76 FR 31843 - Safety Zone; Temporary Change to Enforcement Location of Recurring Fireworks Display Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

...-AA00 Safety Zone; Temporary Change to Enforcement Location of Recurring Fireworks Display Event... Guard is temporarily changing the enforcement location of a safety zone for one specific recurring... originated from a barge but will this year originate from a location on land. The safety zone is necessary to...

Identification of the geographical origins of sea cucumber (Apostichopus japonicus) in northern China by using stable isotope ratios and fatty acid profiles.

PubMed

Zhang, Xufeng; Liu, Yu; Li, Ying; Zhao, Xinda

2017-03-01

Geographic traceability is an important issue for food quality and safety control of seafood. In this study,δ 13 C and δ 15 N values, as well as fatty acid (FA) content of 133 samples of A. japonicus from seven sampling points in northern China Sea were determined to evaluate their applicability in the origin traceability of A. japonicus. Principal component analysis (PCA) and discriminant analysis (DA) were applied to different data sets in order to evaluate their performance in terms of classification or predictive ability. δ 13 C and δ 15 N values could effectively discriminate between different origins of A. japonicus. Significant differences in the FA compositions showed the effectiveness of FA composition as a tool for distinguishing between different origins of A. japonicus. The two technologies, combined with multivariate statistical analysis, can be promising methods to discriminate A. japonicus from different geographical areas. Copyright © 2016. Published by Elsevier Ltd.

Development, fabrication and test of a high purity silica heat shield

NASA Technical Reports Server (NTRS)

Rusert, E. L.; Drennan, D. N.; Biggs, M. S.

1978-01-01

A highly reflective hyperpure ( 25 ppm ion impurities) slip cast fused silica heat shield material developed for planetary entry probes was successfully scaled up. Process development activities for slip casting large parts included green strength improvements, casting slip preparation, aggregate casting, strength, reflectance, and subscale fabrication. Successful fabrication of a one-half scale Saturn probe (shape and size) heat shield was accomplished while maintaining the silica high purity and reflectance through the scale-up process. However, stress analysis of this original aggregate slip cast material indicated a small margin of safety (MS. = +4%) using a factor of safety of 1.25. An alternate hyperpure material formulation to increase the strength and toughness for a greater safety margin was evaluated. The alternate material incorporates short hyperpure silica fibers into the casting slip. The best formulation evaluated has a 50% by weight fiber addition resulting in an 80% increase in flexural strength and a 170% increase in toughness over the original aggregate slip cast materials with comparable reflectance.

Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

PubMed Central

Vollmar, Johanna; Bellmann, Maren Christina; Darstein, Felix; Hoppe-Lotichius, Maria; Mittler, Jens; Heise, Michael; Rüttger, Bernd; Weyer, Veronika; Zimmermann, Anca; Lang, Hauke; Galle, Peter R; Zimmermann, Tim

2015-01-01

Background Expensive pharmaceuticals are a major reason for cost intensive health care systems. Long-term immunosuppressive therapy plays a relevant role after organ transplantation. Patents of original drugs have expired and cheaper products are available. Little data are available regarding efficacy and safety of generic immunosuppressive agents. Methods In this prospective study, 25 patients, who were clinically stable for a minimum of 2 years after liver transplantation, were converted from the original formulations of tacrolimus (TAC) and mycophenolate mofetil to the generics Tacpan® (TAP) and Mowel® (MOW). Patients were followed-up for 6 months. Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands. Results In the matched-pair analysis of TAC trough level/dose ratio, no significant difference was found between TAP/MOW and TAC/mycophenolate mofetil groups. No acute rejection occurred in either group. In total, 17 patients reported mild side effects in the TAP/MOW group. The most common side effects were gastrointestinal symptoms. Intra-individual analysis of costs revealed a considerable cost reduction in the TAP/MOW group (in median 25.03%; P<0.001). Conclusion In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients. PMID:26604701

Circuit board accident--organizational dimension hidden by prescribed safety.

PubMed

de Almeida, Ildeberto Muniz; Buoso, Eduardo; do Amaral Dias, Maria Dionísia; Vilela, Rodolfo Andrade Gouveia

2012-01-01

This study analyzes an accident in which two maintenance workers suffered severe burns while replacing a circuit breaker panel in a steel mill, following model of analysis and prevention of accidents (MAPA) developed with the objective of enlarging the perimeter of interventions and contributing to deconstruction of blame attribution practices. The study was based on materials produced by a health service team in an in-depth analysis of the accident. The analysis shows that decisions related to system modernization were taken without considering their implications in maintenance scheduling and creating conflicts of priorities and of interests between production and safety; and also reveals that the lack of a systemic perspective in safety management was its principal failure. To explain the accident as merely non-fulfillment of idealized formal safety rules feeds practices of blame attribution supported by alibi norms and inhibits possible prevention. In contrast, accident analyses undertaken in worker health surveillance services show potential to reveal origins of these events incubated in the history of the system ignored in practices guided by the traditional paradigm.

The determination of elements in herbal teas and medicinal plant formulations and their tisanes.

PubMed

Pohl, Pawel; Dzimitrowicz, Anna; Jedryczko, Dominika; Szymczycha-Madeja, Anna; Welna, Maja; Jamroz, Piotr

2016-10-25

Elemental analysis of herbal teas and their tisanes is aimed at assessing their quality and safety in reference to specific food safety regulations and evaluating their nutritional value. This survey is dedicated to atomic spectroscopy and mass spectrometry element detection methods and sample preparation procedures used in elemental analysis of herbal teas and medicinal plant formulations. Referring to original works from the last 15 years, particular attention has been paid to tisane preparation, sample matrix decomposition, calibration and quality assurance of results in elemental analysis of herbal teas by different atomic and mass spectrometry methods. In addition, possible sources of elements in herbal teas and medicinal plant formulations have been discussed. Copyright © 2016 Elsevier B.V. All rights reserved.

Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis.

PubMed

Neal, Joseph M

2016-01-01

In 2010, the American Society of Regional Anesthesia and Pain Medicine's evidence-based medicine assessment of ultrasound (US)-guided regional anesthesia (UGRA) analyzed the effect of this nerve localization technology on patient safety. That analysis focused on 4 important regional anesthesia complications: peripheral nerve injury, local anesthetic systemic toxicity (LAST), hemidiaphragmatic paresis (HDP), and pneumothorax. In the intervening 5 years, further research has allowed us to refine our original conclusions. This update reviews previous findings and critically evaluates new literature published since late 2009 that compares the patient safety attributes of UGRA with those of traditional nerve localization methods. As with the previous version of this exercise, analysis focused on randomized controlled trials that compared UGRA with an alternative neural localization method and case series of more than 500 patients. The Jadad score was used to grade individual study quality, and conclusions were graded as to strength of evidence. Of those randomized controlled trials identified by our search techniques, 28 compared the incidence of postoperative nerve symptoms, 27 assessed LAST parameters, 7 studied HDP, and 9 reported the incidence of pneumothorax. The current analysis strengthens our original conclusions that US guidance has no significant effect on the incidence of postoperative neurologic symptoms and that UGRA reduces the incidence and intensity of HDP but does so in an unpredictable manner. Conversely, emerging evidence supports the effectiveness of US guidance for reducing LAST across its clinical presentation continuum. The predicted frequency of pneumothorax has grown smaller in tandem with increased experience with US-guided supraclavicular block. This evidence-based review summarizes both the power and the limitations of UGRA as a tool for improving patient safety. Since the original 2010 publication of this analysis, evidence has continued to support the concept that ultrasound (US) guidance does not meaningfully affect the incidence of peripheral nerve injury (PNI) associated with regional anesthesia. Similar confirmatory evidence attests to US guidance reducing the incidence and intensity of hemidiaphragmatic paresis (HDP) but not eliminating it. Literature published since late 2009 reports the effective role of US guidance in reducing the incidence of local anesthetic systemic toxicity and allows calculation of a lower predicted frequency of pneumothorax associated with US-guided supraclavicular blocks.

Time Factor in the Theory of Anthropogenic Risk Prediction in Complex Dynamic Systems

NASA Astrophysics Data System (ADS)

Ostreikovsky, V. A.; Shevchenko, Ye N.; Yurkov, N. K.; Kochegarov, I. I.; Grishko, A. K.

2018-01-01

The article overviews the anthropogenic risk models that take into consideration the development of different factors in time that influence the complex system. Three classes of mathematical models have been analyzed for the use in assessing the anthropogenic risk of complex dynamic systems. These models take into consideration time factor in determining the prospect of safety change of critical systems. The originality of the study is in the analysis of five time postulates in the theory of anthropogenic risk and the safety of highly important objects. It has to be stressed that the given postulates are still rarely used in practical assessment of equipment service life of critically important systems. That is why, the results of study presented in the article can be used in safety engineering and analysis of critically important complex technical systems.

A Figure of Merit: Quantifying the Probability of a Nuclear Reactor Accident.

PubMed

Wellock, Thomas R

In recent decades, probabilistic risk assessment (PRA) has become an essential tool in risk analysis and management in many industries and government agencies. The origins of PRA date to the 1975 publication of the U.S. Nuclear Regulatory Commission's (NRC) Reactor Safety Study led by MIT professor Norman Rasmussen. The "Rasmussen Report" inspired considerable political and scholarly disputes over the motives behind it and the value of its methods and numerical estimates of risk. The Report's controversies have overshadowed the deeper technical origins of risk assessment. Nuclear experts had long sought to express risk in a "figure of merit" to verify the safety of weapons and, later, civilian reactors. By the 1970s, technical advances in PRA gave the methodology the potential to serve political ends, too. The Report, it was hoped, would prove nuclear power's safety to a growing chorus of critics. Subsequent attacks on the Report's methods and numerical estimates damaged the NRC's credibility. PRA's fortunes revived when the 1979 Three Mile Island accident demonstrated PRA's potential for improving the safety of nuclear power and other technical systems. Nevertheless, the Report's controversies endure in mistrust of PRA and its experts.

Rasmussen's legacy: A paradigm change in engineering for safety.

PubMed

Leveson, Nancy G

2017-03-01

This paper describes three applications of Rasmussen's idea to systems engineering practice. The first is the application of the abstraction hierarchy to engineering specifications, particularly requirements specification. The second is the use of Rasmussen's ideas in safety modeling and analysis to create a new, more powerful type of accident causation model that extends traditional models to better handle human-operated, software-intensive, sociotechnical systems. Because this new model has a formal, mathematical foundation built on systems theory (as was Rasmussen's original model), new modeling and analysis tools become possible. The third application is to engineering hazard analysis. Engineers have traditionally either omitted human from consideration in system hazard analysis or have treated them rather superficially, for example, that they behave randomly. Applying Rasmussen's model of human error to a powerful new hazard analysis technique allows human behavior to be included in engineering hazard analysis. Copyright © 2016 Elsevier Ltd. All rights reserved.

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2011 CFR

2011-01-01

... original FSAR or, as appropriate, the last update to the FSAR under this section. The update shall include... for an ISFSI or MRS shall update periodically, as provided in paragraphs (b) and (c) of this section... applicant commitments developed during the license approval and/or hearing process. (b) Each update shall...

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2014 CFR

2014-01-01

... original FSAR or, as appropriate, the last update to the FSAR under this section. The update shall include... for an ISFSI or MRS shall update periodically, as provided in paragraphs (b) and (c) of this section... applicant commitments developed during the license approval and/or hearing process. (b) Each update shall...

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2013 CFR

2013-01-01

... original FSAR or, as appropriate, the last update to the FSAR under this section. The update shall include... for an ISFSI or MRS shall update periodically, as provided in paragraphs (b) and (c) of this section... applicant commitments developed during the license approval and/or hearing process. (b) Each update shall...

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2012 CFR

2012-01-01

... original FSAR or, as appropriate, the last update to the FSAR under this section. The update shall include... for an ISFSI or MRS shall update periodically, as provided in paragraphs (b) and (c) of this section... applicant commitments developed during the license approval and/or hearing process. (b) Each update shall...

A predictive Bayesian approach to the design and analysis of bridging studies.

PubMed

Gould, A Lawrence; Jin, Tian; Zhang, Li Xin; Wang, William W B

2012-09-01

Pharmaceutical product development culminates in confirmatory trials whose evidence for the product's efficacy and safety supports regulatory approval for marketing. Regulatory agencies in countries whose patients were not included in the confirmatory trials often require confirmation of efficacy and safety in their patient populations, which may be accomplished by carrying out bridging studies to establish consistency for local patients of the effects demonstrated by the original trials. This article describes and illustrates an approach for designing and analyzing bridging studies that fully incorporates the information provided by the original trials. The approach determines probability contours or regions of joint predictive intervals for treatment effect and response variability, or endpoints of treatment effect confidence intervals, that are functions of the findings from the original trials, the sample sizes for the bridging studies, and possible deviations from complete consistency with the original trials. The bridging studies are judged consistent with the original trials if their findings fall within the probability contours or regions. Regulatory considerations determine the region definitions and appropriate probability levels. Producer and consumer risks provide a way to assess alternative region and probability choices. [Supplemental materials are available for this article. Go to the Publisher's online edition of the Journal of Biopharmaceutical Statistics for the following free supplemental resource: Appendix 2: R code for Calculations.].

Nozzle Extension for Safety Air Gun

NASA Technical Reports Server (NTRS)

Zumbrun, H. N.; Croom, Delwin R., Jr.

1986-01-01

New nozzle-extension design overcomes problems and incorporates original commercial nozzle, retaining intrinsic safety features. Components include extension tube, length of which made to suit application; adaptor fitting, and nozzle adaptor repinned to maintain original safety features. Design moves conical airstream to end of extension to blow machine chips away from operator. Nozzle-extension modification allows safe and efficient operation of machine tools while maintaining integrity of orginial safety-air-gun design.

Cross-validation of an employee safety climate model in Malaysia.

PubMed

Bahari, Siti Fatimah; Clarke, Sharon

2013-06-01

Whilst substantial research has investigated the nature of safety climate, and its importance as a leading indicator of organisational safety, much of this research has been conducted with Western industrial samples. The current study focuses on the cross-validation of a safety climate model in the non-Western industrial context of Malaysian manufacturing. The first-order factorial validity of Cheyne et al.'s (1998) [Cheyne, A., Cox, S., Oliver, A., Tomas, J.M., 1998. Modelling safety climate in the prediction of levels of safety activity. Work and Stress, 12(3), 255-271] model was tested, using confirmatory factor analysis, in a Malaysian sample. Results showed that the model fit indices were below accepted levels, indicating that the original Cheyne et al. (1998) safety climate model was not supported. An alternative three-factor model was developed using exploratory factor analysis. Although these findings are not consistent with previously reported cross-validation studies, we argue that previous studies have focused on validation across Western samples, and that the current study demonstrates the need to take account of cultural factors in the development of safety climate models intended for use in non-Western contexts. The results have important implications for the transferability of existing safety climate models across cultures (for example, in global organisations) and highlight the need for future research to examine cross-cultural issues in relation to safety climate. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

[The economics of preventing psycho-social risks].

PubMed

Golzio, Luigi

2014-01-01

The aim of the essay is to show the SHIELD methodology for helping the firm management to improve the risks prevention policy. It has been tested in the field with positive results. SHIELD is a cost-benefit analysis application to compare prevention and non-prevention costs, which arise from non-market risks. In the economic perspective safety risks (which include psycho-social risks) are non-market ones as they cause injures to workers during the job. SHIELD (Social Health Indicators for Economic Labour Decisions), is the original method proposed by the author. It is a cost benefits analysis application, which compares safety prevention and non-prevention costs. The comparison allow stop management to evaluate the efficiency of the current safety prevention policy as it helps top management to answer to the policy question: how much to invest in prevention costs? The costs comparison is obtained through the reclassification of safety costs between prevention and non-prevention costs (which are composed by claim damages and penalty sanction costs). SHIELD has been tested empirically in four companies operating in the agribusiness sector during a research financed by the Assessorato all'Agricoltura and INAI Regionale of Emilia Romagna Region. Results are postive: it has been found that the increase of prevention costs causes the cut of non-prevention costs in all companies looked into, as assumed by the high reliability organization theory. SHIELD can be applied to all companies which must have an accounting system by law, no matter of the industry they act. Its application has limited costs as SHIELD doesn't need changes in the accounting system. Safety costs sustained by the company are simply reclassified in prevention and non-prevention costs. The comparison of these two costs categories has been appreciated by top management of companies investigated as a useful support to decide the risks prevention policy for the company. The SHIELD original feature compared with others cost benefit analysis application is to compute registered costs in the company accounting system.

Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy.

PubMed

Trotta, Francesco; Belleudi, Valeria; Fusco, Danilo; Amato, Laura; Mecozzi, Alessandra; Mayer, Flavia; Sansone, Massimo; Davoli, Marina; Addis, Antonio

2017-03-10

To evaluate the benefit/risk profile of epoetin α biosimilar with the erythropoiesis-stimulating agents (ESAs) originators when administered to naïve patients from clinical practice. Population-based observational cohort study. All residents in the Lazio Region, Italy, with chronic kidney disease (CKD) or cancer retrieved from the Electronic Therapeutic Plan (ETP) Register for ESA between 2012 and 2014. Overall, 13 470 incident ESA users were available for the analysis, 8161 in the CKD and 5309 in the oncology setting, respectively. ESAs identified through the ATC B03XA were divided into 3 groups: (1) biosimilars; (2) epoetin α originator and (3) other originators. Patients were exposed to ESAs from the date of activation of the ETP, until the end of a 6-month follow-up period. Effectiveness (all-cause mortality and blood transfusion) and safety (major cardiovascular events, blood dyscrasia). A composite outcome including all-cause mortality, blood transfusion and major cardiovascular events was predefined. HRs of any outcome were estimated through Cox regression. We found no differences between patients on biosimilars or all originators with regard to the risk estimates of all-cause mortality, blood transfusion, major cardiovascular events and blood dyscrasia in the CKD setting. The composite outcome confirmed these results (biosimilars vs epoetin α originators: adjusted HR=1.02, 95% CI 0.78 to 1.33; biosimilars vs other originators: adjusted HR=1.09, 95% CI 0.85 to 1.41). Comparable risk estimates were observed between biosimilars and all originators in the oncology setting. In both settings, our findings are suggestive of no difference between biosimilars and originators on relevant effectiveness and safety outcomes. This study may contribute to settling future drug policy for the health services and provides reassurance on the approval pathway for biosimilars. The oncology setting merits further research, taking into account tumour types, tumour stage and anticancer chemotherapy administered. 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/.

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

NASA Astrophysics Data System (ADS)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

Evaluation of the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers: a systematic review and documentary analysis.

PubMed

McGraw, Caroline; Drennan, Vari M

2015-02-01

To evaluate the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers. The objective was to identify the extent to which these frameworks take account of the setting where the ulcer originated as being the person's home rather than a hospital setting. Pressure ulcers involving full-thickness skin loss are increasingly being regarded as indicators of nursing patient safety failure, requiring investigation using root cause analysis frameworks. Evidence suggests that root cause analysis frameworks developed in hospital settings ignore the unique dimensions of risk in home healthcare settings. A systematic literature review and documentary analysis of frameworks used to investigate community-acquired grade three and four pressure ulcers by home nursing services in England. No published papers were identified for inclusion in the review. Fifteen patient safety investigative frameworks were collected and analysed. Twelve of the retrieved frameworks were intended for the investigation of community-acquired pressure ulcers; seven of which took account of the setting where the ulcer originated as being the patient's home. This study provides evidence to suggest that many of the root cause analysis frameworks used to investigate community-acquired pressure ulcers in England are unsuitable for this purpose. This study provides researchers and practitioners with evidence of the need to develop appropriate home nursing root cause analysis frameworks to investigate community-acquired pressure ulcers. © 2014 John Wiley & Sons Ltd.

Diverging Conclusions from the Same Meta-Analysis in Drug Safety: Source of Data (Primary Versus Secondary) Takes a Toll.

PubMed

Prada-Ramallal, Guillermo; Takkouche, Bahi; Figueiras, Adolfo

2017-04-01

Meta-analyses of observational studies represent an important tool for assessing efficacy and safety in the pharmacoepidemiologic field. The data from the individual studies are either primary (i.e., collected through interviews or self-administered questionnaires) or secondary (i.e., collected from databases that were established for other purposes). So far, the origin of the data (primary vs. secondary) has not been systematically assessed as a source of heterogeneity in pharmacoepidemiologic meta-analyses. The aim was to assess the impact of considering the source of exposure data as a criterion in sensitivity and subgroup analysis on the conclusions of drug safety meta-analyses. We selected meta-analyses published between 2013 and 2015 in which the intake of frequently used over-the-counter medicines was either the main exposure or a concomitant treatment and the outcome had short latency and induction periods. We stratified the results by origin of data (primary vs. secondary) and compared the new results to those presented originally in the meta-analyses. We used four meta-analyses that fulfilled our criteria of inclusion. The results were selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: original estimate odds ratio (OR) = 1.71 [95% confidence interval (CI) 1.44-2.04], OR primary data = 1.19 (95% CI 0.90-1.58), OR secondary data = 1.81 (95% CI 1.50-2.17); proton pump inhibitors and cardiac events: original estimate hazard ratio (HR) = 1.35 (95% CI 1.18-1.54), HR primary data = 1.05 (95% CI 0.87-1.26), HR secondary data = 1.43 (95% CI 1.23-1.66); non-aspirin non-steroidal anti-inflammatory drugs and myocardial infarction: original estimate risk ratio (RR) = 1.08 (95% CI 0.95-1.22), RR primary data = 0.57 (95% CI 0.34-0.96), RR secondary data = 1.15 (95% CI 1.03-1.28); paracetamol during pregnancy and childhood asthma: original estimate OR = 1.32 (95% CI 1.14-1.52), OR primary data = 1.23 (95% CI 1.06-1.42), OR secondary data = 1.53 (95% CI 1.33-1.75). The results after stratification are considerably modified. It is crucial to explore the origin of the data, either primary or secondary, as a source of heterogeneity in pharmacoepidemiologic meta-analyses to avoid misleading conclusions.

An Examination of How Ratings of Airlines are Effected by Different Types of Information: A Mediation Analysis

NASA Astrophysics Data System (ADS)

Ozyurek, Abdullah Selim

Many dynamics directly or indirectly influence the decision-making process. An individual's demographic features, such as gender, country of origin, and emotions are some of the dynamics. In the aviation domain, air passengers purchase their air travel tickets under those dynamics. The purpose of this study was to determine if the airline type, gender of participants, and participants' country of origin had an effect on ratings of an individual's perception of safety and willingness to fly, and which emotions had a mediating effect on this relationship. The study included Lufthansa Airlines and Turkish Airlines from Europe. The affect was the participants' feeling outcomes of presented airline information. The feelings were Ekman and Friesen's (1971) universal emotions that include happiness, surprise, fear, disgust, anger, and sadness. The results of the study indicated that airline type, gender, and country of origin had a statistically significant effect and significant interaction on safety perception and willingness to fly. Also, emotions were found significant mediators on the mediation paths. Particularly happiness, fear, anger, and disgust emotions had a significant influence on participants' decision outcomes.

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.

10 CFR 72.240 - Conditions for spent fuel storage cask reapproval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... has been determined by the NRC. The application must be accompanied by a safety analysis report (SAR). The new SAR may reference the SAR originally submitted for the approved spent fuel storage cask design. (c) The design of a spent fuel storage cask will be reapproved if the conditions in § 72.238 are met...

An analysis of electronic health record-related patient safety concerns

PubMed Central

Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

2014-01-01

Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them. PMID:24951796

49 CFR 592.2 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OF TRANSPORTATION (CONTINUED) REGISTERED IMPORTERS OF VEHICLES NOT ORIGINALLY MANUFACTURED TO CONFORM TO THE FEDERAL MOTOR VEHICLE SAFETY STANDARDS § 592.2 Purpose. The purpose of this part is to provide... motor vehicles not originally manufactured to conform to all applicable Federal motor vehicle safety...

Non-destructive geographical traceability of sea cucumber (Apostichopus japonicus) using near infrared spectroscopy combined with chemometric methods

PubMed Central

Cai, Rui; Wang, Shisheng; Tang, Bo; Li, Yueqing; Zhao, Weijie

2018-01-01

Sea cucumber is the major tonic seafood worldwide, and geographical origin traceability is an important part of its quality and safety control. In this work, a non-destructive method for origin traceability of sea cucumber (Apostichopus japonicus) from northern China Sea and East China Sea using near infrared spectroscopy (NIRS) and multivariate analysis methods was proposed. Total fat contents of 189 fresh sea cucumber samples were determined and partial least-squares (PLS) regression was used to establish the quantitative NIRS model. The ordered predictor selection algorithm was performed to select feasible wavelength regions for the construction of PLS and identification models. The identification model was developed by principal component analysis combined with Mahalanobis distance and scaling to the first range algorithms. In the test set of the optimum PLS models, the root mean square error of prediction was 0.45, and correlation coefficient was 0.90. The correct classification rates of 100% were obtained in both identification calibration model and test model. The overall results indicated that NIRS method combined with chemometric analysis was a suitable tool for origin traceability and identification of fresh sea cucumber samples from nine origins in China. PMID:29410795

Non-destructive geographical traceability of sea cucumber (Apostichopus japonicus) using near infrared spectroscopy combined with chemometric methods.

PubMed

Guo, Xiuhan; Cai, Rui; Wang, Shisheng; Tang, Bo; Li, Yueqing; Zhao, Weijie

2018-01-01

Sea cucumber is the major tonic seafood worldwide, and geographical origin traceability is an important part of its quality and safety control. In this work, a non-destructive method for origin traceability of sea cucumber ( Apostichopus japonicus ) from northern China Sea and East China Sea using near infrared spectroscopy (NIRS) and multivariate analysis methods was proposed. Total fat contents of 189 fresh sea cucumber samples were determined and partial least-squares (PLS) regression was used to establish the quantitative NIRS model. The ordered predictor selection algorithm was performed to select feasible wavelength regions for the construction of PLS and identification models. The identification model was developed by principal component analysis combined with Mahalanobis distance and scaling to the first range algorithms. In the test set of the optimum PLS models, the root mean square error of prediction was 0.45, and correlation coefficient was 0.90. The correct classification rates of 100% were obtained in both identification calibration model and test model. The overall results indicated that NIRS method combined with chemometric analysis was a suitable tool for origin traceability and identification of fresh sea cucumber samples from nine origins in China.

Fuzzy Bayesian Network-Bow-Tie Analysis of Gas Leakage during Biomass Gasification

PubMed Central

Yan, Fang; Xu, Kaili; Yao, Xiwen; Li, Yang

2016-01-01

Biomass gasification technology has been rapidly developed recently. But fire and poisoning accidents caused by gas leakage restrict the development and promotion of biomass gasification. Therefore, probabilistic safety assessment (PSA) is necessary for biomass gasification system. Subsequently, Bayesian network-bow-tie (BN-bow-tie) analysis was proposed by mapping bow-tie analysis into Bayesian network (BN). Causes of gas leakage and the accidents triggered by gas leakage can be obtained by bow-tie analysis, and BN was used to confirm the critical nodes of accidents by introducing corresponding three importance measures. Meanwhile, certain occurrence probability of failure was needed in PSA. In view of the insufficient failure data of biomass gasification, the occurrence probability of failure which cannot be obtained from standard reliability data sources was confirmed by fuzzy methods based on expert judgment. An improved approach considered expert weighting to aggregate fuzzy numbers included triangular and trapezoidal numbers was proposed, and the occurrence probability of failure was obtained. Finally, safety measures were indicated based on the obtained critical nodes. The theoretical occurrence probabilities in one year of gas leakage and the accidents caused by it were reduced to 1/10.3 of the original values by these safety measures. PMID:27463975

The relationship between patient safety climate and occupational safety climate in healthcare - A multi-level investigation.

PubMed

Pousette, Anders; Larsman, Pernilla; Eklöf, Mats; Törner, Marianne

2017-06-01

Patient safety climate/culture is attracting increasing research interest, but there is little research on its relation with organizational climates regarding other target domains. The aim of this study was to investigate the relationship between patient safety climate and occupational safety climate in healthcare. The climates were assessed using two questionnaires: Hospital Survey on Patient Safety Culture and Nordic Occupational Safety Climate Questionnaire. The final sample consisted of 1154 nurses, 886 assistant nurses, and 324 physicians, organized in 150 work units, within hospitals (117units), primary healthcare (5units) and elderly care (28units) in western Sweden, which represented 56% of the original sample contacted. Within each type of safety climate, two global dimensions were confirmed in a higher order factor analysis; one with an external focus relative the own unit, and one with an internal focus. Two methods were used to estimate the covariation between the global climate dimensions, in order to minimize the influence of bias from common method variance. First multilevel analysis was used for partitioning variances and covariances in a within unit part (individual level) and a between unit part (unit level). Second, a split sample technique was used to calculate unit level correlations based on aggregated observations from different respondents. Both methods showed associations similar in strength between the patient safety climate and the occupational safety climate domains. The results indicated that patient safety climate and occupational safety climate are strongly positively related at the unit level, and that the same organizational processes may be important for the development of both types of organizational climate. Safety improvement interventions should not be separated in different organizational processes, but be planned so that both patient safety and staff safety are considered concomitantly. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Experimental Fuels Facility Re-categorization Based on Facility Segmentation

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

Reiss, Troy P.; Andrus, Jason

The Experimental Fuels Facility (EFF) (MFC-794) at the Materials and Fuels Complex (MFC) located on the Idaho National Laboratory (INL) Site was originally constructed to provide controlled-access, indoor storage for radiological contaminated equipment. Use of the facility was expanded to provide a controlled environment for repairing contaminated equipment and characterizing, repackaging, and treating waste. The EFF facility is also used for research and development services, including fuel fabrication. EFF was originally categorized as a LTHC-3 radiological facility based on facility operations and facility radiological inventories. Newly planned program activities identified the need to receive quantities of fissionable materials in excessmore » of the single parameter subcritical limit in ANSI/ANS-8.1, “Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors” (identified as “criticality list” quantities in DOE-STD-1027-92, “Hazard Categorization and Accident Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,” Attachment 1, Table A.1). Since the proposed inventory of fissionable materials inside EFF may be greater than the single parameter sub-critical limit of 700 g of U-235 equivalent, the initial re-categorization is Hazard Category (HC) 2 based upon a potential criticality hazard. This paper details the facility hazard categorization performed for the EFF. The categorization was necessary to determine (a) the need for further safety analysis in accordance with LWP-10802, “INL Facility Categorization,” and (b) compliance with 10 Code of Federal Regulations (CFR) 830, Subpart B, “Safety Basis Requirements.” Based on the segmentation argument presented in this paper, the final hazard categorization for the facility is LTHC-3. Department of Energy Idaho (DOE-ID) approval of the final hazard categorization determined by this hazard assessment document (HAD) was required per the DOE-ID Supplemental Guidance for DOE-STD-1027-92 based on the proposed downgrade of the initial facility categorization of Hazard Category 2.« less

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

Work Disability Among Native-born and Foreign-born Americans: On Origins, Health, and Social Safety Nets.

PubMed

Engelman, Michal; Kestenbaum, Bert M; Zuelsdorff, Megan L; Mehta, Neil K; Lauderdale, Diane S

2017-12-01

Public debates about both immigration policy and social safety net programs are increasingly contentious. However, little research has explored differences in health within America's diverse population of foreign-born workers, and the effect of these workers on public benefit programs is not well understood. We investigate differences in work disability by nativity and origins and describe the mix of health problems associated with receiving Social Security Disability Insurance benefits. Our analysis draws on two large national data sources-the American Community Survey and comprehensive administrative records from the Social Security Administration-to determine the prevalence and incidence of work disability between 2001 and 2010. In sharp contrast to prior research, we find that foreign-born adults are substantially less likely than native-born Americans to report work disability, to be insured for work disability benefits, and to apply for those benefits. Overall and across origins, the foreign-born also have a lower incidence of disability benefit award. Persons from Africa, Northern Europe, Canada, and parts of Asia have the lowest work disability benefit prevalence rates among the foreign-born; persons from Southern Europe, Western Europe, the former Soviet Union, and the Caribbean have the highest rates.

2010 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2010-07-01

The objective of this study was to establish 2010 safety belt and child safety seat usage rates in Kentucky. The 2010 survey continues to document the results after enactment of the original "second enforcement" statewide mandatory safety belt law in...

2009 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2009-07-01

The objective of this study was to establish 2009 safety belt and child safety seat usage rates in Kentucky. The 2009 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

2002 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2002-07-01

The objective of this study was to establish 2002 safety belt and child safety seat usage rates in Kentucky. The 2002 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

2001 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2001-08-01

The objective of this study was to establish 2001 safety belt and child safety seat usage rates in Kentucky. The 2001 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

Experimenting the hospital survey on patient safety culture in prevention facilities in Italy: psychometric properties.

PubMed

Tereanu, Carmen; Smith, Scott A; Sampietro, Giuseppe; Sarnataro, Francesco; Mazzoleni, Giuliana; Pesenti, Bruno; Sala, Luca C; Cecchetti, Roberto; Arvati, Massimo; Brioschi, Dania; Viscardi, Michela; Prati, Chiara; Barbaglio, Giorgio G

2017-04-01

The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (HSOPS) was designed to assess staff views on patient safety culture in hospital. This study examines psychometrics of the Italian translation of the HSOPS for use in territorial prevention facilities. After minimal adjustments and pre-test of the Italian version, a qualitative cross-sectional study was carried out. Departments of Prevention (DPs) of four Local Health Authorities in Northern Italy. Census of medical and non-medical staff (n. 479). Web-based self-administered questionnaire. Descriptive statistics, internal reliability, Confirmatory Factor Analysis (CFA) and intercorrelations among survey composites. Initial CFA of the 12 patient safety culture composites and 42 items included in the original version of the questionnaire revealed that two dimensions (Staffing and Overall Perception of Patient Safety) and nine individual items did not perform well among Italian territorial Prevention staff. After dropping those composites and items, psychometric properties were acceptable (comparative fit index = 0.94; root mean square error of approximation = 0.04; standardized root mean square residual = 0.04). Internal consistency for each remaining composite met or exceeded the criterion 0.70. Intercorrelations were all statistically significant. Psychometric analyses provided overall support for 10 of the 12 initial patient safety culture composites and 33 of the 42 initial composite items. Although the original instrument was intended for US Hospitals, the Italian translation of the HSOPS adapted for use in territorial prevention facilities performed adequately in Italian DPs. © 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

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

PubMed

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

2016-05-05

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

Proteomics in food: Quality, safety, microbes, and allergens.

PubMed

Piras, Cristian; Roncada, Paola; Rodrigues, Pedro M; Bonizzi, Luigi; Soggiu, Alessio

2016-03-01

Food safety and quality and their associated risks pose a major concern worldwide regarding not only the relative economical losses but also the potential danger to consumer's health. Customer's confidence in the integrity of the food supply could be hampered by inappropriate food safety measures. A lack of measures and reliable assays to evaluate and maintain a good control of food characteristics may affect the food industry economy and shatter consumer confidence. It is imperative to create and to establish fast and reliable analytical methods that allow a good and rapid analysis of food products during the whole food chain. Proteomics can represent a powerful tool to address this issue, due to its proven excellent quantitative and qualitative drawbacks in protein analysis. This review illustrates the applications of proteomics in the past few years in food science focusing on food of animal origin with some brief hints on other types. Aim of this review is to highlight the importance of this science as a valuable tool to assess food quality and safety. Emphasis is also posed in food processing, allergies, and possible contaminants like bacteria, fungi, and other pathogens. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

49 CFR 244.17 - Procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...

49 CFR 244.17 - Procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...

49 CFR 244.17 - Procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...

An overview of microbial food safety programs in beef, pork, and poultry from farm to processing in Canada.

PubMed

Rajić, Andrijana; Waddell, Lisa A; Sargeant, Jan M; Read, Susan; Farber, Jeff; Firth, Martin J; Chambers, Albert

2007-05-01

Canada's vision for the agri-food industry in the 21st century is the establishment of a national food safety system employing hazard analysis and critical control point (HACCP) principles and microbiological verification tools, with traceability throughout the gate-to-plate continuum. Voluntary on-farm food safety (OFFS) programs, based in part on HACCP principles, provide producers with guidelines for good production practices focused on general hygiene and biosecurity. OFFS programs in beef cattle, swine, and poultry are currently being evaluated through a national recognition program of the Canadian Food Inspection Agency. Mandatory HACCP programs in federal meat facilities include microbial testing for generic Escherichia coli to verify effectiveness of the processor's dressing procedure, specific testing of ground meat for E. coli O157:H7, with zero tolerance for this organism in the tested lot, and Salmonella testing of raw products. Health Canada's policy on Listeria monocytogenes divides ready-to-eat products into three risk categories, with products previously implicated as the source of an outbreak receiving the highest priority for inspection and compliance. A national mandatory identification program to track livestock from the herd of origin to carcass inspection has been established. Can-Trace, a data standard for all food commodities, has been designed to facilitate tracking foods from the point of origin to the consumer. Although much work has already been done, a coherent national food safety strategy and concerted efforts by all stakeholders are needed to realize this vision. Cooperation of many government agencies with shared responsibility for food safety and public health will be essential.

Addendum to NuMI shielding assessment

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

Vaziri, Kamran; /Fermilab

2007-10-01

The original safety assessment and the Safety Envelope for the NuMI beam line corresponds to 400 kW of beam power. The Main Injector is currently capable of and approved for producing 500 kW of beam power2. However, operation of the NuMI beam line at 400 kW of power brings up the possibility of an occasional excursion above 400 kW due to better than usual tuning in one of the machines upstream of the NuMI beam line. An excursion above the DOE approved Safety Envelope will constitute a safety violation. The purpose of this addendum is to evaluate the radiological issuesmore » and modifications required to operate the NuMI beam line at 500 kW. This upgrade will allow 400 kW operations with a reasonable safety margin. Configuration of the NuMI beam line, boundaries, safety system and the methodologies used for the calculations are as described in the original NuMI SAD. While most of the calculations presented in the original shielding assessment were based on Monte Carlo simulations, which were based on the design geometries, most of the results presented in this addendum are based on the measurements conducted by the AD ES&H radiation safety group.« less

Targeting safety improvements through identification of incident origination and detection in a near-miss incident learning system.

PubMed

Novak, Avrey; Nyflot, Matthew J; Ermoian, Ralph P; Jordan, Loucille E; Sponseller, Patricia A; Kane, Gabrielle M; Ford, Eric C; Zeng, Jing

2016-05-01

Radiation treatment planning involves a complex workflow that has multiple potential points of vulnerability. This study utilizes an incident reporting system to identify the origination and detection points of near-miss errors, in order to guide their departmental safety improvement efforts. Previous studies have examined where errors arise, but not where they are detected or applied a near-miss risk index (NMRI) to gauge severity. From 3/2012 to 3/2014, 1897 incidents were analyzed from a departmental incident learning system. All incidents were prospectively reviewed weekly by a multidisciplinary team and assigned a NMRI score ranging from 0 to 4 reflecting potential harm to the patient (no potential harm to potential critical harm). Incidents were classified by point of incident origination and detection based on a 103-step workflow. The individual steps were divided among nine broad workflow categories (patient assessment, imaging for radiation therapy (RT) planning, treatment planning, pretreatment plan review, treatment delivery, on-treatment quality management, post-treatment completion, equipment/software quality management, and other). The average NMRI scores of incidents originating or detected within each broad workflow area were calculated. Additionally, out of 103 individual process steps, 35 were classified as safety barriers, the process steps whose primary function is to catch errors. The safety barriers which most frequently detected incidents were identified and analyzed. Finally, the distance between event origination and detection was explored by grouping events by the number of broad workflow area events passed through before detection, and average NMRI scores were compared. Near-miss incidents most commonly originated within treatment planning (33%). However, the incidents with the highest average NMRI scores originated during imaging for RT planning (NMRI = 2.0, average NMRI of all events = 1.5), specifically during the documentation of patient positioning and localization of the patient. Incidents were most frequently detected during treatment delivery (30%), and incidents identified at this point also had higher severity scores than other workflow areas (NMRI = 1.6). Incidents identified during on-treatment quality management were also more severe (NMRI = 1.7), and the specific process steps of reviewing portal and CBCT images tended to catch highest-severity incidents. On average, safety barriers caught 46% of all incidents, most frequently at physics chart review, therapist's chart check, and the review of portal images; however, most of the incidents that pass through a particular safety barrier are not designed to be capable of being captured at that barrier. Incident learning systems can be used to assess the most common points of error origination and detection in radiation oncology. This can help tailor safety improvement efforts and target the highest impact portions of the workflow. The most severe near-miss events tend to originate during simulation, with the most severe near-miss events detected at the time of patient treatment. Safety barriers can be improved to allow earlier detection of near-miss events.

