadian phase of the dmSCN. However, phase shifts of locomotor activity were only observed when the vl-and dmSCN were phase-aligned at the time of stimulation. Our results fit a model in which a vlSCN oscillator phase-gates its own response to light and in turn relays light information to a dmSCN oscillator. This model predicts that the phase misalignment that results from circadian internal desynchronization could preserve the ability of light to induce gene expression within the master circadian clock but impair its ability to induce behavioral phase shifts. PMID:20881133

Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature.

PubMed

Alessandro, Pontis; Luigi, Nappi; Felice, Sorrentino; Maria, Paoletti Anna; Benedetto, Melis Gian; Stefano, Angioni

2017-04-01

Limitated studies have reported the efficacy of GnRH antagonist on endometriosis symptoms. The aim of our study was to review all available trials to investigate the medical treatment of endometriosis with only GnRH antagonists, with special attention to pharmacodynamic activity, safety, and efficacy. Pub Med and Sciencedirect database were searched using terms of "endometriosis treatment", "GnRH antagonist", and "Elagolix". The search was limited to clinical studies published in English. Title and abstract were screened to identify relevant articles. Five studies covering use of GnRH antagonist were found. A phase 1 study evaluated the safety, pharmacokinetics, and inhibitory effects on gonadotropins and estradiol of single dose and 7 day elagolix administration to healthy premenopausal women; two phase II studies evaluated efficacy in patient with endometriosis. Moreover, there are two Phase III clinical trials just completed. GnRH antagonists may have the advantage of oral administration and lower incidence of adverse events. Currently, only Phase II studies have been published demonstrating promising results in terms of efficacy, safety, and tolerability. From the results of the phase III studies, elagolix may become a valuable addition to the armamentarium of pharmacological agents to treat endometriosis-related pain.

Efficacy and safety of tofacitinib for active rheumatoid arthritis with an inadequate response to methotrexate or disease-modifying antirheumatic drugs: a meta-analysis of randomized controlled trials

PubMed Central

Song, Gwan Gyu; Bae, Sang-Cheol

2014-01-01

Background/Aims The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA). Methods A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches. Results Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies. Conclusions Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile. PMID:25228842

Maximum tolerated dose evaluation of the AMPA modulator Org 26576 in healthy volunteers and depressed patients: a summary and method analysis of bridging research in support of phase II dose selection.

PubMed

Nations, Kari R; Bursi, Roberta; Dogterom, Peter; Ereshefsky, Larry; Gertsik, Lev; Mant, Tim; Schipper, Jacques

2012-09-01

A key challenge to dose selection in early central nervous system (CNS) clinical drug development is that patient tolerability profiles often differ from those of healthy volunteers (HVs), yet HVs are the modal population for determining doses to be investigated in phase II trials. Without clear tolerability data from the target patient population, first efficacy trials may include doses that are either too high or too low, creating undue risk for study participants and the development program overall. Bridging trials address this challenge by carefully investigating safety and tolerability in the target population prior to full-scale proof-of-concept trials. Org 26576 is an alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor positive allosteric modulator that acts by modulating ionotropic AMPA-type glutamate receptors to enhance glutamatergic neurotransmission. In preparation for phase II efficacy trials in major depressive disorder (MDD), two separate phase I trials were conducted to evaluate safety, tolerability, and pharmacokinetics in HVs and in the target patient population. Both trials were randomized and placebo controlled, and included multiple rising-dose cohorts (HV range 100-400 mg bid; MDD range 100-600 mg bid). HVs (n = 36) and patients with MDD (n = 54) were dosed under similarly controlled conditions in an inpatient facility, HVs for up to 14 days and MDD patients for up to 28 days. Safety, tolerability, and pharmacokinetics were assessed frequently. Despite comparable pharmacokinetic profiles, the maximum tolerated dose (MTD) in depressed patients was 450 mg bid, twice the MTD established in HVs. No clinically relevant safety issues associated with Org 26576 were noted. This article presents safety, tolerability, and pharmacokinetic data from two different populations examined under similar dosing conditions. The important implications of such bridging work in phase II dose selection are discussed, as are study design and data interpretation challenges.

