Sample records for safety evaluation conducted

  1. Evaluating pedestrian safety improvements : final report.

    DOT National Transportation Integrated Search

    2012-12-01

    The purpose of the study was to evaluate the impact of new pedestrian countermeasure installations on pedestrian safety to assist in informing future pedestrian safety initiatives. In order to address these objectives, the WMU team conducted a litera...

  2. 49 CFR 385.313 - Who will conduct the safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.313 Who will conduct the safety audit? An individual certified under the FMCSA regulations to perform safety audits will conduct the safety audit. ... 49 Transportation 5 2010-10-01 2010-10-01 false Who will conduct the safety audit? 385.313 Section...

  3. 77 FR 72435 - Pipeline Safety: Using Meaningful Metrics in Conducting Integrity Management Program Evaluations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Evaluations AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice... improve performance. For gas transmission pipelines, Sec. Sec. 192.911(i) and 192.945 define the...

  4. 49 CFR 385.315 - Where will the safety audit be conducted?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.315 Where will the safety audit be conducted? The safety audit will generally be conducted at the new entrant's business premises. ... 49 Transportation 5 2010-10-01 2010-10-01 false Where will the safety audit be conducted? 385.315...

  5. A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

    PubMed

    Kim, Seung Won; Kim, Bae-Hwan

    2016-07-01

    Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

  6. Criticality Safety Evaluation for the TACS at DAF

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

    Percher, C. M.; Heinrichs, D. P.

    2011-06-10

    Hands-on experimental training in the physical behavior of multiplying systems is one of ten key areas of training required for practitioners to become qualified in the discipline of criticality safety as identified in DOE-STD-1135-99, Guidance for Nuclear Criticality Safety Engineer Training and Qualification. This document is a criticality safety evaluation of the training activities and operations associated with HS-3201-P, Nuclear Criticality 4-Day Training Course (Practical). This course was designed to also address the training needs of nuclear criticality safety professionals under the auspices of the NNSA Nuclear Criticality Safety Program1. The hands-on, or laboratory, portion of the course will utilizemore » the Training Assembly for Criticality Safety (TACS) and will be conducted in the Device Assembly Facility (DAF) at the Nevada Nuclear Security Site (NNSS). The training activities will be conducted by Lawrence Livermore National Laboratory following the requirements of an Integrated Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of an LLNL Certified Fissile Material Handler.« less

  7. A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

    PubMed Central

    Kim, Seung Won; Kim, Bae-Hwan

    2016-01-01

    Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials. PMID:27437094

  8. Safety halls--an evaluation.

    PubMed

    Nyberg, Anders; Gregersen, Nils Petter; Nolén, Sixten; Engström, Inger

    2005-01-01

    In most countries, drivers licensing systems usually include teaching some aspects of using safety equipment (e.g., airbags and seat belts). However, there is now evidence worldwide that such education is inadequate, as indicated by, for example, the overrepresentation of young drivers who do not use seat belts. A randomized controlled study was conducted in Sweden to evaluate the effects of visiting a facility known as a "safety hall" in combination with the mandatory skid training. The results were assessed to determine the effects of the knowledge and attitudes of learner drivers in the following subjects: airbags, securing loads, seat belts, sitting posture, speed, and tires. An experimental group and a control group comprising 658 and 668 learners, respectively, answered identical questionnaires on three different occasions (pretest, posttest 1, and posttest 2). The results show that, for most of the topics considered, knowledge and attitudes in both groups were better at posttest 2 than at the pretest, and in general, the best knowledge and attitudes were found in the experimental group. The combined safety/skid training seems to have had the greatest effect on seat belts and loads. The findings also indicate that the safety halls can be further improved to achieve an even better effect. The use of safety halls has improved the knowledge and attitudes of learner drivers concerning several important areas related to traffic safety. Since knowledge and attitudes are important predictors of behavior, implementing safety halls can be expected to lead to improvements, especially regarding the use of safety belts and securing loads.

  9. Risk analysis based CWR track buckling safety evaluations

    DOT National Transportation Integrated Search

    2001-01-01

    As part of the Federal Railroad Administrations (FRA) track systems research program, the US DOTS Volpe Center is conducting analytic and experimental investigations to evaluate track lateral strength and stability limits for improved safety an...

  10. Risk analysis based CWR track buckling safety evaluations

    DOT National Transportation Integrated Search

    1999-12-01

    As part of the Federal Railroad Administration's (FRA) track systems research program, the US DOT'S Volpe Center is conducting analytic and experimental investigations to evaluate track lateral strength and stability limits for improved safety and pe...

  11. 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

  12. Compendium of research and evaluations in traffic safety published

    DOT National Transportation Integrated Search

    1996-05-01

    The National Highway Traffic Safety Administration's (NHTSA's) Office of Program Development and Evaluation (OPDE) conducts research projects that investigate human attitudes, behaviors, and failures as they relate to motor vehicle crashes. OPDE focu...

  13. Evaluating the effectiveness of active vehicle safety systems.

    PubMed

    Jeong, Eunbi; Oh, Cheol

    2017-03-01

    Advanced vehicle safety systems have been widely introduced in transportation systems and are expected to enhance traffic safety. However, these technologies mainly focus on assisting individual vehicles that are equipped with them, and less effort has been made to identify the effect of vehicular technologies on the traffic stream. This study proposed a methodology to assess the effectiveness of active vehicle safety systems (AVSSs), which represent a promising technology to prevent traffic crashes and mitigate injury severity. The proposed AVSS consists of longitudinal and lateral vehicle control systems, which corresponds to the Level 2 vehicle automation presented by the National Highway Safety Administration (NHTSA). The effectiveness evaluation for the proposed technology was conducted in terms of crash potential reduction and congestion mitigation. A microscopic traffic simulator, VISSIM, was used to simulate freeway traffic stream and collect vehicle-maneuvering data. In addition, an external application program interface, VISSIM's COM-interface, was used to implement the AVSS. A surrogate safety assessment model (SSAM) was used to derive indirect safety measures to evaluate the effectiveness of the AVSS. A 16.7-km freeway stretch between the Nakdong and Seonsan interchanges on Korean freeway 45 was selected for the simulation experiments to evaluate the effectiveness of AVSS. A total of five simulation runs for each evaluation scenario were conducted. For the non-incident conditions, the rear-end and lane-change conflicts were reduced by 78.8% and 17.3%, respectively, under the level of service (LOS) D traffic conditions. In addition, the average delay was reduced by 55.5%. However, the system's effectiveness was weakened in the LOS A-C categories. Under incident traffic conditions, the number of rear-end conflicts was reduced by approximately 9.7%. Vehicle delays were reduced by approximately 43.9% with 100% of market penetration rate (MPR). These results

  14. An evaluation of two conducted electrical weapons and two probe designs using a swine comparative cardiac safety model.

    PubMed

    Dawes, Donald Murray; Ho, Jeffrey D; Moore, Johanna C; Miner, James R

    2013-09-01

    Despite human laboratory and field studies that have demonstrated a reasonable safety profile for TASER brand conducted electrical weapons (CEW), the results of some swine studies and arrest related deaths temporal to the use of the CEWs continue to raise questions regarding cardiac safety. TASER International, Inc., has released a new CEW, the TASER X2, touted to have a better safety profile than its long-standing predecessor, the TASER X26. We have developed a model to assess the relative cardiac safety of CEWs and used it to compare the TASER X2 and the TASER X26. This safety model was also used to assess the relative safety of an experimental probe design as compared to the standard steel probe. Our results suggest that the TASER X2 has an improved safety margin over the TASER X26. The new probe design also has promise for enhanced cardiac safety, although may have some disadvantages when compared to the existing design which would make field use impractical.

  15. Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.

    PubMed

    Antman, Elliott M

    2017-05-23

    Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The choices made by investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of cardiovascular safety can influence the ability to compare the standard and test agents. Multiple factors reflecting the conduct of a phase 4 RCT for a general medical condition may influence interpretation of a cardiovascular safety signal. The higher the rates of failure to adhere to the protocol and dropout from the study, the greater the risk of bias. Trials evaluating the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) when used for arthritis are difficult to conduct and even more challenging to interpret. Concerns include the comparison of drug regimens that do not provide comparable analgesic efficacy and problems with adherence to the protocol and retention in the study. On the basis of phase 4 RCTs of NSAIDs to date, it appears that a comparatively low dose of celecoxib administered to low-risk subjects is associated with approximately the same cardiovascular risk as NSAIDs with less cyclooxygenase-2 inhibitory activity, but at the cost of not controlling arthritic pain as effectively. © 2017 American Heart Association, Inc.

  16. Health hazard evaluation report HETA 98-0152-2729, Wolfeboro Public Safety Building, Wolfeboro, New Hampshire

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

    Sylvain, D.; Echt, A.

    On March 17, 1998, the National Institute for Occupational Safety and Health (NIOSH) received a Health Hazard Evaluation request (HHE) from the New Hampshire Department of Labor to conduct an evaluation of diesel exhaust exposure at the Wolfeboro Public Safety Building, in Wolfeboro, New Hampshire. The request indicated that Fire and Police personnel were exposed to diesel exhaust from fire apparatus. Asthmatic bronchitis was listed as a health problem resulting from this exposure. On June 23, 1998, NIOSH investigators, accompanied by an industrial hygienist from the New Hampshire Bureau of Health Risk Assessment, conducted an industrial hygiene evaluation at themore » Wolfeboro Public Safety Building.« less

  17. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  18. Safety climate and attitude as evaluation measures of organizational safety.

    PubMed

    Isla Díaz, R; Díaz Cabrera, D

    1997-09-01

    The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

  19. 21 CFR 315.6 - Evaluation of safety.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...

  20. Survey forms for conducting alcohol highway safety surveys.

    DOT National Transportation Integrated Search

    1985-05-01

    Five Alcohol Highway Safety Survey Questionnaires are provided in this : report. The questionnaires are available for use by State and local : jurisdictions interested in assessing and/or evaluating anti-drinking-driving : activities through surveys ...

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

    PubMed

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

    2009-10-01

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

  2. Evaluation of protein safety in the context of agricultural biotechnology.

    PubMed

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

    2008-05-01

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

  3. 16 CFR 1028.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Evaluation and disposition of applications... Section 1028.120 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.120 Evaluation and disposition of applications and proposals for research to be conducted...

  4. 21 CFR 315.6 - Evaluation of safety.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... information, the following types of data: (i) Pharmacology data, (ii) Toxicology data, (iii) Clinical adverse... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...

  5. Teaching Safety Skills to Children to Prevent Gun Play: An Evaluation of in Situ Training

    ERIC Educational Resources Information Center

    Miltenberger, Raymond G.; Gatheridge, Brian J.; Satterlund, Melisa; Egemo-Helm, Kristin R.; Johnson, Brigitte M.; Jostad, Candice; Kelso, Pamela; Flessner, Christopher A.

    2005-01-01

    This study evaluated behavioral skills training with added in situ training for teaching safety skills to prevent gun play. Following baseline, each child received two sessions of behavioral skills training and one in situ training session. Additional in situ training sessions were conducted until the child exhibited the safety skills (don't touch…

  6. Economic evaluation of occupational health and safety programmes in health care.

    PubMed

    Guzman, J; Tompa, E; Koehoorn, M; de Boer, H; Macdonald, S; Alamgir, H

    2015-10-01

    Evidence-based resource allocation in the public health care sector requires reliable economic evaluations that are different from those needed in the commercial sector. To describe a framework for conducting economic evaluations of occupational health and safety (OHS) programmes in health care developed with sector stakeholders. To define key resources and outcomes to be considered in economic evaluations of OHS programmes and to integrate these into a comprehensive framework. Participatory action research supported by mixed qualitative and quantitative methods, including a multi-stakeholder working group, 25 key informant interviews, a 41-member Delphi panel and structured nominal group discussions. We found three resources had top priority: OHS staff time, training the workers and programme planning, promotion and evaluation. Similarly, five outcomes had top priority: number of injuries, safety climate, job satisfaction, quality of care and work days lost. The resulting framework was built around seven principles of good practice that stakeholders can use to assist them in conducting economic evaluations of OHS programmes. Use of a framework resulting from this participatory action research approach may increase the quality of economic evaluations of OHS programmes and facilitate programme comparisons for evidence-based resource allocation decisions. The principles may be applicable to other service sectors funded from general taxes and more broadly to economic evaluations of OHS programmes in general. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. Embedding technology into inter-professional best practices in home safety evaluation.

    PubMed

    Burns, Suzanne Perea; Pickens, Noralyn Davel

    2017-08-01

    To explore inter-professional home evaluators' perspectives and needs for building useful and acceptable decision-support tools for the field of home modifications. Twenty semi-structured interviews were conducted with a range of home modification professionals from different regions of the United States. The interview transcripts were analyzed with a qualitative, descriptive, perspective approach. Technology supports current best practice and has potential to inform decision making through features that could enhance home evaluation processes, quality, efficiency and inter-professional communication. Technological advances with app design have created numerous opportunities for the field of home modifications. Integrating technology and inter-professional best practices will improve home safety evaluation and intervention development to meet client-centred and societal needs. Implications for rehabilitation Understanding home evaluators technology needs for home safety evaluations contributes to the development of app-based assessments. Integrating inter-professional perspectives of best practice and technological needs in an app for home assessments improves processes. Novice and expert home evaluators would benefit from decision support systems embedded in app-based assessments. Adoption of app-based assessment would improve efficiency while remaining client-centred.

  8. Manned space flight nuclear system safety. Volume 7: Literature review. Part 1: Literature search and evaluation

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A review of the literature used in conducting the manned space flight nuclear system safety study is presented. The objectives of the presentation are to identify and evaluate for potential application to study the existing related literature and to provide the information required to include the related literature in the NASA Aerospace Safety Research and Data Institute. More than 15,000 documents were evaluated and identification forms were prepared for 850 reports.

  9. Criticality Safety Evaluation of Standard Criticality Safety Requirements #1-520 g Operations in PF-4

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

    Yamanaka, Alan Joseph Jr.

    Guidance has been requested from the Nuclear Criticality Safety Division (NCSD) regarding processes that involve 520 grams of fissionable material or less. This Level-3 evaluation was conducted and documented in accordance with NCS-AP-004 (Ref. 1), formerly NCS-GUIDE-01. This evaluation is being written as a generic evaluation for all operations that will be able to operate using a 520-gram mass limit. Implementation for specific operations will be performed using a Level 1 CSED, which will confirm and document that this CSED can be used for the specific operation as discussed in NCS-MEMO-17-007 (Ref. 2). This Level 3 CSED updates and supersedesmore » the analysis performed in NCS-TECH-14-014 (Ref. 3).« less

  10. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation.

    PubMed

    Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; van Gurp, Petra J; Wollersheim, Hub

    2013-06-22

    Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient

  11. Safety evaluation of wet reflective pavement markers.

    DOT National Transportation Integrated Search

    2015-09-01

    The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety : strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the : application of wet-reflecti...

  12. Evaluation of On-Farm Food Safety Programming in Pennsylvania: Implications for Extension

    ERIC Educational Resources Information Center

    Nayak, Roshan; Tobin, Daniel; Thomson, Joan; Radhakrishna, Rama; LaBorde, Luke

    2015-01-01

    Penn State Extension conducted on-farm food safety workshops statewide to train fruit and vegetable growers on Good Agricultural Practices (GAPs). These workshops were evaluated using pre- and post-tests to assess the impact of the training on participating growers. Results indicate overall increases in produce growers' knowledge, attitudes,…

  13. Safety evaluation of wet-reflective pavement markings.

    DOT National Transportation Integrated Search

    2015-09-01

    The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the application of wet-reflective p...

  14. Safety evaluation of intersection conflict warning system.

    DOT National Transportation Integrated Search

    2016-06-01

    FHWA organized a pooled fund study of 40 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was intersection conflict warning systems (ICWSs). This strategy is i...

  15. Safety evaluation of STOP AHEAD pavement markings

    DOT National Transportation Integrated Search

    2007-12-01

    The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP AHEAD pav...

  16. Safety evaluation of STOP AHEAD pavement markings

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP AHEAD pav...

  17. 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.

  18. Safety evaluation of advance street name signs

    DOT National Transportation Integrated Search

    2009-06-01

    The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The objective of the pooled fund study was to estimate the safety effectivenes...

  19. HSIS Summary Report: Safety Evaluation of Rolled-in Continuous Shoulder Rumble Strips Installed on Freeways

    DOT National Transportation Integrated Search

    1999-12-01

    This study conducted before and after safety evaluations of projects involving the installation of rolled-in continuous shoulder rumble strips (CSRS) on rural and urban freeways. During resurfacing and shoulder rehabilitation projects, rolled-in CSRS...

  20. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

    PubMed Central

    2013-01-01

    Background Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Methods and design Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. Discussion We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to

  1. Evaluation of the patient safety Leadership Walkabout programme of a hospital in Singapore.

    PubMed

    Lim, Raymond Boon Tar; Ng, Benjamin Boon Lui; Ng, Kok Mun

    2014-02-01

    The Patient Safety Leadership Walkabout (PSLWA) programme is a commonly employed tool in the West, in which senior leaders visit sites within the hospital that are involved in patient care to talk to healthcare staff about patient safety issues. As there is a lack of perspective regarding PSLWA in Asia, we carried out an evaluation of its effectiveness in improving the patient safety culture in Tan Tock Seng Hospital, Singapore. A mixed methods analysis approach was used to review and evaluate all documents, protocols, meeting minutes, post-walkabout surveys, action plans and verbal feedback pertaining to the walkabouts conducted from January 2005 to October 2012. A total of 321 patient safety issues were identified during the study period. Of these, 308 (96.0%) issues were resolved as of November 2012. Among the various categories of issues raised, issues related to work environment were the most common (45.2%). Of all the issues raised during the walkabouts, 72.9% were not identified through other conventional methods of error detection. With respect to the hospital's patient safety culture, 94.8% of the participants reported an increased awareness in patient safety and 90.2% expressed comfort in openly and honestly discussing patient safety issues. PSLWA serves as a good tool to uncover latent errors before actual harm reaches the patient. If properly implemented, it is an effective method for engaging leadership, identifying patient safety issues, and supporting a culture of patient safety in the hospital setting.

  2. Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

    PubMed

    Saito, Masami; Iwasaki, Kiyotaka

    2017-03-01

    Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

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

    PubMed

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

    2013-12-01

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

  4. Effectiveness of health and safety in small enterprises: a systematic review of quantitative evaluations of interventions.

    PubMed

    Breslin, F Curtis; Kyle, Natasha; Bigelow, Philip; Irvin, Emma; Morassaei, Sara; MacEachen, Ellen; Mahood, Quenby; Couban, Rachel; Shannon, Harry; Amick, Benjamin C

    2010-06-01

    This systematic review was conducted to identify effective occupational health and safety interventions for small businesses. The review focused on peer-reviewed intervention studies conducted in small businesses with 100 or fewer employees, that were published in English and several other languages, and that were not limited by publication date. Multidisciplinary members of the review team identified relevant articles and assessed their quality. Studies assessed as medium or high quality had data extracted, which was then synthesized. Five studies were deemed of medium or high quality, and proceeded to data extraction and evidence synthesis. The types of interventions identified: a combination of training and safety audits; and a combination of engineering, training, safety audits, and a motivational component, showed a limited amount of evidence in improving safety outcomes. Overall, this evidence synthesis found a moderate level of evidence for intervention effectiveness, and found no evidence that any intervention had adverse effects. Even though there were few studies that adequately evaluated small business intervention, several studies demonstrate that well-designed evaluations are possible with small businesses. While stronger levels of evidence are required to make recommendations, these interventions noted above were associated with positive changes in safety-related attitudes and beliefs and workplace parties should be aware of them.

  5. Drug safety evaluation of defibrotide.

    PubMed

    Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

    2013-01-01

    Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

  6. Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

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

    Sygitowicz, L S

    2008-03-20

    A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiationmore » Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a

  7. Safety evaluation of centerline plus shoulder rumble strips.

    DOT National Transportation Integrated Search

    2015-06-01

    The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the combined application of centerl...

  8. Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

    PubMed

    Benjamin, Amanda; Gallacher, David J; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Kasai, Cheiko; Ledieu, David; Levesque, Paul; Prelle, Katja; Ratcliffe, Sian; Sannajust, Frederick; Valentin, Jean-Pierre

    2015-01-01

    With the recent development of more sensitive biomarkers to assess kidney injury preclinically, a survey was designed i) to investigate what strategies are used to investigate renal toxicity in both ICH S7A compliant Safety Pharmacology (SP) studies after a single dose of a compound and within repeat-dose toxicity studies by large pharmaceutical companies today; ii) to understand whether renal SP studies have impact or utility in drug development and/or if it may be more appropriate to assess renal effects after multiple doses of compounds; iii) to ascertain how much mechanistic work is performed by the top 15 largest pharmaceutical companies (as determined by R&D revenue size); iv) to gain an insight into the impact of the validation of DIKI biomarkers and their introduction in the safety evaluation paradigm; and v) to understand the impact of renal/urinary safety study data on progression of projects. Two short anonymous surveys were submitted to SP leaders of the top 15 pharmaceutical companies, as defined by 2012 R&D portfolio size. Fourteen multiple choice questions were designed to explore the strategies used to investigate renal effects in both ICH S7A compliant SP studies and within toxicology studies. A 67% and 60% response rate was obtained in the first and second surveys, respectively. Nine out of ten respondent companies conduct renal excretory measurements (eg. urine analysis) in toxicology studies whereas only five out of ten conduct specific renal SP studies; and all of those 5 also conduct the renal excretory measurements in toxicology studies. These companies measure and/or calculate a variety of parameters as part of these studies, and also on a case by case basis include regulatory qualified and non-qualified DIKI biomarkers. Finally, only one company has used renal/urinary functional data alone to stop a project, whereas the majority of respondents combine renal data with other target organ assessments to form an integrated decision-making set

  9. 49 CFR 242.111 - Prior safety conduct as motor vehicle operator.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Prior safety conduct as motor vehicle operator. 242.111 Section 242.111 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION QUALIFICATION AND CERTIFICATION OF CONDUCTORS Program and Eligibility Requirements § 242.111...

  10. Travtek Evaluation Safety Study

    DOT National Transportation Integrated Search

    1996-02-01

    One of the major evaluation goals of the TravTek operational test was to assess the safety impact of the TravTek system as implemented in Orlando, Florida during the 1 -year deployment phase. Also, the results of the TravTek operational test, with re...

  11. Safety evaluation of increasing retroreflectivity of STOP signs

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP signs wit...

  12. 78 FR 69603 - Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... No. FDA-2011-N-0146] RIN 0910-AG66 Accreditation of Third-Party Auditors/Certification Bodies To... entitled ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to... proposed rule entitled ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety...

  13. Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

    ERIC Educational Resources Information Center

    Bresler, B.; And Others

    This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

  14. The Evaluation of the Safety Benefits of Combined Passive and On-Board Active Safety Applications

    PubMed Central

    Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

    2009-01-01

    One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006–2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectivenessof the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries. PMID:20184838

  15. Safety evaluation of increasing retroreflectivity of STOP signs

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized 26 States : to participate in the FHWA Low-Cost Safety Improvements Pooled : Fund Study to evaluate low-cost safety strategies as part of its : strategic highway safety plan support effort. The purp...

  16. Statistical issues in the design, conduct and analysis of two large safety studies.

    PubMed

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  17. The role of quantitative safety evaluation in regulatory decision making of drugs.

    PubMed

    Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat

    2016-01-01

    Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

  18. Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

    PubMed

    Islam, Md Tazul; El-Basyouny, Karim

    2015-07-01

    Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. New conducted electrical weapons: Electrical safety relative to relevant standards.

    PubMed

    Panescu, Dorin; Nerheim, Max; Kroll, Mark W; Brave, Michael A

    2017-07-01

    We have previously published about TASER ® conducted electrical weapons (CEW) compliance with international standards. CEWs deliver electrical pulses that can inhibit a person's neuromuscular control or temporarily incapacitate. An eXperimental Rotating-Field (XRF) waveform CEW and the X2 CEW are new 2-shot electrical weapon models designed to target a precise amount of delivered charge per pulse. They both can deploy 1 or 2 dart pairs, delivered by 2 separate cartridges. Additionally, the XRF controls delivery of incapacitating pulses over 4 field vectors, in a rotating sequence. As in our previous study, we were motivated by the need to understand the cardiac safety profile of these new CEWs. The goal of this paper is to analyze the nominal electrical outputs of TASER XRF and X2 CEWs in reference to provisions of all relevant international standards that specify safety requirements for electrical medical devices and electrical fences. Although these standards do not specifically mention CEWs, they are the closest electrical safety standards and hence give very relevant guidance. The outputs of several TASER XRF and X2 CEWs were measured under normal operating conditions. The measurements were compared against manufacturer specifications. CEWs electrical output parameters were reviewed against relevant safety requirements of UL 69, IEC 60335-2-76 Ed 2.1, IEC 60479-1, IEC 60479-2, AS/NZS 60479.1, AS/NZS 60479.2, IEC 60601-1 and BS EN 60601-1. Our study confirmed that the nominal electrical outputs of TASER XRF and X2 CEWs lie within safety bounds specified by relevant standards.

  20. Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations.

    PubMed

    Anderson, Jocelyn C; Glass, Nancy E; Campbell, Jacquelyn C

    Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence. The protocol presents the technological strategies to promote safety and allow autonomy in participant decision-making throughout the research process, including Voice over Internet Protocol telephone numbers, and tablet-based eligibility screening and data collection. Protocols for management of participants at risk for suicide and/or intimate partner homicide that included automated high-risk messaging to participants and research staff and facilitated disclosure of risk to clinical staff based on participant preferences are discussed. Use of technology and partnership with clinic staff helped to provide an environment where research regarding IPV could be conducted without undue burden or risk to participants. Utilizing tablet-based survey administration provided multiple practical and safety benefits for participants. Most women who screened into high-risk categories for suicide or intimate partner homicide did not choose to have their results shared with their healthcare providers, indicating the importance of allowing participants control over information sharing whenever possible.

  1. 30 CFR 285.800 - How must I conduct my activities to comply with safety and environmental requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... safety and environmental requirements? 285.800 Section 285.800 Mineral Resources MINERALS MANAGEMENT... OUTER CONTINENTAL SHELF Environmental and Safety Management, Inspections, and Facility Assessments for... safety and environmental requirements? (a) You must conduct all activities on your lease or grant under...

  2. Program evaluation of FHWA pedestrian and bicycle safety activities.

    DOT National Transportation Integrated Search

    2011-03-01

    "Introduction : FHWAs Office of Highway Safety (HSA) initiated a program evaluation by Booz Allen Hamilton to assess the overall effectiveness of the Agencys Pedestrian and Bicycle Safety Program. The evaluation covers pedestrian and bicycle sa...

  3. Restaurant supervisor safety training: evaluating a small business training intervention.

    PubMed

    Bush, Diane; Paleo, Lyn; Baker, Robin; Dewey, Robin; Toktogonova, Nurgul; Cornelio, Deogracia

    2009-01-01

    We developed and assessed a program designed to help small business owners/managers conduct short training sessions with their employees, involve employees in identifying and addressing workplace hazards, and make workplace changes (including physical and work practice changes) to improve workplace safety. During 2006, in partnership with a major workers' compensation insurance carrier and a restaurant trade association, university-based trainers conducted workshops for more than 200 restaurant and food service owners/managers. Workshop participants completed posttests to assess their knowledge, attitudes, and intentions to implement health and safety changes. On-site follow-up interviews with 10 participants were conducted three to six months after the training to assess the extent to which program components were used and worksite changes were made. Post-training assessments demonstrated that attendees increased their understanding and commitment to health and safety, and felt prepared to provide health and safety training to their employees. Follow-up interviews indicated that participants incorporated core program concepts into their training and supervision practices. Participants conducted training, discussed workplace hazards and solutions with employees, and made changes in the workplace and work practices to improve workers' health and safety. This program demonstrated that owners of small businesses can adopt a philosophy of employee involvement in their health and safety programs if provided with simple, easy-to-use materials and a training demonstration. Attending a workshop where they can interact with other owners/ managers of small restaurants was also a key to the program's success.

  4. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. 25 CFR 1000.355 - How are trust evaluations conducted?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false How are trust evaluations conducted? 1000.355 Section... EDUCATION ACT Trust Evaluation Review Annual Trust Evaluations § 1000.355 How are trust evaluations conducted? (a) Each year the Secretary's designated representative(s) will conduct trust evaluations for...

  6. Safety evaluation of flashing beacons at STOP-controlled intersections

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was flashing beaco...

  7. Safety evaluation of wet-reflective pavement markings : tech brief.

    DOT National Transportation Integrated Search

    2015-12-01

    The Federal Highway Administration (FHWA) organized : 38 States for the FHWA Evaluation of Low-Cost Safety : Improvements Pooled Fund Study as part of its strategic : highway safety plan support effort. The purpose of the : study is to evaluate the s...

  8. Safety evaluation of offset improvements for left-turn lanes

    DOT National Transportation Integrated Search

    2009-06-01

    The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was offset improve...

  9. Federal Motor Carrier Safety Administration’s Advanced System Testing Utilizing a Data Acquisition System on the Highways (FAST DASH) Safety Technology Evaluation Project #2: Driver Monitoring Final Report.

    DOT National Transportation Integrated Search

    2016-12-01

    An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

  10. Federal Motor Carrier Safety Administration’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #2 : driver monitoring, final report.

    DOT National Transportation Integrated Search

    2016-11-01

    An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

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

    PubMed

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

    2010-12-01

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

  12. Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

    PubMed

    Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

    2016-01-01

    To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

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

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  14. Evaluating a smartphone application to improve child passenger safety and fire safety knowledge and behaviour.

    PubMed

    Omaki, Elise; Shields, Wendy C; McDonald, Eileen; Aitken, Mary E; Bishai, David; Case, James; Gielen, Andrea

    2017-02-01

    Although proven measures for reducing injury due to motor vehicle collision and residential fires exist, the number of families properly and consistently using child passenger restraints and smoke alarms remains low. This paper describes the design of the Safety In Seconds (SIS) 2.0 study, which aims to evaluate the impact of a smartphone app on parents' use of child restraints and smoke alarms. SIS is a multisite randomised controlled trial. Participants are parents of children aged 4-7 years who are visiting the Pediatric Emergency Department or Pediatric Trauma Service. Parents are randomised to receive tailored education about child passenger safety or about fire safety via the SIS smartphone app. A baseline and two follow-up surveys at 3 months and 6 months are conducted. Primary outcomes are: (1) having the correct child restraint for the child's age and size; (2) restraining the child in the back seat of the car; (3) buckling the child up for every ride; (4) having the restraint inspected by a child passenger safety technician; (5) having a working smoke alarm on every level of the home; (6) having hard-wired or lithium battery smoke alarms; (7) having and (8) practising a fire escape plan. Finding ways to communicate with parents about child passenger and fire safety continues to be a research priority. This study will contribute to the evidence about how to promote benefits of proper and consistent child restraint and smoke alarm use. NCT02345941; Pre-results. 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/.

  15. Economic Evaluation of Occupational Safety and Health Interventions From the Employer Perspective

    PubMed Central

    Grimani, Aikaterini; Bergström, Gunnar; Casallas, Martha Isabel Riaño; Aboagye, Emmanuel; Jensen, Irene; Lohela-Karlsson, Malin

    2018-01-01

    Objectives: The aim of this systematic review was to evaluate the cost-effectiveness of occupational safety and health interventions from the employer perspective. Methods: A comprehensive literature search (2005 to 2016) in five electronic databases was conducted. Pre-2005 studies were identified from the reference lists of previous studies and systematic reviews, which have similar objective to those of this search. Results: A total of 19 randomized controlled trials and quasi-experimental studies were included, targeting diverse health problems in a number of settings. Few studies included organizational-level interventions. When viewed in relation to the methodological quality and the sufficiency of economic evidence, five of 11 cost-effective occupational safety and health (OSH) interventions appear to be promising. Conclusion: The present systematic review highlights the need for high-quality economic evidence to evaluate the cost-effectiveness of OSH interventions, especially at organizational-level, in all areas of worker health. PMID:29112631

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

    PubMed Central

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

    2017-01-01

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

  17. 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

  18. Aluminum Data Measurements and Evaluation for Criticality Safety Applications

    NASA Astrophysics Data System (ADS)

    Leal, L. C.; Guber, K. H.; Spencer, R. R.; Derrien, H.; Wright, R. Q.

    2002-12-01

    The Defense Nuclear Facility Safety Board (DNFSB) Recommendation 93-2 motivated the US Department of Energy (DOE) to develop a comprehensive criticality safety program to maintain and to predict the criticality of systems throughout the DOE complex. To implement the response to the DNFSB Recommendation 93-2, a Nuclear Criticality Safety Program (NCSP) was created including the following tasks: Critical Experiments, Criticality Benchmarks, Training, Analytical Methods, and Nuclear Data. The Nuclear Data portion of the NCSP consists of a variety of differential measurements performed at the Oak Ridge Electron Linear Accelerator (ORELA) at the Oak Ridge National Laboratory (ORNL), data analysis and evaluation using the generalized least-squares fitting code SAMMY in the resolved, unresolved, and high energy ranges, and the development and benchmark testing of complete evaluations for a nuclide for inclusion into the Evaluated Nuclear Data File (ENDF/B). This paper outlines the work performed at ORNL to measure, evaluate, and test the nuclear data for aluminum for applications in criticality safety problems.

  19. Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

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

    Farmer, Mitchell T.; Bunt, R.; Corradini, M.

    The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affectmore » reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).« less

  20. Implementation and evaluation of a patient safety course in a problem-based learning program.

    PubMed

    Eltony, Sarah Ahmed; El-Sayed, Nahla Hassan; El-Araby, Shimaa El-Sayed; Kassab, Salah Eldin

    2017-01-01

    Since the development of the WHO patient safety curriculum guide, there has been insufficient reporting regarding the implementation and evaluation of patient safety courses in undergraduate problem-based learning (PBL) programs. This study is designed to implement a patient safety course to undergraduate students in a PBL medical school and evaluate this course by examining its effects on students' knowledge and satisfaction. The target population included year 6 medical students (n = 71) at the Faculty of Medicine, Suez Canal University in Egypt. A 3-day course was conducted addressing three principal topics from the WHO patient safety curriculum guide. The methods of instruction included reflection on students' past experiences, PBL case discussions, and tasks with incident report cards. A pre- and post-test design was used to assess the effect of the course on students' knowledge of inpatient safety topics. Furthermore, students' perceptions of the quality of the course were assessed through a structured self-administered course evaluation questionnaire. The results of the pre- and post-test demonstrated a significant increase (P < 0.05) in the students' mean multiple choice question (MCQ) scores. The MCQ scores for "what is patient safety" topic increased by 50% (P < 0.01). Similarly, the MCQ scores for the "infection control" topic increased by 39% (P < 0.01), and scores for the "medication safety" topic increased by 45% (P < 0.01). The majority of students perceived the different aspects of the course positively, including the structure and introduction of the course (75%) and the communication skills (83.2%) and teamwork skills they had developed (94.4%). The findings of the incident report cards indicated that 46.7% of the students perceived that incidents most commonly take place in the emergency room while only 6.7% in the outpatient clinic. This patient safety education program within a PBL curriculum is positively perceived by students. Furthermore

  1. Safety evaluation of flashing beacons at stop-controlled intersections

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the study is to evaluate the safety ef...

  2. Safety evaluation of STOP AHEAD pavement markings TechBrief

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the study is to evaluate the safety ef...

  3. Evaluating the safety effects of signal improvements.

    DOT National Transportation Integrated Search

    2013-08-01

    There is a need to evaluate the effectiveness of the traffic signal improvements through the development of Crash Modification Factors (CMFs). Recent research has shown that traditional safety evaluation methods have been inadequate in developing CMF...