System Guidelines for EMC Safety-Critical Circuits: Design, Selection, and Margin Demonstration

NASA Technical Reports Server (NTRS)

Lawton, R. M.

1996-01-01

Demonstration of required safety margins on critical electrical/electronic circuits in large complex systems has become an implementation and cost problem. These margins are the difference between the activation level of the circuit and the electrical noise on the circuit in the actual operating environment. This document discusses the origin of the requirement and gives a detailed process flow for the identification of the system electromagnetic compatibility (EMC) critical circuit list. The process flow discusses the roles of engineering disciplines such as systems engineering, safety, and EMC. Design and analysis guidelines are provided to assist the designer in assuring the system design has a high probability of meeting the margin requirements. Examples of approaches used on actual programs (Skylab and Space Shuttle Solid Rocket Booster) are provided to show how variations of the approach can be used successfully.

Geographic authentication of Asian rice (Oryza sativa L.) using multi-elemental and stable isotopic data combined with multivariate analysis.

PubMed

Chung, Ill-Min; Kim, Jae-Kwang; Lee, Kyoung-Jin; Park, Sung-Kyu; Lee, Ji-Hee; Son, Na-Young; Jin, Yong-Ik; Kim, Seung-Hyun

2018-02-01

Rice (Oryza sativa L.) is the world's third largest food crop after wheat and corn. Geographic authentication of rice has recently emerged asan important issue for enhancing human health via food safety and quality assurance. Here, we aimed to discriminate rice of six Asian countries through geographic authentication using combinations of elemental/isotopic composition analysis and chemometric techniques. Principal components analysis could distinguish samples cultivated from most countries, except for those cultivated in the Philippines and Japan. Furthermore, orthogonal projection to latent structure-discriminant analysis provided clear discrimination between rice cultivated in Korea and other countries. The major common variables responsible for differentiation in these models were δ 34 S, Mn, and Mg. Our findings contribute to understanding the variations of elemental and isotopic compositions in rice depending on geographic origins, and offer valuable insight into the control of fraudulent labeling regarding the geographic origins of rice traded among Asian countries. Copyright © 2017 Elsevier Ltd. All rights reserved.

Human factors paradigm and customer care perceptions.

PubMed

Clarke, Colin; Eales-Reynolds, Lesley-Jane

2015-01-01

The purpose of this paper is to examine if customer care (CC) can be directly linked to patient safety through a human factors (HF) framework. Data from an online questionnaire, completed by a convenience healthcare worker sample (n=373), was interrogated using thematic analysis within Vincent et al.'s (1998) HF theoretical framework. This proposes seven areas affecting patient safety: institutional context, organisation and management, work environment, team factors, individual, task and patient. Analysis identified responses addressing all framework areas. Responses (597) principally focused on work environment 40.7 per cent (n=243), organisation and management 28.8 per cent (n=172). Nevertheless, reference to other framework areas were clearly visible within the data: teams 10.2 per cent (n=61), individual 6.7 per cent (n=40), patients 6.0 per cent (n=36), tasks 4.2 per cent (n=24) and institution 3.5 per cent (n=21). Findings demonstrate congruence between CC perceptions and patient safety within a HF framework. The questionnaire requested participants to identify barriers to rather than CC enablers. Although this was at a single site complex organisation, it was similar to those throughout the NHS and other international health systems. CC can be viewed as consonant with patient safety rather than the potentially dangerous consumerisation stance, which could ultimately compromise patient safety. This work provides an original perspective on the link between CC and patient safety and has the potential to re-focus healthcare perceptions.

Update on biosimilars in inflammatory bowel disease: Position and recommendations in Mexico.

PubMed

Mayoral-Zavala, A; Esquivel-Aguilar, A; Del Real-Calzada, C M; Gutiérrez-Grobe, Y; Ramos-García, J; Rocha-Ramírez, J L; Rojas-Illanes, M F; Rubio-Martínez, B; Sánchez-Chávez, X; Yamamoto-Furusho, J K

2018-04-20

The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons. The present review is the first critical analysis by different specialists in the area of gastroenterology on the use of biosimilars in inflammatory bowel disease, the evidence on interchangeability, the extrapolation of indications, efficacy, safety, immunogenicity, and the clinical impact of the Mexican health regulations. The aim of our review was to make the positioning and recommendations of these new therapeutic options known, given that they have a potential cost-benefit for both patients and healthcare institutions. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Contaminants in Foods of Animal Origin in Cameroon: A One Health Vision for Risk Management "from Farm to Fork".

PubMed

Pouokam, Guy B; Foudjo, B U Saha; Samuel, Chi; Yamgai, Philomina Fankam; Silapeux, A Kamda; Sando, Joel Taguemkam; Atonde, G Fankam; Frazzoli, Chiara

2017-01-01

Foods of animal origin represent an important share in the diet of Cameroonian populations. Cameroon is known to be a food basket in the west and central Africa sub-region, and an important supplier of foods on the international markets. In the meantime, food importation is continuously increasing to meet the high demand of a more westernized segment of the population. Cereals, fish, sea products, eggs, honey, shrimps, chicken, and feed ingredients are important share in the international trade of agricultural products. Few controls are made on the quality and safety of these products. Certain safety standards do exist but are still yet to be enforced. Inspections done so far by regulatory authorities are partial and do not cover important hazards that require laboratory analysis. The increasing awareness of population, the burden of new types of disease, as well as the recurrence of food scandals have recently launched a scientific and population debate on the contribution of foods items, especially those of animal origin, to the toxic exposure of food producing animals and humans. This paper critically reviews the occurrence of toxicants in most consumed foods of animal origin in Cameroon. This study included the most consumed food of animal origin, identified during the national household budget survey and contributing to 8.1% of the total diet of an individual. Data evaluated suggest an important contamination by toxic metals, mycotoxins, veterinary drugs' residues, and pesticides. The current national legal framework is briefly analyzed to explore possible intervention measures in the frame of the One Health approach.

Contaminants in Foods of Animal Origin in Cameroon: A One Health Vision for Risk Management “from Farm to Fork”

PubMed Central

Pouokam, Guy B.; Foudjo, B. U. Saha; Samuel, Chi; Yamgai, Philomina Fankam; Silapeux, A. Kamda; Sando, Joel Taguemkam; Atonde, G. Fankam; Frazzoli, Chiara

2017-01-01

Foods of animal origin represent an important share in the diet of Cameroonian populations. Cameroon is known to be a food basket in the west and central Africa sub-region, and an important supplier of foods on the international markets. In the meantime, food importation is continuously increasing to meet the high demand of a more westernized segment of the population. Cereals, fish, sea products, eggs, honey, shrimps, chicken, and feed ingredients are important share in the international trade of agricultural products. Few controls are made on the quality and safety of these products. Certain safety standards do exist but are still yet to be enforced. Inspections done so far by regulatory authorities are partial and do not cover important hazards that require laboratory analysis. The increasing awareness of population, the burden of new types of disease, as well as the recurrence of food scandals have recently launched a scientific and population debate on the contribution of foods items, especially those of animal origin, to the toxic exposure of food producing animals and humans. This paper critically reviews the occurrence of toxicants in most consumed foods of animal origin in Cameroon. This study included the most consumed food of animal origin, identified during the national household budget survey and contributing to 8.1% of the total diet of an individual. Data evaluated suggest an important contamination by toxic metals, mycotoxins, veterinary drugs’ residues, and pesticides. The current national legal framework is briefly analyzed to explore possible intervention measures in the frame of the One Health approach. PMID:28929096

Sociotechnical approaches to workplace safety: Research needs and opportunities.

PubMed

Robertson, Michelle M; Hettinger, Lawrence J; Waterson, Patrick E; Noy, Y Ian; Dainoff, Marvin J; Leveson, Nancy G; Carayon, Pascale; Courtney, Theodore K

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety.

76 FR 34862 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement of a safety zone established on the... original safety zone was established on January 28, 2011. The safety zone is necessary to help ensure the...

Patient safety in surgical environments: cross-countries comparison of psychometric properties and results of the Norwegian version of the Hospital Survey on Patient Safety.

PubMed

Haugen, Arvid S; Søfteland, Eirik; Eide, Geir E; Nortvedt, Monica W; Aase, Karina; Harthug, Stig

2010-09-22

How hospital health care personnel perceive safety climate has been assessed in several countries by using the Hospital Survey on Patient Safety (HSOPS). Few studies have examined safety climate factors in surgical departments per se. This study examined the psychometric properties of a Norwegian translation of the HSOPS and also compared safety climate factors from a surgical setting to hospitals in the United States, the Netherlands and Norway. This survey included 575 surgical personnel in Haukeland University Hospital in Bergen, an 1100-bed tertiary hospital in western Norway: surgeons, operating theatre nurses, anaesthesiologists, nurse anaesthetists and ancillary personnel. Of these, 358 returned the HSOPS, resulting in a 62% response rate. We used factor analysis to examine the applicability of the HSOPS factor structure in operating theatre settings. We also performed psychometric analysis for internal consistency and construct validity. In addition, we compared the percent of average positive responds of the patient safety climate factors with results of the US HSOPS 2010 comparative data base report. The professions differed in their perception of patient safety climate, with anaesthesia personnel having the highest mean scores. Factor analysis using the original 12-factor model of the HSOPS resulted in low reliability scores (r = 0.6) for two factors: "adequate staffing" and "organizational learning and continuous improvement". For the remaining factors, reliability was ≥ 0.7. Reliability scores improved to r = 0.8 by combining the factors "organizational learning and continuous improvement" and "feedback and communication about error" into one six-item factor, supporting an 11-factor model. The inter-item correlations were found satisfactory. The psychometric properties of the questionnaire need further investigations to be regarded as reliable in surgical environments. The operating theatre personnel perceived their hospital's patient safety climate far more negatively than the health care personnel in hospitals in the United States and with perceptions more comparable to those of health care personnel in hospitals in the Netherlands. In fact, the surgical personnel in our hospital may perceive that patient safety climate is less focused in our hospital, at least compared with the results from hospitals in the United States.

Assessment of the structural validity of the domestic violence healthcare providers’ survey questionnaire using a Nigerian sample

PubMed Central

John, Ime A; Lawoko, Stephen

2010-01-01

Abstract: Background: There has been increased advocacy to involve healthcare providers in the prevention of intimate partner violence (IPV) through screening for it in healthcare. Yet, only one in ten providers screen for IPV, suggesting barriers. Understanding the readiness of healthcare providers to screen for IPV is therefore paramount. The Domestic Violence Healthcare Provider Survey Scales (DVHPSS) is a previously validated, comprehensive scale to study readiness of healthcare providers to screen for IPV. However, an understanding of its usefulness in the Sub-Saharan African context remains elusive. The current study undertook to examine the structural validity of the DVHPSS in Nigeria. Methods: Exploratory factor analysis and Cronbach's Alpha were run to reveal the factorial structure and reliability of the instrument/subscales respectively. Established thresholds were used to determine significant factor loadings and alphas coefficient. Results: A six factor model emerged, with 2 factors similar to the original scale, another two differing slightly and a further two factors resulting from a splitting up of the original combination of victim/provider safety to having distinct victim and provider safety subscales. Conclusions: With slight modifications, the DVHPSS can be use to study IPV screening among Nigerian healthcare professionals. Introducing screening protocols could promote better understanding of crucial questions that were lost in the analysis. PMID:21483202

Team Psychological Safety and Team Learning: A Cultural Perspective

ERIC Educational Resources Information Center

Cauwelier, Peter; Ribière, Vincent M.; Bennet, Alex

2016-01-01

Purpose: The purpose of this paper was to evaluate if the concept of team psychological safety, a key driver of team learning and originally studied in the West, can be applied in teams from different national cultures. The model originally validated for teams in the West is applied to teams in Thailand to evaluate its validity, and the views team…

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant issues the original SOLAS...

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

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

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

PubMed

McKinnon, Ross A; Cook, Matthew; Liauw, Winston; Marabani, Mona; Marschner, Ian C; Packer, Nicolle H; Prins, Johannes B

2018-02-01

The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies. The systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups. There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.

Analysis of reactor trips originating in balance of plant systems

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

Stetson, F.T.; Gallagher, D.W.; Le, P.T.

1990-09-01

This report documents the results of an analysis of balance-of-plant (BOP) related reactor trips at commercial US nuclear power plants of a 5-year period, from January 1, 1984, through December 31, 1988. The study was performed for the Plant Systems Branch, Office of Nuclear Reactor Regulation, US Nuclear Regulatory Commission. The objectives of the study were: to improve the level of understanding of BOP-related challenges to safety systems by identifying and categorizing such events; to prepare a computerized data base of BOP-related reactor trip events and use the data base to identify trends and patterns in the population of thesemore » events; to investigate the risk implications of BOP events that challenge safety systems; and to provide recommendations on how to address BOP-related concerns in regulatory context. 18 refs., 2 figs., 27 tabs.« less

The SCALE Verified, Archived Library of Inputs and Data - VALID

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

Marshall, William BJ J; Rearden, Bradley T

The Verified, Archived Library of Inputs and Data (VALID) at ORNL contains high quality, independently reviewed models and results that improve confidence in analysis. VALID is developed and maintained according to a procedure of the SCALE quality assurance (QA) plan. This paper reviews the origins of the procedure and its intended purpose, the philosophy of the procedure, some highlights of its implementation, and the future of the procedure and associated VALID library. The original focus of the procedure was the generation of high-quality models that could be archived at ORNL and applied to many studies. The review process associated withmore » model generation minimized the chances of errors in these archived models. Subsequently, the scope of the library and procedure was expanded to provide high quality, reviewed sensitivity data files for deployment through the International Handbook of Evaluated Criticality Safety Benchmark Experiments (IHECSBE). Sensitivity data files for approximately 400 such models are currently available. The VALID procedure and library continue fulfilling these multiple roles. The VALID procedure is based on the quality assurance principles of ISO 9001 and nuclear safety analysis. Some of these key concepts include: independent generation and review of information, generation and review by qualified individuals, use of appropriate references for design data and documentation, and retrievability of the models, results, and documentation associated with entries in the library. Some highlights of the detailed procedure are discussed to provide background on its implementation and to indicate limitations of data extracted from VALID for use by the broader community. Specifically, external users of data generated within VALID must take responsibility for ensuring that the files are used within the QA framework of their organization and that use is appropriate. The future plans for the VALID library include expansion to include additional experiments from the IHECSBE, to include experiments from areas beyond criticality safety, such as reactor physics and shielding, and to include application models. In the future, external SCALE users may also obtain qualification under the VALID procedure and be involved in expanding the library. The VALID library provides a pathway for the criticality safety community to leverage modeling and analysis expertise at ORNL.« less

EMS providers' perceptions of safety climate and adherence to safe work practices.

PubMed

Eliseo, Laura J; Murray, Kate A; White, Laura F; Dyer, Sophia; Mitchell, Patricia A; Fernandez, William G

2012-01-01

Occupational injuries are an important source of morbidity for emergency medical services (EMS) providers. Previous work has shown that employee perceptions of an organization's commitment to safety (i.e., safety climate) correlate with adherence to safe practices. To assess the association between perceived safety climate and compliance with safety procedures in an urban EMS system with >100,000 calls/year. EMS providers were issued a self-administered survey that included questions on demographics, years of experience, perceived safety climate, and adherence to safety procedures. Safety climate was assessed with a 20-item validated instrument. Adherence to safety procedures was assessed with a nine-item list of safety behaviors. Strict adherence to safety procedures was defined as endorsing "agree" or "strongly agree" on 80% of items. The effect of safety climate on compliance with safe practices was estimated using multiple logistic regression. One hundred ninety-six of 221 providers (89%) completed surveys; 74% were male; the median age was 36-40 years; and the median amount of experience was 8 years. One hundred twenty-seven of 196 respondents (65%) reported strict adherence to safe work practice. Factor analysis confirmed the original six-factor grouping of questions; frequent safety-related feedback/training was significantly associated with safe practices (odds ratio [OR] = 2.14, 95% confidence interval [CI] = 1.01-4.51). EMS workers perceiving a high degree of perceived safety climate was associated with twofold greater odds of self-reported level of strict adherence to safe work practices. Frequent safety-related feedback/training was the one dimension of safety climate that had the strongest association with adherence to safe workplace behaviors.

31 CFR 538.519 - Aircraft and maritime safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... technology to insure the safety of civil aviation and safe operation of U.S.-origin commercial passenger...

76 FR 73511 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement period of a safety zone established on... sight at approximate river mile 117. The original safety zone was established on January 28, 2011. The...

Evaluating the effectiveness of the Safety Investment Program (SIP) policies for Oregon.

DOT National Transportation Integrated Search

2009-10-01

The Safety Investment Program (SIP) was originally called the Statewide Transportation Improvement Program - : Safety Investment Program (STIP-SIP). The concept of the program was first discussed in October 1997 and the : program was adopted by the O...

Bricks-and-mortar and patient safety culture.

PubMed

Brandis, Susan; Schleimer, Stephanie; Rice, John

2017-06-19

Purpose Building a new hospital requires a major investment in capital infrastructure. The purpose of this paper is to investigate the impact of bricks-and-mortar on patient safety culture before and two years after the move of a large tertiary hospital to a greenfield site. The difference in patient safety perceptions between clinical and non-clinical staff is also explored. Design/methodology/approach This research uses data collected from the same workforce across two time periods (2013 and 2015) in a large Australian healthcare service. Validated surveys of patient safety culture ( n=306 and 246) were analysed using descriptive and inferential statistics. Findings Using two-way analysis of variance, the authors found that perceived patient safety culture remains unchanged for staff despite a major relocation and upgrade of services and different perceptions of patient safety culture between staff groups remains the same throughout change. Practical implications A dramatic change in physical context, such as moving an entire hospital, made no measurable impact on perceived patient safety culture by major groups of staff. Improving patient safety culture requires more than investment in buildings and infrastructure. Understanding differences in professional perspectives of patient safety culture may inform organisational management approaches, and enhance the targeting of specific strategies. Originality/value The authors believe this to be the first empirically based paper that investigates the impact of a large investment into hospital capital and a subsequent relocation of services on clinical and non-clinical staff perceptions of patient safety culture.

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

PubMed

Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Systemic Analysis of Foodborne Disease Outbreak in Korea.

PubMed

Lee, Jong-Kyung; Kwak, No-Seong; Kim, Hyun Jung

2016-02-01

This study systemically analyzed data on the prevalence of foodborne pathogens and foodborne disease outbreaks to identify the priorities of foodborne infection risk management in Korea. Multiple correspondence analysis was applied to three variables: origin of food source, phase of food supply chain, and 12 pathogens using 358 cases from 76 original papers and official reports published in 1998-2012. In addition, correspondence analysis of two variables--place and pathogen--was conducted based on epidemiological data of 2357 foodborne outbreaks in 2002-2011 provided by the Korean Ministry of Food and Drug Safety. The results of this study revealed three distinct areas of food monitoring: (1) livestock-derived raw food contaminated with Campylobacter spp., pathogenic Escherichia coli, Salmonella spp., and Listeria monocytogenes; (2) multi-ingredient and ready-to-eat food related to Staphylococcus aureus; and (3) water associated with norovirus. Our findings emphasize the need to track the sources and contamination pathways of foodborne pathogens for more effective risk management.

Artemisia umbelliformis Lam. and Génépi Liqueur: Volatile Profile as Diagnostic Marker for Geographic Origin and To Predict Liqueur Safety.

PubMed

Boggia, Lorenzo; Pignata, Giuseppe; Sgorbini, Barbara; Colombo, Maria Laura; Marengo, Arianna; Casale, Manuela; Nicola, Silvana; Bicchi, Carlo; Rubiolo, Patrizia

2017-04-05

Artemisia umbelliformis, commonly known as "white génépi", is characterized by a volatile fraction rich in α- and β-thujones, two monoterpenoids; under European Union (EU) regulations these are limited to 35 mg/L in Artemisia-based beverages because of their recognized activity on the human central nervous system. This study reports the results of an investigation to define the geographical origin and thujone content of individual plants of A. umbelliformis from different geographical sites, cultivated experimentally at a single site, and to predict the thujone content in the resulting liqueurs through their volatile fraction. Headspace solid phase microextraction (HS-SPME) combined with gas chromatography-mass spectrometry (GC-MS) and non-separative HS-SPME-MS were used as analytical platforms to create a database suitable for chemometric description and prediction through linear discriminant analysis (LDA). HS-SPME-MS was applied to shorten analysis time. With both approaches, a diagnostic prediction of (i) plant geographical origin and (ii) thujone content of plant-related liqueurs could be made.

Retrofit concept for small safety related stationary machines

NASA Astrophysics Data System (ADS)

Epple, S.; Jalba, C. K.; Muminovic, A.; Jung, R.

2017-05-01

More and more old machines have the problem that their control electronics’ lifecycle comes to its intended end of life, whilst the mechanics itself and process capability is still in very good condition. This article shows an example of a reactive ion etcher originally built in 1988, which was refitted with a new control concept. The original control unit was repaired several times based on manufacturer’s obsolescence management. At start of the retrofit project the integrated circuits were no longer available for further repair of the original control unit. Safety, repeatability and stability of the process were greatly improved.

Psychometric Support for an Abbreviated Version of the California School Climate and Safety Survey

ERIC Educational Resources Information Center

Rebelez, Jennica L.; Furlong, Michael J.

2013-01-01

The California School Climate and Safety Survey-Short Form (CSCSS-SF) was developed as a streamlined version (54 items) of the original CSCSS (102 items) for school safety teams to gather information regarding student perceptions of campus climate, safety, and experience of victimization. Using a longitudinal dataset, this study implemented…

Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.

PubMed

Luna, Joaquin; Plata, Manuel; Gonzalez, Mauricio; Correa, Alfonso; Maldonado, Ivete; Nossa, Claudia; Radley, David; Vuocolo, Scott; Haupt, Richard M; Saah, Alfred

2013-01-01

Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women. Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up. There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported. Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women. Clinicaltrials.govNCT00090220.

Long-Term Follow-up Observation of the Safety, Immunogenicity, and Effectiveness of Gardasil™ in Adult Women

PubMed Central

Luna, Joaquin; Plata, Manuel; Gonzalez, Mauricio; Correa, Alfonso; Maldonado, Ivete; Nossa, Claudia; Radley, David; Vuocolo, Scott; Haupt, Richard M.; Saah, Alfred

2013-01-01

Background Previous analyses from a randomized trial in women aged 24–45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women. Methods Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up. Results There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported. Conclusions Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24–45 year-old women. Trial Registration Clinicaltrials.gov NCT00090220 PMID:24391768

30 CFR 57.4761 - Underground shops.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Fire Prevention and... toxic gases from a fire originating in an underground shop where maintenance work is routinely done on...

Improved Safety Margin Characterization of Risk from Loss of Offsite Power

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

Nelson, Paul

Original intent: The original intent of this task was “support of the Risk-Informed Safety Margin Characteristic (RISMC) methodology in order” “to address … efficiency of computation so that more accurate and cost-effective techniques can be used to address safety margin characterizations” (S. M. Hess et al., “Risk-Informed Safety Margin Characterization,” Procs. ICONE17, Brussels, July 2009, CD format). It was intended that “in Task 1 itself this improvement will be directed toward upon the very important issue of Loss of Offsite Power (LOOP) events,” more specifically toward the challenge of efficient computation of the multidimensional nonrecovery integral that has been discussedmore » by many previous contributors to the theory of nuclear safety. It was further envisioned that “three different computational approaches will be explored,” corresponding to the three subtasks listed below; deliverables were tied to the individual subtasks.« less

[Experience feedback committee: a method for patient safety improvement].

PubMed

François, P; Sellier, E; Imburchia, F; Mallaret, M-R

2013-04-01

An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens

PubMed Central

Bassi, Simona; Stroppa, Elisa M.; Moroni, Carlo F.; Arbasi, Maria C.; Trabacchi, Elena; Di Franco, Anna; Lazzaro, Antonio; Bernuzzi, Patrizia; Moretto, Mauro; Arcari, Annalisa; Bosi, Costanza; Riva, Alessandra; Cavanna, Luigi; Vallisa, Daniele

2015-01-01

Background Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients. Materials and methods With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim® and Zarzio®) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed. Results Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim® and Zarzio® was associated with cost reductions of 56% and of 86%, respectively. Discussion Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT. PMID:25761321

Engaging the Somali community in the road safety agenda: a process evaluation from the London borough of Hounslow.

PubMed

Christie, Nicola; Sleney, Judith; Ahmed, Fatima; Knight, Elisabeth

2012-08-01

In the UK the most disadvantaged in society are more likely than those more affluent to be injured or killed in a road traffic collision and therefore it is a major cause of health inequality. There is a strong link between ethnicity, deprivation and injury. Whilst national road traffic injury data does not collect ethnic origin the London accident and analysis group does in terms of broad categories such as 'white', 'black' and 'Asian'. Analysis of this data revealed the over-representation of child pedestrian casualties from a 'black' ethnic origin. This information led road safety practitioners in one London borough to map child pedestrian casualties against census data which identified the Somali community as being particularly at risk of being involved in a road traffic collision. Working with the community they sought to discuss and address road safety issues and introduced practical evidence based approaches such as child pedestrian training. The process evaluation of the project used a qualitative approach and showed that engaging with community partners and working across organisational boundaries was a useful strategy to gain an understanding of the Somali community. A bottom approach provided the community with a sense of control and involvement which appears to add value in terms of reducing the sense of powerlessness that marginalised communities often feel. In terms of evaluation, small projects like these, lend themselves to a qualitative process evaluation though it has to be accepted that the strength of this evidence may be regarded as weak. Where possible routine injury data needs to take into account ethnicity which is a known risk factor for road casualty involvement which needs to be continually monitored.

[Nanomaterials in cosmetics--present situation and future].

PubMed

Masunaga, Takuji

2014-01-01

Cosmetics are consumer products intended to contribute to increasing quality of life and designed for long-term daily use. Due to such features of cosmetics, they are required to ensure quality and safety at a high level, as well as to perform well, in response to consumers' demands. Recently, the technology associated with nanomaterials has progressed rapidly and has been applied to various products, including cosmetics. For example, nano-sized titanium dioxide has been formulated in sunscreen products in pursuit of improving its performance. As some researchers and media have expressed concerns about the safety of nanomaterials, a vague feeling of anxiety has been raised in society. In response to this concern, the Japan Cosmetic Industry Association (JCIA) has begun original research related to the safety assurance of nanomaterials formulated in cosmetics, to allow consumers to use cosmetics without such concerns. This paper describes the activities of the JCIA regarding safety research on nanomaterials, including a survey of the actual usage of nanomaterials in cosmetics, analysis of the existence of nanomaterials on the skin, and assessment of skin carcinogenicity of nano-sized titanium dioxide. It also describes the international status of safety assurance and regulation regarding nanomaterials in cosmetics.

The Road to Psychological Safety: Legal, Scientific, and Social Foundations for a Canadian National Standard on Psychological Safety in the Workplace

ERIC Educational Resources Information Center

Shain, Martin; Arnold, Ian; GermAnn, Kathy

2012-01-01

In Part 1 of this article, the legal and scientific origins of the concept of psychological safety are examined as background to, and support for, the new Canadian National Standard on Psychological Health and Safety in the Workplace (CSA Z1003/BNQ 9700). It is shown that five factors influencing psychological safety can be identified as being…

Sociotechnical approaches to workplace safety: Research needs and opportunities

PubMed Central

Robertson, Michelle M.; Hettinger, Lawrence J.; Waterson, Patrick E.; Ian Noy, Y.; Dainoff, Marvin J.; Leveson, Nancy G.; Carayon, Pascale; Courtney, Theodore K.

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Practitioner Summary: Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety. PMID:25728246

Application of high-resolution melting analysis for authenticity testing of valuable Dendrobium commercial products.

PubMed

Dong, Xiaoman; Jiang, Chao; Yuan, Yuan; Peng, Daiyin; Luo, Yuqin; Zhao, Yuyang; Huang, Luqi

2018-01-01

The accurate identification of botanical origin in commercial products is important to ensure food authenticity and safety for consumers. The Dendrobium species have long been commercialised as functional food supplements and herbal medicines in Asia. Three valuable Dendrobium species, namely Dendrobium officinale, D. huoshanense and D. moniliforme, are often mutually adulterated in trade products in pursuit of higher profit. In this paper, a rapid and reliable semi-quantitative method for identifying the botanical origin of Dendrobium products in terminal markets was developed using high-resolution melting (HRM) analysis with specific primer pairs to target the trnL-F region. The HRM analysis method detected amounts of D. moniliforme adulterants as low as 1% in D. huoshanense or D. officinale products. The results have demonstrated that HRM analysis is a fast and effective tool for the differentiation of these Dendrobium species both for their authenticity as well as for the semi-quantitative determination of the purity of their processed products. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Exploring the impacts of safety culture on immigrants' vulnerability in non-motorized crashes: a cross-sectional study.

PubMed

Chen, Cynthia; Lin, Haiyun; Loo, Becky P Y

2012-02-01

Pedestrians and cyclists are a vulnerable group of road users. Immigrants are disproportionally represented in pedestrian and cyclist crashes. We postulate that the mismatch in safety culture between countries of their origin and the U.S.A. contribute to their vulnerability in pedestrian and cyclist crashes. Over time, the differences may disappear and immigrants' traffic behavior gravitates toward those of native-borns. We describe this process as safety assimilation. Using the pedestrian and cyclist crash database in New York City between 2001 and 2003, we examined the effects of foreign-born population, their countries of origin, and time of entry into the USA on census tract-level pedestrian and cyclist crashes. We find that neighborhoods with a higher concentration of immigrants, especially those from Latin America, Eastern Europe, and Asia, have more crashes. Our results also exhibit a pattern of the hypothesized safety assimilation process. The study suggests a higher level of vulnerability of immigrants to pedestrian and cyclist crashes. We propose that targeted policies and programs need to be developed for immigrants of different countries of origin.

Challenging the immediate causes: A work accident investigation in an oil refinery using organizational analysis.

PubMed

Beltran, Sandra Lorena; Vilela, Rodolfo Andrade de Gouveia; de Almeida, Ildeberto Muniz

2018-01-01

In many companies, investigations of accidents still blame the victims without exploring deeper causes. Those investigations are reactive and have no learning potential. This paper aims to debate the historical organizational aspects of a company whose policy was incubating an accident. The empirical data are analyzed as part of a qualitative study of an accident that occurred in an oil refinery in Brazil in 2014. To investigate and analyse this case we used one-to-one and group interviews, participant observation, Collective Analyses of Work and a documentary review. The analysis was conducted on the basis of concepts of the Organizational Analysis of the event and the Model for Analysis and Prevention of Work Accidents. The accident had its origin in the interaction of social and organizational factors, among them being: excessively standardized culture, management tools and outcome indicators that give a false sense of safety, the decision to speed up the project, the change of operator to facilitate this outcome and performance management that encourages getting around the usual barriers. The superficial accident analysis conducted by the company that ignored human and organizational factors reinforces the traditional safety culture and favors the occurrence of new accidents.

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

Novak, Avrey; Nyflot, Matthew J.; Ermoian, Ralph P.

Purpose: Radiation treatment planning involves a complex workflow that has multiple potential points of vulnerability. This study utilizes an incident reporting system to identify the origination and detection points of near-miss errors, in order to guide their departmental safety improvement efforts. Previous studies have examined where errors arise, but not where they are detected or applied a near-miss risk index (NMRI) to gauge severity. Methods: From 3/2012 to 3/2014, 1897 incidents were analyzed from a departmental incident learning system. All incidents were prospectively reviewed weekly by a multidisciplinary team and assigned a NMRI score ranging from 0 to 4 reflectingmore » potential harm to the patient (no potential harm to potential critical harm). Incidents were classified by point of incident origination and detection based on a 103-step workflow. The individual steps were divided among nine broad workflow categories (patient assessment, imaging for radiation therapy (RT) planning, treatment planning, pretreatment plan review, treatment delivery, on-treatment quality management, post-treatment completion, equipment/software quality management, and other). The average NMRI scores of incidents originating or detected within each broad workflow area were calculated. Additionally, out of 103 individual process steps, 35 were classified as safety barriers, the process steps whose primary function is to catch errors. The safety barriers which most frequently detected incidents were identified and analyzed. Finally, the distance between event origination and detection was explored by grouping events by the number of broad workflow area events passed through before detection, and average NMRI scores were compared. Results: Near-miss incidents most commonly originated within treatment planning (33%). However, the incidents with the highest average NMRI scores originated during imaging for RT planning (NMRI = 2.0, average NMRI of all events = 1.5), specifically during the documentation of patient positioning and localization of the patient. Incidents were most frequently detected during treatment delivery (30%), and incidents identified at this point also had higher severity scores than other workflow areas (NMRI = 1.6). Incidents identified during on-treatment quality management were also more severe (NMRI = 1.7), and the specific process steps of reviewing portal and CBCT images tended to catch highest-severity incidents. On average, safety barriers caught 46% of all incidents, most frequently at physics chart review, therapist’s chart check, and the review of portal images; however, most of the incidents that pass through a particular safety barrier are not designed to be capable of being captured at that barrier. Conclusions: Incident learning systems can be used to assess the most common points of error origination and detection in radiation oncology. This can help tailor safety improvement efforts and target the highest impact portions of the workflow. The most severe near-miss events tend to originate during simulation, with the most severe near-miss events detected at the time of patient treatment. Safety barriers can be improved to allow earlier detection of near-miss events.« less

Testing a Theory-Based Health Communication Program: A Replication of Go Sun Smart in Outdoor Winter Recreation

PubMed Central

ANDERSEN, PETER A.; BULLER, DAVID B.; WALKOSZ, BARBARA J.; MALOY, JULIE; SCOTT, MICHAEL D.; CUTTER, GARY R.; DIGNAN, MARK B.

2010-01-01

The epidemic of preventable skin cancer in the United States creates an urgent need for health communication campaigns to improve sun protection. Go Sun Smart (GSS), a theory-driven multichannel health communication campaign showed positive effects on sun safety behaviors of employees and guests in a randomized trial at high-altitude ski areas. In this article we report findings from the North American GSS campaign for guests at ski areas that comprosed the original control-group resorts, replicating the results of the original guest intervention. Results showed that after GSS was deployed, guests at the original control group ski areas increased sun protection and reported greater recall of sun safety messages. Conversely, GSS had no effect on sunburning attitudes or self-efficacy beliefs. Like the original GSS guest intervention, the present study found that greater exposure to GSS messages was associated with greater use of sunscreen, sunscreen lip balm, and face covering, but not gloves or overall sun protection. There was no evidence that GSS decreased sunburning or attitudes and self-efficacy beliefs regarding sun safety. PMID:19466647

Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

NASA Technical Reports Server (NTRS)

Stamatelatos,Michael; Dezfuli, Homayoon; Apostolakis, George; Everline, Chester; Guarro, Sergio; Mathias, Donovan; Mosleh, Ali; Paulos, Todd; Riha, David; Smith, Curtis;

Quantitative PCR and disaccharide profiling to characterize the animal origin of low-molecular-weight heparins.

PubMed

Houiste, Céline; Auguste, Cécile; Macrez, Céline; Dereux, Stéphanie; Derouet, Angélique; Anger, Pascal

2009-02-01

Low-molecular-weight heparins (LMWHs) are widely used in the management of thrombosis and acute coronary syndromes. They are obtained by the enzymatic or chemical depolymerization of porcine intestinal heparin. Enoxaparin sodium, a widely used LMWH, has a unique and reproducible oligosaccharide profile which is determined by the origin of the starting material and a tightly controlled manufacturing process. Although other enoxaparin-like LMWHs do exist, specific release criteria including the origin of the crude heparin utilized for their production, have not been established. A quantitative polymerase chain reaction method has been developed to ensure the purity of the porcine origin of crude heparin, with a DNA detection limit as low as 1 ppm for bovine, or 10 ppm for ovine contaminants. This method is routinely used as the release acceptance criterion during enoxaparin sodium manufacturing. Furthermore, when the process removes DNA, other analytical techniques can be used to assess any contamination. Disaccharide profiling after exhaustive depolymerization can determine the presence of at least 10% bovine or 20% ovine material; multivariate analysis is useful to perform the data analysis. Consistent with the availability of newer technology, these methods should be required as acceptance criteria for crude heparins used in the manufacture of LMWHs to ensure their safety, quality, and immunologic profile.

A Mathematical Model for Railway Control Systems

NASA Technical Reports Server (NTRS)

Hoover, D. N.

1996-01-01

We present a general method for modeling safety aspects of railway control systems. Using our modeling method, one can progressively refine an abstract railway safety model, sucessively adding layers of detail about how a real system actually operates, while maintaining a safety property that refines the original abstract safety property. This method supports a top-down approach to specification of railway control systems and to proof of a variety of safety-related properties. We demonstrate our method by proving safety of the classical block control system.

Occupational Safety and Health Systems: A Three-Country Comparison.

ERIC Educational Resources Information Center

Singleton, W. T.

1983-01-01

This article compares the occupational safety and health systems of Switzerland, the United Kingdom, and the United States, looking at the origins of their legislation and its effects on occupational safety and health, with a view to determining what lessons may emerge, particularly for developing countries. (Author/SSH)

A Study of the System Safety Concept as it Relates to the New Walter Reed Army Medical Center, Washington, DC.

DTIC Science & Technology

1978-03-31

established the safety level of the% * originally designed facility and the extent of current safety * modifications. The objectives evaluated the...Program could identify many safety hazards thus leading to design improvements. The study provided several recommendations to formalize the Systems Safety... design , construction, and proposed systems management of the new Walter Reed Army Medical Center (WRAMC), Washington, D.C., was conducted during the

Space station pressurized laboratory safety guidelines

NASA Technical Reports Server (NTRS)

Mcgonigal, Les

1990-01-01

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

Identification of potentially emerging food safety issues by analysis of reports published by the European Community's Rapid Alert System for Food and Feed (RASFF) during a four-year period.

PubMed

Kleter, G A; Prandini, A; Filippi, L; Marvin, H J P

2009-05-01

The SAFE FOODS project undertakes to design a new approach towards the early identification of emerging food safety hazards. This study explored the utility of notifications filed through RASFF, the European Commission's Rapid Alert System for Food and Feed, to identify emerging trends in food safety issues. RASFF information and alert notifications published in the four-year period of July 2003-June 2007 were assigned to categories of products and hazards. For chronological trend analysis, a basic time unit of three months was chosen. Data within each hazard category were analyzed for chronological trends, relationships between product and hazard categories, regions of origin, and countries filing the notifications. Conspicuous trends that were observed included a rise in the incidence of food contact substances, particularly 2-isopropyl-thioxanthone, as well as of chemical substances migrating from utensils and fraud-related issues. Temporary increases were noted in the incidences of the unauthorized dye Para Red, genetically modified organisms, the pesticide isophenfos-methyl, and herring worm, Anisakis simplex. National and European authorities themselves have signaled these conspicuous trends and taken measures. It is recommended to add complementary data to RASFF data, including safety assessments, risk management measures, background data on hazards and surveillance patterns, for a holistic approach towards early identification of emerging hazards.

Fuji apple storage time rapid determination method using Vis/NIR spectroscopy.