The quest for modernisation of traditional Chinese medicine

PubMed Central

2013-01-01

Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China. Due to its worldwide use, potential impact on healthcare and opportunities for new drug development, TCM is also of great international interest. Recently, a new era for modernisation of TCM was launched with the successful completion of the Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM) project, the European Union’s Seventh Framework Programme (FP7) coordination action on TCM research. This 3.5-year project that involved inputs from over 200 scientists resulted in the production of 20 editorials and in-depth reviews on different aspects of TCM that were published in a special issue of Journal of Ethnopharmacology (2012; volume 140, issue 3). In this narrative review, we aim to summarise the findings of the FP7 GP-TCM project and highlight the relevance of TCM to modern medicine within a historical and international context. Advances in TCM research since the 1950s can be characterised into three phases: Phase I (1950s-1970s) was fundamental for developing TCM higher education, research and hospital networks in China; Phase II (1980s-2000s) was critical for developing legal, economic and scientific foundations and international networks for TCM; and Phase III (2011 onwards) is concentrating on consolidating the scientific basis and clinical practice of TCM through interdisciplinary, interregional and intersectoral collaborations. Taking into account the quality and safety requirements newly imposed by a globalised market, we especially highlight the scientific evidence behind TCM, update the most important milestones and pitfalls, and propose integrity, integration and innovation as key principles for further modernisation of TCM. These principles will serve as foundations for further research and development of TCM, and for its future integration into tomorrow’s medicine. PMID:23763836

77 FR 15784 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic information, age, membership...

78 FR 20684 - Towing Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Government. DHS does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and...

The power of simplification: Operator interface with the AP1000{sup R} during design-basis and beyond design-basis events

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

Williams, M. G.; Mouser, M. R.; Simon, J. B.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and cost. The passive safety features are designed to function without safety-grade support systems such as component cooling water, service water, compressed air or HVAC. The AP1000 passive safety features achieve and maintain safe shutdown in case of a design-basis accident for 72 hours without need for operator action, meeting the expectations provided in the European Utility Requirements and the Utility Requirement Document for passive plants. Limited operator actions may be required to maintain safe conditionsmore » in the spent fuel pool (SFP) via passive means. This safety approach therefore minimizes the reliance on operator action for accident mitigation, and this paper examines the operator interaction with the Human-System Interface (HSI) as the severity of an accident increases from an anticipated transient to a design basis accident and finally, to a beyond-design-basis event. The AP1000 Control Room design provides an extremely effective environment for addressing the first 72 hours of design-basis events and transients, providing ease of information dissemination and minimal reliance upon operator actions. Symptom-based procedures including Emergency Operating Procedures (EOPs), Abnormal Operating Procedures (AOPs) and Alarm Response Procedures (ARPs) are used to mitigate design basis transients and accidents. Use of the Computerized Procedure System (CPS) aids the operators during mitigation of the event. The CPS provides cues and direction to the operators as the event progresses. If the event becomes progressively worse or lasts longer than 72 hours, and depending upon the nature of failures that may have occurred, minimal operator actions may be required outside of the control room in areas that have been designed to be accessible using components that have been designed to be reliable in these conditions. The primary goal of any such actions is to maintain or refill the passive inventory available to cool the core, containment and spent fuel pool in the safety-related and seismically qualified Passive Containment Cooling Water Storage Tank (PCCWST). The seismically-qualified, ground-mounted Passive Containment Cooling Ancillary Water Storage Tank (PCCAWST) is also available for this function as appropriate. The primary effect of these actions would be to increase the coping time for the AP1000 during design basis events, as well as events such as those described above, from 72 hours without operator intervention to 7 days with minimal operator actions. These Operator actions necessary to protect the health and safety of the public are addressed in the Post-72 Hour procedures, as well as some EOPs, AOPs, ARPs and the Severe Accident Management Guidelines (SAMGs). Should the event continue to become more severe and plant conditions degrade further with indications of inadequate core cooling, the SAMGs provide guidance for strategies to address these hypothetical severe accident conditions. The AP1000 SAMG diagnoses and actions are prioritized to first utilize the AP1000 features that are expected to retain a damaged core inside the reactor vessel. Only one strategy is undertaken at any time. This strategy will be followed and its effectiveness evaluated before other strategies are undertaken. This is a key feature of both the symptom-oriented AP1000 EOPs and the AP1000 SAMGs which maximizes the probability of retaining a damaged core inside the reactor vessel and containment while minimizing the chances for confusion and human errors during implementation. The AP1000 SAMGs are simple and straight-forward and have been developed with considerable input from human factors and plant operations experts. Most importantly, and different from severe accident management strategies for other plants, the AP1000 SAMGs do not require diagnosis of the location of the core (i.e., whether reactor vessel failure has occurred). This is a fundamental consequence of the AP1000 In-Vessel Retention approach, which allows severe accident management to be based on fundamental principles (e.g. provide coolant as close as possible to the core) that do not change during a specific event. This eliminates the need for one of the more difficult diagnostic requirements, since reactor vessel failure does not directly relate to any measurable plant parameter, and differs from other designs in that an engineered failure of the pressure vessel' (e.g. core catcher) is never required. (authors)« less

