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...

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...

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...

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...

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...

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.

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.

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.

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...

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...

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.

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...

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.

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.

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...

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.

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...

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...

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

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…

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

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...

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

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.

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...

[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.

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...

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...

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...

78 FR 48468 - Delphi Corporation, Electronics and Safety Division, Including On-Site Leased Workers From...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

..., Electronics and Safety Division, Including On-Site Leased Workers From Securitas, Bartech, Flint Janitorial... Adjustment Assistance on May 20, 2013, applicable to workers of Delphi Corporation, Electronics and Safety... on- site at the Flint, Michigan location of Delphi Corporation, Electronics and Safety Division. The...

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.

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

An evaluation of the NASA Tech House, including live-in test results, volume 1

NASA Technical Reports Server (NTRS)

Abbott, I. H. A.; Hopping, K. A.; Hypes, W. D.

1979-01-01

The NASA Tech House was designed and constructed at the NASA Langley Research Center, Hampton, Virginia, to demonstrate and evaluate new technology potentially applicable for conservation of energy and resources and for improvements in safety and security in a single-family residence. All technology items, including solar-energy systems and a waste-water-reuse system, were evaluated under actual living conditions for a 1 year period with a family of four living in the house in their normal lifestyle. Results are presented which show overall savings in energy and resources compared with requirements for a defined similar conventional house under the same conditions. General operational experience and performance data are also included for all the various items and systems of technology incorporated into the house design.

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.

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.

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...

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...

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.

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...

78 FR 49684 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-15

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

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.

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

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,...

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.

77 FR 65478 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

77 FR 60044 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

78 FR 65874 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including...

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.

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.

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2011 CFR

2011-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2013 CFR

2013-07-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

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

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.

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

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…

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.

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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.

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...

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...

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...

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...

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...

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

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.

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

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

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.

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.

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...

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.

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

76 FR 35106 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago..., DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent safety zone from Brandon... Safety Zones; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary...

Safety of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), in Kenya, including among HIV-infected and HIV-exposed infants.

PubMed

Laserson, Kayla F; Nyakundi, Daveline; Feikin, Daniel R; Nyambane, Geoffrey; Cook, Earnest; Oyieko, Janet; Ojwando, Joel; Rivers, Stephen B; Ciarlet, Max; Neuzil, Kathleen M; Breiman, Robert F

2012-04-27

Two multicenter Phase III trials were conducted in five countries from March 2007 to March 2009 to evaluate the safety and efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), in Africa and Asia. In this report, we evaluate the safety of this vaccine, including among HIV-infected and HIV-exposed infants, in Kenya. 1308 Infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age. HIV counseling and testing were offered to all participants. A positive PCR result indicated HIV infection; the presence of HIV antibody in PCR-negative children indicated HIV exposure without HIV infection. All serious adverse events (SAE) within 14 days of any dose, and vaccine-related SAEs, intussusception, and deaths occurring at any time during the study, were reported ("SAE surveillance"). In addition, 297 participants were followed for 42 days after any dose for any adverse event (AE), regardless of severity ("intensive safety surveillance"). The safety evaluation was stratified by HIV status. SAEs were reported in 20/649 vaccine recipients (3.1%) and 21/643 placebo recipients (3.3%) within 14 days following vaccination (p = 0.9). The most common SAE in the vaccinated group was pneumonia (1.7%). No individual SAE was significantly more common among vaccine vs. placebo recipients. Seventy-two deaths were reported, 38 (5.9%) and 34 (5.3%) among vaccine and placebo recipients, respectively (p = 0.66). No cases of intussusception were reported. During intensive safety surveillance, 137/147 (93.2%) vaccine recipients and 147/150 (98.0%) placebo recipients experienced one or more AEs (risk ratio = 0.95; 95% CI: 0.91-1.0; p = 0.05). 88.5% of the infants were tested for HIV infection; 21/581 (3.6%) children in the vaccine group and 17/577 (2.9%) in the placebo group were HIV-infected. Among the 37 HIV-infected infants with full safety follow-up, 5/21 (23.8%) vaccine recipients and 2/16 (12.5%) placebo recipients reported an SAE (p

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

Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining

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

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.

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.

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.

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…

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.

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

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

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.

Including safety-net providers in integrated delivery systems: issues and options for policymakers.

PubMed

Witgert, Katherine; Hess, Catherine

2012-08-01

Health care reform legislation has spurred efforts to develop integrated health care delivery systems that seek to coordinate the continuum of health services. These systems may be of particular benefit to patients who face barriers to accessing care or have multiple health conditions. But it remains to be seen how safety-net providers, including community health centers and public hospitals--which have long experience in caring for these vulnerable populations--will be included in integrated delivery systems. This issue brief explores key considerations for incorporating safety-net providers into integrated delivery systems and discusses the roles of state and federal agencies in sup­porting and testing models of integrated care delivery. The authors conclude that the most important principles in creating integrated delivery systems for vulnerable populations are: (1) an emphasis on primary care; (2) coordination of all care, including behavioral, social, and public health services; and (3) accountability for population health outcomes.

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...

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...

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...

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...

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...

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.

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.

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

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

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.

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/

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...

75 FR 26094 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... establishing a temporary safety zone from Brandon Road Lock and Dam to Lake Michigan. This temporary safety...

75 FR 64673 - Safety Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and... Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Ship and...: The Coast Guard will enforce Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des...

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

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.

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

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.

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

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.

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

30 CFR 285.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Activities Conducted Under SAPs, COPs and GAPs Safety Management Systems § 285.810 What must I include in my... your COP (provided under § 285.627(d)) and, when required by this part, your SAP (as provided in § 285...

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Promoting a Culture of Safety as a Patient Safety Strategy

PubMed Central

Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

2015-01-01

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

76 FR 23524 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... safety zone from Brandon Road Lock and Dam to Lake Michigan. This proposed safety zone will cover 77.... This TIR established a 77 mile long safety zone from Brandon Road Lock to Lake Michigan in Chicago, IL...

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

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

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.

FRAMEWORK FOR EVALUATION OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR USE IN SAFETY OR RISK ASSESSMENT

EPA Science Inventory

ABSTRACT

Proposed applications of increasingly sophisticated biologically-based computational models, such as physiologically-based pharmacokinetic (PBPK) models, raise the issue of how to evaluate whether the models are adequate for proposed uses including safety or risk ...

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.

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

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.

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

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.

Key Performance Indicators in the Evaluation of the Quality of Radiation Safety Programs.

PubMed

Schultz, Cheryl Culver; Shaffer, Sheila; Fink-Bennett, Darlene; Winokur, Kay

2016-08-01

Beaumont is a multiple hospital health care system with a centralized radiation safety department. The health system operates under a broad scope Nuclear Regulatory Commission license but also maintains several other limited use NRC licenses in off-site facilities and clinics. The hospital-based program is expansive including diagnostic radiology and nuclear medicine (molecular imaging), interventional radiology, a comprehensive cardiovascular program, multiple forms of radiation therapy (low dose rate brachytherapy, high dose rate brachytherapy, external beam radiotherapy, and gamma knife), and the Research Institute (including basic bench top, human and animal). Each year, in the annual report, data is analyzed and then tracked and trended. While any summary report will, by nature, include items such as the number of pieces of equipment, inspections performed, staff monitored and educated and other similar parameters, not all include an objective review of the quality and effectiveness of the program. Through objective numerical data Beaumont adopted seven key performance indicators. The assertion made is that key performance indicators can be used to establish benchmarks for evaluation and comparison of the effectiveness and quality of radiation safety programs. Based on over a decade of data collection, and adoption of key performance indicators, this paper demonstrates one way to establish objective benchmarking for radiation safety programs in the health care environment.

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...

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

[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.

Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

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

Not Available

1989-04-01

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 Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

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.

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

Evaluation of work zone safety operations and issues.

DOT National Transportation Integrated Search

2006-03-01

Work zone activities are one of the areas with a high potential for compromised safety for workers and road users. Various measures have been taken to increase the level of safety in work zones; including the use of double fines for speeding and the ...

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

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,…

School Bus Safety.

ERIC Educational Resources Information Center

Stroup, Karen Bruner; And Others

1991-01-01

Equipment to allow safe transportation of disabled children is reviewed. Such equipment includes infant car seats, child safety seats, safety vests, and accommodations for children in casts and/or braces. Five principles for evaluation and selection of safe seating options are given as are safety rules and information on standards and resources.…

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...

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...

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.

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

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.

Evaluation of the Efficacy of Simulation Games in Traffic Safety Education of Kindergarten Children.