  4. Economic evaluation in patient safety: a literature review of methods.

    PubMed

    de Rezende, Bruna Alves; Or, Zeynep; Com-Ruelle, Laure; Michel, Philippe

    2012-06-01

    Patient safety practices, targeting organisational changes for improving patient safety, are implemented worldwide but their costs are rarely evaluated. This paper provides a review of the methods used in economic evaluation of such practices. International medical and economics databases were searched for peer-reviewed publications on economic evaluations of patient safety between 2000 and 2010 in English and French. This was complemented by a manual search of the reference lists of relevant papers. Grey literature was excluded. Studies were described using a standardised template and assessed independently by two researchers according to six quality criteria. 33 articles were reviewed that were representative of different patient safety domains, data types and evaluation methods. 18 estimated the economic burden of adverse events, 3 measured the costs of patient safety practices and 12 provided complete economic evaluations. Healthcare-associated infections were the most common subject of evaluation, followed by medication-related errors and all types of adverse events. Of these, 10 were selected that had adequately fulfilled one or several key quality criteria for illustration. This review shows that full cost-benefit/utility evaluations are rarely completed as they are resource intensive and often require unavailable data; some overcome these difficulties by performing stochastic modelling and by using secondary sources. Low methodological transparency can be a problem for building evidence from available economic evaluations. Investing in the economic design and reporting of studies with more emphasis on defining study perspectives, data collection and methodological choices could be helpful for strengthening our knowledge base on practices for improving patient safety.

  5. Evaluation of child safety seat enforcement strategies

    DOT National Transportation Integrated Search

    1989-09-01

    Nine community programs designed to increase child safety seat (CSS) use through public information and education (PI&E) and enforcement were evaluated. An administrative evaluation documented each site's PI&E and enforcement activties. A total of 5,...

  6. Occupational safety of different industrial sectors in Khartoum State, Sudan. Part 1: Safety performance evaluation.

    PubMed

    Zaki, Gehan R; El-Marakby, Fadia A; H Deign El-Nor, Yasser; Nofal, Faten H; Zakaria, Adel M

    2012-12-01

    Safety performance evaluation enables decision makers improve safety acts. In Sudan, accident records, statistics, and safety performance were not evaluated before maintenance of accident records became mandatory in 2005. This study aimed at evaluating and comparing safety performance by accident records among different cities and industrial sectors in Khartoum state, Sudan, during the period from 2005 to 2007. This was a retrospective study, the sample in which represented all industrial enterprises in Khartoum state employing 50 workers or more. All industrial accident records of the Ministry of Manpower and Health and those of different enterprises during the period from 2005 to 2007 were reviewed. The safety performance indicators used within this study were the frequency-severity index (FSI) and fatal and disabling accident frequency rates (DAFR). In Khartoum city, the FSI [0.10 (0.17)] was lower than that in Bahari [0.11 (0.21)] and Omdurman [0.84 (0.34)]. It was the maximum in the chemical sector [0.33 (0.64)] and minimum in the metallurgic sector [0.09 (0.19)]. The highest DAFR was observed in Omdurman [5.6 (3.5)] and in the chemical sector [2.5 (4.0)]. The fatal accident frequency rate in the mechanical and electrical engineering industry was the highest [0.0 (0.69)]. Male workers who were older, divorced, and had lower levels of education had the lowest safety performance indicators. The safety performance of the industrial enterprises in Khartoum city was the best. The safety performance in the chemical sector was the worst with regard to FSI and DAFR. The age, sex, and educational level of injured workers greatly affect safety performance.

  7. Evaluation and Customization of WHO Safety Checklist for Patient Safety in Otorhinolaryngology.

    PubMed

    Dabholkar, Yogesh; Velankar, Haritosh; Suryanarayan, Sneha; Dabholkar, Twinkle Y; Saberwal, Akanksha A; Verma, Bhavika

    2018-03-01

    The WHO has designed a safe surgery checklist to enhance communication and awareness of patient safety during surgery and to minimise complications. WHO recommends that the check-list be evaluated and customised by end users as a tool to promote safe surgery. The aim of present study was to evaluate the impact of WHO safety checklist on patient safety awareness in otorhinolaryngology and to customise it for the speciality. A prospective structured questionnaire based study was done in ENT operating room for duration of 1 month each for cases, before and after implementation of safe surgery checklist. The feedback from respondents (surgeons, nurses and anaesthetists) was used to arrive at a customised checklist for otolaryngology as per WHO guidelines. The checklist significantly improved team member's awareness of patient's identity (from 17 to 86%) and each other's identity and roles (from 46 to 94%) and improved team communication (from 73 to 92%) in operation theatre. There was a significant improvement in preoperative check of equipment and critical events were discussed more frequently. The checklist could be effectively customised to suit otolaryngology needs as per WHO guidelines. The modified checklist needs to be validated by otolaryngology associations. We conclude from our study that the WHO Surgical safety check-list has a favourable impact on patient safety awareness, team-work and communication of operating team and can be customised for otolaryngology setting.

  8. The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report

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

    Nelson, R.C.; Gray, L.B.; Huff, D.A.

    The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment ofmore » the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System.« less

  9. Curriculum and Evaluation Guide for Safety Education Programs. Research and Evaluation Report Series No. 40.00.

    ERIC Educational Resources Information Center

    Lowry, Carlee S.

    Designed to assist Bureau of Indian Affairs school officials in the identification of safety education program needs, this evaluation guide focuses upon the basic operational components in a safety education program. The means for establishing an evaluation design for safety education are presented via a flexible model appropriate for most…

  10. Safety evaluation of right-turn smart channels using automated traffic conflict analysis.

    PubMed

    Autey, Jarvis; Sayed, Tarek; Zaki, Mohamed H

    2012-03-01

    This paper presents the results of a before-after (BA) safety evaluation of a newly proposed design for channelized right-turn lanes. The new design, termed "Smart Channels", decreases the angle of the channelized right turn to approximately 70°. The implementation of these modified right-turn channels is usually advocated to allow for safer pedestrian crossing. However, the benefits also extend to vehicle-vehicle interactions since the new approach angle affords drivers a better view of the traffic stream they are to merge with. The evaluation is conducted using a video-based automated traffic conflict analysis. There are several advantages that support the adoption of traffic conflict techniques in BA safety studies. Traffic conflicts are more frequent than road collisions and are of marginal social cost, they provide insight into the failure mechanism that leads to road collisions, and BA studies based on traffic conflicts can be conducted over shorter periods. As well, the use of automated conflict analysis overcomes the reliability and repeatability problems usually associated with manual conflict observations. Data for three treatment intersections and one control intersection in Penticton, British Columbia, are used in this study. The results of the evaluation show that the implementation of the right-turn treatment has resulted in a considerable reduction in the severity and frequency of merging, rear-end, and total conflicts. The total average hourly conflict was reduced by about 51% while the average conflict severity was reduced by 41%. Copyright © 2011 Elsevier Ltd. All rights reserved.

  11. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

  12. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

  13. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

  14. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

  15. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

  16. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

  17. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

  18. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 9 2014-07-01 2014-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

  19. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

  20. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

  1. Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.

    PubMed

    Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney

    2018-04-01

    levels of patient engagement. As more patient engagement studies are conducted, this framework should be evaluated for associations with patient outcomes.

  2. Evaluating Performance of Highway Safety Projects

    DOT National Transportation Integrated Search

    2016-12-01

    The purpose of this project was to investigate and document methods that the Idaho Transportation Department (ITD) and Local Highway Technical Assistance Council (LHTAC) can use to evaluate the performance of safety projects that have been implemente...

  3. Providing Nuclear Criticality Safety Analysis Education through Benchmark Experiment Evaluation

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

    John D. Bess; J. Blair Briggs; David W. Nigg

    2009-11-01

    One of the challenges that today's new workforce of nuclear criticality safety engineers face is the opportunity to provide assessment of nuclear systems and establish safety guidelines without having received significant experience or hands-on training prior to graduation. Participation in the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and/or the International Reactor Physics Experiment Evaluation Project (IRPhEP) provides students and young professionals the opportunity to gain experience and enhance critical engineering skills.

  4. Criticality Safety Evaluation for Small Sample Preparation and Non-Destructive Assay (NDA) Operations in Wing 7 Basement of the CMR Facility

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

    Kunkle, Paige Elizabeth; Zhang, Ning

    Nuclear Criticality Safety (NCS) has reviewed the fissionable material small sample preparation and NDA operations in Wing 7 Basement of the CMR Facility. This is a Level-1 evaluation conducted in accordance with NCS-AP-004 [Reference 1], formerly NCS-GUIDE-01, and the guidance set forth on use of the Standard Criticality Safety Requirements (SCSRs) [Reference 2]. As stated in Reference 2, the criticality safety evaluation consists of both the SCSR CSED and the SCSR Application CSED. The SCSR CSED is a Level-3 CSED [Reference 3]. This Level-1 CSED is the SCSR Application CSED. This SCSR Application (Level-1) evaluation does not derive controls, itmore » simply applies controls derived from the SCSR CSED (Level-3) for the application of operations conducted here. The controls derived in the SCSR CSED (Level-3) were evaluated via the process described in Section 6.6.5 of SD-130 (also reproduced in Section 4.3.5 of NCS-AP-004 [Reference 1]) and were determined to not meet the requirements for consideration of elevation into the safety basis documentation for CMR. According to the guidance set forth on use of the SCSRs [Reference 2], the SCSR CSED (Level-3) is also applicable to the CMR Facility because the process and the normal and credible abnormal conditions in question are bounded by those that are described in the SCSR CSED. The controls derived in the SCSR CSED include allowances for solid materials and solution operations. Based on the operations conducted at this location, there are less-than-accountable (LTA) amounts of 233U. Based on the evaluation documented herein, the normal and credible abnormal conditions that might arise during the execution of this process will remain subcritical with the following recommended controls.« less

  5. Longitudinal safety evaluation of electric vehicles with the partial wireless charging lane on freeways.

    PubMed

    Li, Ye; Wang, Wei; Xing, Lu; Fan, Qi; Wang, Hao

    2018-02-01

    As an environment friendly transportation mode, the electric vehicle (EV) has drawn an increasing amount of attention from governments, vehicle manufactories and researchers recently. One of the biggest issue impeding EV's popularization associates with the charging process. The wireless charging lane (WCL) has been proposed as a convenient charging facility for EVs. Due to the high costs, the application of WCL on the entire freeways is impractical in the near future, while the partial WCL (PWCL) may be a feasible solution. This study aims to evaluate longitudinal safety of EVs with PWCL on freeways based on simulations. The simulation experiments are firstly designed, including deployment of PWCL on freeways and distribution of state of charge (SOC) of EVs. Then, a vehicle behavior model for EVs is proposed based on the intelligent driver model (IDM). Two surrogate safety measures, derived from time-to-collision (TTC), are utilized as indicators for safety evaluations. Sensitivity analysis is also conducted for related factors. Results show that the distribution of EVs' SOC significantly affect longitudinal safety when the PWCL is utilized. The low SOC in traffic consisting of EVs has the negative effect on longitudinal safety. The randomness and incompliance of EV drivers worsens the safety performance. The sensitivity analysis indicates that the larger maximum deceleration rate results in the higher longitudinal crash risks of EVs, while the length of PWCL has no monotonous effect. Different TTC thresholds also show no impact on results. A case study shows the consistent results. Based on the findings, several suggestions are discussed for EVs' safety improvement. Results of this study provide useful information for freeway safety when EVs are applied in the future. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Influence Map Methodology for Evaluating Systemic Safety Issues

    NASA Technical Reports Server (NTRS)

    2008-01-01

    "Raising the bar" in safety performance is a critical challenge for many organizations, including Kennedy Space Center. Contributing-factor taxonomies organize information about the reasons accidents occur and therefore are essential elements of accident investigations and safety reporting systems. Organizations must balance efforts to identify causes of specific accidents with efforts to evaluate systemic safety issues in order to become more proactive about improving safety. This project successfully addressed the following two problems: (1) methods and metrics to support the design of effective taxonomies are limited and (2) influence relationships among contributing factors are not explicitly modeled within a taxonomy.

  7. Efficacy of the Stranger Safety Abduction-Prevention Program and Parent-Conducted in Situ Training

    ERIC Educational Resources Information Center

    Miltenberger, Raymond G.; Fogel, Victoria A.; Beck, Kimberly V.; Koehler, Shannon; Shayne, Rachel; Noah, Jennifer; McFee, Krystal; Perdomo, Andrea; Chan, Paula; Simmons, Danica; Godish, Danielle

    2013-01-01

    Using a control group design, we evaluated the effectiveness of the "Stranger Safety" DVD (The Safe Side, 2004) and parent training of abduction-prevention skills with 6- to 8-year-old children. Children in the training or control group who did not demonstrate the safety skills received in situ training from their parents. There was no…

  8. Safety evaluation of joint and conventional lane merge configurations for freeway work zones.

    PubMed

    Ishak, Sherif; Qi, Yan; Rayaprolu, Pradeep

    2012-01-01

    Inefficient operation of traffic in work zone areas not only leads to an increase in travel time delays, queue length, and fuel consumption but also increases the number of forced merges and roadway accidents. This study evaluated the safety performance of work zones with a conventional lane merge (CLM) configuration in Louisiana. Analysis of variance (ANOVA) was used to compare the crash rates for accidents involving fatalities, injuries, and property damage only (PDO) in each of the following 4 areas: (1) advance warning area, (2) transition area, (3) work area, and (4) termination area. The analysis showed that the advance warning area had higher fatality, injury, and PDO crash rates when compared to the transition area, work area, and termination area. This finding confirmed the need to make improvements in the advance warning area where merging maneuvers take place. Therefore, a new lane merge configuration, called joint lane merge (JLM), was proposed and its safety performance was examined and compared to the conventional lane merge configuration using a microscopic simulation model (VISSIM), which was calibrated with real-world data from an existing work zone on I-55 and used to simulate a total of 25 different scenarios with different levels of demand and traffic composition. Safety performance was evaluated using 2 surrogate measures: uncomfortable decelerations and speed variance. Statistical analysis was conducted to determine whether the differences in safety performance between both configurations were significant. The safety analysis indicated that JLM outperformed CLM in most cases with low to moderate flow rates and that the percentage of trucks did not have a significant impact on the safety performance of either configuration. Though the safety analysis did not clearly indicate which lane merge configuration is safer for the overall work zone area, it was able to identify the possibly associated safety changes within the work zone area under

  9. Evaluation of the safety performance of highway alignments based on fault tree analysis and safety boundaries.

    PubMed

    Chen, Yikai; Wang, Kai; Xu, Chengcheng; Shi, Qin; He, Jie; Li, Peiqing; Shi, Ting

    2018-05-19

    To overcome the limitations of previous highway alignment safety evaluation methods, this article presents a highway alignment safety evaluation method based on fault tree analysis (FTA) and the characteristics of vehicle safety boundaries, within the framework of dynamic modeling of the driver-vehicle-road system. Approaches for categorizing the vehicle failure modes while driving on highways and the corresponding safety boundaries were comprehensively investigated based on vehicle system dynamics theory. Then, an overall crash probability model was formulated based on FTA considering the risks of 3 failure modes: losing steering capability, losing track-holding capability, and rear-end collision. The proposed method was implemented on a highway segment between Bengbu and Nanjing in China. A driver-vehicle-road multibody dynamics model was developed based on the 3D alignments of the Bengbu to Nanjing section of Ning-Luo expressway using Carsim, and the dynamics indices, such as sideslip angle and, yaw rate were obtained. Then, the average crash probability of each road section was calculated with a fixed-length method. Finally, the average crash probability was validated against the crash frequency per kilometer to demonstrate the accuracy of the proposed method. The results of the regression analysis and correlation analysis indicated good consistency between the results of the safety evaluation and the crash data and that it outperformed the safety evaluation methods used in previous studies. The proposed method has the potential to be used in practical engineering applications to identify crash-prone locations and alignment deficiencies on highways in the planning and design phases, as well as those in service.

  10. Structural safety evaluation of Gerber Arch Dam

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

    Barrie, R.E.

    1995-12-31

    Gerber Dam, a variable radius arch structure, has experienced seepage and extensive freeze-thaw damage since its construction. A construction key was found cracked at its crest. A finite element investigation was made to evaluate the safety of the arch structure. Design methods and assumptions are evaluated. Historical performance is used in the evaluation. Stress levels, patterns, and distributions were evaluated for loads the structure has experienced to determine behavior contributing to seepage and cracking.

  11. 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…

  12. Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

    NASA Astrophysics Data System (ADS)

    Lee, Chang Jae; Yun, Jae Hee

    2017-06-01

    Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

  13. Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

    DTIC Science & Technology

    2005-01-01

    have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

  14. A qualitative evaluation of fire safety education programs for older adults.

    PubMed

    Diekman, Shane T; Stewart, Tamara A; Teh, S Leesia; Ballesteros, Michael F

    2010-03-01

    This article presents a qualitative evaluation of six fire safety education programs for older adults delivered by public fire educators. Our main aims were to explore how these programs are implemented and to determine important factors that may lead to program success, from the perspectives of the public fire educators and the older adults. For each program, we interviewed the public fire educator(s), observed the program in action, and conducted focus groups with older adults attending the program. Analysis revealed three factors that were believed to facilitate program success (established relationships with the older adult community, rapport with older adult audiences, and presentation relevance) as well as three challenges (lack of a standardized curriculum and program implementation strategies, attendance difficulties, and physical limitations due to age). More fire safety education should be developed for older adult populations. For successful programs, public fire educators should address the specific needs of their local older adult community.

  15. Ethnomedical survey and safety evaluation of traditional eye medicines used in Misungwi district, Tanzania

    PubMed Central

    Maregesi, Sheila M.; Messo, Charles W.; Mathias, Juma

    2017-01-01

    Aim: This study aimed at documenting products used as traditional eye medicine (TEM) in Misungwi district, Tanzania, and performing preliminary analysis on safety status. Methodology: Ethnomedical study was conducted in Misungwi district. Information was sourced by face-to-face interview with traditional healers, traditional medicine vendors, and knowledgeable people guided by a well-structured questionnaire. Safety was evaluated by determining pH using pH meter and mineral analysis using the Delta, Portable X-ray fluorescence equipment, and qualitative chemical tests. Results: A total of 23 TEM products were recorded from botanical (79%) and zoological (21%) sources including animal excreta. Liquid preparation ranked highest among dosage forms. Safety evaluation showed that only one product possessed the pH value of 7.4 as recommended for topical ophthalmic medicines. Fourteen minerals were detected and quantified in three samples; some of these minerals are known for their negative effects to the eyes, of medical interest is strontium used for the management of benign eye tumors. Information providers were unaware of health risks associated with the use of TEM. Conclusion: This study has revealed the common use of TEM in Misungwi district. The majority of the products are from the botanical source. Although literature provides supporting data for the application to some of the recorded TEM, safety evaluation by pH and mineral analysis in this study have indicated possible ophthalmological medical problems that could result from using such products. Extensive scientific studies including animal experiments and identification of bioactive compounds are essential to develop safe TEMs. PMID:28163964

  16. TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

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

    Alan Bond

    2001-04-01

    This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

  17. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

  18. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 9 2014-07-01 2014-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

  19. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

  20. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

  1. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

  2. Novel approaches to development, delivery and evaluation of a peer-led occupational safety training for Latino day laborers.

    PubMed

    De Souza, Rachael Ann; Hecker, Steven; de Castro, A B; Stern, Hilary; Hernandez, Araceli; Seixas, Noah

    2012-01-01

    Latino day laborers experience high rates of work-related injuries and are a hard-to-reach group for safety interventions. This study describes the creation and implementation of safety training based in empowerment theory and its evaluation to address three levels in empowerment's hierarchy of change. Pictographic pre- and post-tests were used to assess knowledge level changes. Individual and large-group interviews were conducted to address attitudes and behavior-level changes. Results indicate that day laborers learn and apply lessons from this type of safety training. Findings also offer insight into challenges that day laborers encounter when trying to work safely as well as ideas for future training interventions.

  3. Fire safety evaluation system for NASA office/laboratory buildings

    NASA Astrophysics Data System (ADS)

    Nelson, H. E.

    1986-11-01

    A fire safety evaluation system for office/laboratory buildings is developed. The system is a life safety grading system. The system scores building construction, hazardous areas, vertical openings, sprinklers, detectors, alarms, interior finish, smoke control, exit systems, compartmentation, and emergency preparedness.

  4. A methodology to quantitatively evaluate the safety of a glazing robot.

    PubMed

    Lee, Seungyeol; Yu, Seungnam; Choi, Junho; Han, Changsoo

    2011-03-01

    A new construction method using robots is spreading widely among construction sites in order to overcome labour shortages and frequent construction accidents. Along with economical efficiency, safety is a very important factor for evaluating the use of construction robots in construction sites. However, the quantitative evaluation of safety is difficult compared with that of economical efficiency. In this study, we suggested a safety evaluation methodology by defining the 'worker' and 'work conditions' as two risk factors, defining the 'worker' factor as posture load and the 'work conditions' factor as the work environment and the risk exposure time. The posture load evaluation reflects the risk of musculoskeletal disorders which can be caused by work posture and the risk of accidents which can be caused by reduced concentration. We evaluated the risk factors that may cause various accidents such as falling, colliding, capsizing, and squeezing in work environments, and evaluated the operational risk by considering worker exposure time to risky work environments. With the results of the evaluations for each factor, we calculated the general operational risk and deduced the improvement ratio in operational safety by introducing a construction robot. To verify these results, we compared the safety of the existing human manual labour and the proposed robotic labour construction methods for manipulating large glass panels. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

  5. Teaching safety at a summer camp: evaluation of a fire safety curriculum in an urban community setting.

    PubMed

    Chavez, Audrie A; Duzinski, Sarah V; Wheeler, Tareka C; Lawson, Karla A

    2014-09-01

    To evaluate the effectiveness of the Danger Rangers Fire Safety Curriculum in increasing the fire safety knowledge of low-income, minority children in an urban community setting. Data was collected from child participants via teacher/researcher administered pre-, post-, and retention tests. A self-administered questionnaire was collected from parents pre- and post-intervention to assess fire/burn prevention practices. Paired t-tests were conducted to compare pre-, post-, and retention test mean scores by grade group. McNemar's test was used to determine if there was a change in parent-reported prevention practices following the intervention. The first/second grade group and the third grade group scored significantly higher on the post- and retention test as compared to the pre-test (p<0.0001 for all comparisons). There was no significant change in scores for the pre-k/k group after the intervention. There was a significant increase in 2 of 4 parent-reported fire/burn-related prevention practices after the intervention. Fire safety knowledge improved among first to third grade children, but not among pre-kinder and kindergarten children who participated in the intervention. This study also showed that a program targeted towards children and delivered in a classroom setting has the potential to influence familial prevention practices by proxy. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  6. Evaluation Of The Vehicle Radar Safety Systems Rashid Radar Safety Brake Collision Warning System, Final Report

    DOT National Transportation Integrated Search

    1988-02-01

    THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...

  7. Seismic safety in conducting large-scale blasts

    NASA Astrophysics Data System (ADS)

    Mashukov, I. V.; Chaplygin, V. V.; Domanov, V. P.; Semin, A. A.; Klimkin, M. A.

    2017-09-01

    In mining enterprises to prepare hard rocks for excavation a drilling and blasting method is used. With the approach of mining operations to settlements the negative effect of large-scale blasts increases. To assess the level of seismic impact of large-scale blasts the scientific staff of Siberian State Industrial University carried out expertise for coal mines and iron ore enterprises. Determination of the magnitude of surface seismic vibrations caused by mass explosions was performed using seismic receivers, an analog-digital converter with recording on a laptop. The registration results of surface seismic vibrations during production of more than 280 large-scale blasts at 17 mining enterprises in 22 settlements are presented. The maximum velocity values of the Earth’s surface vibrations are determined. The safety evaluation of seismic effect was carried out according to the permissible value of vibration velocity. For cases with exceedance of permissible values recommendations were developed to reduce the level of seismic impact.

  8. Time-related degradation, a key issue in nuclear plant safety evaluations

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

    Bonzon, L.L.; Bustard, L.D.; Clough, R.L.

    1982-01-01

    Sandia National Laboratories is conducting a number of programs under NRC sponsorship which deal with safety-related equipment qualification issues, including the important aspect of aging. Among these is the Qualification Testing Evaluation (QTE) program which was probably the first to devote significant effort towards aging research and was one of the primary motivators leading to the Workshop. The thrust of the QTE aging efforts has been on elastomeric materials, typically used in electrical cables, seals, gaskets, and the like; currently, efforts are being pursued on plant ambient environments measurements, aging of electronics, and aging of motors. A brief status reportmore » is presented in this paper.« less

  9. 30 CFR 27.9 - Date for conducting tests.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Date for conducting tests. 27.9 Section 27.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS General Provisions § 27.9 Date for conducting tests...

  10. 30 CFR 27.9 - Date for conducting tests.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Date for conducting tests. 27.9 Section 27.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS General Provisions § 27.9 Date for conducting tests...

  11. Quality evaluation of official accident reports conducted by Labour Authorities in Andalusia (Spain).

    PubMed

    Salguero-Caparros, Francisco; Suarez-Cebador, Manuel; Carrillo-Castrillo, Jesús A; Rubio-Romero, Juan Carlos

    2018-01-01

    A public accident investigation is carried out when the consequences of the incident are significant or the accident has occurred in unusual circumstances. We evaluated the quality of the official accident investigations being conducted by Safety Specialists of the Labour Authorities in Andalusia. To achieve this objective, we analysed 98 occupational accident investigations conducted by the Labour Authorities in Andalusia in the last quarter of 2014. Various phases in the accident investigation process were examined, such as the use of the Eurostat variables within European Statistics on Accidents at Work (ESAW), detection of causes, determination of preventive measures, cost analysis of the accidents, identification of noncompliance with legal requirements or the investigation method used. The results of this study show that 77% of the official occupational accident investigation reports analysed were conducted in accordance with all the quality criteria recommended in the literature. To enhance glogal learning, and optimize allocation of resources, we propose the development of a harmonized European model for the public investigation of occupational accidents. Further it would be advisable to create a common classification and coding system for the causes of accidents for all European Union Member States.

  12. An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

    PubMed

    Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

    2016-01-01

    As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

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

    PubMed

    Chen, Ching-Fu; Chen, Shu-Chuan

    2012-07-01

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

  14. Applications of hyperspectral imaging in chicken meat safety and quality detection and evaluation: a review.

    PubMed

    Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan

    2015-01-01

    Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.

  15. Safety evaluation of curve warning speed signs.

    DOT National Transportation Integrated Search

    2011-06-01

    This report presents a review of a research effort to evaluate the safety implications of advisory speeds at horizontal curve locations on Oregon rural two-lane highways. The primary goals of this research effort were to characterize driving operatio...

  16. The quality and safety culture in general hospitals: patients', physicians' and nurses' evaluation of its effect on patient satisfaction.

    PubMed

    Kagan, Ilya; Porat, Nurit; Barnoy, Sivia

    2018-06-21

    To explore the disparities between patients' and health care workers' perception of the quality and safety culture and to explore the relationship between patient perceptions, and engagement in, and satisfaction with their care and treatment. A cross-sectional study was conducted in medical-surgical wards of four Israeli general hospitals. Data were collected using a self-administered questionnaire. Fourteen medical-surgical wards of the four hospitals where data were collected. The sample comprised of 390 physicians and nurses and 726 inpatients admitted for at least 3 days. A self-administered questionnaire that covered the following topics: (i) quality and safety culture, (ii) patient engagement, (iii) patient satisfaction, (iv) an assessment of the care quality and safety in the ward and (v) sociodemographic data. The questionnaire was translated into Arabic and Russian. Sixty nine items were directed to the staff and 71 to patients. Patients evaluated the quality and safety culture significantly higher than did the health care workers. Significant correlations were found between patients' engagement in and satisfaction with their care and their quality and safety assessments. Their evaluation of this culture was the only predictor of their satisfaction and engagement. Arabic-speaking patients rated four variables, including patients' satisfaction with their care, lower than did Hebrew and Russian speakers. Patients have sufficient experience and understanding to form an opinion of the quality and safety of their care. The lower evaluation of the quality and safety culture expressed by health care workers might stem from their more realistic expectations.

  17. Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

    PubMed Central

    Farley, Donna O; Damberg, Cheryl L

    2009-01-01

    Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

  18. 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.

  19. An Evaluation of Proposed School Safety Indicators for Georgia.

    ERIC Educational Resources Information Center

    Todd, Knox H.; Kellermann, Arthur L.; Wald, Marlena; Lipscomb, Leslie; Fajman, Nancy

    One of the tasks of the Council for School Performance is to implement measures of school safety to determine the impact of Georgia Lottery for Education expenditures. During the 1994-95 school year, the council pilot-tested several indicators of school safety. This document presents the results of an evaluation that examined the relevance,…

  20. Evaluation of safety climate and employee injury rates in healthcare.

    PubMed

    Cook, Jacqueline M; Slade, Martin D; Cantley, Linda F; Sakr, Carine J

    2016-09-01

    Safety climates that support safety-related behaviour are associated with fewer work-related injuries, and prior research in industry suggests that safety knowledge and motivation are strongly related to safety performance behaviours; this relationship is not well studied in healthcare settings. We performed analyses of survey results from a Veterans Health Administration (VHA) Safety Barometer employee perception survey, conducted among VHA employees in 2012. The employee perception survey assessed 6 safety programme categories, including management participation, supervisor participation, employee participation, safety support activities, safety support climate and organisational climate. We examined the relationship between safety climate from the survey results on VHA employee injury and illness rates. Among VHA facilities in the VA New England Healthcare System, work-related injury rate was significantly and inversely related to overall employee perception of safety climate, and all 6 safety programme categories, including employee perception of employee participation, management participation, organisational climate, supervisor participation, safety support activities and safety support climate. Positive employee perceptions of safety climate in VHA facilities are associated with lower work-related injury and illness rates. Employee perception of employee participation, management participation, organisational climate, supervisor participation, safety support activities and safety support climate were all associated with lower work-related injury rates. Future implications include fostering a robust safety climate for patients and healthcare workers to reduce healthcare worker injuries. 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/

  1. Safety evaluation of intersection conflict warning systems (ICWS), TechBrief

    DOT National Transportation Integrated Search

    2016-02-02

    The Federal Highway Administration (FHWA) organized 40 States to participate in the FHWA Evaluation of LowCost Safety Improvements Pooled Fund Study (ELCSI-PFS) as part of its strategic highway safety plan support effort. The goal of the ELCSI-PFS re...

  2. Safety evaluation of centerline plus shoulder rumble strips, TechBrief

    DOT National Transportation Integrated Search

    2015-09-01

    The Federal Highway Administration (FHWA) organized 37 States to participate in the FHWA Evaluation of Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the study was to evaluat...

  3. Teaching safety at a summer camp: evaluation of a water safety curriculum in an urban community setting.

    PubMed

    Lawson, Karla A; Duzinski, Sarah V; Wheeler, Tareka; Yuma-Guerrero, Paula J; Johnson, Kelly M K; Maxson, R Todd; Schlechter, Robert

    2012-11-01

    The purpose of this project was to evaluate a water safety curriculum in a low-income, minority-focused, urban youth summer camp. The curriculum is available to Safe Kids Coalitions across the country; however, it has not previously been evaluated. Participants were pre-K to third-grade students (n = 166). Children watched a video and received the curriculum in a classroom setting. Each child was given a pre-, post-, and 3-week retention exam to assess knowledge change. Mean test scores and number of safety rules participants could list were analyzed using paired Student's t tests. Parents were given a baseline survey at the beginning (n = 140) and end of the weeklong curriculum (n = 118). The participants were 50% male, 27.5% Hispanic, 68.7% African American, and 3.8% biracial. Children were divided into three groups: pre-K/kindergarten, first and second grade, and third grade. Children in each of the groups received higher knowledge scores at the posttest (p = .0097, p < .0001, and p < .0001, respectively), with little decline in scores at the 3-week retention exam. Similar results were seen for the ability to list safety rules, though the number fell slightly between the posttest and retention test. The study demonstrates that children possessed more knowledge of water safety after receiving this curriculum. This knowledge increase was maintained through the 3-week retention exam. Further evaluation of the curriculum's content and its impact on water safety beliefs, attitudes, and behaviors are needed, as well as evaluation of additional settings, risk areas, and the role of parental involvement.

  4. Space station pressurized laboratory safety guidelines

    NASA Technical Reports Server (NTRS)

    Mcgonigal, Les

    1990-01-01

    Before technical safety guidelines and requirements are established, a common understanding of their origin and importance must be shared between Space Station Program Management, the User Community, and the Safety organizations involved. Safety guidelines and requirements are driven by the nature of the experiments, and the degree of crew interaction. Hazard identification; development of technical safety requirements; operating procedures and constraints; provision of training and education; conduct of reviews and evaluations; and emergency preplanning are briefly discussed.

  5. Improving the health and safety of 911 emergency call centre agents: an evaluability assessment of a knowledge transfer strategy.

    PubMed

    Dagenais, Christian; Plouffe, Laurence; Gagné, Charles; Toulouse, Georges; Breault, Andrée-Anne; Dupont, Didier

    2017-03-01

    A knowledge transfer (KT) strategy was implemented by the IRSST, an occupational health and safety research institute established in Québec (Canada), to improve the prevention of psychological and musculoskeletal problems among 911 emergency call centre agents. An evaluability assessment was conducted in which each aspect of the KT approach was documented systematically to determine whether the strategy had the potential to be evaluated in terms of its impact on the targeted population. A review of the literature on KT in occupational health and safety and on the evaluation of such KT programmes, along with the development of a logic model based on documentary analysis and semi-structured interviews with key stakeholders, indicated that the KT strategy was likely to have had a positive impact in the 911 emergency call centre sector. Implications for future research are discussed.

  6. Safety evaluation of lane and shoulder width combinations on rural, two-lane, undivided roads

    DOT National Transportation Integrated Search

    2009-06-01

    The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The goal of this study is to evaluate the safety effectiveness of various lane...

  7. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    PubMed

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  8. Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

    PubMed

    Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

    2012-09-01

    Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those

  9. Evaluation of the Coreless Linear Conduction Pump for Thermoelectromagnetic Pumps,

    DTIC Science & Technology

    1991-08-01

    Accession Number: 4466 Publication Date: Aug 01, 1991 Title: Evaluation of the Coreless Linear Conduction Pump for Thermoelectromagnetic Pumps ...083191 Report Prepared for: SDIO/T/SL, Washington, DC 20301-7100 Descriptors, Keywords: Coreless Linear Conduction Pump Thermoelectromagnetic...000001 Record ID: 26727 SUMMARY The purpose of the Coreless Linear Conduction Pump (CLCP) was to evaluate the feasibility of the CLCP as a means of

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

    PubMed

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

    2015-03-01

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

  11. Integration of Occupational Safety to Contractors` or Subcontractors` Performance Evaluation in Construction Projects

    NASA Astrophysics Data System (ADS)

    Kozlovská, Mária; Struková, Zuzana

    2013-06-01

    Several factors should be considered by the owner and general contractor in the process of contractors` and subcontractors` selection and evaluation. The paper reviews the recent models addressed to guide general contractors in subcontractors' selection process and in evaluation of different contractors during the execution of the project. Moreover the paper suggests the impact of different contractors' performance to the overall level of occupational health and safety culture at the sites. It deals with the factors influencing the safety performance of contractors during construction and analyses the methods for assessing the safety performance of construction contractors. The results of contractors' safety performance evaluation could be a useful tool in motivating contractors to achieve better safety outcomes or could have effect on owners` or general contractors' decision making about contractors suitability for future contracting works.

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

    PubMed

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

    2014-04-01

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

  13. The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS).

    PubMed

    Vinardell, M P

    2015-03-01

    In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Research on safety evaluation model for in-vehicle secondary task driving.

    PubMed

    Jin, Lisheng; Xian, Huacai; Niu, Qingning; Bie, Jing

    2015-08-01

    This paper presents a new method for evaluating in-vehicle secondary task driving safety. There are five in-vehicle distracter tasks: tuning the radio to a local station, touching the touch-screen telephone menu to a certain song, talking with laboratory assistant, answering a telephone via Bluetooth headset, and finding the navigation system from Ipad4 computer. Forty young drivers completed the driving experiment on a driving simulator. Measures of fixations, saccades, and blinks are collected and analyzed. Based on the measures of driver eye movements which have significant difference between the baseline and secondary task driving conditions, the evaluation index system is built. The Analytic Network Process (ANP) theory is applied for determining the importance weight of the evaluation index in a fuzzy environment. On the basis of the importance weight of the evaluation index, Fuzzy Comprehensive Evaluation (FCE) method is utilized to evaluate the secondary task driving safety. Results show that driving with secondary tasks greatly distracts the driver's attention from road and the evaluation model built in this study could estimate driving safety effectively under different driving conditions. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  15. Development and validation of a remote home safety protocol.