The comprehensive community-based traffic safety program : phase II, program assessment for District 2 and District 7, final report.

DOT National Transportation Integrated Search

1987-01-01

The program assessment phase was designed to identify community resources and address the recommendation, made in Phase I, that initial countermeasures should target the program areas of occupant protection, alcohol, selective enforcement, and pedest...

The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

PubMed

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2015-06-18

Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

Synthesis of a Novel Energetic Heterocyclic Oxidizer with Higher Energy and Lower Sensitivity (Phase 2) Final Report CRADA No. TC02125.0

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

Pagoria, P. F.; Racoveanu, A.

2017-09-08

This project was a continuation of work originally performed under a Phase 1 of the Small Business Technology Transfer (STIR). The success of the Phase 1 led to the award of a Phase 2 of the STIR. In Phase 1 of the STIR, the target energetic compound, 3,4-bis(4-nitro-l,2,5- oxadiazol-3yl)-1,2,5-oxadiazole-l-oxide (DNTF), was synthesized at the 5g scale and small-scale safety tests were performed. DNTF showed promising performance· and safety properties. DNTF was shown to be relatively insensitive while performing better than the current industry standard, H1vIX, in solid propellant formulations. Because of the successful research and development project involving PSI, LLNLmore » and Aerojet in Phase I of the STIR, the sponsors wanted to obtain larger quantities of DNTF for further testing.« less

Consumption of gluten with gluten-degrading enzyme by celiac patients: A pilot-study

PubMed Central

Tack, Greetje J; van de Water, Jolanda MW; Bruins, Maaike J; Kooy-Winkelaar, Engelina MC; van Bergen, Jeroen; Bonnet, Petra; Vreugdenhil, Anita CE; Korponay-Szabo, Ilma; Edens, Luppo; von Blomberg, B Mary E; Schreurs, Marco WJ; Mulder, Chris J; Koning, Frits

2013-01-01

AIM: To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients. METHODS: Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at baseline included complaints, quality-of-life, serum antibodies, immunophenotyping of T-cells and duodenal mucosa immunohistology. Furthermore, serum and quality of life questionnaires were collected during and after the safety, washout and efficacy phase. Duodenal biopsies were collected after the safety phase and after the efficacy phase. A change in histological evaluation according to the modified Marsh classification was the primary endpoint. RESULTS: In total, 16 adults were enrolled in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The mean score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate and moreover no differences between the groups were observed. During the efficacy phase, neither the placebo nor the AN-PEP group developed significant antibody titers. The IgA-EM concentrations remained negative in both groups. Two patients were excluded from entering the efficacy phase as their mucosa showed an increase of two Marsh steps after the safety phase, yet with undetectable serum antibodies, while 14 patients were considered histologically stable on gluten with AN-PEP. Also after the efficacy phase, no significant deterioration was observed regarding immunohistological and flow cytometric evaluation in the group consuming placebo compared to the group receiving AN-PEP. Furthermore, IgA-tTG deposit staining increased after 2 wk of gluten compared to baseline in four out of seven patients on placebo. In the seven patients receiving AN-PEP, one patient showed increased and one showed decreased IgA-tTG deposits. CONCLUSION: AN-PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN-PEP. PMID:24124328

National Dam Safety Program. Lakeview Estates Dam (MO 11004), Mississippi - Kaskaskia - St. Louis Basin, Warren County, Missouri. Phase I Inspection Report.