PubMed

Liu, Fuqi; Tang, Xuxiang

2015-01-01

Fuji apple storage time rapid determination method using visible/near-infrared (Vis/NIR) spectroscopy was studied in this paper. Vis/NIR diffuse reflection spectroscopy responses to samples were measured for 6 days. Spectroscopy data were processed by stochastic resonance (SR). Principal component analysis (PCA) was utilized to analyze original spectroscopy data and SNR eigen value. Results demonstrated that PCA could not totally discriminate Fuji apples using original spectroscopy data. Signal-to-noise ratio (SNR) spectrum clearly classified all apple samples. PCA using SNR spectrum successfully discriminated apple samples. Therefore, Vis/NIR spectroscopy was effective for Fuji apple storage time rapid discrimination. The proposed method is also promising in condition safety control and management for food and environmental laboratories.

Fuji apple storage time rapid determination method using Vis/NIR spectroscopy

PubMed Central

Liu, Fuqi; Tang, Xuxiang

2015-01-01

Fuji apple storage time rapid determination method using visible/near-infrared (Vis/NIR) spectroscopy was studied in this paper. Vis/NIR diffuse reflection spectroscopy responses to samples were measured for 6 days. Spectroscopy data were processed by stochastic resonance (SR). Principal component analysis (PCA) was utilized to analyze original spectroscopy data and SNR eigen value. Results demonstrated that PCA could not totally discriminate Fuji apples using original spectroscopy data. Signal-to-noise ratio (SNR) spectrum clearly classified all apple samples. PCA using SNR spectrum successfully discriminated apple samples. Therefore, Vis/NIR spectroscopy was effective for Fuji apple storage time rapid discrimination. The proposed method is also promising in condition safety control and management for food and environmental laboratories. PMID:25874818

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

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

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

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

A Simplified Approach to Risk Assessment Based on System Dynamics: An Industrial Case Study.

PubMed

Garbolino, Emmanuel; Chery, Jean-Pierre; Guarnieri, Franck

2016-01-01

Seveso plants are complex sociotechnical systems, which makes it appropriate to support any risk assessment with a model of the system. However, more often than not, this step is only partially addressed, simplified, or avoided in safety reports. At the same time, investigations have shown that the complexity of industrial systems is frequently a factor in accidents, due to interactions between their technical, human, and organizational dimensions. In order to handle both this complexity and changes in the system over time, this article proposes an original and simplified qualitative risk evaluation method based on the system dynamics theory developed by Forrester in the early 1960s. The methodology supports the development of a dynamic risk assessment framework dedicated to industrial activities. It consists of 10 complementary steps grouped into two main activities: system dynamics modeling of the sociotechnical system and risk analysis. This system dynamics risk analysis is applied to a case study of a chemical plant and provides a way to assess the technological and organizational components of safety. © 2016 Society for Risk Analysis.

Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

ClinicalTrials.gov

2017-11-15

Well-differentiated Non-functional NET of Thoracic Origin; Well-differentiated Non-functional NET of Gastrointestinal Origin; Well-differentiated Non-functional NET of Pancreatic Origin; Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma

14 CFR 404.5 - Action on petitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... will not jeopardize public health and safety, the safety or property, or any national security or... it was not included in the original petition; (2) FAA made an important factual error in our denial...

Dynamic analysis methods for detecting anomalies in asynchronously interacting systems

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

Kumar, Akshat; Solis, John Hector; Matschke, Benjamin

2014-01-01

Detecting modifications to digital system designs, whether malicious or benign, is problematic due to the complexity of the systems being analyzed. Moreover, static analysis techniques and tools can only be used during the initial design and implementation phases to verify safety and liveness properties. It is computationally intractable to guarantee that any previously verified properties still hold after a system, or even a single component, has been produced by a third-party manufacturer. In this paper we explore new approaches for creating a robust system design by investigating highly-structured computational models that simplify verification and analysis. Our approach avoids the needmore » to fully reconstruct the implemented system by incorporating a small verification component that dynamically detects for deviations from the design specification at run-time. The first approach encodes information extracted from the original system design algebraically into a verification component. During run-time this component randomly queries the implementation for trace information and verifies that no design-level properties have been violated. If any deviation is detected then a pre-specified fail-safe or notification behavior is triggered. Our second approach utilizes a partitioning methodology to view liveness and safety properties as a distributed decision task and the implementation as a proposed protocol that solves this task. Thus the problem of verifying safety and liveness properties is translated to that of verifying that the implementation solves the associated decision task. We develop upon results from distributed systems and algebraic topology to construct a learning mechanism for verifying safety and liveness properties from samples of run-time executions.« less

The effects of organizational commitment and structural empowerment on patient safety culture.

PubMed

Horwitz, Sujin K; Horwitz, Irwin B

2017-03-20

Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first empirical study to examine the relationship between structural empowerment as proposed by Kanter and the culture of patient safety using physicians.

Safety incidents involving confused and forgetful older patients in a specialised care setting--analysis of the safety incidents reported to the HaiPro reporting system.

PubMed

Kinnunen-Luovi, Kaisa; Saarnio, Reetta; Isola, Arja

2014-09-01

To describe the safety incidents involving confused and forgetful older patients in a specialised care setting entered in the HaiPro reporting system. About 10% of patients experience a safety incident during hospitalisation, which causes or could cause them harm. The possibility of a safety incident during hospitalisation increases significantly with age. A mild or moderate memory disorder and acute confusion are often present in the safety incidents originating with an older patient. The design of the study was action research with this study using findings from one of the first-phase studies, which included qualitative and quantitative analysed data. Data were collected from the reporting system for safety incidents (HaiPro) in a university hospital in Finland. There were 672 reported safety incidents from four acute medical wards during the years 2009-2011, which were scrutinised. Seventy-five of them were linked to a confused patient and were analysed. The majority of the safety incidents analysed involved patient-related accidents. In addition to challenging behaviour, contributing factors included ward routines, shortage of nursing staff, environmental factors and staff knowledge and skills. Nurses tried to secure the patient safety in many different ways, but the modes of actions were insufficient. Nursing staff need evidence-based information on how to assess the cognitive status of a confused patient and how to encounter such patients. The number of nursing staff and ward routines should be examined critically and put in proportion to the care intensity demands caused by the patient's confused state. The findings can be used as a starting point in the prevention of safety incidents and in improving the care of older patients. © 2013 John Wiley & Sons Ltd.

26 CFR 1.42-5 - Monitoring compliance with low-income housing credit requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... be required to retain the original local health, safety, or building code violation reports or... account local health, safety, and building codes (or other habitability standards), and the State or local government unit responsible for making local health, safety, or building code inspections did not issue a...

26 CFR 1.42-5 - Monitoring compliance with low-income housing credit requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... be required to retain the original local health, safety, or building code violation reports or... account local health, safety, and building codes (or other habitability standards), and the State or local government unit responsible for making local health, safety, or building code inspections did not issue a...

The Effectiveness and Safety of Topical Capsaicin in Postherpetic Neuralgia: A Systematic Review and Meta-analysis

PubMed Central

Yong, Yi Lai; Tan, Loh Teng-Hern; Ming, Long Chiau; Chan, Kok-Gan; Lee, Learn-Han; Goh, Bey-Hing; Khan, Tahir Mehmood

2017-01-01

In particular, neuropathic pain is a major form of chronic pain. This type of pain results from dysfunction or lesions in the central and peripheral nervous system. Capsaicin has been traditionally utilized as a medicine to remedy pain. However, the effectiveness and safety of this practice is still elusive. Therefore, this systematic review aimed to investigate the effect of topical capsaicin as a pain-relieving agent that is frequently used in pain management. In brief, all the double-blinded, randomized placebo- or vehicle-controlled trials that were published in English addressing postherpetic neuralgia were included. Meta-analysis was performed using Revman® version 5.3. Upon application of the inclusion and exclusion criteria, only six trials fulfilled all the criteria and were included in the review for qualitative analysis. The difference in mean percentage change in numeric pain rating scale score ranges from -31 to -4.3. This demonstrated high efficacy of topical capsaicin application and implies that capsaicin could result in pain reduction. Furthermore, meta-analysis was performed on five of the included studies. All the results of studies are in favor of the treatment using capsaicin. The incidence of side effects from using topical capsaicin is consistently higher in all included studies, but the significance of safety data cannot be quantified due to a lack of p-values in the original studies. Nevertheless, topical capsaicin is a promising treatment option for specific patient groups or certain neuropathic pain conditions such as postherpetic neuralgia. PMID:28119613

Non-targeted multi-component analytical surveillance of plastic food contact materials: Identification of substances not included in EU positive lists and their risk assessment.

PubMed

Skjevrak, Ingun; Brede, Cato; Steffensen, Inger-Lise; Mikalsen, Arne; Alexander, Jan; Fjeldal, Per; Herikstad, Hallgeir

2005-10-01

A procedure used by the Norwegian Food Safety Authority for surveillance of contaminants from plastic food contact materials (polyolefin drinking bottles, water boilers, polyamide cooking utensils and plastic multi-layer materials) is described. It is based on gas chromatographic-mass spectrometric (GC/MS) analysis of food simulants exposed to plastic materials. Most migrants were substances not-intentionally added to the plastic (degradation products, impurities) or originated from non-plastic components, such as printing inks, adhesives, not-listed additives, solvents and coatings. Hence, the majority of the identified migrants were regulated by the general statements in the EU Framework Regulation, which neither specify limits nor requirements regarding risk assessment, rather than by specific migration controls. Risk assessment has been carried out for selected non-authorized substances. The analysis and the management of these substances and materials with respect to safety represents a challenge to the food authorities.

Next-Generation Telemetry Workstation

NASA Technical Reports Server (NTRS)

2008-01-01

A next-generation telemetry workstation has been developed to replace the one currently used to test and control Range Safety systems. Improving upon the performance of the original system, the new telemetry workstation uses dual-channel telemetry boards for better synchronization of the two uplink telemetry streams. The new workstation also includes an Interrange Instrumentation Group/Global Positioning System (IRIG/GPS) time code receiver board for independent, local time stamping of return-link data. The next-generation system will also record and play back return-link data for postlaunch analysis.

Multi-sectoral action for child safety-a European study exploring implicated sectors.

PubMed

Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

2017-06-01

Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Infrastructural requirements for local implementation of safety policies: the discordance between top-down and bottom-up systems of action.

PubMed

Timpka, Toomas; Nordqvist, Cecilia; Lindqvist, Kent

2009-03-09

Safety promotion is planned and practised not only by public health organizations, but also by other welfare state agencies, private companies and non-governmental organizations. The term 'infrastructure' originally denoted the underlying resources needed for warfare, e.g. roads, industries, and an industrial workforce. Today, 'infrastructure' refers to the physical elements, organizations and people needed to run projects in different societal arenas. The aim of this study was to examine associations between infrastructure and local implementation of safety policies in injury prevention and safety promotion programs. Qualitative data on municipalities in Sweden designated as Safe Communities were collected from focus group interviews with municipal politicians and administrators, as well as from policy documents, and materials published on the Internet. Actor network theory was used to identify weaknesses in the present infrastructure and determine strategies that can be used to resolve these. The weakness identification analysis revealed that the factual infrastructure available for effectuating national strategies varied between safety areas and approaches, basically reflecting differences between bureaucratic and network-based organizational models. At the local level, a contradiction between safety promotion and the existence of quasi-markets for local public service providers was found to predispose for a poor local infrastructure diminishing the interest in integrated inter-agency activities. The weakness resolution analysis showed that development of an adequate infrastructure for safety promotion would require adjustment of the legal framework regulating injury data exchange, and would also require rational financial models for multi-party investments in local infrastructures. We found that the "silo" structure of government organization and assignment of resources was a barrier to collaborative action for safety at a community level. It may therefore be overly optimistic to take for granted that different approaches to injury control, such as injury prevention and safety promotion, can share infrastructure. Similarly, it may be unrealistic to presuppose that safety promotion can reach its potential in terms of injury rate reductions unless the critical infrastructure for this is in place. Such an alignment of the infrastructure to organizational processes requires more than financial investments.

Methodology for safety optimization of highway cross-sections for horizontal curves with restricted sight distance.

PubMed

Ibrahim, Shewkar E; Sayed, Tarek; Ismail, Karim

2012-11-01

Several earlier studies have noted the shortcomings with existing geometric design guides which provide deterministic standards. In these standards the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from the standards. To mitigate these shortcomings, probabilistic geometric design has been advocated where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a mechanism for risk measurement to evaluate the safety impact of deviations from design standards. This paper applies reliability analysis for optimizing the safety of highway cross-sections. The paper presents an original methodology to select a suitable combination of cross-section elements with restricted sight distance to result in reduced collisions and consistent risk levels. The purpose of this optimization method is to provide designers with a proactive approach to the design of cross-section elements in order to (i) minimize the risk associated with restricted sight distance, (ii) balance the risk across the two carriageways of the highway, and (iii) reduce the expected collision frequency. A case study involving nine cross-sections that are parts of two major highway developments in British Columbia, Canada, was presented. The results showed that an additional reduction in collisions can be realized by incorporating the reliability component, P(nc) (denoting the probability of non-compliance), in the optimization process. The proposed approach results in reduced and consistent risk levels for both travel directions in addition to further collision reductions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Sensor technology for hazardous cargo transportation safety.

DOT National Transportation Integrated Search

2013-08-01

The overall goal of this research project was to develop oxidant vapor detection devices that can be : used to ensure the safety of hazardous freight transportation systems. Two nanotechnology-based : systems originally developed for improvised explo...

Heparin pharmacovigilance in Brazil.

PubMed

Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

2011-01-01

To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

SU-E-T-310: Targeting Safety Improvements Through Analysis of Near-Miss Error Detection Points in An Incident Learning Database

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

Novak, A; Nyflot, M; Sponseller, P

2014-06-01

Purpose: Radiation treatment planning involves a complex workflow that can make safety improvement efforts challenging. This study utilizes an incident reporting system to identify detection points of near-miss errors, in order to guide our departmental safety improvement efforts. Previous studies have examined where errors arise, but not where they are detected or their patterns. Methods: 1377 incidents were analyzed from a departmental nearmiss error reporting system from 3/2012–10/2013. All incidents were prospectively reviewed weekly by a multi-disciplinary team, and assigned a near-miss severity score ranging from 0–4 reflecting potential harm (no harm to critical). A 98-step consensus workflow was usedmore » to determine origination and detection points of near-miss errors, categorized into 7 major steps (patient assessment/orders, simulation, contouring/treatment planning, pre-treatment plan checks, therapist/on-treatment review, post-treatment checks, and equipment issues). Categories were compared using ANOVA. Results: In the 7-step workflow, 23% of near-miss errors were detected within the same step in the workflow, while an additional 37% were detected by the next step in the workflow, and 23% were detected two steps downstream. Errors detected further from origination were more severe (p<.001; Figure 1). The most common source of near-miss errors was treatment planning/contouring, with 476 near misses (35%). Of those 476, only 72(15%) were found before leaving treatment planning, 213(45%) were found at physics plan checks, and 191(40%) were caught at the therapist pre-treatment chart review or on portal imaging. Errors that passed through physics plan checks and were detected by therapists were more severe than other errors originating in contouring/treatment planning (1.81 vs 1.33, p<0.001). Conclusion: Errors caught by radiation treatment therapists tend to be more severe than errors caught earlier in the workflow, highlighting the importance of safety checks in dosimetry and physics. We are utilizing our findings to improve manual and automated checklists for dosimetry and physics.« less

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

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

PubMed

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

2018-03-19

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

Psychosocial safety climate, emotional exhaustion, and work injuries in healthcare workplaces.

PubMed

Zadow, Amy Jane; Dollard, Maureen Frances; Mclinton, Sarven Savia; Lawrence, Peter; Tuckey, Michelle Rae

2017-12-01

Preventing work injuries requires a clear understanding of how they occur, how they are recorded, and the accuracy of injury surveillance. Our innovation was to examine how psychosocial safety climate (PSC) influences the development of reported and unreported physical and psychological workplace injuries beyond (physical) safety climate, via the erosion of psychological health (emotional exhaustion). Self-report data (T2, 2013) from 214 hospital employees (18 teams) were linked at the team level to the hospital workplace injury register (T1, 2012; T2, 2013; and T3, 2014). Concordance between survey-reported and registered injury rates was low (36%), indicating that many injuries go unreported. Safety climate was the strongest predictor of T2 registered injury rates (controlling for T1); PSC and emotional exhaustion also played a role. Emotional exhaustion was the strongest predictor of survey-reported total injuries and underreporting. Multilevel analysis showed that low PSC, emanating from senior managers and transmitted through teams, was the origin of psychological health erosion (i.e., low emotional exhaustion), which culminated in greater self-reported work injuries and injury underreporting (both physical and psychological). These results underscore the need to consider, in theory and practice, a dual physical-psychosocial safety explanation of injury events and a psychosocial explanation of injury underreporting. Copyright © 2017 John Wiley & Sons, Ltd.

Human Factors Science: Brief History and Applications to Healthcare.

PubMed

Parker, Sarah Henrickson

2015-12-01

This section will define the science of human factors, its origins, its impact on safety in other domains, and its impact and potential for impact on patient safety. Copyright © 2015 Mosby, Inc. All rights reserved.

Patient safety reporting systems: sustained quality improvement using a multidisciplinary team and "good catch" awards.

PubMed

Herzer, Kurt R; Mirrer, Meredith; Xie, Yanjun; Steppan, Jochen; Li, Matthew; Jung, Clinton; Cover, Renee; Doyle, Peter A; Mark, Lynette J

2012-08-01

Since 1999, hospitals have made substantial commitments to health care quality and patient safety through individual initiatives of executive leadership involvement in quality, investments in safety culture, education and training for medical students and residents in quality and safety, the creation of patient safety committees, and implementation of patient safety reporting systems. At the Weinberg Surgical Suite at The Johns Hopkins Hospital (Baltimore), a 16-operating-room inpatient/outpatient cancer center, a patient safety reporting process was developed to maximize the usefulness of the reports and the long-term sustainability of quality improvements arising from them. A six-phase framework was created incorporating UHC's Patient Safety Net (PSN): Identify, report, analyze, mitigate, reward, and follow up. Unique features of this process included a multidisciplinary team to review reports, mitigate hazards, educate and empower providers, recognize the identifying/reporting individuals or groups with "Good Catch" awards, and follow up to determine if quality improvements were sustained over time. Good Catch awards have been given in recognition of 29 patient safety hazards identified since 2008; in each of these cases, an initiative was developed to mitigate the original hazard. Twenty-five (86%) of the associated quality improvements have been sustained. Two Good Catch award-winning projects--vials of heparin with an unusually high concentration of the drug that posed a potential overdose hazard and a rapid infusion device that resisted practitioner control--are described in detail. A multidisciplinary team's analysis and mitigation of hazards identified in a patient safety reporting process entailed positive recognition with a Good Catch award, education of practitioners, and long-term follow-up.

Collaborating with nurse leaders to develop patient safety practices.

PubMed

Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna

2017-07-03

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

Urban safety restraint use by infants and children under 16 years of age in Virginia : the 2003 survey results.

DOT National Transportation Integrated Search

2004-01-01

The original child restraint law passed in Virginia in 1982 required that children under 4 years of age use a child safety seat, except for those who weighed at least 40 pounds or were at least 40 inches tall, who could use a standard safety belt. In...

Nateglinide versus repaglinide for type 2 diabetes mellitus in China.

PubMed

Li, Chanjuan; Xia, Jielai; Zhang, Gaokui; Wang, Suzhen; Wang, Ling

2009-12-01

The purpose of this study is to evaluate efficacy and safety of nateglinide tablet administration in comparison with those of repaglinide tablet as control on treating type 2 diabetes mellitus in China. Pooled-analysis with analysis of covariance (ANCOVA) method was applied to assess the efficacy and safety based on original data collected from four independent randomized clinical trials with similar research protocols. However meta-analysis was applied based on the outcomes of the four studies. The results by meta-analysis were comparable to those obtained by pooled-analysis. The means of HbA(1c), and fasting blood glucose in both the nateglinide and repaglinide groups were reduced significantly after 12 weeks duration but no statistical differences in reduction between the two groups. The adverse reaction rates were 9.89 and 6.51% in the nateglinide and repaglinide groups respectively, with the rate difference showing no statistical significance, and the Odds Ratio of adverse reaction rate (95% confidence interval) was 1.59 (0.99, 2.55). Both nateglinide and repaglinide administration have similarly significant effects on reducing HbA(1c) and FBG. However, the adverse reaction rate in the nateglinide group is higher than that in the latter using repaglinide but no statistical significance difference as revealed in the four clinical trials detailed below.

20 CFR 410.416 - Determining origin of pneumoconiosis, including statutory presumption.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.416 Determining origin of pneumoconiosis, including statutory...

20 CFR 410.416 - Determining origin of pneumoconiosis, including statutory presumption.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.416 Determining origin of pneumoconiosis, including statutory...

Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis. Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Murri, Daniel G.

2010-01-01

The NASA Engineering and Safety Center (NESC) was requested to establish the Simulation Framework for Rapid Entry, Descent, and Landing (EDL) Analysis assessment, which involved development of an enhanced simulation architecture using the Program to Optimize Simulated Trajectories II (POST2) simulation tool. The assessment was requested to enhance the capability of the Agency to provide rapid evaluation of EDL characteristics in systems analysis studies, preliminary design, mission development and execution, and time-critical assessments. Many of the new simulation framework capabilities were developed to support the Agency EDL Systems Analysis (EDL-SA) team, that is conducting studies of the technologies and architectures that are required to enable higher mass robotic and human mission to Mars. The appendices to the original report are contained in this document.

Major cultural-compatibility complex: considerations on cross-cultural dissemination of patient safety programmes.

PubMed

Jeong, Heon-Jae; Pham, Julius C; Kim, Minji; Engineer, Cyrus; Pronovost, Peter J

2012-07-01

As the importance of patient safety has been broadly acknowledged, various improvement programmes have been developed. Many of the programmes with proven efficacy have been disseminated internationally. However, some of those attempts may encounter unexpected cross-cultural obstacles and may fail to harvest the expected success. Each country has different cultural background that has shaped the behavior of the constituents for centuries. It is crucial to take into account these cultural differences in effectively disseminating these programmes. As an organ transplantation requires tissue-compatibility between the donor and the recipient, there needs to be compatibility between the country where the program was originally developed and the nation implementing the program. Though no detailed guidelines exist to predict success, small-scale pilot tests can help evaluate whether a safety programme will work in a new cultural environment. Furthermore, a pilot programme helps reveal the source of potential conflict, so we can modify the original programme accordingly to better suit the culture to which it is to be applied. In addition to programme protocols, information about the cultural context of the disseminated programme should be conveyed during dissemination. Original programme designers should work closely with partnering countries to ensure that modifications do not jeopardise the original intention of the programme. By following this approach, we might limit barriers originating from cultural differences and increase the likelihood of success in cross-cultural dissemination.

Evaluation of the neighborhood environment walkability scale in Nigeria.

PubMed

Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien

2013-03-21

The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.

Toxicants exposures as novel zoonoses: reflections on sustainable development, food safety and veterinary public health.

PubMed

Frazzoli, C; Mantovani, A

2010-12-01

The modern concept of zoonosis considers any detriment to the health and/or quality of human life resulting from relationships with (other) vertebrate or edible or toxic invertebrate animals. Whereas exposure to toxicants through foods of animal origin (a.o.) is a well-established issue, hereby we discuss it as novel zoonoses, from the standpoints of health implications as well as similarities and differences with classical zoonoses caused by biological agents. Novel toxicant-related zoonoses are linked with new issues in food safety, such as the environment-feed-food chain. In fact, the potential effect of the combined and repeated exposure to dietary toxicants is generally long-term and not readily discernible. Endocrine disrupting chemicals in staple foods of a.o. are discussed as a telling example of a food safety issue summing up critical points covered by the definition of sustainable development, also implicating health risks for generations to come. We suggest some critical points to implement the veterinary public health action in sustainable food safety, such as enhancement of Hazard Analysis and Critical Control Points systems for toxicological risk management. © 2010 Blackwell Verlag GmbH.

[New international initiatives to create systems of effective risk prediction and food safety].

PubMed

Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V

2016-01-01

Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.

78 FR 73169 - Registered Importers of Vehicles Not Originally Manufactured To Conform to the Federal Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-05

... 592 [Docket No. NHTSA-2013-0041; Notice 1] RIN 2127-AL43 Registered Importers of Vehicles Not Originally Manufactured To Conform to the Federal Motor Vehicle Safety Standards AGENCY: National Highway... proposes to clarify NHTSA regulations on registered importers (``RIs'') of motor vehicles not originally...

Healdsburg High School's Course on the Automobile.

ERIC Educational Resources Information Center

Attwood, Philip B.

1995-01-01

Reprints an article originally published in 1937. Discusses the need for some kind of training in automobile safety. Discusses an eight-week high school course on the automobile that covers engine operation, safety, auxiliary systems, and actual driving practice. (RS)

49 CFR 110.30 - Grant application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...). Applicants are required to submit an original and two copies of the application package to: Grants Manager, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building...

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.

PubMed

Grampp, Gustavo; Bonafede, Machaon; Felix, Thomas; Li, Edward; Malecki, Michael; Sprafka, J Michael

2015-03-01

This retrospective analysis assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the USA for branded and generic enoxaparin, a complex injectable subject to immune-related and other adverse events (AEs). Analysis of heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims for commercial and Medicare supplemental-insured individuals newly treated with enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, spontaneous reports from the FDA AE Reporting System were reviewed to identify incidence and attribution of enoxaparin-related reports to specific manufacturers. Specific, dispensed products were identifiable from National Drug Codes only in pharmacy-benefit databases, permitting sensitive comparison of HIT incidence in nearly a third of patients treated with brand or generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of spontaneous reports were processed by generic manufacturers; reports attributable to specific generics were approximately ninefold lower than expected based on market share. Claims data were useful for active surveillance of enoxaparin generics dispensed under pharmacy benefits but not for products administered under medical benefits. These findings suggest that the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars.

Health Care Worker Fatigue.

PubMed

Gardner, Lea Anne; Dubeck, Deborah

2016-08-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, birthing centers, and abortion facilities must file information on incidents and serious events.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

20 CFR 410.456 - Determining origin of pneumoconiosis, including statutory presumption-survivor's claim.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.456 Determining origin of pneumoconiosis...

20 CFR 410.456 - Determining origin of pneumoconiosis, including statutory presumption-survivor's claim.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.456 Determining origin of pneumoconiosis...

A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

PubMed

Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

2015-10-01

Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

Performance and safety testing of lithium batteries for the Expendable, Mobile, ASW Training Target (EMATT)

NASA Astrophysics Data System (ADS)

Hallal, P. B.; Bis, R. F.

1986-08-01

The developmental EMATT (expendable, mobile, ASW training target) may use a high-energy (lithium/sulfuryl chloride) battery system. Safety problems with the original battery cell design were experienced during early performance and safety testing. After redesign of the battery cell, performance and safety tests were made under specified abuse conditions, as well as under simulated launch conditions. The test results showed that the power system now meets all safety requirements, and that the EMATT vehicle is safe to deploy for its engineering development phase.

Fire safety: A case study of technology transfer

NASA Technical Reports Server (NTRS)

Heins, C. F.

1975-01-01

Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

78 FR 42692 - Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-17

... necessary and intended to ensure safety of life on the navigable waters of the United States immediately..., 087[deg]36'09'' W; then back to the point of origin. All vessels must obtain permission from the...

Niacin to Boost Your HDL "Good" Cholesterol

MedlinePlus

... the AIM-HIGH trial. U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm. Accessed May 27, 2011. May 16, 2018 Original article: http://www.mayoclinic.org/diseases-conditions/ ...

How a routine checking of Escherichia coli in retailed food of animal origin can protect consumers against exposition to Campylobacter spp. and Listeria monocytogenes?

PubMed

Trajković-Pavlović, Ljiljana; Novaković, Budimka; Martinov-Cvejin, Mirjana; Gusman, Vera; Bijelović, Sanja; Dragnić, Natasa; Balać, Dragana

2010-08-01

According to the literature that has been published over the last two decades Campylobacter spp i Listeria monocitogens can be identified as causes of numerous diseases derived by consuming food of animal origin. The purpose of this paper was to find out how established national microbiological criteria of the Republic of Serbia on food safety in retailed food of animal origin could contribute to consumer's protection against exposition to foodborne pathogens such as Campylobacter spp. and Listeria monocytogenes. During a routine microbiological safety control of randomly selected 60 samples of fresh poultry meat, 30 samples of other fresh meat readymade for grilling, 30 samples of sausage products, 37 samples of heat-treated meat, 39 samples of toppings for fast food of animal origin and 31 samples of dairy products a national food safety criteria (Escherichia coli, aerobic plate count, Salmonella spp., coagulasa positive Staphylococcus, Proteus spp., sulphito-reducting Clostridia) were applied and, as well as, testing to Campylobacter spp. and Listeria monocitogens. In determination of Campylobacter spp. and Listeria monocytogenes, food quality control methods of the Food and Agriculture Organization (FAO) were applied, while in determination of the other above motioned bacteria, national provisions on microbiological methods were applied who are adjusted to the FAO ones. Related to the national criteria on microbiological food safety, 88 (38.8%) samples, out of the total 227 tested, were rejected. When to these results, the results of laboratory tests on Listeria monocytogens were added, a terminal number of rejected samples were not changed. When to these results, the results of Campylobacter spp. testing were added, 91 (40.1%) out of the 227 samples were unsatisfied. Results of logistic regression model with occurrence of Escherichia coli as dependent variable indicated that Escherichia coli was 4.5 times likely to occur among samples with Campylobacter spp. than among samples without Campylobacter spp. (OR = 4.515, 95% CI: 1.019-20.002). Sensitivity of the fitted model (Hosmer-Lemeshowp = 0.268) was 76.8% and its specificity was 75.0%. At the same time Escherichia coli was confound in all (100%) food samples that were contaminated by Listeria monocytogenes. Statistical analysis indicated that Escherichia coli was completely sensitive to identify all samples contaminated with Listeria monocytogenas and highly sensitive to identify samples contaminated with Campylobacter spp. Nevertheless, 3 (1.3%) of the tested samples were not covered with Escherichia coli.

Safety and efficacy of low molecular weight heparins in children: a systematic review of the literature and meta-analysis of single-arm studies.

PubMed

Bidlingmaier, Christoph; Kenet, Gili; Kurnik, Karin; Mathew, Prasad; Manner, Daniela; Mitchell, Lesley; Krümpel, Anne; Nowak-Göttl, Ulrike

2011-10-01

Within the last two decades low molecular weight heparins (LMWH) have gained increasing widespread use as anticoagulants in children. The use of LMWH has been implemented into clinical care even though there is a lack of firm evidence on the efficacy and safety of LMWH in this population due to the absence of sufficiently powered randomized controlled trials. In the absence of clinical trials, we performed a meta-analysis of available single-arm studies using LMWH in children. A systematic search of electronic databases (Medline, EMBASE, OVID, Web of Science, The Cochrane Library) for studies published from 1980 to 2010 was conducted using keywords in combination both as MeSH terms and text words. Two authors independently screened citations and those meeting a priori defined inclusion criteria were retained. Data on year of publication, study design, country of origin, number of patients, ethnicity, venous thromboembolic events type, and frequency of recurrence and major bleedings were abstracted. Pooled incidence rates (IR) including 95% confidence intervals (95% CIs) on efficacy and safety data of LMWH administration on primary prophylaxis, as well as on secondary prophylaxis in children following symptomatic thromboembolism (TE) were shown. We included 2251 pediatric patients derived from 35 single-arm studies from 12 study countries who were eligible for analysis in the present systematic review. Pooled incidence rates (95% CI) to develop first TE on primary prophylaxis, further TE event on LMWH secondary prophylaxis, or a major bleeding event on LMWH were 0.047 (0.023 to 0.091), 0.052 (0.037 to 0.073) for efficacy, and 0.054 (0.039 to 0.074) for safety (treatment data only), respectively. Efficacy and safety data are comparable with adult data. The present systematic review suggests that use of LMWH in children as primary prophylaxis and in treatment of symptomatic thrombosis is effective and safe. However, properly designed randomized controlled trials are needed. © Thieme Medical Publishers.

A Systematic Review of Primary Care Safety Climate Survey Instruments: Their Origins, Psychometric Properties, Quality, and Usage.

PubMed

Curran, Ciara; Lydon, Sinéad; Kelly, Maureen; Murphy, Andrew; Walsh, Chloe; OʼConnor, Paul

2018-06-01

Safety climate (SC) measurement is a common and feasible method of proactive safety assessment in primary care. However, there is no consensus on which instrument is "best" to use. The aim of the study was to identify the origins, psychometric properties, quality, and SC domains measured by survey instruments used to assess SC in primary care settings. Systematic searches were conducted using Medline, Embase, CINAHL, and PsycInfo in February 2016. English-language, peer-reviewed studies that reported the development and/or use of a SC survey in a primary care setting were included. Two reviewers independently extracted data (survey characteristics, origins, and psychometric properties) from studies and applied the Quality Assessment Tool for Studies with Diverse Designs to assess methodological rigour. Safety climate domains within surveys were deductively analyzed and categorized into common healthcare SC themes. Seventeen SC surveys were identified, of which 16 had been adapted from 2 main U.S. hospital-based surveys. Only 1 survey was developed de novo for a primary care setting. The quantity and quality of psychometric testing varied considerably across the surveys. Management commitment to safety was the most frequently measured SC theme (87.5%). Workload was infrequently measured (25%). Valid and reliable instruments, which are context specific to the healthcare environment for intentional use, are essential to accurately assess SC. Key recommendations include further establishing the construct and criterion-related validity of existing instruments as opposed to developing additional surveys.

Shipping Light: The Case-Oil Trade to Asia, 1870-1915 and Origins of the Supertanker.

ERIC Educational Resources Information Center

Webb, Robert Lloyd

1996-01-01

Recounts the origin and evolution of the America-to-Asia oil shipping business. Originally shipped in tin cans, two to a wooden case, the industry was revolutionized by the development of bulk tankers. Discusses the technological challenges faced by these vessels, safety concerns, and early competition from Russia. (MJP)

Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP).

PubMed

Zscharnack, Matthias; Krause, Christoph; Aust, Gabriela; Thümmler, Christian; Peinemann, Frank; Keller, Thomas; Smink, Jeske J; Holland, Heidrun; Somerson, Jeremy S; Knauer, Jens; Schulz, Ronny M; Lehmann, Jörg

2015-05-20

The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair. The testing strategy addresses biodistribution and tumorigenicity using a multi-step analysis without any cell manipulation to exclude changes of test item characteristics. As a safeguard measurement for meeting regulatory expectations, the project design and goals were discussed continuously with the regulatory authority using a staggered scientific advice concept. Subsequently, the strategy was applied to co.don chondrosphere® (huChon spheroid), a tissue-engineered matrix-free ATMP of human normal chondrocytes. In both the biodistribution and tumorigenicity studies, huChon spheroids were implanted subcutaneously into 40 immunodeficient mice. Biodistribution was studied 1 month after implantation. A skin disc containing the huChon spheroid, two surrounding skin rings and selected organs were analyzed by validated, gender-specific, highly-sensitive triplex qPCR and by immunohistochemistry (IHC). No human DNA was detected in distant skin rings and analyzed organs. IHC revealed no direct or indirect indications of cell migration. Tumorigenicity was assessed 6 months after huChon spheroid implantation by palpation, macroscopic inspection, histology and IHC. No mice from the huChon spheroid group developed a tumor at the implantation site. In two mice, benign tumors were detected that were negative for HLA-ABC, suggesting that they were of spontaneous murine origin. In summary, the presented strategy using a multi-step analysis was confirmed to be suitable for safety studies of ATMPs.

Analysis of food taints and off-flavours: a review.

PubMed

Ridgway, K; Lalljie, S P D; Smith, R M

2010-02-01

Taints and off-flavours in foods are a major concern to the food industry. Identification of the compound(s) causing a taint or off-flavour in food and accurate quantification are critical in assessing the potential safety risks of a product or ingredient. Even when the tainting compound(s) are not at a level that would cause a safety concern, taints and off-flavours can have a significant impact on the quality and consumers' acceptability of products. The analysis of taints and off-flavour compounds presents an analytical challenge especially in an industrial laboratory environment because of the low levels, often complex matrices and potential for contamination from external laboratory sources. This review gives an outline of the origins of chemical taints and off-flavours and looks at the methods used for analysis and the merits and drawbacks of each technique. Extraction methods and instrumentation are covered along with possible future developments. Generic screening methods currently lack the sensitivity required to detect the low levels required for some tainting compounds and a more targeted approach is often required. This review highlights the need for a rapid but sensitive universal method of extraction for the unequivocal determination of tainting compounds in food.

Meat and meat products – analysis of the most common threats in the years 2011-2015 in Rapid Alert System for Food and Feed (RASFF)

PubMed

Kononiuk, Anna D.; Karwowska, Małgorzata

The key tool used in the European Union in order to eliminate the risks associated with the consumption of potentially hazardous food is RASFF - Rapid Alert System for Food and Feed Safety. The RASFF was established to increase accountability and strengthening cooperation between states of the European Union in the field of food safety control. The aim of this study was to explore the trends and temporal and spatial distribution of notifications on food safety hazards between January 2011 and December 2015 with a special emphasis on meat and meat products on the basis of notification from RASFF. The study analyzed notifications on the annual reports of the RASFF published by the European Commission and requests added to the portal RASFF in the period 01.01.2011 - 31.12.2015 on the category of “meat and meat products (other than poultry) and “poultry meat and poultry meat products”. Analysis included detailed information on each notification, such as the classification and date, hazard category, notifying country, country origin. The most common classifications of notification were ‘alert’ and ‘border rejection’. Generally, basis of this notifications were ‘company’s own check’ and ‘official control on the market’. Pathogenic microorganisms were the most often hazard of category in which the higher number of notifications concerned with Salmonella spp. Alert notification which is the most dangerous for consumers were the most common type of classification for notifications on ‘meat and meat product’ category. The most of notifications in category ‘poultry meat and poultry meat products’ were the result of border control. Pathogenic microorganisms were the reason for the huge number of notifications in studied product categories. Many of notifications were associated with products which origin countries were outside RASFF member states.

78 FR 59239 - Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... action is necessary and intended to ensure safety of life on the navigable waters of the United States...'' N, 087[deg]36'24.6'' W; then east back to the point of origin (NAD 83). All vessels must obtain...

Safety-critical event risk associated with cell phone tasks as measured in naturalistic driving studies: A systematic review and meta-analysis.

PubMed

Simmons, Sarah M; Hicks, Anne; Caird, Jeff K

2016-02-01

A systematic review and meta-analysis of naturalistic driving studies involving estimates of safety-critical event risk associated with handheld device use while driving is described. Fifty-seven studies identified from targeted databases, journals and websites were reviewed in depth, and six were ultimately included. These six studies, published between 2006 and 2014, encompass seven sets of naturalistic driver data and describe original research that utilized naturalistic methods to assess the effects of distracting behaviors. Four studies involved non-commercial drivers of light vehicles and two studies involved commercial drivers of trucks and buses. Odds ratios quantifying safety-critical event (SCE) risk associated with talking, dialing, locating or answering, and texting or browsing were extracted. Stratified meta-analysis of pooled odds ratios was used to estimate SCE risk by distraction type; meta-regression was used to test for sources of heterogeneity. The results indicate that tasks that require drivers to take their eyes off the road, such as dialing, locating a phone and texting, increase SCE risk to a greater extent than tasks that do not require eyes off the road such as talking. Although talking on a handheld device did not increase SCE risk, further research is required to determine whether it indirectly influences SCE risk (e.g., by encouraging other cell phone activities). In addition, a number of study biases and quality issues of naturalistic driving studies are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

IAEA Coordinated Research Project on HTGR Reactor Physics, Thermal-hydraulics and Depletion Uncertainty Analysis

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

Strydom, Gerhard; Bostelmann, F.