    PubMed

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

    2018-02-01

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

  16. A probabilistic bridge safety evaluation against floods.

    PubMed

    Liao, Kuo-Wei; Muto, Yasunori; Chen, Wei-Lun; Wu, Bang-Ho

    2016-01-01

    To further capture the influences of uncertain factors on river bridge safety evaluation, a probabilistic approach is adopted. Because this is a systematic and nonlinear problem, MPP-based reliability analyses are not suitable. A sampling approach such as a Monte Carlo simulation (MCS) or importance sampling is often adopted. To enhance the efficiency of the sampling approach, this study utilizes Bayesian least squares support vector machines to construct a response surface followed by an MCS, providing a more precise safety index. Although there are several factors impacting the flood-resistant reliability of a bridge, previous experiences and studies show that the reliability of the bridge itself plays a key role. Thus, the goal of this study is to analyze the system reliability of a selected bridge that includes five limit states. The random variables considered here include the water surface elevation, water velocity, local scour depth, soil property and wind load. Because the first three variables are deeply affected by river hydraulics, a probabilistic HEC-RAS-based simulation is performed to capture the uncertainties in those random variables. The accuracy and variation of our solutions are confirmed by a direct MCS to ensure the applicability of the proposed approach. The results of a numerical example indicate that the proposed approach can efficiently provide an accurate bridge safety evaluation and maintain satisfactory variation.

  17. Railway safety climate: a study on organizational development.

    PubMed

    Cheng, Yung-Hsiang

    2017-09-07

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

  18. Independent evaluation of the transit retrofit package safety applications : final report.

    DOT National Transportation Integrated Search

    2015-02-01

    This report presents the methodology and results of the independent evaluation of retrofit safety packages installed on transit vehicles in the : Safety Pilot Model Deploymentpart of the United States Department of Transportations Intelligent T...

  19. Nuclear criticality safety evaluation of SRS 9971 shipping package

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

    Vescovi, P.J.

    1993-02-01

    This evaluation is requested to revise the criticality evaluation used to generate Chapter 6 (Criticality Evaluation) of the Safety Analysis Report for Packaging (SARP) for shipment Of UO{sub 3} product from the Uranium Solidification Facility (USF) in the SRS 9971 shipping package. The pertinent document requesting this evaluation is included as Attachment I. The results of the evaluation are given in Attachment II which is written as Chapter 6 of a NRC format SARP.

  20. Evaluation and review of the safety management system implementation in the Royal Thai Air Force

    NASA Astrophysics Data System (ADS)

    Chaiwan, Sakkarin

    This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

  1. Kentucky commercial vehicle safety applications evaluation : technical report.

    DOT National Transportation Integrated Search

    2008-01-31

    An advanced-technology Integrated Safety and Security Enforcement System (ISSES), now deployed at three commercial vehicle inspection sites along interstate highways in Kentucky, was evaluated from the point of view of system performance, potential e...

  2. Evaluation of the food safety training for food handlers in restaurant operations

    PubMed Central

    Park, Sung-Hee; Kwak, Tong-Kyung

    2010-01-01

    This study examined the extent of improvement of food safety knowledge and practices of employee through food safety training. Employee knowledge and practice for food safety were evaluated before and after the food safety training program. The training program and questionnaires for evaluating employee knowledge and practices concerning food safety, and a checklist for determining food safety performance of restaurants were developed. Data were analyzed using the SPSS program. Twelve restaurants participated in this study. We split them into two groups: the intervention group with training, and the control group without food safety training. Employee knowledge of the intervention group also showed a significant improvement in their score, increasing from 49.3 before the training to 66.6 after training. But in terms of employee practices and the sanitation performance, there were no significant increases after the training. From these results, we recommended that the more job-specific and hand-on training materials for restaurant employees should be developed and more continuous implementation of the food safety training and integration of employee appraisal program with the outcome of safety training were needed. PMID:20198210

  3. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of color additives. (a) In deciding whether a petition is complete and suitable for filing and in reaching a decision...

  4. Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers

    PubMed Central

    Yin, Ren-Cheng

    2018-01-01

    The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building. PMID:29734736

  5. Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers.

    PubMed

    Hsu, Ting-Yu; Yin, Ren-Cheng; Wu, Yih-Min

    2018-05-05

    The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building.

  6. Evaluating the performance and safety effectiveness of roundabouts.

    DOT National Transportation Integrated Search

    2011-12-01

    This report documents the evaluation of the performance and safety effectiveness of roundabouts within the State of Michigan. The study began with the identification of roundabouts within Michigan. This was followed by collecting data on the geometri...

  7. Safety and capacity evaluation for interstates in Kentucky.

    DOT National Transportation Integrated Search

    2005-04-01

    This analysis and evaluation was directed toward assessing safety and capacity issues on interstates in Kentucky and, particularly, the manner in which commercial vehicle traffic affects these issues. Analyses was undertaken to show past trends and p...

  8. Software Dependability and Safety Evaluations ESA's Initiative

    NASA Astrophysics Data System (ADS)

    Hernek, M.

    ESA has allocated funds for an initiative to evaluate Dependability and Safety methods of Software. The objectives of this initiative are; · More extensive validation of Safety and Dependability techniques for Software · Provide valuable results to improve the quality of the Software thus promoting the application of Dependability and Safety methods and techniques. ESA space systems are being developed according to defined PA requirement specifications. These requirements may be implemented through various design concepts, e.g. redundancy, diversity etc. varying from project to project. Analysis methods (FMECA. FTA, HA, etc) are frequently used during requirements analysis and design activities to assure the correct implementation of system PA requirements. The criticality level of failures, functions and systems is determined and by doing that the critical sub-systems are identified, on which dependability and safety techniques are to be applied during development. Proper performance of the software development requires the development of a technical specification for the products at the beginning of the life cycle. Such technical specification comprises both functional and non-functional requirements. These non-functional requirements address characteristics of the product such as quality, dependability, safety and maintainability. Software in space systems is more and more used in critical functions. Also the trend towards more frequent use of COTS and reusable components pose new difficulties in terms of assuring reliable and safe systems. Because of this, its dependability and safety must be carefully analysed. ESA identified and documented techniques, methods and procedures to ensure that software dependability and safety requirements are specified and taken into account during the design and development of a software system and to verify/validate that the implemented software systems comply with these requirements [R1].

  9. Compendium of traffic safety research projects : 1987-1997

    DOT National Transportation Integrated Search

    1997-09-01

    The National Highway Traffic Safety Administration's (NHTSA) Research and Evaluation Division, Office of Research and Traffic Records, conducts research and evaluation projects dealing with human attitudes, behaviors, and failures (motor vehicle cras...

  10. Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

    PubMed

    Fu, Xiaping; Ying, Yibin

    2016-08-17

    In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

  11. Field evaluation of highway safety hardware maintenance guidelines.

    DOT National Transportation Integrated Search

    1987-01-01

    The objective of this study was to evaluate with field tests, a procedure developed for the Federal Highway Administration for determining frequencies at which highway safety hardware needs to be inspected and repaired. The frequencies arrived at wer...

  12. Improving patient safety through the systematic evaluation of patient outcomes

    PubMed Central

    Forster, Alan J.; Dervin, Geoff; Martin, Claude; Papp, Steven

    2012-01-01

    Despite increased advocacy for patient safety and several large-scale programs designed to reduce preventable harm, most notably surgical checklists, recent data evaluating entire health systems suggests that we are no further ahead in improving patient safety and that hospital complications are no less frequent now than in the 1990s. We suggest that the failure to systematically measure patient safety is the reason for our limited progress. In addition to defining patient safety outcomes and describing their financial and clinical impact, we argue why the failure to implement patient safety measurement systems has compromised the ability to move the agenda forward. We also present an overview of how patient safety can be assessed and the strengths and weaknesses of each method and comment on some of the consequences created by the absence of a systematic measurement system. PMID:23177520

  13. 49 CFR 240.115 - Criteria for consideration of prior safety conduct as a motor vehicle operator.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Criteria for consideration of prior safety conduct as a motor vehicle operator. 240.115 Section 240.115 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION QUALIFICATION AND CERTIFICATION OF LOCOMOTIVE ENGINEERS...

  14. 49 CFR 240.115 - Criteria for consideration of prior safety conduct as a motor vehicle operator.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Criteria for consideration of prior safety conduct as a motor vehicle operator. 240.115 Section 240.115 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION QUALIFICATION AND CERTIFICATION OF LOCOMOTIVE ENGINEERS...

  15. 75 FR 41531 - Brookwood-Sago Mine Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... stated goals and current reporting period. objectives for improving safety. Conduct and report pre-test and post- test results of trainees. Course evaluations of trainer and training materials. The extent... pre-test and post- and improves safety. educational materials test results of the training materials...

  16. Accelerated Evaluation of Automated Vehicles Safety in Lane-Change Scenarios Based on Importance Sampling Techniques

    PubMed Central

    Zhao, Ding; Lam, Henry; Peng, Huei; Bao, Shan; LeBlanc, David J.; Nobukawa, Kazutoshi; Pan, Christopher S.

    2016-01-01

    Automated vehicles (AVs) must be thoroughly evaluated before their release and deployment. A widely used evaluation approach is the Naturalistic-Field Operational Test (N-FOT), which tests prototype vehicles directly on the public roads. Due to the low exposure to safety-critical scenarios, N-FOTs are time consuming and expensive to conduct. In this paper, we propose an accelerated evaluation approach for AVs. The results can be used to generate motions of the other primary vehicles to accelerate the verification of AVs in simulations and controlled experiments. Frontal collision due to unsafe cut-ins is the target crash type of this paper. Human-controlled vehicles making unsafe lane changes are modeled as the primary disturbance to AVs based on data collected by the University of Michigan Safety Pilot Model Deployment Program. The cut-in scenarios are generated based on skewed statistics of collected human driver behaviors, which generate risky testing scenarios while preserving the statistical information so that the safety benefits of AVs in nonaccelerated cases can be accurately estimated. The cross-entropy method is used to recursively search for the optimal skewing parameters. The frequencies of the occurrences of conflicts, crashes, and injuries are estimated for a modeled AV, and the achieved accelerated rate is around 2000 to 20 000. In other words, in the accelerated simulations, driving for 1000 miles will expose the AV with challenging scenarios that will take about 2 to 20 million miles of real-world driving to encounter. This technique thus has the potential to greatly reduce the development and validation time for AVs. PMID:27840592

  17. Accelerated Evaluation of Automated Vehicles Safety in Lane-Change Scenarios Based on Importance Sampling Techniques.

    PubMed

    Zhao, Ding; Lam, Henry; Peng, Huei; Bao, Shan; LeBlanc, David J; Nobukawa, Kazutoshi; Pan, Christopher S

    2017-03-01

    Automated vehicles (AVs) must be thoroughly evaluated before their release and deployment. A widely used evaluation approach is the Naturalistic-Field Operational Test (N-FOT), which tests prototype vehicles directly on the public roads. Due to the low exposure to safety-critical scenarios, N-FOTs are time consuming and expensive to conduct. In this paper, we propose an accelerated evaluation approach for AVs. The results can be used to generate motions of the other primary vehicles to accelerate the verification of AVs in simulations and controlled experiments. Frontal collision due to unsafe cut-ins is the target crash type of this paper. Human-controlled vehicles making unsafe lane changes are modeled as the primary disturbance to AVs based on data collected by the University of Michigan Safety Pilot Model Deployment Program. The cut-in scenarios are generated based on skewed statistics of collected human driver behaviors, which generate risky testing scenarios while preserving the statistical information so that the safety benefits of AVs in nonaccelerated cases can be accurately estimated. The cross-entropy method is used to recursively search for the optimal skewing parameters. The frequencies of the occurrences of conflicts, crashes, and injuries are estimated for a modeled AV, and the achieved accelerated rate is around 2000 to 20 000. In other words, in the accelerated simulations, driving for 1000 miles will expose the AV with challenging scenarios that will take about 2 to 20 million miles of real-world driving to encounter. This technique thus has the potential to greatly reduce the development and validation time for AVs.

  18. Effectiveness of the Marine Corps’ Junior Enlisted Performance Evaluation System: An Evaluation of Proficiency and Conduct Marks

    DTIC Science & Technology

    2017-03-01

    THE MARINE CORPS’ JUNIOR ENLISTED PERFORMANCE EVALUATION SYSTEM: AN EVALUATION OF PROFICIENCY AND CONDUCT MARKS by Richard B. Larger Jr...CORPS’ JUNIOR ENLISTED PERFORMANCE EVALUATION SYSTEM: AN EVALUATION OF PROFICIENCY AND CONDUCT MARKS 5. FUNDING NUMBERS 6. AUTHOR(S) Richard B...in order to improve interpretability and minimize redundancies. 14. SUBJECT TERMS performance evaluation , proficiency marks, conduct marks

  19. Electrical safety of conducted electrical weapons relative to requirements of relevant electrical standards.

    PubMed

    Panescu, Dorin; Nerheim, Max; Kroll, Mark

    2013-01-01

    TASER(®) conducted electrical weapons (CEW) deliver electrical pulses that can inhibit a person's neuromuscular control or temporarily incapacitate. TASER X26, X26P, and X2 are among CEW models most frequently deployed by law enforcement agencies. The X2 CEW uses two cartridge bays while the X26 and X26P CEWs have only one. The TASER X26P CEW electronic output circuit design is equivalent to that of any one of the two TASER X2 outputs. The goal of this paper was to analyze the nominal electrical outputs of TASER X26, X26P, and X2 CEWs in reference to provisions of several international standards that specify safety requirements for electrical medical devices and electrical fences. Although these standards do not specifically mention CEWs, they are the closest electrical safety standards and hence give very relevant guidance. The outputs of two TASER X26 and two TASER X2 CEWs were measured and confirmed against manufacturer and other published specifications. The TASER X26, X26P, and X2 CEWs electrical output parameters were reviewed against relevant safety requirements of UL 69, IEC 60335-2-76 Ed 2.1, IEC 60479-1, IEC 60479-2, AS/NZS 60479.1, AS/NZS 60479.2 and IEC 60601-1. Prior reports on similar topics were reviewed as well. Our measurements and analyses confirmed that the nominal electrical outputs of TASER X26, X26P and X2 CEWs lie within safety bounds specified by relevant requirements of the above standards.

  20. Evaluating safety and operation of high-speed intersections.

    DOT National Transportation Integrated Search

    2010-03-01

    This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...

  1. Production and evaluation of children's dietary life safety index data on metropolitan cities and provinces in Korea

    PubMed Central

    Choi, Young-Sun; Lee, Jung-Sug; Kim, Hye-Young; Kwak, Tong-Kyung; Chung, Hae Rang; Kwon, Sehyug; Choi, Youn-Ju; Lee, Soon-Kyu

    2012-01-01

    This pilot study was performed to produce data of the Children's Dietary Life Safety (CDLS) Index which is required by the Special Act on Safety Management of Children's Dietary Life and to evaluate the CDLS Index for 7 metropolitan cities and 9 provinces in Korea. To calculate the CDLS Index score, data regarding the evaluation indicators in the children's food safety domain and children's nutrition safety domain were collected from the local governments in 2009. For data regarding the indicators in the children's perception & practice domain, a survey was conducted on 2,400 5th grade children selected by stratified sampling in 16 local areas. Relative scores of indicators in each domain were calculated using the data provided by local governments and the survey, the weights are applied on relative scores, and then the CDLS Index scores of local governments were produced by adding scores of the 3 domains. The national average scores of the food safety domain, the nutrition safety domain and the perception and practice domain were 23.74 (14.67-26.50 on a 40-point scale), 16.65 (12.25-19.60 on a 40-point scale), and 14.88 (14.16-15.30 on a 20-point scale), respectively. The national average score of the CDLS Index which was produced by adding the scores of the three domains was 55.27 ranging 46.44-58.94 among local governments. The CDLS Index scores produced in this study may provide the motivation for comparing relative accomplishment and for actively achieving the goals through establishment of the target value by local governments. Also, it can be used as useful data for the establishment and improvement of children's dietary life safety policy at the national level. PMID:23346305

  2. Safety assessment for EPS electron-proton spectrometer

    NASA Technical Reports Server (NTRS)

    Gleeson, P.

    1971-01-01

    A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

  3. Use of safety restraints by law enforcement officers following safety belt training and passage of a statewide belt law

    DOT National Transportation Integrated Search

    1988-04-01

    The report describes work performed in 1984-1985 to develop and evaluate a safety belt program designed for the Maryland State Police - Belt Use Campaign for Law Enforcement (BUCLE), and an evaluation conducted in 1987 to determine the impact of the ...

  4. On Some Methods in Safety Evaluation in Geotechnics

    NASA Astrophysics Data System (ADS)

    Puła, Wojciech; Zaskórski, Łukasz

    2015-06-01

    The paper demonstrates how the reliability methods can be utilised in order to evaluate safety in geotechnics. Special attention is paid to the so-called reliability based design that can play a useful and complementary role to Eurocode 7. In the first part, a brief review of first- and second-order reliability methods is given. Next, two examples of reliability-based design are demonstrated. The first one is focussed on bearing capacity calculation and is dedicated to comparison with EC7 requirements. The second one analyses a rigid pile subjected to lateral load and is oriented towards working stress design method. In the second part, applications of random field to safety evaluations in geotechnics are addressed. After a short review of the theory a Random Finite Element algorithm to reliability based design of shallow strip foundation is given. Finally, two illustrative examples for cohesive and cohesionless soils are demonstrated.

  5. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    PubMed

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  6. To what extent can theory account for the findings of road safety evaluation studies?

    PubMed

    Elvik, Rune

    2004-09-01

    This paper proposes a conceptual framework that can be used to assess to what extent the findings of road safety evaluation research make sense from a theoretical point of view. The effects of road safety measures are modelled as passing through two causal chains. One of these, termed the engineering effect, refers to the intended effects of a road safety measure on a set of risk factors related to accident occurrence or injury severity. The engineering effect of road safety measures is modelled in terms of nine basic risk factors, one or more of which any road safety measure needs to influence in order to have the intended effect on accidents or injuries. The other causal chain producing the effects of road safety measures is termed the behavioural effect, and refers to road user behavioural adaptations to road safety measures. The behavioural effect is related to the engineering effect, in the sense that certain properties of the engineering effect of a road safety measure influence the likelihood that behavioural adaptation will occur. The behavioural effect of a road safety measure is modelled in terms of six factors that influence the likelihood that behavioural adaptation will occur. The nine basic risk factors representing the engineering effect of a road safety measure, and the six factors influencing the likelihood of behavioural adaptation can be used as checklists in assessing whether or not the findings of road safety evaluation studies make sense from a theoretical point of view. At the current state of knowledge, a more stringent evaluation of the extent to which theory can explain the findings of road safety evaluation studies is, in most cases, not possible. Copyright 2003 Elsevier Ltd.

  7. Conducting systematic reviews of economic evaluations.

    PubMed

    Gomersall, Judith Streak; Jadotte, Yuri Tertilus; Xue, Yifan; Lockwood, Suzi; Riddle, Dru; Preda, Alin

    2015-09-01

    In 2012, a working group was established to review and enhance the Joanna Briggs Institute (JBI) guidance for conducting systematic review of evidence from economic evaluations addressing a question(s) about health intervention cost-effectiveness. The objective is to present the outcomes of the working group. The group conducted three activities to inform the new guidance: review of literature on the utility/futility of systematic reviews of economic evaluations and consideration of its implications for updating the existing methodology; assessment of the critical appraisal tool in the existing guidance against criteria that promotes validity in economic evaluation research and two other commonly used tools; and a workshop. The debate in the literature on the limitations/value of systematic review of economic evidence cautions that systematic reviews of economic evaluation evidence are unlikely to generate one size fits all answers to questions about the cost-effectiveness of interventions and their comparators. Informed by this finding, the working group adjusted the framing of the objectives definition in the existing JBI methodology. The shift is away from defining the objective as to determine one cost-effectiveness measure toward summarizing study estimates of cost-effectiveness and informed by consideration of the included study characteristics (patient, setting, intervention component, etc.), identifying conditions conducive to lowering costs and maximizing health benefits. The existing critical appraisal tool was included in the new guidance. The new guidance includes the recommendation that a tool designed specifically for the purpose of appraising model-based studies be used together with the generic appraisal tool for economic evaluations assessment to evaluate model-based evaluations. The guidance produced by the group offers reviewers guidance for each step of the systematic review process, which are the same steps followed in JBI reviews of other

  8. Accelerating evaluation of converged lattice thermal conductivity

    NASA Astrophysics Data System (ADS)

    Qin, Guangzhao; Hu, Ming

    2018-01-01

    High-throughput computational materials design is an emerging area in materials science, which is based on the fast evaluation of physical-related properties. The lattice thermal conductivity (κ) is a key property of materials for enormous implications. However, the high-throughput evaluation of κ remains a challenge due to the large resources costs and time-consuming procedures. In this paper, we propose a concise strategy to efficiently accelerate the evaluation process of obtaining accurate and converged κ. The strategy is in the framework of phonon Boltzmann transport equation (BTE) coupled with first-principles calculations. Based on the analysis of harmonic interatomic force constants (IFCs), the large enough cutoff radius (rcutoff), a critical parameter involved in calculating the anharmonic IFCs, can be directly determined to get satisfactory results. Moreover, we find a simple way to largely ( 10 times) accelerate the computations by fast reconstructing the anharmonic IFCs in the convergence test of κ with respect to the rcutof, which finally confirms the chosen rcutoff is appropriate. Two-dimensional graphene and phosphorene along with bulk SnSe are presented to validate our approach, and the long-debate divergence problem of thermal conductivity in low-dimensional systems is studied. The quantitative strategy proposed herein can be a good candidate for fast evaluating the reliable κ and thus provides useful tool for high-throughput materials screening and design with targeted thermal transport properties.

  9. Electronic clinical safety reporting system: a benefits evaluation.

    PubMed

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  10. Occupational Safety and Health Activities Conducted across Countries in Asia.

    PubMed

    Park, Jung-Keun; Khai, Ton T

    2015-06-01

    Three occupational safety and health (OSH) activities, one international and two national workshops, were documented as part of OSH activities conducted under the International Labor Organization/Korea Partnership Program in the year 2011-2012. This study aimed to provide information on what the three OSH activities were implemented and how they contributed to the improvement of OSH in Asian countries. The international workshop was useful for the participants to understand a variety of information on OSH as well as participatory action-oriented training (PAOT) approaches at the regional and global levels. The two national workshops were practical for participants to strengthen their knowledge and skills on the PAOT at the enterprise and national levels. The study shows that the three OSH activities contributed to the understanding of the participants on OSH and PAOT, and that the activities promoted the improvement of OSH across countries in Asia.

  11. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; Li, Peng; McClure, Leslie A.; Severson, Joan

    2016-01-01

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4–5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children’s immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control). PMID:27918466

  12. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial.

    PubMed

    Schwebel, David C; Li, Peng; McClure, Leslie A; Severson, Joan

    2016-12-02

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4-5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children's immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control).

  13. Longitudinal safety evaluation of connected vehicles' platooning on expressways.

    PubMed

    Rahman, Md Sharikur; Abdel-Aty, Mohamed

    2018-08-01

    Connected vehicles (CV) technology has recently drawn an increasing attention from governments, vehicle manufacturers, and researchers. One of the biggest issues facing CVs popularization associates it with the market penetration rate (MPR). The full market penetration of CVs might not be accomplished recently. Therefore, traffic flow will likely be composed of a mixture of conventional vehicles and CVs. In this context, the study of CV MPR is worthwhile in the CV transition period. The overarching goal of this study was to evaluate longitudinal safety of CV platoons by comparing the implementation of managed-lane CV platoons and all lanes CV platoons (with same MPR) over non-CV scenario. This study applied the CV concept on a congested expressway (SR408) in Florida to improve traffic safety. The Intelligent Driver Model (IDM) along with the platooning concept were used to regulate the driving behavior of CV platoons with an assumption that the CVs would follow this behavior in real-world. A high-level control algorithm of CVs in a managed-lane was proposed in order to form platoons with three joining strategies: rear join, front join, and cut-in joint. Five surrogate safety measures, standard deviation of speed, time exposed time-to-collision (TET), time integrated time-to-collision (TIT), time exposed rear-end crash risk index (TERCRI), and sideswipe crash risk (SSCR) were utilized as indicators for safety evaluation. The results showed that both CV approaches (i.e., managed-lane CV platoons, and all lanes CV platoons) significantly improved the longitudinal safety in the studied expressway compared to the non-CV scenario. In terms of surrogate safety measures, the managed-lane CV platoons significantly outperformed all lanes CV platoons with the same MPR. Different time-to-collision (TTC) thresholds were also tested and showed similar results on traffic safety. Results of this study provide useful insight for the management of CV MPR as managed-lane CV platoons

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

    NASA Astrophysics Data System (ADS)

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

    2017-08-01

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

  15. Training Software Developers and Designers to Conduct Usability Evaluations

    ERIC Educational Resources Information Center

    Skov, Mikael Brasholt; Stage, Jan

    2012-01-01

    Many efforts to improve the interplay between usability evaluation and software development rely either on better methods for conducting usability evaluations or on better formats for presenting evaluation results in ways that are useful for software designers and developers. Both of these approaches depend on a complete division of work between…

  16. Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

    NASA Astrophysics Data System (ADS)

    Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

    2015-05-01

    Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

  17. Evaluation of the anti-hyperglycemic effect and safety of microorganism 1-deoxynojirimycin.

    PubMed

    Takasu, Soo; Parida, Isabella Supardi; Onose, Shinji; Ito, Junya; Ikeda, Ryoichi; Yamagishi, Kenji; Higuchi, Oki; Tanaka, Fukuyo; Kimura, Toshiyuki; Miyazawa, Teruo; Nakagawa, Kiyotaka

    2018-01-01

    1-Deoxynojirimycin (DNJ) is a potent α-glucosidase inhibitor and thus beneficial for prevention of diabetes. While we have succeeded in obtaining the culture supernatant extract (CSE) rich in DNJ from microorganism source, information regarding its anti-hyperglycemic effect and safety were still limited. Therefore, this study was aimed to evaluate the anti-hyperglycemic effect and safety of microorganism DNJ. Oral sucrose tolerance test was performed, and the result showed that CSE was able to significantly suppress the blood glucose elevation and suggested DNJ as the main active compound. To determine its safety, the absorption and excretion of microorganism DNJ were evaluated using 15N labeling method. Our findings investigated the recovery rate of 15N from DNJ reached 80% up to 48 hours after oral administration, suggesting its rapid excretion, suggesting the safety of DNJ. This study verified the functional properties and safety of DNJ from microorganisms, suggesting its potential use for functional purpose.

  18. A bicycle safety index for evaluating urban street facilities.

    PubMed

    Asadi-Shekari, Zohreh; Moeinaddini, Mehdi; Zaly Shah, Muhammad

    2015-01-01

    The objectives of this research are to conceptualize the Bicycle Safety Index (BSI) that considers all parts of the street and to propose a universal guideline with microscale details. A point system method comparing existing safety facilities to a defined standard is proposed to estimate the BSI. Two streets in Singapore and Malaysia are chosen to examine this model. The majority of previous measurements to evaluate street conditions for cyclists usually cannot cover all parts of streets, including segments and intersections. Previous models also did not consider all safety indicators and cycling facilities at a microlevel in particular. This study introduces a new concept of a practical BSI to complete previous studies using its practical, easy-to-follow, point system-based outputs. This practical model can be used in different urban settings to estimate the level of safety for cycling and suggest some improvements based on the standards.

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

    PubMed

    Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

    2003-01-01

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

  20. [Comics for traffic education: evaluation of a traffic safety campaign].

    PubMed

    Bonfadelli, H

    1989-01-01

    Traffic safety campaigns often are ineffective to change driving behavior because they don't reach the target group or are recognized only by people who are already interested or concerned. The evaluation of a traffic safety campaign called "Leo Lässig", addressed to young new drivers, shows that recognition and acceptance by the target group were stimulated by the age-conform means of comic-strips.

  1. Evaluation of the safety of C-spine clearance by paramedics: design and methodology

    PubMed Central

    2011-01-01

    Background Canadian Emergency Medical Services annually transport 1.3 million patients with potential neck injuries to local emergency departments. Less than 1% of those patients have a c-spine fracture and even less (0.5%) have a spinal cord injury. Most injuries occur before the arrival of paramedics, not during transport to the hospital, yet most patients are transported in ambulances immobilized. They stay fully immobilized until a bed is available, or until physician assessment and/or X-rays are complete. The prolonged immobilization is often unnecessary and adds to the burden of already overtaxed emergency medical services systems and crowded emergency departments. Methods/Design The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department. This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule. Discussion Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively

  2. LNG safety assessment evaluation methods : task 3 letter report.

    DOT National Transportation Integrated Search

    2016-07-01

    Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

  3. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

    PubMed Central

    Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

    2012-01-01

    Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

  4. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 40-9086; NRC-2010-0143] Safety Evaluation Report... Deconversion Plant (FEP/DUP) and will be located in Lea County, New Mexico. The NRC has prepared a Safety..., Deconversion and Enrichment Branch, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material...

  5. [Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

    PubMed

    Xie, Yanming; Wei, Xu

    2011-10-01

    Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

  6. Safety evaluation of installing center two-way left-turn lanes on two-lane roads

    DOT National Transportation Integrated Search

    2008-03-01

    The Federal Highway Administration organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was the installation of c...

  7. Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

    PubMed

    Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

    2016-12-20

    Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright

  8. Development of an Evaluation Tool for Online Food Safety Training Programs

    ERIC Educational Resources Information Center

    Neal, Jack A., Jr.; Murphy, Cheryl A.; Crandall, Philip G.; O'Bryan, Corliss A.; Keifer, Elizabeth; Ricke, Steven C.

    2011-01-01

    The objective of this study was to provide the person in charge and food safety instructors an assessment tool to help characterize, identify strengths and weaknesses, determine the completeness of the knowledge gained by the employee, and evaluate the level of content presentation and usability of current retail food safety training platforms. An…

  9. Evaluation of the League General Insurance Company child safety seat distribution program

    DOT National Transportation Integrated Search

    1982-05-01

    This report presents an evaluation of the child safety seat distribution initiated by the League General Insurance Company in June 1979. The program provides child safety seats as a benefit under the company's auto insurance policies to policy-holder...

  10. Evaluating a Computerized Aid for Conducting a Cognitive Task Analysis

    DTIC Science & Technology

    2000-01-01

    in conducting a cognitive task analysis . The conduct of a cognitive task analysis is costly and labor intensive. As a result, a few computerized aids...evaluation of a computerized aid, specifically CAT-HCI (Cognitive Analysis Tool - Human Computer Interface), for the conduct of a detailed cognitive task analysis . A

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

    NASA Astrophysics Data System (ADS)

    Rolita, Lisa; Surarso, Bayu; Gernowo, Rahmat

    2018-02-01

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

  12. 30 CFR 33.7 - Date for conducting tests.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Date for conducting tests. 33.7 Section 33.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General...

  13. 30 CFR 33.7 - Date for conducting tests.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Date for conducting tests. 33.7 Section 33.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General...

  14. 30 CFR 33.7 - Date for conducting tests.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Date for conducting tests. 33.7 Section 33.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General...

  15. 30 CFR 33.7 - Date for conducting tests.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Date for conducting tests. 33.7 Section 33.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General...

  16. 30 CFR 33.7 - Date for conducting tests.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Date for conducting tests. 33.7 Section 33.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL MINES General...

  17. Evaluating the performance and safety effectiveness of roundabouts : appendix.

    DOT National Transportation Integrated Search

    2011-12-01

    This report documents the evaluation of the performance and safety effectiveness of roundabouts within the State of Michigan. The study began with the identification of roundabouts within Michigan. This was followed by collecting data on the geometri...

  18. Conducting Ethical Evaluations with Disadvantaged and Minority Target Groups.

    ERIC Educational Resources Information Center

    English, Brian

    1997-01-01

    This paper examines issues involved in conducting evaluations when participation by the target groups, typically minorities and disadvantaged groups, may put them in jeopardy. Argues that participation by target groups as cooperative partners throughout the evaluation is a way of addressing this dilemma. (SLD)

  19. Evaluating the road safety effects of a fuel cost increase measure by means of zonal crash prediction modeling.

    PubMed

    Pirdavani, Ali; Brijs, Tom; Bellemans, Tom; Kochan, Bruno; Wets, Geert

    2013-01-01

    Travel demand management (TDM) consists of a variety of policy measures that affect the transportation system's effectiveness by changing travel behavior. The primary objective to implement such TDM strategies is not to improve traffic safety, although their impact on traffic safety should not be neglected. The main purpose of this study is to evaluate the traffic safety impact of conducting a fuel-cost increase scenario (i.e. increasing the fuel price by 20%) in Flanders, Belgium. Since TDM strategies are usually conducted at an aggregate level, crash prediction models (CPMs) should also be developed at a geographically aggregated level. Therefore zonal crash prediction models (ZCPMs) are considered to present the association between observed crashes in each zone and a set of predictor variables. To this end, an activity-based transportation model framework is applied to produce exposure metrics which will be used in prediction models. This allows us to conduct a more detailed and reliable assessment while TDM strategies are inherently modeled in the activity-based models unlike traditional models in which the impact of TDM strategies are assumed. The crash data used in this study consist of fatal and injury crashes observed between 2004 and 2007. The network and socio-demographic variables are also collected from other sources. In this study, different ZCPMs are developed to predict the number of injury crashes (NOCs) (disaggregated by different severity levels and crash types) for both the null and the fuel-cost increase scenario. The results show a considerable traffic safety benefit of conducting the fuel-cost increase scenario apart from its impact on the reduction of the total vehicle kilometers traveled (VKT). A 20% increase in fuel price is predicted to reduce the annual VKT by 5.02 billion (11.57% of the total annual VKT in Flanders), which causes the total NOCs to decline by 2.83%. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take when I conduct drilling... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow...

  1. Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

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

    O, J.M.; Higgins, J.; Stephen Fleger - NRC

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« less

  2. The Pennsylvania certified safety committee program: an evaluation of participation and effects on work injury rates.

    PubMed

    Liu, Hangsheng; Burns, Rachel M; Schaefer, Agnes G; Ruder, Teague; Nelson, Christopher; Haviland, Amelia M; Gray, Wayne B; Mendeloff, John

    2010-08-01

    Since 1994, Pennsylvania, like several other states, has provided a 5% discount on workers' compensation insurance premiums for firms with a certified joint labor management safety committee. This study explored the factors affecting program participation and evaluated the effect of this program on work injuries. Using Pennsylvania unemployment insurance data (1996-2006), workers' compensation data (1998-2005), and the safety committee audit data (1999-2007), we conducted propensity score matching and regression analysis on the program's impact on injury rates. Larger firms, firms with higher injury rates, firms in high risk industries, and firms without labor unions were more likely to join the safety committee program and less likely to drop out of the program. The injury rates of participants did not decline more than the rates for non-participants; however, rates at participant firms with good compliance dropped more than the rates at participant firms with poor compliance. Firm size and prior injury rates are key predictors of program participation. Firms that complied with the requirement to train their safety committee members did experience reductions in injuries, but non-compliance with that and other requirements was so widespread that no overall impact of the program could be detected. Copyright 2010 Wiley-Liss, Inc.

  3. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

    PubMed Central

    Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

    2016-01-01

    Background This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. Methods 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. Results No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. Conclusions The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of

  4. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa.

    PubMed

    Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

    2016-01-01

    This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women

  5. The effectiveness of workshops on management evaluation of traffic safety programs.

    DOT National Transportation Integrated Search

    1977-01-01

    Nine management evaluation workshops based on The Evaluation of Highway Traffic Safety Programs' A Manual for Managers were held in various cities throughout the United States by the Office of Manpower Development (NHTSA). The analysis reported here ...