DTIC Science & Technology

1979-09-01

ificatiozh Distributon/ Availabilit oe LAKEVIEW ESTATES DAM WARREN COUNTY, MISSOURI MISSOURI INVENTORY NO. 11004 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY...and *impounds less than 1,000 acre-feet of water . Our inspection and evaluation indicates that the spill- way of Lakeview Estates Dam does not meet...not be measured because of high reservoir level, scalloping near the crest and a berm just under the water surface. Limestone riprap in sizes from sand

Validation of the SEPHIS Program for the Modeling of the HM Process

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

Kyser, E.A.

The SEPHIS computer program is currently being used to evaluate the effect of all process variables on the criticality safety of the HM 1st Uranium Cycle process in H Canyon. The objective of its use has three main purposes. (1) To provide a better technical basis for those process variables that do not have any realistic effect on the criticality safety of the process. (2) To qualitatively study those conditions that have been previously recognized to affect the nuclear safety of the process or additional conditions that modeling has indicated may pose a criticality safety issue. (3) To judge themore » adequacy of existing or future neutron monitors locations in the detection of the initial stages of reflux for specific scenarios.Although SEPHIS generally over-predicts the distribution of uranium to the organic phase, it is a capable simulation tool as long as the user recognizes its biases and takes special care when using the program for scenarios where the prediction bias is non-conservative. The temperature coefficient used by SEPHIS is poor at predicting effect of temperature on uranium extraction for the 7.5 percent TBP used in the HM process. Therefore, SEPHIS should not be used to study temperature related scenarios. However, within normal operating temperatures when other process variables are being studied, it may be used. Care must be is given to understanding the prediction bias and its effect on any conclusion for the particular scenario that is under consideration. Uranium extraction with aluminum nitrate is over-predicted worse than for nitric acid systems. However, the extraction section of the 1A bank has sufficient excess capability that these errors, while relatively large, still allow SEPHIS to be used to develop reasonable qualitative assessments for reflux scenarios. However, high losses to the 1AW stream cannot be modeled by SEPHIS.« less

Flood hazard assessment for french NPPs

NASA Astrophysics Data System (ADS)

Rebour, Vincent; Duluc, Claire-Marie; Guimier, Laurent

2015-04-01

This paper presents the approach for flood hazard assessment for NPP which is on-going in France in the framework of post-Fukushima activities. These activities were initially defined considering both European "stress tests" of NPPs pursuant to the request of the European Council, and the French safety audit of civilian nuclear facilities in the light of the Fukushima Daiichi accident. The main actors in that process are the utility (EDF is, up to date, the unique NPP's operator in France), the regulatory authority (ASN) and its technical support organization (IRSN). This paper was prepared by IRSN, considering official positions of the other main actors in the current review process, it was not officially endorsed by them. In France, flood hazard to be considered for design basis definition (for new NPPs and for existing NPPs in periodic safety reviews conducted every 10 years) was revised before Fukushima-Daichi accident, due to le Blayais NPP December 1999 experience (partial site flooding and loss of some safety classified systems). The paper presents in the first part an overview of the revised guidance for design basis flood. In order to address design extension conditions (conditions that could result from natural events exceeding the design basis events), a set of flooding scenarios have been defined by adding margins on the scenarios that are considered for the design. Due to the diversity of phenomena to be considered for flooding hazard, the margin assessment is specific to each flooding scenario in terms of parameter to be penalized and of degree of variation of this parameter. The general approach to address design extension conditions is presented in the second part of the paper. The next parts present the approach for five flooding scenarios including design basis scenario and additional margin to define design extension scenarios.

The Official Control beyond the Official Control. How To Plan And Schedule Controls Starting From Risk Assessment Along The Agro-Food Supply Chain.