The continued development of High Temperature Gas Cooled Reactors (HTGRs) requires verification of HTGR design and safety features with reliable high fidelity physics models and robust, efficient, and accurate codes. The predictive capability of coupled neutronics/thermal-hydraulics and depletion simulations for reactor design and safety analysis can be assessed with sensitivity analysis (SA) and uncertainty analysis (UA) methods. Uncertainty originates from errors in physical data, manufacturing uncertainties, modelling and computational algorithms. (The interested reader is referred to the large body of published SA and UA literature for a more complete overview of the various types of uncertainties, methodologies and results obtained).more » SA is helpful for ranking the various sources of uncertainty and error in the results of core analyses. SA and UA are required to address cost, safety, and licensing needs and should be applied to all aspects of reactor multi-physics simulation. SA and UA can guide experimental, modelling, and algorithm research and development. Current SA and UA rely either on derivative-based methods such as stochastic sampling methods or on generalized perturbation theory to obtain sensitivity coefficients. Neither approach addresses all needs. In order to benefit from recent advances in modelling and simulation and the availability of new covariance data (nuclear data uncertainties) extensive sensitivity and uncertainty studies are needed for quantification of the impact of different sources of uncertainties on the design and safety parameters of HTGRs. Only a parallel effort in advanced simulation and in nuclear data improvement will be able to provide designers with more robust and well validated calculation tools to meet design target accuracies. In February 2009, the Technical Working Group on Gas-Cooled Reactors (TWG-GCR) of the International Atomic Energy Agency (IAEA) recommended that the proposed Coordinated Research Program (CRP) on the HTGR Uncertainty Analysis in Modelling (UAM) be implemented. This CRP is a continuation of the previous IAEA and Organization for Economic Co-operation and Development (OECD)/Nuclear Energy Agency (NEA) international activities on Verification and Validation (V&V) of available analytical capabilities for HTGR simulation for design and safety evaluations. Within the framework of these activities different numerical and experimental benchmark problems were performed and insight was gained about specific physics phenomena and the adequacy of analysis methods.« less

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu

2017-04-01

To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.

Caring for class III obese patients.

PubMed

Gardner, Lea Anne

2013-11-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

Nanoparticle surface characterization and clustering through concentration-dependent surface adsorption modeling.

PubMed

Chen, Ran; Zhang, Yuntao; Sahneh, Faryad Darabi; Scoglio, Caterina M; Wohlleben, Wendel; Haase, Andrea; Monteiro-Riviere, Nancy A; Riviere, Jim E

2014-09-23

Quantitative characterization of nanoparticle interactions with their surrounding environment is vital for safe nanotechnological development and standardization. A recent quantitative measure, the biological surface adsorption index (BSAI), has demonstrated promising applications in nanomaterial surface characterization and biological/environmental prediction. This paper further advances the approach beyond the application of five descriptors in the original BSAI to address the concentration dependence of the descriptors, enabling better prediction of the adsorption profile and more accurate categorization of nanomaterials based on their surface properties. Statistical analysis on the obtained adsorption data was performed based on three different models: the original BSAI, a concentration-dependent polynomial model, and an infinite dilution model. These advancements in BSAI modeling showed a promising development in the application of quantitative predictive modeling in biological applications, nanomedicine, and environmental safety assessment of nanomaterials.

Heavy metal concentrations in cocoa beans (Theobroma cacao L.) originating from East Luwu, South Sulawesi, Indonesia

NASA Astrophysics Data System (ADS)

Assa, A.; Noor, A.; Yunus, M. R.; Misnawi; Djide, M. N.

2018-03-01

Concentrations of some heavy metals (Pb, Cu, Cd, As and Hg) were assessed for cocoa beans (Theobroma cacao L) originating from East Luwu, South Sulawesi, Indonesia after five-day fermentation. Consisting of PB 123, BR 25, and MCC 02 cocoa clones, the spectrophotometric analysis showed that concentrations of Pb, Cd, As and Hg in the cocoa beans over the three clones was below the detection limits of 0.100; 0.050, 0.010 and 0.005 mg/kg. For Cu, they were 19.343; 10.391, and 18.594 mg/kg respectively, but still below the maximum critical levels, established by the European Food Safety Authority (EFSA). Concentrations of those five heavy metals in the bean shells were found to be parallel to those in the cocoa beans, except for Pb.

School and Community Transportation Safety Awareness.

ERIC Educational Resources Information Center

Pederson, Patricia J.

1994-01-01

A comprehensive school bus safety program designed and implemented in Euclid (Ohio) involves participation by students, drivers, parents, and the community. This article was originally submitted in application for, and the author received, a 1993 Pinnacle of Achievement Award from the Association of School Business Officials. (MLF)

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...

49 CFR 591.8 - Conformance bond and conditions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) IMPORTATION OF VEHICLES AND EQUIPMENT SUBJECT TO FEDERAL SAFETY, BUMPER AND THEFT PREVENTION STANDARDS § 591.8 Conformance bond and conditions. (a) The bond required under section 591.6(c) for importation of a vehicle not originally manufactured...

49 CFR 592.9 - Forfeiture of bond.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Federal motor vehicle safety, bumper, and theft prevention standard in effect at the time the vehicle was... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) REGISTERED IMPORTERS OF VEHICLES NOT ORIGINALLY MANUFACTURED TO CONFORM TO THE FEDERAL MOTOR VEHICLE SAFETY STANDARDS § 592.9 Forfeiture of bond. A Registered...

Using systems thinking in patient safety: a case study on medicines management.

PubMed

Brimble, Mandy; Jones, Aled

2017-06-29

Systems thinking is used as a way of understanding behaviours and actions in complex healthcare organisations. An important premise of the concept is that every action in a system causes a reaction elsewhere in that system. These reactions can lead to unintended consequences, sometimes long after the original action, and so are not always attributed to them. This article applies systems thinking to a medicines management case study, to highlight how quality-improvement practitioners can use the approach to underpin planning and implementation of patient-safety initiatives. The case study is specific to transcribing in children's hospices, but the strategies can be applied to other areas. The article explains that, while root cause analysis tools are useful for identifying the cause of, and possible solutions to, problems, they need to be considered carefully in terms of unintended consequences, and how the system into which the solution is implemented can be affected by the change. Analysis of problems using a systems-thinking approach can help practitioners to develop robust and well informed business cases to present to decision makers.

Investigation of production method, geographical origin and species authentication in commercially relevant shrimps using stable isotope ratio and/or multi-element analyses combined with chemometrics: an exploratory analysis.

PubMed

Ortea, Ignacio; Gallardo, José M

2015-03-01

Three factors defining the traceability of a food product are production method (wild or farmed), geographical origin and biological species, which have to be checked and guaranteed, not only in order to avoid mislabelling and commercial fraud, but also to address food safety issues and to comply with legal regulations. The aim of this study was to determine whether these three factors could be differentiated in shrimps using stable isotope ratio analysis of carbon and nitrogen and/or multi-element composition. Different multivariate statistics methods were applied to different data subsets in order to evaluate their performance in terms of classification or predictive ability. Although the success rates varied depending on the dataset used, the combination of both techniques allowed the correct classification of 100% of the samples according to their actual origin and method of production, and 93.5% according to biological species. Even though further studies including a larger number of samples in each group are needed in order to validate these findings, we can conclude that these methodologies should be considered for studies regarding seafood product authenticity. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validation of the Italian version of the HSE Indicator Tool.

PubMed

Magnavita, N

2012-06-01

An Italian version of the Health & Safety Executive's (HSE) Management Standards Revised Indicator Tool (MS-RIT) has been used to monitor the working conditions that may lead to stress. To initially examine the factor structure of the Italian version of the MS-RIT, in comparison with the original UK tool, and to investigate its validity and reliability; second, to study the association between occupational stress and psychological distress. Workers from 17 companies self-completed the MS-RIT and the General Health Questionnaire used to measure the psychological distress while they waited for their periodic examination at the workplace. Factor analysis was employed to ascertain whether the Italian version maintained the original subdivision into seven scales. Odds ratios were calculated to estimate the risk of impairment associated with exposure to stress at the workplace. In total, 748 workers participated; the response rate was 91%. The factor structure of the Italian MS-RIT corresponded partially to the original UK version. The 'demand', 'control', 'role', ' relationship' and 'colleague-support' scales were equivalent to the UK ones. A principal factor, termed ' elasticity', incorporated the UK 'management-support' and 'change' scales. Reliability analysis of the sub-scales revealed Cronbach's alpha values ranging from 0.75 to 0.86. Our findings confirmed the usefulness of the Italian version of the HSE MS-RIT in stress control.

On the effect of grain burnback on STS-SRM fragment velocity

NASA Astrophysics Data System (ADS)

Eck, Marshall B.; Mukunda, Meera

Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

On the effect of grain burnback on STS-SRM fragment velocity

NASA Astrophysics Data System (ADS)

Eck, Marshall B.; Mukunda, Meera

1991-01-01

Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

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

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

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

Risk management systems for health care and safety development on transplantation: a review and a proposal.

PubMed

Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

2010-05-01

Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports. Copyright (c) 2010. Published by Elsevier Inc.

The {open_quotes}ASR{close_quotes} story where we are and how we got there: A history of Sandia National Laboratories maintenance employee safety committee

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

NONE

1997-08-01

The Area Safety Representative (ASR) Team is an employee based safety committee that was originated in the latter part of 1994. It was introduced by the Operations and Engineering Center ES&H Coordinator who had heard about an employee based safety program implemented at the EG&G Corporation. This information was the first step in creating Sandia`s Maintenance `Area Safety Representative` (ASR) Program. An advertisement went out from the ES&H Coordinator to all the Maintenance Organizations asking for individuals who would be interested in performing as a volunteer safety representative for their section. The interest was moderate but effective. The committee consistedmore » of one volunteer from each of the working sections within the Maintenance Organization, e.e., HVAC Mechanics, Electricians, Millwrights, Plumbers, Sheetmetal Workers, High-Voltage Technicians, a Union Representative, and representatives from the Operations Group that manage sub-contracted personnel. During the past year, organizational changes have brought about the addition of representatives to include the Planners and the Custodians. The original committee members were enrolled in a 30-hour OSHA Voluntary Compliance Outreach Course. This information provided the members with a broad overview of the Safety Guidelines set forth by OSHA for themselves and their coworkers. It is to be noted that this is an employee based safety team. There are no supervisors or managers on the committee but their attendance is always welcomed at the ASR meetings.« less

Original single-incision laparoscopic cholecystectomy for acute inflammation of the gallbladder

PubMed Central

Sasaki, Kazunari; Watanabe, Goro; Matsuda, Masamichi; Hashimoto, Masaji

2012-01-01

AIM: To investigate the safety and feasibility of our original single-incision laparoscopic cholecystectomy (SILC) for acute inflamed gallbladder (AIG). METHODS: One hundred and ten consecutive patients underwent original SILC for gallbladder disease without any selection criteria and 15 and 11 of these were diagnosed with acute cholecystitis and acute gallstone cholangitis, respectively. A retrospective review was performed not only between SILC for AIG and non-AIG, but also between SILC for AIG and traditional laparoscopic cholecystectomy (TLC) for AIG in the same period. RESULTS: Comparison between SILC for AIG and non-AIG revealed that the operative time was longer in SILC for AIG (97.5 min vs 85.0 min, P = 0.03). The open conversion rate (2/26 vs 2/84, P = 0.24) and complication rate (1/26 vs 3/84, P = 1.00) showed no differences, but a need for additional trocars was more frequent in SILC for AIG (5/24 vs 3/82, P = 0.01). Comparison between SILC for AIG and TLC for AIG revealed no differences based on statistical analysis. CONCLUSION: Our original SILC technique was adequately safe and feasible for the treatment of acute cholecystitis and acute gallstone cholangitis. PMID:22408354

Preharvest Food Safety Challenges in Beef and Dairy Production.

PubMed

Smith, David R

2016-08-01

Foods of animal origin, including beef and dairy products, are nutritious and important to global food security. However, there are important risks to human health from hazards that are introduced to beef and dairy products on the farm. Food safety hazards may be chemical, biological, or physical in nature. Considerations about protecting the safety of beef and dairy products must begin prior to harvest because some potential food safety hazards introduced at the farm (e.g., chemical residues) cannot be mitigated by subsequent postharvest food processing steps. Also, some people have preferences for consuming food that has not been through postharvest processing even though those foods may be unsafe because of microbiological hazards originating from the farm. Because of human fallibility and complex microbial ecologies, many of the preharvest hazards associated with beef and dairy products cannot entirely be eliminated, but the risk for most can be reduced through systematic interventions taken on the farm. Beef and dairy farms differ widely in production practices because of differences in natural, human, and capital resources. Therefore, the actions necessary to minimize on-farm food safety hazards must be farm-specific and they must address scientific, political, economic, and practical aspects. Notable successes in controlling and preventing on-farm hazards to food safety have occurred through a combination of voluntary and regulatory efforts.

Complexity of the international agro-food trade network and its impact on food safety.

PubMed

Ercsey-Ravasz, Mária; Toroczkai, Zoltán; Lakner, Zoltán; Baranyi, József

2012-01-01

With the world's population now in excess of 7 billion, it is vital to ensure the chemical and microbiological safety of our food, while maintaining the sustainability of its production, distribution and trade. Using UN databases, here we show that the international agro-food trade network (IFTN), with nodes and edges representing countries and import-export fluxes, respectively, has evolved into a highly heterogeneous, complex supply-chain network. Seven countries form the core of the IFTN, with high values of betweenness centrality and each trading with over 77% of all the countries in the world. Graph theoretical analysis and a dynamic food flux model show that the IFTN provides a vehicle suitable for the fast distribution of potential contaminants but unsuitable for tracing their origin. In particular, we show that high values of node betweenness and vulnerability correlate well with recorded large food poisoning outbreaks.

Dedication file preparation for commercial-grade electric components

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

Hendricks, J.R.; Farwell, C.R. Jr.

1988-01-01

Dedication is the process of making a commercial-grade item into a basic component that can be installed in safety systems. This process ensures that the commercially manufactured items are of the same or equivalent form, fit, function, and materials as the originally provided safety item. This process must ensure that the original utility's equipment qualification program is maintained per licensing commitments to 10CFR50.49 and general design criterion No. 4. Today, utilities recognize the need for establishing a dedication program to provide the flexibility in obtaining replacement items directly from the original manufacturers. This need has arisen because (a) most systemmore » houses, large manufacturers, and component manufacturers will sell their products only through distributors as straight commercial-grade items or only service former clients, and (b) lack of competition for specific safety-related items has resulted in excessive hardware cost and very long delivery schedules, which could affect plant availability. The vehicle for utilities to obtain safety-related items is to establish and manage a comprehensive dedication program for their own use or provide the direction for a nuclear supplier to follow. This paper provides both utilities and nuclear suppliers insight into the complexities of a dedication program. This insight is provided from our experience as a utilities agent and as a third-party nuclear supplier.« less

Multi-level Bayesian safety analysis with unprocessed Automatic Vehicle Identification data for an urban expressway.

PubMed

Shi, Qi; Abdel-Aty, Mohamed; Yu, Rongjie

2016-03-01

In traffic safety studies, crash frequency modeling of total crashes is the cornerstone before proceeding to more detailed safety evaluation. The relationship between crash occurrence and factors such as traffic flow and roadway geometric characteristics has been extensively explored for a better understanding of crash mechanisms. In this study, a multi-level Bayesian framework has been developed in an effort to identify the crash contributing factors on an urban expressway in the Central Florida area. Two types of traffic data from the Automatic Vehicle Identification system, which are the processed data capped at speed limit and the unprocessed data retaining the original speed were incorporated in the analysis along with road geometric information. The model framework was proposed to account for the hierarchical data structure and the heterogeneity among the traffic and roadway geometric data. Multi-level and random parameters models were constructed and compared with the Negative Binomial model under the Bayesian inference framework. Results showed that the unprocessed traffic data was superior. Both multi-level models and random parameters models outperformed the Negative Binomial model and the models with random parameters achieved the best model fitting. The contributing factors identified imply that on the urban expressway lower speed and higher speed variation could significantly increase the crash likelihood. Other geometric factors were significant including auxiliary lanes and horizontal curvature. Copyright © 2015 Elsevier Ltd. All rights reserved.

78 FR 10687 - Notice of Receipt of Petition for Decision That Nonconforming 1992 Porsche Carrera Passenger Cars...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... Passenger Cars Are Eligible for Importation AGENCY: National Highway Traffic Safety Administration, DOT... cars that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety... petitioned NHTSA to decide whether nonconforming 1992 Porsche Carrera passenger cars are eligible for...

75 FR 14484 - Notice of Receipt of Petition for Decision That Nonconforming 1991 Porsche 911 Series Passenger...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... Passenger Cars Are Eligible for Importation AGENCY: National Highway Traffic Safety Administration, DOT... cars, are eligible for importation. SUMMARY: This document announces receipt by the National Highway... cars that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety...

An original bill to extend National Highway Traffic Safety Administration and Federal Motor Carrier Safety Administration authorizations funded by the Highway Trust Fund, and for other purposes.

THOMAS, 111th Congress

Sen. Rockefeller, John D., IV [D-WV

2009-07-22

Senate - 07/22/2009 Placed on Senate Legislative Calendar under General Orders. Calendar No. 123. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

78 FR 14875 - Petition for Waiver of Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-07

... certain provisions of the Federal railroad safety regulations contained at 49 CFR part 232--Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment, End-of-Train Devices. FRA... 232.207(a) for certain Bakken-oil unit trains that originate at refineries in North Dakota. These...

The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

PubMed Central

2014-01-01

The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

PubMed

Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

2017-01-01

Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

Analysis of consumers' preferences and behavior with regard to horse meat using a structured survey questionnaire.

PubMed

Oh, Woon Yong; Lee, Ji Woong; Lee, Chong Eon; Ko, Moon Seok; Jeong, Jae Hong

2009-12-01

In this study, a structured survey questionnaire was used to determine consumers' preferences and behavior with regard to horse meat at a horse meat restaurant located in Jeju, Korea, from October 1 to December 24, 2005. The questionnaire employed in this study consisted of 20 questions designed to characterize six general attributes: horse meat sensory property, physical appearance, health condition, origin, price, and other attributes. Of the 1370 questionnaires distributed, 1126 completed questionnaires were retained based on the completeness of the answers, representing an 82.2% response rate. Two issues were investigated that might facilitate the search for ways to improve horse meat production and marketing programs in Korea. The first step was to determine certain important factors, called principal components, which enabled the researchers to understand the needs of horse meat consumers via principal component analysis. The second step was to define consumer segments with regard to their preferences for horse meat, which was accomplished via cluster analysis. The results of the current study showed that health condition, price, origin, and leanness were the most critical physical attributes affecting the preferences of horse meat consumers. Four segments of consumers, with different demands for horse meat attributes, were identified: origin-sensitive consumers, price-sensitive consumers, quality and safety-sensitive consumers, and non-specific consumers. Significant differences existed among segments of consumers in terms of age, nature of work, frequency of consumption, and general level of acceptability of horse meat.

[Assessing work-related stress: an Italian adaptation of the HSE Management Standards Work-Related Stress Indicator Tool].

PubMed

Marcatto, Francesco; D'Errico, Giuseppe; Di Blas, Lisa; Ferrante, Donatella

2011-01-01

The aim of this paper is to present a preliminary validation of an Italian adaptation of the HSE Management Standards Work-Related Stress Indicator Tool (IT), an instrument for assessing work-related stress at the organizational level, originally developed in Britain by the Health and Safety Executive. A scale that assesses the physical work environment has been added to the original version of the IT. 190 employees of the University of Trieste have been enrolled in the study. A confirmatory analysis showed a satisfactory fit of the eight-factors structure of the instrument. Further psychometric analysis showed adequate internal consistency of the IT scales and good criterion validity, as evidenced by the correlations with self-perception of stress, work satisfaction and motivation. In conclusion, the Indicator Tool proved to be a valid and reliable instrument for the assessment of work-related stress at the organizational level, and it is also compatible with the instructions provided by the Ministry of Labour and Social Policy (Circular letter 18/11/2010).

19. Photocopied 1983, from original drawing (CP12501), Picatinny Arsenal, September ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

19. Photocopied 1983, from original drawing (CP-12501), Picatinny Arsenal, September 25, 1929. BUILDING NO. 448, 'BAG LOADING AREA SAFETY CHUTE--BUILDING T-868 448'. - Picatinny Arsenal, 400 Area, Gun Bag Loading District, State Route 15 near I-80, Dover, Morris County, NJ

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Reliability Analysis for AFTI-F16 SRFCS Using ASSIST and SURE

NASA Technical Reports Server (NTRS)

Wu, N. Eva

2001-01-01

This paper reports the results of a study on reliability analysis of an AFTI-16 Self-Repairing Flight Control System (SRFCS) using software tools SURE (Semi-Markov Unreliability Range Evaluator and ASSIST (Abstract Semi-Markov Specification Interface to the SURE Tool). The purpose of the study is to investigate the potential utility of the software tools in the ongoing effort of the NASA Aviation Safety Program, where the class of systems must be extended beyond the originally intended serving class of electronic digital processors. The study concludes that SURE and ASSIST are applicable to reliability, analysis of flight control systems. They are especially efficient for sensitivity analysis that quantifies the dependence of system reliability on model parameters. The study also confirms an earlier finding on the dominant role of a parameter called a failure coverage. The paper will remark on issues related to the improvement of coverage and the optimization of redundancy level.

Analysis of the criteria used by the International Commission on Radiological Protection to justify the setting of numerical protection level values.

PubMed

2006-01-01

This report compiles the various numerical protection level values published by the International Commission on Radiological Protection (ICRP) since its 1990 Recommendations (Publication 60). Several terms are used to denominate the protection levels: individual dose limit, 'maximum' individual dose, dose constraint, exemption level, exclusion level, action level, or intervention level. The reasons provided by the Commission for selecting the associated numerical values is quoted as far as available. In some cases the rationale is not totally explicit in the original ICRP report concerned; in such cases the Task Group that prepared the present report have proposed their own interpretation. Originally, this report was prepared by a Task Group at CEPN, a French research and development center, in behalf of IRSN, a French public expert body engaged in radiological protection and nuclear safety. It is published here with kind permission by CEPN and IRSN.

Chew on This: Not All First Finger Foods Are Created Equal.

PubMed

Awadalla, Nicol; Pham, Tammy; Milanaik, Ruth

2017-10-01

The American Academy of Pediatrics (AAP) recommends when to start first finger foods (FFFs) and what types of foods to start with, but it is unclear whether products marketed as FFF comply with these recommendations. We evaluated FFF products for compliance with AAP recommendations and product safety using 41 adult product testers, who were asked to dissolve each product in their mouth. Product characteristics, comments pertaining to product safety, and time to dissolve each product were recorded. Only 2 products met all AAP criteria, and safety concerns were raised for an additional 2 products. One product showed a large change in dissolvability after being left out of original packaging. Consumers should not assume that products marketed for infant/toddler consumption comply with AAP recommendations. Also, products left out of original packaging may change consistency, presenting a choking hazard. Additional research is warranted to guide the development of regulations surrounding labeling and marketing of these foods.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

77 FR 37319 - Safety Zone for Fifth Coast Guard District Fireworks Display Pasquotank River; Elizabeth City, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

...-AA00 Safety Zone for Fifth Coast Guard District Fireworks Display Pasquotank River; Elizabeth City, NC... the Pasquotank River, Elizabeth City, North Carolina. The fireworks display ordinarily originated from... vessel traffic in a portion of the Pasquotank River, Elizabeth City, North Carolina, during the event...

78 FR 45999 - Notice of Receipt of Petition for Decision That Nonconforming 2005 Jaguar XKR Passenger Cars Are...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

... Cars Are Eligible for Importation AGENCY: National Highway Traffic Safety Administration, DOT. ACTION... cars that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety... Jaguar XKR passenger cars) and they are capable of being readily altered to conform to the standards...

23 CFR 658.23 - LCV freeze; cargo-carrying unit freeze.

Code of Federal Regulations, 2010 CFR

2010-04-01

... safety purposes and road construction, a State may make minor adjustments of a temporary and emergency... decision is reached that minor adjustments made by a State are not legitimately attributable to road or bridge construction or safety, the FHWA will inform the State, and the original conditions of the freeze...

Automatic crack detection and classification method for subway tunnel safety monitoring.

PubMed

Zhang, Wenyu; Zhang, Zhenjiang; Qi, Dapeng; Liu, Yun

2014-10-16

Cracks are an important indicator reflecting the safety status of infrastructures. This paper presents an automatic crack detection and classification methodology for subway tunnel safety monitoring. With the application of high-speed complementary metal-oxide-semiconductor (CMOS) industrial cameras, the tunnel surface can be captured and stored in digital images. In a next step, the local dark regions with potential crack defects are segmented from the original gray-scale images by utilizing morphological image processing techniques and thresholding operations. In the feature extraction process, we present a distance histogram based shape descriptor that effectively describes the spatial shape difference between cracks and other irrelevant objects. Along with other features, the classification results successfully remove over 90% misidentified objects. Also, compared with the original gray-scale images, over 90% of the crack length is preserved in the last output binary images. The proposed approach was tested on the safety monitoring for Beijing Subway Line 1. The experimental results revealed the rules of parameter settings and also proved that the proposed approach is effective and efficient for automatic crack detection and classification.

Automatic Crack Detection and Classification Method for Subway Tunnel Safety Monitoring

PubMed Central

Zhang, Wenyu; Zhang, Zhenjiang; Qi, Dapeng; Liu, Yun

2014-01-01

Cracks are an important indicator reflecting the safety status of infrastructures. This paper presents an automatic crack detection and classification methodology for subway tunnel safety monitoring. With the application of high-speed complementary metal-oxide-semiconductor (CMOS) industrial cameras, the tunnel surface can be captured and stored in digital images. In a next step, the local dark regions with potential crack defects are segmented from the original gray-scale images by utilizing morphological image processing techniques and thresholding operations. In the feature extraction process, we present a distance histogram based shape descriptor that effectively describes the spatial shape difference between cracks and other irrelevant objects. Along with other features, the classification results successfully remove over 90% misidentified objects. Also, compared with the original gray-scale images, over 90% of the crack length is preserved in the last output binary images. The proposed approach was tested on the safety monitoring for Beijing Subway Line 1. The experimental results revealed the rules of parameter settings and also proved that the proposed approach is effective and efficient for automatic crack detection and classification. PMID:25325337

14 CFR Appendix B to Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2013 CFR

2013-01-01

....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

14 CFR Appendix B to Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2014 CFR

2014-01-01

....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

Safety and efficacy of sertaconazole nitrate cream 2% in the treatment of tinea pedis interdigitalis: a subgroup analysis.

PubMed

Borelli, Claudia; Korting, Hans Christian; Bödeker, Rolf-Hasso; Neumeister, Claudia

2010-02-01

Sertaconazole nitrate is a broad-spectrum antifungal agent indicated in the United States for the treatment of tinea pedis interdigitalis. The objective of this subgroup analysis was to evaluate the safety and efficacy of sertaconazole nitrate cream 2%, specifically in participants with tinea pedis interdigitalis (ie, fungal skin disease of the toe web) of dermatophyte origin. A total of 92 participants were included in this analysis. The primary end points were eradication of the pathogen (confirmed by fungal culture results) and reduction in total clinical score (TCS) of at least 2 points. Secondary end points included reducing signs and symptoms and reporting adverse events (AEs). After 4 weeks of treatment, 88.8% (79/89) of evaluable participants achieved success on the primary end points. Most participants also demonstrated substantial improvement in signs and symptoms after 4 weeks of treatment: 63.7% (58/91) were free of erythema, 33.0% (30/91) were free of desquamation, and 91.2% (83/91) were free of itch. The rate of reported AEs was low (8.7% [8/92]), and none were considered serious. These findings indicate that sertaconazole nitrate cream 2% is highly safe and effective in the treatment of tinea pedis interdigitalis.

2008 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Lamoreaux, Richard W.

2008-01-01

Welcome to the 2008 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. This year, along with full length articles concerning various subject areas, we have provided updates to standard subjects with links back to the 2007 original article. Additionally, we present summaries from the various NASA Range Safety Program activities that took place throughout the year, as well as information on several special projects that may have a profound impact on the way we will do business in the future. The sections include a program overview and 2008 highlights of Range Safety Training; Range Safety Policy; Independent Assessments and Common Risk Analysis Tools Development; Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging Range Safety-related technologies; Special Interests Items that include recent changes in the ELV Payload Safety Program and the VAS explosive siting study; and status reports from all of the NASA Centers that have Range Safety responsibilities. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. We have made a great effort to include the most current information available. We recommend that this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. This is the third year we have utilized this web-based format for the annual report. We continually receive positive feedback on the web-based edition, and we hope you enjoy this year's product as well. It has been a very busy and productive year on many fronts as you will note as you review this report. Thank you to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the years to come.

Efficacy and safety of selective glucocorticoid receptor modulators in comparison to glucocorticoids in arthritis, a systematic review.

PubMed

Safy, M; de Hair, M J H; Jacobs, J W G; Buttgereit, F; Kraan, M C; van Laar, J M

2017-01-01

Long-term treatment with glucocorticoids (GCs) plays an important role in the management of arthritis patients, although the efficacy/safety balance is unfavorable. Alternatives with less (severe) adverse effects but with good efficacy are needed. Selective GC receptor modulators (SGRMs) are designed to engage the GC receptor with dissociative characteristics: transactivation of genes, which is mainly responsible for unwanted effects, is less strong while trans-repression of genes, reducing inflammation, is maintained. It is expected that SGRMs thus have a better efficacy/safety balance than GCs. A systematic review providing an overview of the evidence in arthritis is lacking. To systematically review the current literature on efficacy and safety of oral SGRMs in comparison to GCs in arthritis. A search was performed in Medline, Embase and the Cochrane Library, from inception dates of databases until May 2017. Experimental studies involving animal arthritis models or human material of arthritis patients, as well as clinical studies in arthritis patients were included, provided they reported original data. All types of arthritis were included. Data was extracted on the SGRM studied and on the GC used as reference standard; the design or setting of the study was extracted as well as the efficacy and safety results. A total of 207 articles was retrieved of which 17 articles were eligible for our analysis. Two studies concerned randomized controlled trials (RCT), five studies were pre-clinical studies using human material, and 10 studies involved pre-clinical animal models (acute and/or chronic arthritis induced in mice or rats). PF-04171327, the only compound investigated in a clinical trial setting, had a better efficacy/safety balance compared to GCs: better clinical anti-inflammatory efficacy and similar safety. Studies assessing both efficacy and safety of SGRMs are scarce. There is limited evidence for dissociation of anti-inflammatory and metabolic effects of the SGRMs studied. Development of many SGRMs is haltered in a preclinical phase. One SGRM showed a better clinical efficacy/safety balance.

Deriving and Validating a Road Safety Performance Indicator for Vehicle Fleet Passive Safety

PubMed Central

Page, Marianne; Rackliff, Lucy

2006-01-01

Road safety performance indicators (RSPI) are policy tools which describe the extent of insecure operational safety conditions within traffic systems. This study describes the production of an RSPI which represents the presence within a country’s vehicle fleet, of vehicles that may not effectively protect an occupant in a collision. This work is highly original, as it uses the entire vehicle database of European Union Member States in order to estimate the average level of passive safety offered by the entire fleet in each country. The EuroNCAP safety ratings and vehicle age of each vehicle in each fleet have been obtained to calculate the RSPI. The methodology used could be adopted as an international standard. PMID:16968645

[Current progress in food geographical origin traceability by near infrared spectroscopy technology].

PubMed

Ma, Dong-Hong; Wang, Xi-Chang; Liu, Li-Ping; Liu, Yuan

2011-04-01

The geographical origin traceability of food, an important part of traceability system, is effective in protecting the quality and safety of foodstuffs. Near-infrared spectroscopy (NIR), which is a powerful technique for geographical origin traceability, has attracted extensive attention by scientists due to its speediness, non-pollution and simple operation. This paper presents the advantages and disadvantages of techniques that have been used for food geographical origin traceability. The basic principles of NIR and its applications in different food geographical origin traceability are presented too. Furthermore, problems in applications are analyzed and the future development trends are discussed.

Identification of the Species of Origin for Meat Products by Rapid Evaporative Ionization Mass Spectrometry.

PubMed

Balog, Julia; Perenyi, Dora; Guallar-Hoyas, Cristina; Egri, Attila; Pringle, Steven D; Stead, Sara; Chevallier, Olivier P; Elliott, Chris T; Takats, Zoltan

2016-06-15

Increasingly abundant food fraud cases have brought food authenticity and safety into major focus. This study presents a fast and effective way to identify meat products using rapid evaporative ionization mass spectrometry (REIMS). The experimental setup was demonstrated to be able to record a mass spectrometric profile of meat specimens in a time frame of <5 s. A multivariate statistical algorithm was developed and successfully tested for the identification of animal tissue with different anatomical origin, breed, and species with 100% accuracy at species and 97% accuracy at breed level. Detection of the presence of meat originating from a different species (horse, cattle, and venison) has also been demonstrated with high accuracy using mixed patties with a 5% detection limit. REIMS technology was found to be a promising tool in food safety applications providing a reliable and simple method for the rapid characterization of food products.

75 FR 17604 - Federal Motor Vehicle Safety Standards; Roof Crush Resistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... Safety Analysis & Forensic Engineering, LLC (SAFE) brought to our attention errors in the preamble that incorrectly attributed to it the comments of another organization, Safety Analysis, Inc. Both of these... Safety Analysis, Inc. SAFE noted that there is no affiliation between SAFE and Safety Analysis, Inc. and...

Migration, violence, and safety among migrant sex workers: a qualitative study in two Guatemalan communities.

PubMed

Rocha-Jiménez, Teresita; Brouwer, Kimberly C; Silverman, Jay G; Morales-Miranda, Sonia; Goldenberg, Shira M

2016-09-01

Despite reports of high levels of violence among women migrants in Central America, limited evidence exists regarding the health and safety of migrant sex workers in Central America. This study is based on 16 months of field research (November 2012-February 2014), including ethnographic fieldwork, in-depth interviews, and focus groups conducted with 52 internal and international migrant female sex workers in Tecún Umán and Quetzaltenango, Guatemala, key transit and destination communities for both international and internal migrants. The analysis explored migration-related determinants of susceptibility to violence experienced by migrant sex workers across different phases of migration. Violence in home communities and economic considerations were key drivers of migration. Unsafe transit experiences (eg undocumented border crossings) and negative interactions with authorities in destination settings (eg extortion) contributed to migrant sex workers' susceptibility to violence, while enhanced access to information on immigration policies and greater migration and sex work experience were found to enhance agency and resilience. Findings suggest the urgent need for actions that promote migrant sex workers' safety in communities of origin, transit, and destination, and programmes aimed at preventing and addressing human rights violations within the context of migration and sex work.

Inconsistencies Between Two Cross-Cultural Adaptations of the Hospital Survey on Patient Safety Culture Into French.

PubMed

Boussat, Bastien; François, Patrice; Gandon, Gérald; Giai, Joris; Seigneurin, Arnaud; Perneger, Thomas; Labarère, José

2017-11-15

Two cross-cultural adaptations of the 12-dimension Hospital Survey on Patient Safety Culture (HSOPSC) into French coexist: the Occelli and Vlayen versions. The objective of this study was to assess the psychometric properties of the Occelli version in comparison with those reported for the Vlayen and the original US versions of this instrument. Using the original data from a cross-sectional study of 5,064 employees at a single university hospital in France, we examined the acceptability, internal consistency, factorial structure, and construct validity of the Occelli version of the HSOPSC. The response rate was 76.8% (n = 3888). Our study yielded lower missing value rates (median, 0.4% [range, 0.0%-2.4%] versus 0.8% [range, 0.2%-11.4%]) and lower dimension scores (median, 3.19 [range, 2.67-3.54] versus 3.42 [range, 2.92-3.96]) than those reported for the Vlayen version. Cronbach alphas (median, 0.64; range, 0.56-0.84) compared unfavorably with those reported for the Vlayen (median, 0.73; range, 0.57-0.86) and original US (median, 0.78; range, 0.63-0.84) versions. The results of the confirmatory factor analysis were consistent between the Vlayen and Occelli versions, making it possible to conduct surveys from the 12-dimensional structure with both versions. The inconsistencies observed between the Occelli and Vlayen versions of the HSOPSC may reflect either differences between the translations or heterogeneity in the study population and context. Current evidence does not clearly support the use of one version over the other. The two cross-cultural adaptations of the HSOPSC can be used interchangeably in French-speaking countries.

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets.

PubMed

Brixner, Diana; Maniadakis, Nikos; Kaló, Zoltán; Hu, Shanlian; Shen, Jie; Wijaya, Kalman

2017-09-01

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system's needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

75 FR 15611 - Safety Zone; United Portuguese SES Centennial Festa, San Diego Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

...-AA00 Safety Zone; United Portuguese SES Centennial Festa, San Diego Bay, San Diego, CA AGENCY: Coast... navigable waters of the San Diego Bay in support of the United Portuguese SES Centennial Festa. This... Centennial Festa, which will include a fireworks presentation originating from a tug and barge combination in...

Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

PubMed

Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

2015-01-01

The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

An exploration of workplace social capital as an antecedent of occupational safety and health climate and outcomes in the Chinese education sector.

PubMed

Tang, Jessica Janice; Leka, Stavroula; Hunt, Nigel; MacLennan, Sara

2014-07-01

It is widely acknowledged that teachers are at greater risk of work-related health problems. At the same time, employee perceptions of different dimensions of organizational climate can influence their attitudes, performance, and well-being at work. This study applied and extended a safety climate model in the context of the education sector in Hong Kong. Apart from safety considerations alone, the study included occupational health considerations and social capital and tested their relationships with occupational safety and health (OSH) outcomes. Seven hundred and four Hong Kong teachers completed a range of questionnaires exploring social capital, OSH climate, OSH knowledge, OSH performance (compliance and participation), general health, and self-rated health complaints and injuries. Structural equation modeling (SEM) was used to analyze the relationships between predictive and outcome variables. SEM analysis revealed a high level of goodness of fit, and the hypothesized model including social capital yielded a better fit than the original model. Social capital, OSH climate, and OSH performance were determinants of both positive and negative outcome variables. In addition, social capital not only significantly predicted general health directly, but also had a predictive effect on the OSH climate-behavior-outcome relationship. This study makes a contribution to the workplace social capital and OSH climate literature by empirically assessing their relationship in the Chinese education sector.

Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

McGreevy, Michael W.

1996-01-01

A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

[Analysis of decompression safety during extravehicular activity of astronauts in the light of probability theory].

PubMed

Nikolaev, V P; Katuntsev, V P

1998-01-01

Objectives of the study were comparative assessment of the risk of decompression sickness (DCS) in human subjects during shirt-sleeve simulation of extravehicular activity (EVA) following Russian and U.S. protocols, and analysis of causes of the difference between real and simulated EVA decompression safety. To this end, DCS risk during exposure to a sing-step decompression was estimated with an original method. According to the method, DCS incidence is determined by distribution of nucleation efficacy index (z) in the worst body tissues and its critical values (zm) as a function of initial nitrogen tension in these tissues and final ambient pressure post decompression. Gaussian distribution of z values was calculated basing on results of the DCS risk evaluation on the U.S. EVA protocol in an unsuited chamber test with various pre-breath procedures (Conkin et al., 1987). Half-time of nitrogen washout from the worst tissues was presumed to be 480 min. Calculated DCS risk during short-sleeve EVA simulation by the Russian and U.S. protocols with identical physical loading made up 19.2% and 23.4%, respectively. Effects of the working spacesuit pressure, spacesuit rigidity, metabolic rates during operations in EVA space suit, transcutaneous nitrogen exchange in the oxygen atmosphere of space suit, microgravity, analgesics, short compression due to spacesuit leak tests on the eye of EVA are discussed. Data of the study illustrate and advocate for high decompression safety of current Russian and U.S. EVA protocols.

The impact of health information technology on patient safety.

PubMed

Alotaibi, Yasser K; Federico, Frank

2017-12-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety.  This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient's safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.

The impact of health information technology on patient safety

PubMed Central

Alotaibi, Yasser K.; Federico, Frank

2017-01-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient’s safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes. PMID:29209664

Formal methods for modeling and analysis of hybrid systems

NASA Technical Reports Server (NTRS)

Tiwari, Ashish (Inventor); Lincoln, Patrick D. (Inventor)

2009-01-01

A technique based on the use of a quantifier elimination decision procedure for real closed fields and simple theorem proving to construct a series of successively finer qualitative abstractions of hybrid automata is taught. The resulting abstractions are always discrete transition systems which can then be used by any traditional analysis tool. The constructed abstractions are conservative and can be used to establish safety properties of the original system. The technique works on linear and non-linear polynomial hybrid systems: the guards on discrete transitions and the continuous flows in all modes can be specified using arbitrary polynomial expressions over the continuous variables. An exemplar tool in the SAL environment built over the theorem prover PVS is detailed. The technique scales well to large and complex hybrid systems.