  6. Compendium of Traffic Safety Research Projects: 1985-1995 and Beyond

    DOT National Transportation Integrated Search

    1996-03-01

    The National Highway Traffic Safety Administration's Office of Program : Development and Evaluation (OPDE) conducts research and evaluation projects : dealing with human attitudes, behaviors and failures (motor vehicle crashes). : OPDE's focus is on ...

  7. Continuous Evaluation Of In-Service Highway Safety Feature Performance

    DOT National Transportation Integrated Search

    2002-09-01

    This report documents the research effort, findings, conclusions, and recommendations of a study to develop a program for the continuous in-service evaluation of highway safety features. The study consisted of two phases and eight tasks. An in-servic...

  8. Evaluation of the focused approach to pedestrian safety program

    DOT National Transportation Integrated Search

    2009-02-02

    This report summarizes the results of an evaluation of the Federal Highway Administration (FHWA) Focused Approach to Pedestrian Safety Program. The study was done by the Volpe National Transportation Systems Center at the request of the FHWA Office o...

  9. Conducting Program Evaluation with Hispanics in Rural Settings: Ethical Issues and Evaluation Challenges

    ERIC Educational Resources Information Center

    Loi, Claudia X. Aguado; McDermott, Robert J.

    2010-01-01

    Conducting evaluations that are both valid and ethical is imperative for the support and sustainability of programs that address underserved and vulnerable populations. A key component is to have evaluators who are knowledgeable about relevant cultural issues and sensitive to population needs. Hispanics in rural settings are vulnerable for many…

  10. In vitro and in vivo safety evaluation of Acer tegmentosum.

    PubMed

    Hwang, Youn-Hwan; Park, Hwayong; Ma, Jin Yeul

    2013-06-21

    Acer tegmentosum, which contains salidroside and tyrosol, has been used for the treatment of hepatic disorders in eastern Asia. However, little is known about its safety. To determine the safety of Acer tegmentosum, we evaluated its acute oral toxicity and genotoxicity profiles. Salidroside and tyrosol present in Acer tegmentosum were quantified using high-performance liquid chromatography. Acute oral toxicity testing of Acer tegmentosum was performed in rats. Genotoxicity of Acer tegmentosum was assessed by bacterial reverse mutation, chromosomal aberration, and bone marrow micronucleus tests. All the tests were conducted in accordance with the good laboratory practices. The amounts of salidroside and tyrosol in Acer tegmentosum were found to be 85.01±1.21mg/g and 3.12±0.04mg/g, respectively. In the bacterial reverse mutation test, Acer tegmentosum increased the number of revertant Salmonella typhimurium TA98 colonies, regardless of metabolic activation by S9 mixture. In contrast, Acer tegmentosum application did not significantly increase the number of chromosomal aberrations in Chinese hamster ovary (CHO)-K1 cells and micronucleated polychromatic erythrocytes in mice. In the acute oral toxicity test, the median lethal dose (LD50) of Acer tegmentosum was found to be >2000mg/kg in rats. Take together, Acer tegmentosum exhibits mutagenicity, which was evident from the bacterial reverse mutation test. Further studies are needed to identify the components responsible for such an effect and the underlying mechanisms. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  11. Does lean management improve patient safety culture? An extensive evaluation of safety culture in a radiotherapy institute.

    PubMed

    Simons, Pascale A M; Houben, Ruud; Vlayen, Annemie; Hellings, Johan; Pijls-Johannesma, Madelon; Marneffe, Wim; Vandijck, Dominique

    2015-02-01

    The importance of a safety culture to maximize safety is no longer questioned. However, achieving sustainable culture improvements are less evident. Evidence is growing for a multifaceted approach, where multiple safety interventions are combined. Lean management is such an integral approach to improve safety, quality and efficiency and therefore, could be expected to improve the safety culture. This paper presents the effects of lean management activities on the patient safety culture in a radiotherapy institute. Patient safety culture was evaluated over a three year period using triangulation of methodologies. Two surveys were distributed three times, workshops were performed twice, data from an incident reporting system (IRS) was monitored and results were explored using structured interviews with professionals. Averages, chi-square, logistical and multi-level regression were used for analysis. The workshops showed no changes in safety culture, whereas the surveys showed improvements on six out of twelve dimensions of safety climate. The intention to report incidents not reaching patient-level decreased in accordance with the decreasing number of reports in the IRS. However, the intention to take action in order to prevent future incidents improved (factorial survey presented β: 1.19 with p: 0.01). Due to increased problem solving and improvements in equipment, the number of incidents decreased. Although the intention to report incidents not reaching patient-level decreased, employees experienced sustained safety awareness and an increased intention to structurally improve. The patient safety culture improved due to the lean activities combined with an organizational restructure, and actual patient safety outcomes might have improved as well. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    PubMed

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  13. Safety evaluation methodology for advanced coal extraction systems

    NASA Technical Reports Server (NTRS)

    Zimmerman, W. F.

    1981-01-01

    Qualitative and quantitative evaluation methods for coal extraction systems were developed. The analysis examines the soundness of the design, whether or not the major hazards have been eliminated or reduced, and how the reduction would be accomplished. The quantitative methodology establishes the approximate impact of hazards on injury levels. The results are weighted by peculiar geological elements, specialized safety training, peculiar mine environmental aspects, and reductions in labor force. The outcome is compared with injury level requirements based on similar, safer industries to get a measure of the new system's success in reducing injuries. This approach provides a more detailed and comprehensive analysis of hazards and their effects than existing safety analyses.

  14. Scientific Considerations for Evaluating Cancer Bioassays Conducted by the Ramazzini Institute

    PubMed Central

    Caldwell, Jane C.; Jinot, Jennifer; Evans, Marina V.; Cote, Ila; Vandenberg, John J.

    2013-01-01

    Background: The Ramazzini Institute (RI) has completed nearly 400 cancer bioassays on > 200 compounds. The European Food Safety Authority (EFSA) and others have suggested that study design and protocol differences between the RI and other laboratories by may contribute to controversy regarding cancer hazard findings, principally findings on lymphoma/leukemia diagnoses. Objective: We aimed to evaluate RI study design, protocol differences, and accuracy of tumor diagnoses for their impact on carcinogenic hazard characterization. Methods: We analyzed the findings from a recent Pathology Working Group (PWG) review of RI procedures and tumor diagnoses, evaluated consistency of RI and other laboratory findings for chemicals identified by the RI as positive for lymphoma/leukemia, and examined evidence for a number of other issues raised regarding RI bioassays. The RI cancer bioassay design and protocols were evaluated in the context of relevant risk assessment guidance from international authorities. Discussion: Although the PWG identified close agreement with RI diagnoses for most tumor types, it did not find close agreement for lymphoma/leukemia of the respiratory tract or for neoplasms of the inner ear and cranium. Here we discuss a) the implications of the PWG findings, particularly lymphoma diagnostic issues; b) differences between RI studies and those from other laboratories that are relevant to evaluating RI cancer bioassays; and c) future work that may help resolve some concerns. Conclusions: We concluded that a) issues related to respiratory tract infections have complicated diagnoses at that site (i.e., lymphoma/leukemia), as well as for neoplasms of the inner ear and cranium, and b) there is consistency and value in RI studies for identification of other chemical-related neoplasia. Citation: Gift JS, Caldwell JC, Jinot J, Evans MV, Cote I, Vandenberg JJ. 2013. Scientific considerations for evaluating cancer bioassays conducted by the Ramazzini Institute

  15. 30 CFR 18.9 - Conduct of investigations and tests.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Conduct of investigations and tests. 18.9 Section 18.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES General...

  16. Evaluating safety and operations of high-speed signalized intersections.

    DOT National Transportation Integrated Search

    2010-03-01

    This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...

  17. Evaluation of Gusset Plate Safety in Steel Truss Bridges

    DOT National Transportation Integrated Search

    2011-10-01

    Failure of the I-35 truss bridge in Minneapolis has been attributed to failure of a gusset plate, necessitating : evaluation of gusset plate safety on bridges across the county. FHWA Publication IF-09-014 provides state : DOTs with important guidance...

  18. Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

    PubMed

    Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

    2009-04-01

    To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

  19. CSC Tip Sheets: Conducting and Evaluating Pilot Projects

    EPA Pesticide Factsheets

    Learn how to conduct and evaluate pilot projects, which are opportunities to “test the waters” for your project on a small scale, provide insight and data on what works, and adjust your strategy for full-scale implementation.

  20. Evaluation of the Level of Food Safety Protection Provided by the U.S. Grade "A" Pasteurized Milk Ordinance and Its Associated Cooperative Grade "A" Milk Safety Program.

    PubMed

    Ma, Yinqing; Klontz, Karl C; DiNovi, Michael J; Edwards, Alison J; Hennes, Robert F

    2015-08-01

    The present study was conducted to evaluate the level of food safety protection provided to consumers of Grade "A" milk and milk products in the United States by the National Conference on Interstate Milk Shipments (NCIMS) Grade "A" Milk Safety Program through its implementation and enforcement of the U.S. Grade "A" Pasteurized Milk Ordinance (PMO). The number of reported illnesses associated with Grade "A" milk and milk products in the United States was obtained from state and federal agencies and published articles. The consumption of Grade "A" milk and milk products in the United States was estimated from food consumption survey data for individuals. The level of food safety protection was measured quantitatively using the metric of annual illness attack rate. During a 15-year period (1999 through 2013), the estimated annual illness attack rate was 0.41 reported illnesses per 1 billion exposures (estimated using person-day intake data) or 0.52 reported illnesses per 1 billion lb (454 million kg) of Grade "A" milk and milk products consumed. Food safety protection provided to consumers of Grade "A" milk and milk products by the NCIMS through its implementation and enforcement of the PMO is important given the common consumption of Grade "A" milk and milk products in the United States.

  1. Framework for selection and evaluation of bicycle and pedestrian safety projects in Virginia.

    DOT National Transportation Integrated Search

    2008-01-01

    The Virginia Department of Transportation's (VDOT) Bicycle and Pedestrian Safety (BPS) Program provides funds for implementing short-term, low-cost bicycle and pedestrian safety projects in Virginia. This initiative is administered by evaluating each...

  2. Safety Evaluation of a Novel Strain of Bacteroides fragilis.

    PubMed

    Wang, Ye; Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

    2017-01-01

    Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey's manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro , ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro . This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum.

  3. Triangulation and the importance of establishing valid methods for food safety culture evaluation.

    PubMed

    Jespersen, Lone; Wallace, Carol A

    2017-10-01

    The research evaluates maturity of food safety culture in five multi-national food companies using method triangulation, specifically self-assessment scale, performance documents, and semi-structured interviews. Weaknesses associated with each individual method are known but there are few studies in food safety where a method triangulation approach is used for both data collection and data analysis. Significantly, this research shows that individual results taken in isolation can lead to wrong conclusions, resulting in potentially failing tactics and wasted investments. However, by applying method triangulation and reviewing results from a range of culture measurement tools it is possible to better direct investments and interventions. The findings add to the food safety culture paradigm beyond a single evaluation of food safety culture using generic culture surveys. Copyright © 2017. Published by Elsevier Ltd.

  4. 77 FR 27814 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... NUCLEAR REGULATORY COMMISSION [Project No. 753; NRC-2012-0019] Model Safety Evaluation for Plant... Regulatory Commission (NRC) is announcing the availability of the model safety evaluation (SE) for plant... the Improved Standard Technical Specification (ISTS), NUREG-1431, ``Standard Technical Specifications...

  5. SER assistant: An expert system for safety evaluation reports

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

    DeChaine, M.D.; Levine, S.H.; Feltus, M.A.

    1993-01-01

    The SER Assistant is an expert system that assists engineers to write safety evaluation reports (SERs). Section 50.59 of the Code of Federal Regulations allows modifications to be made to nuclear power plants without prior US Nuclear Regulatory Commission approval if two conditions are satisfied. First, the change must not affect the technical specifications of the plant. Second, the modification must not affect a part of the plant described in the final safety analysis report, or if it does, it must not create an unreviewed safety question. The purpose of an SER is to ensure that these conditions are satisfiedmore » for the proposed modification. The SER Assistant aids this process by providing relevant, but directed, questions and information as well as giving engineers an organized environment to document their thought processes.« less

  6. Performance and evaluation of small construction safety training simulations.

    PubMed

    Wojcik, S M; Kidd, P S; Parshall, M B; Struttmann, T W

    2003-06-01

    Back- and fall-related injuries occur frequently in construction and are costly in terms of workers' compensation claims and lost productivity. Interventions are needed that address the susceptibility to these injuries. The purpose of this study was to develop and test a safety training intervention for small construction companies (evaluation of these simulation exercises, not their effectiveness in preventing injuries. The intervention consisted of six latent-image narrative simulation exercises targeted at prevention of back- or fall-related injuries, which emphasized both the economic impact of injuries and the benefits of individual and organizational prevention strategies. Participants included owner-operators, supervisors and employees. Analyses were completed to determine participant scores on the intervention along with their perceptions of the quality, realism and applicability of the training. Mean pooled performance scores (percentage correct) were 83.3% [standard deviation (SD) = 8.9, n = 143] for three back simulations and 85.2% (SD = 8.9, n = 159) for three fall-related simulations. Mean total evaluation scores (percentage of maximum) were 83.1% (SD = 11.6) and 85.5% (SD = 11.7) for the back and fall simulations, respectively. Quality and realism evaluation scores were significantly higher than scores for applicability to work. Simulations were well received as safety training exercises. Given the heterogeneous work classifications found in small construction companies, it may be preferable to target safety intervention content to specific trades rather than aim for generality across trades.

  7. Findings From the National Machine Guarding Program-A Small Business Intervention: Machine Safety.

    PubMed

    Parker, David L; Yamin, Samuel C; Xi, Min; Brosseau, Lisa M; Gordon, Robert; Most, Ivan G; Stanley, Rodney

    2016-09-01

    The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 to 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of Occupational Safety and Health Administration (OSHA) citations and may result in serious traumatic injury. Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10% point increase in business-level machine scores (P < 0.0001) and a 33% point increase in LOTO program scores (P < 0.0001). Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees.

  8. [Organisational responsibility versus individual responsibility: safety culture? About the relationship between patient safety and medical malpractice law].

    PubMed

    Hart, Dieter

    2009-01-01

    The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.

  9. Safety evaluation of tangeretin and the effect of using emulsion-based delivery system: Oral acute and 28-day sub-acute toxicity study using mice.

    PubMed

    Ting, Yuwen; Chiou, Yi-Shiou; Jiang, Yike; Pan, Min-Hsiung; Lin, Zhengyu; Huang, Qingrong

    2015-08-01

    Polymethoxyflavones, found widely in the peel of citrus fruits, is an emerging group of bioactive compounds with wide arrays of disease prevention functionalities. To understand the potential oral toxicity, tangeretin, being one of the most abundant polymethoxyflavones from natural sources, was used as model compound for the safety evaluation. Acute oral toxicity study was conducted using both male and female mice giving 1000, 2000, or 3000mg/kgbody weight (bw) of tangeretin in oil suspension from single gavage administration. No evidence of death was observed during 14-day post-administration period. Alterations of the hepatic cell and clinical chemistry profile increased dose dependently and exhibited distinct injury recovery pattern among different sexes. To determine the potential safety concern related to emulsification, the sub-acute toxicity of tangeretin in emulsion was evaluated and compared with un-processed oil suspension when conducting the sub-acute toxicity study over 28days. In the sub-acute study, emulsion system did not induce a significant increase of toxicity response. However, the daily low-dose application of tangeretin showed U-shaped dose-response pattern in regard to hepatic alteration. The result from this study can serve as a good safety reference for future application of polymethoxyflavone as a functional ingredient in food. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Evaluation of safety effect of turbo-roundabout lane dividers using floating car data and video observation.

    PubMed

    Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej

    2018-06-01

    Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine

  11. Independent evaluation of light-vehicle safety applications based on vehicle-to-vehicle communications used in the 2012-2013 safety pilot model deployment

    DOT National Transportation Integrated Search

    2015-12-01

    This report presents the methodology and results of the independent evaluation of safety applications for passenger vehicles in the 2012-2013 Safety Pilot Model Deployment, part of the United States Department of Transportations Intelligent Transp...

  12. Safety survey report EBR-II safety survey, ANL-west health protection, industrial safety and fire protection survey

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

    Dunbar, K.A.

    1972-01-10

    A safety survey covering the disciplines of Reactor Safety, Nuclear Criticality Safety, Health Protection and Industrial Safety and Fire Protection was conducted at the ANL-West EBR-II FEF Complex during the period January 10-18, 1972. In addition, the entire ANL-West site was surveyed for Health Protection and Industrial Safety and Fire Protection. The survey was conducted by members of the AEC Chicago Operations Office, a member of RDT-HQ and a member of the RDT-ID site office. Eighteen recommendations resulted from the survey, eleven in the area of Industrial Safety and Fire Protection, five in the area of Reactor Safety and twomore » in the area of Nuclear Criticality Safety.« less

  13. Monopolar radiofrequency treatment of the eyelids: a safety evaluation.

    PubMed

    Biesman, Brian S; Pope, Karl

    2007-07-01

    Monopolar radiofrequency (RF) energy has been used to successfully accomplish noninvasive skin tightening of the face, abdomen, and extremities. Owing to concerns about injury to the eye itself, monopolar RF treatment of the eyelids has not been feasible. The objective was to evaluate the safety of a novel 0.25-cm(2)"shallow" treatment tip for noninvasive tightening of eyelid skin. This was a tripartite study that began with an animal model to evaluate soft tissue effects and temperature change at the ocular surface. Findings were then extrapolated to ex vivo evaluation of human eyelids and ultimately to an in vivo human eyelid safety study. The animal studies demonstrated that the 0.25-cm(2) treatment tip could be used safely on eyelids in conjunction with appropriate ocular protection. The ex vivo human eyelid studies confirmed that, at typical treatment settings, the shallow treatment tip did not produce frank eyelid injury. The in vivo human studies confirmed that, at the tested settings, the novel treatment tip did not injure the eyelids or eyes. If used properly, the 0.25-cm(2) treatment tip can be safely used on human eyelids.

  14. 49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

  15. 49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

  16. 49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

  17. 49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

  18. An empirical Bayes safety evaluation of tram/streetcar signal and lane priority measures in Melbourne.

    PubMed

    Naznin, Farhana; Currie, Graham; Sarvi, Majid; Logan, David

    2016-01-01

    Streetcars/tram systems are growing worldwide, and many are given priority to increase speed and reliability performance in mixed traffic conditions. Research related to the road safety impact of tram priority is limited. This study explores the road safety impacts of tram priority measures including lane and intersection/signal priority measures. A before-after crash study was conducted using the empirical Bayes (EB) method to provide more accurate crash impact estimates by accounting for wider crash trends and regression to the mean effects. Before-after crash data for 29 intersections with tram signal priority and 23 arterials with tram lane priority in Melbourne, Australia, were analyzed to evaluate the road safety impact of tram priority. The EB before-after analysis results indicated a statistically significant adjusted crash reduction rate of 16.4% after implementation of tram priority measures. Signal priority measures were found to reduce crashes by 13.9% and lane priority by 19.4%. A disaggregate level simple before-after analysis indicated reductions in total and serious crashes as well as vehicle-, pedestrian-, and motorcycle-involved crashes. In addition, reductions in on-path crashes, pedestrian-involved crashes, and collisions among vehicles moving in the same and opposite directions and all other specific crash types were found after tram priority implementation. Results suggest that streetcar/tram priority measures result in safety benefits for all road users, including vehicles, pedestrians, and cyclists. Policy implications and areas for future research are discussed.

  19. Findings from the National Machine Guarding Program–A Small Business Intervention: Machine Safety

    PubMed Central

    Yamin, Samuel C.; Xi, Min; Brosseau, Lisa M.; Gordon, Robert; Most, Ivan G.; Stanley, Rodney

    2016-01-01

    Objectives The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 – 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of OSHA citations and may result in serious traumatic injury. Methods Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits and a twelve-month follow-up evaluation. Results The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10-percentage point increase in business-level machine scores (p< 0.0001) and a 33-percentage point increase in LOTO program scores (p <0.0001). Conclusions Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees. PMID:26716850

  20. Stakeholders' Perspectives About and Priorities for Economic Evaluation of Health and Safety Programs in Healthcare.

    PubMed

    Tompa, Emile; de Boer, Henriette; Macdonald, Sara; Alamgir, Hasanat; Koehoorn, Mieke; Guzman, Jaime

    2016-04-01

    This study identified and prioritized resources and outcomes that should be considered in more comprehensive and scientifically rigorous health and safety economic evaluations according to healthcare sector stakeholders. A literature review and stakeholder interviews identified candidate resources and outcomes and then a Delphi panel ranked them. According to the panel, the top five resources were (a) health and safety staff time; (b) training workers; (c) program planning, promotion, and evaluation costs; (d) equipment purchases and upgrades; and (e) administration costs. The top five outcomes were (a) number of injuries, illnesses, and general sickness absences; (b) safety climate; (c) days lost due to injuries, illnesses, and general sickness absences; (d) job satisfaction and engagement; and (e) quality of care and patient safety. These findings emphasize stakeholders' stated priorities and are useful as a benchmark for assessing the quality of health and safety economic evaluations and the comprehensiveness of these findings. © 2016 The Author(s).

  1. GROWTH OF THE INTERNATIONAL CRITICALITY SAFETY AND REACTOR PHYSICS EXPERIMENT EVALUATION PROJECTS

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

    J. Blair Briggs; John D. Bess; Jim Gulliford

    2011-09-01

    Since the International Conference on Nuclear Criticality Safety (ICNC) 2007, the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and the International Reactor Physics Experiment Evaluation Project (IRPhEP) have continued to expand their efforts and broaden their scope. Eighteen countries participated on the ICSBEP in 2007. Now, there are 20, with recent contributions from Sweden and Argentina. The IRPhEP has also expanded from eight contributing countries in 2007 to 16 in 2011. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Criticality Safety Benchmark Experiments1' have increased from 442 evaluations (38000 pages), containing benchmark specifications for 3955 critical ormore » subcritical configurations to 516 evaluations (nearly 55000 pages), containing benchmark specifications for 4405 critical or subcritical configurations in the 2010 Edition of the ICSBEP Handbook. The contents of the Handbook have also increased from 21 to 24 criticality-alarm-placement/shielding configurations with multiple dose points for each, and from 20 to 200 configurations categorized as fundamental physics measurements relevant to criticality safety applications. Approximately 25 new evaluations and 150 additional configurations are expected to be added to the 2011 edition of the Handbook. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Reactor Physics Benchmark Experiments2' have increased from 16 different experimental series that were performed at 12 different reactor facilities to 53 experimental series that were performed at 30 different reactor facilities in the 2011 edition of the Handbook. Considerable effort has also been made to improve the functionality of the searchable database, DICE (Database for the International Criticality Benchmark Evaluation Project) and verify the accuracy of the data contained therein. DICE will be discussed in separate papers at ICNC 2011. The status of the ICSBEP and

  2. Safety Evaluation of a Novel Strain of Bacteroides fragilis

    PubMed Central

    Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

    2017-01-01

    Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey’s manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro, ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro. This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum. PMID:28367145

  3. Do code of conduct audits improve chemical safety in garment factories? Lessons on corporate social responsibility in the supply chain from Fair Wear Foundation.

    PubMed

    Lindholm, Henrik; Egels-Zandén, Niklas; Rudén, Christina

    2016-10-01

    In managing chemical risks to the environment and human health in supply chains, voluntary corporate social responsibility (CSR) measures, such as auditing code of conduct compliance, play an important role. To examine how well suppliers' chemical health and safety performance complies with buyers' CSR policies and whether audited factories improve their performance. CSR audits (n = 288) of garment factories conducted by Fair Wear Foundation (FWF), an independent non-profit organization, were analyzed using descriptive statistics and statistical modeling. Forty-three per cent of factories did not comply with the FWF code of conduct, i.e. received remarks on chemical safety. Only among factories audited 10 or more times was there a significant increase in the number of factories receiving no remarks. Compliance with chemical safety requirements in garment supply chains is low and auditing is statistically correlated with improvements only at factories that have undergone numerous audits.

  4. A Public-Private Consortium Advances Cardiac Safety Evaluation: Achievements of the HESI Cardiac Safety Technical Committee

    EPA Science Inventory

    The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues have been and continue to be a major cause of attrition and withdrawal due to Adverse Drug Reactions (ADRs) in pharmaceutical drug developm...

  5. Meat Safety: An Evaluation of Portuguese Butcher Shops.

    PubMed

    Santos, Ana; Cardoso, Margarida Fonseca; Costa, José M Correia da; Gomes-Neves, Eduarda

    2017-07-01

    Butcher shops are end points in the meat chain, and they can have a determinant role in cross-contamination control. This study aims to determine whether Portuguese butcher shops comply with European and Portuguese law regarding the sale of fresh meat and meat products. Butcher shops (n = 73) were assessed for meat handler and facility hygiene and for maintenance of the premises. Handlers (n = 88) were given a questionnaire composed of questions about knowledge and practice, including hazard analysis and critical control point (HACCP) and good practice in food industry, to assess their knowledge of and compliance with food safety practices. A checklist of 27 items was used to evaluate facility and meat handler hygiene and butcher shop maintenance. Our results revealed some lack of compliance in all the areas evaluated. The mean knowledge and practice score among the operators was 68.0%, and the mean "visual inspection" score for the butcher shops was 64.0%. Severe deficiencies were observed in the mandatory implementation of HACCP principles in this type of small food business. These findings indicate a need to modify training to enhance compliance with European food safety regulations at this step of the meat chain.

  6. Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

    PubMed Central

    Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

    2009-01-01

    Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

  7. 30 CFR 33.8 - Conduct of investigations, tests, and demonstrations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Conduct of investigations, tests, and demonstrations. 33.8 Section 33.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK...

  8. 30 CFR 33.8 - Conduct of investigations, tests, and demonstrations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Conduct of investigations, tests, and demonstrations. 33.8 Section 33.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK...

  9. 30 CFR 33.8 - Conduct of investigations, tests, and demonstrations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Conduct of investigations, tests, and demonstrations. 33.8 Section 33.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK...

  10. 30 CFR 33.8 - Conduct of investigations, tests, and demonstrations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Conduct of investigations, tests, and demonstrations. 33.8 Section 33.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK...

  11. 30 CFR 33.8 - Conduct of investigations, tests, and demonstrations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Conduct of investigations, tests, and demonstrations. 33.8 Section 33.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK...

  12. Wheel climb derailment criteria for evaluation of rail vehicle safety

    DOT National Transportation Integrated Search

    1984-01-01

    Criteria for evaluating safety of rail vehicles with respect to wheel climb derailment are reviewed. The relationship between flanging wheel lateral to veritical force ratio at impending derailment and angle of attack, lateral velocity and longitudin...

  13. Evaluation of the safety benefits of legacy safe routes to school programs

    DOT National Transportation Integrated Search

    2008-08-01

    This study first examined the feasibility of conducting a crash-based assessment of the safety effects of legacy Safe Routes to School : (SRTS) programs. These were SRTS programs operating before the passage of the Safe, Accountable, Flexible, Effici...

  14. A randomized controlled trial to evaluate the Make Safe Happen® app-a mobile technology-based safety behavior change intervention for increasing parents' safety knowledge and actions.

    PubMed

    McKenzie, Lara B; Roberts, Kristin J; Clark, Roxanne; McAdams, Rebecca; Abdel-Rasoul, Mahmoud; Klein, Elizabeth G; Keim, Sarah A; Kristel, Orie; Szymanski, Alison; Cotton, Christopher G; Shields, Wendy C

    2018-03-12

    Many unintentional injuries that occur in and around the home can be prevented through the use of safety equipment and by consistently following existing safety recommendations. Unfortunately, uptake of these safety behaviors is unacceptably low. This paper describes the design of the Make Safe Happen® smartphone application evaluation study, which aims to evaluate a mobile technology-based safety behavior change intervention on parents' safety knowledge and actions. Make Safe Happen® app evaluation study is a randomized controlled trial. Participants will be parents of children aged 0-12 years who are recruited from national consumer online survey panels. Parents will complete a pretest survey, and will be randomized to receive the Make Safe Happen® app or a non-injury-related app, and then complete a posttest follow-up survey after 1 week. Primary outcomes are: (1) safety knowledge; (2) safety behaviors; (3) safety device acquisition and use, and (4) behavioral intention to take safety actions. Anticipated study results are presented. Wide-reaching interventions, to reach substantial parent and caregiver audiences, to effectively reduce childhood injuries are needed. This study will contribute to the evidence-base about how to increase safety knowledge and actions to prevent home-related injuries in children. NCT02751203 ; Pre-results.

  15. Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.

    PubMed

    Cohet, Catherine; Rosillon, Dominique; Willame, Corinne; Haguinet, Francois; Marenne, Marie-Noëlle; Fontaine, Sandrine; Buyse, Hubert; Bauchau, Vincent; Baril, Laurence

    2017-05-25

    Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence. Copyright © 2017 GSK Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

  16. Evaluation of bypass lane safety, operations, and design in Kansas.

    DOT National Transportation Integrated Search

    2015-08-01

    The construction of bypass lanes at rural intersections has typically been considered a low-cost highway safety : improvement by the transportation community. However, this needs to be quantitatively evaluated so that decisions can be made : on wheth...

  17. Evaluation of a safety training program in three food service companies.

    PubMed

    Sinclair, Raymond C; Smith, Randall; Colligan, Michael; Prince, Mary; Nguyen, Trang; Stayner, Leslie

    2003-01-01

    Outcome measures for safety training effectiveness research often do not include measures such as occupational injury experience. Effectiveness mediators also receive sparse attention. A new safety training curriculum was delivered to workers in a stratified random sample of food service facilities across three companies. A similar group of facilities received usual training. We collected post-test measures of demographic variables, safety knowledge, perceptions of transfer of training climate, and workers' compensation claim data for one year after the initial training activities. Knowledge test scores were apparently higher in the new-training units than in the usual-training units. Some demographic variables were inconsistently associated with these differences. Evidence for reduction of the injury rate associated with the new training was observed from two companies but only approached significance for one company. A second company revealed a similar but non-significant trend. Knowledge scores were not significantly associated with lower injury rates. We found evidence that safety training increases knowledge and reduces injuries. We found almost no evidence of effects of training effectiveness mediators, including no relationship between safety knowledge and injury experience. Methodological issues related to conducting a large study may have influenced these results. Although safety training leads to greater knowledge and, in some cases, reduced occupational injuries, the influence of mediating variables remains to be fully explained.

  18. [Safety evaluation and risk control measures of Cassiae Semen].

    PubMed

    Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun

    2017-11-01

    In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over

  19. Consideration of future safety consequences: a new predictor of employee safety.

    PubMed

    Probst, Tahira M; Graso, Maja; Estrada, Armando X; Greer, Sarah

    2013-06-01

    Compliance with safety behaviors is often associated with longer term benefits, but may require some short-term sacrifices. This study examines the extent to which consideration of future safety consequences (CFSC) predicts employee safety outcomes. Two field studies were conducted to evaluate the reliability and validity of the newly developed Consideration of Future Safety Consequences (CFSC) scale. Surveys containing the CFSC scale and other measures of safety attitudes, behaviors, and outcomes were administered during working hours to a sample of 128 pulp and paper mill employees; after revising the CFSC scale based on these initial results, follow-up survey data were collected in a second sample of 212 copper miners. In Study I, CFSC was predictive of employee safety knowledge and motivation, compliance, safety citizenship behaviors, accident reporting attitudes and behaviors, and workplace injuries - even after accounting for conscientiousness and demographic variables. Moreover, the effects of CFSC on the variables generally appear to be direct, as opposed to mediated by safety knowledge or motivation. These findings were largely replicated in Study II. CFSC appears to be an important personality construct that may predict those individuals who are more likely to comply with safety rules and have more positive safety outcomes. Future research should examine the longitudinal stability of CFSC to determine the extent to which this construct is a stable trait, rather than a safety attitude amenable to change over time or following an intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Improvement of older driver safety through self-evaluation : the development of a self-evaluation instrument

    DOT National Transportation Integrated Search

    2000-03-01

    This research project was designed to increase safety in the older driver population by developing and testing a self-evaluation instrument. The instrument is intended for drivers who may be starting to experience declines in driving abilities or los...

  1. A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

    PubMed

    Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

    2016-05-01

    To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. Randomized model-based simulation study. University medical center. A total of 33 third-year medical students. Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. Significant differences exist between safety mechanisms of winged blood collection needles.

  2. Do code of conduct audits improve chemical safety in garment factories? Lessons on corporate social responsibility in the supply chain from Fair Wear Foundation

    PubMed Central

    2016-01-01

    Background In managing chemical risks to the environment and human health in supply chains, voluntary corporate social responsibility (CSR) measures, such as auditing code of conduct compliance, play an important role. Objectives To examine how well suppliers’ chemical health and safety performance complies with buyers’ CSR policies and whether audited factories improve their performance. Methods CSR audits (n = 288) of garment factories conducted by Fair Wear Foundation (FWF), an independent non-profit organization, were analyzed using descriptive statistics and statistical modeling. Results Forty-three per cent of factories did not comply with the FWF code of conduct, i.e. received remarks on chemical safety. Only among factories audited 10 or more times was there a significant increase in the number of factories receiving no remarks. Conclusions Compliance with chemical safety requirements in garment supply chains is low and auditing is statistically correlated with improvements only at factories that have undergone numerous audits. PMID:27611103

  3. Preventing Fire Death and Injury, Conducting a Fire Drill in a Group Home [and] When You Need a Fire Safety Expert. National Fire Safety Certification System. Continuing Education Program. Volume 1, Numbers 1-3.

    ERIC Educational Resources Information Center

    Walker, Bonnie

    Three booklets provide fire safety information for staff of residential facilities serving people with developmental disabilities. Booklets focus on: (1) preventing fire death and injury, (2) conducting a fire drill in a group home, and (3) the role of fire safety experts. The first booklet stresses the elimination of the following dangers:…

  4. [Safety evaluation of niuhuang jiedu tablet].

    PubMed

    Feng, Yu-Ling; Miao, Jia-wei; Li, Jing; Sung, An-Sheng; Liu, Jie

    2014-09-01

    Realgar-containing Niuhuang Jiedu tablet (NHJD) has been applied in clinic for more than 800 years. However, because realgar contains arsenic (As), it has aroused wide concerns and controversies both at home and abroad. Currently, there are two misunderstandings about realgar-containing Chinese patent medicines. First, some people exaggerated realgar's toxicity as that of arsenic. Second, they recommended to remove realgar from traditional Chinese medicine compounds. In this paper, the authors summarized the advance in studies on NHJD, and proposed different opinions: (1) It is inappropriate to take total As as the index in safety evaluation of NHJD. (2) The toxicity of NHJD is dependent on the dose and duration of administration. (3) Realgar is an active ingredient of NHJD, and shall be deeply studied. Classic realgar-containing traditional Chinese medicine prescriptions, such as Niuhuang Jiedu tablet, shall be evaluated with rigorous modern scientific basis, with the aim to guide rational and safe application.

  5. Safety and toxicological evaluation of a novel anti-obesity formulation LI85008F in animals.

    PubMed

    Krishnaraju, A V; Sundararaju, D; Srinivas, P; Rao, C V; Sengupta, K; Trimurtulu, G

    2010-02-01

    LI85008F is a novel synergistic composition of Moringa oleifera, Murraya koenigi, and Curcuma longa. These herbs are well recognized and widely used in ayurvedic system of medicine for treating a variety of diseases and are also have been used for culinary purposes for thousands of years. LI85008F inhibits preadipocyte differentiation and potentiates lipid breakdown in mature adipocytes. In diet-induced obese rats, LI85008F significantly reduced weight gain and improved serum adiponectin levels. These findings motivated the authors to determine the broad-spectrum safety of LI85008F. Acute oral toxicity, acute dermal toxicity, primary skin irritation, primary eye irritation, and dose-dependent 28-day sub-acute toxicity studies were conducted. The acute oral LD50 of LI85008F was greater than 5000 mg/kg in female SD rats and no changes in body weight or adverse effects were observed following necropsy. Acute dermal LD50 of LI85008F was greater than 2000 mg/kg. LI85008F was classified as non-irritating to skin in a primary dermal irritation study conducted using New Zealand Albino rabbits. LI85008F caused minimal irritation to eyes in a primary eye irritation test conducted on New Zealand Albino rabbits. A dose-dependent 28-day sub-acute toxicity study demonstrated no significant changes in selected organ weights. Evaluations on hematology, clinical chemistry, and histopathology did not show any significant adverse changes. The NOAEL of LI85008F was found to be greater than 2500 mg/kg body weight. These results demonstrate the broad spectrum safety of LI85008F in animal models.