PubMed

Panunzio, M F; Caporizzi, R; Lagravinese, D; Conversano, M

2015-01-01

Every year the Italian Ministry of Health, on the basis of regional data, draws up the "Report on Official Controls" to be submitted to the Parliament. The report contains abundant data, diagrams and charts and illustrates the number and type of official controls (OC) performed by the pertinent Bodies (Ministry of Health, Regional and Local Health Authorities) over the previous year on Food Business Operators (FBO), in accordance with the EC Regulation 882/2004. The trend - which has consolidated over the years - relates to the multiplicity of OC and shows a decrease of such controls compared to an increase in "non-conformities". OC frequency is established by the Regional Authorities on the basis of the categorisation of both a "generic risk" for companies calculated taking into account the probability of occurrence of a "non-conformity", and a "specific" risk, assessed on the basis of the results of the OC actually performed on a given "Operatore del Settore Alimentare" (Food Sector Operator, in Italian: OSA). Thus, categorisation (i.e. the probability of occurrence of non-conformities) is the main driver of the OC scheduling and planning process. We have been asking ourselves whether the current OC planning/scheduling method is still suitable for ensuring food safety in the face of internalisation of the food supply chain. As a matter of fact, food safety is now becoming increasingly variable due to the globalization of consumption where "farm to fork", rather than "border to fork", food safety must be ensured. On the basis of these considerations, a different OC planning /scheduling method is being proposed based on the assessment of risks and the estimation of the occurrence of the same along the agro-food chain.

Improved truck safety at traffic signals (phase A).

DOT National Transportation Integrated Search

2008-01-01

This project is developing new traffic signal control logic to improve the safety of heavy vehicles on high speed approaches to signalized intersections using wireless communications between the heavy vehicle and the traffic signal controller. The pr...

Integrated vehicle-based safety systems : third annual report.

DOT National Transportation Integrated Search

2009-10-01

The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative : research program being conducted by an industry consortium led by the University of Michigan : Transportation Research Institute (UMTRI). The goal of ...

Integrated Vehicle-Based Safety Systems Third Annual Report

DOT National Transportation Integrated Search

2009-10-01

The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative research program being conducted by an industry consortium led by the University of Michigan Transportation Research Institute (UMTRI). The goal of the ...

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...

78 FR 18618 - National Offshore Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age, membership in an...

The emergency data set for the German Electronic Health Card--which benefits can be expected?

PubMed

Born, Judith; Albert, Jürgen; Butz, Norbert; Loos, Stefan; Schenkel, Johannes; Gipp, Christoph; Juhra, Christian

2015-01-01

In order to improve access to pre-existing patient information in case of emergency, the German Electronic Health Card (EHC) is supposed to hold emergency data. As a basis, the German Medical Association developed an emergency data set, which provides the possibility to store information on prior diagnoses, medications, allergies and other emergency-relevant information. One main objective of the study is to evaluate the usefulness of the emergency data in specific emergency situations. Within a two-phase exploratory study, a total of 64 paper-based emergency data sets were completed by primary care physicians, and then were evaluated by clinicians, emergency physicians, and paramedics. Clinicians, emergency physicians as well as paramedics rated the emergency data set in more than 70% of the reviewed cases as very useful or useful. The greatest benefit was attributed to the information on diagnoses and medication. The implementation of an emergency data on the EHC has the potential to improve safety, quality and efficiency of emergency care.

Dysregulation of Ion Homeostasis by Antifungal Agents

PubMed Central

Zhang, Yongqiang; Muend, Sabina; Rao, Rajini

2012-01-01

Ion-signaling and transduction networks are central to fungal development and virulence because they regulate gene expression, filamentation, host association, and invasion, pathogen stress response and survival. Dysregulation of ion homeostasis rapidly mediates cell death, forming the mechanistic basis by which a growing number of amphipathic but structurally unrelated compounds elicit antifungal activity. Included in this group is carvacrol, a terpenoid phenol that is a prominent component of oregano and other plant essential oils. Carvacrol triggers an early dose-dependent Ca2+ burst and long lasting pH changes in the model yeast Saccharomyces cerevisiae. The distinct phases of ionic transients and a robust transcriptional response that overlaps with Ca2+ stress and nutrient starvation point to specific signaling events elicited by plant terpenoid phenols, rather than a non-specific lesion of the membrane, as was previously considered. We discuss the potential use of plant essential oils and other agents that disrupt ion-signaling pathways as chemosensitizers to augment conventional antifungal therapy, and to convert fungistatic drugs with strong safety profiles into fungicides. PMID:22493595

Dysregulation of ion homeostasis by antifungal agents.