ERIC Educational Resources Information Center

Renaud, Lise; Suissa, Samy

1989-01-01

Uses a post-test-only control group study to evaluate the effect of three different types of simulation games used to teach traffic safety to kindergarten students. Results suggest that games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior with this age group. (FMW)

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.

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...

Tornadoes: Nature's Most Violent Storms. A Preparedness Guide Including Safety Information for Schools.

ERIC Educational Resources Information Center

American National Red Cross, Washington, DC.

This preparedness guide explains and describes tornadoes, and includes safety information for schools. A tornado is defined as a violently rotating column of air extending from a thunderstorm to the ground. The guide explains the cause of tornadoes, provides diagrams of how they form, describes variations of tornadoes, and classifies tornadoes by…

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

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.

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.

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.

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.

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.

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...

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...

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...

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

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...

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...

Evaluating Otto the Auto: Does Engagement in an Interactive Website Improve Young Children's Transportation Safety?

PubMed

Schwebel, David C; Johnston, Anna; Shen, Jiabin; Li, Peng

2017-07-19

Transportation-related injuries are a leading cause of pediatric death, and effective interventions are limited. Otto the Auto is a website offering engaging, interactive activities. We evaluated Otto among a sample of sixty-nine 4- and 5-year-old children, who participated in a randomized parallel group design study. Following baseline evaluation, children engaged with either Otto or a control website for 2 weeks and then were re-evaluated. Children who used Otto failed to show increases in transportation safety knowledge or behavior compared to the control group, although there was a dosage effect whereby children who engaged in the website more with parents gained safer behavior patterns. We conclude Otto may have some efficacy when engaged by children with their parents, but continued efforts to develop and refine engaging, effective, theory-driven strategies to teach children transportation safety, including via internet, should be pursued.

33 CFR 165.930 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety Zone, Brandon Road Lock... Guard District § 165.930 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY REGULATED NAVIGATION...

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

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

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

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...

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...

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].

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...

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

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.

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads

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

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 :...

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.

Evaluation of safety treatments for roadside culverts.

DOT National Transportation Integrated Search

2009-04-24

Roadside cross-drainage culverts have been found to impact vehicle accident injury levels. : Designers have commonly used three safety treatments to protect errant drivers from culvert accidents. : These treatments have included: culvert extension, g...

Mission Safety Evaluation Report for STS-32, Postflight Edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1990-01-01

The topics covered include: (1) an STS-32 mission summary; (2) safety risk factors/issues; (3) resolved STS-32 safety risk factors; (4) STS-32 inflight anomalies; (5) STS-28 inflight anomalies; and (6) STS-32 inflight anomalies. Background information and a list of acronyms are also presented.

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.

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.

[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.

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.

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

Mission Safety Evaluation Report for STS-43, Postflight Edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Some of the topics covered include: (1) an STS-43 mission summary; (2) safety risks factors/issues; (3) resolved STS-43 safety risk factors; (4) STS-40 inflight anomalies; (5) STS-37 inflight anomalies; and (6) STS-43 inflight anomalies. Background information and a list of acronyms are also presented.

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

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.

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.

The Evaluation of the North Carolina K-9 Traffic Safety Curriculum: Methodology, Findings, and Recommendations.

ERIC Educational Resources Information Center

Padgett, Susan S.

The evaluation of the traffic safety curriculum as presented to K-9 students in North Carolina focused on three areas: (1) the extent to which students acquired the information included in the curriculum, (2) the extent to which students showed a change in their actual pedestrian and bicyclist behavior, and (3) the extent to which teachers made…

Evaluating Otto the Auto: Does Engagement in an Interactive Website Improve Young Children’s Transportation Safety?

PubMed Central

Johnston, Anna; Shen, Jiabin; Li, Peng

2017-01-01

Transportation-related injuries are a leading cause of pediatric death, and effective interventions are limited. Otto the Auto is a website offering engaging, interactive activities. We evaluated Otto among a sample of sixty-nine 4- and 5-year-old children, who participated in a randomized parallel group design study. Following baseline evaluation, children engaged with either Otto or a control website for 2 weeks and then were re-evaluated. Children who used Otto failed to show increases in transportation safety knowledge or behavior compared to the control group, although there was a dosage effect whereby children who engaged in the website more with parents gained safer behavior patterns. We conclude Otto may have some efficacy when engaged by children with their parents, but continued efforts to develop and refine engaging, effective, theory-driven strategies to teach children transportation safety, including via internet, should be pursued. PMID:28753920

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.

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

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...

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.

[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.

Do Undergraduate Engineering Faculty Include Occupational and Public Health and Safety in the Engineering Curriculum?

ERIC Educational Resources Information Center

Farwell, Dianna; And Others

1995-01-01

The purpose of this study was to determine whether and, if so, why engineering faculty include occupational and public health and safety in their undergraduate engineering courses. Data were collected from 157 undergraduate engineering faculty from 65 colleges of engineering in the United States. (LZ)

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...

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...

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…

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...

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 �

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.

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...

Evaluating the safety risk of roadside features for rural two-lane roads using reliability analysis.

PubMed

Jalayer, Mohammad; Zhou, Huaguo

2016-08-01

The severity of roadway departure crashes mainly depends on the roadside features, including the sideslope, fixed-object density, offset from fixed objects, and shoulder width. Common engineering countermeasures to improve roadside safety include: cross section improvements, hazard removal or modification, and delineation. It is not always feasible to maintain an object-free and smooth roadside clear zone as recommended in design guidelines. Currently, clear zone width and sideslope are used to determine roadside hazard ratings (RHRs) to quantify the roadside safety of rural two-lane roadways on a seven-point pictorial scale. Since these two variables are continuous and can be treated as random, probabilistic analysis can be applied as an alternative method to address existing uncertainties. Specifically, using reliability analysis, it is possible to quantify roadside safety levels by treating the clear zone width and sideslope as two continuous, rather than discrete, variables. The objective of this manuscript is to present a new approach for defining the reliability index for measuring roadside safety on rural two-lane roads. To evaluate the proposed approach, we gathered five years (2009-2013) of Illinois run-off-road (ROR) crash data and identified the roadside features (i.e., clear zone widths and sideslopes) of 4500 300ft roadway segments. Based on the obtained results, we confirm that reliability indices can serve as indicators to gauge safety levels, such that the greater the reliability index value, the lower the ROR crash rate. Copyright © 2016 Elsevier Ltd. All rights reserved.

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 ...

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

TenHaken, Ron; Daniels, B.; Becker, M.; Barnes, Zack; Donovan, Shawn; Manley, Brenda

2007-01-01

Throughout 2006, Range Safety was involved in a number of exciting and challenging activities and events, from developing, implementing, and supporting Range Safety policies and procedures-such as the Space Shuttle Launch and Landing Plans, the Range Safety Variance Process, and the Expendable Launch Vehicle Safety Program procedures-to evaluating new technologies. Range Safety training development is almost complete with the last course scheduled to go on line in mid-2007. Range Safety representatives took part in a number of panels and councils, including the newly formed Launch Constellation Range Safety Panel, the Range Commanders Council and its subgroups, the Space Shuttle Range Safety Panel, and the unmanned aircraft systems working group. Space based range safety demonstration and certification (formerly STARS) and the autonomous flight safety system were successfully tested. The enhanced flight termination system will be tested in early 2007 and the joint advanced range safety system mission analysis software tool is nearing operational status. New technologies being evaluated included a processor for real-time compensation in long range imaging, automated range surveillance using radio interferometry, and a space based range command and telemetry processor. Next year holds great promise as we continue ensuring safety while pursuing our quest beyond the Moon to Mars.

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.

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...

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...

Safety performance functions for intersections : final report, December 2009.

DOT National Transportation Integrated Search

2009-12-01

Road safety management activities include screening the network for sites with a potential for safety improvement (Network : Screening), diagnosing safety problems at specific sites, and evaluating the safety effectiveness of implemented : countermea...

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.

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.

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 :...

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...

Cornell Alliance for Science Evaluation of Consensus on Genetically Modified Food Safety: Weaknesses in Study Design

PubMed Central

Antoniou, Michael N.; Robinson, Claire J.

2017-01-01

Cornell Alliance for Science has launched an initiative in which “citizen scientists” are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance’s citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS’s statement. We identify a number of fundamental weaknesses in the Alliance’s study design, including evaluation is based only on information provided in the publication abstract; there is a lack of clarity as to what material is included in the 12,000 study abstracts to be reviewed, since the number of appropriately designed investigations addressing GM food safety are few; there is uncertainty as to whether studies of toxic effects arising from GM crop-associated pesticides will be included; there is a lack of clarity regarding whether divergent yet equally valid interpretations of the same study will be taken into account; and there is no definition of the cutoff point for consensus or non-consensus on GM food safety. In addition, vital industry proprietary biosafety data on GM crops and associated pesticides are not publicly available and is thus cannot inform this project. Based on these weaknesses in the study design, we believe it is questionable as to whether any objective or meaningful conclusion can be drawn from the Alliance’s initiative. PMID:28447029

Cornell Alliance for Science Evaluation of Consensus on Genetically Modified Food Safety: Weaknesses in Study Design.