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a) General. A flight safety analysis must include a time delay analysis that establishes the mean elapsed time between the violation of a flight termination rule and the time when the flight safety system is...

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a) General. A flight safety analysis must include a time delay analysis that establishes the mean elapsed time between the violation of a flight termination rule and the time when the flight safety system is...

'It's a cultural expectation...' The pressure on medical trainees to work independently in clinical practice.

PubMed

Kennedy, Tara J T; Regehr, Glenn; Baker, G Ross; Lingard, Lorelei A

2009-07-01

Medical trainees demonstrate a reluctance to ask for help unless they believe it is absolutely necessary, a situation which could impact on the safety of patients. This study aimed to develop a theoretical exploration of the pressure on medical trainees to be independent and to generate theory-based approaches to the implications for patient safety of this pressure towards independent working. In Phase 1, 88 teaching team members from internal and emergency medicine were observed during clinical activities (216 hours), and 65 participants completed brief interviews. In Phase 2, 36 in-depth interviews were conducted using video vignettes. Data collection and analysis employed grounded theory methodology. Participants conceived that the pressure towards independence in clinical work originated in trainees' desire to lay claim to the identity of a doctor (as a member of a group of autonomous high achievers), and in organisational issues such as heavy workloads and constant evaluations. The identity and organisational issues related to the pressure towards independence were explored through the lenses of established theories from education and psychology. Consideration of Lave and Wenger's situated learning theory suggests that giving attention to the 'independent doctor' ideal, through measures such as involving trainees when their supervisors ask for help, could impact the safety of teaching team practice. Amalberti et al.'s migration model explains how pressures to maximise productivity and individual gain may cause teaching teams to migrate beyond the boundaries of safe practice and suggests that managing triggers (such as workload and high-stakes evaluations) for violations of safe practice might improve safety. Implementation and evaluation of these theory-based approaches to the safety of teaching team practice would contribute to a better understanding of the links between trainee independence and patient safety.

Transportation systems safety hazard analysis tool (SafetyHAT) user guide (version 1.0)

DOT National Transportation Integrated Search

2014-03-24

This is a user guide for the transportation system Safety Hazard Analysis Tool (SafetyHAT) Version 1.0. SafetyHAT is a software tool that facilitates System Theoretic Process Analysis (STPA.) This user guide provides instructions on how to download, ...

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Applying the AcciMap methodology to investigate the tragic Sewol Ferry accident in South Korea.

PubMed

Lee, Samuel; Moh, Young Bo; Tabibzadeh, Maryam; Meshkati, Najmedin

2017-03-01

This study applies the AcciMap methodology, which was originally proposed by Professor Jens Rasmussen (1997), to the analysis of the tragic Sewol Ferry accident in South Korea on April 16, 2014, which killed 304 mostly young people and is considered as a national disaster in that country. This graphical representation, by incorporating associated socio-technical factors into an integrated framework, provides a big-picture to illustrate the context in which an accident occurred as well as the interactions between different levels of the studied system that resulted in that event. In general, analysis of past accidents within the stated framework can define the patterns of hazards within an industrial sector. Such analysis can lead to the definition of preconditions for safe operations, which is a main focus of proactive risk management systems. In the case of the Sewol Ferry accident, a lot of the blame has been placed on the Sewol's captain and its crewmembers. However, according to this study, which relied on analyzing all available sources published in English and Korean, the disaster is the result of a series of lapses and disregards for safety across different levels of government and regulatory bodies, Chonghaejin Company, and the Sewol's crewmembers. The primary layers of the AcciMap framework, which include the political environment and non-proactive governmental body; inadequate regulations and their lax oversight and enforcement; poor safety culture; inconsideration of human factors issues; and lack of and/or outdated standard operating and emergency procedures were not only limited to the maritime industry in South Korea, and the Sewol Ferry accident, but they could also subject any safety-sensitive industry anywhere in the world. Copyright © 2016 Elsevier Ltd. All rights reserved.

Improving patient safety in Libya: insights from a British health system perspective.

PubMed

Elmontsri, Mustafa; Almashrafi, Ahmed; Dubois, Elizabeth; Banarsee, Ricky; Majeed, Azeem

2018-04-16

Purpose Patient safety programmes aim to make healthcare safe for both patients and health professionals. The purpose of this paper is to explore the UK's patient safety improvement programmes over the past 15 years and explore what lessons can be learnt to improve Libyan healthcare patient safety. Design/methodology/approach Publications focusing on UK patient safety were searched in academic databases and content analysed. Findings Several initiatives have been undertaken over the past 15 years to improve British healthcare patient safety. Many stakeholders are involved, including regulatory and professional bodies, educational providers and non-governmental organisations. Lessons can be learnt from the British journey. Practical implications Developing a national patient safety strategy for Libya, which reflects context and needs is paramount. Above all, Libyan patient safety programmes should reference internationally approved guidelines, evidence, policy and learning from Britain's unique experience. Originality/value This review examines patient safety improvement strategies adopted in Britain to help developing country managers to progress local strategies based on lessons learnt from Britain's unique experience.

Application of real-time PCR (qPCR) for characterization of microbial populations and type of milk in dairy food products.

PubMed

Agrimonti, Caterina; Bottari, Benedetta; Sardaro, Maria Luisa Savo; Marmiroli, Nelson

2017-09-08

Dairy foods represent an important sector of the food market for their nutritional qualities and their organoleptic characteristics, which are often linked to tradition and to region. These products are typically protected by labels such as PDO (Protected Designation of Origin) and PGI (Protected Geographical Indication). Real-time PCR (qPCR) is a fundamental tool in "Food Genomics;" a discipline concerned with the residual DNA in food, which, alongside traditional physical and chemical methods, is frequently used to determine product safety, quality and authenticity. Compared to conventional or "end-point" PCR, qPCR incorporates continuous monitoring of reaction progress, thereby enabling quantification of target DNA. This review describes qPCR applications to the analysis of microbiota, and to the identification of the animal species source of milk from which dairy products have been made. These are important aspects for ensuring safety and authenticity. The various applications of qPCR are discussed, as well as advantages and disadvantages in comparison with other analytical methods.

Line-scan spatially offset Raman spectroscopy for inspecting subsurface food safety and quality

NASA Astrophysics Data System (ADS)

Qin, Jianwei; Chao, Kuanglin; Kim, Moon S.

2016-05-01

This paper presented a method for subsurface food inspection using a newly developed line-scan spatially offset Raman spectroscopy (SORS) technique. A 785 nm laser was used as a Raman excitation source. The line-shape SORS data was collected in a wavenumber range of 0-2815 cm-1 using a detection module consisting of an imaging spectrograph and a CCD camera. A layered sample, which was created by placing a plastic sheet cut from the original container on top of cane sugar, was used to test the capability for subsurface food inspection. A whole set of SORS data was acquired in an offset range of 0-36 mm (two sides of the laser) with a spatial interval of 0.07 mm. Raman spectrum from the cane sugar under the plastic sheet was resolved using self-modeling mixture analysis algorithms, demonstrating the potential of the technique for authenticating foods and ingredients through packaging. The line-scan SORS measurement technique provides a new method for subsurface inspection of food safety and quality.

Nozzle extension design status report

NASA Technical Reports Server (NTRS)

Classen, L. B.

1972-01-01

Twenty possible concepts of a possible nozzle/nozzle extension interface were originated. Not all of the concepts were considered worthy of analysis time. Six of them were thermally analyzed and three were stress analyzed. These analyses were done to determine which of the concepts would have the best chance of succeeding, that is, they were a screening process which was to allow rating of one concept against another. This was done because adequate material properties to determine absolute stress levels were not available at the time of the analyses. Through all of the concepts still exhibit some areas of negative margin of safety, concept no. 1 shows good promise that, with slight modifications, it could have all positive margins of safety. Another significant question, regarding these designs, has to do with the Grafoil seals and insulators. Some additional data was just recently received on Grafoil properties, but it was too late to incorporate in the analyses. The new data were not significantly different from the properties which were used.

Understanding diagnostic errors in medicine: a lesson from aviation

PubMed Central

Singh, H; Petersen, L A; Thomas, E J

2006-01-01

The impact of diagnostic errors on patient safety in medicine is increasingly being recognized. Despite the current progress in patient safety research, the understanding of such errors and how to prevent them is inadequate. Preliminary research suggests that diagnostic errors have both cognitive and systems origins. Situational awareness is a model that is primarily used in aviation human factors research that can encompass both the cognitive and the systems roots of such errors. This conceptual model offers a unique perspective in the study of diagnostic errors. The applicability of this model is illustrated by the analysis of a patient whose diagnosis of spinal cord compression was substantially delayed. We suggest how the application of this framework could lead to potential areas of intervention and outline some areas of future research. It is possible that the use of such a model in medicine could help reduce errors in diagnosis and lead to significant improvements in patient care. Further research is needed, including the measurement of situational awareness and correlation with health outcomes. PMID:16751463

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

2006-01-01

System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

78 FR 43967 - Mercedes-Benz USA, LLC, on Behalf of Daimler AG, Grant of Petition for Decision of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... Federal Motor Vehicle Safety Standard (FMVSS) No. 110, Tire selection and rims and motor home/recreation... affixed to the driver's side B-pillar.* * * (b) Tire size designation, indicated by the headings ``size'' or ``original tire size'' or ``original size,'' and ``spare tire'' or ``spare,'' for the tires...

Published GMO studies find no evidence of harm when corrected for multiple comparisons.

PubMed

Panchin, Alexander Y; Tuzhikov, Alexander I

2017-03-01

A number of widely debated research articles claiming possible technology-related health concerns have influenced the public opinion on genetically modified food safety. We performed a statistical reanalysis and review of experimental data presented in some of these studies and found that quite often in contradiction with the authors' conclusions the data actually provides weak evidence of harm that cannot be differentiated from chance. In our opinion the problem of statistically unaccounted multiple comparisons has led to some of the most cited anti-genetically modified organism health claims in history. We hope this analysis puts the original results of these studies into proper context.

Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials.

PubMed

Bornstein, Natan M; Guekht, Alla; Vester, Johannes; Heiss, Wolf-Dieter; Gusev, Eugene; Hömberg, Volker; Rahlfs, Volker W; Bajenaru, Ovidiu; Popescu, Bogdan O; Muresanu, Dafin

2018-04-01

This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period. Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke. All included studies had a prospective, randomized, double-blind, placebo-controlled design. The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke. For five studies, original analysis data were available for meta-analysis (individual patient data analysis); for four studies, aggregate data were used. The combination by meta-analytic procedures was pre-planned and the methods of synthesis were pre-defined under blinded conditions. Search deadline for the present meta-analysis was December 31, 2016. The nonparametric Mann-Whitney (MW) effect size for National Institutes of Health Stroke Scale (NIHSS) on day 30 (or 21), combining the results of nine randomized, controlled trials by means of the robust Wei-Lachin pooling procedure (maximin-efficient robust test), indicated superiority of Cerebrolysin as compared with placebo (MW 0.60, P < 0.0001, N = 1879). The combined number needed to treat for clinically relevant changes in early NIHSS was 7.7 (95% CI 5.2 to 15.0). The additional full-scale ordinal analysis of modified Rankin Scale at day 90 in moderate to severe patients resulted in MW 0.61 with statistical significance in favor of Cerebrolysin (95% CI 0.52 to 0.69, P = 0.0118, N = 314). Safety aspects were comparable to placebo. Our meta-analysis confirms previous evidence that Cerebrolysin has a beneficial effect on early global neurological deficits in patients with acute ischemic stroke.

Analysis of alternatives for using cable bolts as primary support at two low-seam coal mines

PubMed Central

Esterhuizen, Gabriel S.; Tulu, Ihsan B.

2016-01-01

Cable bolts are sometimes used in low-seam coal mines to provide support in difficult ground conditions. This paper describes cable bolting solutions at two low-seam coal mines in similar ground conditions. Both mines used support systems incorporating cable bolts as part of the primary support system. Two original cable bolt based support systems as well as two modified systems are evaluated to estimate their ability to prevent large roof falls. One of the support systems incorporated passive cable bolts, while the other used pre-tensioned cable bolts. The results and experience at the mines showed that the modified systems provided improved stability over the original support systems. The presence of the cable bolts is the most important contribution to stability against large roof falls, rather than the details of the support pattern. It was also found that a heavy steel channel can improve the safety of the system because of the ‘sling’ action it provides. Additionally, the analysis showed that fully-grouted rebar bolts load much earlier than the cable bolts, and pre-tensioning of the cable bolts can result in a more uniform distribution of loading in the roof. PMID:27722019

Making the Hubble Space Telescope servicing mission safe

NASA Technical Reports Server (NTRS)

Bahr, N. J.; Depalo, S. V.

1992-01-01

The implementation of the HST system safety program is detailed. Numerous safety analyses are conducted through various phases of design, test, and fabrication, and results are presented to NASA management for discussion during dedicated safety reviews. Attention is given to the system safety assessment and risk analysis methodologies used, i.e., hazard analysis, fault tree analysis, and failure modes and effects analysis, and to how they are coupled with engineering and test analysis for a 'synergistic picture' of the system. Some preliminary safety analysis results, showing the relationship between hazard identification, control or abatement, and finally control verification, are presented as examples of this safety process.

Safety analysts training

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

Bolton, P.

The purpose of this task was to support ESH-3 in providing Airborne Release Fraction and Respirable Fraction training to safety analysts at LANL who perform accident analysis, hazard analysis, safety analysis, and/or risk assessments at nuclear facilities. The task included preparation of materials for and the conduct of two 3-day training courses covering the following topics: safety analysis process; calculation model; aerosol physic concepts for safety analysis; and overview of empirically derived airborne release fractions and respirable fractions.

Materials for lithium-ion battery safety.

PubMed

Liu, Kai; Liu, Yayuan; Lin, Dingchang; Pei, Allen; Cui, Yi

2018-06-01

Lithium-ion batteries (LIBs) are considered to be one of the most important energy storage technologies. As the energy density of batteries increases, battery safety becomes even more critical if the energy is released unintentionally. Accidents related to fires and explosions of LIBs occur frequently worldwide. Some have caused serious threats to human life and health and have led to numerous product recalls by manufacturers. These incidents are reminders that safety is a prerequisite for batteries, and serious issues need to be resolved before the future application of high-energy battery systems. This Review aims to summarize the fundamentals of the origins of LIB safety issues and highlight recent key progress in materials design to improve LIB safety. We anticipate that this Review will inspire further improvement in battery safety, especially for emerging LIBs with high-energy density.

Materials for lithium-ion battery safety

PubMed Central

Liu, Kai

2018-01-01

Lithium-ion batteries (LIBs) are considered to be one of the most important energy storage technologies. As the energy density of batteries increases, battery safety becomes even more critical if the energy is released unintentionally. Accidents related to fires and explosions of LIBs occur frequently worldwide. Some have caused serious threats to human life and health and have led to numerous product recalls by manufacturers. These incidents are reminders that safety is a prerequisite for batteries, and serious issues need to be resolved before the future application of high-energy battery systems. This Review aims to summarize the fundamentals of the origins of LIB safety issues and highlight recent key progress in materials design to improve LIB safety. We anticipate that this Review will inspire further improvement in battery safety, especially for emerging LIBs with high-energy density. PMID:29942858

The new interactive CESAR

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

Fox, P.B.; Yatabe, M.

1987-01-01

In this report the Nuclear Criticality Safety Analytical Methods Resource Center describes a new interactive version of CESAR, a critical experiments storage and retrieval program available on the Nuclear Criticality Information System (NCIS) database at Lawrence Livermore National Laboratory. The original version of CESAR did not include interactive search capabilities. The CESAR database was developed to provide a convenient, readily accessible means of storing and retrieving code input data for the SCALE Criticality Safety Analytical Sequences and the codes comprising those sequences. The database includes data for both cross section preparation and criticality safety calculations. 3 refs., 1 tab.

New interactive CESAR

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

Fox, P.B.; Yatabe, M.

1987-01-01

The Nuclear Criticality Safety Analytical Methods Resource Center announces the availability of a new interactive version of CESAR, a critical experiments storage and retrieval program available on the Nuclear Criticality Information System (NCIS) data base at Lawrence Livermore National Laboratory. The original version of CESAR did not include interactive search capabilities. The CESAR data base was developed to provide a convenient, readily accessible means of storing and retrieving code input data for the SCALE criticality safety analytical sequences and the codes comprising those sequences. The data base includes data for both cross-section preparation and criticality safety calculations.

Improved processes for meeting the data requirements for implementing the Highway Safety Manual (HSM) and Safety Analyst in Florida.

DOT National Transportation Integrated Search

2014-03-01

Recent research in highway safety has focused on the more advanced and statistically proven techniques of highway : safety analysis. This project focuses on the two most recent safety analysis tools, the Highway Safety Manual (HSM) : and SafetyAnalys...

Notice to Readers: The Effect of Falsified Clostridium difficile Infections Surveillance Data on Results Reported in MMWR.

PubMed

2015-09-11

In 2012, MMWR published the report, "Vital Signs: Preventing Clostridium difficile Infections," which examined Clostridium difficile infection (CDI) surveillance data. This report contained several errors pertaining to Emerging Infections Program (EIP) data. These errors occurred as a result of scientific misconduct by a former employee of the Oregon Health Authority. The Public Health Service Office of Research Integrity has determined that the former employee falsified or fabricated data for 56 Oregon EIP CDI case report forms (https://ori.hhs.gov/content/case-summary-asherin-ryan). The authors re-analyzed the EIP data to determine if the removal of all Oregon CDI cases (57 total cases) from the 10,342 cases included in the original publication altered the previously reported results. It did not. Re-analysis confirms the conclusions in the original report. Data in the original report from sources other than the Oregon Health Authority (i.e., from other EIP sites, the National Healthcare Safety Network, and Illinois, Massachusetts, and New York CDI prevention programs) were not involved in the research misconduct.Errata for the 2012 report have been published in this issue of MMWR.

The psychometric properties of the 'Hospital Survey on Patient Safety Culture' in Dutch hospitals.

PubMed

Smits, Marleen; Christiaans-Dingelhoff, Ingrid; Wagner, Cordula; Wal, Gerrit van der; Groenewegen, Peter P

2008-11-07

In many different countries the Hospital Survey on Patient Safety Culture (HSOPS) is used to assess the safety culture in hospitals. Accordingly, the questionnaire has been translated into Dutch for application in the Netherlands. The aim of this study was to examine the underlying dimensions and psychometric properties of the questionnaire in Dutch hospital settings, and to compare these results with the original questionnaire used in USA hospital settings. The HSOPS was completed by 583 staff members of four general hospitals, three teaching hospitals, and one university hospital in the Netherlands. Confirmatory factor analyses were performed to examine the applicability of the factor structure of the American questionnaire to the Dutch data. Explorative factor analyses were performed to examine whether another composition of items and factors would fit the data better. Supplementary psychometric analyses were performed, including internal consistency and construct validity. The confirmatory factor analyses were based on the 12-factor model of the original questionnaire and resulted in a few low reliability scores. 11 Factors were drawn with explorative factor analyses, with acceptable reliability scores and a good construct validity. Two items were removed from the questionnaire. The composition of the factors was very similar to that of the original questionnaire. A few items moved to another factor and two factors turned out to combine into a six-item dimension. All other dimensions consisted of two to five items. The Dutch translation of the HSOPS consists of 11 factors with acceptable reliability and good construct validity. and is similar to the original HSOPS factor structure.

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.

PubMed

Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T

2017-04-01

Objective The US Food and Drug Administration (FDA) approves indications for prescription drugs based on premarket pivotal clinical studies designed to demonstrate safety and efficacy. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects Recently approved (2005-2014) prescription drug indications for conditions treated by otolaryngologists or their multidisciplinary teams. Drugs could be authorized for treatment of otolaryngologic disease upon initial approval (original indications) or thereafter via supplemental applications (supplemental indications). Methods Pivotal studies were categorized by enrollment, randomization, blinding, comparator type, and primary endpoint. Results Between 2005 and 2014, the FDA approved 48 otolaryngologic prescription drug indications based on 64 pivotal studies, including 21 original indications (19 drugs, 31 studies) and 27 supplemental indications (18 drugs, 33 studies). Median enrollment was 299 patients (interquartile range, 198-613) for original indications and 197 patients (interquartile range, 64-442) for supplemental indications. Most indications were supported by ≥1 randomized study (original: 20/21 [95%], supplemental: 21/27 [78%]) and ≥1 double-blinded study (original: 14/21 [67%], supplemental: 17/27 [63%]). About half of original indications (9/21 [43%]) and one-quarter of supplemental indications (7/27 [26%]) were supported by ≥1 active-controlled study. Nearly half (original: 8/21 [38%], supplemental: 14/27 [52%]) of all indications were approved based exclusively on studies using surrogate markers as primary endpoints. Conclusion The quality of clinical evidence supporting FDA approval of otolaryngologic prescription drug indications varied widely. Otolaryngologists should consider limitations in premarket evidence when helping patients make informed treatment decisions about newly approved drugs.

A Systematic Review and Meta-Analysis on the Safety of Vascular Endothelial Growth Factor (VEGF) Inhibitors for the Treatment of Retinopathy of Prematurity

PubMed Central

Pertl, Laura; Steinwender, Gernot; Mayer, Christoph; Hausberger, Silke; Pöschl, Eva-Maria; Wackernagel, Werner; Wedrich, Andreas; El-Shabrawi, Yosuf; Haas, Anton

2015-01-01

Introduction Laser photocoagulation is the current gold standard treatment for proliferative retinopathy of prematurity (ROP). However, it permanently reduces the visual field and might induce myopia. Vascular endothelial growth factor (VEGF) inhibitors for the treatment of ROP may enable continuing vascularization of the retina, potentially allowing the preservation of the visual field. However, for their use in infants concern remains. This meta-analysis explores the safety of VEGF inhibitors. Methods The Ovid Interface was used to perform a systematic review of the literature in the databases PubMed, EMBASE and the Cochrane Library. Results This meta-analysis included 24 original reports (including 1.457 eyes) on VEGF inhibitor treatment for ROP. The trials were solely observational except for one randomized and two case-control studies. We estimated a 6-month risk of retreatment per eye of 2.8%, and a 6-month risk of ocular complication without the need of retreatment of 1.6% per eye. Systemic complications were only reported as isolated incidents. Discussion VEGF inhibitors seem to be associated with low recurrence rates and ocular complication rates. They may have the benefit of potentially allowing the preservation of visual field and lower rates of myopia. Due to the lack of data, the risk of systemic side effects cannot be assessed. PMID:26083024

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia.

PubMed

Katagiri, Hideaki; Taketsuna, Masanori; Kondo, Shinpei; Kajimoto, Kenta; Aoi, Etsuko; Tanji, Yuka

2018-01-01

To assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM) in patients with acute agitation associated with schizophrenia in a real-world clinical setting. The postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study). Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration. Effectiveness and safety from initial RAIM administration were evaluated using the Positive and Negative Syndrome Scale-Excited Component score and treatment-emergent adverse events (TEAEs), respectively. The effectiveness and safety analysis set included a total of 521 and 522 patients, respectively. A majority of patients received 10 mg of RAIM (475/522 patients, 91.0%). The mean ± SD total Positive and Negative Syndrome Scale-Excited Component score was 23.6±6.2 (n=318) at baseline (before initial RAIM administration), 17.4±6.8 (n=280) at 2 hours after initial administration, 16.2±6.8 (n=246) 2 days after final administration, 14.9±6.2 (n=248) 3 days after final administration, 13.8±5.9 (n=242) 4 days after final administration, 13.2±5.8 (n=221) 7 days after initial administration, and 13.4±6.2 (n=351) at final observation (with the last observation carried forward approach), showing that reduction in agitation seen with RAIM was sustained with oral dose of olanzapine. The most common TEAEs were dyslalia and somnolence (each event occurred in four patients), and abnormal hepatic function and constipation (occurred in three patients). One serious adverse event of sudden cardiac death occurred after transitioned to oral olanzapine with many other antipsychotic drugs. In the treatment of acute agitation associated with schizophrenia, RAIM could be generally transitioned to oral olanzapine without exacerbating adverse events or losing treatment effect.

Improving patient safety: lessons from rock climbing.

PubMed

Robertson, Nic

2012-02-01

How to improve patient safety remains an intractable problem, despite large investment and some successes. Academics have argued that the root of the problem is a lack of a comprehensive 'safety culture' in hospitals. Other safety-critical industries such as commercial aviation invest heavily in staff training to develop such a culture, but comparable programmes are almost entirely absent from the health care sector. In rock climbing and many other dangerous activities, the 'buddy system' is used to ensure that safety systems are adhered to despite adverse circumstances. This system involves two or more people using simple checks and clear communication to prevent problems causing harm. Using this system as an example could provide a simple, original and entertaining way of introducing medical students to the idea that human factors are central to ensuring patient safety. Teaching the buddy system may improve understanding and acceptance of other patient safety initiatives, and could also be used by junior doctors as a tool to improve the safety of their practice. © Blackwell Publishing Ltd 2012.

Origin and Subsequent Modifications of Explosive Safety Quantity- Distance (ESQD) Standards for Mass Detonating Explosives with Special Reference to Naval Vessels. Volume 2. Appendices

DTIC Science & Technology

1978-05-01

quite heated’ discussion; further, some individuals may be in conflict with one another and speaking only to their own momentary self -interest or...Explosives Safety Board has a charter with resposibilities derived from Acts of Congress and from DoD Directives. Specifically in the area of travel fund

9 CFR 96.2 - Prohibition of casings due to African swine fever and bovine spongiform encephalopathy.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Safety and Inspection Service at 9 CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5. (3... food in accordance with the requirements established by the Food Safety and Inspection Service at 9 CFR... establishment does not receive or process any live swine and uses only pork and pork products that originate in...

78 FR 25577 - Safety Zone, Figure Eight Causeway Channel; Figure Eight Island, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the... the point of origin. This safety zone will be effective from 8 p.m. to 11 p.m. on May 31, 2013. In the... 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this...

Environmental quality of mussel farms in the Vigo estuary: pollution by PAHs, origin and effects on reproduction.

PubMed

Ruiz, Y; Suarez, P; Alonso, A; Longo, E; Villaverde, A; San Juan, F

2011-01-01

This work analyzes the influence of environmental and physiological parameters on PAHs accumulation in cultured mussels. Lipid content and reproductive stage are directly related with PAHs accumulation pattern. We observed a rapid accumulation and depuration of PAHs, mainly during periods of nutrients accumulation, spawns and gonadic restorations. Correlations between PAHs accumulation and physiological status indicate when mussels are more susceptible to adverse effects of these pollutants. A positive correlation between mutagenic congener's accumulation and occurrence of gonadic neoplastic disorders is shown for the first time in mussels. Molecular indices were used to identify the origin of hydrocarbons accumulated by Mytilus, showing a chronic pyrolytic pollution and pollutant episodes by petrogenic sources and biomass combustion in the studied area. Multivariate analysis suggests the possibility of including physiological parameters of sentinel organisms in environmental biomonitoring programs, mainly in aquaculture areas, taking into account their two aspects: farms productivity and human food safety. Copyright © 2010 Elsevier Ltd. All rights reserved.

Mass spectrometry in grape and wine chemistry. Part II: The consumer protection.

PubMed

Flamini, Riccardo; Panighel, Annarita

2006-01-01

Controls in food industry are fundamental to protect the consumer health. For products of high quality, warranty of origin and identity is required and analytical control is very important to prevent frauds. In this article, the "state of art" of mass spectrometry in enological chemistry as a consumer safety contribute is reported. Gas chromatography-mass spectrometry (GC/MS) and liquid-chromatography-mass spectrometry (LC/MS) methods have been developed to determine pesticides, ethyl carbamate, and compounds from the yeast and bacterial metabolism in wine. The presence of pesticides in wine is mainly linked to the use of dicarboxyimide fungicides on vineyard shortly before the harvest to prevent the Botrytis cinerea attack of grape. Pesticide residues are regulated at maximum residue limits in grape of low ppm levels, but significantly lower levels in wine have to be detected, and mass spectrometry offers effective and sensitive methods. Moreover, mass spectrometry represent an advantageous alternative to the radioactive-source-containing electron capture detector commonly used in GC analysis of pesticides. Analysis of ochratoxin A (OTA) in wine by LC/MS and multiple mass spectrometry (MS/MS) permits to confirm the toxin presence without the use of expensive immunoaffinity columns, or time and solvent consuming sample derivatization procedures. Inductively coupled plasma-mass spectrometry (ICP/MS) is used to control heavy metals contamination in wine, and to verify the wine origin and authenticity. Isotopic ratio-mass spectrometry (IRMS) is applied to reveal wine watering and sugar additions, and to determine the product origin and traceability.

Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis.

PubMed

Simoens, Steven; Jacobs, Ira; Popovian, Robert; Isakov, Leah; Shane, Lesley G

2017-10-01

Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters). When evaluated alongside professional guidance on conducting BIA, the majority of BIAs identified were generally in line with international recommendations. However, a lack of peer-reviewed journal articles and considerable shortcomings in the publications were identified. Deficiencies included a limited range of cost parameters, a reliance on assumptions for parameters such as uptake and drug pricing, a lack of expert validation, and a limited range of sensitivity analyses that were based on arbitrary ranges. The rationale for the methods employed, limitations of the BIA approach, and instructions for local adaptation often were inadequately discussed. To understand fully the potential economic impact and value of biosimilars, the impact of biosimilar supply, manufacturer-provided supporting services, and price competition should be included in BIAs. Alternative approaches, such as cost minimization, which requires evidence demonstrating similarity to the originator biologic, and those that integrate a range of economic assessment methods, are needed to assess the value of biosimilars.

Construction of Traceability System for Quality Safety of Cereal and Oil Products

NASA Astrophysics Data System (ADS)

Zheng, Huoguo; Liu, Shihong; Meng, Hong; Hu, Haiyan

After several significant food safety incident, global food industry and governments in many countries are putting increasing emphasis on establishment of food traceability systems. Food traceability has become an effective way in food quality and safety management. The traceability system for quality safety of cereal and oil products was designed and implemented with HACCP and FMECA method, encoding, information processing, and hardware R&D technology etc, according to the whole supply chain of cereal and oil products. Results indicated that the system provide not only the management in origin, processing, circulating and consuming for enterprise, but also tracing service for customers and supervisor by means of telephone, internet, SMS, touch machine and mobile terminal.

14 CFR 417.231 - Collision avoidance analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Collision avoidance analysis. 417.231..., DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.231 Collision avoidance analysis. (a) General. A flight safety analysis must include a collision avoidance analysis that...

78 FR 32412 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

...) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic...

Development of an updated tensile neck injury criterion.

PubMed

Parr, Jeffrey C; Miller, Michael E; Schubert Kabban, Christine M; Pellettiere, Joseph A; Perry, Chris E

2014-10-01

Ejection neck safety remains a concern in military aviation with the growing use of helmet mounted displays (HMDs) worn for entire mission durations. The original USAF tensile neck injury criterion proposed by Carter et al. (4) is updated and an injury protection limit for tensile loading is presented to evaluate escape system and HMD safety. An existent tensile neck injury criterion was updated through the addition of newer post mortem human subject (PMHS) tensile loading and injury data and the application of Survival Analysis to account for censoring in this data. The updated risk function was constructed with a combined human subject (N = 208) and PMHS (N = 22) data set. An updated AIS 3+ tensile neck injury criterion is proposed based upon human and PMHS data. This limit is significantly more conservative than the criterion proposed by Carter in 2000, yielding a 5% risk of AIS 3+ injury at a force of 1136 N as compared to a corresponding force of 1559 N. The inclusion of recent PMHS data into the original tensile neck injury criterion results in an injury protection limit that is significantly more conservative, as recent PMHS data is substantially less censored than the PMHS data included in the earlier criterion. The updated tensile risk function developed in this work is consistent with the tensile risk function published by the Federal Aviation Administration used as the basis for their neck injury criterion for side facing aircraft seats.

CASKS (Computer Analysis of Storage casKS): A microcomputer based analysis system for storage cask design review. User`s manual to Version 1b (including program reference)

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

Chen, T.F.; Gerhard, M.A.; Trummer, D.J.

CASKS (Computer Analysis of Storage casKS) is a microcomputer-based system of computer programs and databases developed at the Lawrence Livermore National Laboratory (LLNL) for evaluating safety analysis reports on spent-fuel storage casks. The bulk of the complete program and this user`s manual are based upon the SCANS (Shipping Cask ANalysis System) program previously developed at LLNL. A number of enhancements and improvements were added to the original SCANS program to meet requirements unique to storage casks. CASKS is an easy-to-use system that calculates global response of storage casks to impact loads, pressure loads and thermal conditions. This provides reviewers withmore » a tool for an independent check on analyses submitted by licensees. CASKS is based on microcomputers compatible with the IBM-PC family of computers. The system is composed of a series of menus, input programs, cask analysis programs, and output display programs. All data is entered through fill-in-the-blank input screens that contain descriptive data requests.« less

Compressive strength of human openwedges: a selection method

NASA Astrophysics Data System (ADS)

Follet, H.; Gotteland, M.; Bardonnet, R.; Sfarghiu, A. M.; Peyrot, J.; Rumelhart, C.

2004-02-01

A series of 44 samples of bone wedges of human origin, intended for allograft openwedge osteotomy and obtained without particular precautions during hip arthroplasty were re-examined. After viral inactivity chemical treatment, lyophilisation and radio-sterilisation (intended to produce optimal health safety), the compressive strength, independent of age, sex and the height of the sample (or angle of cut), proved to be too widely dispersed [ 10{-}158 MPa] in the first study. We propose a method for selecting samples which takes into account their geometry (width, length, thicknesses, cortical surface area). Statistical methods (Principal Components Analysis PCA, Hierarchical Cluster Analysis, Multilinear regression) allowed final selection of 29 samples having a mean compressive strength σ_{max} =103 MPa ± 26 and with variation [ 61{-}158 MPa] . These results are equivalent or greater than average materials currently used in openwedge osteotomy.

A comprehensive review of the implementation of hazard analysis critical control point (HACCP) to the production of flour and flour-based products.

PubMed

Arvanitoyannis, Ioannis S; Traikou, Athina

2005-01-01

The production of flour and semolina and their ensuing products, such as bread, cake, spaghetti, noodles, and corn flakes, is of major importance, because these products constitute some of the main ingredients of the human diet. The Hazard Analysis Critical Control Point (HACCP) system aims at ensuring the safety of these products. HACCP has been implemented within the frame of this study on various products of both Asian and European origin; the hazards, critical control limits (CCLs), observation practices, and corrective actions have been summarized in comprehensive tables. Furthermore, the various production steps, packaging included, were thoroughly analyzed, and reference was made to both the traditional and new methodologies in an attempt to pinpoint the occurring differences (advantages and disadvantages) per process.

Migration, violence, and safety among migrant sex workers: A qualitative study in two Guatemalan communities

PubMed Central

Rocha-Jiménez, Teresita; Brouwer, Kimberly C.; Silverman, Jay G.; Morales-Miranda, Sonia

2016-01-01

Despite reports of high levels of violence among women migrants in Central America, limited evidence exists regarding the health and safety of migrant sex workers in Central America. This study is based on 16 months of field research (November 2012–February 2015), including ethnographic fieldwork, in-depth interviews, and focus groups conducted with 52 internal and international migrant female sex workers in Tecún Úman and Quetzaltenango, Guatemala, key transit and destination communities for both international and internal migrants. The analysis explored migration-related determinants of susceptibility to violence experienced by migrant sex workers across different phases of migration. Violence in home communities and economic considerations were key drivers of migration. Unsafe transit experiences (e.g., undocumented border crossings) and negative interactions with authorities in destination settings (e.g., extortion) contributed to migrant sex workers’ susceptibility to violence, while enhanced access to information on immigration policies and greater migration and sex work experience were found to enhance agency and resilience. Findings suggest an urgent need for actions that promote migrant sex workers’ safety in communities of origin, transit, and destination, and programmes aimed at preventing and addressing human rights violations within the context of migration and sex work. PMID:27439656

An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies

PubMed Central

Yuksel, Mustafa; Gonul, Suat; Laleci Erturkmen, Gokce Banu; Sinaci, Ali Anil; Invernizzi, Paolo; Facchinetti, Sara; Migliavacca, Andrea; Bergvall, Tomas; Depraetere, Kristof; De Roo, Jos

2016-01-01

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information. PMID:27123451

The effect of structural empowerment of nurses on quality outcomes in hospitals: a scoping review.

PubMed

Goedhart, Nicole S; van Oostveen, Catharina J; Vermeulen, Hester

2017-04-01

To assess and synthesise studies reporting direct associations between the structural empowerment of frontline nurses and quality outcomes, and to identify gaps in the current literature. The empowerment of nurses seems essential for delivering high-quality patient care. Understanding the relationship between empowerment and quality outcomes would enable nurse managers to make informed choices on improving the quality of care. A scoping review examining the relationship between the structural empowerment of nurses and the quality, effectiveness, safety, efficiency and patient-centredness of care in hospitals. Searching in MEDLINE, CINAHL, Business Source Premier and Embase identified 672 potentially relevant articles. Independent selection, quality assessment, data extraction and analysis were completed. Twelve cross-sectional studies originating from North America were included. These studies showed a variety of quality outcomes and statistics used. All studies reported positive associations between the structural empowerment of nurses, nurse assessed quality of care and patient safety climate, and work and unit effectiveness. Nurses having access to empowering structures positively affects the quality outcomes, i.e. quality, effectiveness, safety, efficiency and patient-centredness of patient care in hospitals. Nurse managers and leaders should ensure empowering work conditions for nurses in order to increase hospitals' quality of patient care. © 2017 John Wiley & Sons Ltd.

Food-poisoning and commercial air travel.

PubMed

McMullan, R; Edwards, P J; Kelly, M J; Millar, B C; Rooney, P J; Moore, J E

2007-09-01

With the introduction of budget airlines and greater competitiveness amongst all airlines, air travel has now become an extremely popular form of travel, presenting its own unique set of risks from food poisoning. Foodborne illness associated with air travel is quite uncommon in the modern era. However, when it occurs, it may have serious implications for passengers and when crew are affected, has the potential to threaten safety. Quality, safe, in-flight catering relies on high standards of food preparation and storage; this applies at the airport kitchens (or at subcontractors' facilities), on the aircraft and in the transportation vehicles which carry the food from the ground source to the aircraft. This is especially challenging in certain countries. Several foodborne outbreaks have been recorded by the airline industry as a result of a number of different failures of these systems. These have provided an opportunity to learn from past mistakes and current practice has, therefore, reached such a standard so as to minimise risk of failures of this kind. This review examines: (i) the origin of food safety in modern commercial aviation; (ii) outbreaks which have occurred previously relating to aviation travel; (iii) the microbiological quality of food and water on board commercial aircraft; and (iv) how Hazard Analysis Critical Control Points may be employed to maintain food safety in aviation travel.

Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America.

PubMed

Nelson, Anita; Parke, Susanne; Mellinger, Uwe; Zampaglione, Edio; Schmidt, Anja

2014-03-01

This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding patterns were calculated based on bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. In total, 499 women, aged 18-35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1-12, an average 23.5% of women had absent scheduled (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding started after a median of 2 days after intake of the last DNG-containing pill. For safety, data included from 147 women followed over an additional 16 months were added to the original 13-cycle data set. Treatment-related adverse events (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the entire 28-month study period. A COC with E2V and DNG was shown to provide effective contraception in women aged 18-35 years in North America.

Civility norms, safety climate, and safety outcomes: a preliminary investigation.