  6. 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...

  7. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  8. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  9. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  10. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  11. The art of appropriate evaluation : a guide for highway safety program managers

    DOT National Transportation Integrated Search

    2008-08-01

    The guide, updated from its original release in 1999, is intended for project managers who will oversee the evaluation of traffic safety programs. It describes the benefits of evaluation and provides an overview of the steps involved. The guide inclu...

  12. The art of appropriate evaluation : a guide for highway safety program managers

    DOT National Transportation Integrated Search

    2008-12-01

    The guide, updated from its original release in 1999, is intended for project managers who will oversee the evaluation of traffic safety programs. It describes the benefits of evaluation and provides an overview of the steps involved. The guide inclu...

  13. Safety Evaluation of Red Light Running Camera Intersections in Illinois

    DOT National Transportation Integrated Search

    2017-04-01

    As a part of this research, the safety performance of red light running (RLR) camera systems was evaluated for a sample of 41 intersections and 60 RLR camera approaches located on state routes under IDOTs jurisdiction in the Chicago suburbs. Compr...

  14. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese.

    PubMed

    Astegiano, Sara; Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-08-28

    Traditional products and related processes must be safe to protect consumers' health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (A w )] were performed as well. Shiga-toxin Escherichia coli , aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae , E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and A w values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and A w are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  15. Evaluation of conductive concrete for anti-static flooring applications

    NASA Astrophysics Data System (ADS)

    Yehia, Sherif; Qaddoumi, Nasser; Hassan, Mohamed; Swaked, Bassam

    2015-04-01

    Static electricity, exchange of electrons, and retention of charge between any two materials due to contact and separation are affected by the condition of the materials being nonconductive or insulated from ground. Several work environments, such as electronics industry, hospitals, offices, and computer rooms all require electro-static discharge (ESD) mitigation. Carpet Tile, Carpet Broadloom, Vinyl Tile, Vinyl sheet, Epoxy and Rubber are examples of existing flooring systems in the market. However, each system has its advantages and limitations. Conductive concrete is a relatively new material technology developed to achieve high electrical conductivity and high mechanical strength. The conductive concrete material can be an economical alternative for these ESD flooring systems. In this paper, the effectiveness of conductive concrete as an anti-static flooring system was evaluated. The initial results indicated that the proposed conductive concrete flooring and ground system met the acceptance criteria stated by ASTM F150.

  16. Consumer and farmer safety evaluation of application of botanical pesticides in black pepper crop protection.

    PubMed

    Hernández-Moreno, David; Soffers, Ans E M F; Wiratno; Falke, Hein E; Rietjens, Ivonne M C M; Murk, Albertinka J

    2013-06-01

    This study presents a consumer and farmer safety evaluation on the use of four botanical pesticides in pepper berry crop protection. The pesticides evaluated include preparations from clove, tuba root, sweet flag and pyrethrum. Their safety evaluation was based on their active ingredients being eugenol, rotenone, β-asarone and pyrethrins, respectively. Botanical pesticides from Acorus calamus are of possible concern because of the genotoxic and carcinogenic ingredient β-asarone although estimated margins of exposure (MOE) for consumers indicate a low priority for risk management. For the other three botanical pesticides the margin of safety (MOS) between established acute reference doses and/or acceptable daily intake values and intake estimates for the consumer, resulting from their use as a botanical pesticide are not of safety concern, with the exception for levels of rotenone upon use of tuba root extracts on stored berries. Used levels of clove and pyrethrum as botanical pesticides in pepper berry crop production is not of safety concern for consumers or farmers, whereas for use of tuba root and sweet flag some risk factors were defined requiring further evaluation and/or risk management. It seems prudent to look for alternatives for use of sweet flag extracts containing β-asarone. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Does external evaluation of laboratories improve patient safety?

    PubMed

    Noble, Michael A

    2007-01-01

    Laboratory accreditation and External Quality Assessment (also called proficiency testing) are mainstays of laboratory quality assessment and performance. Both practices are associated with examples of improved laboratory performance. The relationship between laboratory performance and improved patient safety is more difficult to assess because of the many variables that are involved with patient outcome. Despite this difficulty, the argument to continue external evaluation of laboratories is too compelling to consider the alternative.

  18. Evaluation of Patient Safety Indicators in Semnan City Hospitals by Using the Patient Safety Friendly Hospital Initiative (PSFHI).

    PubMed

    Babamohamadi, Hassan; Nemati, Roghayeh Khabiri; Nobahar, Monir; Keighobady, Seifullah; Ghazavi, Soheila; Izadi-Sabet, Farideh; Najafpour, Zhila

    2016-08-01

    Nowadays, patient safety issue is among one of the main concerns of the hospital policy worldwide. This study aimed to evaluate the patient safety status in hospitals affiliated to Semnan city, using the WHO model for Patient Safety Friendly Hospital Initiatives (PSFHI) in summer 2014. That was a cross sectional descriptive study that addressed patient safety , which explained the current status of safety in the Semnan hospitals using by instrument of Patient safety friendly initiative standards (PSFHI). Data was collected from 5 hospitals in Semnan city during four weeks in May 2014. The finding of 5 areas examined showed that some components in critical standards had disadvantages. Critical standards of hospitals including areas of leadership and administration, patient and public involvement and safe evidence-based clinical practice, safe environment with and lifetime education in a safe and secure environment were analyzed. The domain of patient and public involvement obtained the lowest mean score and the domain of safe environment obtained the highest mean score in the surveyed hospitals. All the surveyed hospitals had a poor condition regarding standards based on patient safety. Further, the identified weak points are almost the same in the hospitals. Therefore, In order to achieve a good level of all aspects of the protocol, the goals should be considered in the level of strategic planning at hospitals. An effective execution of patient safety creatively may depend on the legal infrastructure and enforcement of standards by hospital management, organizational liability to expectation of patients, safety culture in hospitals.

  19. Evaluating Models of Human Performance: Safety-Critical Systems Applications

    NASA Technical Reports Server (NTRS)

    Feary, Michael S.

    2012-01-01

    This presentation is part of panel discussion on Evaluating Models of Human Performance. The purpose of this panel is to discuss the increasing use of models in the world today and specifically focus on how to describe and evaluate models of human performance. My presentation will focus on discussions of generating distributions of performance, and the evaluation of different strategies for humans performing tasks with mixed initiative (Human-Automation) systems. I will also discuss issues with how to provide Human Performance modeling data to support decisions on acceptability and tradeoffs in the design of safety critical systems. I will conclude with challenges for the future.

  20. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  1. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  2. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching a...

  3. A new method to evaluate future impact of vehicle safety technology in Sweden.

    PubMed

    Strandroth, Johan; Sternlund, Simon; Tingvall, Claes; Johansson, Roger; Rizzi, Matteo; Kullgren, Anders

    2012-10-01

    In the design of a safe road transport system there is a need to better understand the safety challenges lying ahead. One way of doing that is to evaluate safety technology with retrospective analysis of crashes. However, by using retros- pective data there is the risk of adapting safety innovations to scenarios irrelevant in the future. Also, challenges arise as safety interventions do not act alone but are rather interacting components in a complex road transport system. The objective of this study was therefore to facilitate the prioritizing of road safety measures by developing and applying a new method to consider possible impact of future vehicle safety technology. The key point was to project the chain of events leading to a crash today into the crashes for a given time in the future. Assumptions on implementation on safety technologies were made and these assump- tions were applied on the crashes of today. It was estimated which crashes would be prevented and the residual was analyzed to identify the characteristics of future crashes. The Swedish Transport Administration's in-depth studies of fatal crashes from 2010 involving car passengers (n=156) were used. This study estimated that the number of killed car occupant would be reduced with 53 percent from the year 2010 to 2020. Through this new method, valuable information regarding the characteristic of the future crashes was found. The results of this study showed that it was possible to evaluate future impact of vehicle safety technology if detailed and representative crash data is available.

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

    PubMed

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

    2006-03-01

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

  5. Integrated indicator to evaluate vehicle performance across: Safety, fuel efficiency and green domains.

    PubMed

    Torrao, G; Fontes, T; Coelho, M; Rouphail, N

    2016-07-01

    In general, car manufacturers face trade-offs between safety, efficiency and environmental performance when choosing between mass, length, engine power, and fuel efficiency. Moreover, the information available to the consumers makes difficult to assess all these components at once, especially when aiming to compare vehicles across different categories and/or to compare vehicles in the same category but across different model years. The main objective of this research was to develop an integrated tool able to assess vehicle's performance simultaneously for safety and environmental domains, leading to the research output of a Safety, Fuel Efficiency and Green Emissions (SEG) indicator able to evaluate and rank vehicle's performance across those three domains. For this purpose, crash data was gathered in Porto (Portugal) for the period 2006-2010 (N=1374). The crash database was analyzed and crash severity prediction models were developed using advanced logistic regression models. Following, the methodology for the SEG indicator was established combining the vehicle's safety and the environmental evaluation into an integrated analysis. The obtained results for the SEG indicator do not show any trade-off between vehicle's safety, fuel consumption and emissions. The best performance was achieved for newer gasoline passenger vehicles (<5year) with a smaller engine size (<1400cm(3)). According to the SEG indicator, a vehicle with these characteristics can be recommended for a safety-conscious profile user, as well as for a user more interested in fuel economy and/or in green performance. On the other hand, for larger engine size vehicles (>2000cm(3)) the combined score for safety user profile was in average more satisfactory than for vehicles in the smaller engine size group (<1400cm(3)), which suggests that in general, larger vehicles may offer extra protection. The achieved results demonstrate that the developed SEG integrated methodology can be a helpful tool for

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

    PubMed

    Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

    2012-07-01

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

  7. Evaluation of Margins of Safety in Brazed Joints

    NASA Technical Reports Server (NTRS)

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

    2009-01-01

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

  8. Evaluating the Impact of Radio Frequency Identification Retained Surgical Instruments Tracking on Patient Safety: Literature Review.

    PubMed

    Schnock, Kumiko O; Biggs, Bonnie; Fladger, Anne; Bates, David W; Rozenblum, Ronen

    2017-02-22

    Retained surgical instruments (RSI) are one of the most serious preventable complications in operating room settings, potentially leading to profound adverse effects for patients, as well as costly legal and financial consequences for hospitals. Safety measures to eliminate RSIs have been widely adopted in the United States and abroad, but despite widespread efforts, medical errors with RSI have not been eliminated. Through a systematic review of recent studies, we aimed to identify the impact of radio frequency identification (RFID) technology on reducing RSI errors and improving patient safety. A literature search on the effects of RFID technology on RSI error reduction was conducted in PubMed and CINAHL (2000-2016). Relevant articles were selected and reviewed by 4 researchers. After the literature search, 385 articles were identified and the full texts of the 88 articles were assessed for eligibility. Of these, 5 articles were included to evaluate the benefits and drawbacks of using RFID for preventing RSI-related errors. The use of RFID resulted in rapid detection of RSI through body tissue with high accuracy rates, reducing risk of counting errors and improving workflow. Based on the existing literature, RFID technology seems to have the potential to substantially improve patient safety by reducing RSI errors, although the body of evidence is currently limited. Better designed research studies are needed to get a clear understanding of this domain and to find new opportunities to use this technology and improve patient safety.

  9. Development and evaluation of the Kids Count Farm Safety Lesson.

    PubMed

    Liller, K D; Noland, V; Rijal, P; Pesce, K; Gonzalez, R

    2002-11-01

    The Kids Count Farm Safety Lesson was delivered to nearly 2,000 fifth-grade students in 15 rural schools in Hillsborough County, Florida. The lesson covered animal, machinery, water, and general safety topics applicable to farming in Florida. A staggered pretest-posttest study design was followed whereby five schools received a multiple-choice pretest and posttest and the remainder of the schools (N = 10) received the posttest only. Results of the study showed a significant increase in the mean number of correct answers on the posttests compared to the pretests. There was no significant difference in the mean number of correct answers of those students who received the pretest and those students who had not, eliminating a "pretest" effect. This study fills an important gap in the literature by evaluating a farm safety curriculum offered in the elementary school setting. It also included migrant schoolchildren in the study population. It is strongly recommended that agricultural safety information be included into the health education curriculum of these elementary schools.

  10. Evaluation of experimental methods for assessing safety for ultrasound radiation force elastography.

    PubMed

    Skurczynski, M J; Duck, F A; Shipley, J A; Bamber, J C; Melodelima, D

    2009-08-01

    Standard test tools have been evaluated for the assessment of safety associated with a prototype transducer intended for a novel radiation force elastographic imaging system. In particular, safety has been evaluated by direct measurement of temperature rise, using a standard thermal test object, and detection of inertial cavitation from acoustic emission. These direct measurements have been compared with values of the thermal index and mechanical index, calculated from acoustic measurements in water using standard formulae. It is concluded that measurements using a thermal test object can be an effective alternative to the calculation of thermal index for evaluating thermal hazard. Measurement of the threshold for cavitation was subject to considerable variability, and it is concluded that the mechanical index still remains the preferred standard means for assessing cavitation hazard.

  11. Safety evaluation of some wild plants in the New Nordic Diet.

    PubMed

    Mithril, Charlotte; Dragsted, Lars Ove

    2012-12-01

    One of the dietary components in the New Nordic Diet, is plants from the wild countryside. However, these may have a high content of bioactive components, some of which could be toxic in larger quantities. The objective of this paper is to outline a strategy for safety evaluation of wild plants not covered in current food compositional databases and to apply the method for selected plants used in the New Nordic Diet recipes. Four examples of typical wild edible plants were evaluated (stinging nettle, sorrel, chickweed and common lambsquarters), and based on substantial equivalence with known food plants the majority of the bioactive components reported were within the range experienced when eating or drinking typical food stuffs. For most compounds the hazards could be evaluated as minor. The only precaution found was for common lambsquarters because of its presumed high level of oxalic acid. It is concluded that a substance-by-substance evaluation of intake by equivalence to common foods is a useful and efficient strategy to evaluate the safety of newly introduced wild edible plants. Further evaluation and better compositional analyses are warranted before a daily consumption of significant amounts of wild edible plants can be generally regarded as safe. Copyright © 2012 Elsevier Ltd. All rights reserved.

  12. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a decision on any petition filed under section 409...

  13. A Scoping Review of Peer-led Education in Patient Safety Training

    PubMed Central

    McLachlan, Andrew J.; Chen, Timothy F.

    2018-01-01

    Objective. To examine the literature pertaining to the use of peer-led education in patient safety. Findings. Four studies met the inclusion criteria: two were conducted in health care students and two in medical practitioners. Three studies used pre-post evaluation, with one containing a comparator group. One study a post-intervention evaluation only. All studies undertook Kirkpatrick Level 2 evaluations, showing significant improvements in attitudes and knowledge. One study undertook Level 3 and 4 evaluations, showing improvement in self-reported behaviors and engagement in quality improvement initiatives. Summary. There are few studies evaluating peer-led education in patient safety and formal and high-quality evaluations are lacking. PMID:29606704

  14. Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

    PubMed Central

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

  15. Evaluation of Pavement Safety Performance

    DOT National Transportation Integrated Search

    2015-02-01

    The intent of this study was to isolate the effects of various low-cost pavement treatments on roadway safety. This was a retrospective study of pavement safety performance, looking back at crash data before and after treatments were installed. Both ...

  16. Evaluation of US 119 Pine Mountain safety improvements : final report.

    DOT National Transportation Integrated Search

    2007-09-01

    The Transportation Center at the University of Kentucky was requested to perform an evaluation of the safety improvement project over a 7.1-mile section of US 119 on t he Whitesburg side of Pine Mountain in Letcher County to determine whether the typ...

  17. Evaluating the effectiveness of a logger safety training program.

    PubMed

    Bell, Jennifer L; Grushecky, Shawn T

    2006-01-01

    Logger safety training programs are rarely, if ever, evaluated as to their effectiveness in reducing injuries. Workers' compensation claim rates were used to evaluate the effectiveness of a logger safety training program, the West Virginia Loggers' Safety Initiative (LSI). There was no claim rate decline detected in the majority (67%) of companies that participated in all 4 years of the LSI. Furthermore, their rate did not differ from the rest of the WV logging industry that did not participate in the LSI. Worker turnover was significantly related to claim rates; companies with higher turnover of employees had higher claim rates. Companies using feller bunchers to harvest trees at least part of the time had a significantly lower claim rate than companies not using them. Companies that had more inspections per year had lower claim rates. High injury rates persist even in companies that receive safety training; high employee turnover may affect the efficacy of training programs. The logging industry should be encouraged to facilitate the mechanization of logging tasks, to address barriers to employee retention, and to increase the number of in-the-field performance monitoring inspections. Impact on industry There are many states whose logger safety programs include only about 4-8 hours of safe work practices training. These states may look to West Virginia's expanded training program (the LSI) as a model for their own programs. However, the LSI training may not be reaching loggers due to the delay in administering training to new employees and high levels of employee turnover. Regardless of training status, loggers' claim rates decline significantly the longer they work for a company. It may be that high injury rates in the state of West Virginia would be best addressed by finding ways to encourage and facilitate companies to become more mechanized in their harvesting practices, and to increase employee tenure. Increasing the number of yearly performance inspections

  18. Safety and operational performance evaluation of four types of exit ramps on Florida's freeways (final report).

    DOT National Transportation Integrated Search

    2010-12-01

    This project mainly focuses on exit ramp performance analysis of safety and operations. In addition, issues of advance guide sign for exit ramp are also mentioned. : Safety analysis evaluates safety performances of different exit ramps used in Florid...

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

    NASA Astrophysics Data System (ADS)

    Du, Xiaorong

    2017-04-01

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

  20. [In silico, in vitro, in omic experimental models and drug safety evaluation].

    PubMed

    Claude, Nancy; Goldfain-Blanc, Françoise; Guillouzo, André

    2009-01-01

    Over the last few decades, toxicology has benefited from scientific, technical, and bioinformatic developments relating to patient safety assessment during clinical and drug marketing studies. Based on this knowledge, new in silico, in vitro, and "omic" experimental models are emerging. Although these models cannot currently replace classic safety evaluations performed on laboratory animals, they allow compounds with unacceptable toxicity to be rejected in the early stages of drug development, thereby reducing the number of laboratory animals needed. In addition, because these models are particularly adapted to mechanistic studies, they can help to improve the relevance of the data obtained, thus enabling better prevention and screening of the adverse effects that may occur in humans. Much progress remains to be done, especially in the field of validation. Nevertheless, current efforts by industrial, academic laboratories, and regulatory agencies should, in coming years, significantly improve preclinical drug safety evaluation thanks to the integration of these new methods into the drug research and development process.

  1. LANL Safety Conscious Work Environment (SCWE) Self-Assessment

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

    Hargis, Barbara C.

    2014-01-29

    On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance providedmore » by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.« less

  2. Implementation of non-condensable gases condensation suppression model into the WCOBRA/TRAC-TF2 LOCA safety evaluation code

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

    Liao, J.; Cao, L.; Ohkawa, K.

    2012-07-01

    The non-condensable gases condensation suppression model is important for a realistic LOCA safety analysis code. A condensation suppression model for direct contact condensation was previously developed by Westinghouse using first principles. The model is believed to be an accurate description of the direct contact condensation process in the presence of non-condensable gases. The Westinghouse condensation suppression model is further revised by applying a more physical model. The revised condensation suppression model is thus implemented into the WCOBRA/TRAC-TF2 LOCA safety evaluation code for both 3-D module (COBRA-TF) and 1-D module (TRAC-PF1). Parametric study using the revised Westinghouse condensation suppression model ismore » conducted. Additionally, the performance of non-condensable gases condensation suppression model is examined in the ACHILLES (ISP-25) separate effects test and LOFT L2-5 (ISP-13) integral effects test. (authors)« less

  3. Laboratory evaluation of alcohol safety interlock systems. Volume 1 : summary report

    DOT National Transportation Integrated Search

    1974-01-01

    The report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were developed...

  4. Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries.

    PubMed

    Davis, Niall F; Cunnane, Eoghan M; Mooney, Rory O'C; Forde, James C; Walsh, Michael T

    2018-05-01

    To evaluate the feasibility of a novel "safety-valve" device for preventing catheter related urethral trauma during urethral catheterization (UC). To assess the opinions of clinicians on the performance of the safety-valve device. A validated prototype "safety-valve" device for preventing catheter balloon inflation related urethral injuries was prospectively piloted in male patients requiring UC in a tertiary referral teaching hospital (n = 100). The device allows fluid in the catheter system to decant through an activated safety threshold pressure valve if the catheter anchoring balloon is misplaced. Users evaluated the "safety-valve" with an anonymous questionnaire. The primary outcome measurement was prevention of anchoring balloon inflation in the urethra. Secondary outcome measurement was successful inflation of urinary catheter anchoring balloon in the bladder. Patient age was 76 ± 12 years and American Society of Anaesthesiologists grade was 3 ± 1.4. The "safety-valve" was utilized by 34 clinicians and activated in 7% (n = 7/100) patients during attempted UC, indicating that the catheter anchoring balloon was incorrectly positioned in the patient's urethra. In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 31 of 34 (91%) clinicians completed the questionnaire. Ten percent (n = 3/31) of respondents had previously inflated a urinary catheter anchoring balloon in the urethra and 100% (n = 31) felt that a safety mechanism for preventing balloon inflation in the urethra should be compulsory for all UCs. The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. 2003 motor vehicle occupant safety survey. Volume 2, Safety belt report

    DOT National Transportation Integrated Search

    2003-09-01

    The 2003 Motor Vehicle Occupant Safety Survey was the fifth in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

  6. Safety evaluation for packaging (onsite) plutonium recycle test reactor graphite cask

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

    Romano, T.

    This safety evaluation for packaging (SEP) provides the evaluation necessary to demonstrate that the Plutonium Recycle Test Reactor (PRTR) Graphite Cask meets the requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for transfer of Type B, fissile, non-highway route controlled quantities of radioactive material within the 300 Area of the Hanford Site. The scope of this SEP includes risk, shieldling, criticality, and.tiedown analyses to demonstrate that onsite transportation safety requirements are satisfied. This SEP also establishes operational and maintenance guidelines to ensure that transport of the PRTR Graphite Cask is performed safely in accordance with WHC-CM-2-14. This SEP is validmore » until October 1, 1999. After this date, an update or upgrade to this document is required.« less

  7. A long-term plan for evaluating the FHWA's Office of Safety programs : final draft

    DOT National Transportation Integrated Search

    2006-01-01

    The purpose of this report is to develop a generalized plan for evaluating and measuring the effectiveness of the major safety programs of the the FHWA Office of Safety. This report is organized into three sections in order to coincide with the state...

  8. Evaluating life-safety risk of fieldwork at New Zealand's active volcanoes

    NASA Astrophysics Data System (ADS)

    Deligne, Natalia; Jolly, Gill; Taig, Tony; Webb, Terry

    2014-05-01

    Volcano observatories monitor active or potentially active volcanoes. Although the number and scope of remote monitoring instruments and methods continues to grow, in-person field data collection is still required for comprehensive monitoring. Fieldwork anywhere, and especially in mountainous areas, contains an element of risk. However, on volcanoes with signs of unrest, there is an additional risk of volcanic activity escalating while on site, with potentially lethal consequences. As an employer, a volcano observatory is morally and sometimes legally obligated to take reasonable measures to ensure staff safety and to minimise occupational risk. Here we present how GNS Science evaluates life-safety risk for volcanologists engaged in fieldwork on New Zealand volcanoes with signs of volcanic unrest. Our method includes several key elements: (1) an expert elicitation for how likely an eruption is within a given time frame, (2) quantification of, based on historical data when possible, given a small, moderate, or large eruption, the likelihood of exposure to near-vent processes, ballistics, or surge at various distances from the vent, and (3) estimate of fatality rate given exposure to these volcanic hazards. The final product quantifies hourly fatality risk at various distances from a volcanic vent; various thresholds of risk (for example, zones with more than 10-5 hourly fatality risk) trigger different levels of required approval to undertake work. Although an element of risk will always be present when conducting fieldwork on potentially active volcanoes, this is a first step towards providing objective guidance for go/no go decisions for volcanic monitoring.

  9. Safety incentive and penalty provisions in Indian construction projects and their impact on safety performance.

    PubMed

    Hasan, Abid; Jha, Kumar Neeraj

    2013-01-01

    Safety incentive and penalty (I/P) provisions in construction contracts are one of the most common forms of I/P. Contradictory opinions on the effectiveness of these provisions have been expressed in the literature. Statistics on safety provisions were collected from 32 construction projects, which include both types of contracts - those with safety I/P provisions and those without them. Although inclusion of safety I/P provisions in contracts helps in improving the overall safety performance in construction projects, further scope for improvement still exists. Literature review and structured personal interviews, coupled with a survey based on preliminary questionnaire, revealed that successful formulation and implementation of such provisions are dependent on 25 attributes which need the attention of both clients and contractors. A questionnaire-based survey was conducted to evaluate these attributes. The six factors extracted by carrying out factor analysis are: incentive distribution method, proper labour training, special attention to risky situations, role of safety committee and sub-contractors, specialised works and safety equipments, and right form of I/P. If taken care of, these attributes have the potential to improve the safety performance in construction projects. The results would be useful to clients and contractors in implementing the safety I/P provisions and thereby improving safety performance.

  10. 25 CFR 224.132 - How does the Director conduct a periodic review and evaluation?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false How does the Director conduct a periodic review and... DETERMINATION ACT Periodic Reviews § 224.132 How does the Director conduct a periodic review and evaluation? (a) The Director will conduct a periodic review and evaluation under the TERA, in consultation with the...

  11. Evaluation of the efficacy of simulation games in traffic safety education of kindergarten children.

    PubMed Central

    Renaud, L; Suissa, S

    1989-01-01

    Using a simulation game designed to teach children to obey certain traffic safety rules, an experimental study was conducted with 136 five-year-old children in four Quebec schools. Within each classroom, subjects were randomly divided into four groups: three intervention groups and one control group. Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes, behavior, and transfer of learning of pedestrian traffic safety. Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age. PMID:2916716

  12. Evaluation of the efficacy of simulation games in traffic safety education of kindergarten children.

    PubMed

    Renaud, L; Suissa, S

    1989-03-01

    Using a simulation game designed to teach children to obey certain traffic safety rules, an experimental study was conducted with 136 five-year-old children in four Quebec schools. Within each classroom, subjects were randomly divided into four groups: three intervention groups and one control group. Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes, behavior, and transfer of learning of pedestrian traffic safety. Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age.

  13. SRTC criticality safety technical review: Nuclear Criticality Safety Evaluation 93-04 enriched uranium receipt

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

    Rathbun, R.

    Review of NMP-NCS-930087, {open_quotes}Nuclear Criticality Safety Evaluation 93-04 Enriched Uranium Receipt (U), July 30, 1993, {close_quotes} was requested of SRTC (Savannah River Technology Center) Applied Physics Group. The NCSE is a criticality assessment to determine the mass limit for Engineered Low Level Trench (ELLT) waste uranium burial. The intent is to bury uranium in pits that would be separated by a specified amount of undisturbed soil. The scope of the technical review, documented in this report, consisted of (1) an independent check of the methods and models employed, (2) independent HRXN/KENO-V.a calculations of alternate configurations, (3) application of ANSI/ANS 8.1,more » and (4) verification of WSRC Nuclear Criticality Safety Manual procedures. The NCSE under review concludes that a 500 gram limit per burial position is acceptable to ensure the burial site remains in a critically safe configuration for all normal and single credible abnormal conditions. This reviewer agrees with that conclusion.« less

  14. Design and evaluation of simulation scenarios for a program introducing patient safety, teamwork, safety leadership, and simulation to healthcare leaders and managers.

    PubMed

    Cooper, Jeffrey B; Singer, Sara J; Hayes, Jennifer; Sales, Michael; Vogt, Jay W; Raemer, Daniel; Meyer, Gregg S

    2011-08-01

    We developed a training program to introduce managers and informal leaders of healthcare organizations to key concepts of teamwork, safety leadership, and simulation to motivate them to act as leaders to improve safety within their sphere of influence. This report describes the simulation scenario and debriefing that are core elements of that program. Twelve teams of clinician and nonclinician managers were selected from a larger set of volunteers to participate in a 1-day, multielement training program. Two simulation exercises were developed: one for teams of nonclinicians and the other for clinicians or mixed groups. The scenarios represented two different clinical situations, each designed to engage participants in discussions of their safety leadership and teamwork issues immediately after the experience. In the scenarios for nonclinicians, participants conducted an anesthetic induction and then managed an ethical situation. The scenario for clinicians simulated a consulting visit to an emergency room that evolved into a problem-solving challenge. Participants in this scenario had a limited time to prepare advice for hospital leadership on how to improve observed safety and cultural deficiencies. Debriefings after both types of scenarios were conducted using principles of "debriefing with good judgment." We assessed the relevance and impact of the program by analyzing participant reactions to the simulation through transcript data and facilitator observations as well as a postcourse questionnaire. The teams generally reported positive perceptions of the relevance and quality of the simulation with varying types and degrees of impact on their leadership and teamwork behaviors. These kinds of clinical simulation exercises can be used to teach healthcare leaders and managers safety leadership and teamwork skills and behaviors.

  15. 75 FR 63609 - Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Safety and Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... safety of the offshore facility, including ensuring that all contractors and subcontractors have safety... safety analysis (task level); (3) Procedures to verify that contractors are conducting their activities in accordance with the operator's SEMS program and an evaluation to ensure that contractors have the...

  16. Evaluating North Carolina Food Pantry Food Safety-Related Operating Procedures.

    PubMed

    Chaifetz, Ashley; Chapman, Benjamin

    2015-11-01

    Almost one in seven American households were food insecure in 2012, experiencing difficulty in providing enough food for all family members due to a lack of resources. Food pantries assist a food-insecure population through emergency food provision, but there is a paucity of information on the food safety-related operating procedures used in the pantries. Food pantries operate in a variable regulatory landscape; in some jurisdictions, they are treated equivalent to restaurants, while in others, they operate outside of inspection regimes. By using a mixed methods approach to catalog the standard operating procedures related to food in 105 food pantries from 12 North Carolina counties, we evaluated their potential impact on food safety. Data collected through interviews with pantry managers were supplemented with observed food safety practices scored against a modified version of the North Carolina Food Establishment Inspection Report. Pantries partnered with organized food bank networks were compared with those that operated independently. In this exploratory research, additional comparisons were examined for pantries in metropolitan areas versus nonmetropolitan areas and pantries with managers who had received food safety training versus managers who had not. The results provide a snapshot of how North Carolina food pantries operate and document risk mitigation strategies for foodborne illness for the vulnerable populations they serve. Data analysis reveals gaps in food safety knowledge and practice, indicating that pantries would benefit from more effective food safety training, especially focusing on formalizing risk management strategies. In addition, new tools, procedures, or policy interventions might improve information actualization by food pantry personnel.

  17. Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

    PubMed

    Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

    2018-06-01

    Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

  18. Implementing AORN recommended practices for medication safety.

    PubMed

    Hicks, Rodney W; Wanzer, Linda J; Denholm, Bonnie

    2012-12-01

    Medication errors in the perioperative setting can result in patient morbidity and mortality. The AORN "Recommended practices for medication safety" provide guidance to perioperative nurses in developing, implementing, and evaluating safe medication use practices. These practices include recognizing risk points in the medication use process, collaborating with pharmacy staff members, conducting preoperative assessments and postoperative evaluations (eg, medication reconciliation), and handling hazardous medications and pharmaceutical waste. Strategies for successful implementation of the recommended practices include promoting a basic understanding of the nurse's role in the medication use process and developing a medication management plan as well as policies and procedures that support medication safety and activities to measure compliance with safe practices. Published by Elsevier Inc.

  19. 2007 motor vehicle occupant safety survey. Volume 5, Child safety seat report

    DOT National Transportation Integrated Search

    2009-04-01

    The 2007 Motor Vehicle Occupant Safety Survey (MVOSS) was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conduct...

  20. Occupational Safety and Health Professionals' Training in Italy: Qualitative Evaluation Using T-LAB

    ERIC Educational Resources Information Center

    Papaleo, Bruno; Cangiano, Giovanna; Calicchia, Sara

    2013-01-01

    Purpose: The purpose of this paper is to describe the evaluation of a training course on chemicals for occupational safety and health (OSH) professionals. The study aims were to assess the effectiveness of the course; to find out what type of training met these workers' needs best, as their role is vital in the management of safety at work; and to…

  1. Safety analysis and review system (SARS) assessment report

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

    Browne, E.T.

    1981-03-01

    Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

  2. 2000 motor vehicle occupant safety survey. Volume 5, Child safety seat report

    DOT National Transportation Integrated Search

    2002-06-01

    The 2000 Motor Vehicle Occupant Safety Survey was the fourth in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by S...

  3. 1998 Motor Vehicle Occupant Safety Survey. Volume 3, Child safety seat report

    DOT National Transportation Integrated Search

    2000-07-01

    The 1998 Motor Vehicle Occupant Safety Survey was the third in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by th...

  4. CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

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

    Kessler, S

    2009-04-21

    With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007

  5. Evaluation of FY 1987 safety belt use law state enforcement grants

    DOT National Transportation Integrated Search

    1991-03-01

    The report presents information and an evaluation of safety belt use law enforcement grants provided to 17 states through supplemental 403 grants during FY 1987. Elmira-type programs were to serve as a model in order to demonstrate that basic enforce...

  6. 78 FR 3311 - Safety Enhancements, Certification of Airports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... the airport non-movement area, and (5) Requiring certificate holders to conduct pavement surface... (SMGCS). Non-Movement Area Safety Training... YES NO. Runway Pavement Surface Evaluation.. YES NO. In... 139 to host scheduled passenger carrying operations of an air carrier operating aircraft designed for...

  7. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

  8. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow...

  9. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

  10. 30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

  11. Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

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

    Not Available

    1989-10-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2more » and 3, the staff safety evaluations of those systems are included herein. 85 refs.« less

  12. Effects of patient safety auditing in hospital care: results of a mixed-method evaluation (part 1).

    PubMed

    Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Westert, Gert P; Boeijen, Wilma; Teerenstra, Steven; van Gurp, Petra J; Wollersheim, Hub

    2018-06-15

    To evaluate the effectiveness of internal auditing in hospital care focussed on improving patient safety. A before-and-after mixed-method evaluation study was carried out in eight departments of a university medical center in the Netherlands. Internal auditing and feedback focussed on improving patient safety. The effect of internal auditing was assessed 15 months after the audit, using linear mixed models, on the patient, professional, team and departmental levels. The measurement methods were patient record review on adverse events (AEs), surveys regarding patient experiences, safety culture and team climate, analysis of administrative hospital data (standardized mortality rate, SMR) and safety walk rounds (SWRs) to observe frontline care processes on safety. The AE rate decreased from 36.1% to 31.3% and the preventable AE rate from 5.5% to 3.6%; however, the differences before and after auditing were not statistically significant. The patient-reported experience measures regarding patient safety improved slightly over time (P < 0.001). The SMR, patient safety culture and team climate remained unchanged after the internal audit. The SWRs showed that medication safety and information security were improved (P < 0.05). Internal auditing was associated with improved patient experiences and observed safety on wards. No effects were found on adverse outcomes, safety culture and team climate 15 months after the internal audit.