PubMed

Antoniou, Michael N; Robinson, Claire J

2017-01-01

Cornell Alliance for Science has launched an initiative in which "citizen scientists" are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance's citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS's statement. We identify a number of fundamental weaknesses in the Alliance's study design, including evaluation is based only on information provided in the publication abstract; there is a lack of clarity as to what material is included in the 12,000 study abstracts to be reviewed, since the number of appropriately designed investigations addressing GM food safety are few; there is uncertainty as to whether studies of toxic effects arising from GM crop-associated pesticides will be included; there is a lack of clarity regarding whether divergent yet equally valid interpretations of the same study will be taken into account; and there is no definition of the cutoff point for consensus or non-consensus on GM food safety. In addition, vital industry proprietary biosafety data on GM crops and associated pesticides are not publicly available and is thus cannot inform this project. Based on these weaknesses in the study design, we believe it is questionable as to whether any objective or meaningful conclusion can be drawn from the Alliance's initiative.

Implementation and evaluation of a prototype consumer reporting system for patient safety events.

PubMed

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

2017-08-01

No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline. Mixed methods evaluation. The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015. Patients, family members and caregivers associated with two US healthcare systems. A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries. Key informant interviews, measurement of website traffic and analysis of completed reports. Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups. While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Preliminary Evaluation of an Aviation Safety Thesaurus' Utility for Enhancing Automated Processing of Incident Reports

NASA Technical Reports Server (NTRS)

Barrientos, Francesca; Castle, Joseph; McIntosh, Dawn; Srivastava, Ashok

2007-01-01

This document presents a preliminary evaluation the utility of the FAA Safety Analytics Thesaurus (SAT) utility in enhancing automated document processing applications under development at NASA Ames Research Center (ARC). Current development efforts at ARC are described, including overviews of the statistical machine learning techniques that have been investigated. An analysis of opportunities for applying thesaurus knowledge to improving algorithm performance is then presented.

Methods for addressing "innocent bystanders" when evaluating safety of concomitant vaccines.

PubMed

Wang, Shirley V; Abdurrob, Abdurrahman; Spoendlin, Julia; Lewis, Edwin; Newcomer, Sophia R; Fireman, Bruce; Daley, Matthew F; Glanz, Jason M; Duffy, Jonathan; Weintraub, Eric S; Kulldorff, Martin

2018-04-01

The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of Medicine and Department of Health and Human Services. The recommended childhood immunization schedule includes multiple vaccines in a visit. A key concern is safety of concomitant (same day) versus separate day vaccination. This paper addresses a methodological challenge for observational studies using a self-controlled design to investigate the safety of concomitant vaccination. We propose a process for distinguishing which of several concomitantly administered vaccines is responsible for increased risk of an adverse event while adjusting for confounding due to relationships between effect modifying risk factors and concomitant vaccine combinations. We illustrate the approach by re-examining the known increase in risk of seizure 7 to 10 days after measles-mumps-rubella (MMR) vaccination and evaluating potential independent or modifying effects of other vaccines. Initial analyses suggested that DTaP had both an independent and potentiating effect on seizure. After accounting for the relationship between age at vaccination and vaccine combination, there was little evidence for increased risk of seizure with same day administration of DTaP and MMR; incidence rate ratio, 95% confidence interval 1.2 (0.9-1.6), P value = θ.226. We have shown that when using a self-controlled design to investigate safety of concomitant vaccination, it can be critically important to adjust for time-invariant effect modifying risk factors, such as age at time of vaccination, which are structurally related to vaccination patterns due to recommended immunization schedules. Copyright © 2018 John Wiley & Sons, Ltd.

Tools and Techniques for Evaluating the Effects of Maintenance Resource Management (MRM) in Air Safety

NASA Technical Reports Server (NTRS)

Taylor, James C.

2002-01-01

This research project was designed as part of a larger effort to help Human Factors (HF) implementers, and others in the aviation maintenance community, understand, evaluate, and validate the impact of Maintenance Resource Management (MRM) training programs, and other MRM interventions; on participant attitudes, opinions, behaviors, and ultimately on enhanced safety performance. It includes research and development of evaluation methodology as well as examination of psychological constructs and correlates of maintainer performance. In particular, during 2001, three issues were addressed. First a prototype process for measuring performance was developed and used. Second an automated calculator was developed to aid the HF implementer user in analyzing and evaluating local survey data. These results include being automatically compared with the experience from all MRM programs studied since 1991. Third the core survey (the Maintenance Resource Management Technical Operations Questionnaire, or 'MRM/TOQ') was further developed and tested to include topics of added relevance to the industry.

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

Applications of emerging imaging techniques for meat quality and safety detection and evaluation: A review.

PubMed

Xiong, Zhenjie; Sun, Da-Wen; Pu, Hongbin; Gao, Wenhong; Dai, Qiong

2017-03-04

With improvement in people's living standards, many people nowadays pay more attention to quality and safety of meat. However, traditional methods for meat quality and safety detection and evaluation, such as manual inspection, mechanical methods, and chemical methods, are tedious, time-consuming, and destructive, which cannot meet the requirements of modern meat industry. Therefore, seeking out rapid, non-destructive, and accurate inspection techniques is important for the meat industry. In recent years, a number of novel and noninvasive imaging techniques, such as optical imaging, ultrasound imaging, tomographic imaging, thermal imaging, and odor imaging, have emerged and shown great potential in quality and safety assessment. In this paper, a detailed overview of advanced applications of these emerging imaging techniques for quality and safety assessment of different types of meat (pork, beef, lamb, chicken, and fish) is presented. In addition, advantages and disadvantages of each imaging technique are also summarized. Finally, future trends for these emerging imaging techniques are discussed, including integration of multiple imaging techniques, cost reduction, and developing powerful image-processing algorithms.

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...

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.

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...

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

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.

78 FR 36091 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Evaluation of features to support safety and quality in general practice clinical software

PubMed Central

2011-01-01

Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

Using the electronic health record to build a culture of practice safety: evaluating the implementation of trigger tools in one general practice.

PubMed

Margham, Tom; Symes, Natalie; Hull, Sally A

2018-04-01

Identifying patients at risk of harm in general practice is challenging for busy clinicians. In UK primary care, trigger tools and case note reviews are mainly used to identify rates of harm in sample populations. This study explores how adaptions to existing trigger tool methodology can identify patient safety events and engage clinicians in ongoing reflective work around safety. Mixed-method quantitative and narrative evaluation using thematic analysis in a single East London training practice. The project team developed and tested five trigger searches, supported by Excel worksheets to guide the case review process. Project evaluation included summary statistics of completed worksheets and a qualitative review focused on ease of use, barriers to implementation, and perception of value to clinicians. Trigger searches identified 204 patients for GP review. Overall, 117 (57%) of cases were reviewed and 62 (53%) of these cases had patient safety events identified. These were usually incidents of omission, including failure to monitor or review. Key themes from interviews with practice members included the fact that GPs' work is generally reactive and GPs welcomed an approach that identified patients who were 'under the radar' of safety. All GPs expressed concern that the tool might identify too many patients at risk of harm, placing further demands on their time. Electronic trigger tools can identify patients for review in domains of clinical risk for primary care. The high yield of safety events engaged clinicians and provided validation of the need for routine safety checks. © British Journal of General Practice 2018.

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...

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.

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

76 FR 2829 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

77 FR 20295 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

77 FR 35854 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 52462 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 73966 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

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.

Methodological approaches to evaluate the impact of FDA drug safety communications.

PubMed

Kesselheim, Aaron S; Campbell, Eric G; Schneeweiss, Sebastian; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Seeger, John D; Brownstein, John S; Woloshin, Steven; Schwartz, Lisa M; Toomey, Timothy; Dal Pan, Gerald J; Avorn, Jerry

2015-06-01

When the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians. The effectiveness of the communication-how drug safety messaging conveyed in FDA DSCs changes patient or prescriber behavior-may depend on multiple factors, including the way physicians and patients learn about the information, their understanding of the issues conveyed, and their perception of the importance of the information. In 2013, the FDA issued two DSCs addressing critical new warnings related to products containing the sedative/hypnotic zolpidem. In this article, we describe a core set of research initiatives that can be used to study how zolpidem-related DSCs affected subsequent physician and patient decision making. These research initiatives include analyzing drug utilization patterns and related health outcomes; comparing zolpidem-containing products against a comparator with similar indications [eszopiclone (Lunesta)] not covered by the 2013 DSCs; and surveying patients and qualitatively evaluating the dissemination of information regarding these drugs in traditional and social-media channels. Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.