PubMed

McGonagle, Alyssa K; Walsh, Benjamin M; Kath, Lisa M; Morrow, Stephanie L

2014-10-01

Working environments that are both civil and safe are good for business and employee well-being. Civility has been empirically linked to such important outcomes as organizational performance and individuals' positive work-related attitudes, yet research relating civility to safety is lacking. In this study, we link perceptions of civility norms to perceptions of safety climate and safety outcomes. Drawing on social exchange theory, we proposed and tested a model in 2 samples wherein civility norms indirectly relate to safety outcomes through associations with various safety climate facets. Our results supported direct relationships between civility and management safety climate and coworker safety climate. Additionally, indirect effects of civility norms on unsafe behaviors and injuries were observed. Indirect effects of civility norms on unsafe behaviors were observed through coworker safety climate and work-safety tension. Indirect effects of civility norms on injuries were observed through management safety climate and work-safety tension for full-time employees, although these effects did not hold for part-time employees. This study provides initial evidence that researchers and practitioners may want to look beyond safety climate to civility norms to more comprehensively understand the origins of unsafe behaviors and injuries and to develop appropriate preventive interventions. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

Application of hazard analysis and critical control point methodology and risk-based grading to consumer food safety surveys.

PubMed

Røssvoll, Elin Halbach; Ueland, Øydis; Hagtvedt, Therese; Jacobsen, Eivind; Lavik, Randi; Langsrud, Solveig

2012-09-01

Traditionally, consumer food safety survey responses have been classified as either "right" or "wrong" and food handling practices that are associated with high risk of infection have been treated in the same way as practices with lower risks. In this study, a risk-based method for consumer food safety surveys has been developed, and HACCP (hazard analysis and critical control point) methodology was used for selecting relevant questions. We conducted a nationally representative Web-based survey (n = 2,008), and to fit the self-reported answers we adjusted a risk-based grading system originally developed for observational studies. The results of the survey were analyzed both with the traditional "right" and "wrong" classification and with the risk-based grading system. The results using the two methods were very different. Only 5 of the 10 most frequent food handling violations were among the 10 practices associated with the highest risk. These 10 practices dealt with different aspects of heat treatment (lacking or insufficient), whereas the majority of the most frequent violations involved storing food at room temperature for too long. Use of the risk-based grading system for survey responses gave a more realistic picture of risks associated with domestic food handling practices. The method highlighted important violations and minor errors, which are performed by most people and are not associated with significant risk. Surveys built on a HACCP-based approach with risk-based grading will contribute to a better understanding of domestic food handling practices and will be of great value for targeted information and educational activities.

77 FR 15784 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic information, age, membership...

78 FR 20684 - Towing Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Government. DHS does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and...

7 CFR 65.175 - Ground pork.

Code of Federal Regulations, 2011 CFR

2011-01-01

... pork of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.170 - Ground lamb.

Code of Federal Regulations, 2010 CFR

2010-01-01

... lamb of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.160 - Ground chicken.

Code of Federal Regulations, 2011 CFR

2011-01-01

... comminuted chicken of skeletal origin that is produced in conformance with all applicable Food Safety and... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.175 - Ground pork.

Code of Federal Regulations, 2014 CFR

2014-01-01

... pork of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.170 - Ground lamb.

Code of Federal Regulations, 2011 CFR

2011-01-01

... lamb of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.170 - Ground lamb.

Code of Federal Regulations, 2012 CFR

2012-01-01

... lamb of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.170 - Ground lamb.

Code of Federal Regulations, 2013 CFR

2013-01-01

... lamb of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.175 - Ground pork.

Code of Federal Regulations, 2012 CFR

2012-01-01

... pork of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.165 - Ground goat.

Code of Federal Regulations, 2010 CFR

2010-01-01

... goat of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.175 - Ground pork.

Code of Federal Regulations, 2010 CFR

2010-01-01

... pork of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.175 - Ground pork.

Code of Federal Regulations, 2013 CFR

2013-01-01

... pork of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.160 - Ground chicken.

Code of Federal Regulations, 2012 CFR

2012-01-01

... comminuted chicken of skeletal origin that is produced in conformance with all applicable Food Safety and... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.170 - Ground lamb.

Code of Federal Regulations, 2014 CFR

2014-01-01

... lamb of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.160 - Ground chicken.

Code of Federal Regulations, 2013 CFR

2013-01-01

... comminuted chicken of skeletal origin that is produced in conformance with all applicable Food Safety and... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.160 - Ground chicken.

Code of Federal Regulations, 2010 CFR

2010-01-01

... comminuted chicken of skeletal origin that is produced in conformance with all applicable Food Safety and... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.165 - Ground goat.

Code of Federal Regulations, 2014 CFR

2014-01-01

... goat of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.165 - Ground goat.

Code of Federal Regulations, 2011 CFR

2011-01-01

... goat of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.165 - Ground goat.

Code of Federal Regulations, 2012 CFR

2012-01-01

... goat of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.165 - Ground goat.

Code of Federal Regulations, 2013 CFR

2013-01-01

... goat of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

7 CFR 65.160 - Ground chicken.

Code of Federal Regulations, 2014 CFR

2014-01-01

... comminuted chicken of skeletal origin that is produced in conformance with all applicable Food Safety and... OF BEEF, PORK, LAMB, CHICKEN, GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS...

Determination and Identification of a Specific Marker Compound for Discriminating Shrub Chaste Tree Fruit from Agnus Castus Fruit Based on LC/MS Metabolic Analysis.

PubMed

Yahagi, Tadahiro; Masada, Sayaka; Oshima, Naohiro; Suzuki, Ryuta; Matsufuji, Hiroshi; Takahashi, Yutaka; Watanabe, Masato; Yahara, Shoji; Iida, Osamu; Kawahara, Nobuo; Maruyama, Takuro; Goda, Yukihiro; Hakamatsuka, Takashi

2016-01-01

Shrub Chaste Tree Fruit (SCTF) is defined as the fruits of Vitex rotundifolia L. f. and V. trifolia L. and has been used as a component of some traditional Japanese medicines (Kampo formulations). Agnus Castus Fruit (ACF) is defined as the dried ripe fruits of V. agnus-castus L.; it is used in traditional European medicines, but is becoming popular in Japan as both an over-the-counter drug and as an ingredient in health foods for treating premenstrual syndrome (PMS). To ensure the efficacy and safety of both SCTF and ACF products, it is important to precisely authenticate their botanical origins and to clearly distinguish between SCTF and ACF. Therefore, we tried to identify SCTF-specific marker compounds based on LC/MS metabolic analysis. The multivariate analysis of LC/MS data from SCTF and ACF samples furnished candidate marker compounds of SCTF. An SCTF-specific marker was isolated from SCTF crude drugs and identified as 3-O-trans-feruloyl tormentic acid on the basis of spectroscopic data from NMR and MS. Since avoiding contamination from closely related species is a significant requirement for pharmaceuticals of natural origin, this information will be valuable for the quality control of both SCTF and ACF products from the viewpoint of regulatory science.

Application of the Life Safety Code to a Historic Test Stand

NASA Technical Reports Server (NTRS)

Askins, Bruce; Lemke, Paul R.; Lewis, William L.; Covell, Carol C.

2011-01-01

NASA has conducted a study to assess alternatives to refurbishing existing launch vehicle modal test facilities as opposed to developing new test facilities to meet the demands of a very fiscally constrained test and evaluation environment. The results of this study showed that Marshall Space Flight Center (MSFC) Test Stand (TS) 4550 could be made compliant, within reasonable cost and schedule impacts, if safety processes and operational limitations were put in place to meet the safety codes and concerns of the Fire Marshall. Trades were performed with key selection criteria to ensure that appropriate levels of occupant safety are incorporated into test facility design modifications. In preparation for the ground vibration tests that were to be performed on the Ares I launch vehicle, the Ares Flight and Integrated Test Office (FITO) organization evaluated the available test facility options, which included the existing mothballed structural dynamic TS4550 used by Apollo and Shuttle, alternative ground vibration test facilities at other locations, and construction of a new dynamic test stand. After an exhaustive assessment of the alternatives, the results favored modifying the TS4550 because it was the lowest cost option and presented the least schedule risk to the NASA Constellation Program for Ares Integrated Vehicle Ground Vibration Test (IVGVT). As the renovation design plans and drawings were being developed for TS4550, a safety concern was discovered the original design for the construction of the test stand, originally built for the Apollo Program and renovated for the Shuttle Program, was completed before NASA s adoption of the currently imposed safety and building codes per National Fire Protection Association Life Safety Code [NFPA 101] and International Building Codes. The initial FITO assessment of the design changes, required to make TS4550 compliant with current safety and building standards, identified a significant cost increase and schedule impact. An effort was launched to thoroughly evaluate the applicable life safety requirements, examine the context in which they were derived, and determine a means by which the TS4550 modifications could be made within budget and on schedule, while still providing the occupants with appropriate levels of safety.

[Failure mode and effects analysis to improve quality in clinical trials].

PubMed

Mañes-Sevilla, M; Marzal-Alfaro, M B; Romero Jiménez, R; Herranz-Alonso, A; Sanchez Fresneda, M N; Benedi Gonzalez, J; Sanjurjo-Sáez, M

The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Mammalian cell line-based bioassays for toxicological evaluation of landfill leachate treated by Pseudomonas sp. ISTDF1.

PubMed

Ghosh, Pooja; Das, Mihir Tanay; Thakur, Indu Shekhar

2014-01-01

Landfill leachate has become a serious environmental concern because of the presence of many hazardous compounds which even at trace levels are a threat to human health and environment. Therefore, it is important to assess the toxicity of leachate generated and discharge it conforming to the safety standards. The present work examined the efficiency of an earlier reported Pseudomonas sp. strain ISTDF1 for detoxification of leachate collected from Okhla landfill site (New Delhi, India). GC-MS analysis performed after treatment showed the removal of compounds like alpha-limonene diepoxide, brominated dioxin-2-one, Bisphenol A, nitromusk, phthalate derivative, and nitrobenzene originally found in untreated leachate. ICP-AES analysis for heavy metals also showed reduction in concentrations of Zn, Cd, Cr, Fe, Ni, and Pb bringing them within the limit of safety discharge. Methyl tetrazolium (MTT) assay for cytotoxicity, alkaline comet assay for genotoxicity, and 7-ethoxyresorufin-O-deethylase (EROD) assay for dioxin-like behavior were carried out in human hepato-carcinoma cell line HepG2 to evaluate the toxic potential of treated and untreated leachates. The bacterium reduced toxicity as shown by 2.5-fold reduction of MTT EC50 value, 7-fold reduction in Olive Tail Moment, and 2.8-fold reduction in EROD induction after 240 h of bacterial treatment.

49 CFR 583.8 - Procedure for determining country of origin for engines and transmissions (for purposes of...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Procedure for determining country of origin for engines and transmissions (for purposes of determining the information specified by §§ 583.5(a)(4) and 583.5(a)(5) only). 583.8 Section 583.8 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY...

78 FR 18618 - National Offshore Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age, membership in an...

77 FR 7170 - National Boating Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... specific problems. We will consider applications for seven positions that expire or become vacant on... race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity...

Seafood traceability: current needs, available tools, and biotechnological challenges for origin certification.

PubMed

Leal, Miguel Costa; Pimentel, Tânia; Ricardo, Fernando; Rosa, Rui; Calado, Ricardo

2015-06-01

Market globalization and recurring food safety alerts have resulted in a growing consumer awareness of the need for food traceability. This is particularly relevant for seafood due to its perishable nature and importance as a key protein source for the population of the world. Here, we provide an overview of the current needs for seafood origin traceability, along with the limitations and challenges for its implementation. We focus on geochemical, biochemical, and molecular tools and how they should be optimized to be implemented globally and to address our societal needs. We suggest that seafood traceability is key to enforcing food safety regulations and fisheries control, combat fraud, and fulfill present and future expectations of conscientious producers, consumers, and authorities. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

DOT National Transportation Integrated Search

2010-12-01

This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

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

Front line manager's quick reference guide for organizational impact analysis.

PubMed

McCauley, Darendia

2013-09-01

In reference to the original research questions, there is organizational documented support for the QRG. FLMs perceived the QRG to have both effectiveness and utility. Both less experienced FLMs and more experienced FLMs found the QRG to be helpful, as indicated by intended use, with more experienced FLMs indicating a higher intended use. The ATO Office Safety Programs Fatigue Risk Management Group has requested an expansion of the QRG, including fatigue-related issues. Overall, the QRG has proven to be a useful and convenient document for all FLMs. As it becomes a recognizable and essential resource in both the training and management tool box, the use of the QRG will likely grow.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Evaluation of psychometric properties of the German Hospital Survey on Patient Safety Culture and its potential for cross-cultural comparisons: a cross-sectional study.

PubMed

Gambashidze, Nikoloz; Hammer, Antje; Brösterhaus, Mareen; Manser, Tanja

2017-11-09

To study the psychometric characteristics of German version of the Hospital Survey on Patient Safety Culture and to compare its dimensionality to other language versions in order to understand the instrument's potential for cross-national studies. Cross-sectional multicentre study to establish psychometric properties of German version of the survey instrument. 73 units from 37 departments of two German university hospitals. Clinical personnel (n=995 responses, response rate 39.6%). Psychometric properties (eg, model fit, internal consistency, construct validity) of the instrument and comparison of dimensionality across different language translations. The instrument demonstrated acceptable to good internal consistency (Cronbach's alpha 0.64-0.88). Confirmatory factor analysis of the original 12-factor model resulted in marginally satisfactory model fit (root mean square error of approximation (RMSEA)=0.05; standardised root mean residual (SRMR)=0.05; comparative fit index (CFI)=0.90; goodness of fit index (GFI)=0.88; Tucker-Lewis Index (TLI)=0.88). Exploratory factor analysis resulted in an alternative eight-factor model with good model fit (RMSEA=0.05; SRMR=0.05; CFI=0.95; GFI=0.91; TLI=0.94) and good internal consistency (Cronbach's alpha 0.73-0.87) and construct validity. Analysis of the dimensionality compared with models from 10 other language versions revealed eight dimensions with relatively stable composition and appearance across different versions and four dimensions requiring further improvement. The German version of Hospital Survey on Patient Safety Culture demonstrated satisfactory psychometric properties for use in German hospitals. However, our comparison of instrument dimensionality across different language versions indicates limitations concerning cross-national studies. Results of this study can be considered in interpreting findings across national contexts, in further refinement of the instrument for cross-national studies and in better understanding the various facets and dimensions of patient safety culture. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Levetiracetam Versus Phenytoin for Seizure Prophylaxis Following Traumatic Brain Injury: A Systematic Review and Meta-Analysis.

PubMed

Yang, Yong; Zheng, Fangshuo; Xu, Xin; Wang, Xuefeng

2016-08-01

Seizure following traumatic brain injury (TBI) constitutes a common complication that requires effective prevention to improve the outcome of TBI. Phenytoin has been the only recommended antiepileptic drug (AED) for seizure prophylaxis; however, several shortcomings have affected its use. Intravenous levetiracetam has been available since 2006 and has been increasingly accepted as a seizure prophylaxis for brain injury, mainly due to its favorable pharmacokinetic features and minimal adverse events profile. However, the efficacy and safety of levetiracetam versus phenytoin for seizure prophylaxis following TBI are not well clarified. The aim of this study was to assess the efficacy and safety of levetiracetam versus phenytoin for seizure prophylaxis following TBI. We conducted a search of the MEDLINE, EMBASE, and Cochrane library databases to March 2016, and screened original research that included patients with TBI who received levetiracetam. We included randomized controlled trials (RCTs) or controlled observational cohort studies that compared levetiracetam and phenytoin, as well as uncontrolled case series regarding prophylactic levetiracetam following TBI. The outcomes included early or late seizure prophylaxis and safety. The estimates of seizure prophylaxis were pooled using a meta-analysis, and the estimates for the case series were pooled using descriptive statistics. A total of 1614 patients from 11 studies were included in this review, of whom 1285 patients from eight controlled studies (one RCT and seven cohort studies) were included in the meta-analysis. Levetiracetam was not superior to phenytoin with regard to early seizure prophylaxis (risk ratio [RR] 1.10, 95 % confidence interval [CI] 0.64-1.88); the estimate of early seizure incidence was 0.05 (95 % CI 0.02-0.08). Three studies that assessed late seizure did not indicate the superiority of levetiracetam to phenytoin. There were no differences in mortality during hospitalization or after 6 months, or in the number of patients with adverse reactions between levetiracetam and phenytoin. Levetiracetam does not appear to be superior to phenytoin in efficacy or safety with regard to early or late seizure prophylaxis following TBI; however, no class I evidence was identified. Additional evidence from high-quality studies is required.

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

PubMed

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

2015-10-01

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

Checklists in Neurosurgery to Decrease Preventable Medical Errors: A Review

PubMed Central

Enchev, Yavor

2015-01-01

Neurosurgery represents a zero tolerance environment for medical errors, especially preventable ones like all types of wrong site surgery, complications due to the incorrect positioning of patients for neurosurgical interventions and complications due to failure of the devices required for the specific procedure. Following the excellent and encouraging results of the safety checklists in intensive care medicine and in other surgical areas, the checklist was naturally introduced in neurosurgery. To date, the reported world experience with neurosurgical checklists is limited to 15 series with fewer than 20,000 cases in various neurosurgical areas. The purpose of this review was to study the reported neurosurgical checklists according to the following parameters: year of publication; country of origin; area of neurosurgery; type of neurosurgical procedure-elective or emergency; person in charge of the checklist completion; participants involved in completion; whether they prevented incorrect site surgery; whether they prevented complications due to incorrect positioning of the patients for neurosurgical interventions; whether they prevented complications due to failure of the devices required for the specific procedure; their specific aims; educational preparation and training; the time needed for checklist completion; study duration and phases; number of cases included; barriers to implementation; efforts to implementation; team appreciation; and safety outcomes. Based on this analysis, it could be concluded that neurosurgical checklists represent an efficient, reliable, cost-effective and time-saving tool for increasing patient safety and elevating the neurosurgeons’ self-confidence. Every neurosurgical department must develop its own neurosurgical checklist or adopt and modify an existing one according to its specific features and needs in an attempt to establish or develop its safety culture. The world, continental, regional and national neurosurgical societies could promote safety checklists and their benefits. PMID:26740891

Safety System Design for Technology Education. A Safety Guide for Technology Education Courses K-12.

ERIC Educational Resources Information Center

North Carolina State Dept. of Public Instruction, Raleigh. Div. of Vocational Education.

This manual is designed to involve both teachers and students in planning and controlling a safety system for technology education classrooms. The safety program involves students in the design and maintenance of the system by including them in the analysis of the classroom environment, job safety analysis, safety inspection, and machine safety…

14 CFR Appendix B of Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2010 CFR

2010-01-01

... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

14 CFR Appendix B of Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2012 CFR

2012-01-01

... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

14 CFR Appendix B of Part 415 - Safety Review Document Outline

Code of Federal Regulations, 2011 CFR

2011-01-01

... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

A 3-year hygiene and safety monitoring of a meat processing plant which uses raw materials of global origin.

PubMed

Manios, Stavros G; Grivokostopoulos, Nikolaos C; Bikouli, Vasiliki C; Doultsos, Dimitrios A; Zilelidou, Evangelia A; Gialitaki, Maria A; Skandamis, Panagiotis N

2015-09-16

A systematic approach in monitoring the hygiene of a meat processing plant using classical microbiological analyses combined with molecular characterization tools may assist in the safety of the final products. This study aimed: (i) to evaluate the total hygiene level and, (ii) to monitor and characterize the occurrence and spread of Salmonella spp. and Listeria monocytogenes in the environment and the final products of a meat industry that processes meat of global origin. In total, 2541 samples from the processing environment, the raw materials, and the final products were collected from a Greek meat industry in the period 2011-2013. All samples were subjected to enumeration of total viable counts (TVC), Escherichia coli (EC) and total coliforms (TCC) and the detection of Salmonella spp., while 709 of these samples were also analyzed for the presence L. monocytogenes. Pathogen isolates were serotyped and further characterized for their antibiotic resistance and subtyped by PFGE. Raw materials were identified as the primary source of contamination, while improper handling might have also favored the proliferation of the initial microbial load. The occurrence of Salmonella spp. and L. monocytogenes reached 5.5% and 26.9%, respectively. Various (apparent) cross-contamination or persistence trends were deduced based on PFGE analysis results. Salmonella isolates showed wide variation in their innate antibiotic resistance, contrary to L. monocytogenes ones, which were found susceptible to all antibiotics except for cefotaxime. The results emphasize the biodiversity of foodborne pathogens in a meat industry and may be used by meat processors to understand the spread of pathogens in the processing environment, as well as to assist the Food Business Operator (FBO) in establishing effective criteria for selection of raw materials and in improving meat safety and quality. This approach can limit the increase of microbial contamination during the processing steps observed in our study as well as the cross contamination of meat products. Copyright © 2014 Elsevier B.V. All rights reserved.

78 FR 36790 - Commercial Fishing Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... Homeland Security (DHS) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and...

Evolution in performance assessment modeling as a result of regulatory review

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

Rowat, J.H.; Dolinar, G.M.; Stephens, M.E.

1995-12-31

AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteformmore » as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.« less

14 CFR 417.227 - Toxic release hazard analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Toxic release hazard analysis. 417.227..., DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.227 Toxic release hazard analysis. A flight safety analysis must establish flight commit criteria that protect the public from any...

41 CFR 102-80.130 - Who must perform the equivalent level of safety analysis?

Code of Federal Regulations, 2010 CFR

2010-07-01

...-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety Analysis... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who must perform the equivalent level of safety analysis? 102-80.130 Section 102-80.130 Public Contracts and Property Management...

A Synthetic Vision Preliminary Integrated Safety Analysis

NASA Technical Reports Server (NTRS)

Hemm, Robert; Houser, Scott

2001-01-01

This report documents efforts to analyze a sample of aviation safety programs, using the LMI-developed integrated safety analysis tool to determine the change in system risk resulting from Aviation Safety Program (AvSP) technology implementation. Specifically, we have worked to modify existing system safety tools to address the safety impact of synthetic vision (SV) technology. Safety metrics include reliability, availability, and resultant hazard. This analysis of SV technology is intended to be part of a larger effort to develop a model that is capable of "providing further support to the product design and development team as additional information becomes available". The reliability analysis portion of the effort is complete and is fully documented in this report. The simulation analysis is still underway; it will be documented in a subsequent report. The specific goal of this effort is to apply the integrated safety analysis to SV technology. This report also contains a brief discussion of data necessary to expand the human performance capability of the model, as well as a discussion of human behavior and its implications for system risk assessment in this modeling environment.

'Remixing Rasmussen': The evolution of Accimaps within systemic accident analysis.

PubMed

Waterson, Patrick; Jenkins, Daniel P; Salmon, Paul M; Underwood, Peter

2017-03-01

Throughout Jens Rasmussen's career there has been a continued emphasis on the development of methods, techniques and tools for accident analysis and investigation. In this paper we focus on the evolution and development of one specific example, namely Accimaps and their use for accident analysis. We describe the origins of Accimaps followed by a review of 27 studies which have applied and adapted Accimaps over the period 2000-2015 to a range of domains and types of accident. Aside from demonstrating the versatility and popularity of the method, part of the motivation for the review of the use of Accimaps is to address the question of what constitutes a sound, usable, valid and reliable approach to systemic accident analysis. The findings from the review demonstrate continuity with the work carried out by Rasmussen, as well as significant variation (e.g., changes to the Accimap, used of additional theoretical and practice-oriented perspectives on safety). We conclude the paper with some speculations regarding future extension and adaptation of the Accimap approach including the possibility of using hybrid models for accident analysis. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Transportation of Organs by Air: Safety, Quality, and Sustainability Criteria.

PubMed

Mantecchini, L; Paganelli, F; Morabito, V; Ricci, A; Peritore, D; Trapani, S; Montemurro, A; Rizzo, A; Del Sordo, E; Gaeta, A; Rizzato, L; Nanni Costa, A

2016-03-01

The outcomes of organ transplantation activities are greatly affected by the ability to haul organs and medical teams quickly and safely. Organ allocation and usage criteria have greatly improved over time, whereas the same result has not been achieved so far from the transport point of view. Safety and the highest level of service and efficiency must be reached to grant transplant recipients the healthiest outcome. The Italian National Transplant Centre (CNT), in partnership with the regions and the University of Bologna, has promoted a thorough analysis of all stages of organ transportation logistics chains to produce homogeneous and shared guidelines throughout the national territory, capable of ensuring safety, reliability, and sustainability at the highest levels. The mapping of all 44 transplant centers and the pertaining airport network has been implemented. An analysis of technical requirements among organ shipping agents at both national and international level has been promoted. A national campaign of real-time monitoring of organ transport activities at all stages of the supply chain has been implemented. Parameters investigated have been hospital and region of both origin and destination, number and type of organs involved, transport type (with or without medical team), stations of arrival and departure, and shipping agents, as well as actual times of activities involved. National guidelines have been issued to select organ storage units and shipping agents on the basis of evaluation of efficiency, reliability, and equipment with reference to organ type and ischemia time. Guidelines provide EU-level standards on technical equipment of aircrafts, professional requirements of shipping agencies and cabin crew, and requirements on service provision, including pricing criteria. The introduction in the Italian legislation of guidelines issuing minimum requirements on topics such as the medical team, packaging, labeling, safety and integrity, identification, real-time monitoring of temperature, and traceability of the organ during the logistics chain is deemed a valid response to the necessity of improving safety, reliability, and sustainability of organ transplantation activities in Italy. Copyright © 2016 Elsevier Inc. All rights reserved.

[Topical issues of biological safety under current conditions. Part 2. Conceptual, terminological, and definitive framework of biological safety].

PubMed

Onishchenko, G G; Smolenskiĭ, V Iu; Ezhlova, E B; Demina, Iu V; Toporkov, V P; Toporkov, A V; Liapin, M N; Kutyrev, V V

2013-01-01

In accordance with the established conceptual base for the up-to-date broad interpretation of biological safety, and IHR (2005), developed is the notional, terminological, and definitive framework, comprising 33 elements. Key item of the nomenclature is the biological safety that is identified as population safety (individual, social, national) from direct and (or) human environment mediated (occupational, socio-economic, geopolitical infrastructures, ecological system) exposures to hazardous biological factors. Ultimate objective of the biological safety provision is to prevent and liquidate aftermaths of emergency situations of biological character either of natural or human origin (anthropogenic) arising from direct and indirect impact of the biological threats to the public health compatible with national and international security hazard. Elaborated terminological framework allows for the construction of self-sufficient semantic content for biological safety provision, subject to formalization in legislative, normative and methodological respects and indicative of improvement as regards organizational and structural-functional groundwork of the Russian Federation National chemical and biological safety system, which is to become topical issue of Part 3.

43 CFR 12.805 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, which... a duty-free entry certificate is issued). Components of foreign origin of the same class or kind for...

43 CFR 12.805 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, which... a duty-free entry certificate is issued). Components of foreign origin of the same class or kind for...

75 FR 74022 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Nuclear Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an...

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

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

CROWE, R.D.; PIEPHO, M.G.

2000-03-23

This document provided the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report''. All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.

Planned Safety Analysis of the ACTS-CC 02 Trial: A Randomized Phase III Trial of S-1 With Oxaliplatin Versus Tegafur and Uracil With Leucovorin as Adjuvant Chemotherapy for High-Risk Stage III Colon Cancer.

PubMed

Kusumoto, Tetsuya; Sunami, Eiji; Ota, Mitsuyoshi; Yoshida, Kazuhiro; Sakamoto, Yoshiyuki; Tomita, Naohiro; Maeda, Atsuyuki; Mochizuki, Izumi; Okabe, Michio; Kunieda, Katsuyuki; Yamauchi, Junichiro; Itabashi, Michio; Kotake, Kenjiro; Takahashi, Keiichi; Baba, Hideo; Boku, Narikazu; Aiba, Keisuke; Ishiguro, Megumi; Morita, Satoshi; Sugihara, Kenichi

2018-06-01

This trial was designed to verify the superiority of 6 months of postoperative adjuvant chemotherapy with SOX (S-1 with oxaliplatin) with UFT (tegafur and uracil) with LV (leucovorin) in terms of disease-free survival in patients with high-risk stage III colon cancer. We report the results of a planned safety analysis. Patients who underwent curative resection for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries) were randomly assigned to receive either UFT/LV (300-600 mg/d UFT with 75 mg/d LV on days 1-28, every 35 days, for 5 cycles) or SOX (100 mg/m 2 of oxaliplatin on day 1 with 80-120 mg/d S-1 on days 1-14, every 21 days, for 8 cycles). Treatment status and safety were evaluated. A total of 966 patients were enrolled, and 932 patients were included in safety analyses. The planned 6-month protocol treatment was received by 76.9% of the patients in the UFT/LV group and 65.8% of those in the SOX group. The overall incidence of any Grade adverse events (AEs) were 91.3% in the UFT/LV group and 98.7% in the SOX group, and those of Grade ≥ 3 AEs were 16.1% and 36.1%, respectively. As for Grade ≥ 3 AEs, leukopenia, neutropenia, thrombocytopenia, and sensory neuropathy were more common in the SOX group. The incidence of Grade ≥ 3 sensory peripheral neuropathy was 4.6% in the SOX group. The completion rate of adjuvant SOX and its incidence of AEs were acceptable in patients with colon cancer. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

National Conference for College and University Safety Educators Association (First, Central Missouri State University, Warrensburg, August 16-17, 1975). Sefety Monographs for Schools and Colleges No. 36.

ERIC Educational Resources Information Center

Green, Jack N., Ed.

This publication is a compilation of five papers that were originally presented at the 1975 National Conference of the College and University Safety Educators Association. Most of the booklet consists of the text of these papers; also included are a copy of the conference agenda and a complete roster of conference participants. The five papers…

Concept analysis of safety climate in healthcare providers.

PubMed

Lin, Ying-Siou; Lin, Yen-Chun; Lou, Meei-Fang

2017-06-01

To report an analysis of the concept of safety climate in healthcare providers. Compliance with safe work practices is essential to patient safety and care outcomes. Analysing the concept of safety climate from the perspective of healthcare providers could improve understanding of the correlations between safety climate and healthcare provider compliance with safe work practices, thus enhancing quality of patient care. Concept analysis. The electronic databases of CINAHL, MEDLINE, PubMed and Web of Science were searched for literature published between 1995-2015. Searches used the keywords 'safety climate' or 'safety culture' with 'hospital' or 'healthcare'. The concept analysis method of Walker and Avant analysed safety climate from the perspective of healthcare providers. Three attributes defined how healthcare providers define safety climate: (1) creation of safe working environment by senior management in healthcare organisations; (2) shared perception of healthcare providers about safety of their work environment; and (3) the effective dissemination of safety information. Antecedents included the characteristics of healthcare providers and healthcare organisations as a whole, and the types of work in which they are engaged. Consequences consisted of safety performance and safety outcomes. Most studies developed and assessed the survey tools of safety climate or safety culture, with a minority consisting of interventional measures for improving safety climate. More prospective studies are needed to create interventional measures for improving safety climate of healthcare providers. This study is provided as a reference for use in developing multidimensional safety climate assessment tools and interventional measures. The values healthcare teams emphasise with regard to safety can serve to improve safety performance. Having an understanding of the concept of and interventional measures for safety climate allows healthcare providers to ensure the safety of their operations and their patients. © 2016 John Wiley & Sons Ltd.

Interchange Safety Analysis Tool (ISAT) : user manual

DOT National Transportation Integrated Search

2007-06-01

This User Manual describes the usage and operation of the spreadsheet-based Interchange Safety Analysis Tool (ISAT). ISAT provides design and safety engineers with an automated tool for assessing the safety effects of geometric design and traffic con...

Radioactive dispersion analysis for hypothetical nuclear power plant (NPP) candidate site in Perak state, Malaysia

NASA Astrophysics Data System (ADS)

Shamsuddin, Shazmeen Daniar; Basri, Nor Afifah; Omar, Nurlyana; Koh, Meng-Hock; Ramli, Ahmad Termizi; Saridan Wan Hassan, Wan Muhamad

2017-10-01

Malaysia is planning to build a nuclear power plant (NPP) by 2030 to diversify the national electricity supply and resources. Selection of an NPP site must consider various factors, especially nuclear safety consideration to fulfil the nuclear safety objectives. Environmental Risk Assessment Analysis is a part of safety requirements by the International Atomic Energy Agency (IAEA) prior to the NPP commissioning process. Risk Assessments Analysis (RIA) is compulsory for the NPP site evaluation. One of RIA methods are Radioactive Dispersion Analysis using probabilistic risk analysis software. It is also important to perform studies to estimate the impact to the neighbouring population in the case of a nuclear accident at the power plant. In the present work, aimed to study the impact of a hypothetical nuclear accident by simulating the dispersion pattern of radionuclides originated from a candidate site at Manjung, Perak. The work has been performed using the HotSpot Health Physics codes. Two types of radionuclides have been considered namely 137Cs and 131I. In calculations, the initial concentration of radioactive materials of Fukushima Daiichi accident data are used which are 2.06 x 1016 Bq and 1.68 x 1017 Bq respectively for the two radionuclides. The result shows that the dispersion distance obtained from both software are not the same. It shows that 137Cs and 131I can be dispersed as far as 16 km and 80 km away from the site during radiological accident respectively, reaching major towns in Perak. Using HOTSPOT, the estimated total effective dose equivalent (TEDE) for 137Cs and 131I at major towns in Perak such as Lumut and Sitiawan are 1.2 mSv and 9.9 mSv. As for Taiping, Ipoh, Kampar, and Teluk Intan the estimated TEDE is around 0.2 mSv and 1.6 mSv respectively. In conclusion, the dispersion can reach as far as 80 km from the site. However, estimated annual effective dose is not more than 1 mSv limit, which is considered acceptable in the point of view of radiological health risk for human and the environment.

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

PubMed

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

2015-03-01

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting field collection activities) indicated that training on field research safety issues would be helpful, and even more (71% overall; 93% from institutions conducting field collection activities) would consider participation in such a training course. Results obtained from this study can be used to develop a field research safety toolkit and associated training curricula specifically targeted to biological safety professionals.

Consumer-driven definition of traditional food products and innovation in traditional foods. A qualitative cross-cultural study.

PubMed

Guerrero, Luis; Guàrdia, Maria Dolors; Xicola, Joan; Verbeke, Wim; Vanhonacker, Filiep; Zakowska-Biemans, Sylwia; Sajdakowska, Marta; Sulmont-Rossé, Claire; Issanchou, Sylvie; Contel, Michele; Scalvedi, M Luisa; Granli, Britt Signe; Hersleth, Margrethe

2009-04-01

Traditional food products (TFP) are an important part of European culture, identity, and heritage. In order to maintain and expand the market share of TFP, further improvement in safety, health, or convenience is needed by means of different innovations. The aim of this study was to obtain a consumer-driven definition for the concept of TFP and innovation and to compare these across six European countries (Belgium, France, Italy, Norway, Poland and Spain) by means of semantic and textual statistical analyses. Twelve focus groups were performed, two per country, under similar conditions. The transcriptions obtained were submitted to an ordinary semantic analysis and to a textual statistical analysis using the software ALCESTE. Four main dimensions were identified for the concept of TFP: habit-natural, origin-locality, processing-elaboration and sensory properties. Five dimensions emerged around the concept of innovation: novelty-change, variety, processing-technology, origin-ethnicity and convenience. TFP were similarly perceived in the countries analysed, while some differences were detected for the concept of innovation. Semantic and statistical analyses of the focus groups led to similar results for both concepts. In some cases and according to the consumers' point of view the application of innovations may damage the traditional character of TFP.

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

Height outcome of the recombinant human growth hormone treatment in patients with SHOX gene haploinsufficiency: a meta-analysis.

PubMed

Massart, Francesco; Bizzi, Martina; Baggiani, Angelo; Miccoli, Mario

2013-04-01

Patients with mutations or deletions of the SHOX gene present variable growth impairment, with or without mesomelic skeletal dysplasia. If untreated, short patients with SHOX haplodeficiency (SHOXD) remain short into adulthood. Although recombinant human growth hormone (rhGH) treatment improves short-term linear growth, there are episodic data on the final height of treated SHOXD subjects. After a thorough search of the published literature for pertinent studies, we undertook a meta-analysis evaluation of the efficacy and safety of rhGH treatment in SHOXD patients. In SHOXD patients, administration of rhGH progressively improved the height deficit from baseline to 24 months, although the major catch-up growth was detected after 12 months. The rhGH-induced growth appeared constant until final height. Our meta-analysis suggested rhGH therapy improves height outcome of SHOXD patients, though future studies using carefully titrated rhGH protocols are needed. Original submitted 29 October 2012; Revision submitted 22 February 2013.

Investigation of a Verification and Validation Tool with a Turbofan Aircraft Engine Application

NASA Technical Reports Server (NTRS)

Uth, Peter; Narang-Siddarth, Anshu; Wong, Edmond

2018-01-01

The development of more advanced control architectures for turbofan aircraft engines can yield gains in performance and efficiency over the lifetime of an engine. However, the implementation of these increasingly complex controllers is contingent on their ability to provide safe, reliable engine operation. Therefore, having the means to verify the safety of new control algorithms is crucial. As a step towards this goal, CoCoSim, a publicly available verification tool for Simulink, is used to analyze C-MAPSS40k, a 40,000 lbf class turbo-fan engine model developed at NASA for testing new control algorithms. Due to current limitations of the verification software, several modifications are made to C-MAPSS40k to achieve compatibility with CoCoSim. Some of these modifications sacrifice fidelity to the original model. Several safety and performance requirements typical for turbofan engines are identified and constructed into a verification framework. Preliminary results using an industry standard baseline controller for these requirements are presented. While verification capabilities are demonstrated, a truly comprehensive analysis will require further development of the verification tool.

Distributional impacts of water markets on small farmers: Is there a safety net?

NASA Astrophysics Data System (ADS)

Hadjigeorgalis, Ereney

2008-10-01

The United Nations 2006 human development report states that water markets have not been shown to protect the interests of the poor, while other research has found that water markets have benefited smaller, resource-constrained farmers. This article provides insight into this international development debate by analyzing the impact of water markets on small farmers in the Limarí River Basin of Chile. The analysis is based on data collected from an extensive in-person survey of 316 farmers in the basin. Results show that water markets in the basin have been successful in moving water and water rights from low- to high-valued uses and that resource-constrained farmers use temporary water sales as a safety net. The long-term beneficial effects of water market trades for the most resource-constrained farmers, however, remain unclear. These results are relevant to both Chile and a host of developing countries where agriculture is a predominant activity and water resources are scarce. They are also applicable to the western United States, where water market trades often originate in the agricultural sector.

[Implementation and validation in the Italian context of the HSE management standards: a contribution to provide a practical model for the assessment of work-related stress].

PubMed

Iavicoli, S; Natali, E; Rondinone, B M; Castaldi, T; Persechino, B

2010-01-01

Over the last years, stress has been recognized as a potential work-related risk factor. Unfortunately, work-related stress is a very delicate subject, especially because it is difficult to assess it objectively and in broadly acceptable terms. In fact, work-related stress is a subjective personal response to a specific work environment, ad is of a multifactorial origin. In order to provide a practical tool for the assessment of work-related stress, the authors carried out a thorough benchmarking analysis of the various models to manage work stress problems adopted by EU countries. As a result, the authors have chosen to apply and implement the Health and Safety Executive (HSE) Management Standards approach in the Italian context. In compliance with the European Framework Agreement signed on October 8, 2004, HSE Management Standards ask for the coordinated and integrated involvement of workers and safety personnel and represent a valid assessment approach based on principles widely acknowledged in the scientific literature.

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

K Basin Hazard Analysis

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

PECH, S.H.

This report describes the methodology used in conducting the K Basins Hazard Analysis, which provides the foundation for the K Basins Final Safety Analysis Report. This hazard analysis was performed in accordance with guidance provided by DOE-STD-3009-94, Preparation Guide for U. S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports and implements the requirements of DOE Order 5480.23, Nuclear Safety Analysis Report.

75 FR 69648 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an amendment to the...

Narrative thematic analysis of baccalaureate nursing students' reflections: critical thinking in the clinical education context.