  13. In vitro evaluation of the Medtronic cardioplegia safety system.

    PubMed

    Trowbridge, C C; Woods, K R; Muhle, M L; Niimi, K S; Tremain, K D; Jiang, J; Stammers, A H

    2000-03-01

    Myocardial preservation demands the precise and accurate delivery of cardioplegic solutions to provide nutritive delivery and metabolic waste removal. The purpose of this study was to evaluate the performance characteristics of the Medtronic CSS Cardioplegia Safety System in an in vitro setting. The CSS was evaluated under the following conditions: blood to crystalloid ratios of 1:0, 1:1, 4:1, 8:1, 0:1; potassium concentrations of 10, 20, and 40 mEq L-1; volumetric delivery collection at 100, 250, 500, 750, and 990 mL/min; pressure accuracy at 100 and 300 mmHg; and system safety mechanisms. Measured and predicted values from the CSS were compared using one way ANOVA, with statistical significance accepted at p < or = 0.05. The measured values for the tested ratios and volume collections were all within the manufacturer's technical parameters. Potassium concentration results were all within expected values except at 100 mL/min, where the measured value of 17.1 +/- 2.1 mmol was lower than the expected 20.0 +/- 0.2 mmol (p < .034). As flow rates changed, the CSS line pressure error was constant (0.5 to 3.7%), and the only significant difference was observed at 100 mmHg, 500 mL/min (102.3 +/- 1.7 vs. 100.0 +/- 0.0 mmHg, P < .003). The device performed accurately and reliably under all simulated safety conditions, including bubble detection, over pressurization and battery backup. In conclusion, the performance of the CSS was within the manufacturer's specifications for the majority of the tested conditions and operated safely when challenged under varying conditions.

  14. On the use of naturalistic methods to examine safety-relevant behaviours amongst children and evaluate a cycling education program.

    PubMed

    Hatfield, J; Dozza, M; Patton, D A; Maharaj, P; Boufous, S; Eveston, T

    2017-11-01

    School-based cycling education programs aim to improve cycling safety and participation amongst children. Available research suggests that typical programs, which focus on bicycle manoeuvring skills, have limited effects on behaviour observed on a track or planned route. The current study uses theoretically more valid, naturalistic cycling data, to evaluate Safe Cycle, a program that incorporates hazard and self-awareness training. Soon after Safe Cycle was delivered at treatment schools, research bicycles instrumented with a rearward- and a forward-facing camera were loaned to six children from treatment schools and six children from (waitlist) control schools. In each group half the children were in Year 6, and half were in Year 7/8. Each child was instructed to ride the research bicycle instead of their own bicycle for the 1-2 weeks that they had a research bicycle. Video data were reduced using a purpose-designed coding scheme that identified whether participants performed specific safety-relevant behaviours in appropriate circumstances. While the participants controlled their bicycles well, gave way appropriately to traffic at intersections, and stopped at red lights, participants frequently removed one or both hands from the handlebars, and seldom signalled turns, conducted over-shoulder-checks when changing lanes, or looked in multiple directions at intersections (except when crossing a road). While aspects of design and small sample sizes limited evaluation findings, this research demonstrated the feasibility and potential of naturalistic data to support cycling education program evaluation. Further, the study substantially extended available naturalistic study of children's cycling behaviour to highlight behaviours which might be targeted by cycling safety initiatives. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

    PubMed

    Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

    2016-02-15

    While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule. Copyright © 2015 Elsevier Ltd. All rights

  16. [Validation of a questionnaire to evaluate patient safety in clinical laboratories].

    PubMed

    Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

    2012-01-01

    The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

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

    PubMed

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

    2016-08-17

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

  18. Nuclear criticality safety evaluation of SRS 9971 shipping package. [SRS (Savannah River Site)

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

    Vescovi, P.J.

    1993-02-01

    This evaluation is requested to revise the criticality evaluation used to generate Chapter 6 (Criticality Evaluation) of the Safety Analysis Report for Packaging (SARP) for shipment Of UO[sub 3] product from the Uranium Solidification Facility (USF) in the SRS 9971 shipping package. The pertinent document requesting this evaluation is included as Attachment I. The results of the evaluation are given in Attachment II which is written as Chapter 6 of a NRC format SARP.

  19. MRI Evaluation and Safety in the Developing Brain

    PubMed Central

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

    2015-01-01

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

  20. A high-fidelity Monte Carlo evaluation of CANDU-6 safety parameters

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

    Kim, Y.; Hartanto, D.

    2012-07-01

    Important safety parameters such as the fuel temperature coefficient (FTC) and the power coefficient of reactivity (PCR) of the CANDU-6 (CANada Deuterium Uranium) reactor have been evaluated by using a modified MCNPX code. For accurate analysis of the parameters, the DBRC (Doppler Broadening Rejection Correction) scheme was implemented in MCNPX in order to account for the thermal motion of the heavy uranium nucleus in the neutron-U scattering reactions. In this work, a standard fuel lattice has been modeled and the fuel is depleted by using the MCNPX and the FTC value is evaluated for several burnup points including the mid-burnupmore » representing a near-equilibrium core. The Doppler effect has been evaluated by using several cross section libraries such as ENDF/B-VI, ENDF/B-VII, JEFF, JENDLE. The PCR value is also evaluated at mid-burnup conditions to characterize safety features of equilibrium CANDU-6 reactor. To improve the reliability of the Monte Carlo calculations, huge number of neutron histories are considered in this work and the standard deviation of the k-inf values is only 0.5{approx}1 pcm. It has been found that the FTC is significantly enhanced by accounting for the Doppler broadening of scattering resonance and the PCR are clearly improved. (authors)« less

  1. Safety evaluation report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan

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

    Not Available

    1991-01-01

    This safety evaluation report (SER) was prepared by the US Nuclear Regulatory Commission (NRC) staff and represents the second and last supplement (SSER 2) to the staff's original SER published as Volume 3 of NUREG-1232 in April 1989. Supplement 1 of Volume 3 of NUREG-1232 (SSER 1) was published in October 1989. Like its predecessors, SSER 2 is composed of numerous safety evaluations by the staff regarding specific elements contained in the Browns Ferry Nuclear Performance Plan (BFNPP), Volume 3 (up to and including Revision 2), submitted by the Tennessee Valley Authority (TVA) for the Browns Ferry Nuclear Plant (BFN).more » The Browns Ferry Nuclear Plant consists of three boiling-water reactors (BWRs) at a site in Limestone County, Alabama. The BFNPP describes the corrective action plans and commitments made by TVA to resolve deficiencies with its nuclear programs before the startup of Unit 2. The staff has inspected and will continue to inspect TVA's implementation of these BFNPP corrective action plans that address staff concerns about TVA's nuclear program. SSER 2 documents the NRC staff's safety evaluations and conclusions for those elements of the BFNPP that were not previously addressed by the staff or that remained open as a result of unresolved issues identified by the staff in previous SERs and inspections.« less

  2. Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

    PubMed

    Asturias, Edwin J; Wharton, Melinda; Pless, Robert; MacDonald, Noni E; Chen, Robert T; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N; Hartigan-Go, Kenneth; Zuber, Patrick L F

    2016-06-17

    In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. 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...

  4. Laboratory evaluation of alcohol safety interlock systems. Volume 2 : instrument screening experiments

    DOT National Transportation Integrated Search

    1974-01-01

    The report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were developed...

  5. Safety culture among pediatric surgeons: A national survey of attitudes and perceptions of patient safety.

    PubMed

    Berman, Loren; Rangel, Shawn; Goldin, Adam; Skarda, David; Ottosen, Madelene; Bliss, David; Valusek, Patricia; Fallat, Mary; Tsao, KuoJen

    2018-03-01

    Improving the culture of safety within health care is an essential component of preventing errors and improving overall health care quality. The purpose of this study was to characterize the attitudes and perceptions of patient safety among pediatric surgeons. We conducted a cross-sectional online survey of American Pediatric Surgery Association members. Survey items assessed surgeons' knowledge, attitudes, and perceptions of patient safety. We performed descriptive statistics and evaluated associations between respondent characteristics and survey responses. Response rate was 38% (353/928). Surgeons in academic practice (96% vs 83% private, P=0.01) and in leadership positions (98% vs 92%, P=0.03) were more likely to feel actively engaged in patient safety initiatives. Surgeons in private practice were less likely to feel safe having their own children undergo surgery at their institution (80% vs 96% academic, P<0.005). Pediatric surgeons have disparate attitudes and perceptions of patient safety within their hospitals. Significant variation exists based on surgeon characteristics. These findings underscore the need to identify barriers to surgeon engagement and develop educational initiatives to empower surgeons as leaders in improving patient safety culture. V. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Evaluation of the US Department of Energy's occupational safety and health program for its government-owned contractor-operated facilities

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

    Not Available

    The purpose of this report is to present to Secretary of Energy James Watkins the findings and recommendations of the Occupational Safety and Health Administration's (OSHA) evaluation of the Department of Energy's (DOE) programs for worker safety and health at DOE's government-owned contractor-operated (GOCO) nuclear facilities. The OSHA evaluation is based on an intensive and comprehensive review and analysis of DOE's worker safety and health programs including: written programs; safety and health inspection programs; and the adequacy of resource, training, and management controls. The evaluation began on April 10, 1990 and involved over three staff years before its conclusion. Themore » evaluation was initiated by former Secretary of Labor Elizabeth Dole in response to Secretary of Energy James Watkins' request that OSHA assist him in determining the actions needed to assure that DOE has an exemplary safety and health program in place at its GOCOs. 6 figs.« less

  7. Summary and evaluation of responses received on the alcohol safety interlock system

    DOT National Transportation Integrated Search

    1971-05-01

    This report summarizes and evaluates devices and suggestions provided by respondents to the DOT Prospectus entitled "Some Considerations Related to the Development of an Alcohol Safety Interlock System (ASIS)". The responses are categorized into: (1)...

  8. Evaluation of New Thermally Conductive Geopolymer in Thermal Energy Storage

    NASA Astrophysics Data System (ADS)

    Černý, Matěj; Uhlík, Jan; Nosek, Jaroslav; Lachman, Vladimír; Hladký, Radim; Franěk, Jan; Brož, Milan

    This paper describes an evaluation of a newly developed thermally conductive geopolymer (TCG), consisting of a mixture of sodium silicate and carbon micro-particles. The TCG is intended to be used as a component of high temperature energy storage (HTTES) to improve its thermal diffusivity. Energy storage is crucial for both ecological and economical sustainability. HTTES plays a vital role in solar energy technologies and in waste heat recovery. The most advanced HTTES technologies are based on phase change materials or molten salts, but suffer with economic and technological limitations. Rock or concrete HTTES are cheaper, but they have low thermal conductivity without incorporation of TCG. It was observed that TCG is stable up to 400 °C. The thermal conductivity was measured in range of 20-23 W m-1 K-1. The effect of TCG was tested by heating a granite block with an artificial fissure. One half of the fissure was filled with TCG and the other with ballotini. 28 thermometers, 5 dilatometers and strain sensors were installed on the block. The heat transport experiment was evaluated with COMSOL Multiphysics software.

  9. Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

    PubMed

    Pauwels, Marleen; Rogiers, Vera

    2004-06-15

    Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

  10. Safety of topical minoxidil solution: a one-year, prospective, observational study.

    PubMed

    Shapiro, Jerry

    2003-01-01

    Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

  11. Evaluating conducting network based transparent electrodes from geometrical considerations

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

    Kumar, Ankush; Kulkarni, G. U., E-mail: guk@cens.res.in

    2016-01-07

    Conducting nanowire networks have been developed as viable alternative to existing indium tin oxide based transparent electrode (TE). The nature of electrical conduction and process optimization for electrodes have gained much from the theoretical models based on percolation transport using Monte Carlo approach and applying Kirchhoff's law on individual junctions and loops. While most of the literature work pertaining to theoretical analysis is focussed on networks obtained from conducting rods (mostly considering only junction resistance), hardly any attention has been paid to those made using template based methods, wherein the structure of network is neither similar to network obtained frommore » conducting rods nor similar to well periodic geometry. Here, we have attempted an analytical treatment based on geometrical arguments and applied image analysis on practical networks to gain deeper insight into conducting networked structure particularly in relation to sheet resistance and transmittance. Many literature examples reporting networks with straight or curvilinear wires with distributions in wire width and length have been analysed by treating the networks as two dimensional graphs and evaluating the sheet resistance based on wire density and wire width. The sheet resistance values from our analysis compare well with the experimental values. Our analysis on various examples has revealed that low sheet resistance is achieved with high wire density and compactness with straight rather than curvilinear wires and with narrower wire width distribution. Similarly, higher transmittance for given sheet resistance is possible with narrower wire width but of higher thickness, minimal curvilinearity, and maximum connectivity. For the purpose of evaluating active fraction of the network, the algorithm was made to distinguish and quantify current carrying backbone regions as against regions containing only dangling or isolated wires. The treatment can be helpful in

  12. Evaluating conducting network based transparent electrodes from geometrical considerations

    NASA Astrophysics Data System (ADS)

    Kumar, Ankush; Kulkarni, G. U.

    2016-01-01

    Conducting nanowire networks have been developed as viable alternative to existing indium tin oxide based transparent electrode (TE). The nature of electrical conduction and process optimization for electrodes have gained much from the theoretical models based on percolation transport using Monte Carlo approach and applying Kirchhoff's law on individual junctions and loops. While most of the literature work pertaining to theoretical analysis is focussed on networks obtained from conducting rods (mostly considering only junction resistance), hardly any attention has been paid to those made using template based methods, wherein the structure of network is neither similar to network obtained from conducting rods nor similar to well periodic geometry. Here, we have attempted an analytical treatment based on geometrical arguments and applied image analysis on practical networks to gain deeper insight into conducting networked structure particularly in relation to sheet resistance and transmittance. Many literature examples reporting networks with straight or curvilinear wires with distributions in wire width and length have been analysed by treating the networks as two dimensional graphs and evaluating the sheet resistance based on wire density and wire width. The sheet resistance values from our analysis compare well with the experimental values. Our analysis on various examples has revealed that low sheet resistance is achieved with high wire density and compactness with straight rather than curvilinear wires and with narrower wire width distribution. Similarly, higher transmittance for given sheet resistance is possible with narrower wire width but of higher thickness, minimal curvilinearity, and maximum connectivity. For the purpose of evaluating active fraction of the network, the algorithm was made to distinguish and quantify current carrying backbone regions as against regions containing only dangling or isolated wires. The treatment can be helpful in predicting

  13. Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

    PubMed

    Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

    2013-01-01

    Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta

  14. Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture.

    PubMed

    Bump, Gregory M; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G; Jasti, Harish; McCausland, Julie B; Itri, Jason N; Patel, Rita M; Buchert, Andrew

    2015-03-01

    The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time.

  15. Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture

    PubMed Central

    Bump, Gregory M.; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G.; Jasti, Harish; McCausland, Julie B.; Itri, Jason N.; Patel, Rita M.; Buchert, Andrew

    2015-01-01

    Background The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. Objective We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Methods Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Results Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Conclusions Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time. PMID:26217435

  16. Safety Evaluation of Roundabouts in Georgia

    DOT National Transportation Integrated Search

    2018-02-28

    Several previous studies have documented significant safety benefits of roundabouts in the United Sates. However, the safety benefits for a given roundabout may vary depending on factors such as the familiarity of the driving population to roundabout...

  17. Safety Evaluation of Roundabouts in Georgia

    DOT National Transportation Integrated Search

    2018-02-02

    Several previous studies have documented significant safety benefits of roundabouts in the United Sates. However, the safety benefits for a given roundabout may vary depending on factors such as the familiarity of the driving population to roundabout...

  18. Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use.

    PubMed

    Soejima, Kyoko; Edmonson, Jonathan; Ellingson, Michael L; Herberg, Ben; Wiklund, Craig; Zhao, Jing

    2016-10-01

    Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  19. An evaluation of a new instrument to measure organisational safety culture values and practices.

    PubMed

    Díaz-Cabrera, D; Hernández-Fernaud, E; Isla-Díaz, R

    2007-11-01

    The main aim of this research is to evaluate a safety culture measuring instrument centred upon relevant organisational values and practices related to the safety management system. Seven dimensions that reflect underlying safety meanings are proposed. A second objective is to explore the four cultural orientations in the field of safety arising from the competing values framework. The study sample consisted of 299 participants from five companies in different sectors. The results show six dimensions of organisational values and practices and different company profiles in the organisations studied. The four cultural orientations proposed by the competing values framework are not confirmed. Nevertheless, a coexistence of diverse cultural orientations or paradoxes in the companies is observed.

  20. Safety evaluation of improved curve delineation

    DOT National Transportation Integrated Search

    2009-01-01

    The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the pooled fund study is to estimate t...

  1. Evaluation of Four Bedside Test Systems for Card Performance, Handling and Safety.

    PubMed

    Giebel, Felix; Picker, Susanne M; Gathof, Birgit S

    2008-01-01

    SUMMARY: OBJECTIVE: Pretransfusion ABO compatibility testing is a simple and required precaution against ABO-incompatible transfusion, which is one of the greatest threats in transfusion medicine. While distinct agglutination is most important for correct test interpretation, protection against infectious diseases and ease of handling are crucial for accurate test performance. Therefore, the aim of this study was to evaluate differences in test card design, handling, and user safety. DESIGN: Four different bedside test cards with pre-applied antibodies were evaluated by 100 medical students using packed red blood cells of different ABO blood groups. Criteria of evaluation were: agglutination, labelling, handling, and safety regarding possible user injuries. Criteria were rated subjectively according to German school notes ranging from 1 = very good to 6 = very bad/insufficient. RESULTS: Overall, all cards received very good/good marks. The ABO blood group was identified correctly in all cases. Three cards (no. 1, no. 3, no. 4) received statistically significant (p < 0.008) prominence (mean values shown) concerning clearness of agglutination (1.7-1.9 vs. 2.4 for no. 2). Systems with dried antibodies (no. 2, no. 4) outmatched the other systems with respect to overall test system performance (2.0 vs. 2.8-2.9), labelling (1.5 vs. 2.2-2.4), handling (1.9-2.0 vs. 2.5), and user safety (2.5 vs. 3.4). Analysis of card self-explanation revealed no remarkable differences. CONCLUSION: Despite good performance of all card systems tested, the best results when including all criteria evaluated were obtained with card no. 4 (particularly concerning clear agglutination), followed by cards no. 2, no. 1, and no. 3.

  2. How to quantitatively evaluate safety of driver behavior upon accident? A biomechanical methodology

    PubMed Central

    Zhang, Wen; Cao, Jieer

    2017-01-01

    How to evaluate driver spontaneous reactions in various collision patterns in a quantitative way is one of the most important topics in vehicle safety. Firstly, this paper constructs representative numerical crash scenarios described by impact velocity, impact angle and contact position based on finite element (FE) computation platform. Secondly, a driver cabin model is extracted and described in the well validated multi-rigid body (MB) model to compute the value of weighted injury criterion to quantitatively assess drivers’ overall injury under certain circumstances. Furthermore, based on the coupling of FE and MB, parametric studies on various crash scenarios are conducted. It is revealed that the WIC (Weighted Injury Criteria) value variation law under high impact velocities is quite distinct comparing with the one in low impact velocities. In addition, the coupling effect can be elucidated by the fact that the difference of WIC value among three impact velocities under smaller impact angles tends to be distinctly higher than that under larger impact angles. Meanwhile, high impact velocity also increases the sensitivity of WIC under different collision positions and impact angles. Results may provide a new methodology to quantitatively evaluate driving behaviors and serve as a significant guiding step towards collision avoidance for autonomous driving vehicles. PMID:29240789

  3. How to quantitatively evaluate safety of driver behavior upon accident? A biomechanical methodology.

    PubMed

    Zhang, Wen; Cao, Jieer; Xu, Jun

    2017-01-01

    How to evaluate driver spontaneous reactions in various collision patterns in a quantitative way is one of the most important topics in vehicle safety. Firstly, this paper constructs representative numerical crash scenarios described by impact velocity, impact angle and contact position based on finite element (FE) computation platform. Secondly, a driver cabin model is extracted and described in the well validated multi-rigid body (MB) model to compute the value of weighted injury criterion to quantitatively assess drivers' overall injury under certain circumstances. Furthermore, based on the coupling of FE and MB, parametric studies on various crash scenarios are conducted. It is revealed that the WIC (Weighted Injury Criteria) value variation law under high impact velocities is quite distinct comparing with the one in low impact velocities. In addition, the coupling effect can be elucidated by the fact that the difference of WIC value among three impact velocities under smaller impact angles tends to be distinctly higher than that under larger impact angles. Meanwhile, high impact velocity also increases the sensitivity of WIC under different collision positions and impact angles. Results may provide a new methodology to quantitatively evaluate driving behaviors and serve as a significant guiding step towards collision avoidance for autonomous driving vehicles.

  4. Autonomous Flight Safety System September 27, 2005, Aircraft Test

    NASA Technical Reports Server (NTRS)

    Simpson, James C.

    2005-01-01

    This report describes the first aircraft test of the Autonomous Flight Safety System (AFSS). The test was conducted on September 27, 2005, near Kennedy Space Center (KSC) using a privately-owned single-engine plane and evaluated the performance of several basic flight safety rules using real-time data onboard a moving aerial vehicle. This test follows the first road test of AFSS conducted in February 2005 at KSC. AFSS is a joint KSC and Wallops Flight Facility (WEF) project that is in its third phase of development. AFSS is an independent subsystem intended for use with Expendable Launch Vehicles that uses tracking data from redundant onboard sensors to autonomously make flight termination decisions using software-based rules implemented on redundant flight processors. The goals of this project are to increase capabilities by allowing launches from locations that do not have or cannot afford extensive ground-based range safety assets, to decrease range costs, and to decrease reaction time for special situations. The mission rules are configured for each operation by the responsible Range Safety authorities and can be loosely categorized in four major categories: Parameter Threshold Violations, Physical Boundary Violations present position and instantaneous impact point (TIP), Gate Rules static and dynamic, and a Green-Time Rule. Examples of each of these rules were evaluated during this aircraft test.

  5. Infant toxicology: state of the science and considerations in evaluation of safety.

    PubMed

    Neal-Kluever, April; Aungst, Jason; Gu, Yan; Hatwell, Karen; Muldoon-Jacobs, Kristi; Liem, Ayesha; Ogungbesan, Adejoke; Shackelford, Mary

    2014-08-01

    Differences in the physiology and biological susceptibilities of adults and infants have led to growing interest in safety evaluation methods for exposures from infant formula packaging. In addition to potential physiological differences, infants aged 0-6 months may consume a sole source of food, infant formula or breast milk, and consume higher amounts of food relative to body weight compared to adults. While the duration of the exposure is short compared to the expected lifespan of the individual, it occurs during a period of important developmental processes. The purpose of this document is to (1) review key biological and exposure elements that may impact the evaluation of safety for food contact products intended for use by infants, (2) summarize the current reproductive and developmental toxicity testing protocols available, and (3) identify potential data gaps concerning this period of development. Published by Elsevier Ltd.

  6. 15 CFR 270.200 - Technical conduct of investigation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.200 Technical conduct of investigation. (a... hours of the event, if possible. The Director may establish and deploy a Team to conduct the preliminary...

  7. 15 CFR 270.200 - Technical conduct of investigation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.200 Technical conduct of investigation. (a... hours of the event, if possible. The Director may establish and deploy a Team to conduct the preliminary...

  8. 15 CFR 270.200 - Technical conduct of investigation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.200 Technical conduct of investigation. (a... hours of the event, if possible. The Director may establish and deploy a Team to conduct the preliminary...

  9. 15 CFR 270.200 - Technical conduct of investigation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.200 Technical conduct of investigation. (a... hours of the event, if possible. The Director may establish and deploy a Team to conduct the preliminary...

  10. 15 CFR 270.200 - Technical conduct of investigation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.200 Technical conduct of investigation. (a... hours of the event, if possible. The Director may establish and deploy a Team to conduct the preliminary...

  11. Some considerations on the safety evaluation of nonviral microbial pesticides

    PubMed Central

    Shadduck, J. A.

    1983-01-01

    The tactics and rationale of maximum challenge safety tests for nonviral microbial pesticides have been reviewed. Maximum challenge tests and a tier approach to data collection for regulatory purposes offer the best opportunities to detect the acute effects of entomopathogenic organisms in mammals. Premature condemnation of promising organisms that are based on incomplete results of maximum challenge tests must be avoided. Further investigations should be conducted on the role of mammalian immune response in resistance to entomopathogenic organisms and on the value of medium- or long-term exposure tests. PMID:6601535

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

    DOT National Transportation Integrated Search

    1998-02-01

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

  13. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Total Knee Arthroplasty.

    PubMed

    Soffin, Ellen M; Gibbons, Melinda M; Ko, Clifford Y; Kates, Stephen L; Wick, Elizabeth; Cannesson, Maxime; Scott, Michael J; Wu, Christopher L

    2018-06-08

    Enhanced recovery after surgery (ERAS) has rapidly gained popularity in a variety of surgical subspecialities. A large body of literature suggests that ERAS leads to superior outcomes, improved patient satisfaction, reduced length of hospital stay, and cost benefits, without affecting rates of readmission after surgery. These patterns have been described for patients undergoing elective total knee arthroplasty (TKA); however, adoption of ERAS to orthopedic surgery has lagged behind other surgical disciplines. The Agency for Healthcare Research and Quality, in partnership with the American College of Surgeons and the Johns Hopkins Medicine Armstrong Institute (AI) for Patient Safety and Quality, has developed the Safety Program for Improving Surgical Care and Recovery. The program comprises a national effort to incorporate best practice in perioperative care and improve patient safety, for over 750 hospitals and multiple procedures over the next 5 years, including orthopedic surgery. We have conducted a full evidence review of anesthetic interventions to derive anesthesiology-related components of an evidence-based ERAS pathway for TKA. A PubMed search was performed for each protocol component, focusing on the highest levels of evidence in the literature. Search findings are summarized in narrative format. Anesthesiology components of care were identified and evaluated across the pre-, intra-, and postoperative phases. A summary of the best available evidence, together with recommendations for inclusion in ERAS protocols for TKA, is provided. There is extensive evidence in the literature, and from society guidelines to support the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery goals for TKA.

  14. MRI evaluation and safety in the developing brain.

    PubMed

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

    2015-03-01

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

  15. An evaluation of an airline cabin safety education program for elementary school children.

    PubMed

    Liao, Meng-Yuan

    2014-04-01

    The knowledge, attitude, and behavior intentions of elementary school students about airline cabin safety before and after they took a specially designed safety education course were examined. A safety education program was designed for school-age children based on the cabin safety briefings airlines given to their passengers, as well as on lessons learned from emergency evacuations. The course is presented in three modes: a lecture, a demonstration, and then a film. A two-step survey was used for this empirical study: an illustrated multiple-choice questionnaire before the program, and, upon completion, the same questionnaire to assess its effectiveness. Before the program, there were significant differences in knowledge and attitude based on school locations and the frequency that students had traveled by air. After the course, students showed significant improvement in safety knowledge, attitude, and their behavior intention toward safety. Demographic factors, such as gender and grade, also affected the effectiveness of safety education. The study also showed that having the instructor directly interact with students by lecturing is far more effective than presenting the information using only video media. A long-term evaluation, the effectiveness of the program, using TV or video accessible on the Internet to deliver a cabin safety program, and a control group to eliminate potential extraneous factors are suggested for future studies. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

    PubMed Central

    2011-01-01

    Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID

  17. Evaluation of Physiology Lectures Conducted by Students: Comparison between Evaluation by Staff and Students

    ERIC Educational Resources Information Center

    Kommalage, Mahinda; Gunawardena, Sampath

    2011-01-01

    As a peer-assisted learning process, minilectures on physiology were conducted by students. During this process, students lecture to their colleagues in the presence of faculty staff members. These lectures were evaluated by faculty staff and students simultaneously. The aim of this study was to compare feedback from faculty members and students…

  18. 49 CFR 199.237 - Other alcohol-related conduct.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Other alcohol-related conduct. 199.237 Section 199... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.237 Other alcohol-related conduct. (a) No operator shall...

  19. 49 CFR 199.237 - Other alcohol-related conduct.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Other alcohol-related conduct. 199.237 Section 199... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Alcohol Misuse Prevention Program § 199.237 Other alcohol-related conduct. (a) No operator shall...

  20. Evaluating the safety impact of adaptive cruise control in traffic oscillations on freeways.

    PubMed

    Li, Ye; Li, Zhibin; Wang, Hao; Wang, Wei; Xing, Lu

    2017-07-01

    Adaptive cruise control (ACC) has been considered one of the critical components of automated driving. ACC adjusts vehicle speeds automatically by measuring the status of the ego-vehicle and leading vehicle. Current commercial ACCs are designed to be comfortable and convenient driving systems. Little attention is paid to the safety impacts of ACC, especially in traffic oscillations when crash risks are the highest. The primary objective of this study was to evaluate the impacts of ACC parameter settings on rear-end collisions on freeways. First, the occurrence of a rear-end collision in a stop-and-go wave was analyzed. A car-following model in an integrated ACC was developed for a simulation analysis. The time-to-collision based factors were calculated as surrogate safety measures of the collision risk. We also evaluated different market penetration rates considering that the application of ACC will be a gradual process. The results showed that the safety impacts of ACC were largely affected by the parameters. Smaller time delays and larger time gaps improved safety performance, but inappropriate parameter settings increased the collision risks and caused traffic disturbances. A higher reduction of the collision risk was achieved as the ACC vehicle penetration rate increased, especially in the initial stage with penetration rates of less than 30%. This study also showed that in the initial stage, the combination of ACC and a variable speed limit achieved better safety improvements on congested freeways than each single technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. 21 CFR 601.35 - Evaluation of safety.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... information, the following types of data: (A) Pharmacology data, (B) Toxicology data, (C) Clinical adverse event data, and (D) Radiation safety assessment. (2) The amount of new safety data required will depend... relevant to risk and will specify the amount and type of safety data that are appropriate for each category...

  2. Study of a safety margin system for powered-lift STOL aircraft

    NASA Technical Reports Server (NTRS)

    Heffley, R. K.; Jewell, W. F.

    1978-01-01

    A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

  3. Analysis of existing work-zone devices with MASH safety performance criteria.

    DOT National Transportation Integrated Search

    2009-02-01

    Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

  4. A review on the benchmarking concept in Malaysian construction safety performance

    NASA Astrophysics Data System (ADS)

    Ishak, Nurfadzillah; Azizan, Muhammad Azizi

    2018-02-01

    Construction industry is one of the major industries that propels Malaysia's economy in highly contributes to our nation's GDP growth, yet the high fatality rates on construction sites have caused concern among safety practitioners and the stakeholders. Hence, there is a need of benchmarking in performance of Malaysia's construction industry especially in terms of safety. This concept can create a fertile ground for ideas, but only in a receptive environment, organization that share good practices and compare their safety performance against other benefit most to establish improvement in safety culture. This research was conducted to study the awareness important, evaluate current practice and improvement, and also identify the constraint in implement of benchmarking on safety performance in our industry. Additionally, interviews with construction professionals were come out with different views on this concept. Comparison has been done to show the different understanding of benchmarking approach and how safety performance can be benchmarked. But, it's viewed as one mission, which to evaluate objectives identified through benchmarking that will improve the organization's safety performance. Finally, the expected result from this research is to help Malaysia's construction industry implement best practice in safety performance management through the concept of benchmarking.

  5. Evaluation of the Quality of Occupational Health and Safety Management Systems Based on Key Performance Indicators in Certified Organizations.

    PubMed

    Mohammadfam, Iraj; Kamalinia, Mojtaba; Momeni, Mansour; Golmohammadi, Rostam; Hamidi, Yadollah; Soltanian, Alireza

    2017-06-01

    Occupational Health and Safety Management Systems are becoming more widespread in organizations. Consequently, their effectiveness has become a core topic for researchers. This paper evaluates the performance of the Occupational Health and Safety Assessment Series 18001 specification in certified companies in Iran. The evaluation is based on a comparison of specific criteria and indictors related to occupational health and safety management practices in three certified and three noncertified companies. Findings indicate that the performance of certified companies with respect to occupational health and safety management practices is significantly better than that of noncertified companies. Occupational Health and Safety Assessment Series 18001-certified companies have a better level of occupational health and safety; this supports the argument that Occupational Health and Safety Management Systems play an important strategic role in health and safety in the workplace.

  6. Usability evaluation of a medication reconciliation tool: Embedding safety probes to assess users' detection of medication discrepancies.

    PubMed

    Russ, Alissa L; Jahn, Michelle A; Patel, Himalaya; Porter, Brian W; Nguyen, Khoa A; Zillich, Alan J; Linsky, Amy; Simon, Steven R

    2018-06-01

    An electronic medication reconciliation tool was previously developed by another research team to aid provider-patient communication for medication reconciliation. To evaluate the usability of this tool, we integrated artificial safety probes into standard usability methods. The objective of this article is to describe this method of using safety probes, which enabled us to evaluate how well the tool supports users' detection of medication discrepancies. We completed a mixed-method usability evaluation in a simulated setting with 30 participants: 20 healthcare professionals (HCPs) and 10 patients. We used factual scenarios but embedded three artificial safety probes: (1) a missing medication (i.e., omission); (2) an extraneous medication (i.e., commission); and (3) an inaccurate dose (i.e., dose discrepancy). We measured users' detection of each probe to estimate the probability that a HCP or patient would detect these discrepancies. Additionally, we recorded participants' detection of naturally occurring discrepancies. Each safety probe was detected by ≤50% of HCPs. Patients' detection rates were generally higher. Estimates indicate that a HCP and patient, together, would detect 44.8% of these medication discrepancies. Additionally, HCPs and patients detected 25 and 45 naturally-occurring discrepancies, respectively. Overall, detection of medication discrepancies was low. Findings indicate that more advanced interface designs are warranted. Future research is needed on how technologies can be designed to better aid HCPs' and patients' detection of medication discrepancies. This is one of the first studies to evaluate the usability of a collaborative medication reconciliation tool and assess HCPs' and patients' detection of medication discrepancies. Results demonstrate that embedded safety probes can enhance standard usability methods by measuring additional, clinically-focused usability outcomes. The novel safety probes we used may serve as an initial, standard

  7. Food Safety at Farmers' Markets: A Knowledge Synthesis of Published Research.

    PubMed

    Young, Ian; Thaivalappil, Abhinand; Reimer, Danielle; Greig, Judy

    2017-12-01

    Farmers' markets are increasingly popular venues in North America for the sale of fresh produce and other foods. However, the nature of their operation can present possible food safety issues, challenges, and risks to consumers. A knowledge synthesis was conducted to identify, characterize, and summarize published research on the microbial food safety issues and implications associated with farmers' markets. A scoping review was conducted using the following steps: comprehensive search strategy, relevance screening of abstracts, and characterization of relevant articles. Two subsets of data were prioritized for more detailed systematic review (data extraction and risk-of-bias assessment) and meta-analysis: (i) studies comparing the microbial safety of foods from farmers' markets versus other sources and (ii) studies evaluating the use of food safety practices at farmers' markets. Overall, 83 relevant studies were identified. The majority of studies were published as journal articles (64%), used a cross-sectional design (81%), and were conducted in the United States (78%). Most studies (39%; n = 32) investigated stakeholder, mostly consumer (n = 22), attitudes toward food safety at farmers' markets. Limited but heterogeneous evidence indicated a higher prevalence of Campylobacter and Salmonella in chicken meat from farmers' markets versus other retail sources, but there was no difference in the microbial contamination of fresh produce. Studies evaluating the use of food safety practices at farmers' markets identified some gaps; for example, the average prevalence of vendor hand washing was 4% (95% confidence interval: 0 to 11%; I 2 = 27%; n = 5 studies). Twelve foodborne outbreaks and case reports were identified, resulting in a total of 411 illnesses, 38 hospitalizations, and two deaths from 1994 to 2016. Only five intervention studies were identified. Key knowledge gaps and areas warranting future research, training, and education are highlighted and discussed.

  8. An evaluation of Winnipeg's photo enforcement safety program: results of time series analyses and an intersection camera experiment.