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.

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).

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

Evaluation of the Safety Edge application in Oregon.

DOT National Transportation Integrated Search

2012-03-01

This report summarizes a recent assessment of the Safety Edge SM that was performed to determine the feasibility of using this pavement edge treatment on Oregon construction projects. The report includes a review of research that has been published a...

Evaluation of the safety edge application in Oregon.

DOT National Transportation Integrated Search

2012-03-01

This report summarizes a recent assessment of the Safety Edge SM that was performed to determine the feasibility of using this pavement edge treatment on Oregon construction projects. The report includes a review of research that has been published a...

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...

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...

Evaluated community fire safety interventions in the United States: a review of current literature.

PubMed

Ta, Van M; Frattaroli, Shannon; Bergen, Gwendolyn; Gielen, Andrea Carlson

2006-06-01

The purpose of the study was to assess the state of fire prevention research, provide an updated synthesis of evaluated fire prevention programs, and discuss the role of fire fighters and data systems in prevention efforts. The review included all evaluations of U.S. based fire prevention interventions published between January 1998 and September 2004 and any earlier articles about U.S. fire prevention interventions not included in two prior review articles. We retrieved information from each identified study including evaluation findings, involvement of fire service personnel and use of existing data systems. We identified twelve articles: seven reported on smoke alarm interventions, three on multi-faceted programs, and two other programs. Five programs involved fire service personnel in the design, implementation, and/or evaluation, and three used existing data systems. Studies reviewed suggest that canvassing and smoke alarm installations are the most effective means of distributing alarms and increasing the functional status of distributed alarms. The functionality of smoke alarms, an issue noted in earlier reviews, remains a problem. Programs involving partnerships with fire departments have indicated success in preventing fires and deaths, improving smoke alarm ownership and functional status, and improving children's fire safety knowledge. Using existing data systems to target and to evaluate interventions was effective. In the years since prior reviews, some improvements in the rigor of evaluation designs have been made, but there is still a need for high quality evaluations that will inform fire injury prevention efforts.

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.

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...

Economic evaluation of occupational safety preventive measures in a hospital.

PubMed

Ramos, Delfina G; Arezes, Pedro M; Afonso, Paulo

2015-01-01

When an organization performs an integrated analysis of risks through its Occupational Health and Safety Management System, several steps are suggested to address the implications of the identified risks. Namely, the organization should make a detailed analysis of the monetary impact for the organization of each of the preventive measures considered. However, it is also important to perform an analysis of the impact of each measure on society (externalities). The aim of this paper is to present a case study related to the application of the proposed economic evaluation methodology. An analysis of the work accidents in a hospital has been made. Three of the major types of accidents have been selected: needle stings, falls and excessive strain. Following the risk assessment, some preventive measures have been designed. Subsequently, the Benefit/Cost ratio (B/C) of these measures has been calculated, both in financial terms (from the organization's perspective) and in economic terms (including the benefits for the worker and for the Society). While the financial ratio is only advantageous in some cases, when the externalities are taken into account, the B/C ratio increases significantly. It is important to consider external benefits to make decisions concerning the implementation of preventive measures in Occupational Health and Safety projects.

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.

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

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...

[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.

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

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...

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...

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...

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...

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...

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...

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...

Incorporating organisational safety culture within ergonomics practice.

PubMed

Bentley, Tim; Tappin, David

2010-10-01

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

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.

System Vaccinology for the Evaluation of Influenza Vaccine Safety by Multiplex Gene Detection of Novel Biomarkers in a Preclinical Study and Batch Release Test

PubMed Central

Mizukami, Takuo; Momose, Haruka; Kuramitsu, Madoka; Takizawa, Kazuya; Araki, Kumiko; Furuhata, Keiko; Ishii, Ken J.; Hamaguchi, Isao; Yamaguchi, Kazunari

2014-01-01

Vaccines are beneficial and universal tools to prevent infectious disease. Thus, safety of vaccines is strictly evaluated in the preclinical phase of trials and every vaccine batch must be tested by the National Control Laboratories according to the guidelines published by each country. Despite many vaccine production platforms and methods, animal testing for safety evaluation is unchanged thus far. We recently developed a systems biological approach to vaccine safety evaluation where identification of specific biomarkers in a rat pre-clinical study evaluated the safety of vaccines for pandemic H5N1 influenza including Irf7, Lgals9, Lgalsbp3, Cxcl11, Timp1, Tap2, Psmb9, Psme1, Tapbp, C2, Csf1, Mx2, Zbp1, Ifrd1, Trafd1, Cxcl9, β2m, Npc1, Ngfr and Ifi47. The current study evaluated whether these 20 biomarkers could evaluate the safety, batch-to-batch and manufacturer-to-manufacturer consistency of seasonal trivalent influenza vaccine using a multiplex gene detection system. When we evaluated the influenza HA vaccine (HAv) from four different manufactures, the biomarker analysis correlated to findings from conventional animal use tests, such as abnormal toxicity test. In addition, sensitivity of toxicity detection and differences in HAvs were higher and more accurate than with conventional methods. Despite a slight decrease in body weight caused by HAv from manufacturer B that was not statistically significant, our results suggest that HAv from manufacturer B is significantly different than the other HAvs tested with regard to Lgals3bp, Tapbp, Lgals9, Irf7 and C2 gene expression in rat lungs. Using the biomarkers confirmed in this study, we predicted batch-to-batch consistency and safety of influenza vaccines within 2 days compared with the conventional safety test, which takes longer. These biomarkers will facilitate the future development of new influenza vaccines and provide an opportunity to develop in vitro methods of evaluating batch-to-batch consistency and

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.

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...

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...

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...

Evaluation of pedestrian safety at intersections: A theoretical framework based on pedestrian-vehicle interaction patterns.

PubMed

Ni, Ying; Wang, Menglong; Sun, Jian; Li, Keping

2016-11-01

Pedestrians are the most vulnerable road users, and pedestrian safety has become a major research focus in recent years. Regarding the quality and quantity issues with collision data, conflict analysis using surrogate safety measures has become a useful method to study pedestrian safety. However, given the inequality between pedestrians and vehicles in encounters and the multiple interactions between pedestrians and vehicles, it is insufficient to simply use the same indicator(s) or the same way to aggregate indicators for all conditions. In addition, behavioral factors cannot be neglected. To better use information extracted from trajectories for safety evaluation and pay more attention on effects of behavioral factors, this paper develops a more sophisticated framework for pedestrian conflict analysis that takes pedestrian-vehicle interactions into consideration. A concept of three interaction patterns has been proposed for the first time, namely "hard interaction," "no interaction," and "soft-interaction." Interactions have been categorized under one of these patterns by analyzing profiles of speed and conflict indicators during the whole interactive processes. In this paper, a support vector machine (SVM) approach has been adopted to classify severity levels for a dataset including 1144 events extracted from three intersections in Shanghai, China, followed by an analysis of variable importance. The results revealed that different conflict indicators have different contributions to indicating the severity level under various interaction patterns. Therefore, it is recommended either to use specific conflict indicators or to use weighted indicator aggregation for each interaction pattern when evaluating pedestrian safety. The implementation has been carried out at the fourth crosswalk, and the results indicate that the proposed method can achieve a higher accuracy and better robustness than conventional methods. Furthermore, the method is helpful for better

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.

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.

78 FR 36092 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

78 FR 40635 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

[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.

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

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.

Treatment options for nonalcoholic steatohepatitis - a safety evaluation.

PubMed

Issa, Danny; Wattacheril, Julia; Sanyal, Arun J

2017-08-01

There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.

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.

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.

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.

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...

Food Safety Education Using Music Parodies

ERIC Educational Resources Information Center

Winter, Carl K.; Fraser, Angela M.; Gleason, Jeanne B.; Hovey, Susan K.; McCurdy, Sandra M.; Snider, O. Sue

2009-01-01

Musical parodies of contemporary songs with their lyrics altered to address current food safety issues were incorporated into a variety of food safety educational programs and the effectiveness of the music was evaluated by semiquantitative and qualitative measures. Audiences receiving the music-enriched curricula included school foodservice…

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...