PubMed

Zhang, Yongqiang; Muend, Sabina; Rao, Rajini

2012-01-01

Ion-signaling and transduction networks are central to fungal development and virulence because they regulate gene expression, filamentation, host association, and invasion, pathogen stress response and survival. Dysregulation of ion homeostasis rapidly mediates cell death, forming the mechanistic basis by which a growing number of amphipathic but structurally unrelated compounds elicit antifungal activity. Included in this group is carvacrol, a terpenoid phenol that is a prominent component of oregano and other plant essential oils. Carvacrol triggers an early dose-dependent Ca(2+) burst and long lasting pH changes in the model yeast Saccharomyces cerevisiae. The distinct phases of ionic transients and a robust transcriptional response that overlaps with Ca(2+) stress and nutrient starvation point to specific signaling events elicited by plant terpenoid phenols, rather than a non-specific lesion of the membrane, as was previously considered. We discuss the potential use of plant essential oils and other agents that disrupt ion-signaling pathways as chemosensitizers to augment conventional antifungal therapy, and to convert fungistatic drugs with strong safety profiles into fungicides.

Single pilot IFR accident data analysis

NASA Technical Reports Server (NTRS)

Harris, D. F.; Morrisete, J. A.

1982-01-01

The aircraft accident data recorded and maintained by the National Transportation Safety Board for 1964 to 1979 were analyzed to determine what problems exist in the general aviation single pilot instrument flight rules environment. A previous study conducted in 1978 for the years 1964 to 1975 provided a basis for comparison. The purpose was to determine what changes, if any, have occurred in trends and cause-effect relationships reported in the earlier study. The increasing numbers have been tied to measures of activity to produce accident rates which in turn were analyzed in terms of change. Where anomalies or unusually high accident rates were encountered, further analysis was conducted to isolate pertinent patterns of cause factors and/or experience levels of involved pilots. The bulk of the effort addresses accidents in the landing phase of operations. A detailed analysis was performed on controlled/uncontrolled collisions and their unique attributes delineated. Estimates of day vs. night general aviation activity and accident rates were obtained.

Spent Nuclear Fuel (SNF) project Integrated Safety Management System phase I and II Verification Review Plan

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

CARTER, R.P.

1999-11-19

The U.S. Department of Energy (DOE) commits to accomplishing its mission safely. To ensure this objective is met, DOE issued DOE P 450.4, Safety Management System Policy, and incorporated safety management into the DOE Acquisition Regulations ([DEAR] 48 CFR 970.5204-2 and 90.5204-78). Integrated Safety Management (ISM) requires contractors to integrate safety into management and work practices at all levels so that missions are achieved while protecting the public, the worker, and the environment. The contractor is required to describe the Integrated Safety Management System (ISMS) to be used to implement the safety performance objective.

"Evidence" Under a Magnifying Glass: Thoughts on Safety Argument Epistemology

NASA Technical Reports Server (NTRS)

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

2015-01-01

Common definitions of "safety case" emphasize that evidence is the basis of a safety argument, yet few widely referenced works explicitly define "evidence". Their examples suggest that similar things can be regarded as evidence. But the category evidence seems to contain (1) processes for finding things out, (2) information resulting from such processes, and (3) relevant documents. Moreover, any item of evidence could be replaced by further argument. Normative models of informal argumentation do not offer clear guidance on when a safety argument should cite evidence rather than appeal to a more detailed argument. Disciplines such as the law address the problem with a practical, domain-specific epistemology. In this paper, we explore these problems associated with evidence citations in safety arguments, identify goals for a theory of safety argument evidence and a practical safety argument epistemology, propose a model of safety evidence citation that advances the identified goals, and present a related extension to the Goal Structuring Notation (GSN).

Structural Deterministic Safety Factors Selection Criteria and Verification

NASA Technical Reports Server (NTRS)

Verderaime, V.

1992-01-01

Though current deterministic safety factors are arbitrarily and unaccountably specified, its ratio is rooted in resistive and applied stress probability distributions. This study approached the deterministic method from a probabilistic concept leading to a more systematic and coherent philosophy and criterion for designing more uniform and reliable high-performance structures. The deterministic method was noted to consist of three safety factors: a standard deviation multiplier of the applied stress distribution; a K-factor for the A- or B-basis material ultimate stress; and the conventional safety factor to ensure that the applied stress does not operate in the inelastic zone of metallic materials. The conventional safety factor is specifically defined as the ratio of ultimate-to-yield stresses. A deterministic safety index of the combined safety factors was derived from which the corresponding reliability proved the deterministic method is not reliability sensitive. The bases for selecting safety factors are presented and verification requirements are discussed. The suggested deterministic approach is applicable to all NASA, DOD, and commercial high-performance structures under static stresses.