    PubMed

    Vanlaar, Ward; Robertson, Robyn; Marcoux, Kyla

    2014-01-01

    The objective of this study was to evaluate the impact of Winnipeg's photo enforcement safety program on speeding, i.e., "speed on green", and red-light running behavior at intersections as well as on crashes resulting from these behaviors. ARIMA time series analyses regarding crashes related to red-light running (right-angle crashes and rear-end crashes) and crashes related to speeding (injury crashes and property damage only crashes) occurring at intersections were conducted using monthly crash counts from 1994 to 2008. A quasi-experimental intersection camera experiment was also conducted using roadside data on speeding and red-light running behavior at intersections. These data were analyzed using logistic regression analysis. The time series analyses showed that for crashes related to red-light running, there had been a 46% decrease in right-angle crashes at camera intersections, but that there had also been an initial 42% increase in rear-end crashes. For crashes related to speeding, analyses revealed that the installation of cameras was not associated with increases or decreases in crashes. Results of the intersection camera experiment show that there were significantly fewer red light running violations at intersections after installation of cameras and that photo enforcement had a protective effect on speeding behavior at intersections. However, the data also suggest photo enforcement may be less effective in preventing serious speeding violations at intersections. Overall, Winnipeg's photo enforcement safety program had a positive net effect on traffic safety. Results from both the ARIMA time series and the quasi-experimental design corroborate one another. However, the protective effect of photo enforcement is not equally pronounced across different conditions so further monitoring is required to improve the delivery of this measure. Results from this study as well as limitations are discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

  9. Evaluation of Portable Multi-Gas Analyzers for use by Safety Personnel

    NASA Technical Reports Server (NTRS)

    Lueck, D. E.; Meneghelli, B. J.; Bardel, D. N.

    1998-01-01

    During confined space entry operations as well as Shuttle-safing operations, United Space Alliance (USA)/National Aeronautics and Space Administration (NASA) safety personnel use a variety of portable instrumentation to monitor for hazardous levels of compounds such as nitrogen dioxide (N%), monomethylhydrazine (NMM), FREON 21, ammonia (NH3), oxygen (O2), and combustibles (as hydrogen (H2)). Except for O2 and H2, each compound is monitored using a single analyzer. In many cases these analyzers are 5 to 10 years old and require frequent maintenance. In addition, they are cumbersome to carry and tend to make the job of personnel monitoring physically taxing. As part of an effort to upgrade the sensor technology background information was requested from a total of 27 manufacturers of portable multi-gas instruments. A set of criteria was established to determine which vendors would be selected for laboratory evaluation. These criteria were based on requests made by USA/NASA Safety personnel in order to meet requirements within their respective areas for confined-space and Shuttle-safing operations. Each of the 27 manufacturers of multi-gas analyzers was sent a copy of the criteria and asked to fill in the appropriate information pertaining to their instrumentation. Based on the results of the sensor criteria worksheets, a total of 9 vendors out of 27 surveyed manufacturers were chosen for evaluation. Each vendor included in the final evaluation process was requested to configure each of two analyzers with NO2, NH3, O2, and combustible sensors. A set of lab tests was designed in order to determine which of the multi-gas instruments under evaluation was best suited for use in both shuttle and confined space operations. These tests included linearity/repeatability, zero/span drift response/recovery, humidity, interference, and maintenance. At the conclusion of lab testing three vendors were selected for additional field testing. Based on the results of both the lab and

  10. Active drug safety surveillance: a tool to improve public health.

    PubMed

    Platt, Richard; Madre, Leanne; Reynolds, Robert; Tilson, Hugh

    2008-12-01

    Ensuring that drugs have an acceptable safety profile and are used safely is a major public health priority. The Centers for Education and Research on Therapeutics (CERTs) convened experts from academia, government, and industry to assess strategies to increase the speed and predictive value of generating and evaluating safety signals, and to identify next steps to improve the US system for identifying and evaluating potential safety signals. The CERTs convened a think tank comprising representatives of the groups noted above to address these goals. Participants observed that, with the increasing availability of electronic health data, opportunities have emerged to more accurately characterize and confirm potential safety issues. The gain for public health from a highly coordinated network of population-based databases for active surveillance is great and within reach, although operational questions remain. A collaborative network must create a working definition of a safety signal, screening algorithms, and criteria and strategies to confirm or refute a signal once identified through screening. Guidelines are needed for when and how to communicate a signal exists and is being evaluated, as well as the outcome of that evaluation. A public-private partnership to create a network of government and private databases to routinely evaluate and prioritize safety questions is in the public interest. Better methods are needed, and a knowledgeable workforce is required to conduct the surveillance and understand how to interpret the results. The international community will benefit from the availability of better methods and more experts. Copyright (c) 2008 John Wiley & Sons, Ltd.

  11. Technical evaluation of the susceptibility of safety-related systems to flooding caused by the failure of non-Category I systems for Turkey Point Nuclear Power Plant, Units 3 and 4

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

    Collins, E.K.

    1979-08-01

    Three separate reviews of the Turkey Point Units 3 and 4 were conducted by the FPLCO between 1972 and 1975. Initially, at the request of NBC in 1972, the FPLCO reviewed several water systems as sources of flooding. Subsequently, as a result of an abnormal occurrence, the drainage system was reviewed. Finally, the facilities were again reviewed at NRC's request and both the potential sources of flooding and safety-related equipment which could be damaged by flooding were identified. The sources of flooding and the appropriate safety equipment are discussed. An evaluation is presented of measures that were taken by FPLCOmore » to minimize the danger of flooding and to protect safety-related equipment.« less

  12. Construction safety research in the United States: targeting the Hispanic workforce

    PubMed Central

    Brunette, M

    2004-01-01

    While it is known that Hispanics have a continuous growing participation in the construction workforce and that their fatal and non-fatal occupational injuries are higher than any other ethnic group, very little construction safety and health research has been conducted in the United States. Research that focuses on safety and health of Hispanic workers employed in the construction industry might prove beneficial in reducing injuries and promoting safe and decent workplaces for all. The purpose of this article was twofold. First, to propose a research agenda where topics such as surveillance, intervention research on high risk occupations, intervention effectiveness evaluation, design and development of effective and appropriate safety training and educational materials, and the socioeconomic impact of injuries and illnesses, are investigated among the Hispanic construction workforce. Second, to present relevant aspects inherent to this particular population that need to be incorporated into the design and development stages of any safety and health research initiative. They include the occupational, social, economic, and cultural background of Hispanic workers; use of a participatory approach, proper selection and use of translation methods; and conducting collaborative research. Certain limitations and challenges related to the availability of resources for conducting safety and health research on Hispanic workers are further discussed. PMID:15314054

  13. Construction safety research in the United States: targeting the Hispanic workforce.

    PubMed

    Brunette, M J

    2004-08-01

    While it is known that Hispanics have a continuous growing participation in the construction workforce and that their fatal and non-fatal occupational injuries are higher than any other ethnic group, very little construction safety and health research has been conducted in the United States. Research that focuses on safety and health of Hispanic workers employed in the construction industry might prove beneficial in reducing injuries and promoting safe and decent workplaces for all. The purpose of this article was twofold. First, to propose a research agenda where topics such as surveillance, intervention research on high risk occupations, intervention effectiveness evaluation, design and development of effective and appropriate safety training and educational materials, and the socioeconomic impact of injuries and illnesses, are investigated among the Hispanic construction workforce. Second, to present relevant aspects inherent to this particular population that need to be incorporated into the design and development stages of any safety and health research initiative. They include the occupational, social, economic, and cultural background of Hispanic workers; use of a participatory approach, proper selection and use of translation methods; and conducting collaborative research. Certain limitations and challenges related to the availability of resources for conducting safety and health research on Hispanic workers are further discussed.

  14. Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

    PubMed

    Schwatka, Natalie V; Rosecrance, John C

    2016-06-16

    There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

  15. [Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

    PubMed

    Yang, Wei; Xie, Yanming; Zhuang, Yan

    2011-10-01

    There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

  16. Passive Safety Features Evaluation of KIPT Neutron Source Facility

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

    Zhong, Zhaopeng; Gohar, Yousry

    2016-06-01

    Argonne National Laboratory (ANL) of the United States and Kharkov Institute of Physics and Technology (KIPT) of Ukraine have cooperated on the development, design, and construction of a neutron source facility. The facility was constructed at Kharkov, Ukraine and its commissioning process is underway. It will be used to conduct basic and applied nuclear research, produce medical isotopes, and train young nuclear specialists. The facility has an electron accelerator-driven subcritical assembly. The electron beam power is 100 kW using 100 MeV electrons. Tungsten or natural uranium is the target material for generating neutrons driving the subcritical assembly. The subcritical assemblymore » is composed of WWR-M2 - Russian fuel assemblies with U-235 enrichment of 19.7 wt%, surrounded by beryllium reflector assembles and graphite blocks. The subcritical assembly is seated in a water tank, which is a part of the primary cooling loop. During normal operation, the water coolant operates at room temperature and the total facility power is ~300 KW. The passive safety features of the facility are discussed in in this study. Monte Carlo computer code MCNPX was utilized in the analyses with ENDF/B-VII.0 nuclear data libraries. Negative reactivity temperature feedback was consistently observed, which is important for the facility safety performance. Due to the design of WWR-M2 fuel assemblies, slight water temperature increase and the corresponding water density decrease produce large reactivity drop, which offset the reactivity gain by mistakenly loading an additional fuel assembly. The increase of fuel temperature also causes sufficiently large reactivity decrease. This enhances the facility safety performance because fuel temperature increase provides prompt negative reactivity feedback. The reactivity variation due to an empty fuel position filled by water during the fuel loading process is examined. Also, the loading mistakes of removing beryllium reflector assemblies

  17. A novel framework to evaluate pedestrian safety at non-signalized locations.

    PubMed

    Fu, Ting; Miranda-Moreno, Luis; Saunier, Nicolas

    2018-02-01

    This paper proposes a new framework to evaluate pedestrian safety at non-signalized crosswalk locations. In the proposed framework, the yielding maneuver of a driver in response to a pedestrian is split into the reaction and braking time. Hence, the relationship of the distance required for a yielding maneuver and the approaching vehicle speed depends on the reaction time of the driver and deceleration rate that the vehicle can achieve. The proposed framework is represented in the distance-velocity (DV) diagram and referred as the DV model. The interactions between approaching vehicles and pedestrians showing the intention to cross are divided in three categories: i) situations where the vehicle cannot make a complete stop, ii) situations where the vehicle's ability to stop depends on the driver reaction time, and iii) situations where the vehicle can make a complete stop. Based on these classifications, non-yielding maneuvers are classified as "non-infraction non-yielding" maneuvers, "uncertain non-yielding" maneuvers and "non-yielding" violations, respectively. From the pedestrian perspective, crossing decisions are classified as dangerous crossings, risky crossings and safe crossings accordingly. The yielding compliance and yielding rate, as measures of the yielding behavior, are redefined based on these categories. Time to crossing and deceleration rate required for the vehicle to stop are used to measure the probability of collision. Finally, the framework is demonstrated through a case study in evaluating pedestrian safety at three different types of non-signalized crossings: a painted crosswalk, an unprotected crosswalk, and a crosswalk controlled by stop signs. Results from the case study suggest that the proposed framework works well in describing pedestrian-vehicle interactions which helps in evaluating pedestrian safety at non-signalized crosswalk locations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Systemic safety project selection tool.

    DOT National Transportation Integrated Search

    2013-07-01

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

  19. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  20. Evaluation of hydraulic conductivities calculated from multi-port permeameter measurements

    USGS Publications Warehouse

    Wolf, Steven H.; Celia, Michael A.; Hess, Kathryn M.

    1991-01-01

    A multiport permeameter was developed for use in estimating hydraulic conductivity over intact sections of aquifer core using the core liner as the permeameter body. Six cores obtained from one borehole through the upper 9 m of a stratified glacial-outwash aquifer were used to evaluate the reliability of the permeameter. Radiographs of the cores were used to assess core integrity and to locate 5- to 10-cm sections of similar grain size for estimation of hydraulic conductivity. After extensive testing of the permeameter, hydraulic conductivities were determined for 83 sections of the six cores. Other measurement techniques included permeameter measurements on repacked sections of core, estimates based on grain-size analyses, and estimates based on borehole flowmeter measurements. Permeameter measurements of 33 sections of core that had been extruded, homogenized, and repacked did not differ significantly from the original measurements. Hydraulic conductivities estimated from grain-size distributions were slightly higher than those calculated from permeameter measurements; the significance of the difference depended on the estimating equation used. Hydraulic conductivities calculated from field measurements, using a borehole flowmeter in the borehole from which the cores were extracted, were significantly higher than those calculated from laboratory measurements and more closely agreed with independent estimates of hydraulic conductivity based on tracer movement near the borehole. This indicates that hydraulic conductivities based on laboratory measurements of core samples may underestimate actual field hydraulic conductivities in this type of stratified glacial-outwash aquifer.

  1. The Ergonomic Program Implementation Continuum (EPIC): integration of health and safety--a process evaluation in the healthcare sector.

    PubMed

    Baumann, Andrea; Holness, D Linn; Norman, Patrica; Idriss-Wheeler, Dina; Boucher, Patricia

    2012-07-01

    This article presents a health and safety intervention model and the use of process evaluation to assess a participatory ergonomic intervention. The effectiveness of the Ergonomic Program Implementation Continuum (EPIC) was assessed at six healthcare pilot sites in Ontario, Canada. The model provided a framework to demonstrate evaluation findings. Participants reported that EPIC was thorough and identified improvements related to its use. Participants believed the program contributed to advancing an organizational culture of safety (COS). Main barriers to program uptake included resistance to change and need for adequate funding and resources. The dedication of organizational leaders and consultant coaches was identified as essential to the program's success. In terms of impact on industry, findings contribute to the evidence-based knowledge of health and safety interventions and support use of the framework for creating a robust infrastructure to advance organizational COS and link staff safety and wellness with patient safety in healthcare. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

  2. National Chemistry Teacher Safety Survey

    NASA Astrophysics Data System (ADS)

    Plohocki, Barbra A.

    This study evaluated the status of secondary school instructional chemistry laboratory safety using a survey instrument which focused on Teacher background Information, Laboratory Safety Equipment, Facility Safety, General Safety, and a Safety Content Knowledge Survey. A fifty question survey instrument based on recent research and questions developed by the researcher was mailed to 500 secondary school chemistry teachers who participated in the 1993 one-week Woodrow Wilson National Fellowship Foundation Chemistry Institute conducted at Princeton University, New Jersey. The data received from 303 respondents was analyzed by t tests and Analysis of Variance (ANOVA). The level of significance for the study was set at ~\\ <.05. There was no significant mean difference in test performance on the Safety Content Knowledge Survey and secondary school chemistry teachers who have had undergraduate and/or graduate safety training and those who have not had undergraduate and/or graduate safety training. Secondary school chemistry teachers who attended school district sponsored safety inservices did not score higher on the Safety Content Knowledge Survey than teachers who did not attend school district sponsored safety inservice sessions. The type of school district (urban, suburban, or rural) had no significant correlation to the type of laboratory safety equipment found in the instructional chemistry laboratory. The certification area (chemistry or other type of certificate which may or may not include chemistry) of the secondary school teacher had no significant correlation to the type of laboratory equipment found in the instructional chemistry laboratory. Overall, this study indicated a majority of secondary school chemistry teachers were interested in attending safety workshops applicable to chemistry safety. Throughout this research project, many teachers indicated they were not adequately instructed on the collegiate level in science safety and had to rely on common

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

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

    Filss, Martin; Wallner, Christian

    2013-07-01

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

  4. A Safety Program that Integrated Behavior-Based Safety and Traditional Safety Methods and Its Effects on Injury Rates of Manufacturing Workers

    ERIC Educational Resources Information Center

    Hermann, Jaime A.; Ibarra, Guillermo V.; Hopkins, B. L.

    2010-01-01

    The present research examines the effects of a complex safety program that combined Behavior-Based Safety (BBS) and traditional safety methods. The study was conducted in an automobile parts plant in Mexico. Two sister plants served as comparison. Some of the components of the safety programs addressed behaviors of managers and included methods…

  5. Improving railroad safety and rail passenger technology through targeted research demonstrations : 1992-1997

    DOT National Transportation Integrated Search

    1999-08-01

    The Office of Railroad Development of the Federal Railroad Administration conducts research, development, test, and evaluation projects to directly support the Federal Railroad Administrations safety responsibility and to enhance the railroad system,...

  6. Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

    PubMed

    Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

    2017-08-23

    The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development

  7. Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists

    PubMed Central

    Fois, Romano A.; McLachlan, Andrew J.; Chen, Timothy F.

    2017-01-01

    Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns’ patient safety attitudes. However, other factors likely influenced their attitudes in the longer term. PMID:28289295

  8. Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists.

    PubMed

    Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

    2017-02-25

    Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns' patient safety attitudes. However, other factors likely influenced their attitudes in the longer term.

  9. Safety in Outdoor Adventure Programs. S.O.A.P. Safety Policy.

    ERIC Educational Resources Information Center

    MacDonald, Wayne, Comp.; And Others

    Drafted in 1978 as a working document for Safety in Outdoor Adventure Programs (S.O.A.P.) by a council of outdoor adventure programmers, checklists outline standard accepted safety policy for Outdoor Adventure Programs and Wilderness Adventure Programs conducted through public or private agencies in California. Safety policy emphasizes: the…

  10. An open-label, single arm, phase III clinical study to evaluate the efficacy and safety of CJ smallpox vaccine in previously vaccinated healthy adults.

    PubMed

    Kim, Nak-Hyun; Kang, Yu Min; Kim, Gayeon; Choe, Pyoeng Gyun; Song, Jin Su; Lee, Kwang-Hee; Seong, Baik-Lin; Park, Wan Beom; Kim, Nam Joong; Oh, Myoung-don

    2013-10-25

    The increased possibility of bioterrorism has led to reinitiation of smallpox vaccination. In Korea, more than 30 years have passed since the last smallpox vaccinations, and even people who were previously vaccinated are not regarded as adequately protected against smallpox. We evaluated the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy adults previously vaccinated against smallpox. We conducted an open label, single arm, phase III clinical trial to evaluate the efficacy and safety of CJ-50300. Healthy volunteers, previously vaccinated against smallpox, born between 1950 and 1978 were enrolled. CJ-50300 was administered with a bifurcated needle over the deltoid muscle according to the recommended method. The rate of the cutaneous take reaction, humoral immunogenicity, and safety of the vaccine was assessed. Of 145 individuals enrolled for vaccination, 139 completed the study. The overall rates of cutaneous take reactions and humoral immunogenicity were 95.0% (132/139) and 88.5% (123/139), respectively. Although 95.9% (139/145) reported adverse events related to vaccination, no serious adverse reactions were observed. CJ-50300 can be used safely and effectively in healthy adults previously vaccinated against smallpox. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Safety evaluation of trelagliptin in the treatment of Japanese type 2 diabetes mellitus patients.

    PubMed

    Kaku, Kohei

    2017-11-01

    Trelagliptin is a novel, long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM) in japan. The safety and efficacy of trelagliptin has been evaluated in three published clinical trials to date: one phase II and two phase III studies. As trelagliptin only requires dosing once per week, this new agent has the potential to improve compliance and subsequently, glycaemic control, in patients with T2DM. Areas covered: This article reviews the available safety data for trelagliptin from published clinical trials, and evaluates the published safety profile relative to competitor once-daily and once-weekly DPP-4 inhibitors. Expert opinion: Clinical trial data to date suggest that trelagliptin is a safe and efficacious medication with a similar safety profile to once-daily DPP-4 inhibitors, and to the once-weekly DPP-4 inhibitor, omarigliptin. Trelagliptin is well tolerated when given alone, and in combination with other anti-diabetic medications. An advantage of trelagliptin over existing once-daily DPP-4 inhibitors is the decrease of dosing frequency, rather than once-daily. No specific, serious adverse events have been reported for trelagliptin in published clinical trials, making it an attractive alternative to other DPP-4 inhibitors.

  12. Drug-nutrient interactions and their implications for safety evaluations.

    PubMed

    Conner, M W; Newberne, P M

    1984-06-01

    In order to assess the relevance of the drug-nutrient interactions described in this chapter to routine toxicologic studies, the range of nutrient concentrations within which these interactions may occur must be compared to the range of nutrient concentrations found in routinely used rodent diets. While obviously deficient levels of some nutrients were supplied to demonstrate some of the interactions, others occur when the nutrients are present in adequate or excess levels, such as might be found in commercially available diets. These diets are known to vary from batch to batch in nutrient content. A lifetime toxicity/carcinogenicity bioassay using rodents may last longer than 2 years, during which time several batches of diet will be used. The variation in diet composition, coupled with inadequate diet description, makes nutrient-toxin interactions not only possible, but difficult to recognize. These considerations raise the practical and philosophical question as to what type of diet is most appropriate for rodents used for safety evaluation of drugs and chemicals. Is it appropriate to use diets that vary unpredictably in nutrient content, that infer a degree of protection against chemical carcinogenesis and which supply some nutrients such as protein in great excess of dietary needs? Is the increase in sensitivity to chemical carcinogens of animals fed purified diets desirable or does this increased sensitivity of the bioassay exceed that required to assess the risk of human exposure? In other words, is the use of purified diets likely to increase the number of false positive results? Proper interpretation and extrapolation of safety evaluation studies requires adequate description of the test system. Given the profound influence of diet on the response to some toxins, the composition of the diet should, ideally, be defined with the same rigor as are the test compound and the strain, age, sex, and housing conditions of the animals. It is likely, however, that

  13. Alcohol safety action projects evaluation of operations : data, table of results, and formulation

    DOT National Transportation Integrated Search

    1979-06-01

    This volume contains the data used in the evaluation of 35 Alcohol Safety Action Projects implemented throughout the country. Historical background, discussion of analytic results and factors affecting impact detecion are contained in the document ti...

  14. Verification and Implementation of Operations Safety Controls for Flight Missions

    NASA Technical Reports Server (NTRS)

    Jones, Cheryl L.; Smalls, James R.; Carrier, Alicia S.

    2010-01-01

    Approximately eleven years ago, the International Space Station launched the first module from Russia, the Functional Cargo Block (FGB). Safety and Mission Assurance (S&MA) Operations (Ops) Engineers played an integral part in that endeavor by executing strict flight product verification as well as continued staffing of S&MA's console in the Mission Evaluation Room (MER) for that flight mission. How were these engineers able to conduct such a complicated task? They conducted it based on product verification that consisted of ensuring that safety requirements were adequately contained in all flight products that affected crew safety. S&MA Ops engineers apply both systems engineering and project management principles in order to gain a appropriate level of technical knowledge necessary to perform thorough reviews which cover the subsystem(s) affected. They also ensured that mission priorities were carried out with a great detail and success.

  15. Safety evaluation of genetically modified DAS-40278-9 maize in a subchronic rodent feeding study.

    PubMed

    Zou, Shiying; Lang, Tianqi; Liu, Xu; Huang, Kunlun; He, Xiaoyun

    2018-07-01

    Genetically modified (GM) maize, DAS-40278-9, expresses the aryloxyalkanoate dioxygenase-1 (AAD-1) protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) herbicides. The aad-1 gene, which expresses the AAD-1 protein, was derived from Gram-negative soil bacterium, Sphingobium herbicidovorans. A 90-day sub-chronic toxicity study was conducted on rats as a component of the safety evaluation of DAS-40278-9 maize. Rats were given formulated diets containing maize grain from DAS-40278-9 or a non-GM near isogenic control comparator at an incorporation rate of 12.5%, 25%, or 50% (w/w), respectively for 90 days. In addition, another group of rats was fed a basic rodent diet. Animals were evaluated by cage-side and hand-held detailed clinical observations, ophthalmic examinations, body weights/body weight gains, feed consumption, hematology, serum chemistry, selected organ weights, and gross and histopathological examinations. Under the condition of this study, DAS-40278-9 maize did not cause any treatment-related effects in rats compared with rats fed diets containing non-GM maize. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. Challenging patient safety culture: survey results.

    PubMed

    Hellings, Johan; Schrooten, Ward; Klazinga, Niek; Vleugels, Arthur

    2007-01-01

    The purpose of this paper is to measure patient safety culture in five Belgian general hospitals. Safety culture plays an important role in the approach towards greater patient safety in hospitals. The Patient Safety Culture Hospital questionnaire was distributed hospital-wide in five general hospitals. It evaluates ten patient safety culture dimensions and two outcomes. The scores were expressed as the percentage of positive answers towards patient safety for each dimension. The survey was conducted from March through November 2005. In total, 3,940 individuals responded (overall response rate = 77 per cent), including 2,813 nurses and assistants, 462 physicians, 397 physiotherapists, laboratory and radiology assistants, social workers and 64 pharmacists and pharmacy assistants. The dimensional positive scores were found to be low to average in all the hospitals. The lowest scores were "hospital management support for patient safety" (35 per cent), "non-punitive response to error" (36 per cent), "hospital transfers and transitions" (36 per cent), "staffing" (38 per cent), and "teamwork across hospital units" (40 per cent). The dimension "teamwork within hospital units" generated the highest score (70 per cent). Although the same dimensions were considered problematic in the different hospitals, important variations between the five hospitals were observed. A comprehensive and tailor-made plan to improve patient safety culture in these hospitals can now be developed. Results indicate that important aspects of the patient safety culture in these hospitals need improvement. This is an important challenge to all stakeholders wishing to improve patient safety.

  17. Human health safety evaluation of cosmetics in the EU: a legally imposed challenge to science.

    PubMed

    Pauwels, M; Rogiers, V

    2010-03-01

    As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alone piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.

  18. Integrated Vehicle-Based Safety Systems (IVBSS) Light Vehicle Field Operational Test Independent Evaluation

    DOT National Transportation Integrated Search

    2011-10-01

    This report presents the methodology and results of the independent evaluation of a prototype integrated crash warning system for : light vehicles as part of the Integrated Vehicle-Based Safety Systems initiative of the United States Department of : ...

  19. A Study of the System Safety Concept as it Relates to the New Walter Reed Army Medical Center, Washington, DC.

    DTIC Science & Technology

    1978-03-31

    established the safety level of the% * originally designed facility and the extent of current safety * modifications. The objectives evaluated the...Program could identify many safety hazards thus leading to design improvements. The study provided several recommendations to formalize the Systems Safety... design , construction, and proposed systems management of the new Walter Reed Army Medical Center (WRAMC), Washington, D.C., was conducted during the

  20. Current collectors for improved safety

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

    Abdelmalak, Michael Naguib; Allu, Srikanth; Dudney, Nancy J.

    A battery electrode assembly includes a current collector with conduction barrier regions having a conductive state in which electrical conductivity through the conduction barrier region is permitted, and a safety state in which electrical conductivity through the conduction barrier regions is reduced. The conduction barrier regions change from the conductive state to the safety state when the current collector receives a short-threatening event. An electrode material can be connected to the current collector. The conduction barrier regions can define electrical isolation subregions. A battery is also disclosed, and methods for making the electrode assembly, methods for making a battery, andmore » methods for operating a battery.« less

  1. Evaluation of aviation-based safety team training in a hospital in The Netherlands.

    PubMed

    De Korne, Dirk F; Van Wijngaarden, Jeroen D H; Van Dyck, Cathy; Hiddema, U Francis; Klazinga, Niek S

    2014-01-01

    The purpose of this paper is to evaluate the implementation of a broad-scale team resource management (TRM) program on safety culture in a Dutch eye hospital, detailing the program's content and procedures. Aviation-based TRM training is recognized as a useful approach to increase patient safety, but little is known about how it affects safety culture. Pre- and post-assessments of the hospitals' safety culture was based on interviews with ophthalmologists, anesthesiologists, residents, nurses, and support staff. Interim observations were made at training sessions and in daily hospital practice. The program consisted of safety audits of processes and (team) activities, interactive classroom training sessions by aviation experts, a flight simulator session, and video recording of team activities with subsequent feedback. Medical professionals considered aviation experts inspiring role models and respected their non-hierarchical external perspective and focus on medical-technical issues. The post-assessment showed that ophthalmologists and other hospital staff had become increasingly aware of safety issues. The multidisciplinary approach promoted social (team) orientation that replaced the former functionally-oriented culture. The number of reported near-incidents greatly increased; the number of wrong-side surgeries stabilized to a minimum after an initial substantial reduction. The study was observational and the hospital's variety of efforts to improve safety culture prevented us from establishing a causal relation between improvement and any one specific intervention. Aviation-based TRM training can be a useful to stimulate safety culture in hospitals. Safety and quality improvements are not single treatment interventions but complex socio-technical interventions. A multidisciplinary system approach and focus on "team" instead of "profession" seems both necessary and difficult in hospital care.

  2. An Evaluation of a Parent Implemented in Situ Pedestrian Safety Skills Intervention for Individuals with Autism

    ERIC Educational Resources Information Center

    Harriage, Bethany; Blair, Kwang-Sun Cho; Miltenberger, Raymond

    2016-01-01

    This study evaluated an in situ pedestrian safety skills intervention for three individuals with autism, as implemented by their parents. Specifically, this study examined the utility of behavioral skills training (BST) in helping parents implement most-to-least prompting procedures in training their children to use pedestrian safety skills in…

  3. Evaluation of Key Factors Impacting Feeding Safety in the Neonatal Intensive Care Unit: A Systematic Review.

    PubMed

    Matus, Bethany A; Bridges, Kayla M; Logomarsino, John V

    2018-06-21

    Individualized feeding care plans and safe handling of milk (human or formula) are critical in promoting growth, immune function, and neurodevelopment in the preterm infant. Feeding errors and disruptions or limitations to feeding processes in the neonatal intensive care unit (NICU) are associated with negative safety events. Feeding errors include contamination of milk and delivery of incorrect or expired milk and may result in adverse gastrointestinal illnesses. The purpose of this review was to evaluate the effect(s) of centralized milk preparation, use of trained technicians, use of bar code-scanning software, and collaboration between registered dietitians and registered nurses on feeding safety in the NICU. A systematic review of the literature was completed, and 12 articles were selected as relevant to search criteria. Study quality was evaluated using the Downs and Black scoring tool. An evaluation of human studies indicated that the use of centralized milk preparation, trained technicians, bar code-scanning software, and possible registered dietitian involvement decreased feeding-associated error in the NICU. A state-of-the-art NICU includes a centralized milk preparation area staffed by trained technicians, care supported by bar code-scanning software, and utilization of a registered dietitian to improve patient safety. These resources will provide nurses more time to focus on nursing-specific neonatal care. Further research is needed to evaluate the impact of factors related to feeding safety in the NICU as well as potential financial benefits of these quality improvement opportunities.

  4. 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.

  5. Evaluation of a Conductive Elastomer Seal for Spacecraft

    NASA Technical Reports Server (NTRS)

    Daniels, C. C.; Mather, J. L.; Oravec, H. A.; Dunlap, P. H., Jr.

    2016-01-01

    An electrically conductive elastomer was evaluated as a material candidate for a spacecraft seal. The elastomer used electrically conductive constituents as a means to reduce the resistance between mating interfaces of a sealed joint to meet spacecraft electrical bonding requirements. The compound's outgassing levels were compared against published NASA requirements. The compound was formed into a hollow O-ring seal and its compression set was measured. The O-ring seal was placed into an interface and the electrical resistance and leak rate were quantified. The amount of force required to fully compress the test article in the sealing interface and the force needed to separate the joint were also measured. The outgassing and resistance measurements were below the maximum allowable levels. The room temperature compression set and leak rates were fairly high when compared against other typical spacecraft seal materials, but were not excessive. The compression and adhesion forces were desirably low. Overall, the performance of the elastomer compound was sufficient to be considered for future spacecraft seal applications.

  6. Evaluation of criteria for developing traffic safety materials for Latinos.

    PubMed

    Streit-Kaplan, Erica L; Miara, Christine; Formica, Scott W; Gallagher, Susan Scavo

    2011-03-01

    This quantitative study assessed the validity of guidelines that identified four key characteristics of culturally appropriate Spanish-language traffic safety materials: language, translation, formative evaluation, and credible source material. From a sample of 190, the authors randomly selected 12 Spanish-language educational materials for analysis by 15 experts. Hypotheses included that the experts would rate materials with more of the key characteristics as more effective (likely to affect behavioral change) and rate materials originally developed in Spanish and those that utilized formative evaluation (e.g., pilot tests, focus groups) as more culturally appropriate. Although results revealed a weak association between the number of key characteristics in a material and the rating of its effectiveness, reviewers rated materials originally created in Spanish and those utilizing formative evaluation as significantly more culturally appropriate. The findings and methodology demonstrated important implications for developers and evaluators of any health-related materials for Spanish speakers and other population groups.

  7. Prospective clinical evaluation of the Polyperf® Safe, a safety Huber needle, in cancer patients.

    PubMed

    Goossens, Godelieve A; Moons, Philip; Jérôme, Martine; Stas, Marguerite

    2011-01-01

    Evaluation of the Polyperf® Safe (PPS) needle on safety and user-friendliness, as experienced by first-time and non-first-time users of the device. A prospective, descriptive study was carried out at the University Hospitals Leuven, Belgium. Five hundred PPS needles were individually evaluated in cancer patients. Different aspects of the PPS were assessed: packaging, needle insertion, and needle removal. Nurses were asked whether they had previously inserted or removed this type of needle. We compared the PPS needle with the standard Gripper® needle in terms of safety, ease of use, and ease of training. Three hundred sixty-six evaluation forms were available for analysis (73.2%). Packaging and access evaluations were scored positively, except for two aspects: (1) needle stability, and (2) ease of dressing. Ease of removal was scored unsatisfactory in up to 22.4% of the registrations. Pain at insertion was reported in about 20% registrations, and blood contact was reported by 2.5% of non-first-time users. Safety was scored as good, although ease of use and ease in training scored 25.4% and 43.8%, respectively, lower than the Gripper®. In general, nurses evaluated the PPS positively, with the exception of needle stability, ease of dressing, and ease of removal. No needlestick accidents were recorded. Aspects of ease of use and ease of training for PPS needles scored less than those for the Gripper® needles in up to one-third of the registrations.

  8. Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

    PubMed

    Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B

    2008-05-01

    Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.

  9. 25 CFR 1000.366 - Can the Department conduct more than one trust evaluation per Tribe per year?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AMENDMENTS TO THE INDIAN SELF-DETERMINATION AND EDUCATION ACT Trust Evaluation Review Annual Trust Evaluations § 1000.366 Can the Department conduct more than one trust evaluation per Tribe per year? Trust... 25 Indians 2 2010-04-01 2010-04-01 false Can the Department conduct more than one trust evaluation...

  10. Cycling transport safety quantification

    NASA Astrophysics Data System (ADS)

    Drbohlav, Jiri; Kocourek, Josef

    2018-05-01

    Dynamic interest in cycling transport brings the necessity to design safety cycling infrastructure. In las few years, couple of norms with safety elements have been designed and suggested for the cycling infrastructure. But these were not fully examined. The main parameter of suitable and fully functional transport infrastructure is the evaluation of its safety. Common evaluation of transport infrastructure safety is based on accident statistics. These statistics are suitable for motor vehicle transport but unsuitable for the cycling transport. Cycling infrastructure evaluation of safety is suitable for the traffic conflicts monitoring. The results of this method are fast, based on real traffic situations and can be applied on any traffic situations.

  11. Assessing safety culture in NICU: psychometric properties of the Italian version of Safety Attitude Questionnaire and result implications.

    PubMed

    Zenere, Alessandra; Zanolin, M Elisabetta; Negri, Roberta; Moretti, Francesca; Grassi, Mario; Tardivo, Stefano

    2016-04-01

    Neonatal intensive care units (NICUs) are a high-risk setting. The Safety Attitude Questionnaire (SAQ) is a widely used tool to measure safety culture. The aims of the study are to verify the psychometric properties of the Italian version of SAQ, to evaluate safety culture in the NICUs and to identify improvement interventions. A cross-sectional study was conducted in 6 level III NICUs. The SAQ was translated into Italian and adapted to the context, a confirmatory factor analysis (CFA) was performed to validate the questionnaire. 193 questionnaires were collected. The mean response rate was 59.7% (range 44.5%-95.7%). The answers were analysed according to six factors: f1 - teamwork climate, f2 - safety climate, f3 - job satisfaction, f4 - stress recognition, f5 - perception of management, f6 - working conditions. The CFA indexes were adequate (McDonald's omega indexes varied from 0.74 to 0.94, the SRMR index was equal to 0.79 and the RMSEA index was 0.070, 95% CI = 0.063-0.078). The mean composite score was 57.6 (SD 17.9), ranging between 42.3 and 69.7 on a standardized 100-point scale. We highlighted significant differences among units and professions (P < 0.05). The Italian version of the SAQ proved to be an effective tool to evaluate and compare the safety culture in the NICUs. The obtained scores significantly varied both within and among the NICUs. The organizational and structural characteristics of the involved hospitals probably affect the safety culture perception by the staff. © 2015 John Wiley & Sons, Ltd.