A Process-Centered Tool for Evaluating Patient Safety Performance and Guiding Strategic Improvement

DTIC Science & Technology

2005-01-01

next patient safety steps in individual health care organizations. The low priority given to Category 3 (Focus on patients , other customers , and...presents a patient safety applicator tool for implementing and assessing patient safety systems in health care institutions. The applicator tool consists...the survey rounds. The study addressed three research questions: 1. What critical processes should be included in health care patient safety systems

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 ...

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

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...

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...

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

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk

[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.

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.

Clinical safety and effectiveness evaluation of a new antimicrobial wound dressing designed to manage exudate, infection and biofilm.

PubMed

Metcalf, Daniel G; Parsons, David; Bowler, Philip G

2017-02-01

The objective of this work was to evaluate the safety and effectiveness of a next-generation antimicrobial wound dressing (NGAD; AQUACEL ® Ag+ Extra™ dressing) designed to manage exudate, infection and biofilm. Clinicians were requested to evaluate the NGAD within their standard protocol of care for up to 4 weeks, or as long as deemed clinically appropriate, in challenging wounds that were considered to be impeded by suspected biofilm or infection. Baseline information and post-evaluation dressing safety and effectiveness data were recorded using standardised evaluation forms. This data included wound exudate levels, wound bed appearance including suspected biofilm, wound progression, skin health and dressing usage. A total of 112 wounds from 111 patients were included in the evaluations, with a median duration of 12 months, and biofilm was suspected in over half of all wounds (54%). After the introduction of the NGAD, exudate levels had shifted from predominantly high or moderate to low or moderate levels, while biofilm suspicion fell from 54% to 27% of wounds. Wound bed coverage by tissue type was generally shifted from sloughy or suspected biofilm towards predominantly granulation tissue after the inclusion of the NGAD. Stagnant (65%) and deteriorating wounds (27%) were shifted to improved (65%) or healed wounds (13%), while skin health was also reported to have improved in 63% of wounds. High levels of clinician satisfaction with the dressing effectiveness and change frequency were accompanied by a low number of dressing-related adverse events (n = 3; 2·7%) and other negative observations or comments. This clinical user evaluation supports the growing body of evidence that the anti-biofilm technology in the NGAD results in a safe and effective dressing for the management of a variety of challenging wound types. © 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

Systematic evaluation of non-animal test methods for skin sensitisation safety assessment.

PubMed

Reisinger, Kerstin; Hoffmann, Sebastian; Alépée, Nathalie; Ashikaga, Takao; Barroso, Joao; Elcombe, Cliff; Gellatly, Nicola; Galbiati, Valentina; Gibbs, Susan; Groux, Hervé; Hibatallah, Jalila; Keller, Donald; Kern, Petra; Klaric, Martina; Kolle, Susanne; Kuehnl, Jochen; Lambrechts, Nathalie; Lindstedt, Malin; Millet, Marion; Martinozzi-Teissier, Silvia; Natsch, Andreas; Petersohn, Dirk; Pike, Ian; Sakaguchi, Hitoshi; Schepky, Andreas; Tailhardat, Magalie; Templier, Marie; van Vliet, Erwin; Maxwell, Gavin

2015-02-01

The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitization potency prediction. The results of the first phase – systematic evaluation of 16 test methods – are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data,potential for throughput, transferability and accessibility in cooperation with the test method developers.A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy – combined with bioavailability and skin metabolism data and exposure consideration – is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients.

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...

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.

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

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

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...

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/.

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Electrical Safety: Safety and Health for Electrical Trades. Student Manual.

ERIC Educational Resources Information Center

Fowler, Thaddeus W.; Miles, Karen K.

This document is designed to teach learners in secondary and postsecondary electrical trades courses to recognize, evaluate, and control hazards associated with electrical work, The manual's eight sections each include some or all of the following components: instructional text; definitions; case studies illustrating key safety considerations;…

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

PubMed

Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

2016-12-01

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

The Effectiveness of a Bicycle Safety Program for Improving Safety-Related Knowledge and Behavior in Young Elementary Students

PubMed Central

Glang, Ann

2010-01-01

Objective The purpose of this study was to evaluate the “Bike Smart” program, an eHealth software program that teaches bicycle safety behaviors to young children. Methods Participants were 206 elementary students in grades kindergarten to 3. A random control design was employed to evaluate the program, with students assigned to either the treatment condition (Bike Smart) or the control condition (a video on childhood safety). Outcome measures included computer-based knowledge items (safety rules, helmet placement, hazard discrimination) and a behavioral measure of helmet placement. Results Results demonstrated that regardless of gender, cohort, and grade the participants in the treatment group showed greater gains than control participants in both the computer-presented knowledge items (p > .01) and the observational helmet measure (p > .05). Conclusions Findings suggest that the Bike Smart program can be a low cost, effective component of safety training packages that include both skills-based and experiential training. PMID:19755497

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

Screening of repeated dose toxicity data present in SCC(NF)P/SCCS safety evaluations of cosmetic ingredients.

PubMed

Vinken, Mathieu; Pauwels, Marleen; Ates, Gamze; Vivier, Manon; Vanhaecke, Tamara; Rogiers, Vera

2012-03-01

Alternative methods, replacing animal testing, are urgently needed in view of the European regulatory changes in the field of cosmetic products and their ingredients. In this context, a joint research initiative called SEURAT was recently raised by the European Commission and COLIPA, representing the European cosmetics industry, with the overall goal of developing an animal-free repeated dose toxicity testing strategy for human safety assessment purposes. Although cosmetic ingredients are usually harmless for the consumer, one of the initial tasks of this research consortium included the identification of organs that could potentially be affected by cosmetic ingredients upon systemic exposure. The strategy that was followed hereof is described in the present paper and relies on the systematic evaluation, by using a self-generated electronic databank, of published reports issued by the scientific committee of DG SANCO responsible for the safety of cosmetic ingredients. By screening of the repeated dose toxicity studies present in these reports, it was found that the liver is potentially the most frequently targeted organ by cosmetic ingredients when orally administered to experimental animals, followed by the kidney and the spleen. Combined listing of altered morphological, histopathological, and biochemical parameters subsequently indicated the possible occurrence of hepatotoxicity, including steatosis and cholestasis, triggered by a limited number of cosmetic compounds. These findings are not only of relevance for the in vitro modeling efforts and choice of compounds to be tested in the SEURAT project cluster, but also demonstrate the importance of using previously generated toxicological data through an electronic databank for addressing specific questions regarding the safety evaluation of cosmetic ingredients.

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.

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…

Improved guidelines for estimating the Highway safety manual calibration factors.

DOT National Transportation Integrated Search

2016-01-01

Crash prediction models can be used to predict the number of crashes and evaluate roadway safety. Part C of the first edition of the Highway Safety Manual (HSM) provides safety performance functions (SPFs). The HSM addendum that includes freeway and ...

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

PubMed

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

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...

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

PubMed

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

2014-02-01

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

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.

A Framework for Including Family Health Spillovers in Economic Evaluation

PubMed Central

Al-Janabi, Hareth; van Exel, Job; Brouwer, Werner; Coast, Joanna

2016-01-01

Health care interventions may affect the health of patients’ family networks. It has been suggested that these “health spillovers” should be included in economic evaluation, but there is not a systematic method for doing this. In this article, we develop a framework for including health spillovers in economic evaluation. We focus on extra-welfarist economic evaluations where the objective is to maximize health benefits from a health care budget (the “health care perspective”). Our framework involves adapting the conventional cost-effectiveness decision rule to include 2 multiplier effects to internalize the spillover effects. These multiplier effects express the ratio of total health effects (for patients and their family networks) to patient health effects. One multiplier effect is specified for health benefit generated from providing a new intervention, one for health benefit displaced by funding this intervention. We show that using multiplier effects to internalize health spillovers could change the optimal funding decisions and generate additional health benefits to society. PMID:26377370

Stakeholder evaluation of an online program to promote physical activity and workplace safety for individuals with disability.

PubMed

Nery-Hurwit, Mara; Kincl, Laurel; Driver, Simon; Heller, Brittany

2017-08-01

Individuals with disabilities face increasing health and employment disparities, including increased risk of morbidity and mortality and decreased earnings, occupational roles, and greater risk of injury at work. Thus, there is a need to improve workplace safety and health promotion efforts for people with disability. The purpose of this study was to obtain stakeholder feedback about an online program, Be Active, Work Safe, which was developed to increase the physical activity and workplace safety practices of individuals with disability. Eight stakeholders (content experts and individuals with disability) evaluated the 8-week online program and provided feedback on accessibility, usability, and content using quantitative and qualitative approaches. Stakeholders suggested changes to the organization, layout and accessibility, and content. This included making a stronger connection between the physical activity and workplace safety components of the program, broadening content to apply to individuals in different vocational fields, and reducing the number of participant assessments. Engaging stakeholders in the development of health promotion programs is critical to ensure the unique issues of the population are addressed and facilitate engagement in the program. Feedback provided by stakeholders improved the program and provided insight on barriers for adoption of the program. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2014-10-01

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

76 FR 65609 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship Canal... enforcement of regulation. SUMMARY: The Coast Guard will enforce a segment of the Safety Zone; Brandon Road....S. Army Corps of Engineers' dispersal barrier maintenance operations. During the enforcement period...