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

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

2007-01-01

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

Safety planning in focus groups of Malawian women living with HIV: helping each other deal with violence and abuse.

PubMed

Mkandawire-Valhmu, Lucy; Stevens, Patricia E; Kako, Peninnah M; Dressel, Anne

2013-11-01

In this critical ethnography, 72 HIV-infected women in Southern Malawi participated in 12 focus groups discussing the impact of HIV and violence. Our analysis, informed by a postcolonial feminist perspective, revealed women's capacity to collectively engage in safety planning. We present our findings about women's experiences based on narratives detailing how women collectively strategized safety planning efforts to mitigate the impact of violence. This study helps to fill a gap in the literature on the intersection between HIV and violence in women's lives. Strategies discussed by the women could form a basis for safety planning interventions for women in similar circumstances.

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

NASA Technical Reports Server (NTRS)

1972-01-01

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

Validation of an Integrated Hydrogen Energy Station

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

Heydorn, Edward C

This report presents the results of a 10-year project conducted by Air Products and Chemicals, Inc. (Air Products) to determine the feasibility of coproducing hydrogen with electricity. The primary objective was to demonstrate the technical and economic viability of a hydrogen energy station using a high-temperature fuel cell designed to produce power and hydrogen. This four-phase project had intermediate go/no-go decisions and the following specific goals: Complete a technical assessment and economic analysis of the use of high-temperature fuel cells, including solid oxide and molten carbonate, for the co-production of power and hydrogen (energy park concept). Build on the experiencemore » gained at the Las Vegas H2 Energy Station and compare/contrast the two approaches for co-production. Determine the applicability of co-production from a high-temperature fuel cell for the existing merchant hydrogen market and for the emerging hydrogen economy. Demonstrate the concept on natural gas for six months at a suitable site with demand for both hydrogen and electricity. Maintain safety as the top priority in the system design and operation. Obtain adequate operational data to provide the basis for future commercial activities, including hydrogen fueling stations. Work began with the execution of the cooperative agreement with DOE on 30 September 2001. During Phase 1, Air Products identified high-temperature fuel cells as having the potential to meet the coproduction targets, and the molten carbonate fuel cell system from FuelCell Energy, Inc. (FuelCell Energy) was selected by Air Products and DOE following the feasibility assessment performed during Phase 2. Detailed design, construction and shop validation testing of a system to produce 250 kW of electricity and 100 kilograms per day of hydrogen, along with site selection to include a renewable feedstock for the fuel cell, were completed in Phase 3. The system also completed six months of demonstration operation at the wastewater treatment facility operated by Orange County Sanitation District (OCSD, Fountain Valley, CA). As part of achieving the objective of operating on a renewable feedstock, Air Products secured additional funding via an award from the California Air Resources Board. The South Coast Air Quality Management District also provided cost share which supported the objectives of this project. System operation at OCSD confirmed the results from shop validation testing performed during Phase 3. Hydrogen was produced at rates and purity that met the targets from the system design basis, and coproduction efficiency exceeded the 50% target set in conjunction with input from the DOE. Hydrogen production economics, updated from the Phase 2 analysis, showed pricing of $5 to $6 per kilogram of hydrogen using current gas purification systems. Hydrogen costs under $3 per kilogram are achievable if next-generation electrochemical separation technologies become available.« less

Transactions of the Twenty-First Water Reactor Safety Information Meeting

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

Monteleone, S.

1993-10-01

This report contains summaries of papers on reactor safety research to be presented at the 21st Water Reactor Safety Information Meeting at the Bethesda Marriott Hotel, Bethesda, Maryland, October 25--27, 1993. The summaries briefly describe the programs and results of nuclear safety research sponsored by the Office of Nuclear Regulatory Research, US NRC. Summaries of invited papers concerning nuclear safety issues from US government laboratories, the electric utilities, the Electric Power Research Institute (EPRI), the nuclear industry, and from foreign governments and industry are also included. The summaries have been compiled in one report to provide a basis for meaningfulmore » discussion and information exchange during the course of the meeting and are given in the order of their presentation in each session.« less

Evaluating the Safety of New Vaccines: Summary of a Workshop

PubMed Central

Ellenberg, Susan S.; Foulkes, Mary A.; Midthun, Karen; Goldenthal, Karen L.

2005-01-01

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions. PMID:15855455