  12. Evaluating safety and operation of high-speed signalized intersections : final report, March 2010.

    DOT National Transportation Integrated Search

    2010-03-01

    This Final Report reviews a research effort to evaluate the safety and operations of high-speed intersections in the State of : Oregon. In particular, this research effort focuses on four-leg, signalized intersections with speed limits of 45 mph or :...

  13. Evaluation of Safety, Quality and Productivity in Construction

    NASA Astrophysics Data System (ADS)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

    This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

  14. Techniques to evaluate the importance of common cause degradation on reliability and safety of nuclear weapons.

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

    Darby, John L.

    2011-05-01

    As the nuclear weapon stockpile ages, there is increased concern about common degradation ultimately leading to common cause failure of multiple weapons that could significantly impact reliability or safety. Current acceptable limits for the reliability and safety of a weapon are based on upper limits on the probability of failure of an individual item, assuming that failures among items are independent. We expanded the current acceptable limits to apply to situations with common cause failure. Then, we developed a simple screening process to quickly assess the importance of observed common degradation for both reliability and safety to determine if furthermore » action is necessary. The screening process conservatively assumes that common degradation is common cause failure. For a population with between 100 and 5000 items we applied the screening process and conclude the following. In general, for a reliability requirement specified in the Military Characteristics (MCs) for a specific weapon system, common degradation is of concern if more than 100(1-x)% of the weapons are susceptible to common degradation, where x is the required reliability expressed as a fraction. Common degradation is of concern for the safety of a weapon subsystem if more than 0.1% of the population is susceptible to common degradation. Common degradation is of concern for the safety of a weapon component or overall weapon system if two or more components/weapons in the population are susceptible to degradation. Finally, we developed a technique for detailed evaluation of common degradation leading to common cause failure for situations that are determined to be of concern using the screening process. The detailed evaluation requires that best estimates of common cause and independent failure probabilities be produced. Using these techniques, observed common degradation can be evaluated for effects on reliability and safety.« less

  15. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  16. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  17. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  18. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  19. Natural Gas Vehicle Cylinder Safety, Training and Inspection Project

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

    Hank Seiff

    2008-12-31

    Under the auspices of the National Energy Technology Laboratory and the US Department of Energy, the Clean Vehicle Education Foundation conducted a three-year program to increase the understanding of the safe and proper use and maintenance of vehicular compressed natural gas (CNG) fuel systems. High-pressure fuel systems require periodic inspection and maintenance to insure safe and proper operation. The project addressed the needs of CNG fuel containers (cylinders) and associated high-pressure fuel system components related to existing law, codes and standards (C&S), available training and inspection programs, and assured coordination among vehicle users, public safety officials, fueling station operators andmore » training providers. The program included a public and industry awareness campaign, establishment and administration of a cylinder inspector certification training scholarship program, evaluation of current safety training and testing practices, monitoring and investigation of CNG vehicle incidents, evaluation of a cylinder recertification program and the migration of CNG vehicle safety knowledge to the nascent hydrogen vehicle community.« less

  20. Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

    PubMed

    Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

    2006-04-01

    Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

  1. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir (I): a drug use investigation.

    PubMed

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2014-11-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. We conducted a drug use investigation of peramivir from October 2010 to February 2012 and evaluated its safety and effectiveness under routine clinical settings. We collected data of 1309 patients from 189 facilities across Japan and examined safety in 1174 patients and effectiveness in 1158 patients. In total, 143 adverse events were observed with an incidence rate of 7.33% (86/1174). Of these, 78 events were adverse drug reactions (ADRs) with an incidence rate of 4.34% (51/1174). The most frequently reported ADRs were diarrhea, vomiting, and nausea, with incidence rates of 1.87% (22/1174), 0.85% (10/1174), and 0.68% (8/1174), respectively. Moreover, no ADR was reported as serious. ADR onset was within 3 days after the start of peramivir administration in 91.0% (71 events) of the 78 ADRs, and ADRs were resolved or improved within 7 days after onset in 96.2% (75 events) of the 78 ADRs. Neither patient characteristics nor treatment factors appeared to significantly affect drug safety. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. The present study demonstrates the safety and effectiveness of peramivir under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  2. Human health safety evaluation of cosmetics in the EU: A legally imposed challenge to science

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

    Pauwels, M., E-mail: Marleen.Pauwels@vub.ac.b; Rogiers, V.

    As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alonemore » piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.« less

  3. Diverging diamond interchange performance evaluation (I-44 and Route 13)

    DOT National Transportation Integrated Search

    2011-02-01

    Performance evaluation was conducted on the first diverging diamond interchange (DDI) or double : crossover interchange (DCD) constructed in the United States. This evaluation assessed traffic operations, safety and : public perceptions t...

  4. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    PubMed

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  5. Evaluation of the comfort and convenience of safety belt systems in 1980 and 1981 model vehicles

    DOT National Transportation Integrated Search

    1981-03-01

    An analysis was conducted of both user and vehicle characteristics that influence the user perceptions of safety belt system comfort and convenience. A research design was developed involving various passenger cars, vans, and pickups, and a set of dr...

  6. Evaluation of seven in vitro alternatives for ocular safety testing.

    PubMed

    Bruner, L H; Kain, D J; Roberts, D A; Parker, R D

    1991-07-01

    Seven in vitro assays were evaluated to determine if any were useful as screening procedures in ocular safety assessment. Seventeen test materials (chemicals, household cleaners, hand soaps, dishwashing liquids, shampoos, and liquid laundry detergents) were tested in each assay. In vivo ocular irritation scores for the materials were obtained from existing rabbit low volume eye test (LVET) data. The seven assays evaluated included the silicon microphysiometer (SM), luminescent bacteria toxicity test (LBT), neutral red assay (NR), total protein assay (TP), Tetrahymena thermophila motility assay (TTMA), bovine eye/chorioallantoic membrane assay (BE/CAM), and the EYTEX system (ETS). For the seventeen materials used in this study there was a significant correlation between the in vivo irritant potential and in vitro data for all the tests except the EYTEX System (SM, r = -0.87; LBT, r = -0.91; NR, r = -0.85; TTMA, r = 0.78; TP, r = -0.86; ETS, r = 0.29). The irritation classifications provided by the BE/CAM also did not correspond with the actual in vivo irritancy potential of the test materials. The result of this study suggested it may be possible to classify materials into broad irritancy categories with some of the assays. This would allow their use as screens prior to limited in vivo confirmation in the ocular safety assessment process.

  7. Evaluating the effectiveness of Behavior-Based Safety education methods for commercial vehicle drivers.

    PubMed

    Wang, Xuesong; Xing, Yilun; Luo, Lian; Yu, Rongjie

    2018-08-01

    Risky driving behavior is one of the main causes of commercial vehicle related crashes. In order to achieve safer vehicle operation, safety education for drivers is often provided. However, the education programs vary in quality and may not always be successful in reducing crash rates. Behavior-Based Safety (BBS) education is a popular approach found effective by numerous studies, but even this approach varies as to the combination of frequency, mode and content used by different education providers. This study therefore evaluates and compares the effectiveness of BBS education methods. Thirty-five drivers in Shanghai, China, were coached with one of three different BBS education methods for 13 weeks following a 13-week baseline phase with no education. A random-effects negative binomial (NB) model was built and calibrated to investigate the relationship between BBS education and the driver at-fault safety-related event rate. Based on the results of the random-effects NB model, event modification factors (EMF) were calculated to evaluate and compare the effectiveness of the methods. Results show that (1) BBS education was confirmed to be effective in safety-related event reduction; (2) the most effective method among the three applied monthly face-to-face coaching, including feedback with video and statistical data, and training on strategies to avoid driver-specific unsafe behaviors; (3) weekly telephone coaching using statistics and strategies was rated by drivers as the most convenient delivery mode, and was also significantly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

  8. Reliability and safety of functional capacity evaluation in patients with whiplash associated disorders.

    PubMed

    Trippolini, M A; Reneman, M F; Jansen, B; Dijkstra, P U; Geertzen, J H B

    2013-09-01

    Whiplash-associated disorders (WAD) are a burden for both individuals and society. It is recommended to evaluate patients with WAD at risk of chronification to enhance rehabilitation and promote an early return to work. In patients with low back pain (LBP), functional capacity evaluation (FCE) contributes to clinical decisions regarding fitness-for-work. FCE should have demonstrated sufficient clinimetric properties. Reliability and safety of FCE for patients with WAD is unknown. Thirty-two participants (11 females and 21 males; mean age 39.6 years) with WAD (Grade I or II) were included. The FCE consisted of 12 tests, including material handling, hand grip strength, repetitive arm movements, static arm activities, walking speed, and a 3 min step test. Overall the FCE duration was 60 min. The test-retest interval was 7 days. Interclass correlations (model 1) (ICCs) and limits of agreement (LoA) were calculated. Safety was assessed by a Pain Response Questionnaire, observation criteria and heart rate monitoring. ICCs ranged between 0.57 (3 min step test) and 0.96 (short two-handed carry). LoA relative to mean performance ranged between 15 % (50 m walking test) and 57 % (lifting waist to overhead). Pain reactions after WAD FCE decreased within days. Observations and heart rate measurements fell within the safety criteria. The reliability of the WAD FCE was moderate in two tests, good in five tests and excellent in five tests. Safety-criteria were fulfilled. Interpretation at the patient level should be performed with care because LoA were substantial.

  9. An Economic Evaluation of Food Safety Education Interventions: Estimates and Critical Data Gaps.

    PubMed

    Zan, Hua; Lambea, Maria; McDowell, Joyce; Scharff, Robert L

    2017-08-01

    The economic evaluation of food safety interventions is an important tool that practitioners and policy makers use to assess the efficacy of their efforts. These evaluations are built on models that are dependent on accurate estimation of numerous input variables. In many cases, however, there is no data available to determine input values and expert opinion is used to generate estimates. This study uses a benefit-cost analysis of the food safety component of the adult Expanded Food and Nutrition Education Program (EFNEP) in Ohio as a vehicle for demonstrating how results based on variable values that are not objectively determined may be sensitive to alternative assumptions. In particular, the focus here is on how reported behavioral change is translated into economic benefits. Current gaps in the literature make it impossible to know with certainty how many people are protected by the education (what are the spillover effects?), the length of time education remains effective, and the level of risk reduction from change in behavior. Based on EFNEP survey data, food safety education led 37.4% of participants to improve their food safety behaviors. Under reasonable default assumptions, benefits from this improvement significantly outweigh costs, yielding a benefit-cost ratio of between 6.2 and 10.0. Incorporation of a sensitivity analysis using alternative estimates yields a greater range of estimates (0.2 to 56.3), which highlights the importance of future research aimed at filling these research gaps. Nevertheless, most reasonable assumptions lead to estimates of benefits that justify their costs.

  10. Safety evaluation of the temporary consolidant based on a zebrafish embryo model.

    PubMed

    Zhang, Lu; Zhang, Xiao Yan; Hu, Yulan; Zhang, Bing Jian

    2018-05-07

    Temporary consolidants, such as cyclododecane, menthol, coumarin, and ethyl maltol, are proved to be effective for urgent conservation in archaeological field. However, the safety of these temporary consolidants is still unknown although they are always heavily used in archaeological field. Thus reports on the toxicity of these temporary consolidants are limited. Here, a zebrafish model was used for safety evaluation of these four temporary consolidants. In the present study, four temporary consolidants, including cyclododecane, menthol, coumarin, and ethyl maltol, at different concentrations were incubated with zebrafish embryos, and their biological toxic effects were firstly evaluated. It was shown that embryo exposure to temporary consolidants resulted in an increased mortality and malformation rate, and a decreased hatching rate. The order of embryo toxicity of the four types of temporary consolidants tested was menthol > coumarin > ethyl maltol > cyclododecane. Although the embryo toxicity of cyclododecane was minimal, some studies have indicated that this temporary consolidant could be bioaccumulated. The results also suggested that the zebrafish embryos can serve as a reliable model for the evaluation of embryo toxicity of temporary consolidants, as this model could offer the possibility to perform the rapid, medium throughput, cost-effective analyses. Copyright © 2018 Elsevier Ltd. All rights reserved.

  11. 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...

  12. Safety evaluation of advance street name signs

    DOT National Transportation Integrated Search

    2009-06-01

    The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the pooled fund study is to estimate t...

  13. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey

    PubMed Central

    Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

    2016-01-01

    Background Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. Objective To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. Methods A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. Results The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of “staff training and skills” were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. Conclusion The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety. PMID:27524887

  14. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey.

    PubMed

    Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

    2016-01-01

    Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of "staff training and skills" were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety.

  15. Effect of Traffic Position Accuracy for Conducting Safe Airport Surface Operations

    NASA Technical Reports Server (NTRS)

    Jones, Denise R.; Prinzel, Lawrence J., III; Bailey, Randall E.; Arthur, Jarvis J., III; Barnes, James R.

    2014-01-01

    The Next Generation Air Transportation System (NextGen) concept proposes many revolutionary operational concepts and technologies, such as display of traffic information and movements, airport moving maps (AMM), and proactive alerts of runway incursions and surface traffic conflicts, to deliver an overall increase in system capacity and safety. A piloted simulation study was conducted at the National Aeronautics and Space Administration (NASA) Langley Research Center to evaluate the ability to conduct safe and efficient airport surface operations while utilizing an AMM displaying traffic of various position accuracies as well as the effect of traffic position accuracy on airport conflict detection and resolution (CD&R) capability. Nominal scenarios and off-nominal conflict scenarios were conducted using 12 airline crews operating in a simulated Memphis International Airport terminal environment. The data suggest that all traffic should be shown on the airport moving map, whether qualified or unqualified, and conflict detection and resolution technologies provide significant safety benefits. Despite the presence of traffic information on the map, collisions or near collisions still occurred; when indications or alerts were generated in these same scenarios, the incidences were averted.

  16. Laboratory evaluation of alcohol safety interlock systems. Volume 3 : instrument performance at high BAL

    DOT National Transportation Integrated Search

    1974-01-01

    This report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were develope...

  17. Safety analysts training

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

    Bolton, P.

    The purpose of this task was to support ESH-3 in providing Airborne Release Fraction and Respirable Fraction training to safety analysts at LANL who perform accident analysis, hazard analysis, safety analysis, and/or risk assessments at nuclear facilities. The task included preparation of materials for and the conduct of two 3-day training courses covering the following topics: safety analysis process; calculation model; aerosol physic concepts for safety analysis; and overview of empirically derived airborne release fractions and respirable fractions.

  18. Safety Evaluation of Crocin (a constituent of saffron) Tablets in Healthy Volunteers

    PubMed Central

    Mohamadpour, Amir Houshang; Ayati, Zahara; Parizadeh, Mohammad–Reza; Rajbai, Omid; Hosseinzadeh, Hossein

    2013-01-01

    Objective(s): Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. Materials and Methods: The study was a randomized, double-blind, placebo-controlled design consisting of one month treatment of crocin tablets. Volunteers who fulfilled inclusion and exclusion criteria were randomized into 2 groups of 22 each (males and females) and received 20 mg crocin tablets or placebo. General measures of health were recorded during the study such as hematological, biochemical, hormonal and urinary parameters in pre and post-treatment periods. Results: No major adverse events were reported during the trial. Crocin tablets did not change the above parameters except that it decreased amylase, mixed white blood cells and PTT in healthy volunteers after one month. Conclusion: This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period. PMID:23638291

  19. The Triangle Model for evaluating the effect of health information technology on healthcare quality and safety

    PubMed Central

    Kern, Lisa M; Abramson, Erika; Kaushal, Rainu

    2011-01-01

    With the proliferation of relatively mature health information technology (IT) systems with large numbers of users, it becomes increasingly important to evaluate the effect of these systems on the quality and safety of healthcare. Previous research on the effectiveness of health IT has had mixed results, which may be in part attributable to the evaluation frameworks used. The authors propose a model for evaluation, the Triangle Model, developed for designing studies of quality and safety outcomes of health IT. This model identifies structure-level predictors, including characteristics of: (1) the technology itself; (2) the provider using the technology; (3) the organizational setting; and (4) the patient population. In addition, the model outlines process predictors, including (1) usage of the technology, (2) organizational support for and customization of the technology, and (3) organizational policies and procedures about quality and safety. The Triangle Model specifies the variables to be measured, but is flexible enough to accommodate both qualitative and quantitative approaches to capturing them. The authors illustrate this model, which integrates perspectives from both health services research and biomedical informatics, with examples from evaluations of electronic prescribing, but it is also applicable to a variety of types of health IT systems. PMID:21857023

  20. Influenza vaccines: Evaluation of the safety profile

    PubMed Central

    Trombetta, Claudia Maria; Gianchecchi, Elena; Montomoli, Emanuele

    2018-01-01

    ABSTRACT The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated. Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults. The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods. PMID:29297746

  1. A theory-driven, longitudinal evaluation of the impact of team training on safety culture in 24 hospitals.

    PubMed

    Jones, Katherine J; Skinner, Anne M; High, Robin; Reiter-Palmon, Roni

    2013-05-01

    Effective teamwork facilitates collective learning, which is integral to safety culture. There are no rigorous evaluations of the impact of team training on the four components of safety culture-reporting, just, flexible and learning cultures. We evaluated the impact of a year-long team training programme on safety culture in 24 hospitals using two theoretical frameworks. We used two quasi-experimental designs: a cross-sectional comparison of hospital survey on patient safety culture (HSOPS) results from an intervention group of 24 hospitals to a static group of 13 hospitals and a pre-post comparison of HSOPS results within intervention hospitals. Dependent variables were HSOPS items representing the four components of safety culture; independent variables were derived from items added to the HSOPS that measured the extent of team training, learning and transfer. We used a generalised linear mixed model approach to account for the correlated nature of the data. 59% of 2137 respondents from the intervention group reported receiving team training. Intervention group HSOPS scores were significantly higher than static group scores in three dimensions assessing the flexible and learning components of safety culture. The distribution of the adoption of team behaviours (transfer) varied in the intervention group from 2.8% to 31.0%. Adoption of team behaviours was significantly associated with odds of an individual reacting more positively at reassessment than baseline to nine items reflecting all four components of safety culture. Team training can result in transformational change in safety culture when the work environment supports the transfer of learning to new behaviour.

  2. Revitalizing Nuclear Safety Research.

    ERIC Educational Resources Information Center

    National Academy of Sciences - National Research Council, Washington, DC.

    This report covers the general issues involved in nuclear safety research and points out the areas needing detailed consideration. Topics included are: (1) "Principles of Nuclear Safety Research" (examining who should fund, who should conduct, and who should set the agenda for nuclear safety research); (2) "Elements of a Future…

  3. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

  4. A Safety Evaluation of Empagliflozin for the Treatment of Type 2 Diabetes

    PubMed Central

    Neeland, Ian J.; Salahuddin, Usman; McGuire, Darren K.

    2016-01-01

    Introduction Empagliflozin is a sodium glucose co-transporter 2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) by enhancing urinary glucose excretion. Empagliflozin is effective at lowering glycosylated hemoglobin and was recently proven superior to placebo for reduction of cardiovascular disease (CVD) risk. As with any new drug, there are safety considerations that inform its potential use in patients with T2DM. Areas Covered Here, we evaluate the safety of empagliflozin and provide an expert opinion as to its current and future role in the treatment of patients with T2DM. A search of the English language literature was performed using PubMed search terms: “empagliflozin”, “sodium glucose cotransporter 2 inhibitors”, and “drug safety”. Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included. Expert Opinion The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD. Ongoing trials will continue to address the safety and efficacy of empagliflozin and expand our clinical knowledge of this medication. PMID:26695551

  5. Predicting the effectiveness of road safety campaigns through alternative research designs.

    PubMed

    Adamos, Giannis; Nathanail, Eftihia

    2016-12-01

    A large number of road safety communication campaigns have been designed and implemented in the recent years; however their explicit impact on driving behavior and road accident rates has been estimated in a rather low proportion. Based on the findings of the evaluation of three road safety communication campaigns addressing the issues of drinking and driving, seat belt usage, and driving fatigue, this paper applies different types of research designs (i.e., experimental, quasi-experimental, and non-experimental designs), when estimating the effectiveness of road safety campaigns, implements a cross-design assessment, and conducts a cross-campaign evaluation. An integrated evaluation plan was developed, taking into account the structure of evaluation questions, the definition of measurable variables, the separation of the target audience into intervention (exposed to the campaign) and control (not exposed to the campaign) groups, the selection of alternative research designs, and the appropriate data collection methods and techniques. Evaluating the implementation of different research designs in estimating the effectiveness of road safety campaigns, results showed that the separate pre-post samples design demonstrated better predictability than other designs, especially in data obtained from the intervention group after the realization of the campaign. The more constructs that were added to the independent variables, the higher the values of the predictability were. The construct that most affects behavior is intention, whereas the rest of the constructs have a lower impact on behavior. This is particularly significant in the Health Belief Model (HBM). On the other hand, behavioral beliefs, normative beliefs, and descriptive norms, are significant parameters for predicting intention according to the Theory of Planned Behavior (TPB). The theoretical and applied implications of alternative research designs and their applicability in the evaluation of road safety

  6. How do people evaluate social sexual conduct at work? A psycholegal model.

    PubMed

    Wiener, R L; Hurt, L E

    2000-02-01

    The authors tested a psycholegal model of how people evaluate social sexual conduct at work with videotaped reenactments of interviews with alleged complainants, perpetrators, and other workers. Participants (200 full-time male and female workers) were randomly assigned to evaluate the complaints with either the reasonable person or reasonable woman legal standard. Participants answered questions about sexual harassment law and completed the Ambivalent Sexism Inventory. Participants who took the reasonable woman perspective, as compared with those who took the reasonable person perspective, were more likely to find the conduct harassing; this was especially the case among participants high in hostile sexism. Medium-sized gender effects were found in the severe case but were absent in the weaker, more ambiguous case. The implications of these findings for hostile work environment law are discussed.

  7. Hazardous material transportation safety and security field operational test final evaluation plan : executive summary

    DOT National Transportation Integrated Search

    2003-03-17

    The purpose of this effort is to independently evaluate the Battelle Operational Test Team to test methods for leveraging technology and operations to improve HAZMAT transport security, safety, and operational efficiency. As such, the preceding techn...

  8. Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

    PubMed

    Hong, Bonnie; Du, Yingzhou; Mukerji, Pushkor; Roper, Jason M; Appenzeller, Laura M

    2017-07-12

    Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

  9. Medication safety infrastructure in critical-access hospitals in Florida.

    PubMed

    Winterstein, Almut G; Hartzema, Abraham G; Johns, Thomas E; De Leon, Jessica M; McDonald, Kathie; Henshaw, Zak; Pannell, Robert

    2006-03-01

    The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

  10. [Evaluation of the effectiveness of occupational safety and health inspections of construction sites in the Piedmont region from 2001 to 2005].

    PubMed

    Bruno, Santina; Bena, Antonella; Debernardi, Maria Luisa; Nava, S; Pastore, Raffaella; Proietti, C; Quarta, D

    2009-01-01

    To assess the effectiveness of safety inspections in the construction industry in Piedmont in terms of exposure to risk and injuries. We conducted a retrospective analysis of the surveillance activities carried out in Piedmont between 2001 and 2005: to this purpose, we used a logical framework and we identified indicators to evaluate the process and its impact on exposure and injuries. fixed standards involving the number of safety inspections and the type of constructions under control were respected; there was always sufficient diversity among the public works under control, although local health units used different working methods. Impact on exposure and injuries: injury rates in the construction industry in Piedmont showed a decreasing trend and systematically lower values compared to national rates. Injury rates in the "roads and railways" sector showed an increasing trend owing to the great number of public works under construction. In this case, the effect of preventive measures seems less noticeable, but this mainly depends on methodological limits, such as mismatch between numerator and denominator, difficulties in estimating the number of workers actually present on the sites, underreporting of minor events. Despite the limitations of a retrospective analysis, the Piedmont safety inspection programme for the construction industry showed coherence with the objectives and had a positive impact on injury rates.

  11. Transit Bus Safety Oversight

    DOT National Transportation Integrated Search

    1998-11-17

    After the National Transportation Safety Board conducted several accident investigations involving transit buses (Normandy, Missouri; Cosmopolis, Washington; New York, New York; and Nashville, Tennesee) and held a public hearing on transit bus safety...

  12. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of Sciences-National Research Council. A petition will not be denied, however, by reason of the... of Sciences-National Research Council if, from available evidence, the Commissioner finds that the... purposes of this section, the principles for evaluating safety of additives set forth in the above...

  13. Evaluation of countermeasures for red light running by traffic simulator-based surrogate safety measures.

    PubMed

    Lee, Changju; So, Jaehyun Jason; Ma, Jiaqi

    2018-01-02

    The conflicts among motorists entering a signalized intersection with the red light indication have become a national safety issue. Because of its sensitivity, efforts have been made to investigate the possible causes and effectiveness of countermeasures using comparison sites and/or before-and-after studies. Nevertheless, these approaches are ineffective when comparison sites cannot be found, or crash data sets are not readily available or not reliable for statistical analysis. Considering the random nature of red light running (RLR) crashes, an inventive approach regardless of data availability is necessary to evaluate the effectiveness of each countermeasure face to face. The aims of this research are to (1) review erstwhile literature related to red light running and traffic safety models; (2) propose a practical methodology for evaluation of RLR countermeasures with a microscopic traffic simulation model and surrogate safety assessment model (SSAM); (3) apply the proposed methodology to actual signalized intersection in Virginia, with the most prevalent scenarios-increasing the yellow signal interval duration, installing an advance warning sign, and an RLR camera; and (4) analyze the relative effectiveness by RLR frequency and the number of conflicts (rear-end and crossing). All scenarios show a reduction in RLR frequency (-7.8, -45.5, and -52.4%, respectively), but only increasing the yellow signal interval duration results in a reduced total number of conflicts (-11.3%; a surrogate safety measure of possible RLR-related crashes). An RLR camera makes the greatest reduction (-60.9%) in crossing conflicts (a surrogate safety measure of possible angle crashes), whereas increasing the yellow signal interval duration results in only a 12.8% reduction of rear-end conflicts (a surrogate safety measure of possible rear-end crash). Although increasing the yellow signal interval duration is advantageous because this reduces the total conflicts (a possibility of total

  14. A trigger-based design for evaluating the safety of in utero antiretroviral exposure in uninfected children of human immunodeficiency virus-infected mothers.

    PubMed

    Williams, Paige L; Seage, George R; Van Dyke, Russell B; Siberry, George K; Griner, Raymond; Tassiopoulos, Katherine; Yildirim, Cenk; Read, Jennifer S; Huo, Yanling; Hazra, Rohan; Jacobson, Denise L; Mofenson, Lynne M; Rich, Kenneth

    2012-05-01

    The Pediatric HIV/AIDS Cohort Study's Surveillance Monitoring of ART Toxicities Study is a prospective cohort study conducted at 22 US sites between 2007 and 2011 that was designed to evaluate the safety of in utero antiretroviral drug exposure in children not infected with human immunodeficiency virus who were born to mothers who were infected. This ongoing study uses a "trigger-based" design; that is, initial assessments are conducted on all children, and only those meeting certain thresholds or "triggers" undergo more intensive evaluations to determine whether they have had an adverse event (AE). The authors present the estimated rates of AEs for each domain of interest in the Surveillance Monitoring of ART Toxicities Study. They also evaluated the efficiency of this trigger-based design for estimating AE rates and for testing associations between in utero exposures to antiretroviral drugs and AEs. The authors demonstrate that estimated AE rates from the trigger-based design are unbiased after correction for the sensitivity of the trigger for identifying AEs. Even without correcting for bias based on trigger sensitivity, the trigger approach is generally more efficient for estimating AE rates than is evaluating a random sample of the same size. Minor losses in efficiency when comparing AE rates between persons exposed and unexposed in utero to particular antiretroviral drugs or drug classes were observed under most scenarios.

  15. A Trigger-based Design for Evaluating the Safety of In Utero Antiretroviral Exposure in Uninfected Children of Human Immunodeficiency Virus-Infected Mothers

    PubMed Central

    Williams, Paige L.; Seage, George R.; Van Dyke, Russell B.; Siberry, George K.; Griner, Raymond; Tassiopoulos, Katherine; Yildirim, Cenk; Read, Jennifer S.; Huo, Yanling; Hazra, Rohan; Jacobson, Denise L.; Mofenson, Lynne M.; Rich, Kenneth

    2012-01-01

    The Pediatric HIV/AIDS Cohort Study’s Surveillance Monitoring of ART Toxicities Study is a prospective cohort study conducted at 22 US sites between 2007 and 2011 that was designed to evaluate the safety of in utero antiretroviral drug exposure in children not infected with human immunodeficiency virus who were born to mothers who were infected. This ongoing study uses a “trigger-based” design; that is, initial assessments are conducted on all children, and only those meeting certain thresholds or “triggers” undergo more intensive evaluations to determine whether they have had an adverse event (AE). The authors present the estimated rates of AEs for each domain of interest in the Surveillance Monitoring of ART Toxicities Study. They also evaluated the efficiency of this trigger-based design for estimating AE rates and for testing associations between in utero exposures to antiretroviral drugs and AEs. The authors demonstrate that estimated AE rates from the trigger-based design are unbiased after correction for the sensitivity of the trigger for identifying AEs. Even without correcting for bias based on trigger sensitivity, the trigger approach is generally more efficient for estimating AE rates than is evaluating a random sample of the same size. Minor losses in efficiency when comparing AE rates between persons exposed and unexposed in utero to particular antiretroviral drugs or drug classes were observed under most scenarios. PMID:22491086

  16. Arizona Traffic Safety Education, K-8. Bicycle Safety, Grade 3.

    ERIC Educational Resources Information Center

    Mesa Public Schools, AZ.

    One in a series designed to assist Arizona elementary and junior high school teachers in developing children's traffic safety skills, this curriculum guide for grade 3 contains seven lessons on bicycles and an appendix on conducting a bicycle rodeo. Introductory information provided for the teacher includes basic highway safety concepts, stressing…

  17. Guidance for Evaluating the Safety of Experimental Releases of Mosquitoes, Emphasizing Mark-Release-Recapture Techniques

    PubMed Central

    Charlwood, J. Derek; Harrington, Laura C.; Lounibos, L. Philip; Reisen, William K.; Tabachnick, Walter J.

    2018-01-01

    Abstract Experimental releases of mosquitoes are performed to understand characteristics of populations related to the biology, ability to transmit pathogens, and ultimately their control. In this article, we discuss considerations related to the safety of experimental releases of living mosquitoes, applying principles of good practice in vector biology that protect human health and comfort. We describe specific factors of experimental releases of mosquitoes that we believe are critical to inform institutional biosafety committees and similar review boards to which proposals to conduct mosquito release experiments have been submitted. In this study, “experimental releases” means those that do not significantly increase vector capacity or nuisance biting relative to the unperturbed natural baseline. This document specifically does not address releases of mosquitoes for ongoing control programs or trials of new control methods for which broader assessments of risk are required. It also does not address releases of transgenic or exotic (non-native) mosquito species, both of which require particular regulatory approval. Experimental releases may include females and males and evaluation must consider their effects based on the number released, their genotype and phenotype, the environment into which they are released, and postrelease collection activities. We consider whether increases of disease transmission and nuisance biting might result from proposed experimental releases against the backdrop of natural population size variation. We recommend that experimental releases be conducted in a manner that can be reasonably argued to have insignificant negative effects. Reviewers of proposals for experimental releases should expect applicants to provide such an argument based on evidence from similar studies and their planned activities. This document provides guidance for creating and evaluating such proposals. PMID:29337660

  18. Guidance for Evaluating the Safety of Experimental Releases of Mosquitoes, Emphasizing Mark-Release-Recapture Techniques.

    PubMed

    Benedict, Mark Q; Charlwood, J Derek; Harrington, Laura C; Lounibos, L Philip; Reisen, William K; Tabachnick, Walter J

    2018-01-01

    Experimental releases of mosquitoes are performed to understand characteristics of populations related to the biology, ability to transmit pathogens, and ultimately their control. In this article, we discuss considerations related to the safety of experimental releases of living mosquitoes, applying principles of good practice in vector biology that protect human health and comfort. We describe specific factors of experimental releases of mosquitoes that we believe are critical to inform institutional biosafety committees and similar review boards to which proposals to conduct mosquito release experiments have been submitted. In this study, "experimental releases" means those that do not significantly increase vector capacity or nuisance biting relative to the unperturbed natural baseline. This document specifically does not address releases of mosquitoes for ongoing control programs or trials of new control methods for which broader assessments of risk are required. It also does not address releases of transgenic or exotic (non-native) mosquito species, both of which require particular regulatory approval. Experimental releases may include females and males and evaluation must consider their effects based on the number released, their genotype and phenotype, the environment into which they are released, and postrelease collection activities. We consider whether increases of disease transmission and nuisance biting might result from proposed experimental releases against the backdrop of natural population size variation. We recommend that experimental releases be conducted in a manner that can be reasonably argued to have insignificant negative effects. Reviewers of proposals for experimental releases should expect applicants to provide such an argument based on evidence from similar studies and their planned activities. This document provides guidance for creating and evaluating such proposals.

  19. Safety Evaluation Report for the Claiborne Enrichment Center, Homer, Louisiana (Docket No. 70-3070)

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

    Not Available

    1994-01-01

    This report documents the US Nuclear Regulatory Commission (NRC) staff review and safety evaluation of the Louisiana Energy Services, L.P. (LES, the applicant) application for a license to possess and use byproduct, source, and special nuclear material and to enrich natural uranium to a maximum of 5 percent U-235 by the gas centrifuge process. The plant, to be known as the Claiborne Enrichment Center (CEC), would be constructed near the town of Homer in Claiborne Parish, Louisiana. At full production in a given year, the plant will receive approximately 4,700 tonnes of feed UF{sub 6} and produce 870 tonnes ofmore » low-enriched UF{sub 6}, and 3,830 tonnes of depleted UF{sub 6} tails. Facility construction, operation, and decommissioning are expected to last 5, 30, and 7 years, respectively. The objective of the review is to evaluate the potential adverse impacts of operation of the facility on worker and public health and safety under both normal operating and accident conditions. The review also considers the management organization, administrative programs, and financial qualifications provided to assure safe design and operation of the facility. The NRC staff concludes that the applicant`s descriptions, specifications, and analyses provide an adequate basis for safety review of facility operations and that construction and operation of the facility does not pose an undue risk to public health and safety.« less

  20. A long-term follow-up evaluation of electronic health record prescribing safety

    PubMed Central

    Abramson, Erika L; Malhotra, Sameer; Osorio, S Nena; Edwards, Alison; Cheriff, Adam; Cole, Curtis; Kaushal, Rainu

    2013-01-01

    Objective To be eligible for incentives through the Electronic Health Record (EHR) Incentive Program, many providers using older or locally developed EHRs will be transitioning to new, commercial EHRs. We previously evaluated prescribing errors made by providers in the first year following transition from a locally developed EHR with minimal prescribing clinical decision support (CDS) to a commercial EHR with robust CDS. Following system refinements, we conducted this study to assess the rates and types of errors 2 years after transition and determine the evolution of errors. Materials and methods We conducted a mixed methods cross-sectional case study of 16 physicians at an academic-affiliated ambulatory clinic from April to June 2010. We utilized standardized prescription and chart review to identify errors. Fourteen providers also participated in interviews. Results We analyzed 1905 prescriptions. The overall prescribing error rate was 3.8 per 100 prescriptions (95% CI 2.8 to 5.1). Error rates were significantly lower 2 years after transition (p<0.001 compared to pre-implementation, 12 weeks and 1 year after transition). Rates of near misses remained unchanged. Providers positively appreciated most system refinements, particularly reduced alert firing. Discussion Our study suggests that over time and with system refinements, use of a commercial EHR with advanced CDS can lead to low prescribing error rates, although more serious errors may require targeted interventions to eliminate them. Reducing alert firing frequency appears particularly important. Our results provide support for federal efforts promoting meaningful use of EHRs. Conclusions Ongoing error monitoring can allow CDS to be optimally tailored and help achieve maximal safety benefits. Clinical Trials Registration ClinicalTrials.gov, Identifier: NCT00603070. PMID:23578816