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...

An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review

PubMed Central

Zhang, Longhao; Zhao, Pujing; Chen, Ying; Zhang, Mingming

2015-01-01

Background From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. Objective To evaluate the effectiveness of HFE interventions in improving health care workers’ outcomes and patient safety and to assess the quality of the available evidence. Methods We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. Results For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers’ quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers’ attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. Conclusion The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need

[Agricultural biotechnology safety assessment].

PubMed

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

2015-01-01

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

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

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)...

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.

Safety evaluation of intersections with dynamic use of exit-lanes for left-turn using field data.

PubMed

Zhao, Jing; Liu, Yue

2017-05-01

As a newly proposed unconventional intersection design, the exit-lanes for left-turn (EFL) intersection is found to be effective in increasing the intersection capacity with high level of application flexibility, especially under heavy left-turn traffic conditions. However, the operational safety of EFL is of most concern to the authority prior to its implementation. This paper evaluates the safety of the EFL intersections by studying the behavior of left-turn maneuvers using field data collected at 7 locations in China. A total of 22830 left-turn vehicles were captured, in which 9793 vehicles turned left using the mixed-usage area. Four potential safety problems, including the red-light violations, head-on collision risks, trapped vehicles, and rear-end crash risks, were discussed. Statistical analyses were carried out to compare the safety risk between the EFL intersection and the conventional one. Results indicate that the safety problems of EFL intersections mainly lie in higher percentages in red-light violations at the pre-signal (1.83% higher), wrong-way violation problems during the peak hours (the violation rate reaches up to 11.07%), and the lower travel speeds in the mixed-usage area (18.75% lower). Such risks can be counteracted, however, by providing more guiding information, installing cameras to investigate and punish violation maneuvers, and adjusting design parameter values for layout design and signal timing, respectively. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

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

PubMed Central

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

2014-01-01

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

Safety 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...

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...

A Study on Urban Road Traffic Safety Based on Matter Element Analysis

PubMed Central

Hu, Qizhou; Zhou, Zhuping; Sun, Xu

2014-01-01

This paper examines a new evaluation of urban road traffic safety based on a matter element analysis, avoiding the difficulties found in other traffic safety evaluations. The issue of urban road traffic safety has been investigated through the matter element analysis theory. The chief aim of the present work is to investigate the features of urban road traffic safety. Emphasis was placed on the construction of a criterion function by which traffic safety achieved a hierarchical system of objectives to be evaluated. The matter element analysis theory was used to create the comprehensive appraisal model of urban road traffic safety. The technique was used to employ a newly developed and versatile matter element analysis algorithm. The matter element matrix solves the uncertainty and incompatibility of the evaluated factors used to assess urban road traffic safety. The application results showed the superiority of the evaluation model and a didactic example was included to illustrate the computational procedure. PMID:25587267

Analysis of School Food Safety Programs Based on HACCP Principles

ERIC Educational Resources Information Center

Roberts, Kevin R.; Sauer, Kevin; Sneed, Jeannie; Kwon, Junehee; Olds, David; Cole, Kerri; Shanklin, Carol

2014-01-01

Purpose/Objectives: The purpose of this study was to determine how school districts have implemented food safety programs based on HACCP principles. Specific objectives included: (1) Evaluate how schools are implementing components of food safety programs; and (2) Determine foodservice employees food-handling practices related to food safety.…

[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

The patient safety culture: a systematic review by characteristics of Hospital Survey on Patient Safety Culture dimensions.

PubMed

Reis, Cláudia Tartaglia; Paiva, Sofia Guerra; Sousa, Paulo

2018-05-08

To learn the weaknesses and strengths of safety culture as expressed by the dimensions measured by the Hospital Survey on Patient Safety Culture (HSOPSC) at hospitals in the various cultural contexts. The aim of this study was to identify studies that have used the HSOPSC to collect data on safety culture at hospitals; to survey their findings in the safety culture dimensions and possible contributions to improving the quality and safety of hospital care. Medline (via PubMed), Web of Science and Scopus were searched from 2005 to July 2016 in English, Portuguese and Spanish. Studies were identified using specific search terms and inclusion criteria. A total of 33 articles, reporting on 21 countries, was included. Scores were extracted by patient safety culture dimensions assessed by the HSOPSC. The quality of the studies was evaluated by the STROBE Statement. The dimensions that proved strongest were 'Teamwork within units' and 'Organisational learning-continuous improvement'. Particularly weak dimensions were 'Non-punitive response to error', 'Staffing', 'Handoffs and transitions' and 'Teamwork across units'. The studies revealed a predominance of hospital organisational cultures that were underdeveloped or weak as regards patient safety. For them to be effective, safety culture evaluation should be tied to strategies designed to develop safety culture hospital-wide.

Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects.

PubMed

Miller, Ann K; Harrell, Emma; Ye, Li; Baptiste-Brown, Sharon; Kleim, Jőrg-Peter; Ohrt, Colin; Duparc, Stephan; Möhrle, Jörg J; Webster, Alison; Stinnett, Sandra; Hughes, Arlene; Griffith, Sandy; Beelen, Andrew P

2013-12-01

The long-acting 8-aminoquinoline tafenoquine (TQ) coadministered with chloroquine (CQ) may radically cure Plasmodium vivax malaria. Coadministration therapy was evaluated for a pharmacokinetic interaction and for pharmacodynamic, safety and tolerability characteristics. Healthy subjects, 18-55 years old, without documented glucose-6-phosphate dehydrogenase deficiency, received CQ alone (days 1-2, 600 mg; and day 3, 300 mg), TQ alone (days 2 and 3, 450 mg) or coadministration therapy (day 1, CQ 600 mg; day 2, CQ 600 mg + TQ 450 mg; and day 3, CQ 300 mg + TQ 450 mg) in a randomized, double-blind, parallel-group study. Blood samples for pharmacokinetic and pharmacodynamic analyses and safety data, including electrocardiograms, were collected for 56 days. The coadministration of CQ + TQ had no effect on TQ AUC0-t , AUC0-∞ , Tmax or t1/2 . The 90% confidence intervals of CQ + TQ vs. TQ for AUC0-t , AUC0-∞ and t1/2 indicated no drug interaction. On day 2 of CQ + TQ coadministration, TQ Cmax and AUC0-24 increased by 38% (90% confidence interval 1.27, 1.64) and 24% (90% confidence interval 1.04, 1.46), respectively. The pharmacokinetics of CQ and its primary metabolite desethylchloroquine were not affected by TQ. Coadministration had no clinically significant effect on QT intervals and was well tolerated. No clinically significant safety or pharmacokinetic/pharmacodynamic interactions were observed with coadministered CQ and TQ in healthy subjects. © 2013 The British Pharmacological Society.

Evaluation of boldenone as a growth promoter in broilers: safety and meat quality aspects.

PubMed

Elmajdoub, Abdelrazzag; Garbaj, Aboubaker; Abolghait, Said; El-Mahmoudy, Abubakr

2016-04-01

The object of this study was to evaluate the safety and meat quality criteria in broilers following intramuscular injection of boldenone. Twenty-four broiler chicks, divided into two groups, were used in the present study. Boldenone was injected intramuscularly at a single-dose level of 5 mg/kg body weight into 12 broiler chicks at 2 weeks old; the other 12 chicks were injected with sesame oil and kept as controls. Blood samples were collected from the wing and metatarsal veins after 1, 2, and 3 weeks through the experimental course for hematological and clinic-chemical safety parameters. On the last day, chicks were humanely sacrificed and livers and kidneys were removed for histopathological examination. Breast muscles were also removed to assess meat-quality parameters. Boldenone significantly (p < 0.05) increased total erythrocytic count and hemoglobin and hematocrit values, while mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration indices decreased. Leukogram showed leukopenia, lymphopenia, and granulocytosis (p < 0.05) as compared to control. Hepatorenal biomarkers, including alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, urea, and creatinine were significantly (p < 0.05) higher than the corresponding control values. Additionally, boldenone significantly (p < 0.05) increased metabolic markers, including total protein, globulins, cholesterol, triacylglycerols, and glucose, with parallel decreases in albumin and albumin/globulin ratio. Degenerative changes were recorded in liver and kidney tissues from chicks treated with boldenone. Muscle samples exhibited raised pH values and higher microbial counts as compared to the corresponding control. These data may discourage the use of boldenone as a growth promoter in broilers due to safety and meat quality reasons. Copyright © 2016. Published by Elsevier B.V.