PubMed

Naber, Jessica L; Hall, Joanne; Schadler, Craig Matthew

2014-09-01

This study sought to identify characteristics of clinically situated critical thinking in nursing students' reflections, originally part of a study guided by Richard Paul's model of critical thinking. Nurses are expected to apply critical thinking in all practice situations to improve health outcomes, including patient safety and satisfaction. In a previous study, Paul's model of critical thinking was used to develop questions for reflective writing assignments. Within that study, 30 nursing students completed six open-ended narratives of nurse-patient clinical encounters during an 8-week period. Improvements were seen in critical thinking scores after the intervention. This article reports the qualitative analysis of the content of six open-ended narratives. Six overarching themes were identified and combined into a tentative conceptual model. Faculty's understanding of the characteristics of critical thinking in the context of clinical education will help them to teach and evaluate students' progress and competencies for future practice.

Methods for the analysis of azo dyes employed in food industry--A review.

PubMed

Yamjala, Karthik; Nainar, Meyyanathan Subramania; Ramisetti, Nageswara Rao

2016-02-01

A wide variety of azo dyes are generally added for coloring food products not only to make them visually aesthetic but also to reinstate the original appearance lost during the production process. However, many countries in the world have banned the use of most of the azo dyes in food and their usage is highly regulated by domestic and export food supplies. The regulatory authorities and food analysts adopt highly sensitive and selective analytical methods for monitoring as well as assuring the quality and safety of food products. The present manuscript presents a comprehensive review of various analytical techniques used in the analysis of azo dyes employed in food industries of different parts of the world. A brief description on the use of different extraction methods such as liquid-liquid, solid phase and membrane extraction has also been presented. Copyright © 2015 Elsevier Ltd. All rights reserved.

Profiling contextual factors which influence safety in heavy vehicle industries.

PubMed

Edwards, Jason R D; Davey, Jeremy; Armstrong, Kerry A

2014-12-01

A significant proportion of worker fatalities within Australia result from truck-related incidents. Truck drivers face a number of health and safety concerns. Safety culture, viewed here as the beliefs, attitudes and values shared by an organisation's workers, which interact with their surrounding context to influence behaviour, may provide a valuable lens for exploring safety-related behaviours in heavy vehicle operations. To date no major research has examined safety culture within heavy vehicle industries. As safety culture provides a means to interpret experiences and generate behaviour, safety culture research should be conducted with an awareness of the context surrounding safety. The current research sought to examine previous health and safety research regarding heavy vehicle operations to profile contextual factors which influence health and safety. A review of 104 peer-reviewed papers was conducted. Findings of these papers were then thematically analysed. A number of behaviours and scenarios linked with crashes and non-crash injuries were identified, along with a selection of health outcomes. Contextual factors which were found to influence these outcomes were explored. These factors were found to originate from government departments, transport organisations, customers and the road and work environment. The identified factors may provide points of interaction, whereby culture may influence health and safety outcomes. Copyright © 2014. Published by Elsevier Ltd.

Making Sense of a Negative Clinical Trial Result: A Bayesian Analysis of a Clinical Trial of Lorazepam and Diazepam for Pediatric Status Epilepticus.

PubMed

Chamberlain, Daniel B; Chamberlain, James M

2017-01-01

We demonstrate the application of a Bayesian approach to a recent negative clinical trial result. A Bayesian analysis of such a trial can provide a more useful interpretation of results and can incorporate previous evidence. This was a secondary analysis of the efficacy and safety results of the Pediatric Seizure Study, a randomized clinical trial of lorazepam versus diazepam for pediatric status epilepticus. We included the published results from the only prospective pediatric study of status in a Bayesian hierarchic model, and we performed sensitivity analyses on the amount of pooling between studies. We evaluated 3 summary analyses for the results: superiority, noninferiority (margin <-10%), and practical equivalence (within ±10%). Consistent with the original study's classic analysis of study results, we did not demonstrate superiority of lorazepam over diazepam. There is a 95% probability that the true efficacy of lorazepam is in the range of 66% to 80%. For both the efficacy and safety outcomes, there was greater than 95% probability that lorazepam is noninferior to diazepam, and there was greater than 90% probability that the 2 medications are practically equivalent. The results were largely driven by the current study because of the sample sizes of our study (n=273) and the previous pediatric study (n=61). Because Bayesian analysis estimates the probability of one or more hypotheses, such an approach can provide more useful information about the meaning of the results of a negative trial outcome. In the case of pediatric status epilepticus, it is highly likely that lorazepam is noninferior and practically equivalent to diazepam. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Virulence-Associated Genome Mutations of Murine Rotavirus Identified by Alternating Serial Passages in Mice and Cell Cultures

PubMed Central

Tatsumi, Masatoshi; Tsutsumi, Hiroyuki

2014-01-01

ABSTRACT Although significant clinical efficacy and safety of rotavirus vaccines were recently revealed in many countries, the mechanism of their attenuation is not well understood. We passaged serially a cell culture-adapted murine rotavirus EB strain in mouse pups or in cell cultures alternately and repeatedly and fully sequenced all 11 genes of 21 virus samples passaged in mice or in cell cultures. Sequence analysis revealed that mouse-passaged viruses that regained virulence almost consistently acquired four kinds of amino acid (aa) substitutions in VP4 and substitution in aa 37 (Val to Ala) in NSP4. In addition, they gained and invariably conserved the 3′ consensus sequence in NSP1. The molecular changes occurred along with the acquisition of virulence during passages in mice and then disappeared following passages in cell cultures. Intraperitoneal injection of recombinant NSP4 proteins confirmed the aa 37 site as important for its diarrheagenic activity in mice. These genome changes are likely to be correlated with rotavirus virulence. IMPORTANCE Serial passage of a virulent wild-type virus in vitro often results in loss of virulence of the virus in an original animal host, while serial passage of a cell culture-adapted avirulent virus in vivo often gains virulence in an animal host. Actually, live attenuated virus vaccines were originally produced by serial passage in cell cultures. Although clinical efficacy and safety of rotavirus vaccines were recently revealed, the mechanism of their attenuation is not well understood. We passaged serially a murine rotavirus by alternating switch of host (mice or cell cultures) repeatedly and sequenced the eleven genes of the passaged viruses to identify mutations associated with the emergence or disappearance of virulence. Sequence analysis revealed that changes in three genes (VP4, NSP1, and NSP4) were associated with virulence in mice. Intraperitoneal injection of recombinant NSP4 proteins confirmed its diarrheagenic activity in mice. These genome changes are likely to be correlated with rotavirus virulence. PMID:24599996

Virulence-associated genome mutations of murine rotavirus identified by alternating serial passages in mice and cell cultures.

PubMed

Tsugawa, Takeshi; Tatsumi, Masatoshi; Tsutsumi, Hiroyuki

2014-05-01

Although significant clinical efficacy and safety of rotavirus vaccines were recently revealed in many countries, the mechanism of their attenuation is not well understood. We passaged serially a cell culture-adapted murine rotavirus EB strain in mouse pups or in cell cultures alternately and repeatedly and fully sequenced all 11 genes of 21 virus samples passaged in mice or in cell cultures. Sequence analysis revealed that mouse-passaged viruses that regained virulence almost consistently acquired four kinds of amino acid (aa) substitutions in VP4 and substitution in aa 37 (Val to Ala) in NSP4. In addition, they gained and invariably conserved the 3' consensus sequence in NSP1. The molecular changes occurred along with the acquisition of virulence during passages in mice and then disappeared following passages in cell cultures. Intraperitoneal injection of recombinant NSP4 proteins confirmed the aa 37 site as important for its diarrheagenic activity in mice. These genome changes are likely to be correlated with rotavirus virulence. Serial passage of a virulent wild-type virus in vitro often results in loss of virulence of the virus in an original animal host, while serial passage of a cell culture-adapted avirulent virus in vivo often gains virulence in an animal host. Actually, live attenuated virus vaccines were originally produced by serial passage in cell cultures. Although clinical efficacy and safety of rotavirus vaccines were recently revealed, the mechanism of their attenuation is not well understood. We passaged serially a murine rotavirus by alternating switch of host (mice or cell cultures) repeatedly and sequenced the eleven genes of the passaged viruses to identify mutations associated with the emergence or disappearance of virulence. Sequence analysis revealed that changes in three genes (VP4, NSP1, and NSP4) were associated with virulence in mice. Intraperitoneal injection of recombinant NSP4 proteins confirmed its diarrheagenic activity in mice. These genome changes are likely to be correlated with rotavirus virulence.

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... occurs; (2) A flight safety official's decision and reaction time, including variation in human response... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Time delay analysis. 417.221 Section 417... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a...

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... occurs; (2) A flight safety official's decision and reaction time, including variation in human response... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Time delay analysis. 417.221 Section 417... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a...

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... occurs; (2) A flight safety official's decision and reaction time, including variation in human response... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Time delay analysis. 417.221 Section 417... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a...

14 CFR 417.217 - Overflight gate analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Overflight gate analysis. 417.217 Section..., DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.217 Overflight gate analysis. For a launch that involves flight over a populated or other protected area, the flight safety...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2014 CFR

2014-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2013 CFR

2013-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2010 CFR

2010-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2011 CFR

2011-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2012 CFR

2012-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

Information Services at the Nuclear Safety Analysis Center.

ERIC Educational Resources Information Center

Simard, Ronald

This paper describes the operations of the Nuclear Safety Analysis Center. Established soon after an accident at the Three Mile Island nuclear power plant near Harrisburg, Pennsylvania, its efforts were initially directed towards a detailed analysis of the accident. Continuing functions include: (1) the analysis of generic nuclear safety issues,…

Health Information Technology in Healthcare Quality and Patient Safety: Literature Review.

PubMed

Feldman, Sue S; Buchalter, Scott; Hayes, Leslie W

2018-06-04

The area of healthcare quality and patient safety is starting to use health information technology to prevent reportable events, identify them before they become issues, and act on events that are thought to be unavoidable. As healthcare organizations begin to explore the use of health information technology in this realm, it is often unclear where fiscal and human efforts should be focused. The purpose of this study was to provide a foundation for understanding where to focus health information technology fiscal and human resources as well as expectations for the use of health information technology in healthcare quality and patient safety. A literature review was conducted to identify peer-reviewed publications reporting on the actual use of health information technology in healthcare quality and patient safety. Inductive thematic analysis with open coding was used to categorize a total of 41 studies. Three pre-set categories were used: prevention, identification, and action. Three additional categories were formed through coding: challenges, outcomes, and location. This study identifies five main categories across seven study settings. A majority of the studies used health IT for identification and prevention of healthcare quality and patient safety issues. In this realm, alerts, clinical decision support, and customized health IT solutions were most often implemented. Implementation, interface design, and culture were most often noted as challenges. This study provides valuable information as organizations determine where they stand to get the most "bang for their buck" relative to health IT for quality and patient safety. Knowing what implementations are being effectivity used by other organizations helps with fiscal and human resource planning as well as managing expectations relative to cost, scope, and outcomes. The findings from this scan of the literature suggest that having organizational champion leaders that can shepherd implementation, impact culture, and bridge knowledge with developers would be a valuable resource allocation to consider. ©Sue S Feldman, Scott Buchalter, Leslie W. Hayes. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 04.06.2018.

Tracing the foundations of a conceptual framework for a patient safety ontology.

PubMed

Runciman, William B; Baker, G Ross; Michel, Philippe; Dovey, Susan; Lilford, Richard J; Jensen, Natasja; Flin, Rhona; Weeks, William B; Lewalle, Pierre; Larizgoitia, Itziar; Bates, David

2010-12-01

In work for the World Alliance for Patient Safety on research methods and measures and on defining key concepts for an International Patient Safety Classification (ICPS), it became apparent that there was a need to try to understand how the meaning of patient safety and underlying concepts relate to the existing safety and quality frameworks commonly used in healthcare. To unfold the concept of patient safety and how it relates to safety and quality frameworks commonly used in healthcare and to trace the evolution of the ICPS framework as a basis of the electronic capture of the component elements of patient safety. The ICPS conceptual framework for patient safety has its origins in existing frameworks and an international consultation process. Although its 10 classes and their semantic relationships may be used as a reference model for different disciplines, it must remain dynamic in the ever-changing world of healthcare. By expanding the ICPS by examining data from all available sources, and ensuring rigorous compliance with the latest principles of informatics, a deeper interdisciplinary approach will progressively be developed to address the complex, refractory problem of reducing healthcare-associated harm.

30 CFR 22.11 - Instructions on handling future changes in design.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Certification Center, 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 23.14 - Instructions for handling future changes in design.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 23.14 - Instructions for handling future changes in design.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 22.11 - Instructions on handling future changes in design.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Certification Center, 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 23.14 - Instructions for handling future changes in design.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 22.11 - Instructions on handling future changes in design.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Certification Center, 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 23.14 - Instructions for handling future changes in design.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 23.14 - Instructions for handling future changes in design.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

30 CFR 22.11 - Instructions on handling future changes in design.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Certification Center, 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

43 CFR 12.830 - Buy American Act-Construction materials.

Code of Federal Regulations, 2010 CFR

2010-10-01

... articles, materials or supplies. However, emergency life safety systems, such as emergency lighting, fire... States exceeds 50 percent of the cost of all its components. Components of foreign origin of the same...

43 CFR 12.830 - Buy American Act-Construction materials.

Code of Federal Regulations, 2011 CFR

2011-10-01

... articles, materials or supplies. However, emergency life safety systems, such as emergency lighting, fire... States exceeds 50 percent of the cost of all its components. Components of foreign origin of the same...

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...

Statistical Approaches to Assess Biosimilarity from Analytical Data.

PubMed

Burdick, Richard; Coffey, Todd; Gutka, Hiten; Gratzl, Gyöngyi; Conlon, Hugh D; Huang, Chi-Ting; Boyne, Michael; Kuehne, Henriette

2017-01-01

Protein therapeutics have unique critical quality attributes (CQAs) that define their purity, potency, and safety. The analytical methods used to assess CQAs must be able to distinguish clinically meaningful differences in comparator products, and the most important CQAs should be evaluated with the most statistical rigor. High-risk CQA measurements assess the most important attributes that directly impact the clinical mechanism of action or have known implications for safety, while the moderate- to low-risk characteristics may have a lower direct impact and thereby may have a broader range to establish similarity. Statistical equivalence testing is applied for high-risk CQA measurements to establish the degree of similarity (e.g., highly similar fingerprint, highly similar, or similar) of selected attributes. Notably, some high-risk CQAs (e.g., primary sequence or disulfide bonding) are qualitative (e.g., the same as the originator or not the same) and therefore not amenable to equivalence testing. For biosimilars, an important step is the acquisition of a sufficient number of unique originator drug product lots to measure the variability in the originator drug manufacturing process and provide sufficient statistical power for the analytical data comparisons. Together, these analytical evaluations, along with PK/PD and safety data (immunogenicity), provide the data necessary to determine if the totality of the evidence warrants a designation of biosimilarity and subsequent licensure for marketing in the USA. In this paper, a case study approach is used to provide examples of analytical similarity exercises and the appropriateness of statistical approaches for the example data.

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

Solid hemangioblastoma in the cerebellopontine angle: Importance of external carotid blood supply with regard to the probable site of origin and preoperative embolization.

PubMed

Meena, Rajesh Kumar; Dhandapani, Sivashanmugam; Gupta, Vivek; Anirudh, Srinivasan; Chatterjee, Debajyoti

2016-01-01

Hemangioblastoma (HBL) is rare in the cerebellopontine angle (CPA) with questionable origin and limited access for circumferential dissection and "en-bloc" excision. We report a case of surgical removal of large solid CPA-HBL and discuss the pattern of blood supply suggesting its origin and indicating preoperative embolization. The solid and highly vascular CPA-HBL had feeders mainly from neuromeningeal division of ascending pharyngeal branch of external carotid artery, suggesting true extra-axial origin. We could achieve "en-bloc" excision without significant blood loss or morbidity using preoperative embolization. Large solid HBL is rare in CPA necessitating arduous "en-bloc" excision. The pattern of blood supply probably indicates the site of origin and safety of preoperative embolization.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

The angular structure of ONC201, a TRAIL pathway-inducing compound, determines its potent anti-cancer activity

PubMed Central

Wagner, Jessica; Kline, Christina Leah; Pottorf, Richard S.; Nallaganchu, Bhaskara Rao; Olson, Gary L.; Dicker, David T.; Allen, Joshua E.; El-Deiry, Wafik S.

2014-01-01

We previously identified TRAIL-inducing compound 10 (TIC10), also known as NSC350625 or ONC201, from a NCI chemical library screen as a small molecule that has potent anti-tumor efficacy and a benign safety profile in preclinical cancer models. The chemical structure that was originally published by Stahle, et. al. in the patent literature was described as an imidazo[1,2-a]pyrido[4,3-d]pyrimidine derivative. The NCI and others generally accepted this as the correct structure, which was consistent with the mass spectrometry analysis outlined in the publication by Allen et. al. that first reported the molecule's anticancer properties. A recent publication demonstrated that the chemical structure of ONC201 material from the NCI is an angular [3,4-e] isomer of the originally disclosed, linear [4,3-d] structure. Here we confirm by NMR and X-ray structural analysis of the dihydrochloride salt form that the ONC201 material produced by Oncoceutics is the angular [3,4-e] structure and not the linear structure originally depicted in the patent literature and by the NCI. Similarly, in accordance with our biological evaluation, the previously disclosed anti-cancer activity is associated with the angular structure and not the linear isomer. Together these studies confirm that ONC201, produced by Oncoceutics or obtained from the NCI, possesses an angular [3,4-e] structure that represents the highly active anti-cancer compound utilized in prior preclinical studies and now entering clinical trials in advanced cancers. PMID:25587031

The angular structure of ONC201, a TRAIL pathway-inducing compound, determines its potent anti-cancer activity.

PubMed

Wagner, Jessica; Kline, Christina Leah; Pottorf, Richard S; Nallaganchu, Bhaskara Rao; Olson, Gary L; Dicker, David T; Allen, Joshua E; El-Deiry, Wafik S

2014-12-30

We previously identified TRAIL-inducing compound 10 (TIC10), also known as NSC350625 or ONC201, from a NCI chemical library screen as a small molecule that has potent anti-tumor efficacy and a benign safety profile in preclinical cancer models. The chemical structure that was originally published by Stahle, et. al. in the patent literature was described as an imidazo[1,2-a]pyrido[4,3-d]pyrimidine derivative. The NCI and others generally accepted this as the correct structure, which was consistent with the mass spectrometry analysis outlined in the publication by Allen et. al. that first reported the molecule's anticancer properties. A recent publication demonstrated that the chemical structure of ONC201 material from the NCI is an angular [3,4-e] isomer of the originally disclosed, linear [4,3-d] structure. Here we confirm by NMR and X-ray structural analysis of the dihydrochloride salt form that the ONC201 material produced by Oncoceutics is the angular [3,4-e] structure and not the linear structure originally depicted in the patent literature and by the NCI. Similarly, in accordance with our biological evaluation, the previously disclosed anti-cancer activity is associated with the angular structure and not the linear isomer. Together these studies confirm that ONC201, produced by Oncoceutics or obtained from the NCI, possesses an angular [3,4-e] structure that represents the highly active anti-cancer compound utilized in prior preclinical studies and now entering clinical trials in advanced cancers.

HEALTH AND SAFETY ORGANIZING: OCAW’S WORKER-TO-WORKER HEALTH AND SAFETY TRAINING PROGRAM*

PubMed Central

SLATIN, CRAIG

2018-01-01

In 1987, the Oil, Chemical, and Atomic Workers International Union (OCAW) was funded as one of the original eleven awardees of the Superfund Worker Training Program of the National Institute of Environmental Health Sciences. The OCAW, with the Labor Institute, developed a hazardous waste worker and hazardous materials emergency responder health and safety training program that was specific to its members in the represented industries. A social history is developed to explore a union-led, worker health education intervention. The program sought to develop worker-trainers who would conduct the training, using the Small-Group Activity Method, participate in curriculum development, and ultimately use health and safety training as a vehicle for identifying, developing, and mobilizing health and safety activists among the membership. Although the direction for this effort came from progressive leadership, it arose from the political economy of labor/management relations within specific industrial sectors. PMID:17208754

Big data in food safety: An overview.

PubMed

Marvin, Hans J P; Janssen, Esmée M; Bouzembrak, Yamine; Hendriksen, Peter J M; Staats, Martijn

2017-07-24

Technology is now being developed that is able to handle vast amounts of structured and unstructured data from diverse sources and origins. These technologies are often referred to as big data, and open new areas of research and applications that will have an increasing impact in all sectors of our society. In this paper we assessed to which extent big data is being applied in the food safety domain and identified several promising trends. In several parts of the world, governments stimulate the publication on internet of all data generated in public funded research projects. This policy opens new opportunities for stakeholders dealing with food safety to address issues which were not possible before. Application of mobile phones as detection devices for food safety and the use of social media as early warning of food safety problems are a few examples of the new developments that are possible due to big data.

Comparative efficacy and safety in ESA biosimilars vs. originators in adults with chronic kidney disease: a systematic review and meta-analysis.

PubMed

Amato, Laura; Addis, Antonio; Saulle, Rosella; Trotta, Francesco; Mitrova, Zuzana; Davoli, Marina

2018-06-01

Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking. We performed a systematic literature search of CENTRAL, PubMed, and Embase through November 11, 2015. Our inclusion criteria encompassed randomized, controlled clinical trials that evaluated the comparative effectiveness of different ESAs originators and/or biosimilar. The considered participants were adults aged 18 years or older with anemia due to CKD. The overall quality of evidence was assessed using the GRADE system. We identified 30 eligible studies including 7843 patients with CKD, and 21/30 studies included patients using hemodialysis or peritoneal dialysis. Compared with ESA biosimilars, epoetin α did not statistically differ for any of the ten measured outcomes. The quality of evidence varied from low to very low. In the comparison between epoetin α vs. darbepoetin α, no differences were observed for all outcomes, but blood transfusions showed favorable results for darbepoetin α: RR 2.18 (1.31-3.62). The quality of evidence varied from low to very low. No differences were observed between epoetin β and methoxy polyethylene glycol-epoetin β, and between darbepoetin α and methoxy polyethylene glycol-epoetin β, the quality of evidence varied from moderate to very low. Data from 31 included studies allowed to pool data in meta-analysis related to four different comparisons and eleven outcome measures. Nevertheless, only one result was statistically significant in favor of darbepoetin α in the comparison with epoetin α concerning blood transfusions. For all the other outcomes and comparisons, we did not find any differences in terms of efficacy and security between the EPO considered. The quality of evidence is quite low, and further research could change these results. Further high quality studies examining the comparative effectiveness of ESAs need to be conducted.

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

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

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

1992-01-01

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

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

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

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

1992-12-01

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

Transcranial Direct Current Stimulation in Epilepsy.

PubMed

San-Juan, Daniel; Morales-Quezada, León; Orozco Garduño, Adolfo Josué; Alonso-Vanegas, Mario; González-Aragón, Maricarmen Fernández; Espinoza López, Dulce Anabel; Vázquez Gregorio, Rafael; Anschel, David J; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is an emerging non-invasive neuromodulation therapy in epilepsy with conflicting results in terms of efficacy and safety. Review the literature about the efficacy and safety of tDCS in epilepsy in humans and animals. We searched studies in PubMed, MedLine, Scopus, Web of Science and Google Scholar (January 1969 to October 2013) using the keywords 'transcranial direct current stimulation' or 'tDCS' or 'brain polarization' or 'galvanic stimulation' and 'epilepsy' in animals and humans. Original articles that reported tDCS safety and efficacy in epileptic animals or humans were included. Four review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions, PRISMA guidelines and Jadad Scale. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies. We analyzed 9 articles with different methodologies (3 animals/6 humans) with a total of 174 stimulated individuals; 109 animals and 65 humans. In vivo and in vitro animal studies showed that direct current stimulation can successfully induce suppression of epileptiform activity without neurological injury and 4/6 (67%) clinical studies showed an effective decrease in epileptic seizures and 5/6 (83%) reduction of inter-ictal epileptiform activity. All patients tolerated tDCS well. tDCS trials have demonstrated preliminary safety and efficacy in animals and patients with epilepsy. Further larger studies are needed to define the best stimulation protocols and long-term follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.

Safety philosophy of gas turbine high temperature reactor (GTHTR300)

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

Shoji Katanishi; Kazuhiko Kunitomi; Shusaku Shiozawa

2002-07-01

Japan Atomic Energy Research Institute (JAERI) has undertaken the study of an original design concept of gas turbine high temperature reactor, the GTHTR300. The general concept of this study is development of a greatly simplified design that leads to substantially reduced technical and cost requirements. Newly proposed design features enable the GTHTR300 to be an efficient and economically competitive reactor in 2010's. Also, the GTHTR300 fully takes advantage of its inherent safety characteristics. The safety philosophy of the GTHTR300 is developed based on the HTTR (High Temperature Engineering Test Reactor) of JAERI which is the first HTGR in Japan. Majormore » features of the newly proposed safety philosophy for the GTHTR300 are described in this article. (authors)« less

Efficacy and safety of meditative movement therapies in fibromyalgia syndrome: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Langhorst, Jost; Klose, Petra; Dobos, Gustav J; Bernardy, Kathrin; Häuser, Winfried

2013-01-01

A systematic review with meta-analysis of the efficacy and safety of meditative movement therapies (Qigong, Tai Chi and Yoga) in fibromyalgia syndrome (FMS) was carried out. We screened Clinicaltrials.Gov, Cochrane Library, PsycINFO, PubMed and Scopus (through December 2010) and the reference sections of original studies for meditative movement therapies (MMT) in FMS. Randomized controlled trials (RCT) comparing MMT to controls were analysed. Outcomes of efficacy were pain, sleep, fatigue, depression and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD [95% confidence interval]). Outcomes of safety were drop out because of adverse events and serious adverse events. A total of 7 out of 117 studies with 362 subjects and a median of 12 sessions (range 8-24) were included. MMT reduced sleep disturbances (-0.61 [-0.95, -0.27]; 0.0004), fatigue (-0.66 [-0.99, -0.34]; <0.0001), depression (-0.49 [-0.76, -0.22]; 0.0004) and limitations of HRQOL (-0.59 [-0.93, -0.24]; 0.0009), but not pain (-0.35 [-0.80, 0.11]; 0.14) compared to controls at final treatment. The significant effects on sleep disturbances (-0.52 [-0.97, -0.07]; 0.02) and HRQOL (-0.66 [-1.31, -0.01]; 0.05) could be maintained after a median of 4.5 (range 3-6) months. In subgroup analyses, only Yoga yielded significant effects on pain, fatigue, depression and HRQOL at final treatment. Drop out rate because of adverse events was 3.1%. No serious adverse events were reported. MMT are safe. Yoga had short-term beneficial effects on some key domains of FMS. There is a need for high-quality studies with larger sample sizes to confirm the results.

What have we learned from reporting safety incidents in the Surgical Block?: Cross-sectional descriptive study of two-years of activity of a multidisciplinary analytical group.

PubMed

Caba Barrientos, F; Rodríguez Morillo, A; Galisteo Domínguez, R; Del Nozal Nalda, M; Almeida González, C V; Echevarría Moreno, M

2018-05-01

Incident Reporting Systems (IRS) are considered a tool that facilitates learning and safety culture. Using the experience gained with SENSAR, we evaluated the feasibility and the activity of a multidisciplinary group analyzing incidents in the surgical patient notified to a general community system, that of the Observatory for Patient Safety (OPS). Cross-sectional observational study planned for two years. After training in the analysis, a multidisciplinary group was created in terms of specialties and professional categories, which would analyze the incidents in the surgical patient notified to the OPS. Incidents are classified and their circumstances analyzed. Between March 2015 and 2017, 95 incidents were reported (4 by non-professionals). Doctors reported more than nurses, at 54 (56.84%) vs. 37 (38.94%). The anaesthesia unit reported most at 46 (48.42%) (P=.025). The types of incidents mainly related to the care procedure (30.52%); to the preoperative period (42.10%); and to the place, the surgical area (48.42%). Significant differences were detected according to the origin of the notifier (P=.03). No harm, or minor morbidity, constituted 88% of the incidents. Errors were identified in 79%. The analysis of the incidents directed the measures to be taken. The activity undertaken by the multidisciplinary analytical group during the period of study facilitated knowledge of the system among the professionals and enabled the identification of areas for improvement in the Surgical Block at different levels. Copyright © 2017 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2010 CFR

2010-07-01

... equivalent level of safety. (c) As a third option, other technical analysis procedures, as approved by the... Equivalent Level of Safety Analysis § 102-80.115 Is there more than one option for establishing that an... areas of safety. Available safe egress times would be developed based on analysis of a number of assumed...

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

On the origin of synthetic life: attribution of output to a particular algorithm

NASA Astrophysics Data System (ADS)

Yampolskiy, Roman V.

2017-01-01

With unprecedented advances in genetic engineering we are starting to see progressively more original examples of synthetic life. As such organisms become more common it is desirable to gain an ability to distinguish between natural and artificial life forms. In this paper, we address this challenge as a generalized version of Darwin’s original problem, which he so brilliantly described in On the Origin of Species. After formalizing the problem of determining the samples’ origin, we demonstrate that the problem is in fact unsolvable. In the general case, if computational resources of considered originator algorithms have not been limited and priors for such algorithms are known to be equal, both explanations are equality likely. Our results should attract attention of astrobiologists and scientists interested in developing a more complete theory of life, as well as of AI-Safety researchers.

Evaluation of the efficacy and safety of bromocriptine QR in type 2 diabetes.

PubMed

Ramteke, Karuna Balwant; Ramanand, Sunita Jaiprakash; Ramanand, Jaiprakash B; Jain, Suyog Subhas; Raparti, Girish Tulsidas; Patwardhan, Milind Hari; Murthy, Mangala; Ghanghas, Ravi G

2011-07-01

Diabetes mellitus is a chronic metabolic disorder of endocrinal origin with multiorgan involement. Today's physician has a lot many options to choose for treating type 2 diabetes, but does not always manages to achieve optimal glycemic control. The newer drug bromocriptine acts by novel hypothalamic circadian rhythm resetting mechanism. To evaluate the efficacy and safety of bromocriptine QR in type 2 diabetes. 105 patients according to inclusion and exclusion criteria were randomized into three groups by simple randomization. Group 1 received bromocriprine 2.4 mg once daily, group 2 received metformin 500 mg twice daily while group 3 received bromocriprine 1.6 mg daily and metformin 500 mg twice daily. Baseline measurement of fasting and postprandial blood sugar, HbA1(C) and BMI were followed up at 6(th) and 12(th) weeks. Safety evaluation was done by questioning the patient and also through routine hematological and biochemical parameters. Z test was used for analysis. Group 1 showed significant reduction in fasting and postprandial sugar and HbA(1c) at 12 weeks. While groups 2 and 3 showed even higher reduction in these parameters albeit with slightly more adverse drug events like nausea, vomiting compared to group 1. Bromocriptine QR is an effective and safe antidiabetic drug which can be employed as monotherapy or in conjuction with metformin to achieve and maintain optimal glycemic control.

Postauthorization safety study of Clottafact® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study.

PubMed

Négrier, C; Ducloy-Bouthors, A-S; Piriou, V; De Maistre, E; Stieltjes, N; Borel-Derlon, A; Colson, P; Picard, J; Lambert, T; Claeyssens, S; Boileau, S; Bertrand, A; André, M-H; Fourrier, F; Ozier, Y; Sié, P; Gruel, Y; Tellier, Z

2018-02-01

A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact ® in acquired fibrinogen deficiency in real-life medical practice in France. One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed. One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%). The Clottafact ® safety profile observed during the study matched the known profile of fibrinogen during use. © 2017 International Society of Blood Transfusion.

30 CFR 20.14 - Instructions for handling future changes in lamp design.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., 765 Technology Drive, Triadelphia, WV 26059, requesting an extension of the original approval and... that are critical to the safety of the product; and (iv) All documentation, including drawings and...

Estimating the safety benefits of context sensitive solutions.

DOT National Transportation Integrated Search

2011-11-01

Context Sensitive Solutions (CSS), also commonly known by the original name Context Sensitive Design : (CSD), is an alternative approach to the conventional transportation-oriented decision-making and design : processes. The CSS approach can be used ...

47 CFR 80.409 - Station logs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... radiotelephone operating location while the vessel is being navigated. All entries in their original form must be... occurrences which may appear to be of importance to safety of life or property at sea, must be entered...

Viewpoint on ISA TR84.0.02--simplified methods and fault tree analysis.

PubMed

Summers, A E

2000-01-01

ANSI/ISA-S84.01-1996 and IEC 61508 require the establishment of a safety integrity level for any safety instrumented system or safety related system used to mitigate risk. Each stage of design, operation, maintenance, and testing is judged against this safety integrity level. Quantitative techniques can be used to verify whether the safety integrity level is met. ISA-dTR84.0.02 is a technical report under development by ISA, which discusses how to apply quantitative analysis techniques to safety instrumented systems. This paper discusses two of those techniques: (1) Simplified equations and (2) Fault tree analysis.

A Content Analysis of Health and Safety Communications Among Internet-Based Sex Work Advertisements: Important Information for Public Health.

PubMed

Kille, Julie; Bungay, Vicky; Oliffe, John; Atchison, Chris

2017-04-13

The capacity to advertise via the Internet continues to contribute to the shifting dynamics in adult commercial sex work. eHealth interventions have shown promise to promote Internet-based sex workers' health and safety internationally, yet minimal attention has been paid in Canada to developing such interventions. Understanding the information communicated in Internet-based sex work advertisements is a critical step in knowledge development to inform such interventions. The purpose of this content analysis was to increase our understanding of the health and safety information within the Internet advertisements among women, men, and transgender sex workers and to describe how this information may be utilized to inform eHealth service development for this population. A total of 75 Internet-based sex worker advertisements (45 women, 24 men, and 6 transgender persons) were purposefully selected from 226 advertisements collected as part of a larger study in Western Canada. Content analysis was employed to guide data extraction about demographic characteristics, sexual services provided, service restrictions, health practices and concerns, safety and security, and business practices. Frequencies for each variable were calculated and further classified by gender. Thematic analysis was then undertaken to situate the communications within the social and commercialized contexts of the sex industry. Four communications themes were identified: (1) demographic characteristics; (2) sexual services; (3) health; and (4) safety and security. White was the most common ethnicity (46/75, 61%) of advertisements. It was found that 20-29 years of age accounted for 32 of the 51 advertisements that provided age. Escort, the only legal business title, was the most common role title used (48/75, 64%). In total, 85% (64/75) of advertisements detailed lists of sexual services provided and 41% (31/75) of advertisements noted never offering uncovered services (ie, no condom). Gender and the type of Web-based platform mattered for information communicated. It was found that 35 of the 45 women's advertisements were situated in personal websites and hosted details about nonsexual aspects of an appointment. Men and transworkers used Internet classified advertisement platforms with predetermined categories. Communications about sexually transmitted infections (STIs) occurred in only 16% (12/75) of advertisements with men accounting for 7. Women's advertisements accounted for 26 of the 37 advertisements noting safety restrictions. Zero men or transpersons restricted alcohol or drug use. In total, 75% (56/75) of advertisements offered out-call services and the average minimal hourly rate ranged from Can $140/h to Can $200/h. The study findings contribute to understandings about the diverse platforms used in commercial sex advertisements, and how sex workers frame information for potential clients. This information affords health care providers and policy makers insights to how they might assist with promoting the health of Internet-based sex workers and their clients. ©Julie Kille, Vicky Bungay, John Oliffe, Chris Atchison. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.04.2017.

Improving safety on rural local and tribal roads site safety analysis - user guide #1.

DOT National Transportation Integrated Search

2014-08-01

This User Guide presents an example of how rural local and Tribal practitioners can study conditions at a preselected site. It demonstrates the step-by-step safety analysis process presented in Improving Safety on Rural Local and Tribal Roads Saf...

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...

Writing a Cochrane systematic review on preventive interventions to improve safety: the case of the construction industry.

PubMed

van der Molen, H F; Hoonakker, P L T; Lehtola, Marika M; Hsiao, H; Haslam, R A; Hale, A R; Verbeek, J H

2009-01-01

The objective of this paper is to describe the main steps and to conduct a systematic literature review on preventive interventions concerning work-related injuries and to illustrate the process. Based on the Cochrane handbook, a structured framework of six steps was outlined for the development of a systematic review. This framework was used to describe a Cochrane systematic review (CSR) on the effectiveness of interventions to prevent work related injuries in the construction industry. The 6 main steps to write a CSR were: formulating the problem and objectives; locating and selecting studies; assessing study quality; collecting data; analysing data and presenting results; and interpreting results. The CSR on preventing injuries in the construction industry yielded five eligible intervention studies. Re-analysis of original injury data of the studies on regulatory interventions, through correcting for pre-intervention injury trends led to different conclusions about the effectiveness of interventions than those reported in the original studies. The Cochrane handbook for systematic reviews of interventions provides a practical and feasible six-step framework for developing and reporting a systematic review for preventive interventions.

Infusing Reliability Techniques into Software Safety Analysis

NASA Technical Reports Server (NTRS)

Shi, Ying

2015-01-01

Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.

Stability of Large Parallel Tunnels Excavated in Weak Rocks: A Case Study

NASA Astrophysics Data System (ADS)

Ding, Xiuli; Weng, Yonghong; Zhang, Yuting; Xu, Tangjin; Wang, Tuanle; Rao, Zhiwen; Qi, Zufang

2017-09-01

Diversion tunnels are important structures for hydropower projects but are always placed in locations with less favorable geological conditions than those in which other structures are placed. Because diversion tunnels are usually large and closely spaced, the rock pillar between adjacent tunnels in weak rocks is affected on both sides, and conventional support measures may not be adequate to achieve the required stability. Thus, appropriate reinforcement support measures are needed, and the design philosophy regarding large parallel tunnels in weak rocks should be updated. This paper reports a recent case in which two large parallel diversion tunnels are excavated. The rock masses are thin- to ultra-thin-layered strata coated with phyllitic films, which significantly decrease the soundness and strength of the strata and weaken the rocks. The behaviors of the surrounding rock masses under original (and conventional) support measures are detailed in terms of rock mass deformation, anchor bolt stress, and the extent of the excavation disturbed zone (EDZ), as obtained from safety monitoring and field testing. In situ observed phenomena and their interpretation are also included. The sidewall deformations exhibit significant time-dependent characteristics, and large magnitudes are recorded. The stresses in the anchor bolts are small, but the extents of the EDZs are large. The stability condition under the original support measures is evaluated as poor. To enhance rock mass stability, attempts are made to reinforce support design and improve safety monitoring programs. The main feature of these attempts is the use of prestressed cables that run through the rock pillar between the parallel tunnels. The efficacy of reinforcement support measures is verified by further safety monitoring data and field test results. Numerical analysis is constantly performed during the construction process to provide a useful reference for decision making. The calculated deformations are in good agreement with the measured data, and the calculated forces of newly added cables show that the designed reinforcement is necessary and ensures sufficient stability. Finally, the role of safety monitoring in the evaluation of rock mass stability and the consideration of tunnel group effect are discussed. The work described in this paper aims to deepen the understanding of rock mass behaviors of large parallel tunnels in weak rocks and to improve the design philosophy.

Development of the Social Capital Questionnaire in Greece.

PubMed

Kritsotakis, George; Koutis, Antonis D; Alegakis, Athanassios K; Philalithis, Anastas E

2008-06-01

The Greek version of the social capital questionnaire (SCQ-G) was evaluated in a sample of 521 adults drawn from three different urban areas in Greece. Exploratory factor analysis followed by multi-trait scaling yielded six factors: Participation in the Community, Feelings of Safety, Family/Friends Connections, Value of Life and Social Agency, Tolerance of Diversity, and Work Connections. The factor solution is similar to the patterns identified originally in Australia and the US. Variations suggest that social capital does not share the same structure in different countries. The SCQ-G is a useful scale to measure individual-level social capital in Greece. Social capital measurement tools should be validated in each cultural or national setting in which they are used.

Relationships between psychological safety climate facets and safety behavior in the rail industry: a dominance analysis.

PubMed

Morrow, Stephanie L; McGonagle, Alyssa K; Dove-Steinkamp, Megan L; Walker, Curtis T; Marmet, Matthew; Barnes-Farrell, Janet L

2010-09-01

The goals of this study were twofold: (1) to confirm a relationship between employee perceptions of psychological safety climate and safety behavior for a sample of workers in the rail industry and (2) to explore the relative strengths of relationships between specific facets of safety climate and safety behavior. Non-management rail maintenance workers employed by a large North American railroad completed a survey (n=421) regarding workplace safety perceptions and behaviors. Three facets of safety climate (management safety, coworker safety, and work-safety tension) were assessed as relating to individual workers' reported safety behavior. All three facets were significantly associated with safety behavior. Dominance analysis was used to assess the relative importance of each facet as related to the outcome, and work-safety tension evidenced the strongest relationship with safety behavior. Published by Elsevier Ltd.

Collapse Mechanisms Of Masonry Structures

NASA Astrophysics Data System (ADS)

Zuccaro, G.; Rauci, M.

2008-07-01

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of one of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.

Collapse Mechanisms Of Masonry Structures

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

Zuccaro, G.; Rauci, M.

2008-07-08

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of onemore » of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.« less

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.205 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... one analysis must be compatible in form and content with the data input requirements of any other... TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.205 General. (a) Public risk management. A flight safety analysis must demonstrate that a launch operator will, for each launch, control the risk to...

9 CFR 151.11 - Form of books of record.

Code of Federal Regulations, 2010 CFR

2010-01-01

... safety film exposed at a reduction ratio not to exceed 24 diameters. All information on the original... be indexed to state the numbers of the pedigree certificates on the roll of film it contains. [24 FR...

Safety Grooving

NASA Technical Reports Server (NTRS)

1985-01-01

Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association (IG&GA), the industry expanded into highway and pedestrian applications. The technique originated at Langley, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle's cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots and other potentially slippery surfaces.

The use of fatigue tests in the manufacture of automotive steel wheels.

NASA Astrophysics Data System (ADS)

Drozyner, P.; Rychlik, A.

2016-08-01

Production for the automotive industry must be particularly sensitive to the aspect of safety and reliability of manufactured components. One of such element is the rim, where durability is a feature which significantly affects the safety of transport. Customer complaints regarding this element are particularly painful for the manufacturer because it is almost always associated with the event of accident or near-accident. Authors propose original comprehensive method of quality control at selected stages of rims production: supply of materials, production and pre-shipment inspections. Tests by the proposed method are carried out on the originally designed inertial fatigue machine The machine allows bending fatigue tests in the frequency range of 0 to 50 Hz at controlled increments of vibration amplitude. The method has been positively verified in one of rims factory in Poland. Implementation resulted in an almost complete elimination of complaints resulting from manufacturing and material errors.

10 CFR 72.248 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR).

PubMed

Bongiovanni, Alberto; Monti, Manuela; Foca, Flavia; Recine, Federica; Riva, Nada; Di Iorio, Valentina; Liverani, Chiara; De Vita, Alessandro; Miserocchi, Giacomo; Mercatali, Laura; Amadori, Dino; Ibrahim, Toni

2017-01-01

Anthracycline and ifosfamide-based chemotherapy represents a widely used regimen both in early and advanced settings in soft tissue sarcoma (STS). Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. The aim of this study was to assess the efficacy and safety of biosimilar G-CSF in these patients. Between 2003 and 2013, 67 patients with soft tissue tumors under epirubicin and ifosfamide (EI) treatment receiving biosimilar filgrastim (Zarzio®), originator filgrastim (Granulokine®, Neupogen®), and lenograstim (only originator Myelostim®) as primary prophylaxis for a total of 260 cycles of therapy were retrospectively analyzed. Baseline patient characteristics were summarized in a propensity score (PS). The incidence of febrile neutropenia (FN) was 44.0 % in biosimilar filgrastim, 40.0 % in originator filgrastim, and 45.5 % in the lenograstim groups (p = 0.935). All grade and G4 neutropenia were similar in the three groups with the same safety profile. The use of biosimilar filgrastim achieved cost savings of €225.25 over originator filgrastim and €262.00 over lenograstim. Biosimilar G-CSF was effective in preventing FN and in reducing the need for hospitalization in STS patients undergoing EI treatment. It also proved comparable to its reference products from both a clinical and cost-effective standpoint.

Space Station Furnace Facility. Volume 2: Requirements Definition and Conceptual Design Study. Appendix 3: Environment Analysis. Volume 2; Appendix 3

NASA Technical Reports Server (NTRS)

1992-01-01

A Preliminary Safety Analysis (PSA) is being accomplished as part of the Space Station Furnace Facility (SSFF) contract. This analysis is intended to support SSFF activities by analyzing concepts and designs as they mature to develop essential safety requirements for inclusion in the appropriate specifications, and designs, as early as possible. In addition, the analysis identifies significant safety concerns that may warrant specific trade studies or design definition, etc. The analysis activity to date concentrated on hazard and hazard cause identification and requirements development with the goal of developing a baseline set of detailed requirements to support trade study, specifications development, and preliminary design activities. The analysis activity will continue as the design and concepts mature. Section 2 defines what was analyzed, but it is likely that the SSFF definitions will undergo further changes. The safety analysis activity will reflect these changes as they occur. The analysis provides the foundation for later safety activities. The hazards identified will in most cases have Preliminary Design Review (PDR) applicability. The requirements and recommendations developed for each hazard will be tracked to ensure proper and early resolution of safety concerns.

Defining attributes of patient safety through a concept analysis.

PubMed

Kim, Linda; Lyder, Courtney H; McNeese-Smith, Donna; Leach, Linda Searle; Needleman, Jack

2015-11-01

The aim of this study was to report an analysis of the concept of patient safety. Despite recent increase in the number of work being done to clarify the concept and standardize measurement of patient safety, there are still huge variations in how the term is conceptualized and how to measure patient safety data across various healthcare settings and in research. Concept analysis. A literature search was conducted through PubMed and Cumulative Index to Nursing and Allied Health Literature, Plus using the terms 'patient safety' in the title and 'concept analysis,' 'attributes' or 'definition' in the title and or abstract. All English language literature published between 2002-2014 were considered for the review. Walker and Avant's method guided this analysis. The defining attributes of patient safety include prevention of medical errors and avoidable adverse events, protection of patients from harm or injury and collaborative efforts by individual healthcare providers and a strong, well-integrated healthcare system. The application of Collaborative Alliance of Nursing Outcomes indicators as empirical referents would facilitate the measurement of patient safety. With the knowledge gained from this analysis, nurses may improve patient surveillance efforts that identify potential hazards before they become adverse events and have a stronger voice in health policy decision-making that influence implementation efforts aimed at promoting patient safety, worldwide. Further studies are needed on development of a conceptual model and framework that can aid with collection and measurement of standardized patient safety data. © 2015 John Wiley & Sons Ltd.

European Workshop Industrical Computer Science Systems approach to design for safety

NASA Technical Reports Server (NTRS)

Zalewski, Janusz

1992-01-01

This paper presents guidelines on designing systems for safety, developed by the Technical Committee 7 on Reliability and Safety of the European Workshop on Industrial Computer Systems. The focus is on complementing the traditional development process by adding the following four steps: (1) overall safety analysis; (2) analysis of the functional specifications; (3) designing for safety; (4) validation of design. Quantitative assessment of safety is possible by means of a modular questionnaire covering various aspects of the major stages of system development.

Workarounds in the Workplace: A Second Look.

PubMed

Seaman, Jennifer B; Erlen, Judith A

2015-01-01

Nursing workarounds have garnered increased attention over the past 15 years, corresponding with an increased focus on patient safety and evidence-based practice and a rise in the use of health information technologies (HITs). Workarounds have typically been viewed as deviations from best practice that put patients at risk for poor outcomes. However, this narrow view fails to take into consideration the multifactorial origins of workarounds. The authors explore the ways in which evidence-based protocols and HIT, designed to improve patient safety and quality, can have an unintended consequence of increasing the likelihood of nurses engaging in workarounds. The article also examines workarounds considering the ethical obligations of both nurses and administrative leaders to optimize patient safety and quality.

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

PubMed

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

Billings, C. E.; Lauber, J. K.; Funkhouser, H.; Lyman, E. G.; Huff, E. M.

1976-01-01

The origins and development of the NASA Aviation Safety Reporting System (ASRS) are briefly reviewed. The results of the first quarter's activity are summarized and discussed. Examples are given of bulletins describing potential air safety hazards, and the disposition of these bulletins. During the first quarter of operation, the ASRS received 1464 reports; 1407 provided data relevant to air safety. All reports are being processed for entry into the ASRS data base. During the reporting period, 130 alert bulletins describing possible problems in the aviation system were generated and disseminated. Responses were received from FAA and others regarding 108 of the alert bulletins. Action was being taken with respect to 70 of the 108 responses received. Further studies are planned of a number of areas, including human factors problems related to automation of the ground and airborne portions of the national aviation system.

Defensive efficacy interim design: Dynamic benefit/risk ratio view using probability of success.

PubMed

Tang, Zhongwen

2017-01-01

Traditional efficacy interim design is based on alpha spending which does not have intuitive interpretation and hence is difficult to communicate with non-statistician colleagues. The alpha-spending approach is based on efficacy alone and hence does not have the flexibility to incorporate newly emerged safety signal. Newly emerged safety signal may nullify the originally set efficacy boundary. In contrast, the probability of success (POS) concept has intuitive interpretation and hence can facilitate our communication with non-statistician colleagues and help to obtain health authority (HA) buying. The success criteria of POS are not restricted to statistical significance. Hence, POS has the capability to incorporate both efficacy and safety information. We propose to use POS and its credible interval to design efficacy interim. In the proposed method, the efficacy boundary is adjustable to offset newly emerged safety signal.

77 FR 45282 - NRC Position on the Relationship Between General Design Criteria and Technical Specification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

..., are described in the final safety analysis report (FSAR). The staff safety evaluation documents the acceptability of these analyses, and it is the combination of the FSAR analyses and the staff safety evaluation... analysis, maintain their capability to perform their safety functions. Technical Specification Operability...

An approach to model reactor core nodalization for deterministic safety analysis

NASA Astrophysics Data System (ADS)

Salim, Mohd Faiz; Samsudin, Mohd Rafie; Mamat @ Ibrahim, Mohd Rizal; Roslan, Ridha; Sadri, Abd Aziz; Farid, Mohd Fairus Abd

2016-01-01

Adopting good nodalization strategy is essential to produce an accurate and high quality input model for Deterministic Safety Analysis (DSA) using System Thermal-Hydraulic (SYS-TH) computer code. The purpose of such analysis is to demonstrate the compliance against regulatory requirements and to verify the behavior of the reactor during normal and accident conditions as it was originally designed. Numerous studies in the past have been devoted to the development of the nodalization strategy for small research reactor (e.g. 250kW) up to the bigger research reactor (e.g. 30MW). As such, this paper aims to discuss the state-of-arts thermal hydraulics channel to be employed in the nodalization for RTP-TRIGA Research Reactor specifically for the reactor core. At present, the required thermal-hydraulic parameters for reactor core, such as core geometrical data (length, coolant flow area, hydraulic diameters, and axial power profile) and material properties (including the UZrH1.6, stainless steel clad, graphite reflector) have been collected, analyzed and consolidated in the Reference Database of RTP using standardized methodology, mainly derived from the available technical documentations. Based on the available information in the database, assumptions made on the nodalization approach and calculations performed will be discussed and presented. The development and identification of the thermal hydraulics channel for the reactor core will be implemented during the SYS-TH calculation using RELAP5-3D® computer code. This activity presented in this paper is part of the development of overall nodalization description for RTP-TRIGA Research Reactor under the IAEA Norwegian Extra-Budgetary Programme (NOKEBP) mentoring project on Expertise Development through the Analysis of Reactor Thermal-Hydraulics for Malaysia, denoted as EARTH-M.

An approach to model reactor core nodalization for deterministic safety analysis

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

Salim, Mohd Faiz, E-mail: mohdfaizs@tnb.com.my; Samsudin, Mohd Rafie, E-mail: rafies@tnb.com.my; Mamat Ibrahim, Mohd Rizal, E-mail: m-rizal@nuclearmalaysia.gov.my

Adopting good nodalization strategy is essential to produce an accurate and high quality input model for Deterministic Safety Analysis (DSA) using System Thermal-Hydraulic (SYS-TH) computer code. The purpose of such analysis is to demonstrate the compliance against regulatory requirements and to verify the behavior of the reactor during normal and accident conditions as it was originally designed. Numerous studies in the past have been devoted to the development of the nodalization strategy for small research reactor (e.g. 250kW) up to the bigger research reactor (e.g. 30MW). As such, this paper aims to discuss the state-of-arts thermal hydraulics channel to bemore » employed in the nodalization for RTP-TRIGA Research Reactor specifically for the reactor core. At present, the required thermal-hydraulic parameters for reactor core, such as core geometrical data (length, coolant flow area, hydraulic diameters, and axial power profile) and material properties (including the UZrH{sub 1.6}, stainless steel clad, graphite reflector) have been collected, analyzed and consolidated in the Reference Database of RTP using standardized methodology, mainly derived from the available technical documentations. Based on the available information in the database, assumptions made on the nodalization approach and calculations performed will be discussed and presented. The development and identification of the thermal hydraulics channel for the reactor core will be implemented during the SYS-TH calculation using RELAP5-3D{sup ®} computer code. This activity presented in this paper is part of the development of overall nodalization description for RTP-TRIGA Research Reactor under the IAEA Norwegian Extra-Budgetary Programme (NOKEBP) mentoring project on Expertise Development through the Analysis of Reactor Thermal-Hydraulics for Malaysia, denoted as EARTH-M.« less

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Nuclear Safety Information Center, Its Products and Services

ERIC Educational Resources Information Center

Buchanan, J. R.

1970-01-01

The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

Software Safety Analysis of a Flight Guidance System

NASA Technical Reports Server (NTRS)

Butler, Ricky W. (Technical Monitor); Tribble, Alan C.; Miller, Steven P.; Lempia, David L.

2004-01-01

This document summarizes the safety analysis performed on a Flight Guidance System (FGS) requirements model. In particular, the safety properties desired of the FGS model are identified and the presence of the safety properties in the model is formally verified. Chapter 1 provides an introduction to the entire project, while Chapter 2 gives a brief overview of the problem domain, the nature of accidents, model based development, and the four-variable model. Chapter 3 outlines the approach. Chapter 4 presents the results of the traditional safety analysis techniques and illustrates how the hazardous conditions associated with the system trace into specific safety properties. Chapter 5 presents the results of the formal methods analysis technique model checking that was used to verify the presence of the safety properties in the requirements model. Finally, Chapter 6 summarizes the main conclusions of the study, first and foremost that model checking is a very effective verification technique to use on discrete models with reasonable state spaces. Additional supporting details are provided in the appendices.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

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

75 FR 65704 - Office of Hazardous Materials Safety; Notice of Applications for Modification of Special Permit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... Peninsula Airways 49 CFR 173.302(f).. To reissue the permit Inc. (PenAir), originally issued on an Anchorage, AK. emergency basis authorizing the transportation incommerce of compressed oxygen without rigid...

78 FR 12418 - Office of Hazardous Materials Safety Actions on Special Permit Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... commerce of damaged or defective lithium ion batteries (originally approved under CA2011050032) that do not... lithium Administration battery along with Washington, DC. the SAFER assembly (modes 1, 3, 4, 5) 15793-N...

75 FR 8239 - School Food Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... 0584-AD65 School Food Safety Program Based on Hazard Analysis and Critical Control Point Principles... Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP) was published on... of Management and Budget (OMB) cleared the associated information collection requirements (ICR) on...

A Framework for Assessment of Aviation Safety Technology Portfolios

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.

2014-01-01

The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

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

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

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

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis.

PubMed

Costello, S P; Soo, W; Bryant, R V; Jairath, V; Hart, A L; Andrews, J M

2017-08-01

Faecal microbiota transplantation (FMT) is emerging as a novel therapy for ulcerative colitis (UC). Interpretation of efficacy of FMT for UC is complicated by differences among studies in blinding, FMT administration procedures, intensity of therapy and donor stool processing methods. To determine whether FMT is effective and safe for the induction of remission in active UC. Medline (Ovid), Embase and the Cochrane Library were searched from inception through February 2017. Original studies reporting remission rates following FMT for active UC were included. All study designs were included in the systematic review and a meta-analysis performed including only randomised controlled trials (RCTs). There were 14 cohort studies and four RCTs that used markedly different protocols. In the meta-analysis of RCTs, clinical remission was achieved in 39 of 140 (28%) patients in the donor FMT groups compared with 13 of 137 (9%) patients in the placebo groups; odds ratio 3.67 (95% CI: 1.82-7.39, P<.01). Clinical response was achieved in 69 of 140 (49%) donor FMT patients compared to 38 of 137 (28%) placebo patients; odds ratio 2.48 (95% CI: 1.18-5.21, P=.02). In cohort studies, 39 of 168 (24%; 95% CI: 11%-40%) achieved clinical remission. Despite variation in processes, FMT appears to be effective for induction of remission in UC, with no major short-term safety signals. Further studies are needed to better define dose frequency and preparation methods, and to explore its feasibility, efficacy and safety as a maintenance agent. © 2017 John Wiley & Sons Ltd.

Multilevel model of safety climate for furniture industries.

PubMed

Rodrigues, Matilde A; Arezes, Pedro M; Leão, Celina P

2015-01-01

Furniture companies can analyze their safety status using quantitative measures. However, the data needed are not always available and the number of accidents is under-reported. Safety climate scales may be an alternative. However, there are no validated Portuguese scales that account for the specific attributes of the furniture sector. The current study aims to develop and validate an instrument that uses a multilevel structure to measure the safety climate of the Portuguese furniture industry. The Safety Climate in Wood Industries (SCWI) model was developed and applied to the safety climate analysis using three different scales: organizational, group and individual. A multilevel exploratory factor analysis was performed to analyze the factorial structure. The studied companies' safety conditions were also analyzed. Different factorial structures were found between and within levels. In general, the results show the presence of a group-level safety climate. The scores of safety climates are directly and positively related to companies' safety conditions; the organizational scale is the one that best reflects the actual safety conditions. The SCWI instrument allows for the identification of different safety climates in groups that comprise the same furniture company and it seems to reflect those groups' safety conditions. The study also demonstrates the need for a multilevel analysis of the studied instrument.

Motorcoach and school bus fire safety analysis.

DOT National Transportation Integrated Search

2016-11-01

This report documents a motorcoach and school bus fire safety analysis performed by the John A. Volpe National Transportation Systems Center (Volpe) for the Federal Motor Carrier Safety Administration. This report aims to: 1) identify the causes, fre...

Tracking the use of onboard safety technologies across the truck fleet.

DOT National Transportation Integrated Search

2009-03-01

The Transportation Safety Analysis and the Automotive Analysis Divisons at the University of Michigan Transportation Research Institute (UMTRI) initiated the Onboard Safety Technologies project in 2007, supported by FMCSA, to collect detailed informa...

Motorcoach and school bus fire safety analysis : technology brief.

DOT National Transportation Integrated Search

2016-11-01

In 2009, the Federal Motor Carrier Safety Administration (FMCSA) published findings from a study entitled Motorcoach Fire Safety Analysis. The objective of this study was to gather and analyze information regarding the causes, frequency, and se...

Multi-level hot zone identification for pedestrian safety.

PubMed

Lee, Jaeyoung; Abdel-Aty, Mohamed; Choi, Keechoo; Huang, Helai

2015-03-01

According to the National Highway Traffic Safety Administration (NHTSA), while fatalities from traffic crashes have decreased, the proportion of pedestrian fatalities has steadily increased from 11% to 14% over the past decade. This study aims at identifying two zonal levels factors. The first is to identify hot zones at which pedestrian crashes occurs, while the second are zones where crash-involved pedestrians came from. Bayesian Poisson lognormal simultaneous equation spatial error model (BPLSESEM) was estimated and revealed significant factors for the two target variables. Then, PSIs (potential for safety improvements) were computed using the model. Subsequently, a novel hot zone identification method was suggested to combine both hot zones from where vulnerable pedestrians originated with hot zones where many pedestrian crashes occur. For the former zones, targeted safety education and awareness campaigns can be provided as countermeasures whereas area-wide engineering treatments and enforcement may be effective safety treatments for the latter ones. Thus, it is expected that practitioners are able to suggest appropriate safety treatments for pedestrian crashes using the method and results from this study. Copyright © 2015 Elsevier Ltd. All rights reserved.

Variation in Fumonisin and Ochratoxin Production Associated with Differences in Biosynthetic Gene Content in Aspergillus niger and A. welwitschiae Isolates from Multiple Crop and Geographic Origins

PubMed Central

Susca, Antonia; Proctor, Robert H.; Morelli, Massimiliano; Haidukowski, Miriam; Gallo, Antonia; Logrieco, Antonio F.; Moretti, Antonio

2016-01-01

The fungi Aspergillus niger and A. welwitschiae are morphologically indistinguishable species used for industrial fermentation and for food and beverage production. The fungi also occur widely on food crops. Concerns about their safety have arisen with the discovery that some isolates of both species produce fumonisin (FB) and ochratoxin A (OTA) mycotoxins. Here, we examined FB and OTA production as well as the presence of genes responsible for synthesis of the mycotoxins in a collection of 92 A. niger/A. welwitschiae isolates from multiple crop and geographic origins. The results indicate that (i) isolates of both species differed in ability to produce the mycotoxins; (ii) FB-nonproducing isolates of A. niger had an intact fumonisin biosynthetic gene (fum) cluster; (iii) FB-nonproducing isolates of A. welwitschiae exhibited multiple patterns of fum gene deletion; and (iv) OTA-nonproducing isolates of both species lacked the ochratoxin A biosynthetic gene (ota) cluster. Analysis of genome sequence data revealed a single pattern of ota gene deletion in the two species. Phylogenetic analysis suggest that the simplest explanation for this is that ota cluster deletion occurred in a common ancestor of A. niger and A. welwitschiae, and subsequently both the intact and deleted cluster were retained as alternate alleles during divergence of the ancestor into descendent species. Finally, comparison of results from this and previous studies indicate that a majority of A. niger isolates and a minority of A. welwitschiae isolates can produce FBs, whereas, a minority of isolates of both species produce OTA. The comparison also suggested that the relative abundance of each species and frequency of FB/OTA-producing isolates can vary with crop and/or geographic origin. PMID:27667988

A comparative study of allowable pesticide residue levels on produce in the United States

PubMed Central

2012-01-01

Background The U.S. imports a substantial and increasing portion of its fruits and vegetables. The U.S. Food and Drug Administration currently inspects less than one percent of import shipments. While countries exporting to the U.S. are expected to comply with U.S. tolerances, including allowable pesticide residue levels, there is a low rate of import inspections and few other incentives for compliance. Methods This analysis estimates the quantity of excess pesticide residue that could enter the U.S. if exporters followed originating country requirements but not U.S. pesticide tolerances, for the top 20 imported produce items based on quantities imported and U.S. consumption levels. Pesticide health effects data are also shown. Results The model estimates that for the identified items, 120 439 kg of pesticides in excess of U.S. tolerances could potentially be imported to the U.S., in cases where U.S. regulations are more protective than those of originating countries. This figure is in addition to residues allowed on domestic produce. In the modeling, the top produce item, market, and pesticide of concern were oranges, Chile, and Zeta-Cypermethrin. Pesticides in this review are associated with health effects on 13 body systems, and some are associated with carcinogenic effects. Conclusions There is a critical information gap regarding pesticide residues on produce imported to the U.S. Without a more thorough sampling program, it is not possible accurately to characterize risks introduced by produce importation. The scenario presented herein relies on assumptions, and should be considered illustrative. The analysis highlights the need for additional investigation and resources for monitoring, enforcement, and other interventions, to improve import food safety and reduce pesticide exposures in originating countries. PMID:22293037

Variation in Fumonisin and Ochratoxin Production Associated with Differences in Biosynthetic Gene Content in Aspergillus niger and A. welwitschiae Isolates from Multiple Crop and Geographic Origins.

PubMed

Susca, Antonia; Proctor, Robert H; Morelli, Massimiliano; Haidukowski, Miriam; Gallo, Antonia; Logrieco, Antonio F; Moretti, Antonio

2016-01-01

The fungi Aspergillus niger and A. welwitschiae are morphologically indistinguishable species used for industrial fermentation and for food and beverage production. The fungi also occur widely on food crops. Concerns about their safety have arisen with the discovery that some isolates of both species produce fumonisin (FB) and ochratoxin A (OTA) mycotoxins. Here, we examined FB and OTA production as well as the presence of genes responsible for synthesis of the mycotoxins in a collection of 92 A. niger/A. welwitschiae isolates from multiple crop and geographic origins. The results indicate that (i) isolates of both species differed in ability to produce the mycotoxins; (ii) FB-nonproducing isolates of A. niger had an intact fumonisin biosynthetic gene (fum) cluster; (iii) FB-nonproducing isolates of A. welwitschiae exhibited multiple patterns of fum gene deletion; and (iv) OTA-nonproducing isolates of both species lacked the ochratoxin A biosynthetic gene (ota) cluster. Analysis of genome sequence data revealed a single pattern of ota gene deletion in the two species. Phylogenetic analysis suggest that the simplest explanation for this is that ota cluster deletion occurred in a common ancestor of A. niger and A. welwitschiae, and subsequently both the intact and deleted cluster were retained as alternate alleles during divergence of the ancestor into descendent species. Finally, comparison of results from this and previous studies indicate that a majority of A. niger isolates and a minority of A. welwitschiae isolates can produce FBs, whereas, a minority of isolates of both species produce OTA. The comparison also suggested that the relative abundance of each species and frequency of FB/OTA-producing isolates can vary with crop and/or geographic origin.

Organized labor and the origins of the Occupational Safety and Health Act.

PubMed

Asher, Robert

2014-11-01

New Solutions is republishing this 1991 article by Robert Asher, which reviews the history of organized labor's efforts in the United States to secure health and safety protections for workers. The 1877 passage of the Massachusetts factory inspection law and the implementation of primitive industrial safety inspection systems in many states paralleled labor action for improved measures to protect workers' health and safety. In the early 1900s labor was focusing on workers' compensation laws. The New Deal expanded the federal government's role in worker protection, supported at least by the Congress of Industrial Organizations (CIO), but challenged by industry and many members of the U.S. Congress. The American Federation of Labor (AFL) and the CIO backed opposing legal and inspection strategies in the late 1940s and through the 1950s. Still, by the late 1960s, several unions were able to help craft the Occupational Safety and Health Act of 1970 and secure new federal protections for U.S. workers.

L-Band Digital Aeronautical Communications System Engineering - Initial Safety and Security Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.

PSD Source Classification for Safety Kleen's Lubricating Oil Recovery Facility

EPA Pesticide Factsheets

This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

33 CFR 165.775 - Safety Zone; Captain of the Port Zone Jacksonville; Offshore Cape Canaveral, Florida.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Zone A originates from the baseline at position 28°45.7′ N, 080°42.7′ W; then proceeds northeast to 28... the baseline at position 28°31.3′ N, 080°33.4′ W. (2) Zone (B) is defined by four latitude and longitude corner points. Zone B originates from the baseline at position 28°40.1′ N, 080°38.4′ W; then...

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

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

Applying Failure Modes, Effects, And Criticality Analysis And Human Reliability Analysis Techniques To Improve Safety Design Of Work Process In Singapore Armed Forces

DTIC Science & Technology

2016-09-01

an instituted safety program that utilizes a generic risk assessment method involving the 5-M (Mission, Man, Machine , Medium and Management) factor...the Safety core value is hinged upon three key principles—(1) each soldier has a crucial part to play, by adopting safety as a core value and making...it a way of life in his unit; (2) safety is an integral part of training, operations and mission success, and (3) safety is an individual, team and

[Identification of original species of Mantidis Oötheca (Sangpiaoxiao) based on DNA barcoding].

PubMed

Wang, Xi; Hou, Fei-xia; Wang, Yi-xuan; Wang, Yu-xian; Li, Jun-de; Yuan, Yuan; Peng, Cheng; Guo, Jin-lin

2015-10-01

Both market research and literature reports both found that the ootheca of mantodea was all used as medicine. However, Chinese Pharmacopoeia only records the ootheca of three mantis species. The clinical use of ootheca unrecorded in Chinese Pharmacopoeia, will pose potential risks to drug safety. It's urgent to identify the origin of Mantidis Oötheca. The current researches about original animal in Mantidis Oötheca are based on morphology and unanimous. DNA barcoding fill gaps of the traditional morphological identification, which is widely used in animal classification studies. This study first use DNA barcoding to analyze genetic distance among different Mantidis Oötheca types, align COI sequences between mantis and Mantidis Oötheca and construct the phylogeny tree. The result confirmed that Tenodera sinensis and Hierodula patellifera were the origin insects of Tuanpiaoxiao and Heipiaoxiao, respectively, and Statilia maculate and Mantis religiosa were the origin insects of Changpiaoxiao.

Modelling safety of multistate systems with ageing components

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

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

Statewide crash analysis and forecasting.

DOT National Transportation Integrated Search

2008-11-20

There is a need for the development of safety analysis tools to allow Penn DOT to better assess the safety performance of road : segments in the Commonwealth. The project utilized a safety management system database at Penn DOT that integrates crash,...

The effects of a lean transition on process times, patients and employees.

PubMed

Simons, Pascale; Backes, Huub; Bergs, Jochen; Emans, Davy; Johannesma, Madelon; Jacobs, Maria; Marneffe, Wim; Vandijck, Dominique

2017-03-13

Purpose Treatment delays must be avoided, especially in oncology, to assure sustainable high-quality health care and increase the odds of survival. The purpose of this paper is to hypothesize that waiting times would decrease and patients and employees would benefit, when specific lean interventions are incorporated in an organizational improvement approach. Design/methodology/approach In 2013, 15 lean interventions were initiated to improve flow in a single radiotherapy institute. Process/waiting times, patient satisfaction, safety, employee satisfaction, and absenteeism were evaluated using a mixed methods methodology (2010-2014). Data from databases, surveys, and interviews were analyzed by time series analysis, χ 2 , multi-level regression, and t-tests. Findings Median waiting/process times improved from 20.2 days in 2012 to 16.3 days in 2014 ( p<0.001). The percentage of palliative patients for which waiting times had exceeded Dutch national norms (ten days) improved from 35 (six months in 2012: pre-intervention) to 16 percent (six months in 2013-2014: post-intervention; p<0.01), and the percentage exceeding national objectives (seven days) from 22 to 17 percent ( p=0.44). For curative patients, exceeding of norms (28 days) improved from 17 (2012) to 8 percent (2013-2014: p=0.05), and for the objectives (21 days) from 18 to 10 percent ( p<0.01). Reported safety incidents decreased 47 percent from 2009 to 2014, whereas safety culture, awareness, and intention to solve problems improved. Employee satisfaction improved slightly, and absenteeism decreased from 4.6 (2010) to 2.7 percent (2014; p<0.001). Originality/value Combining specific lean interventions with an organizational improvement approach improved waiting times, patient safety, employee satisfaction, and absenteeism on the short term. Continuing evaluation of effects should study the improvements sustainability.

Characteristics of Interstate Motorcoach Carriers With Elevated Rates of Crashes and Inspection Violations

PubMed Central

Cheung, Ivan; Braver, Elisa R.

2012-01-01

Widely-publicized fatal motorcoach crashes have caused public concern about their safety. This study estimated crash and violation rates among interstate motorcoach carriers based on 2005–2011 data obtained from the Federal Motor Carrier Safety Administration (FMCSA). Motorcoach carriers with relatively high crash and violation rates were compared with those with better safety records. The principal component analysis produced three orthogonal factors that captured the majority (63 percent) of the total variance in the data set. Motorcoach carriers operating 10 or fewer motorcoaches were more likely to be classified in both the high crash rate and the high inspection and violation rates group. Those carriers with 10 or fewer years in business were more likely to be classified in the high inspection and violation rates group. The vast majority of motorcoach carriers with problematic safety records were non-scheduled route providers (charters). Scheduled-service motorcoach carriers identified as providing at least occasional curbside service, defined as picking up or dropping off passengers at a place other than a traditional terminal at the origin or destination, had an increased risk of involvement in fatal crashes compared with other scheduled-service carriers (1.4 per 100 vehicles, 95% C.I.: 0.1–2.7 versus 0.2, 95% C.I.: 0.0–0.5). The data did not indicate whether crashes or violations occurred during the trips where curbside service was provided. These findings suggest that FMCSA and the states need to have the resources necessary for close monitoring of motorcoach carriers, particularly high-risk ones such as small and less experienced motorcoach carriers. PMID:23169116

Long term safety of sacral nerve modulation in medicare beneficiaries.

PubMed

Chughtai, Bilal; Sedrakyan, Art; Isaacs, Abby; Lee, Richard; Te, Alexis; Kaplan, Steven

2015-09-01

Sacral nerve stimulation (SNS) is FDA approved as second-line therapy for both urinary and bowel control. However, there is limited evidence regarding long term safety. We determined adverse events associated with SNS among Medicare beneficiaries. We used the 5% national random sample of Medicare claims for 2001-2011 to identify patients. Patients who underwent SNS implantation were identified with Current Procedure Terminology (CPT-4) codes. We determined safety of SNS using analysis of complication occurrences on day of surgery and during 5 years following initial procedure. SAS v9.3 statistical package was used. One thousand four hundred seventy-four patients underwent treatment with SNS in the 5% national sample of Medicare patients within the time period. Representative of real-world patients undergoing SNS surgery, comorbidities included hypertension (69.3%), diabetes (29.4%), chronic pulmonary disease (25.5%), hypothyroidism (25.2%), and depression (22.7%). Few complications occurred on day of surgery. At 90 days, 3.2% of patients had bowel complications, 2.0% urological, 9.4% infectious, and 1.5% stroke. Overall, bowel, neurological health event occurrences were consistent with prior year rates, while infectious events decreased. Of 206 patients who were followed for at least 5 years, 17.3% had devices removed and 11.3% replaced, with 26.1% having at least one of those, leaving 73.9% with original devices. Urological, infectious, and bowel complication occurrences were low after SNS among Medicare beneficiaries with multiple comorbidities. There were infrequent serious complications like hemorrhage and stroke postoperatively. Although SNS appears safe in this high-risk population, a comprehensive registry will ensure continuous safety. © 2014 Wiley Periodicals, Inc.

Food safety knowledge on the Bt mutant protein Cry8Ka5 employed in the development of coleopteran-resistant transgenic cotton plants.

PubMed

Farias, Davi F; Peijnenburg, Ad A C M; Grossi-de-Sá, Maria F; Carvalho, Ana F U

2015-01-01

Insecticidal Cry proteins from Bacillus thuringiensis (Bt) have been exploited in the development of genetically modified (GM) crops for pest control. However, several pests are still difficult to control such as the coleopteran boll weevil Anthonomus grandis. By applying in vitro molecular evolution to the cry8Ka1 gene sequence, variants were generated with improved activity against A. grandis. Among them, Cry8Ka5 mutant protein showed coleoptericidal activity 3-fold higher (LC50 2.83 μg/mL) than that of the original protein (Cry8Ka1). Cry8Ka5 has been used in breeding programs in order to obtain coleopteran-resistant cotton plants. Nevertheless, there is some concern in relation to the food safety of transgenic crops, especially to the heterologously expressed proteins. In this context, our research group has performed risk assessment studies on Cry8Ka5, using the tests recommended by Codex as well as tests that we proposed as alternative and/or complementary approaches. Our results on the risk analysis of Cry8Ka5 taken together with those of other Cry proteins, point out that there is a high degree of certainty on their food safety. It is reasonable to emphasize that most safety studies on Cry proteins have essentially used the Codex approach. However, other methodologies would potentially provide additional information such as studies on the effects of Cry proteins and derived peptides on the indigenous gastrointestinal microbiota and on intestinal epithelial cells of humans. Additionally, emerging technologies such as toxicogenomics potentially will offer sensitive alternatives for some current approaches or methods.

Food safety knowledge on the Bt mutant protein Cry8Ka5 employed in the development of coleopteran-resistant transgenic cotton plants

PubMed Central

Farias, Davi F; Peijnenburg, Ad A C M; Grossi-de-Sá, Maria F; Carvalho, Ana F U

2015-01-01

Insecticidal Cry proteins from Bacillus thuringiensis (Bt) have been exploited in the development of genetically modified (GM) crops for pest control. However, several pests are still difficult to control such as the coleopteran boll weevil Anthonomus grandis. By applying in vitro molecular evolution to the cry8Ka1 gene sequence, variants were generated with improved activity against A. grandis. Among them, Cry8Ka5 mutant protein showed coleoptericidal activity 3-fold higher (LC50 2.83 μg/mL) than that of the original protein (Cry8Ka1). Cry8Ka5 has been used in breeding programs in order to obtain coleopteran-resistant cotton plants. Nevertheless, there is some concern in relation to the food safety of transgenic crops, especially to the heterologously expressed proteins. In this context, our research group has performed risk assessment studies on Cry8Ka5, using the tests recommended by Codex as well as tests that we proposed as alternative and/or complementary approaches. Our results on the risk analysis of Cry8Ka5 taken together with those of other Cry proteins, point out that there is a high degree of certainty on their food safety. It is reasonable to emphasize that most safety studies on Cry proteins have essentially used the Codex approach. However, other methodologies would potentially provide additional information such as studies on the effects of Cry proteins and derived peptides on the indigenous gastrointestinal microbiota and on intestinal epithelial cells of humans. Additionally, emerging technologies such as toxicogenomics potentially will offer sensitive alternatives for some current approaches or methods. PMID:26513483

Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union.

PubMed

Bolognesi, Claudia; Castoldi, Anna F; Crebelli, Riccardo; Barthélémy, Eric; Maurici, Daniela; Wölfle, Detlef; Volk, Katharina; Castle, Laurence

2017-06-01

Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Initial empirical analysis of nuclear power plant organization and its effect on safety performance

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

Olson, J.; McLaughlin, S.D.; Osborn, R.N.

This report contains an analysis of the relationship between selected aspects of organizational structure and the safety-related performance of nuclear power plants. The report starts by identifying and operationalizing certain key dimensions of organizational structure that may be expected to be related to plant safety performance. Next, indicators of plant safety performance are created by combining existing performance measures into more reliable indicators. Finally, the indicators of plant safety performance using correlational and discriminant analysis. The overall results show that plants with better developed coordination mechanisms, shorter vertical hierarchies, and a greater number of departments tend to perform more safely.

ASIL determination for motorbike's Electronics Throttle Control System (ETCS) mulfunction

NASA Astrophysics Data System (ADS)

Zaman Rokhani, Fakhrul; Rahman, Muhammad Taqiuddin Abdul; Ain Kamsani, Noor; Sidek, Roslina Mohd; Saripan, M. Iqbal; Samsudin, Khairulmizam; Khair Hassan, Mohd

2017-11-01

Electronics Throttle Control System (ETCS) is the principal electronic unit in all fuel injection engine motorbike, augmenting the engine performance efficiency in comparison to the conventional carburetor based engine. ETCS is regarded as a safety-critical component, whereby ETCS malfunction can cause unintended acceleration or deceleration event, which can be hazardous to riders. In this study, Hazard Analysis and Risk Assessment, an ISO26262 functional safety standard analysis has been applied on motorbike's ETCS to determine the required automotive safety integrity level. Based on the analysis, the established automotive safety integrity level can help to derive technical and functional safety measures for ETCS development.

Partnerships: The Path to Improving Crisis Communication

DTIC Science & Technology

2007-03-01

News Media Perceives Relationships with Public Safety.................32 Table 4. Public Safety SWOT Analysis ...opportunities and threats ( SWOT ) of the Seattle fire and police departments. The SWOT analysis is an assessment tool common to strategic planning for...requirements for training • Lack of strategic planning experience Table 4. Public Safety SWOT Analysis 46 Table 4 compares the strengths and

Transportation research into practice : a multi-agency government perspective

DOT National Transportation Integrated Search

2012-10-22

Safety is the top priority of the US Department of Transportation (DOT), with much of its $1B of annual : research and development budget focused on this priority. Each organization within DOT, and its : oversight origination, the National Transporta...