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.

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...

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.

Teaching children about bicycle safety: an evaluation of the New Jersey Bike School program.

PubMed

Lachapelle, Ugo; Noland, Robert B; Von Hagen, Leigh Ann

2013-03-01

There are multiple health and environmental benefits associated with increasing bicycling among children. However, the use of bicycles is also associated with severe injuries and fatalities. In order to reduce bicycle crashes, a bicycling education program was implemented in selected New Jersey schools and summer camps as part of the New Jersey Safe Routes to School Program. Using a convenience sample of participants to the program, an opportunistic study was designed to evaluate the effectiveness of two bicycle education programs, the first a more-structured program delivered in a school setting, with no on-road component, and the other a less structured program delivered in a summer camp setting that included an on-road component. Tests administered before and after training were designed to assess knowledge acquired during the training. Questions assessed children's existing knowledge of helmet use and other equipment, bicycle safety, as well as their ability to discriminate hazards and understand rules of the road. Participating children (n=699) also completed a travel survey that assessed their bicycling behavior and their perception of safety issues. Response to individual questions, overall pre- and post-training test scores, and changes in test scores were compared using comparison of proportion, t-tests, and ordinary least-squares (OLS) regression. Improvements between the pre-training and post-training test are apparent from the frequency distribution of test results and from t-tests. Both summer camps and school-based programs recorded similar improvements in test results. Children who bicycled with their parents scored higher on the pre-training test but did not improve as much on the post-training test. Without evaluating long-term changes in behavior, it is difficult to ascertain how successful the program is on eventual behavioral and safety outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

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...

To include or not to include: Evaluations and reasoning about the failure to include peers with autism spectrum disorder in elementary students.

PubMed

Bottema-Beutel, Kristen; Turiel, Elliot; DeWitt, Mila N; Wolfberg, Pamela J

2017-01-01

Given the significant role that typically developing children play in the social lives of children with autism spectrum disorder, it is important to understand how they evaluate and reason about the inclusion/exclusion of children with autism spectrum disorder in social situations. The objective of this study is to determine elementary students' evaluations, reasoning patterns, and reasoning complexity regarding the failure to include children with autism spectrum disorder in social activities. Forty-four elementary-aged students participated in interviews, which included vignettes describing four contexts in which a child with autism spectrum disorder is not invited to a social event. Responses were analyzed according to social domain theory, an approach emphasizing that children identify and coordinate different domains of social knowledge, including the moral, personal, societal, and prudential. Results showed that regardless of grade and context, most children judge that failure to include on the basis of disability status is not acceptable. However, the complexity of children's reasoning (i.e. the extent to which they drew upon and coordinated multiple domains) was higher in older children. Mean complexity scores were also higher in a birthday party context as compared to a playdate context. We offer implications for future research and practice regarding the social inclusion of children with autism spectrum disorder. © The Author(s) 2016.

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.

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.

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

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.

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...

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.

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…

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

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.

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.

[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.

Unsaponifiable matter from oil of green coffee beans: cosmetic properties and safety evaluation.

PubMed

Wagemaker, Tais A L; Campos, Patrícia M B G Maia; Fernandes, Ana Sofia; Rijo, Patrícia; Nicolai, Marisa; Roberto, Amílcar; Rosado, Catarina; Reis, Catarina; Rodrigues, Luis M; Carvalho, Cássia Regina Limonta; Maia, Nilson Borlina; Guerreiro Filho, Oliveiro

2016-10-01

Unsaponifiable matter (UM), a fraction of green coffee oil (GCO) contains functional compounds responsible for desirable cosmetic properties such as UV-B absorption. To evaluate oil content and sun protection factor (SPF) variability of the two most important species of coffee and, the toxic and cytotoxic effects, as well as cosmetic properties, including antioxidant and antimicrobial activities of UM obtained from green Coffea arabica seed oil. The safety and potential cosmetic properties of UM extracted from green coffee oil (GCO) were evaluated by the brine shrimp viability and the MTT cytotoxicity assays. The SPF and antioxidant activity were evaluated using in vitro methods. Relevant cytotoxicity was found against keratinocytes for concentrations ≥25 µg/mL and in the brine shrimp assay (LC50 24 µg/mL). Antimicrobial and antioxidant activities (IC50 1448 µg/mL) were low in UM but SPF was 10 times higher than in GCO. UM is a novel potential UV-B absorbent but its use as a cosmetic ingredient should be better considered due to the considerable cytotoxicity shown in the experimental conditions described.

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

PubMed

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

2014-03-01

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

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.

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the

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 ...

Evaluation of the Safety and Tolerability of Conjunctival Ring for Posterior Segment of the Eye.

PubMed

Kinoshita, Satoshi; Ohguchi, Takeshi; Noda, Kousuke; Murata, Miyuki; Yasueda, Shin-Ichi; Obata, Haruka; Matsunaga, Toru; Fukushima, Tsutomu; Kanda, Atsuhiro; Ishida, Susumu

2017-08-01

To evaluate the safety and tolerability of conjunctival rings (CRs), a novel device for drug delivery to the posterior segment of the eye. In animal studies, CRs containing 5% dexamethasone sodium phosphate (DSP) or vehicle solution were placed on the right and left eyes of C57BL/6J mice, respectively. Contact lenses (CLs) containing vehicle solution were used as a control. Twenty-four hours after placement of the CRs, corneal fluorescein staining was graded based on the McDonald-Shadduck scoring system, ranging from 0 to 4. In humans, CRs containing vehicle solution were placed on the right eye of healthy volunteers for 9 hours. The corneal curvature, corneal thickness, intraocular pressure, visual acuity, tear production (Schirmer I test), tear film break-up time and fluorescein staining scores of the cornea (scores ranging from 0 to 3) and conjunctiva (scores ranging from 0 to 6) were assessed before and after wearing the CRs. The release characteristics of DSP from CRs were also evaluated. In animal experiments, corneal fluorescein staining scores were 1 or less in all the groups, and there was no significant difference between the CR group and the CL group. In the preclinical safety evaluation of CR for humans, ophthalmic examination revealed that CR caused no significant changes in all the parameters investigated including corneal curvature (p = 0.77), corneal thickness (p = 0.96), intraocular pressure (p = 0.59), visual acuity (p = 0.14), Schirmer I test results (p = 0.76), tear film break-up time (p = 0.68), corneal fluorescein staining scores (p = 0.64), and conjunctival fluorescein staining scores (p = 0.52). The DSP release from CRs occurs within a few hours, which is similar to the drug-release property of medicated CL, as reported previously. The current data showed the safety and tolerability of CR as a drug delivery device for the treatment of posterior segment diseases.

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

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

PubMed

Bhatti, Junaid A; Ahmed, Aizaz

2014-01-01

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

Neonatal Outcomes Following Delivery in Water: Evaluation of Safety in a District General Hospital

PubMed Central

Zengeya, Stanley T; Cochrane, Lesley; Sleath, Maxine

2018-01-01

Introduction Giving birth in water has increased in popularity over recent years, with potential benefits in terms of maternal comfort and decreased rates of instrumental delivery. Some concerns have been raised about possible adverse neonatal outcomes, including hypothermia and respiratory distress. There is not currently, however, a clear consensus in the literature. This study sought to assess the safety of delivering in water for low-risk vaginal deliveries in a District General Hospital in the United Kingdom. Methods Prospectively collected hospital data was obtained for all deliveries between 1 April 2014 and 31 March 2016 at the Great Western Hospital, Swindon. The dataset was limited to full-term babies born by unassisted vaginal delivery following spontaneous labour; 3507 babies were included in the analyses. Pre-specified outcomes included neonatal unit admission, Apgar scores, and temperature after delivery. Results During the two-year period studied, there were 592 waterbirths and 2915 non-waterbirths. There was no significant difference in rates of neonatal unit admission between waterbirths and non-waterbirths. One-minute Apgar scores were slightly higher among those born in water (P = 0.04); this difference attenuated by five minutes of age. There was no difference in temperature after delivery between the two groups. Conclusions An evaluation of safety in a District General Hospital has demonstrated similar postnatal outcomes among babies born in water, compared to those born on land. Further work examining longer-term outcomes would help assess whether this persists beyond the newborn period. PMID:29686950

Neonatal Outcomes Following Delivery in Water: Evaluation of Safety in a District General Hospital.

PubMed

Peacock, Phil J; Zengeya, Stanley T; Cochrane, Lesley; Sleath, Maxine

2018-02-20

Introduction Giving birth in water has increased in popularity over recent years, with potential benefits in terms of maternal comfort and decreased rates of instrumental delivery. Some concerns have been raised about possible adverse neonatal outcomes, including hypothermia and respiratory distress. There is not currently, however, a clear consensus in the literature. This study sought to assess the safety of delivering in water for low-risk vaginal deliveries in a District General Hospital in the United Kingdom. Methods Prospectively collected hospital data was obtained for all deliveries between 1 April 2014 and 31 March 2016 at the Great Western Hospital, Swindon. The dataset was limited to full-term babies born by unassisted vaginal delivery following spontaneous labour; 3507 babies were included in the analyses. Pre-specified outcomes included neonatal unit admission, Apgar scores, and temperature after delivery. Results During the two-year period studied, there were 592 waterbirths and 2915 non-waterbirths. There was no significant difference in rates of neonatal unit admission between waterbirths and non-waterbirths. One-minute Apgar scores were slightly higher among those born in water (P = 0.04); this difference attenuated by five minutes of age. There was no difference in temperature after delivery between the two groups. Conclusions An evaluation of safety in a District General Hospital has demonstrated similar postnatal outcomes among babies born in water, compared to those born on land. Further work examining longer-term outcomes would help assess whether this persists beyond the newborn period.

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

Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects

PubMed Central

Miller, Ann K; Harrell, Emma; Ye, Li; Baptiste-Brown, Sharon; Kleim, Jőrg-Peter; Ohrt, Colin; Duparc, Stephan; Möhrle, Jörg J; Webster, Alison; Stinnett, Sandra; Hughes, Arlene; Griffith, Sandy; Beelen, Andrew P

2013-01-01

Aims The long-acting 8-aminoquinoline tafenoquine (TQ) coadministered with chloroquine (CQ) may radically cure Plasmodium vivax malaria. Coadministration therapy was evaluated for a pharmacokinetic interaction and for pharmacodynamic, safety and tolerability characteristics. Methods Healthy subjects, 18–55 years old, without documented glucose-6-phosphate dehydrogenase deficiency, received CQ alone (days 1–2, 600 mg; and day 3, 300 mg), TQ alone (days 2 and 3, 450 mg) or coadministration therapy (day 1, CQ 600 mg; day 2, CQ 600 mg + TQ 450 mg; and day 3, CQ 300 mg + TQ 450 mg) in a randomized, double-blind, parallel-group study. Blood samples for pharmacokinetic and pharmacodynamic analyses and safety data, including electrocardiograms, were collected for 56 days. Results The coadministration of CQ + TQ had no effect on TQ AUC0–t, AUC0–∞, Tmax or t1/2. The 90% confidence intervals of CQ + TQ vs. TQ for AUC0–t, AUC0–∞ and t1/2 indicated no drug interaction. On day 2 of CQ + TQ coadministration, TQ Cmax and AUC0–24 increased by 38% (90% confidence interval 1.27, 1.64) and 24% (90% confidence interval 1.04, 1.46), respectively. The pharmacokinetics of CQ and its primary metabolite desethylchloroquine were not affected by TQ. Coadministration had no clinically significant effect on QT intervals and was well tolerated. Conclusions No clinically significant safety or pharmacokinetic/pharmacodynamic interactions were observed with coadministered CQ and TQ in healthy subjects. PMID:23701202

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

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.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Bonesteel, Charles

1998-01-01

This report describes a methodology for analyzing the safety and operational impacts of emerging air traffic technologies. The approach integrates traditional reliability models of the system infrastructure with models that analyze the environment within which the system operates, and models of how the system responds to different scenarios. Products of the analysis include safety measures such as predicted incident rates, predicted accident statistics, and false alarm rates; and operational availability data. The report demonstrates the methodology with an analysis of the operation of the Center-TRACON Automation System at Dallas-Fort Worth International Airport.

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

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

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

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.

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

A Human Reliability Based Usability Evaluation Method for Safety-Critical Software

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

Phillippe Palanque; Regina Bernhaupt; Ronald Boring

2006-04-01

Recent years have seen an increasing use of sophisticated interaction techniques including in the field of safety critical interactive software [8]. The use of such techniques has been required in order to increase the bandwidth between the users and systems and thus to help them deal efficiently with increasingly complex systems. These techniques come from research and innovation done in the field of humancomputer interaction (HCI). A significant effort is currently being undertaken by the HCI community in order to apply and extend current usability evaluation techniques to these new kinds of interaction techniques. However, very little has been donemore » to improve the reliability of software offering these kinds of interaction techniques. Even testing basic graphical user interfaces remains a challenge that has rarely been addressed in the field of software engineering [9]. However, the non reliability of interactive software can jeopardize usability evaluation by showing unexpected or undesired behaviors. The aim of this SIG is to provide a forum for both researchers and practitioners interested in testing interactive software. Our goal is to define a roadmap of activities to cross fertilize usability and reliability testing of these kinds of systems to minimize duplicate efforts in both communities.« less

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...

System safety education focused on flight safety

NASA Technical Reports Server (NTRS)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

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 : ...

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.

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.

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…

2011 Annual Criticality Safety Program Performance Summary

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

Andrea Hoffman

fuel plate bundles to 1085 grams U-235, which is the maximum loading of an ATR fuel element. The overloaded fuel plate bundle contained 1097 grams U-235 and was assembled under an 1100 gram U-235 limit in 1982. In 2003, the limit was reduced to 1085 grams citing a new criticality safety evaluation for ATR fuel elements. The fuel plate bundle inventories were not checked for compliance prior to implementing the reduced limit. A subsequent review of the NMIS inventory did not identify further violations. Requirements Management - The INL Criticality Safety program is organized and well documented. The source requirements for the INL Criticality Safety Program are from 10 CFR 830.204, DOE Order 420.1B, Chapter III, 'Nuclear Criticality Safety,' ANSI/ANS 8-series Industry Standards, and DOE Standards. These source requirements are documented in LRD-18001, 'INL Criticality Safety Program Requirements Manual.' The majority of the criticality safety source requirements are contained in DOE Order 420.1B because it invokes all of the ANSI/ANS 8-Series Standards. DOE Order 420.1B also invokes several DOE Standards, including DOE-STD-3007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities.' DOE Order 420.1B contains requirements for DOE 'Heads of Field Elements' to approve the criticality safety program and specific elements of the program, namely, the qualification of criticality staff and the method for preparing criticality safety evaluations. This was accomplished by the approval of SAR-400, 'INL Standardized Nuclear Safety Basis Manual,' Chapter 6, 'Prevention of Inadvertent Criticality.' Chapter 6 of SAR-400 contains sufficient detail and/or reference to the specific DOE and contractor documents that adequately describe the INL Criticality Safety Program per the elements specified in DOE Order 420.1B. The Safety Evaluation Report for SAR-400 specifically recognizes that the approval of SAR-400 approves the INL

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.

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2010 CFR

2010-07-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2011 CFR

2011-01-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

PubMed

Becker, Lillian C; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

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.

Using the Tritium Plasma Experiment to evaluate ITER PFC safety

NASA Astrophysics Data System (ADS)

Longhurst, Glen R.; Anderl, Robert A.; Bartlit, John R.; Causey, Rion A.; Haines, John R.

The Tritium Plasma Experiment was assembled at Sandia National Laboratories, Livermore to investigate interactions between dense plasmas at low energies and plasma-facing component materials. This apparatus has the unique capability of replicating plasma conditions in a tokamak divertor with particle flux densities of 2 x 10(exp 19) ions/((sq cm)(s)) and a plasma temperature of about 15 eV using a plasma that includes tritium. With the closure of the Tritium Research Laboratory at Livermore, the experiment was moved to the Tritium Systems Test Assembly facility at Los Alamos National Laboratory. An experimental program has been initiated there using the Tritium Plasma Experiment to examine safety issues related to tritium in plasma-facing components, particularly the ITER divertor. Those issues include tritium retention and release characteristics, tritium permeation rates and transient times to coolant streams, surface modification and erosion by the plasma, the effects of thermal loads and cycling, and particulate production. A considerable lack of data exists in these areas for many of the materials, especially beryllium, being considered for use in ITER. Not only will basic material behavior with respect to safety issues in the divertor environment be examined, but innovative techniques for optimizing performance with respect to tritium safety by material modification and process control will be investigated. Supplementary experiments will be carried out at the Idaho National Engineering Laboratory and Sandia National Laboratory to expand and clarify results obtained on the Tritium Plasma Experiment.

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,…

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.

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 :...

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.

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

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.

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

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.

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.

Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

PubMed

Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

2018-03-27

Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships