15 CFR 270.205 - Reports.

Code of Federal Regulations, 2012 CFR

2012-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.205 Reports. (a) Not later than 90 days after completing an investigation, a Team shall issue a public report which includes: (1) An analysis of the likely technical cause...

15 CFR 270.205 - Reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Investigations § 270.205 Reports. (a) Not later than 90 days after completing an investigation, a Team shall issue a public report which includes: (1) An analysis of the likely technical cause...

Changing conversations: teaching safety and quality in residency training.

PubMed

Voss, John D; May, Natalie B; Schorling, John B; Lyman, Jason A; Schectman, Joel M; Wolf, Andrew M D; Nadkarni, Mohan M; Plews-Ogan, Margaret

2008-11-01

Improving patient safety and quality in health care is one of medicine's most pressing challenges. Residency training programs have a unique opportunity to meet this challenge by training physicians in the science and methods of patient safety and quality improvement (QI).With support from the Health Resources and Services Administration, the authors developed an innovative, longitudinal, experiential curriculum in patient safety and QI for internal medicine residents at the University of Virginia. This two-year curriculum teaches the critical concepts and skills of patient safety and QI: systems thinking and human factors analysis, root cause analysis (RCA), and process mapping. Residents apply these skills in a series of QI and patient safety projects. The constructivist educational model creates a learning environment that actively engages residents in improving the quality and safety of their medical practice.Between 2003 and 2005, 38 residents completed RCAs of adverse events. The RCAs identified causes and proposed useful interventions that have produced important care improvements. Qualitative analysis demonstrates that the curriculum shifted residents' thinking about patient safety to a systems-based approach. Residents completed 237 outcome assessments during three years. Results indicate that seminars met predefined learning objectives and were interactive and enjoyable. Residents strongly believe they gained important skills in all domains.The challenge to improve quality and safety in health care requires physicians to learn new knowledge and skills. Graduate medical education can equip new physicians with the skills necessary to lead the movement to safer and better quality of care for all patients.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Safety organizing, emotional exhaustion, and turnover in hospital nursing units.

PubMed

Vogus, Timothy J; Cooil, Bruce; Sitterding, Mary; Everett, Linda Q

2014-10-01

Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on how engaging in safety organizing affects caregivers. While we know that organizational processes can have divergent effects on organizational and employee outcomes, little research exists on the effects of pursuing highly reliable performance through safety organizing on caregivers. Specifically, we examined whether, and the conditions under which, safety organizing affects RN emotional exhaustion and nursing unit turnover rates. Subjects included 1352 RNs in 50 intensive care, internal medicine, labor, and surgery nursing units in 3 Midwestern acute-care hospitals who completed questionnaires between August and December 2011 and 50 Nurse Managers from the units who completed questionnaires in December 2012. Cross-sectional analyses of RN emotional exhaustion linked to survey data on safety organizing and hospital incident reporting system data on adverse event rates for the year before survey administration. Cross-sectional analysis of unit-level RN turnover rates for the year following the administration of the survey linked to survey data on safety organizing. Multilevel regression analysis indicated that safety organizing was negatively associated with RN emotional exhaustion on units with higher rates of adverse events and positively associated with RN emotional exhaustion with lower rates of adverse events. Tobit regression analyses indicated that safety organizing was associated with lower unit level of turnover rates over time. Safety organizing is beneficial to caregivers in multiple ways, especially on nursing units with high levels of adverse events and over time.

Food safety attitudes in college students: a structural equation modeling analysis of a conceptual model.

PubMed

Booth, Rachelle; Hernandez, Magaly; Baker, Erica L; Grajales, Tevni; Pribis, Peter

2013-01-30

College students are one of the most at-risk population groups for food poisoning, due to risky food safety behaviors. Using the Likert Scale, undergraduate students were asked to participate in a Food Safety Survey which was completed by 499 students ages 18-25. Data was analyzed using SPSS and AMOS statistical software. Four conceptual definitions regarding food safety were defined as: general food safety, bacterial food safety, produce food safety, and politics associated with food safety. Knowledge seems to be an important factor in shaping students attitudes regarding general and bacterial safety. Ethnicity plays a role in how people view the politics of food safety, and the safety of organic foods.

Rural and Urban Crashes: A Comparative Analysis

DOT National Transportation Integrated Search

1996-08-01

National Highway Traffic Safety Administration's National Center for Statistics : and Analysis (NCSA) recently completed a study comparing the characteristics of : crashes occurring in rural areas to the characteristics of crashes occurring in : urba...

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What happens after completion of the safety audit... REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after completion of the safety audit? (a) Upon completion of the safety audit, the auditor will review the findings...

Food Safety Attitudes in College Students: A Structural Equation Modeling Analysis of a Conceptual Model

PubMed Central

Booth, Rachelle; Hernandez, Magaly; Baker, Erica L.; Grajales, Tevni; Pribis, Peter

2013-01-01

College students are one of the most at-risk population groups for food poisoning, due to risky food safety behaviors. Using the Likert Scale, undergraduate students were asked to participate in a Food Safety Survey which was completed by 499 students ages 18–25. Data was analyzed using SPSS and AMOS statistical software. Four conceptual definitions regarding food safety were defined as: general food safety, bacterial food safety, produce food safety, and politics associated with food safety. Knowledge seems to be an important factor in shaping students attitudes regarding general and bacterial safety. Ethnicity plays a role in how people view the politics of food safety, and the safety of organic foods. PMID:23364131

Randomized controlled trial to determine the effectiveness of an interactive multimedia food safety education program for clients of the special supplemental nutrition program for women, infants, and children.

PubMed

Trepka, Mary Jo; Newman, Frederick L; Davila, Evelyn P; Matthew, Karen J; Dixon, Zisca; Huffman, Fatma G

2008-06-01

Pregnant women and the very young are among those most susceptible to foodborne infections and at high risk of a severe outcome from foodborne infections. To determine if interactive multimedia is a more effective method than pamphlets for delivering food safety education to Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients. A randomized controlled trial of WIC clients was conducted. Self-reported food safety practices were compared between pre- and postintervention questionnaires completed >or=2 months after the intervention. Pregnant WIC clients or female caregivers (usually mothers) of WIC clients who were 18 years of age or older and able to speak and read English were recruited from an inner-city WIC clinic. Participants were randomized to receive food safety pamphlets or complete an interactive multimedia food safety education program on a computer kiosk. Change from pre- to postintervention food safety scores. A mean food safety score was determined for each participant for the pre- and postintervention questionnaires. The scores were used in a two-group repeated measures analysis of variance. Of the 394 participants, 255 (64.7%) completed the postintervention questionnaire. Satisfaction with the program was high especially among those with no education beyond high school. When considering a repeated measures analysis of variance model with the two fixed between-subject effects of group and age, a larger improvement in score in the interactive multimedia group than in the pamphlet group (P=0.005) was found, but the size of the group effect was small (partial eta(2)=0.033). Women aged 35 years or older in the interactive multimedia group had the largest increase in score. The interactive multimedia was well-accepted and resulted in improved self-reported food safety practices, suggesting that interactive multimedia is an effective option for food safety education in WIC clinics.

Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

PubMed

Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

2017-05-03

Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Safety improvement from edge lines on rural two-lane highways (with three-years before and one-year after crash data analysis).

DOT National Transportation Integrated Search

2012-04-01

The previous study Impact of Edge Lines on Safety of Rural Two-Lane Highways completed in 2005 concluded: with edge lines, centralization of vehicles positions is more apparent during night time, which reduces the risk of run-off road (ROR) and he...

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.

Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey.

PubMed

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-10-01

To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's alpha coefficients ranged from 0.50 to 0.89. It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes.

Implementation of the WHO Surgical Safety Checklist in an Ethiopian Referral Hospital

PubMed Central

2014-01-01

Background The WHO Surgical Safety Checklist has a growing evidence base to support its role in improving perioperative safety, although its impact is likely to be directly related to the effectiveness of its implementation. There remains a paucity of documented experience from low-resource settings on Checklist implementation approaches. We report an implementation strategy in a public referral hospital in Addis Ababa, Ethiopia, based on consultation, local leadership, formal introduction, and supported supervision with subsequent audit and feedback. Methods Planning, implementation and assessment took place from December 2011 to December 2012. The planning phase, from December 2011 until April 2012, involved a multidisciplinary consultative approach using local leaders, volunteer clinicians, and staff from non-governmental organisations, to draw up a locally agreed and appropriate Checklist. Implementation in April 2012 involved formal teaching and discussion, simulation sessions and role play, with supportive supervision following implementation. Assessment was performed using completed Checklist analysis and staff satisfaction questionnaires at one month and further Checklist analysis combined with semi-structured interviews in December 2012. Results and discussion Checklist compliance rates were 83% for general anaesthetics at one month after implementation, with an overall compliance rate of 65% at eight months. There was a decrease in Checklist compliance over the period of the study to less than 20% by the end of the study period. The ‘Sign out’ section was reported as being the most difficult section of the Checklist to complete, and was missed completely in 21% of cases. The most commonly missed single item was the team introduction at the start of each case. However, we report high staff satisfaction with the Checklist and enthusiasm for its continued use. Conclusion We report a detailed implementation strategy for introducing the WHO Surgical Safety Checklist to a low-resource setting. We show that this approach can lead to high completion rates and high staff satisfaction, albeit with a drop in completion rates over time. We argue that maximal benefit of the Surgical Safety Checklist is likely to be when it engenders a conversation around patient safety within a department, and when there is local ownership of this process. PMID:24678854

Posttest analysis of the FFTF inherent safety tests

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

Padilla, A. Jr.; Claybrook, S.W.

Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactormore » and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code.« less

Driver performance measurement and analysis system (DPMAS). Volume 1, Description and operations manual

DOT National Transportation Integrated Search

1976-08-01

A prototype driver performance measurement and analysis system (DPMAS) has been developed for the National Highway Traffic Safety Administration (NHTSA). This system includes a completely instrumented 1974 Chevrolet Impala capable of digitally record...

The Necessity of Functional Analysis for Space Exploration Programs

NASA Technical Reports Server (NTRS)

Morris, A. Terry; Breidenthal, Julian C.

2011-01-01

As NASA moves toward expanded commercial spaceflight within its human exploration capability, there is increased emphasis on how to allocate responsibilities between government and commercial organizations to achieve coordinated program objectives. The practice of program-level functional analysis offers an opportunity for improved understanding of collaborative functions among heterogeneous partners. Functional analysis is contrasted with the physical analysis more commonly done at the program level, and is shown to provide theoretical performance, risk, and safety advantages beneficial to a government-commercial partnership. Performance advantages include faster convergence to acceptable system solutions; discovery of superior solutions with higher commonality, greater simplicity and greater parallelism by substituting functional for physical redundancy to achieve robustness and safety goals; and greater organizational cohesion around program objectives. Risk advantages include avoidance of rework by revelation of some kinds of architectural and contractual mismatches before systems are specified, designed, constructed, or integrated; avoidance of cost and schedule growth by more complete and precise specifications of cost and schedule estimates; and higher likelihood of successful integration on the first try. Safety advantages include effective delineation of must-work and must-not-work functions for integrated hazard analysis, the ability to formally demonstrate completeness of safety analyses, and provably correct logic for certification of flight readiness. The key mechanism for realizing these benefits is the development of an inter-functional architecture at the program level, which reveals relationships between top-level system requirements that would otherwise be invisible using only a physical architecture. This paper describes the advantages and pitfalls of functional analysis as a means of coordinating the actions of large heterogeneous organizations for space exploration programs.

Development and psychometric testing of an instrument to measure safety climate perceptions in community pharmacy.

PubMed

Newham, Rosemary; Bennie, Marion; Maxwell, David; Watson, Anne; de Wet, Carl; Bowie, Paul

2014-12-01

A positive and strong safety culture underpins effective learning from patient safety incidents in health care, including the community pharmacy (CP) setting. To build this culture, perceptions of safety climate must be measured with context-specific and reliable instruments. No pre-existing instruments were specifically designed or suitable for CP within Scotland. We therefore aimed to develop a psychometrically sound instrument to measure perceptions of safety climate within Scottish CPs. The first stage, development of a preliminary instrument, comprised three steps: (i) a literature review; (ii) focus group feedback; and (iii) content validation. The second stage, psychometric testing, consisted of three further steps: (iv) a pilot survey; (v) a survey of all CP staff within a single health board in NHS Scotland; and (vi) application of statistical methods, including principal components analysis and calculation of Cronbach's reliability coefficients, to derive the final instrument. The preliminary questionnaire was developed through a process of literature review and feedback. This questionnaire was completed by staff in 50 CPs from the 131 (38%) sampled. 250 completed questionnaires were suitable for analysis. Psychometric evaluation resulted in a 30-item instrument with five positively correlated safety climate factors: leadership, teamwork, safety systems, communication and working conditions. Reliability coefficients were satisfactory for the safety climate factors (α > 0.7) and overall (α = 0.93). The robust nature of the technical design and testing process has resulted in the development of an instrument with sufficient psychometric properties, which can be implemented in the community pharmacy setting in NHS Scotland. © 2014 John Wiley & Sons, Ltd.

Workforce Perceptions of Hospital Safety Culture: Development and Validation of the Patient Safety Climate in Healthcare Organizations Survey

PubMed Central

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-01-01

Objective To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Data Sources/Study Setting Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Study Design Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. Data Collection We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). Principal Findings We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's α coefficients ranged from 0.50 to 0.89. Conclusions It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes. PMID:17850530

Complete Genome Sequence of the Probiotic Strain Lactobacillus salivarius LPM01

PubMed Central

Codoñer, Francisco M.; Martinez-Blanch, Juan F.; Acevedo-Piérart, Marcelo; Ormeño, M. Loreto; Ramón, Daniel

2016-01-01

Lactobacillus salivarius LPM01 (DSM 22150) is a probiotic strain able to improve health status in immunocompromised people. Here, we report its complete genome sequence deciphered by PacBio single-molecule real-time (SMRT) technology. Analysis of the sequence may provide insights into its functional activity and safety assessment. PMID:27881545

Canister Storage Building (CSB) Hazard Analysis Report

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

POWERS, T.B.

2000-03-16

This report describes the methodology used in conducting the Canister Storage Building (CSB) Hazard Analysis to support the final CSB Safety Analysis Report and documents the results. This report describes the methodology used in conducting the Canister Storage Building (CSB) hazard analysis to support the CSB final safety analysis report (FSAR) and documents the results. The hazard analysis process identified hazardous conditions and material-at-risk, determined causes for potential accidents, identified preventive and mitigative features, and qualitatively estimated the frequencies and consequences of specific occurrences. The hazard analysis was performed by a team of cognizant CSB operations and design personnel, safetymore » analysts familiar with the CSB, and technical experts in specialty areas. The material included in this report documents the final state of a nearly two-year long process. Attachment A provides two lists of hazard analysis team members and describes the background and experience of each. The first list is a complete list of the hazard analysis team members that have been involved over the two-year long process. The second list is a subset of the first list and consists of those hazard analysis team members that reviewed and agreed to the final hazard analysis documentation. The material included in this report documents the final state of a nearly two-year long process involving formal facilitated group sessions and independent hazard and accident analysis work. The hazard analysis process led to the selection of candidate accidents for further quantitative analysis. New information relative to the hazards, discovered during the accident analysis, was incorporated into the hazard analysis data in order to compile a complete profile of facility hazards. Through this process, the results of the hazard and accident analyses led directly to the identification of safety structures, systems, and components, technical safety requirements, and other controls required to protect the public, workers, and environment.« less

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;

Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative.

PubMed

Haynes, Alex B; Edmondson, Lizabeth; Lipsitz, Stuart R; Molina, George; Neville, Bridget A; Singer, Sara J; Moonan, Aunyika T; Childers, Ashley Kay; Foster, Richard; Gibbons, Lorri R; Gawande, Atul A; Berry, William R

2017-12-01

To determine whether completion of a voluntary, checklist-based surgical quality improvement program is associated with reduced 30-day postoperative mortality. Despite evidence of efficacy of team-based surgical safety checklists in improving perioperative outcomes in research trials, effective methods of population-based implementation have been lacking. The Safe Surgery 2015 South Carolina program was designed to foster state-wide engagement of hospitals in a voluntary, collaborative implementation of a checklist program. We compared postoperative mortality rates after inpatient surgery in South Carolina utilizing state-wide all-payer discharge claims from 2008 to 2013, linked with state vital statistics, stratifying hospitals on the basis of completion of the checklist program. Changes in risk-adjusted 30-day mortality were compared between hospitals, using propensity score-adjusted difference-in-differences analysis. Fourteen hospitals completed the program by December 2013. Before program launch, there was no difference in mortality trends between the completion cohort and all others (P = 0.33), but postoperative mortality diverged thereafter (P = 0.021). Risk-adjusted 30-day mortality among completers was 3.38% in 2010 and 2.84% in 2013 (P < 0.00001), whereas mortality among other hospitals (n = 44) was 3.50% in 2010 and 3.71% in 2013 (P = 0.3281), reflecting a 22% difference between the groups on difference-in-differences analysis (P = 0.0021). Despite similar pre-existing rates and trends of postoperative mortality, hospitals in South Carolina completing a voluntary checklist-based surgical quality improvement program had a reduction in deaths after inpatient surgery over the first 3 years of the collaborative compared with other hospitals in the state. This may indicate that effective large-scale implementation of a team-based surgical safety checklist is feasible.

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

Napper, P.R.; Carpenter, W.R.; Garner, R.W.

By DOE-ID Order 5481.1A, a five year currency review is required of the Safety Analysis Reports of all ID or ID contractor operations having hazards of a type and magnitude not routinely encountered and/or accepted by the public. In keeping with this order, a currency review has been performed of the Advanced Test Reactor Critical Facility (ADTRC) Safety Analysis Report (SAR), Issue 003, 1990. The objectives of this currency review were to: evaluate the content, completeness, clarity of presentation and compliance with NRC Regulatory Guides and DOE Orders, etc., and evaluate the technical content of the SAR, particularly the Technicalmore » Specifications, and to evaluate the safety of continued operation of the ATRC. The reviewers concluded that although improvements may be needed in the overall content, clarity, and demonstration of compliance with current orders and regulations, the safety of the ATRC is in no way compromised and no unreviewed safety questions were identified. 6 figs., 3 tabs.« less

75 FR 43092 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... completed a system safety review of the aircraft fuel system against fuel tank safety standards introduced... Limited has completed a system safety review of the aircraft fuel system against fuel tank safety... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2011 CFR

2011-07-01

... certificate or a Safety Management Certificate; (3) Periodic audits including— (i) An annual verification... safety management audit and when is it required to be completed? 96.320 Section 96.320 Navigation and... SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be...

Complete Genome Sequence of the Probiotic Strain Lactobacillus salivarius LPM01.

PubMed

Chenoll, Empar; Codoñer, Francisco M; Martinez-Blanch, Juan F; Acevedo-Piérart, Marcelo; Ormeño, M Loreto; Ramón, Daniel; Genovés, Salvador

2016-11-23

Lactobacillus salivarius LPM01 (DSM 22150) is a probiotic strain able to improve health status in immunocompromised people. Here, we report its complete genome sequence deciphered by PacBio single-molecule real-time (SMRT) technology. Analysis of the sequence may provide insights into its functional activity and safety assessment. Copyright © 2016 Chenoll et al.

Predicting safety culture: the roles of employer, operations manager and safety professional.

PubMed

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus.

PubMed

Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F

2016-11-01

We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.

A measurement tool to assess culture change regarding patient safety in hospital obstetrical units.

PubMed

Kenneth Milne, J; Bendaly, Nicole; Bendaly, Leslie; Worsley, Jill; FitzGerald, John; Nisker, Jeff

2010-06-01

Clinical error in acute care hospitals can only be addressed by developing a culture of safety. We sought to develop a cultural assessment survey (CAS) to assess patient safety culture change in obstetrical units. Interview prompts and a preliminary questionnaire were developed through a literature review of patient safety and "high reliability organizations," followed by interviews with members of the Managing Obstetrical Risk Efficiently (MOREOB) Program of the Society of Obstetricians and Gynaecologists of Canada. Three hundred preliminary questionnaires were mailed, and 21 interviews and 9 focus groups were conducted with the staff of 11 hospital sites participating in the program. To pilot test the CAS, 350 surveys were mailed to staff in participating hospitals, and interviews were conducted with seven nurses and five physicians who had completed the survey. Reliability analysis was conducted on four units that completed the CAS prior to and following the implementation of the first MOREOB module. Nineteen values and 105 behaviours, practices, and perceptions relating to patient safety were identified and included in the preliminary questionnaire, of which 143 of 300 (47.4%) were returned. Among the 220 cultural assessment surveys returned (62.9%), six cultural scales emerged: (1) patient safety as everyone's priority; (2) teamwork; (3) valuing individuals; (4) open communication; (5) learning; and (6) empowering individuals. The reliability analysis found all six scales to have internal reliability (Cronbach alpha), ranging from 0.72 (open communication) to 0.84 (valuing individuals). The CAS developed for this study may enable obstetrical units to assess change in patient safety culture.

Analyzing and strengthening the vaccine safety program in Manitoba.

PubMed

Montalban, J M; Ogbuneke, C; Hilderman, T

2014-12-04

The emergence of a novel influenza A virus in 2009 and the rapid introduction of new pandemic vaccines prompted an analysis of the current state of the adverse events following immunization (AEFI) surveillance response in several provinces. To highlight aspects of the situational analysis of the Manitoba Health, Healthy Living and Seniors (MHHLS's) AEFI surveillance system and to demonstrate how common business techniques could be usefully applied to a provincial vaccine safety monitoring program. Situational analysis of the AEFI surveillance system in Manitoba was developed through a strengths-weaknesses-opportunities-threats (SWOT) analysis and informed by the National Immunization Strategy vaccine safety priorities. Strategy formulation was developed by applying the threats-opportunities-weaknesses-strengths (TOWS) matrix. Thirteen strategies were formulated that use strengths to either take advantage of opportunities or avoid threats, that exploit opportunities to overcome weaknesses, or that rectify weaknesses to circumvent threats. These strategies entailed the development of various tools and resources, most of which are either actively underway or completed. The SWOT analysis and the TOWS matrix enabled MHHLS to enhance the capacity of its vaccine safety program.

Analyzing and strengthening the vaccine safety program in Manitoba

PubMed Central

Montalban, JM; Ogbuneke, C; Hilderman, T

2014-01-01

Background: The emergence of a novel influenza A virus in 2009 and the rapid introduction of new pandemic vaccines prompted an analysis of the current state of the adverse events following immunization (AEFI) surveillance response in several provinces. Objectives To highlight aspects of the situational analysis of the Manitoba Health, Healthy Living and Seniors (MHHLS’s) AEFI surveillance system and to demonstrate how common business techniques could be usefully applied to a provincial vaccine safety monitoring program. Method Situational analysis of the AEFI surveillance system in Manitoba was developed through a strengths-weaknesses-opportunities-threats (SWOT) analysis and informed by the National Immunization Strategy vaccine safety priorities. Strategy formulation was developed by applying the threats-opportunities-weaknesses-strengths (TOWS) matrix. Results Thirteen strategies were formulated that use strengths to either take advantage of opportunities or avoid threats, that exploit opportunities to overcome weaknesses, or that rectify weaknesses to circumvent threats. These strategies entailed the development of various tools and resources, most of which are either actively underway or completed. Conclusion The SWOT analysis and the TOWS matrix enabled MHHLS to enhance the capacity of its vaccine safety program. PMID:29769910

Patient Turnover: A Concept Analysis.

PubMed

VanFosson, Christopher A; Yoder, Linda H; Jones, Terry L

Patient turnover influences the quality and safety of patient care. However, variations in the conceptual underpinnings of patient turnover limit the understanding of the phenomenon. A concept analysis was completed to clarify the role of patient turnover in relation to outcomes in the acute care hospital setting. The defining attributes, antecedents, consequences, and empirical referents of patient turnover were proposed. Nursing leaders should account for patient turnover in workload and staffing calculations. Further research is needed to clarify the influence of patient turnover on the quality and safety of nursing care using a unified understanding of the phenomenon.

77 FR 75833 - Airworthiness Directives; Airbus Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... accordance with Airbus SB A300-57-6053 (Mod. 10453). Therefore and pending completion of the full analysis using a refined Finite Element Model, EASA [European Aviation Safety Agency] issued AD 2009-0094 [which...

Nonoccupant Fatalities Associated with Backing Crashes

DOT National Transportation Integrated Search

1997-02-01

National Highway Traffic Safety Administration's National Center for Statistics : and Analysis (NCSA) recently completed a study of data from the National Center : Health Statistics (NCHS) to obtain an estimate of the number of nonoccupant : fataliti...

Continuing Education in Patient Safety: Massive Open Online Courses as a New Training Tool.

PubMed

Sarabia-Cobo, Carmen María; Torres-Manrique, Blanca; Ortego-Mate, Ma Carmen; Salvadores-Fuentes, Paloma; Sáenz-Jalón, María

2015-10-01

Describe the use of two massive open online courses designed to provide education on patient safety. Review follow-up evaluation data from the courses. DISCLOSURE STATEMENT: Neither the planners nor the authors have any conflicts of interest to disclose. The Nursing School of the University of Cantabria conducted a training session on patient safety through two massive open online courses (MOOCs) aimed at the general population and especially Spanish-speaking health professionals. This study aimed to analyze the profile of health professionals who have completed the courses, their degree of satisfaction, and the percentage of completion. In this retrospective and observational study, two MOOCs on clinical safety were created through an online platform (MiríadaX). Quantitative analysis of the profile of health professionals, their degree of satisfaction, and the percentage of completion was performed. A total of 12,400 students were enrolled, and the average completion rate was 32%. The profile of the average student was female, 37 years old, college educated, a nurse in a hospital, and interested in the course because it may be useful for performing her work. Fifty-five percent of students were very satisfied with the course. MOOCs are considered to be effective and easily accessible, with quality content for professional continuing education that encourages interdisciplinary work and meeting professionals from around the world. Copyright 2015, SLACK Incorporated.

Use of platelet rich plasma for the treatment of bicipital tendinopathy in spinal cord injury:: a pilot study.

PubMed

Ibrahim, Victor M; Groah, Suzanne L; Libin, Alexander; Ljungberg, Inger H

2012-01-01

The purpose of study is to explore the efficacy and safety of platelet rich plasma (PRP) in the nonoperative management of shoulder tendinopathy amongst individuals with spinal cord injury. This objective was met by completing a pilot study on the effectiveness and safety of a PRP injection into the biceps tendon demonstrating clinical and ultrasonagraphic pathology. Recent analysis of the preliminary pilot data has demonstrated remarkably convincing results demonstrating both the safety and efficacy of this novel intervention.

Safety of famciclovir in patients with herpes zoster and genital herpes.

PubMed Central

Saltzman, R; Jurewicz, R; Boon, R

1994-01-01

Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide. An integrated safety evaluation has been performed and includes over 1,600 patients from 11 completed, randomized, double-blind clinical trials and 2 open trials. The famciclovir population consisted of 816 herpes zoster patients (four trials), 409 patients with acute genital herpesvirus infections (seven trials), and 382 patients from two genital herpes suppression studies. Overall, the famciclovir-treated patient population was 57.7% female and ranged in age from 15 to 102 years (mean, 42.6 years), with 31.2% aged 50 years or more and 15.7% aged 65 years or more. The mean duration of exposure to famciclovir was 28.8 days (5.8 days excluding suppression studies). The total daily doses ranged from 125 mg to 2.25 g. The most common adverse experiences reported as related to study medication (famciclovir and placebo) were headache, nausea, and diarrhea. The frequencies of adverse experiences and laboratory abnormalities (hematology, clinical chemistry, and urinalysis parameters) were similar in both famciclovir and placebo recipients. Thus, safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerated well by patients with either herpes zoster or genital and has a safety profile comparable to that of placebo. PMID:7840587

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false What happens after completion of the safety audit...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after...

Testing of Safety-Critical Software Embedded in an Artificial Heart

NASA Astrophysics Data System (ADS)

Cha, Sungdeok; Jeong, Sehun; Yoo, Junbeom; Kim, Young-Gab

Software is being used more frequently to control medical devices such as artificial heart or robotic surgery system. While much of software safety issues in such systems are similar to other safety-critical systems (e.g., nuclear power plants), domain-specific properties may warrant development of customized techniques to demonstrate fitness of the system on patients. In this paper, we report results of a preliminary analysis done on software controlling a Hybrid Ventricular Assist Device (H-VAD) developed by Korea Artificial Organ Centre (KAOC). It is a state-of-the-art artificial heart which completed animal testing phase. We performed software testing in in-vitro experiments and animal experiments. An abnormal behaviour, never detected during extensive in-vitro analysis and animal testing, was found.

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Investigation and identification of factors affecting migrating peasant workers' usage of safety footwear in the Chinese construction industry.

PubMed

Suo, Qinghui; Zhang, Daming

2017-09-01

A sample of 300 migrating peasant workers from 15 Chinese building construction sites completed a demographic questionnaire to investigate the usage of safety footwear. The survey form was constructed based on the theory of planned behaviour, and a total of 12 questions focusing on the workers' past experience, attitudes, subjective norms and perceived behavioural control were included in the survey. It was found that 92% of the participants did not wear safety footwear while working on construction sites, although more than 91% of them believed that safety footwear would protect the foot from injury; none of the participants had been provided free safety footwear by their employer. Regression analysis shows that employers' attitude is the most important factor affecting their usage of safety footwear, 'providing free safety footwear' and 'comfortability of the safety footwear' ranking second and third respectively.

Patient safety culture: finding meaning in patient experiences.

PubMed

Bishop, Andrea C; Cregan, Brianna R

2015-01-01

The purpose of this paper is to determine what patient and family stories can tell us about patient safety culture within health care organizations and how patients experience patient safety culture. A total of 11 patient and family stories of adverse event experiences were examined in September 2013 using publicly available videos on the Canadian Patient Safety Insitute web site. Videos were transcribed verbatim and collated as one complete data set. Thematic analysis was used to perform qualitative inquiry. All qualitative analysis was done using NVivo 10 software. A total of three themes were identified: first, Being Passed Around; second, Not Having the Conversation; and third, the Person Behind the Patient. Results from this research also suggest that while health care organizations and providers might expect patients to play a larger role in managing their health, there may be underlying reasons as to why patients are not doing so. The findings indicate that patient experiences and narratives are useful sources of information to better understand organizational safety culture and patient experiences of safety while hospitalized. Greater inclusion and analysis of patient safety narratives is important in understanding the needs of patients and how patient safety culture interventions can be improved to ensure translation of patient safety strategies at the frontlines of care. Greater acknowledgement of the patient and family experience provides organizations with an integral perspective to assist in defining and addressing deficiencies within their patient safety culture and to identify opportunities for improvement.

Application of demographic analysis to pedestrian safety : [project summary].

DOT National Transportation Integrated Search

2017-05-01

FDOT has been working diligently to improve its facilities for pedestrians and cyclists, including : initiatives like the Complete Streets Policy and Implementation Plan. However, one of the : challenges facing FDOT is targeting those areas of greate...

Data mining and visualization of the Alabama accident database

DOT National Transportation Integrated Search

2000-08-01

The Alabama Department of Public Safety has developed and maintains a centralized database that contain traffic accident data collected from crash report completed by local police officers and state troopers. The Critical Analysis Reporting Environme...

Safety and efficiency of flow diverters for treating small intracranial aneurysms: A systematic review and meta-analysis.

PubMed

Yao, Xiyang; Ma, Junwei; Li, Haiying; Shen, Haitao; Lu, Xiaojun; Chen, Gang

2017-02-01

Background We evaluated the safety and efficiency of flow diverters (FDs) in treating small intracranial aneurysms (IAs). Materials and Methods We reviewed the literature published in PubMed and EMBASE. R for Project software was used to calculate the complete aneurysm occlusion rates, procedure-related neurologic mortality, procedure-related neurologic morbidity and procedure-related permanent morbidity. Results Ten observational studies were included in this analysis. The complete aneurysm occlusion rate was 84.23% (80.34%-87.76%), the procedure-related neurologic mortality was 0.87% (0.29%-1.74%), the procedure-related neurologic morbidity rate was 5.22% (3.62%-7.1%), the intracerebral haemorrhage rate was 1.42% (0.64%-2.49%), the ischemic rate was 2.35% (1.31%-3.68%), the subarachnoid haemorrhage rate was 0.03% (0%-0.32%) and the procedure-related permanent morbidity was 2.41% (0.81%-4.83%). Conclusions Treatment of small IAs with FDs may be correlated with high complete occlusion rates and low complication rates. Future long-term follow-up randomized trials will determine the optimal treatment for small IAs.

Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists

PubMed Central

Fois, Romano A.; McLachlan, Andrew J.; Chen, Timothy F.

2017-01-01

Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns’ patient safety attitudes. However, other factors likely influenced their attitudes in the longer term. PMID:28289295

Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists.

PubMed

Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

2017-02-25

Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns' patient safety attitudes. However, other factors likely influenced their attitudes in the longer term.

Fractional watt Vuillemier cryogenic refrigerator program engineering notebook. Volume 2: Stress analysis

NASA Technical Reports Server (NTRS)

Miller, W. S.

1974-01-01

A structural analysis performed on the 1/4-watt cryogenic refrigerator. The analysis covered the complete assembly except for the cooling jacket and mounting brackets. Maximum stresses, margin of safety, and natural frequencies were calculated for structurally loaded refrigerator components shown in assembly drawings. The stress analysis indicates that the design is satisfactory for the specified vibration environment, and the proof, burst, and normal operating loads.

Occupational safety beliefs among Latino residential roofing workers.

PubMed

Arcury, Thomas A; Summers, Phillip; Carrillo, Lourdes; Grzywacz, Joseph G; Quandt, Sara A; Mills, Thomas H

2014-06-01

This analysis describes beliefs about work safety and personal protective equipment (PPE) among Latino roofing workers, it delineates their perceptions of work environment characteristics that affect work safety and PPE use, and it describes how they experience work injuries and the consequences of these injuries. In-depth interviews were completed with 10 current and former Latino residential roofers. Interview transcripts were subjected to systematic qualitative analysis. Participants' valued productivity over safety, and this had a negative influence on their safety behavior and reduced their PPE use. They understood that roofing was hazardous. They limited use of PPE when they felt it reduced productivity and when it was uncomfortable. Work environment characteristics that affected safety included company size, the physical demands of the job, lack of training, the need for work, general life stress, and distractions at work. An injury had to result in lost work time to be considered significant. Access to health care is limited by employers not providing Workers' compensation. Future research is needed to substantiate these descriptive results and to delineate factors that are associated with safety behavior and use of PPE. Interventions, based on a lay health educator model, are needed to improve safety in this population. Safety regulations need to be evaluated and their enforcement needs to be improved. © 2013 Wiley Periodicals, Inc.

Roy's safety-first portfolio principle in financial risk management of disastrous events.

PubMed

Chiu, Mei Choi; Wong, Hoi Ying; Li, Duan

2012-11-01

Roy pioneers the concept and practice of risk management of disastrous events via his safety-first principle for portfolio selection. More specifically, his safety-first principle advocates an optimal portfolio strategy generated from minimizing the disaster probability, while subject to the budget constraint and the mean constraint that the expected final wealth is not less than a preselected disaster level. This article studies the dynamic safety-first principle in continuous time and its application in asset and liability management. We reveal that the distortion resulting from dropping the mean constraint, as a common practice to approximate the original Roy's setting, either leads to a trivial case or changes the problem nature completely to a target-reaching problem, which produces a highly leveraged trading strategy. Recognizing the ill-posed nature of the corresponding Lagrangian method when retaining the mean constraint, we invoke a wisdom observed from a limited funding-level regulation of pension funds and modify the original safety-first formulation accordingly by imposing an upper bound on the funding level. This model revision enables us to solve completely the safety-first asset-liability problem by a martingale approach and to derive an optimal policy that follows faithfully the spirit of the safety-first principle and demonstrates a prominent nature of fighting for the best and preventing disaster from happening. © 2012 Society for Risk Analysis.

Electrical deaths in the US construction: an analysis of fatality investigations.

PubMed

Zhao, Dong; Thabet, Walid; McCoy, Andrew; Kleiner, Brian

2014-01-01

Electrocution is among the 'fatal four' in US construction according to the Occupational Safety and Health Administration. Learning from failures is believed to be an effective path to success, with deaths being the most serious system failures. This paper examined the failures in electrical safety by analysing all electrical fatality investigations (N = 132) occurring between 1989 and 2010 from the Fatality Assessment and Control Evaluation programme that is completed by the National Institute of Occupational Safety and Health. Results reveal the features of the electrical fatalities in construction and disclose the most common electrical safety challenges on construction sites. This research also suggests the sociotechnical system breakdowns and the less effectiveness of current safety training programmes may significantly contribute to worker's unsafe behaviours and electrical fatality occurrences.

Fatalities Associated with Carbon Monoxide Poisoning from Motor Vehicles in 1993

DOT National Transportation Integrated Search

1996-12-01

National Highway Traffic Safety Administration's National Center for Statistics : and Analysis (NCSA) recently completed a study of data from the National Center : for Health Statistics (NCHS) to obtain an estimate of the number of persons : killed a...

Research notes : evaluation of the oregon medically at-risk driver program.

DOT National Transportation Integrated Search

2009-05-01

Dr. James Strathman, a Portland State University researcher, recently completed an assessment of the safety risk of persons whose licenses were suspended under the Oregon Medically At-Risk Driver program. The results of the analysis suggested modific...

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient panel will provide steering to the research. The PMOS and PIRT aim to provide a reliable means of eliciting patient views about patient safety. Both interventions are likely to have relevance and practical utility for all NHS hospital trusts.

Developing an industry-oriented safety curriculum using the Delphi technique.

PubMed

Chen, Der-Fa; Wu, Tsung-Chih; Chen, Chi-Hsiang; Chang, Shu-Hsuan; Yao, Kai-Chao; Liao, Chin-Wen

2016-09-01

In this study, we examined the development of industry-oriented safety degree curricula at a college level. Based on a review of literature on the practices and study of the development of safety curricula, we classified occupational safety and health curricula into the following three domains: safety engineering, health engineering, and safety and health management. We invited 44 safety professionals to complete a four-round survey that was designed using a modified Delphi technique. We used Chi-square statistics to test the panel experts' consensus on the significance of the items in the three domains and employed descriptive statistics to rank the participants' rating of each item. The results showed that the top three items for each of the three domains were Risk Assessment, Dangerous Machinery and Equipment, and Fire and Explosion Prevention for safety engineering; Ergonomics, Industrial Toxicology, and Health Risk Assessment for health engineering; and Industrial Safety and Health Regulations, Accident Investigation and Analysis, and Emergency Response for safety and health management. Only graduates from safety programmes who possess practical industry-oriented abilities can satisfy industry demands and provide value to the existence of college safety programmes.

Effects of Defensive Vehicle Handling on Novice Driver Safety : Phase 3. Data Analysis and Results

DOT National Transportation Integrated Search

2010-09-01

This project evaluates the effectiveness of a multistage driver education program for Montanas young : drivers. A total of 347 teenaged drivers who had completed high school driver education agreed to participate. : These drivers were randomly spl...

ESSAA: Embedded system safety analysis assistant

NASA Technical Reports Server (NTRS)

Wallace, Peter; Holzer, Joseph; Guarro, Sergio; Hyatt, Larry

1987-01-01

The Embedded System Safety Analysis Assistant (ESSAA) is a knowledge-based tool that can assist in identifying disaster scenarios. Imbedded software issues hazardous control commands to the surrounding hardware. ESSAA is intended to work from outputs to inputs, as a complement to simulation and verification methods. Rather than treating the software in isolation, it examines the context in which the software is to be deployed. Given a specified disasterous outcome, ESSAA works from a qualitative, abstract model of the complete system to infer sets of environmental conditions and/or failures that could cause a disasterous outcome. The scenarios can then be examined in depth for plausibility using existing techniques.

An assessment of safety climate, job satisfaction and turnover intention relationships using a national sample of workers from the USA.

PubMed

Smith, Todd D

2018-03-01

The association between safety climate, job satisfaction and turnover intention has not been thoroughly researched. This research is needed so that safety researchers and practitioners can begin to delineate the impact of safety on organizational and business outcomes. A path analysis was completed using data from a national sample of workers from the USA (n = 1525). The overall fit of the model was excellent and analyses determined that both training and resource adequacy positively affected safety climate and job satisfaction. Safety climate also positively influenced job satisfaction. Both safety climate and job satisfaction were negatively associated with respondents' turnover intention. In the study, the relationship between job satisfaction and turnover intention is reiterated in a sample of workers across many industries. This study is novel because it is one of the first studies to confirm that turnover intention is reduced with increased safety climate in a diverse sample of workers.

The culture of patient safety in an Iranian intensive care unit.

PubMed

Abdi, Zhaleh; Delgoshaei, Bahram; Ravaghi, Hamid; Abbasi, Mohsen; Heyrani, Ali

2015-04-01

To explore nurses' and physicians' attitudes and perceptions relevant to safety culture and to elicit strategies to promote safety culture in an intensive care unit. A strong safety culture is essential to ensure patient safety in the intensive care unit. This case study adopted a mixed method design. The Safety Attitude Questionnaire (SAQ-ICU version), assessing the safety climate through six domains, was completed by nurses and physicians (n = 42) in an academic intensive care unit. Twenty semi-structured interviews and document analyses were conducted as well. Interviews were analysed using a framework analysis method. Mean scores across the six domains ranged from 52.3 to 72.4 on a 100-point scale. Further analysis indicated that there were statistically significant differences between physicians' and nurses' attitudes toward teamwork (mean scores: 64.5/100 vs. 52.6/100, d = 1.15, t = 3.69, P < 0.001) and job satisfaction (mean scores: 78.2/100 vs. 57.7/100, d = 1.5, t = 4.8, P < 0.001). Interviews revealed several safety challenges including underreporting, failure to learn from errors, lack of speaking up, low job satisfaction among nurses and ineffective nurse-physician communication. The results indicate that all the domains need improvements. However, further attention should be devoted to error reporting and analysis, communication and teamwork among professional groups, and nurses' job satisfaction. Nurse managers can contribute to promoting a safety culture by encouraging staff to report errors, fostering learning from errors and addressing inter-professional communication problems. © 2013 John Wiley & Sons Ltd.

Crew Exploration Vehicle Ascent Abort Coverage Analysis

NASA Technical Reports Server (NTRS)

Abadie, Marc J.; Berndt, Jon S.; Burke, Laura M.; Falck, Robert D.; Gowan, John W., Jr.; Madsen, Jennifer M.

2007-01-01

An important element in the design of NASA's Crew Exploration Vehicle (CEV) is the consideration given to crew safety during various ascent phase failure scenarios. To help ensure crew safety during this critical and dynamic flight phase, the CEV requirements specify that an abort capability must be continuously available from lift-off through orbit insertion. To address this requirement, various CEV ascent abort modes are analyzed using 3-DOF (Degree Of Freedom) and 6-DOF simulations. The analysis involves an evaluation of the feasibility and survivability of each abort mode and an assessment of the abort mode coverage using the current baseline vehicle design. Factors such as abort system performance, crew load limits, thermal environments, crew recovery, and vehicle element disposal are investigated to determine if the current vehicle requirements are appropriate and achievable. Sensitivity studies and design trades are also completed so that more informed decisions can be made regarding the vehicle design. An overview of the CEV ascent abort modes is presented along with the driving requirements for abort scenarios. The results of the analysis completed as part of the requirements validation process are then discussed. Finally, the conclusions of the study are presented, and future analysis tasks are recommended.

An Educational Intervention to Enhance Nurse Leaders' Perceptions of Patient Safety Culture

PubMed Central

Ginsburg, Liane; Norton, Peter G; Casebeer, Ann; Lewis, Steven

2005-01-01

Objective To design a training intervention and then test its effect on nurse leaders' perceptions of patient safety culture. Study Setting Three hundred and fifty-six nurses in clinical leadership roles (nurse managers and educators/CNSs) in two Canadian multi-site teaching hospitals (study and control). Study Design A prospective evaluation of a patient safety training intervention using a quasi-experimental untreated control group design with pretest and posttest. Nurses in clinical leadership roles in the study group were invited to participate in two patient safety workshops over a 6-month period. Individuals in the study and control groups completed surveys measuring patient safety culture and leadership for improvement prior to training and 4 months following the second workshop. Extraction Methods Individual nurse clinical leaders were the unit of analysis. Exploratory factor analysis of the safety culture items was conducted; repeated-measures analysis of variance and paired t-tests were used to evaluate the effect of the training intervention on perceived safety culture (three factors). Hierarchical regression analyses looked at the influence of demographics, leadership for improvement, and the training intervention on nurse leaders' perceptions of safety culture. Principal Findings A statistically significant improvement in one of three safety culture measures was shown for the study group (p<.001) and a significant decline was seen on one of the safety culture measures for the control group (p<.05). Leadership support for improvement was found to explain significant amounts of variance in all three patient safety culture measures; workshop attendance explained significant amounts of variance in one of the three safety culture measures. The total R2 for the three full hierarchical regression models ranged from 0.338 and 0.554. Conclusions Sensitively delivered training initiatives for nurse leaders can help to foster a safety culture. Organizational leadership support for improvement is, however, also critical for fostering a culture of safety. Together, training interventions and leadership support may have the most significant impact on patient safety culture. PMID:16033489

Motor Vehicle Crashes as a Leading Cause of Death in 1994

DOT National Transportation Integrated Search

1998-03-01

National Highway Traffic Safety Administration's National Center for Statistics : and Analysis (NCSA) recently completed a study of data on the causes of death : for all persons, by age and sex, which occurred in the U. S. in 1994. The : purpose of t...

Los Angeles congestion reduction demonstration (Metro ExpressLanes) program. National evaluation : content analysis test plan.

DOT National Transportation Integrated Search

1998-11-01

This flyer summarizes the identified human factors research needs for integrated in-vehicle systems for transit vehicles, one of five configurations of in-vehicle safety and driver information systems. A complete review of the research needs for all ...

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

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

2007-01-01

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

Preliminary hazards analysis -- vitrification process

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

Coordes, D.; Ruggieri, M.; Russell, J.

1994-06-01

This paper presents a Preliminary Hazards Analysis (PHA) for mixed waste vitrification by joule heating. The purpose of performing a PHA is to establish an initial hazard categorization for a DOE nuclear facility and to identify those processes and structures which may have an impact on or be important to safety. The PHA is typically performed during and provides input to project conceptual design. The PHA is then followed by a Preliminary Safety Analysis Report (PSAR) performed during Title 1 and 2 design. The PSAR then leads to performance of the Final Safety Analysis Report performed during the facility`s constructionmore » and testing. It should be completed before routine operation of the facility commences. This PHA addresses the first four chapters of the safety analysis process, in accordance with the requirements of DOE Safety Guidelines in SG 830.110. The hazards associated with vitrification processes are evaluated using standard safety analysis methods which include: identification of credible potential hazardous energy sources; identification of preventative features of the facility or system; identification of mitigative features; and analyses of credible hazards. Maximal facility inventories of radioactive and hazardous materials are postulated to evaluate worst case accident consequences. These inventories were based on DOE-STD-1027-92 guidance and the surrogate waste streams defined by Mayberry, et al. Radiological assessments indicate that a facility, depending on the radioactive material inventory, may be an exempt, Category 3, or Category 2 facility. The calculated impacts would result in no significant impact to offsite personnel or the environment. Hazardous materials assessment indicates that a Mixed Waste Vitrification facility will be a Low Hazard facility having minimal impacts to offsite personnel and the environment.« less

Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

PubMed

Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

2010-12-01

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

75 FR 70106 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... states: Viking Air Limited has completed a system safety review of the aircraft fuel system against fuel... safety review of the aircraft fuel system against fuel tank safety standards introduced in Chapter 525 of... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

Ruxolitinib for the treatment of inadequately controlled polycythemia vera without splenomegaly: 80-week follow-up from the RESPONSE-2 trial.

PubMed

Griesshammer, Martin; Saydam, Guray; Palandri, Francesca; Benevolo, Giulia; Egyed, Miklos; Callum, Jeannie; Devos, Timothy; Sivgin, Serdar; Guglielmelli, Paola; Bensasson, Caroline; Khan, Mahmudul; Ronco, Julian Perez; Passamonti, Francesco

2018-05-27

RESPONSE-2 is a phase 3 study comparing the efficacy and safety of ruxolitinib with the best available therapy (BAT) in hydroxyurea-resistant/hydroxyurea-intolerant polycythemia vera (PV) patients without palpable splenomegaly. This analysis evaluated the durability of the efficacy and safety of ruxolitinib after patients completed the visit at week 80 or discontinued the study. Endpoints included proportion of patients achieving hematocrit control (< 45%), proportion of patients achieving complete hematologic remission (CHR) at week 28, and the durability of hematocrit control and CHR. At the time of analysis, 93% (69/74) of patients randomized to ruxolitinib were receiving ruxolitinib; while in the BAT arm, 77% (58/75) of patients crossed over to ruxolitinib after week 28. No patient remained on BAT by week 80. Among patients who achieved a hematocrit response at week 28, the probability of maintaining response up to week 80 was 78% in the ruxolitinib arm. At week 80, durable CHR was achieved in 18 patients (24%) in the ruxolitinib arm versus 2 patients (3%) in the BAT arm. The safety profile of ruxolitinib was consistent with previous reports. These data support that ruxolitinib treatment should be considered also as a standard of care for hydroxyurea-resistant/hydroxyurea-intolerant PV patients without palpable splenomegaly.

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

PubMed

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

2010-12-01

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

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

PubMed

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

2018-01-01

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

15 CFR 270.205 - Reports.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false Reports. 270.205 Section 270.205... SAFETY TEAMS Investigations § 270.205 Reports. (a) Not later than 90 days after completing an investigation, a Team shall issue a public report which includes: (1) An analysis of the likely technical cause...

15 CFR 270.205 - Reports.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 15 Commerce and Foreign Trade 1 2014-01-01 2014-01-01 false Reports. 270.205 Section 270.205... SAFETY TEAMS Investigations § 270.205 Reports. (a) Not later than 90 days after completing an investigation, a Team shall issue a public report which includes: (1) An analysis of the likely technical cause...

15 CFR 270.205 - Reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false Reports. 270.205 Section 270.205... SAFETY TEAMS Investigations § 270.205 Reports. (a) Not later than 90 days after completing an investigation, a Team shall issue a public report which includes: (1) An analysis of the likely technical cause...

Perceptions of medical graduates and their workplace supervisors towards a medical school clinical audit program.

PubMed

Davis, Stephanie; O'Ferrall, Ilse; Hoare, Samuel; Caroline, Bulsara; Mak, Donna B

2017-07-07

This study explores how medical graduates and their workplace supervisors perceive the value of a structured clinical audit program (CAP) undertaken during medical school. Medical students at the University of Notre Dame Fremantle complete a structured clinical audit program in their final year of medical school.  Semi-structured interviews were conducted with 12 Notre Dame graduates (who had all completed the CAP), and seven workplace supervisors (quality and safety staff and clinical supervisors).  Purposeful sampling was used to recruit participants and data were analysed using thematic analysis. Both graduates and workplace supervisors perceived the CAP to be valuable. A major theme was that the CAP made a contribution to individual graduate's medical practice, including improved knowledge in some areas of patient care as well as awareness of healthcare systems issues and preparedness to undertake scientifically rigorous quality improvement activities. Graduates perceived that as a result of the CAP, they were confident in undertaking a clinical audit after graduation.  Workplace supervisors perceived the value of the CAP beyond an educational experience and felt that the audits undertaken by students improved quality and safety of patient care. It is vital that health professionals, including medical graduates, be able to carry out quality and safety activities in the workplace. This study provides evidence that completing a structured clinical audit during medical school prepares graduates to undertake quality and safety activities upon workplace entry. Other health professional faculties may be interested in incorporating a similar program in their curricula.

Design and Testing of BACRA, a Web-Based Tool for Middle Managers at Health Care Facilities to Lead the Search for Solutions to Patient Safety Incidents

PubMed Central

Mira, José Joaquín; Vicente, Maria Asuncion; Fernandez, Cesar; Guilabert, Mercedes; Ferrús, Lena; Zavala, Elena; Silvestre, Carmen; Pérez-Pérez, Pastora

2016-01-01

Background Lack of time, lack of familiarity with root cause analysis, or suspicion that the reporting may result in negative consequences hinder involvement in the analysis of safety incidents and the search for preventive actions that can improve patient safety. Objective The aim was develop a tool that enables hospitals and primary care professionals to immediately analyze the causes of incidents and to propose and implement measures intended to prevent their recurrence. Methods The design of the Web-based tool (BACRA) considered research on the barriers for reporting, review of incident analysis tools, and the experience of eight managers from the field of patient safety. BACRA’s design was improved in successive versions (BACRA v1.1 and BACRA v1.2) based on feedback from 86 middle managers. BACRA v1.1 was used by 13 frontline professionals to analyze incidents of safety; 59 professionals used BACRA v1.2 and assessed the respective usefulness and ease of use of both versions. Results BACRA contains seven tabs that guide the user through the process of analyzing a safety incident and proposing preventive actions for similar future incidents. BACRA does not identify the person completing each analysis since the password introduced to hide said analysis only is linked to the information concerning the incident and not to any personal data. The tool was used by 72 professionals from hospitals and primary care centers. BACRA v1.2 was assessed more favorably than BACRA v1.1, both in terms of its usefulness (z=2.2, P=.03) and its ease of use (z=3.0, P=.003). Conclusions BACRA helps to analyze incidents of safety and to propose preventive actions. BACRA guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task. BACRA is useful and easy to use. PMID:27678308

Design and Testing of BACRA, a Web-Based Tool for Middle Managers at Health Care Facilities to Lead the Search for Solutions to Patient Safety Incidents.

PubMed

Carrillo, Irene; Mira, José Joaquín; Vicente, Maria Asuncion; Fernandez, Cesar; Guilabert, Mercedes; Ferrús, Lena; Zavala, Elena; Silvestre, Carmen; Pérez-Pérez, Pastora

2016-09-27

Lack of time, lack of familiarity with root cause analysis, or suspicion that the reporting may result in negative consequences hinder involvement in the analysis of safety incidents and the search for preventive actions that can improve patient safety. The aim was develop a tool that enables hospitals and primary care professionals to immediately analyze the causes of incidents and to propose and implement measures intended to prevent their recurrence. The design of the Web-based tool (BACRA) considered research on the barriers for reporting, review of incident analysis tools, and the experience of eight managers from the field of patient safety. BACRA's design was improved in successive versions (BACRA v1.1 and BACRA v1.2) based on feedback from 86 middle managers. BACRA v1.1 was used by 13 frontline professionals to analyze incidents of safety; 59 professionals used BACRA v1.2 and assessed the respective usefulness and ease of use of both versions. BACRA contains seven tabs that guide the user through the process of analyzing a safety incident and proposing preventive actions for similar future incidents. BACRA does not identify the person completing each analysis since the password introduced to hide said analysis only is linked to the information concerning the incident and not to any personal data. The tool was used by 72 professionals from hospitals and primary care centers. BACRA v1.2 was assessed more favorably than BACRA v1.1, both in terms of its usefulness (z=2.2, P=.03) and its ease of use (z=3.0, P=.003). BACRA helps to analyze incidents of safety and to propose preventive actions. BACRA guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task. BACRA is useful and easy to use.

Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: primary analysis of the randomized, open-label MABLE study

PubMed Central

Michallet, Anne-Sophie; Aktan, Melih; Hiddemann, Wolfgang; Ilhan, Osman; Johansson, Peter; Laribi, Kamel; Meddeb, Balkis; Moreno, Carol; Raposo, João; Schuh, Anna; Ünal, Ali; Widenius, Tom; Bernhardt, Alf; Kellershohn, Kerstin; Messeri, Dimitri; Osborne, Stuart; Leblond, Véronique

2018-01-01

MABLE investigated the efficacy and safety of rituximab plus bendamustine or rituximab plus chlorambucil in fludarabine-ineligible patients with chronic lymphocytic leukemia. Patients received rituximab plus bendamustine or rituximab plus chlorambucil every four weeks for six cycles. Rituximab plus chlorambucil-treated patients without a complete response after Cycle 6 received chlorambucil monotherapy for at least six additional cycles or until complete response. The primary endpoint was complete response rate (confirmed by bone marrow biopsy) after Cycle 6 in first-line patients. Secondary endpoints included progression-free survival, overall survival, minimal residual disease, and safety. Overall, 357 patients were randomized (rituximab plus bendamustine, n=178; rituximab plus chlorambucil, n=179; intent-to-treat population), including 241 first-line patients (n=121 and n=120, respectively); 355 patients received treatment (n=177 and n=178, respectively; safety population). In first-line patients, complete response rate after Cycle 6 (rituximab plus bendamustine, 24%; rituximab plus chlorambucil, 9%; P=0.002) and median progression-free survival (rituximab plus bendamustine, 40 months; rituximab plus chlorambucil, 30 months; P=0.003) were higher with rituximab plus bendamustine than rituximab plus chlorambucil. Overall response rate and overall survival were not different. In first-line patients with a complete response, minimal residual disease-negativity was higher with rituximab plus bendamustine than rituximab plus chlorambucil (66% vs. 36%). Overall adverse event incidence was similar (rituximab plus bendamustine, 98%; rituximab plus chlorambucil, 97%). Rituximab plus bendamustine may be a valuable first-line option for fludarabine-ineligible patients with chronic lymphocytic leukemia. PMID:29419437

Safety Network to Detect Performance Degradation and Pilot Incapacitation (Reseau de securite pour detecter la degradation des performances et la defaillance du pilote)

DTIC Science & Technology

1990-09-01

military pilot acceptance of a safety network system would be based , as always, on the following: a. Do I really need such a system and will it be a...inferring pilot state based on computer analysis of pilot control inputs (or lack of)l. Having decided that the pilot is incapacitated, PMAS would alert...the advances being made in neural network computing machinery have necessitated a complete re-thinking of the conventional serial von Neuman machine

Surgical Safety Checklist compliance: a job done poorly!

PubMed

Sparks, Eric A; Wehbe-Janek, Hania; Johnson, Rebecca L; Smythe, W Roy; Papaconstantinou, Harry T

2013-11-01

The Surgical Safety Checklist (SSC) has been introduced as an effective tool for reducing perioperative mortality and complications. Although reported completion rates are high, objective compliance is not well defined. The purpose of this retrospective analysis is to determine SSC compliance as measured by accuracy and completion, and factors that can affect compliance. In September 2010, our institution implemented an adaptation of the World Health Organization's SSC in an effort to improve patient safety and outcomes. A tool was developed for objective evaluation of overall compliance (maximum score 40) that was an aggregate score of completion and accuracy (20 each). Random samples of SSCs were analyzed at specific, predefined, time points throughout the first year after implementation. Procedure start time, operative time, and case complexity were assessed to determine association with compliance. A total of 671 SSCs were analyzed. The participation rate improved from 33% (95 of 285) at week 1 to 94% (249 of 265) at 1 year (p < 0.0001, chi-square test). Mean overall compliance score was 27.7 (± 5.4 SD) of 40 possible points (69.3% ± 13.5% of total possible score; n = 671) and did not change over time. Although completion scores were high (16.9 ± 2.7 out of 20 [84.5% ± 13.6%]), accuracy was poor (10.8 ± 3.4 out of 20 [54.1% ± 16.9%]). Overall compliance score was significantly associated with case start-time (p < 0.05), and operative time and case complexity showed no association. Our data indicate that although implementation of an SSC results in a high level of overall participation and completion, accuracy remained poor. Identification of barriers to effective use is needed, as improper checklist use can adversely affect patient safety. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2010 CFR

2010-07-01

... up the safety management system. (c) Actions required during safety management audits for a company... management system, as defined in subpart B of this part. (2) Make sure the audit complies with this subpart... safety management system is found during an audit, it must be reported in writing by the auditor: (1) For...

Sun safety knowledge and practice in UK postal delivery workers.

PubMed

Houdmont, J; Davis, S; Griffiths, A

2016-06-01

Postal delivery workers spend a large proportion of their work time outdoors, placing them at increased risk of skin cancer. To date, no studies have examined occupational sun safety knowledge and practice within this group in the UK. To describe the occupational sun safety knowledge and practice of UK postal delivery workers and to investigate the association of demographic, personal and occupational factors with knowledge and practice in order to identify potential strategies for improving sun safety in this occupational group. Postal delivery workers completed a questionnaire that collected data on occupational sun safety knowledge and practice in addition to demographic, personal and workplace characteristics. One-way analysis of variances were applied to assess differences in knowledge and practice by these characteristics. A total of 1153 postal delivery workers completed the questionnaire, a 60% response rate. Thirty-three per cent reported receiving sun safety training within the previous 12 months. The majority of respondents reported correct knowledge on three of the six domains and good practice on four of the six behavioural domains. However, only one-fifth of respondents reported wearing sunglasses and ensuring a plentiful intake of water. Knowledge and practice differed significantly according to demographic, personal and workplace characteristics. There is a need to raise the profile of occupational skin cancer in this occupational group and to increase the priority given to occupational sun safety policies alongside targeted and tailored interventions, the effect of which can be evaluated. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine.

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

PubMed

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

2017-08-01

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

Delivering on the Promise of CLER: A Patient Safety Rotation That Aligns Resident Education With Hospital Processes.

PubMed

Patel, Ekta; Muthusamy, Veena; Young, John Q

2018-06-01

Residency programs must provide training in patient safety. Yet, significant gaps exist among published patient safety curricula. The authors developed a rotation designed to be scalable to an entire residency, built on sound pedagogy, aligned with hospital safety processes, and effective in improving educational outcomes. From July 2015 to May 2017, each second-year resident completed the two-week rotation. Residents engaged the foundational science asynchronously via multiple modalities and then practiced applying key concepts during a mock root cause analysis. Next, each resident performed a special review of an actual adverse patient event and presented findings to the hospital's Special Review Committee (SRC). Multiple educational outcomes were assessed, including resident satisfaction and attitudes (postrotation survey), changes in knowledge via pre- and posttest, quality of the residents' written safety analyses and oral presentations (per survey of SRC members), and organizational changes that resulted from the residents' reviews. Twenty-two residents completed the rotation. Most components were rated favorably; 80% (12/15 respondents) indicated interest in future patient safety work. Knowledge improved by 44.3% (P < .0001; pretest mean 23.7, posttest mean 34.2). Compared to faculty, SRC members rated the quality of residents' written reviews as superior and the quality of the rated oral presentations as either comparable or superior. The reviews identified a variety of safety vulnerabilities and led to multiple corrective actions. The authors will evaluate the curriculum in a controlled trial with better measures of change in behavior. Further tests of the curriculum's scalability to other contexts are needed.

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

Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

PubMed

MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

2014-01-01

Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

The affect heuristic in occupational safety.

PubMed

Savadori, Lucia; Caovilla, Jessica; Zaniboni, Sara; Fraccaroli, Franco

2015-07-08

The affect heuristic is a rule of thumb according to which, in the process of making a judgment or decision, people use affect as a cue. If a stimulus elicits positive affect then risks associated to that stimulus are viewed as low and benefits as high; conversely, if the stimulus elicits negative affect, then risks are perceived as high and benefits as low. The basic tenet of this study is that affect heuristic guides worker's judgment and decision making in a risk situation. The more the worker likes her/his organization the less she/he will perceive the risks as high. A sample of 115 employers and 65 employees working in small family agricultural businesses completed a questionnaire measuring perceived safety costs, psychological safety climate, affective commitment and safety compliance. A multi-sample structural analysis supported the thesis that safety compliance can be explained through an affect-based heuristic reasoning, but only for employers. Positive affective commitment towards their family business reduced employers' compliance with safety procedures by increasing the perceived cost of implementing them.

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

Perceived safety and teen risk taking in online chat sites.

PubMed

McCarty, Cheryl; Prawitz, Aimee D; Derscheid, Linda E; Montgomery, Bette

2011-03-01

Framed by theories of adolescent development, this study explored relationships among adolescents' perceptions of chat-site safety, time spent chatting, and risky online behaviors. Tenth graders (N = 139) in rural Midwestern U.S. schools completed surveys. Factor analysis produced three factors each for perception of safety and risk-taking behaviors. Regression analyses revealed that perception of safety factors were useful in predicting online risk-taking behaviors. Teens with more social discomfort and those who thought it was safe to reveal personal information and trust chat-site "friends" were more likely to take risks. As time spent in chat sites increased, so did risk-taking behaviors. Implications for educators and parents are discussed, such as initiation of conversations about safe Internet use, parental participation in chat sites as teens' invited "friends," and school programs to teach safe online practices.

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Identification of Suicide Risk Among Rural Youth: Implications for the Use of HEADSS

PubMed Central

Biddle, Virginia Sue; Sekula, L. Kathleen; Zoucha, Rick; Puskar, Kathryn R.

2009-01-01

Introduction Nurse practitioners have the power to detect suicide risk and prevent suicide, a problem plaguing rural areas of the United States. Suicide risk assessment can be completed using the HEADSS (Home, Education, Activities, Drug use and abuse, Sexual behavior, and Suicidality and depression) interview instrument. The purpose of this study was to determine if HEADSS is appropriate for guiding suicide risk assessment of rural adolescents. Method High school students in Southwestern Pennsylvania completed qualitative questions from the Child Behavior Checklist and Coping Response Inventory as part of the Intervention to Promote Mental Health in Rural Youth. Qualitative content analysis was performed. Results Prominent themes identified by participants included academic performance, relationships, dislikes about school, friends, death, mental health, and the future. Several minor themes concerned safety. Most known risk factors for suicide were concerns of participants. Discussion The expansion of HEADSS to include death and safety should be considered. The modified version—HEADDSSS— can be used to guide suicide risk assessment of youth in rural Pennsylvania, ensuring both thoroughness of assessment and safety. PMID:20417887

Children's Explanations of the Causes of Wellness, Illness, and Injury.

ERIC Educational Resources Information Center

Phillips, G. M.; And Others

This study examined children's explanatory style for health- and safety-related events. Fifty children (ages 8 to 11) were interviewed using 12 health-related questions based on Seligman's Content Analysis of Verbatim Explanations (CAVE) method. Children and their mothers also completed a health status form, which included questions on the…

The implementation of a Hazard Analysis and Critical Control Point management system in a peanut butter ice cream plant.

PubMed

Hung, Yu-Ting; Liu, Chi-Te; Peng, I-Chen; Hsu, Chin; Yu, Roch-Chui; Cheng, Kuan-Chen

2015-09-01

To ensure the safety of the peanut butter ice cream manufacture, a Hazard Analysis and Critical Control Point (HACCP) plan has been designed and applied to the production process. Potential biological, chemical, and physical hazards in each manufacturing procedure were identified. Critical control points for the peanut butter ice cream were then determined as the pasteurization and freezing process. The establishment of a monitoring system, corrective actions, verification procedures, and documentation and record keeping were followed to complete the HACCP program. The results of this study indicate that implementing the HACCP system in food industries can effectively enhance food safety and quality while improving the production management. Copyright © 2015. Published by Elsevier B.V.

Influence of parental perception of school safety and gender on children's physical activity in Mexico: A cross sectional study.

PubMed

Hutchens, Amy; Soltero, Erica G; Barquera, Simón; Lévesque, Lucie; Jauregui, Edtna; López Y Taylor, Juan; Lee, Rebecca E

2016-01-01

This cross sectional study aims to determine the effects of gender and parental perception of safety at school on children's physical activity (PA) levels. Parents of school aged Mexican children residing in Guadalajara, Mexico City, and Puerto Vallarta, completed surveys about their children's PA measures. The physical activity indicators were evaluated using linear and logistical regression models. Analysis did not indicate that gender moderated the relationship between parental perception of safety and PA measures, but significant gender issues exist with girls participating less than boys in the three measures of PA in this study (p<0.001). Results suggest the need for additional interventions promoting physical activity in girls in Mexico.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Perceptions of medical graduates and their workplace supervisors towards a medical school clinical audit program

PubMed Central

O'Ferrall, Ilse; Hoare, Samuel; Caroline, Bulsara; Mak, Donna B.

2017-01-01

Objectives This study explores how medical graduates and their workplace supervisors perceive the value of a structured clinical audit program (CAP) undertaken during medical school. Methods Medical students at the University of Notre Dame Fremantle complete a structured clinical audit program in their final year of medical school.  Semi-structured interviews were conducted with 12 Notre Dame graduates (who had all completed the CAP), and seven workplace supervisors (quality and safety staff and clinical supervisors).  Purposeful sampling was used to recruit participants and data were analysed using thematic analysis. Results Both graduates and workplace supervisors perceived the CAP to be valuable. A major theme was that the CAP made a contribution to individual graduate’s medical practice, including improved knowledge in some areas of patient care as well as awareness of healthcare systems issues and preparedness to undertake scientifically rigorous quality improvement activities. Graduates perceived that as a result of the CAP, they were confident in undertaking a clinical audit after graduation.  Workplace supervisors perceived the value of the CAP beyond an educational experience and felt that the audits undertaken by students improved quality and safety of patient care. Conclusions It is vital that health professionals, including medical graduates, be able to carry out quality and safety activities in the workplace. This study provides evidence that completing a structured clinical audit during medical school prepares graduates to undertake quality and safety activities upon workplace entry. Other health professional faculties may be interested in incorporating a similar program in their curricula.  PMID:28692425

A Technology Solution Strengthens Comprehensive Environmental Management

DTIC Science & Technology

2012-05-23

General Navigation  Chemical Approval Example  NEPA Coordination Example  Safety PPE Example  Summary Marine Corps Support Facility...coordination, completion and documentation through automated workflows of various business processes  Chemical Approval  NEPA Coordination  Safety ...Completion Diagram Government Employee/M CMC MCMC Chemical Manager MCMC HS&E Specialist IMO Chemical Safety Specialist IMO Chemical Environmental

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

PubMed Central

Chahal, Harinder S; Sigelman, Daniel W; Stacy, Sylvie; Sclar, Joshua; Ddamulira, Barbara

2015-01-01

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study. Data sources All applications for which FDA’s Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. Results 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters. PMID:26063327

Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.

PubMed

Quinn, Julie-Anne; Munoz, Flor M; Gonik, Bernard; Frau, Lourdes; Cutland, Clare; Mallett-Moore, Tamala; Kissou, Aimee; Wittke, Frederick; Das, Manoj; Nunes, Tony; Pye, Savia; Watson, Wendy; Ramos, Ana-Maria Alguacil; Cordero, Jose F; Huang, Wan-Ting; Kochhar, Sonali; Buttery, Jim

2016-12-01

Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. Copyright © 2016. Published by Elsevier Ltd.

RS-84 Engine Completes Design Review

NASA Technical Reports Server (NTRS)

2003-01-01

This is an artist's concept of the kerosene-fueled RS-84 engine, one of several technologies competing to power NASA's next generation of launch vehicles. The RS-84 has successfully completed its preliminary design review as a reusable, liquid kerosene booster engine that will deliver a thrust level of 1 million pounds of force. The preliminary design review is a lengthy technical analysis that evaluates engine design according to stringent system requirements. The review ensures development is on target to meet Next Generation Launch Technology goals: Improved safety, reliability, and cost.

Aluminum Data Measurements and Evaluation for Criticality Safety Applications

NASA Astrophysics Data System (ADS)

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

2002-12-01

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

Automated Hazard Analysis

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

Riddle, F. J.

2003-06-26

The Automated Hazard Analysis (AHA) application is a software tool used to conduct job hazard screening and analysis of tasks to be performed in Savannah River Site facilities. The AHA application provides a systematic approach to the assessment of safety and environmental hazards associated with specific tasks, and the identification of controls regulations, and other requirements needed to perform those tasks safely. AHA is to be integrated into existing Savannah River site work control and job hazard analysis processes. Utilization of AHA will improve the consistency and completeness of hazard screening and analysis, and increase the effectiveness of the workmore » planning process.« less

Characterisation of occupational blood and body fluid exposures beyond the Needlestick Safety and Prevention Act.

PubMed

Green-McKenzie, Judith; McCarthy, Ronda B; Shofer, Frances S

2016-09-01

To describe the use of mandated safety engineered sharps devices (SESDs) and personal protective equipment in healthcare workers (HCWs) with occupational body fluid exposures (BFE) since the Needlestick Safety and Prevention Act. Two questionnaires were administered, over 3 years, to HCWs who reported sharps or splash BFEs. Descriptive statistics and chi-square analysis were used. Of the 498 questionnaires completed, nurses completed 262 (53%), house staff 155 (32 %), technicians 63 (13%) and phlebotomists 11 (2%). Four (1%) completers reported 'other' and three (1%) reported unknown. Sharps injuries accounted for 349 (70%) of the BFEs. SESDs were utilised 43% (128/299) of the time with a 54% (70/130) activation rate. Phlebotomists (80%; 8/10) and nurses (59%; 79/267) used SESDs more than doctors (27%; 31/86) and technicians (26%; 10/39) ( P <0.0001). Fifty-four percent (185/207) of HCWs reported having had training on SESD use; nurses (64%; 98/154) and phlebotomists (70%; 7/8) significantly more so than house staff (44%; 59/133) and technicians (44%; 21/48) ( P <0.05). Most splash BFEs were to the eyes 73% (91/149). Five percent (4/79) of HCWs used protective eyewear. Systematic regular training, appropriate protocols and iteratively providing the safest SESDs based on HCW experience and technological advances will further reduce the physical and emotional toll of BFEs.

ORNL necessary and sufficient standards for environment, safety, and health. Final report of the Identification Team for other industrial, radiological, and non-radiological hazard facilities

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

NONE

1998-07-01

This Necessary and Sufficient (N and S) set of standards is for Other Industrial, Radiological, and Non-Radiological Hazard Facilities at Oak Ridge National Laboratory (ORNL). These facility classifications are based on a laboratory-wide approach to classify facilities by hazard category. An analysis of the hazards associated with the facilities at ORNL was conducted in 1993. To identify standards appropriate for these Other Industrial, Radiological, and Non-Radiological Hazard Facilities, the activities conducted in these facilities were assessed, and the hazards associated with the activities were identified. A preliminary hazards list was distributed to all ORNL organizations. The hazards identified in priormore » hazard analyses are contained in the list, and a category of other was provided in each general hazard area. A workshop to assist organizations in properly completing the list was held. Completed hazard screening lists were compiled for each ORNL division, and a master list was compiled for all Other Industrial, Radiological Hazard, and Non-Radiological facilities and activities. The master list was compared against the results of prior hazard analyses by research and development and environment, safety, and health personnel to ensure completeness. This list, which served as a basis for identifying applicable environment, safety, and health standards, appears in Appendix A.« less

Characterisation of occupational blood and body fluid exposures beyond the Needlestick Safety and Prevention Act

PubMed Central

Green-McKenzie, Judith; McCarthy, Ronda B; Shofer, Frances S

2016-01-01

Objective: To describe the use of mandated safety engineered sharps devices (SESDs) and personal protective equipment in healthcare workers (HCWs) with occupational body fluid exposures (BFE) since the Needlestick Safety and Prevention Act. Methods: Two questionnaires were administered, over 3 years, to HCWs who reported sharps or splash BFEs. Descriptive statistics and chi-square analysis were used. Results: Of the 498 questionnaires completed, nurses completed 262 (53%), house staff 155 (32 %), technicians 63 (13%) and phlebotomists 11 (2%). Four (1%) completers reported ‘other’ and three (1%) reported unknown. Sharps injuries accounted for 349 (70%) of the BFEs. SESDs were utilised 43% (128/299) of the time with a 54% (70/130) activation rate. Phlebotomists (80%; 8/10) and nurses (59%; 79/267) used SESDs more than doctors (27%; 31/86) and technicians (26%; 10/39) (P <0.0001). Fifty-four percent (185/207) of HCWs reported having had training on SESD use; nurses (64%; 98/154) and phlebotomists (70%; 7/8) significantly more so than house staff (44%; 59/133) and technicians (44%; 21/48) (P <0.05). Most splash BFEs were to the eyes 73% (91/149). Five percent (4/79) of HCWs used protective eyewear. Conclusions: Systematic regular training, appropriate protocols and iteratively providing the safest SESDs based on HCW experience and technological advances will further reduce the physical and emotional toll of BFEs. PMID:28989483

Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

PubMed

Hong, Bonnie; Du, Yingzhou; Mukerji, Pushkor; Roper, Jason M; Appenzeller, Laura M

2017-07-12

Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly recognize their roles and functions so as to realize the safety expectations invested in them by organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

Scott, Jason; Waring, Justin; Heavey, Emily; Dawson, Pamela

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement. Results will be disseminated to study participants as well as through peer-reviewed outputs. PMID:24833698

A psychometric evaluation of the Chinese version of the nursing home survey on patient safety culture.

PubMed

Lin, Shu-Yuan; Tseng, Wei Ting; Hsu, Miao-Ju; Chiang, Hui-Ying; Tseng, Hui-Chen

2017-12-01

To test the psychometric properties of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among staff in long-term care facilities. The Nursing Home Survey on Patient Safety Culture scale is a standard tool for safety culture assessment in nursing homes. Extending its application to different types of long-term care facilities and varied ethnic populations is worth pursuing. A national random survey. A total of 306 managers and staff completed the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among 30 long-term care facilities in Taiwan. Content validity and construct validity were tested by content validity index (CVI) and principal axis factor analysis (PAF) with Promax rotation. Concurrent validity was tested through correlations between the scale and two overall rating items. Reliability was computed by intraclass correlation coefficient and Cronbach's α coefficients. Statistical analyses such as descriptive, Pearson's and Spearman's rho correlations and PAF were completed. Scale-level and item-level CVIs (0.91-0.98) of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale were satisfactory. Four-factor construct and merged item composition differed from the Nursing Home Survey on Patient Safety Culture scale, and it accounted for 53% of variance. Concurrent validity was evident by existing positive correlations between the scale and two overall ratings of resident safety. Cronbach's α coefficients of the subscales and the Chinese version of the Nursing Home Survey on Patient Safety Culture scale ranged from .76-.94. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale identified essential dimensions to reflect the important features of a patient safety culture in long-term care facilities. The researchers introduced the Chinese version of the Nursing Home Survey on Patient Safety Culture for safety culture assessment in long-term care facilities, but further testing of the reliability of the scale in a large Chinese sample and in different long-term care facilities was recommended. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale was developed to increase the users' intention towards safety culture assessment. It can identify areas for improvement, understand safety culture changes over time and evaluate the effectiveness of interventions. © 2017 John Wiley & Sons Ltd.

Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies.

PubMed

Giovannoni, Gavin; Kappos, Ludwig; Gold, Ralf; Khatri, Bhupendra O; Selmaj, Krzysztof; Umans, Kimberly; Greenberg, Steven J; Sweetser, Marianne; Elkins, Jacob; McCroskery, Peter

2016-09-01

Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis. Cumulative incidence of treatment-emergent adverse events (AEs) was the primary endpoint. This analysis included 2236 patients with 5214 patient-years of exposure to daclizumab. The cumulative incidence of any AE was 84% and of any serious AE excluding MS relapse was 16%. The incidences of AEs when evaluated by 6-month intervals remained stable over the 6.5 years of maximum follow-up. Most AEs were mild or moderate in severity. An important safety concern associated with daclizumab therapy involved hepatic AEs (16%) and serum transaminase elevations at least three times the upper limit of normal (10%), most of which were asymptomatic, self-limiting, and non-recurring. Cumulative incidences of cutaneous, infectious, and gastrointestinal AEs were 33%, 59%, and 25%, respectively; most events either resolved spontaneously or were treated successfully with standard medical interventions and did not result in discontinuation of treatment. This integrated analysis demonstrates that treatment of RRMS with daclizumab for periods of up to 6.5 years is associated with an acceptable safety profile with no evidence of cumulative toxicity over time. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Perceptions of sexual partner safety.

PubMed

Masaro, C L; Dahinten, V S; Johnson, J; Ogilvie, G; Patrick, D M

2008-06-01

Many individuals select sexual partners based on assumed partner STI/HIV safety, yet few studies have investigated how these assumptions are formed. The objective of this research was to determine the extent to which partner safety beliefs were used to evaluate partner safety, and whether these beliefs influenced perceptions of personal STI/HIV risk. Participants (n = 317) recruited from an STI clinic completed a structured self-report questionnaire. A Partner Safety Beliefs Scale (PSBS) was developed to determine the factors that most influenced perceived partner safety. Exploratory factor analysis showed that a single factor accounted for 46% of the variance in the PSBS; with an internal consistency of 0.92. Linear regression was used to determine factors predictive of perceived personal STI/HIV risk. Participants endorsed statements indicating that knowing or trusting a sexual partner influences their beliefs about their partner's safety. Linear regression analysis indicated that education, income, number of sexual partners, and PSBS scores were significant predictors of perceived personal STI/HIV risk. The results of this study indicate that many individuals are relying on partner attributes and relationship characteristics when assessing the STI/HIV status of a sexual partner, and that this reliance is associated with a decreased perception of personal STI/HIV risk. Prevention campaigns need to acknowledge that people are likely to evaluate sexual partners whom they know and trust as safe. Dispelling erroneous beliefs about the ability to select safe partners is needed to promote safer sexual behavior.

The Patient Safety Leadership Academy at the University of Pennsylvania: the first cohort's learning experience.

PubMed

Wurster, Angela B; Pearson, Kathy; Sonnad, Seema S; Mullen, James L; Kaiser, Larry R

2007-01-01

We based the Patient Safety Leadership Academy (PSLA) on the premise that improving management skills could improve patient safety and employee satisfaction. Fellows completed baseline surveys on leadership skills knowledge, patient safety knowledge, and program goals. They completed the same surveys 7 months later at the final PSLA session. The fellows also completed a survey assessing how PSLA improved expertise and comparing PSLA to other patient safety learning opportunities. Matched pairs t tests were used to compare baseline and postprogram results. Baseline scores indicated appropriateness of focusing on leadership, with average leadership knowledge (2.48) significantly lower than patient safety knowledge (3.22). For patient safety, postprogram results were significant for 8 of 10 questions. All results were significant for leadership. Fellows also rated skills covered by the curriculum on a scale of 1 to 10. For all areas, the median score for knowledge gained was 7. When compared with other patient safety learning experiences, participants rated PSLA as 4 or 5, where 1 indicated the other experience much more valuable and 5 much more valuable. PSLA demonstrates that leadership skills are perceived as important by physicians and managers in surgical areas. This study demonstrated that a leadership skills approach to patient safety training could improve knowledge in specific leadership areas and general patient safety.

The predictive validity of safety climate.

PubMed

Johnson, Stephen E

2007-01-01

Safety professionals have increasingly turned their attention to social science for insight into the causation of industrial accidents. One social construct, safety climate, has been examined by several researchers [Cooper, M. D., & Phillips, R. A. (2004). Exploratory analysis of the safety climate and safety behavior relationship. Journal of Safety Research, 35(5), 497-512; Gillen, M., Baltz, D., Gassel, M., Kirsch, L., & Vacarro, D. (2002). Perceived safety climate, job Demands, and coworker support among union and nonunion injured construction workers. Journal of Safety Research, 33(1), 33-51; Neal, A., & Griffin, M. A. (2002). Safety climate and safety behaviour. Australian Journal of Management, 27, 66-76; Zohar, D. (2000). A group-level model of safety climate: Testing the effect of group climate on microaccidents in manufacturing jobs. Journal of Applied Psychology, 85(4), 587-596; Zohar, D., & Luria, G. (2005). A multilevel model of safety climate: Cross-level relationships between organization and group-level climates. Journal of Applied Psychology, 90(4), 616-628] who have documented its importance as a factor explaining the variation of safety-related outcomes (e.g., behavior, accidents). Researchers have developed instruments for measuring safety climate and have established some degree of psychometric reliability and validity. The problem, however, is that predictive validity has not been firmly established, which reduces the credibility of safety climate as a meaningful social construct. The research described in this article addresses this problem and provides additional support for safety climate as a viable construct and as a predictive indicator of safety-related outcomes. This study used 292 employees at three locations of a heavy manufacturing organization to complete the 16 item Zohar Safety Climate Questionnaire (ZSCQ) [Zohar, D., & Luria, G. (2005). A multilevel model of safety climate: Cross-level relationships between organization and group-level climates. Journal of Applied Psychology, 90(4), 616-628]. In addition, safety behavior and accident experience data were collected for 5 months following the survey and were statistically analyzed (structural equation modeling, confirmatory factor analysis, exploratory factor analysis, etc.) to identify correlations, associations, internal consistency, and factorial structures. Results revealed that the ZSCQ: (a) was psychometrically reliable and valid, (b) served as an effective predictor of safety-related outcomes (behavior and accident experience), and (c) could be trimmed to an 11 item survey with little loss of explanatory power. Practitioners and researchers can use the ZSCQ with reasonable certainty of the questionnaire's reliability and validity. This provides a solid foundation for the development of meaningful organizational interventions and/or continued research into social factors affecting industrial accident experience.

Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme

PubMed Central

Angelo, Maria-Genalin; David, Marie-Pierre; Zima, Julia; Baril, Laurence; Dubin, Gary; Arellano, Felix; Struyf, Frank

2014-01-01

Purpose The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies. Methods Unsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies. Results Thirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0–113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups. Conclusions Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women. PMID:24644063

Cyber-Informed Engineering: The Need for a New Risk Informed and Design Methodology

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

Price, Joseph Daniel; Anderson, Robert Stephen

Current engineering and risk management methodologies do not contain the foundational assumptions required to address the intelligent adversary’s capabilities in malevolent cyber attacks. Current methodologies focus on equipment failures or human error as initiating events for a hazard, while cyber attacks use the functionality of a trusted system to perform operations outside of the intended design and without the operator’s knowledge. These threats can by-pass or manipulate traditionally engineered safety barriers and present false information, invalidating the fundamental basis of a safety analysis. Cyber threats must be fundamentally analyzed from a completely new perspective where neither equipment nor human operationmore » can be fully trusted. A new risk analysis and design methodology needs to be developed to address this rapidly evolving threatscape.« less

Failing to Fix What is Found: Risk Accommodation in the Oil and Gas Industry.

PubMed

Stackhouse, Madelynn R D; Stewart, Robert

2017-01-01

The present program of research synthesizes the findings from three studies in line with two goals. First, the present research explores how the oil and gas industry is performing at risk mitigation in terms of finding and fixing errors when they occur. Second, the present research explores what factors in the work environment relate to a risk-accommodating environment. Study 1 presents a descriptive evaluation of high-consequence incidents at 34 oil and gas companies over a 12-month period (N = 873), especially in terms of those companies' effectiveness at investigating and fixing errors. The analysis found that most investigations were fair in terms of quality (mean = 75.50%), with a smaller proportion that were weak (mean = 11.40%) or strong (mean = 13.24%). Furthermore, most companies took at least one corrective action for high-consequence incidents, but few of these corrective actions were confirmed as having been completed (mean = 13.77%). In fact, most corrective actions were secondary interim administrative controls (e.g., having a safety meeting) rather than fair or strong controls (e.g., training, engineering elimination). Study 2a found that several environmental factors explain the 56.41% variance in safety, including management's disengagement from safety concerns, finding and fixing errors, safety management system effectiveness, training, employee safety, procedures, and a production-over-safety culture. Qualitative results from Study 2b suggest that a compliance-based culture of adhering to liability concerns, out-group blame, and a production-over-safety orientation may all impede safety effectiveness. © 2016 Society for Risk Analysis.

[Relationship between perceptions of safety climate at workplace and depressive disorders in manufacturing workers].

PubMed

Liu, Xu-hua; Xiao, Ya-ni; Huang, Zhi-xiong; Huang, Shao-bin; Cao, Xiao-ou; Guan, Dong-bo; Chen, Wei-qing

2013-04-01

To investigate the risk factors for depressive disorders in manufacturing workers and to provide a basis for developing health promotion measures at workplace. A questionnaire survey was performed in 8085 front-line production workers from 33 manufacturing enterprises in Nanhai District of Foshan, Guangdong Province, China. The questionnaire contained a survey of demographic characteristics, the Safety Climate Scale, the Center for Epidemiological Studies Depression Scale, etc. The multilevel logistic regression analysis was applied to investigate the risk factors for depressive disorders in workers. A total of 6260 workers completed the survey; their mean age was 31.1 ± 8.6 years, and 53.2% of them were males. The multilevel logistic regression analysis showed that after adjustment for sociodemographic factors such as age, sex, and martial status, more depressive disorders were reported in the enterprises with higher score of "production safety training" than in those with lower score (OR = 1.46, 95%CI = 1.07 ∼ 1.97); fewer depressive disorders were reported in the enterprises with higher score of "colleagues concerned about production safety" than in those with lower score (OR = 0.08, 95%CI = 0.03 ∼ 0.26); the relationships of "safety warnings and precautions" and "managers concerned about production safety" with workers' depressive disorders were not statistically significant (OR = 0.78, 95%CI = 0.48 ∼ 1.28; OR = 1.08, 95%CI = 0.68 ∼ 1.72). Depressive disorders in manufacturing workers are related to the safety climate at workplace, which indicates that a good safety climate at workplace should be created to prevent and control depressive disorders in workers.

Safety and efficacy of flow diverter treatment for blood blister-like aneurysm: A systematic review and meta-analysis.

PubMed

Zhu, Deyuan; Yan, Yazhou; Zhao, Puyuan; Duan, Guoli; Zhao, Rui; Liu, Jianmin; Huang, Qinghai

2018-06-23

To clarify the safety and efficacy of flow diverter (FD) treatment for blood blister-like aneurysm (BBA), we conducted a systematic review and literature analyzing perioperative and long-term clinical and angiographic outcomes. A comprehensive review of the up-to-date literature for studies with >2 patients related to FD treatment of BBAs published was performed. Random-effects meta-analysis was used to pool the following outcomes: complete occlusion, technical success, aneurysm recurrence, rebleeding, perioperative mortality, perioperative stroke, procedure-related morbidity and mortality, long-term neurological morbidity and mortality, and overall good neurological outcome. We included 15 non-comparative studies with 165 target BBAs. Complete occlusion rates were 72% (95%CI= 0.59-0.85). Recurrence occurred in 13% (95%CI= -0.04-0.29) and rebleeding in 3% (95%CI = -0.02-0.07) of patients. Procedure-related morbidity and mortality were 26% (95%CI =0.19-0.33) and 3% (95%CI= -0.01-0.07), respectively. Long-term good outcome was 83% (95% CI = 0.77-0.89). Subgroup analysis indicated that single FD strategy for BBA seemed to have a higher good outcome rate compared to overlapped FD strategy (89.9% versus 61.9%, OR=1.42, 95%CI=1.25-14.98, P=0.02). Complete occlusion rate and procedure-related morbidity rate did not see any significant difference between these two strategies. Our meta-analysis suggests that in select cases, FD can be safe and effective. Single FD strategy may result in a higher good outcome rate compared to overlapped FD strategy. Ultimately, treatment of BBA should be considered on a case-by-case basis to maximize patient benefits and limit the risk of perioperative complications. Copyright © 2018. Published by Elsevier Inc.

Development of a generalized perturbation theory method for sensitivity analysis using continuous-energy Monte Carlo methods

DOE PAGES

Perfetti, Christopher M.; Rearden, Bradley T.

2016-03-01

The sensitivity and uncertainty analysis tools of the ORNL SCALE nuclear modeling and simulation code system that have been developed over the last decade have proven indispensable for numerous application and design studies for nuclear criticality safety and reactor physics. SCALE contains tools for analyzing the uncertainty in the eigenvalue of critical systems, but cannot quantify uncertainty in important neutronic parameters such as multigroup cross sections, fuel fission rates, activation rates, and neutron fluence rates with realistic three-dimensional Monte Carlo simulations. A more complete understanding of the sources of uncertainty in these design-limiting parameters could lead to improvements in processmore » optimization, reactor safety, and help inform regulators when setting operational safety margins. A novel approach for calculating eigenvalue sensitivity coefficients, known as the CLUTCH method, was recently explored as academic research and has been found to accurately and rapidly calculate sensitivity coefficients in criticality safety applications. The work presented here describes a new method, known as the GEAR-MC method, which extends the CLUTCH theory for calculating eigenvalue sensitivity coefficients to enable sensitivity coefficient calculations and uncertainty analysis for a generalized set of neutronic responses using high-fidelity continuous-energy Monte Carlo calculations. Here, several criticality safety systems were examined to demonstrate proof of principle for the GEAR-MC method, and GEAR-MC was seen to produce response sensitivity coefficients that agreed well with reference direct perturbation sensitivity coefficients.« less

Types and patterns of safety concerns in home care: client and family caregiver perspectives

PubMed Central

Tong, Catherine E.; Sims-Gould, Joanie; Martin-Matthews, Anne

2016-01-01

Objective Drawing on interviews with home care clients and their family caregivers, we sought to understand how these individuals conceptualize safety in the provision and receipt of home care, how they promote safety in the home space and how their safety concerns differ from those of home support workers. Design In-depth, semi-structured interviews were conducted with clients and family caregivers. The analysis included topic and analytical coding of participants' verbatim accounts. Setting Interviews were completed in British Columbia, Canada. Participants Totally 82 clients and 55 caregivers participated. Results Clients and family caregivers identified three types of safety concerns: physical, spatial and interpersonal. These concerns are largely multi-dimensional and intersectional. We present a conceptual model of client and caregiver safety concerns. We also examine the factors that intensify and mitigate safety concerns in the home. Conclusions In spite of safety concerns, clients and family caregivers overwhelmingly prefer to receive care in the home setting. Spatial and physical concerns are the most salient. The financial burden of creating a safe care space should not be the client's alone to bear. The conceptualization and promotion of safety in home care must recognize the roles, responsibilities and perspectives of all of the actors involved, including workers, clients and their caregivers. PMID:26832159

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

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

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

2013-11-07

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

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

Campbell, J.A.; Clauss, S.A.; Grant, K.E.

The objectives of this task are to develop and document extraction and analysis methods for organics in waste tanks, and to extend these methods to the analysis of actual core samples to support the Waste Tank organic Safety Program. This report documents progress at Pacific Northwest Laboratory (a) during FY 1994 on methods development, the analysis of waste from Tank 241-C-103 (Tank C-103) and T-111, and the transfer of documented, developed analytical methods to personnel in the Analytical Chemistry Laboratory (ACL) and 222-S laboratory. This report is intended as an annual report, not a completed work.

Hydrothermal Liquefaction Treatment Preliminary Hazard Analysis Report

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

Lowry, Peter P.; Wagner, Katie A.

A preliminary hazard assessment was completed during February 2015 to evaluate the conceptual design of the modular hydrothermal liquefaction treatment system. The hazard assessment was performed in 2 stages. An initial assessment utilizing Hazard Identification and Preliminary Hazards Analysis (PHA) techniques identified areas with significant or unique hazards (process safety-related hazards) that fall outside of the normal operating envelope of PNNL and warranted additional analysis. The subsequent assessment was based on a qualitative What-If analysis. This analysis was augmented, as necessary, by additional quantitative analysis for scenarios involving a release of hazardous material or energy with the potential for affectingmore » the public.« less

Can staff and patient perspectives on hospital safety predict harm-free care? An analysis of staff and patient survey data and routinely collected outcomes

PubMed Central

Lawton, Rebecca; O'Hara, Jane Kathryn; Sheard, Laura; Reynolds, Caroline; Cocks, Kim; Armitage, Gerry; Wright, John

2015-01-01

Background Patients have the potential to provide feedback on the safety of their care. Recently, tools have been developed that ask patients to provide feedback on those factors that are known to contribute to safety, therefore providing information that can be used proactively to manage safety in hospitals. The aim of this study was to investigate whether the safety information provided by patients is different from that provided by staff and whether it is related to safety outcomes. Method Data were collected from 33 hospital wards across 3 acute hospital Trusts in the UK. Staff on these wards were asked to complete the four outcome measures of the Hospital Survey of Patient Safety Culture, while patients were asked to complete the Patient Measure of Safety and the friends and family test. We also collated publicly reported safety outcome data for ‘harm-free care’ on each ward. This patient safety thermometer measure is used in the UK NHS to record the percentage of patients on a single day of each month on every ward who have received harm-free care (ie, no pressure ulcers, falls, urinary tract infections and hospital acquired new venous thromboembolisms). These data were used to address questions about the relationship between measures and the extent to which patient and staff perceptions of safety predict safety outcomes. Results The friends and family test, a single item measure of patient experience was associated with patients’ perceptions of safety, but was not associated with safety outcomes. Staff responses to the patient safety culture survey were not significantly correlated with patient responses to the patient measure of safety, but both independently predicted safety outcomes. The regression models showed that staff perceptions (adjusted r2=0.39) and patient perceptions (adjusted r2=0.30) of safety independently predicted safety outcomes. When entered together both measures accounted for 49% of the variance in safety outcomes (adjusted r2=0.49), suggesting that there is overlap but some unique variance is also explained by these two measures. Based on responses to the Patient Measure of Safety it was also possible to identify differences between the acute Hospital Trusts. Discussion The findings suggest that although the views of patients and staff predict some overlapping variance in patient safety outcomes, both also offer a unique perspective on patient safety, contributing independently to the prediction of safety outcomes. These findings suggest that feedback from patients about the safety of the care that they receive can be used, in addition to data from staff to drive safety improvements in healthcare. Trial registration number ISRCTN07689702. PMID:25862755

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

[Adverse events management. Methods and results of a development project].

PubMed

Rabøl, Louise Isager; Jensen, Elisabeth Brøgger; Hellebek, Annemarie H; Pedersen, Beth Lilja

2006-11-27

This article describes the methods and results of a project in the Copenhagen Hospital Corporation (H:S) on preventing adverse events. The aim of the project was to raise awareness about patients' safety, test a reporting system for adverse events, develop and test methods of analysis of events and propagate ideas about how to prevent adverse events. H:S developed an action plan and a reporting system for adverse events, founded an organization and developed an educational program on theories and methods of learning from adverse events for both leaders and employees. During the three-year period from 1 January 2002 to 31 December 2004, the H:S staff reported 6011 adverse events. In the same period, the organization completed 92 root cause analyses. More than half of these dealt with events that had been optional to report, the other half events that had been mandatory to report. The number of reports and the front-line staff's attitude towards reporting shows that the H:S succeeded in founding a safety culture. Future work should be centred on developing and testing methods that will prevent adverse events from happening. The objective is to suggest and complete preventive initiatives which will help increase patient safety.

Automation for System Safety Analysis

NASA Technical Reports Server (NTRS)

Malin, Jane T.; Fleming, Land; Throop, David; Thronesbery, Carroll; Flores, Joshua; Bennett, Ted; Wennberg, Paul

2009-01-01

This presentation describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Development and Assessment of a Medication Safety Measurement Program in a Long-Term Care Pharmacy.

PubMed

Hertig, John B; Hultgren, Kyle E; Parks, Scott; Rondinelli, Rick

2016-02-01

Medication errors continue to be a major issue in the health care system, including in long-term care facilities. While many hospitals and health systems have developed methods to identify, track, and prevent these errors, long-term care facilities historically have not invested in these error-prevention strategies. The objective of this study was two-fold: 1) to develop a set of medication-safety process measures for dispensing in a long-term care pharmacy, and 2) to analyze the data from those measures to determine the relative safety of the process. The study was conducted at In Touch Pharmaceuticals in Valparaiso, Indiana. To assess the safety of the medication-use system, each step was documented using a comprehensive flowchart (process flow map) tool. Once completed and validated, the flowchart was used to complete a "failure modes and effects analysis" (FMEA) identifying ways a process may fail. Operational gaps found during FMEA were used to identify points of measurement. The research identified a set of eight measures as potential areas of failure; data were then collected on each one of these. More than 133,000 medication doses (opportunities for errors) were included in the study during the research time frame (April 1, 2014, and ended on June 4, 2014). Overall, there was an approximate order-entry error rate of 15.26%, with intravenous errors at 0.37%. A total of 21 errors migrated through the entire medication-use system. These 21 errors in 133,000 opportunities resulted in a final check error rate of 0.015%. A comprehensive medication-safety measurement program was designed and assessed. This study demonstrated the ability to detect medication errors in a long-term pharmacy setting, thereby making process improvements measureable. Future, larger, multi-site studies should be completed to test this measurement program.

Exploring the possibility of a common structural model measuring associations between safety climate factors and safety behaviour in health care and the petroleum sectors.

PubMed

Olsen, Espen

2010-09-01

The aim of the present study was to explore the possibility of identifying general safety climate concepts in health care and petroleum sectors, as well as develop and test the possibility of a common cross-industrial structural model. Self-completion questionnaire surveys were administered in two organisations and sectors: (1) a large regional hospital in Norway that offers a wide range of hospital services, and (2) a large petroleum company that produces oil and gas worldwide. In total, 1919 and 1806 questionnaires were returned from the hospital and petroleum organisation, with response rates of 55 percent and 52 percent, respectively. Using a split sample procedure principal factor analysis and confirmatory factor analysis revealed six identical cross-industrial measurement concepts in independent samples-five measures of safety climate and one of safety behaviour. The factors' psychometric properties were explored with satisfactory internal consistency and concept validity. Thus, a common cross-industrial structural model was developed and tested using structural equation modelling (SEM). SEM revealed that a cross-industrial structural model could be identified among health care workers and offshore workers in the North Sea. The most significant contributing variables in the model testing stemmed from organisational management support for safety and supervisor/manager expectations and actions promoting safety. These variables indirectly enhanced safety behaviour (stop working in dangerous situations) through transitions and teamwork across units, and teamwork within units as well as learning, feedback, and improvement. Two new safety climate instruments were validated as part of the study: (1) Short Safety Climate Survey (SSCS) and (2) Hospital Survey on Patient Safety Culture-short (HSOPSC-short). Based on development of measurements and structural model assessment, this study supports the possibility of a common safety climate structural model across health care and the offshore petroleum industry. 2010 Elsevier Ltd. All rights reserved.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

The impact of safety organizing, trusted leadership, and care pathways on reported medication errors in hospital nursing units.

PubMed

Vogus, Timothy J; Sutcliffe, Kathleen M

2011-01-01

Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.

The Role of Safety Culture in Influencing Provider Perceptions of Patient Safety.

PubMed

Bishop, Andrea C; Boyle, Todd A

2016-12-01

To determine how provider perceptions of safety culture influence their involvement in patient safety practices. Health-care providers were surveyed in 2 tertiary hospitals located in Atlantic Canada, composed of 4 units in total. The partial least squares (PLS) approach to structural equation modeling was used to analyze the data. Latent variables provider PLS model encompassed the hypothesized relationships between provider characteristics, safety culture, perceptions of patient safety practices, and actual performance of patient safety practices, using the Health Belief Model (HBM) as a guide. Data analysis was conducted using SmartPLS. A total of 113 health-care providers completed a survey out of an eligible 318, representing a response rate of 35.5%. The final PLS model showed acceptable internal consistency with all four latent variables having a composite reliability score above the recommended 0.70 cutoff value (safety culture = 0.86, threat = 0.76, expectations = 0.83, PS practices = 0.75). Discriminant validity was established, and all path coefficients were found to be significant at the α = 0.05 level using nonparametric bootstrapping. The survey results show that safety culture accounted for 34% of the variance in perceptions of threat and 42% of the variance in expectations. This research supports the role that safety culture plays in the promotion and maintenance of patient safety activities for health-care providers. As such, it is recommended that the introduction of new patient safety strategies follow a thorough exploration of an organization's safety culture.

Project Sedan, On-Site Radiological Safety Report

DTIC Science & Technology

1962-10-23

construction site between U2a & 95 U3a Complete construction area average 100 7/12/62 1530 Outside Bunker 2-300 50 7/12/62 1532 Inside Bunker 2-330 4 39...Analysis of Weather and Surface Radiation Data SC 202F Long Range Blast Propagation REECO 203F On-Site Rad-Safe AEC/ USBM 204F Structural Survey of

Adoptive immunotherapy for B-cell malignancies using CD19-targeted chimeric antigen receptor T-cells: A systematic review of efficacy and safety.

PubMed

Hao, Lu; Li, Tongtong; Chang, Lung-Ji; Chen, Xiaochuan

2017-08-01

Adoptive infusion of chimeric antigen receptor transduced T-cells (CAR-T) is a powerful tool of immunotherapy for hematological malignancies, as evidenced by recently published and unpublished clinical results. In this report, we performed a meta-analysis to evaluate the efficacy and side effects of CAR-T on relapsed B-cell malignancies, including leukemia and lymphoma. Clinical studies investigating efficacy and safety of CAR-T in acute and chronic lymphocytic leukemia and lymphoma were identified by searching PubMed and EMBASE. Outcomes of efficacy subjected to analysis were the rates of complete remission (CR) and partial remission (PR). The safety parameters were the prevalence of adverse effects including fever, hypotension, and acute renal failure. Meta analyses were performed using R software. Weighted hazard ratio (HR) with 95% confidence intervals was calculated for each outcome. Fixed or random-effects models were employed depending on the heterogeneity across the included studies. Nineteen published clinical studies, with a total of 391 patients were included for the meta-analysis. The pooled rate of complete remission was 55% (95% CI 41%-69%); the pooled rate of partial remission was 25% (95% CI: 19%-33%). The prevalence of fever was 62% (95% CI: 41%-79%); the hypotension was 22% (95% CI: 15%-31%); acute renal failure was 24% (95% CI: 16%-34%). All adverse effects were manageable and no death was reported due to toxicity. CD19-targeted CAR-T is an effective modality in treating refractory B-cell malignancies including acute and chronic lymphatic leukemia, Hodjkin's and non-Hodjkin's lymphoma. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

2015-06-01

Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

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

Subsurface safety valves: safety asset or safety liability

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

Busch, J.M.; Llewelyn, D.C.G.; Policky, B.J.

1983-10-01

This paper summarizes the methods used to compare the risk of a blowout for a well completed with a subsurface safety valve (SSSV) vs. a completion without an SSSV. These methods, which could be applied to any field, include a combination of SSSV reliability and conventional risk analyses. The Kuparuk River Unit Working Interest Owners recently formed a group to examine the risks associated with installing and maintaining SSSV's in the Kuparuk field. The group was charged with answering the question: ''Assuming Kuparuk field operating conditions, are SSSV's a safety asset, or do numerous operating and maintenance procedures make themmore » a safety liability.'' The results indicate that for the Kuparuk River Unit, an SSSV becomes a safety liability when the mean time between SSSV failures is less than one year. Since current SSSV mean time to failure (MTTF) at Kuparuk is approximately 1000 days, they are considered a safety asset.« less

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.

Identifying and addressing the limitations of safety climate surveys.

PubMed

O'Connor, Paul; Buttrey, Samuel E; O'Dea, Angela; Kennedy, Quinn

2011-08-01

There are a variety of qualitative and quantitative tools for measuring safety climate. However, questionnaires are by far the most commonly used methodology. This paper reports the descriptive analysis of a large sample of safety climate survey data (n=110,014) collected over 10 years from U.S. Naval aircrew using the Command Safety Assessment Survey (CSAS). The analysis demonstrated that there was substantial non-random response bias associated with the data (the reverse worded items had a unique pattern of responses, there was a increasing tendency over time to only provide a modal response, the responses to the same item towards the beginning and end of the questionnaire did not correlate as highly as might be expected, and the faster the questionnaire was completed the higher the frequency of modal responses). It is suggested that the non-random responses bias was due to the negative effect on participant motivation of a number of factors (questionnaire design, lack of a belief in the importance of the response, participant fatigue, and questionnaire administration). Researchers must consider the factors that increase the likelihood of non-random measurement error in safety climate survey data and cease to rely on data that are solely collected using a long and complex questionnaire. In the absence of valid and reliable data it will not be possible for organizations to take the measures required to improve safety climate. Copyright © 2011 Elsevier B.V. All rights reserved.

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

Accelerated Monte Carlo Simulation for Safety Analysis of the Advanced Airspace Concept

NASA Technical Reports Server (NTRS)

Thipphavong, David

2010-01-01

Safe separation of aircraft is a primary objective of any air traffic control system. An accelerated Monte Carlo approach was developed to assess the level of safety provided by a proposed next-generation air traffic control system. It combines features of fault tree and standard Monte Carlo methods. It runs more than one order of magnitude faster than the standard Monte Carlo method while providing risk estimates that only differ by about 10%. It also preserves component-level model fidelity that is difficult to maintain using the standard fault tree method. This balance of speed and fidelity allows sensitivity analysis to be completed in days instead of weeks or months with the standard Monte Carlo method. Results indicate that risk estimates are sensitive to transponder, pilot visual avoidance, and conflict detection failure probabilities.

Completeness of Methicillin-Resistant Staphylococcus aureus Bloodstream Infection Reporting From Outpatient Hemodialysis Facilities to the National Healthcare Safety Network, 2013.

PubMed

Nguyen, Duc B; See, Isaac; Gualandi, Nicole; Shugart, Alicia; Lines, Christi; Bamberg, Wendy; Dumyati, Ghinwa; Harrison, Lee H; Lesher, Lindsey; Nadle, Joelle; Petit, Susan; Ray, Susan M; Schaffner, William; Townes, John; Njord, Levi; Sievert, Dawn; Thompson, Nicola D; Patel, Priti R

2016-02-01

Reports of bloodstream infections caused by methicillin-resistant Staphylococcus aureus among chronic hemodialysis patients to 2 Centers for Disease Control and Prevention surveillance systems (National Healthcare Safety Network Dialysis Event and Emerging Infections Program) were compared to evaluate completeness of reporting. Many methicillin-resistant S. aureus bloodstream infections identified in hospitals were not reported to National Healthcare Safety Network Dialysis Event.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

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

Finite element analysis of 2-Station hip himulator

NASA Astrophysics Data System (ADS)

Fazli, M. I. M.; Yahya, A.; Shahrom, A.; Nawawi, S. W.; Zainudin, M. R.; Nazarudin, M. S.

2017-10-01

This paper presented the analysis of materials and design architecture of 2-station hip simulator. Hip simulator is a machine used to conduct the joint and wear test of hip prosthetic. In earlier work, the hip simulator was modified and some improvement were made by using SolidWorks software. The simulator consists of 3DOF which controlled by separate stepper motor and a static load that set up by manual method in each station. In this work, finite element analysis (FEA) of hip simulator was implemented to analyse the structure of the design and selected materials used for simulator component. The analysis is completed based on two categories which are safety factor and stress tests. Both design drawing and FEA was done using SolidWorks software. The study of the two categories is performed by applying the peak load up to 4000N on the main frame that is embedded with metal-on-metal hip prosthesis. From FEA, the value of safety factor and degree of stress formation are successfully obtained. All the components exceed the value of 2 for safety factor analysis while the degree of stress formation shows higher value compare to the yield strength of the material. With this results, it provides information regarding part of simulator which are susceptible to destruct. Besides, the results could be used for design improvement and certify the stability of the hip simulator in real application.

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND ASSISTED... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the...

29 CFR 1952.242 - Completed developmental steps.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... § 1952.10 the Alaska Safety and Health Poster for private and public employees was approved by the... completed hiring of its industrial health staff by October 1, 1976 (41 FR 52556). (e) In accordance with...

29 CFR 1952.242 - Completed developmental steps.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... § 1952.10 the Alaska Safety and Health Poster for private and public employees was approved by the... completed hiring of its industrial health staff by October 1, 1976 (41 FR 52556). (e) In accordance with...

29 CFR 1952.242 - Completed developmental steps.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... § 1952.10 the Alaska Safety and Health Poster for private and public employees was approved by the... completed hiring of its industrial health staff by October 1, 1976 (41 FR 52556). (e) In accordance with...

Active Transportation on a Complete Street: Perceived and Audited Walkability Correlates

PubMed Central

Jensen, Wyatt A.; Smith, Ken R.; Brewer, Simon C.; Amburgey, Jonathan W.; McIff, Brett

2017-01-01

Few studies of walkability include both perceived and audited walkability measures. We examined perceived walkability (Neighborhood Environment Walkability Scale—Abbreviated, NEWS-A) and audited walkability (Irvine–Minnesota Inventory, IMI) measures for residents living within 2 km of a “complete street”—one renovated with light rail, bike lanes, and sidewalks. For perceived walkability, we found some differences but substantial similarity between our final scales and those in a prior published confirmatory factor analysis. Perceived walkability, in interaction with distance, was related to complete street active transportation. Residents were likely to have active transportation on the street when they lived nearby and perceived good aesthetics, crime safety, and traffic safety. Audited walkability, analyzed with decision trees, showed three general clusters of walkability areas, with 12 specific subtypes. A subset of walkability items (n = 11), including sidewalks, zebra-striped crosswalks, decorative sidewalks, pedestrian signals, and blank walls combined to cluster street segments. The 12 subtypes yielded 81% correct classification of residents’ active transportation. Both perceived and audited walkability were important predictors of active transportation. For audited walkability, we recommend more exploration of decision tree approaches, given their predictive utility and ease of translation into walkability interventions. PMID:28872595

Active Transportation on a Complete Street: Perceived and Audited Walkability Correlates.

PubMed

Jensen, Wyatt A; Brown, Barbara B; Smith, Ken R; Brewer, Simon C; Amburgey, Jonathan W; McIff, Brett

2017-09-05

Few studies of walkability include both perceived and audited walkability measures. We examined perceived walkability (Neighborhood Environment Walkability Scale-Abbreviated, NEWS-A) and audited walkability (Irvine-Minnesota Inventory, IMI) measures for residents living within 2 km of a "complete street"-one renovated with light rail, bike lanes, and sidewalks. For perceived walkability, we found some differences but substantial similarity between our final scales and those in a prior published confirmatory factor analysis. Perceived walkability, in interaction with distance, was related to complete street active transportation. Residents were likely to have active transportation on the street when they lived nearby and perceived good aesthetics, crime safety, and traffic safety. Audited walkability, analyzed with decision trees, showed three general clusters of walkability areas, with 12 specific subtypes. A subset of walkability items ( n = 11), including sidewalks, zebra-striped crosswalks, decorative sidewalks, pedestrian signals, and blank walls combined to cluster street segments. The 12 subtypes yielded 81% correct classification of residents' active transportation. Both perceived and audited walkability were important predictors of active transportation. For audited walkability, we recommend more exploration of decision tree approaches, given their predictive utility and ease of translation into walkability interventions.

10 CFR 835.901 - Radiation safety training.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Radiation safety training. 835.901 Section 835.901 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Radiation Safety Training § 835.901 Radiation safety training. (a) Each individual shall complete radiation safety training on the topics established at § 835...

Impact of design features upon perceived tool usability and safety

NASA Astrophysics Data System (ADS)

Wiker, Steven F.; Seol, Mun-Su

2005-11-01

While injuries from powered hand tools are caused by a number of factors, this study looks specifically at the impact of the tools design features on perceived tool usability and safety. The tools used in this study are circular saws, power drills and power nailers. Sixty-nine males and thirty-two females completed an anonymous web-based questionnaire that provided orthogonal view photographs of the various tools. Subjects or raters provided: 1) description of the respondents or raters, 2) description of the responses from the raters, and 3) analysis of the interrelationships among respondent ratings of tool safety and usability, physical metrics of the tool, and rater demographic information. The results of the study found that safety and usability were dependent materially upon rater history of use and experience, but not upon training in safety and usability, or quality of design features of the tools (e.g., grip diameters, trigger design, guards, etc.). Thus, positive and negative transfer of prior experience with use of powered hand tools is far more important than any expectancy that may be driven by prior safety and usability training, or from the visual cues that are provided by the engineering design of the tool.

Development of NASA's Accident Precursor Analysis Process Through Application on the Space Shuttle Orbiter

NASA Technical Reports Server (NTRS)

Maggio, Gaspare; Groen, Frank; Hamlin, Teri; Youngblood, Robert

2010-01-01

Accident Precursor Analysis (APA) serves as the bridge between existing risk modeling activities, which are often based on historical or generic failure statistics, and system anomalies, which provide crucial information about the failure mechanisms that are actually operative in the system. APA docs more than simply track experience: it systematically evaluates experience, looking for under-appreciated risks that may warrant changes to design or operational practice. This paper presents the pilot application of the NASA APA process to Space Shuttle Orbiter systems. In this effort, the working sessions conducted at Johnson Space Center (JSC) piloted the APA process developed by Information Systems Laboratories (ISL) over the last two years under the auspices of NASA's Office of Safety & Mission Assurance, with the assistance of the Safety & Mission Assurance (S&MA) Shuttle & Exploration Analysis Branch. This process is built around facilitated working sessions involving diverse system experts. One important aspect of this particular APA process is its focus on understanding the physical mechanism responsible for an operational anomaly, followed by evaluation of the risk significance of the observed anomaly as well as consideration of generalizations of the underlying mechanism to other contexts. Model completeness will probably always be an issue, but this process tries to leverage operating experience to the extent possible in order to address completeness issues before a catastrophe occurs.

Defense Safety Oversight Council (DSOC) Reducing Vehicular Vibration and Impact

DTIC Science & Technology

2013-10-10

Data Collection Analysis/Writing Total Funding = Planned Completion Medical Research and Materiel Command U.S. Army Aeromedical Research...newly introduced to the UK in 2000-2001 • Little was known about long term health effects of monocular helmet mounted displays Purpose • Analyze data ...Collate data then analyze questionnaires and examinations for statistical differences Product/Payoff • Increased knowledge of risks to Apache

A novel integrated approach for the hazardous radioactive dust source terms estimation in future nuclear fusion power plants.

PubMed

Poggi, L A; Malizia, A; Ciparisse, J F; Gaudio, P

2016-10-01

An open issue still under investigation by several international entities working on the safety and security field for the foreseen nuclear fusion reactors is the estimation of source terms that are a hazard for the operators and public, and for the machine itself in terms of efficiency and integrity in case of severe accident scenarios. Source term estimation is a crucial key safety issue to be addressed in the future reactors safety assessments, and the estimates available at the time are not sufficiently satisfactory. The lack of neutronic data along with the insufficiently accurate methodologies used until now, calls for an integrated methodology for source term estimation that can provide predictions with an adequate accuracy. This work proposes a complete methodology to estimate dust source terms starting from a broad information gathering. The wide number of parameters that can influence dust source term production is reduced with statistical tools using a combination of screening, sensitivity analysis, and uncertainty analysis. Finally, a preliminary and simplified methodology for dust source term production prediction for future devices is presented.

Tiger Team Assessments seventeen through thirty-five: A summary and analysis

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

Not Available

1992-12-01

On June 27, 1989, the Secretary of Energy, Admiral James D. Watkins, US Navy (Retired), announced a 10-Point Plan to strengthen environmental, safety, and health (ES H) programs and waste management activities at the US Department of Energy (DOE). The third initiative called for establishing an independent audit (the Tiger Teams) to assess DOE's major operating facilities and laboratories. As of November 1992, all 35 Tiger Team Assessments were completed and formally reported to the Secretary. In May 1991 a report providing an analysis and summary of the findings and root causes identified by the first 16 Tiger Team Assessmentsmore » was completed and submitted to the Secretary of Energy and to all DOE program managers. This document is intended to provide an easily used and easily understood summary and analysis of the information contained in Tiger Team Assessments numbers 17 through 35 to help DOE achieve ES H excellence.« less

9 CFR 113.110 - Clostridium Botulinum Type C Bacterin-Toxoid.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released. (a) Purity test. Final container samples of completed product from each serial... test. Bulk or final container samples of completed product from each serial shall be tested for safety...

9 CFR 113.110 - Clostridium Botulinum Type C Bacterin-Toxoid.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released. (a) Purity test. Final container samples of completed product from each serial... test. Bulk or final container samples of completed product from each serial shall be tested for safety...

Evaluating the effect of distractions in the operating room on clinical decision-making and patient safety.

PubMed

Murji, Ally; Luketic, Lea; Sobel, Mara L; Kulasegaram, Kulamakan Mahan; Leyland, Nicholas; Posner, Glenn

2016-10-01

Answering telephone calls and pagers is common distraction in the operating room. We sought to evaluate the impact of distractions on patient care by (1) assessing the accuracy and safety of responses to clinical questions posed to a surgeon while operating and (2) determining whether pager distractions affect simulation-based surgical performance. We conducted a randomized crossover study of obstetrics and gynecology residents. After studying a patient sign-out list, subjects performed a virtual salpingectomy. They were randomized to a distraction phase followed by quiet phase or vice versa. In the distraction phase, a pager beeped and subjects were asked questions based on the sign-out list. Accuracy of responses and the number of unsafe responses were recorded. In the quiet phase, trainees performed the task uninterrupted. Measures of surgical performance were successful task completion, time to task completion and operative blood loss. The mean score for correct responses to clinical questions during the distracted phase was 80 % (SD ±14 %). Nineteen residents (63 %) made at least 1 unsafe clinical decision while operating on the simulator (range 0-3). Subjects were more likely to successfully complete the surgical task in the allotted time under the quiet compared to distraction condition (OR 11.3, p = 0.03). There was no difference between the conditions in paired analysis for mean time (seconds) to task completion [426 (SD 133) vs. 440 (SD 186), p = 0.61] and mean operative blood loss (mL) [73.14 (SD 106) vs. 112.70 (SD 358), p = 0.47]. Distractions in the operating room may have a profound impact on patient safety on the wards. While multitasking in a simulated setting, the majority of residents made at least one unsafe clinical decision. Pager distractions also hindered surgical residents' ability to complete a simulated laparoscopic task in the allotted time without affecting other variables of surgical performance.

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.

A nationwide hospital survey on patient safety culture in Belgian hospitals: setting priorities at the launch of a 5-year patient safety plan.

PubMed

Vlayen, Annemie; Hellings, Johan; Claes, Neree; Peleman, Hilde; Schrooten, Ward

2012-09-01

To measure patient safety culture in Belgian hospitals and to examine the homogeneous grouping of underlying safety culture dimensions. The Hospital Survey on Patient Safety Culture was distributed organisation-wide in 180 Belgian hospitals participating in the federal program on quality and safety between 2007 and 2009. Participating hospitals were invited to submit their data to a comparative database. Homogeneous groups of underlying safety culture dimensions were sought by hierarchical cluster analysis. 90 acute, 42 psychiatric and 11 long-term care hospitals submitted their data for comparison to other hospitals. The benchmark database included 55 225 completed questionnaires (53.7% response rate). Overall dimensional scores were low, although scores were found to be higher for psychiatric and long-term care hospitals than for acute hospitals. The overall perception of patient safety was lower in French-speaking hospitals. Hierarchical clustering of dimensions resulted in two distinct clusters. Cluster I grouped supervisor/manager expectations and actions promoting safety, organisational learning-continuous improvement, teamwork within units and communication openness, while Cluster II included feedback and communication about error, overall perceptions of patient safety, non-punitive response to error, frequency of events reported, teamwork across units, handoffs and transitions, staffing and management support for patient safety. The nationwide safety culture assessment confirms the need for a long-term national initiative to improve patient safety culture and provides each hospital with a baseline patient safety culture profile to direct an intervention plan. The identification of clusters of safety culture dimensions indicates the need for a different approach and context towards the implementation of interventions aimed at improving the safety culture. Certain clusters require unit level improvements, whereas others demand a hospital-wide policy.

Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

PubMed Central

West, Jonathan; Ogston, Simon; Foerster, John

2016-01-01

Background Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse. Objective In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods). Results In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time. Limitations Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria. Conclusions These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes. PMID:27168193

"Chance favors only the prepared mind": preparing minds to systematically reduce hazards in the testing process in primary care.

PubMed

Singh, Ranjit; Hickner, John; Mold, Jim; Singh, Gurdev

2014-03-01

Testing plays a vital role in primary care. Failures in the process are common and can be harmful. As the great 19th century microbiologist Louis Pasteur put it "chance favors only the prepared mind." Our objective is to prepare minds in primary care practices to improve safety in the testing process. Various principles from safety science can be applied. A prospective methodology that uses an anonymous practice survey based on concepts from failure modes and effects analysis is proposed. Responses are used to rank perceived hazards in the testing process, leading to prioritization of areas for intervention. Secondary data analysis (using data from a study of medication safety) was used to explore the value of this approach in the context of assessing the testing process. At 3 primary care practice sites, a total of 61 staff members completed 4 survey items examining the testing process. Comparison across practices shows that each has a distinct profile of hazards, which would lead each on a different path toward improvement. The proposed approach treats each practice as a unique complex adaptive system aiming to help it thrive by inculcating trust, mutual respect, and collaboration. Implications for patient safety research and practice are discussed.

Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid.

PubMed

Birch, Nick; Graham, Jon; Priestley, Tom; Heywood, Chris; Sakel, Mohamed; Gall, Angela; Nunn, Andrew; Signal, Nada

2017-06-19

The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015.

Teaching Health and Safety: Preparing Staff for the Unexpected.

ERIC Educational Resources Information Center

Cronin, Greg

1999-01-01

Discusses methods for training camp counselors in safety standards. Safety awareness and camp wellness should be introduced during staff interviews. During precamp training, staff should complete a test in OSHA requirements, followed by role playing to expand staff's knowledge in each OSHA safety and health area. First aid training, fire safety,…

Safety recommendation : operator fatigue

DOT National Transportation Integrated Search

1999-06-01

During the 1980s, the National Transportation Safety Board investigated several accindets that involved operator fatigue. Following completion of these accident investigations, the Safety Board in 1989 issues three recommendation to the U.S. Departme...

Complete mucosal healing of distal lesions induced by twice-daily budesonide 2-mg foam promoted clinical remission of mild-to-moderate ulcerative colitis with distal active inflammation: double-blind, randomized study.

PubMed

Naganuma, Makoto; Aoyama, Nobuo; Tada, Tomohiro; Kobayashi, Kiyonori; Hirai, Fumihito; Watanabe, Kenji; Watanabe, Mamoru; Hibi, Toshifumi

2018-04-01

Budesonide foam is used for the topical treatment of distal ulcerative colitis. This phase III study was performed to confirm mucosal healing and other therapeutic effects of twice-daily budesonide 2-mg foam in patients with mild-to-moderate ulcerative colitis including left-sided colitis and pancolitis. This was a multicenter, randomized, placebo-controlled, double-blind trial. A total of 126 patients with mild-to-moderate ulcerative colitis with active inflammation in the distal colon were randomized to two groups receiving twice-daily budesonide 2 mg/25 ml foam or placebo foam. The primary endpoint was the percentage of complete mucosal healing of distal lesions (endoscopic subscore of 0) at week 6. Some patients continued the treatment through week 12. Drug efficacy and safety were evaluated. The percentages of both complete mucosal healing of distal lesions and clinical remission were significantly improved in the budesonide as compared with the placebo group (p = 0.0003 and p = 0.0035). Subgroup analysis showed similar efficacy of budesonide foam for complete mucosal healing of distal lesions and clinical remission regardless of disease type. The clinical remission percentage tended to be higher in patients achieving complete mucosal healing of distal lesions than in other patients. There were no safety concerns with budesonide foam. This study confirmed for the first time complete mucosal healing with twice-daily budesonide 2-mg foam in mild-to-moderate ulcerative colitis with distal active inflammation. The results also indicated that complete mucosal healing of distal lesions by budesonide foam promotes clinical remission of ulcerative colitis. Clinical trial registration no.: Japic CTI-142704.

The Safety Culture Enactment Questionnaire (SCEQ): Theoretical model and empirical validation.

PubMed

de Castro, Borja López; Gracia, Francisco J; Tomás, Inés; Peiró, José M

2017-06-01

This paper presents the Safety Culture Enactment Questionnaire (SCEQ), designed to assess the degree to which safety is an enacted value in the day-to-day running of nuclear power plants (NPPs). The SCEQ is based on a theoretical safety culture model that is manifested in three fundamental components of the functioning and operation of any organization: strategic decisions, human resources practices, and daily activities and behaviors. The extent to which the importance of safety is enacted in each of these three components provides information about the pervasiveness of the safety culture in the NPP. To validate the SCEQ and the model on which it is based, two separate studies were carried out with data collection in 2008 and 2014, respectively. In Study 1, the SCEQ was administered to the employees of two Spanish NPPs (N=533) belonging to the same company. Participants in Study 2 included 598 employees from the same NPPs, who completed the SCEQ and other questionnaires measuring different safety outcomes (safety climate, safety satisfaction, job satisfaction and risky behaviors). Study 1 comprised item formulation and examination of the factorial structure and reliability of the SCEQ. Study 2 tested internal consistency and provided evidence of factorial validity, validity based on relationships with other variables, and discriminant validity between the SCEQ and safety climate. Exploratory Factor Analysis (EFA) carried out in Study 1 revealed a three-factor solution corresponding to the three components of the theoretical model. Reliability analyses showed strong internal consistency for the three scales of the SCEQ, and each of the 21 items on the questionnaire contributed to the homogeneity of its theoretically developed scale. Confirmatory Factor Analysis (CFA) carried out in Study 2 supported the internal structure of the SCEQ; internal consistency of the scales was also supported. Furthermore, the three scales of the SCEQ showed the expected correlation patterns with the measured safety outcomes. Finally, results provided evidence of discriminant validity between the SCEQ and safety climate. We conclude that the SCEQ is a valid, reliable instrument supported by a theoretical framework, and it is useful to measure the enactment of safety culture in NPPs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nurses' response to parents' 'speaking-up' efforts to ensure their hospitalized child's safety: an attribution theory perspective.

PubMed

Bsharat, Sondos; Drach-Zahavy, Anat

2017-09-01

To understand how attribution processes (control and stability), which the nurse attributes to parental involvement in maintaining child safety, determine the nurse's response to a safety alert. Participation of parents in maintaining their child's safety is shown to reduce the incidence of and risk of clinical errors. Unless nurses respond appropriately to parents' safety alerts, this potential source of support could diminish. A 2 (controllability: high vs. low) × 2 (consistency: high vs. low) factorial design. Data were collected during the period 2013-2014 in paediatric wards. Four variants of scenarios were created corresponding to the different combinations of these variables. A total of 126 nurses read a scenario and completed self-report questionnaires measuring their response to the parent's safety alert. Additional data were collected about the manipulation check, safety norms in the ward and demographic variables. Data were analysed using analysis of variance. Results showed a main effect of stability and a significant two-way interaction effect of stability and controllability, on a nurse's tendency to help the parent and fix the safety problem. Furthermore, safety norms were significantly related to nurses' response. These findings contribute to the understanding of antecedents that affect nurses' responses to parents' speaking-up initiatives: whether nurses will reject or heed the alert. Theoretical and practical implications for promoting parents' engagement in their safety are discussed. © 2017 John Wiley & Sons Ltd.

Early survival and safety of ALPPS: first report of the International ALPPS Registry.

PubMed

Schadde, Erik; Ardiles, Victoria; Robles-Campos, Ricardo; Malago, Massimo; Machado, Marcel; Hernandez-Alejandro, Roberto; Soubrane, Olivier; Schnitzbauer, Andreas A; Raptis, Dimitri; Tschuor, Christoph; Petrowsky, Henrik; De Santibanes, Eduardo; Clavien, Pierre-Alain

2014-11-01

To assess safety and outcomes of the novel 2-stage hepatectomy, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS), using an international registry. ALPPS induces accelerated growth of small future liver remnants (FLR) to allow curative resection of liver tumors. There is concern about safety based on reports of higher morbidity and mortality. A Web-based data entry system was created with password access and data pseudoencryption (NCT01924741). All patients with complete 90-day data were included. Multivariate logistic regression analysis was performed to identify independent risk factors for severe complications and mortality and volume growth of the FLR. Complete data were available for 202 patients. A total of 141 (70%) patients had colorectal liver metastases (CRLM). Median starting standardized future liver remnants of 21% increased by 80% within a median of 7 days. Ninety-day mortality was 19/202 (9%). Severe complications including mortalities (Clavien-Dindo≥IIIb) occurred in 27% of patients. Independent factors for severe complications were red blood cell transfusion [odds ratio (OR), 5.2), ALPPS stage I operating time greater than 300 minutes (OR, 4.4), age more than 60 years (OR, 3.8), and non-CRLM (OR, 2.7). Age, use of Pringle maneuver, and histologic changes led to less volume growth. In patients younger than 60 years with CRLM, 90-day mortality was similar to conventional 2-stage hepatectomies for CRLM. This is the first analysis of the ALPPS registry showing that ALPPS has increased perioperative morbidity and mortality in older patients but better outcomes in patients with CRLM.

[Compliance with the surgical safety checklist and surgical events detected by the Global Trigger Tool].

PubMed

Menéndez Fraga, M D; Cueva Álvarez, M A; Franco Castellanos, M R; Fernández Moral, V; Castro Del Río, M P; Arias Pérez, J I; Fernández León, A; Vázquez Valdés, F

2016-06-01

The implementing of the WHO Surgical Safety Checklist (SSC) has helped to improve patient safety. The aim of this study was to assess the level of compliance of the SSC, and incorporating the non-compliances as «triggers» in the Global Trigger Tool (GTT). Acute Geriatric Hospital (200 beds). Retrospective study, study period: 2011-2014. The SSC formulary and the methodology of the GTT were used for the analysis of electronic medical records and the compliance with the SSC. The NCCP MERP categories were used to assess the severity of the harm. Out of all the electronic medical records (EMR), a total of 227 (23.6%) discharged patients (1.7% of interventions in the four year study period) were analysed. All (100%) of the EMR included the SSC, with 94.4% of the items being completed, and 28.2% of SSC had all items completed in the 3 phases of the process. Surgical adverse events decreased from 16.3% in 2011 to 9.4% in 2014 (P=.2838, not significant), and compliance with all items of SSC was increased from 18.6% to 39.1% (P=.0246, significant). The GTT systematises and evaluates, at low cost, the triggers and incidents/ AEs found in the EMR in order to assess the compliance with the SSC and consider non-compliance of SSC as «triggers» for further analysis. This strategy has never been referred to in the GTT or in the SCC formulary. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

Protection and Safety.

ERIC Educational Resources Information Center

American School Board Journal, 1964

1964-01-01

Several aspects of school safety and protection are presented for school administrators and architects. Among those topics discussed are--(1) life safety, (2) vandalism controlled through proper design, (3) personal protective devices, and (4) fire alarm systems. Another critical factor in providing a complete school safety program is proper…

Effects of North Carolina's mandatory safety belt law on children.

PubMed Central

Margolis, L. H.; Bracken, J.; Stewart, J. R.

1996-01-01

OBJECTIVES: To assess the effect of the North Carolina law mandating that all front seat passengers use a safety belt on children 4 through 15 years of age. METHODS: North Carolina collision reports, completed by local police or the state highway patrol for crashes with greater than $500 worth of damage, were analyzed using time series analysis on the monthly percentage of deaths and serious injuries between January of 1980 and February of 1994. RESULTS: Following the 1985 implementation of the law, children 4 to 15 years of age experienced a 42% decline in deaths and serious injuries. CONCLUSIONS: The mandatory safety belt law in North Carolina has been associated with a decline in deaths and serious injuries. Additional research in needed to assess the seat belt behaviors of this age group as well as the specific effects of seat belt use using outcome measures more precise than those available in police crash reports. PMID:9346051

Efficacy and Safety of Complete RAAS Blockade with ALISKIREN in Patients with Refractory Proteinuria Who were already on Combined ACE Inhibitor, ARB, and Aldosterone Antagonist.

PubMed

Panattil, Prabitha; Sreelatha, M

2016-09-01

Proteinuria is always associated with intrinsic kidney disese and is a strong predictor of later development of End Stage Renal Disease (ESRD). As Renin Angiotensin Aldosterone System (RAAS) has a role in mediating proteinuria, inhibitors of this system are renoprotective and patients with refractory proteinuria are put on a combination of these agents. The routinely employed triple blockade of RAAS with Angiotensin Converting Enzyme (ACE) inhibitor, ARB and Aldosterone antagonist has many limitations. Addition of Aliskiren to this combination suppresses the RAAS at the earliest stage and can offset many of these limitations. This study was conducted to assess the safety and efficacy of complete RAAS blockade by the addition of Aliskiren in those patients with refractory proteinuria who were already on triple blockade with ACE inhibitor, ARB and Aldosterone antagonist. This study was conducted in Nephrology Department, Calicut Medical College. A total of 36 patients with refractory proteinuria who were already on ACE inhibitor, ARB and Aldosterone antagonist were divided in to two groups A and B. Group A received Aliskiren in addition to the above combination whereas group B continued the same treatment for 12 weeks. Efficacy of the treatment was assessed by recording 24hr urine protein and safety by S.Creatinine, S.Potassium every 2 weeks of the treatment period. Statistical analysis of the lab values was done using SPSS software. Unpaired t-test, Paired t-test and Chi-square test were done for data analysis. Statistical analysis revealed that addition of Aliskiren to the combination therapy with ACE inhibitor+ ARB+ Aldosterone antagonist offers no advantage. But mean reduction in proteinuria was more with Group A than Group B. There is no statistically significant change in S.Creatinine and S.Potassium at the end of treatment. As proteinuria is a strong risk factor for progression to ESRD, even a mild decrease in proteinuria by treatment is renoprotective. Hence treatment with group A may be considered clinically superior to group B with no alteration in safety and tolerability. But further multicentre studies with larger sample size and dose escalation are required for confirmation.

Use of spaced education to deliver a curriculum in quality, safety and value for postgraduate medical trainees: trainee satisfaction and knowledge.

PubMed

Bruckel, Jeffrey; Carballo, Victoria; Kalibatas, Orinta; Soule, Michael; Wynne, Kathryn E; Ryan, Megan P; Shaw, Tim; Co, John Patrick T

2016-03-01

Quality, patient safety and value are important topics for graduate medical education (GME). Spaced education delivers case-based content in a structured longitudinal experience. Use of spaced education to deliver quality and safety education in GME at an institutional level has not been previously evaluated. To implement a spaced education course in quality, safety and value; to assess learner satisfaction; and to describe trainee knowledge in these areas. We developed a case-based spaced education course addressing learning objectives related to quality, safety and value. This course was offered to residents and fellows about two-thirds into the academic year (March 2014) and new trainees during orientation (June 2014). We assessed learner satisfaction by reviewing the course completion rate and a postcourse survey, and trainee knowledge by the per cent of correct responses. The course was offered to 1950 trainees. A total of 305 (15.6%) enrolled in the course; 265/305 (86.9%) answered at least one question, and 106/305 (34.8%) completed the course. Fewer participants completed the March programme compared with the orientation programme (42/177 (23.7%) vs 64/128 (50.0%), p<0.001). Completion rates differed by specialty, 80/199 (40.2%) in non-surgical specialties compared with 16/106 (24.5%) in surgical specialties (p=0.008). The proportion of questions answered correctly on the first attempt was 53.2% (95% CI 49.4% to 56.9%). Satisfaction among those completing the programme was high. Spaced education can help deliver and assess learners' understanding of quality, safety and value principles. Offering a voluntary course may result in low completion. Learners were satisfied with their experience and were introduced to new concepts. 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/

Information Extraction for System-Software Safety Analysis: Calendar Year 2008 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2009-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Validation of Alternatives to High Volatile Organic Compound Solvents Used in Aeronautical Antifriction Bearing Cleaning

DTIC Science & Technology

2006-10-17

Name, address, telephone number, and technical point of contact at company supplying product. (3) Material safety data sheet (MSDS) and label...existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments...Depot level maintenance cleaning. Data analysis and interpretation are based on analytical test results as well as visual inspections performed on

Intrinsic Remediation Engineering Evaluation/Cost Analysis for Car Care Center at Bolling Air Force Base, Washington, DC

DTIC Science & Technology

1997-01-01

supplemented using established literature values for similar aquifer materials . The groundwater sampling activities and analytical results from both...subsurface materials recovered. Observed soil classification types compared very favorably to the soil classifications determined by the CPT tests. 0 2.1.5...other similar substances were handled in a manner consistent with accepted safety procedures and standard operating practices. Well completion materials

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing.

PubMed

Boudreaux, Edwin D; Brown, Gregory K; Stanley, Barbara; Sadasivam, Rajani S; Camargo, Carlos A; Miller, Ivan W

2017-05-15

Safety planning is a brief intervention that has become an accepted practice in many clinical settings to help prevent suicide. Even though it is quick compared to other approaches, it frequently requires 20 min or more to complete, which can impede adoption. A self-administered, Web-based safety planning application could potentially reduce clinician time, help promote standardization and quality, and provide enhanced ability to share the created plan. The aim of this study was to design, build, and test the usability of a Web-based, self-administered safety planning application. We employed a user-centered software design strategy led by a multidisciplinary team. The application was tested for usability with a target sample of suicidal patients. Detailed observations, structured usability ratings, and Think Aloud procedures were used. Suicidal ideation intensity and perceived ability to cope were assessed pre-post engagement with the Web application. A total of 30 participants were enrolled. Usability ratings were generally strong, and all patients successfully built a safety plan. However, the completeness of the safety plan varied. The mean number of steps completed was 5.5 (SD 0.9) out of 6, with 90% (27/30) of participants completing at least 5 steps and 67% (20/30) completing all 6 steps. Some safety planning steps were viewed as inapplicable to some individuals. Some confusion in instructions led to modifications to improve understandability of each step. Ratings of suicide intensity after completion of the application were significantly lower than preratings, pre: mean 5.11 (SD 2.9) versus post: mean 4.46 (SD 3.0), t 27 =2.49, P=.02. Ratings of ability to cope with suicidal thoughts after completion of the application were higher than preratings, with the difference approaching statistical significance, pre: mean 5.93 (SD 2.9), post: mean 6.64 (SD 2.4), t 27 =-2.03, P=.05. We have taken the first step toward identifying the components needed to maximize usability of a self-administered, Web-based safety planning application. Results support initial consideration of the application as an adjunct to clinical contact. This allows for the clinician or other personnel to provide clarification, when needed, to help the patient build the plan, and to help review and revise the draft. ©Edwin D Boudreaux, Gregory K Brown, Barbara Stanley, Rajani S Sadasivam, Carlos A Camargo Jr, Ivan W Miller. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.05.2017.

Practical Child Safety Education in England: A National Survey of the Child Safety Education Coalition

ERIC Educational Resources Information Center

Mulvaney, Caroline A.; Watson, Michael C.; Walsh, Patrick

2013-01-01

Objective: To examine the provision of practical safety education by Child Safety Education Coalition (CSEC) organizations in England. Design: A postal survey. Setting: Providers of child practical safety education who were also part of CSEC. Methods: In February 2010 all CSEC organizations were sent a self-completion postal questionnaire which…

Safety in the Chemical Laboratory: Safety in the Chemistry Laboratories: A Specific Program.

ERIC Educational Resources Information Center

Corkern, Walter H.; Munchausen, Linda L.

1983-01-01

Describes a safety program adopted by Southeastern Louisiana University. Students are given detailed instructions on laboratory safety during the first laboratory period and a test which must be completely correct before they are allowed to return to the laboratory. Test questions, list of safety rules, and a laboratory accident report form are…

Switching From Donepezil to Rivastigmine Is Well Tolerated: Results of an Open-Label Safety and Tolerability Study

PubMed Central

Sadowsky, Carl H.; Farlow, Martin R.; Atkinson, Leone; Steadman, Jennifer; Koumaras, Barbara; Chen, Michael; Mirski, Dario

2005-01-01

Background: Transitioning patients between cholinesterase inhibitors was thought to require a washout period to avoid cholinergic toxicity; however, evidence suggests that abrupt discontinuation of donepezil may lead to cognitive decline. We evaluated the safety and tolerability of an immediate switch from donepezil to rivastigmine. Method: This is an analysis of the safety and tolerability data from the first 28 days of an open-label, multicenter, prospective trial, conducted from August 2002 to August 2003, in which patients satisfying NINCDS-ADRDA criteria for probable Alzheimer's disease were administered rivastigmine 1.5 mg b.i.d. within 24 to 36 hours of donepezil discontinuation. Results are compared with adverse event rates from a retrospective analysis of a pivotal, placebo-controlled trial examining patients not previously treated with a cholinesterase inhibitor. Results: Fifty-eight of 61 patients completed the first 28 days, with no suspected drug-related discontinuations during this period. Incidence of overall gastrointestinal adverse events at day 7 was 8.2%, and at day 28 was 11.5%. The corresponding rate for rivastigmine-treated patients in the retrospective analysis of the pivotal trial for day 7 was 3.3%. Conclusion: These study results suggest that transitioning patients from donepezil to rivastigmine without a washout period is safe and well tolerated. PMID:15841194

Online patient safety education programme for junior doctors: is it worthwhile?

PubMed

McCarthy, S E; O'Boyle, C A; O'Shaughnessy, A; Walsh, G

2016-02-01

Increasing demand exists for blended approaches to the development of professionalism. Trainees of the Royal College of Physicians of Ireland participated in an online patient safety programme. Study aims were: (1) to determine whether the programme improved junior doctors' knowledge, attitudes and skills relating to error reporting, open communication and care for the second victim and (2) to establish whether the methodology facilitated participants' learning. 208 junior doctors who completed the programme completed a pre-online questionnaire. Measures were "patient safety knowledge and attitudes", "medical safety climate" and "experience of learning". Sixty-two completed the post-questionnaire, representing a 30 % matched response rate. Participating in the programme resulted in immediate (p < 0.01) improvement in skills such as knowing when and how to complete incident forms and disclosing errors to patients, in self-rated knowledge (p < 0.01) and attitudes towards error reporting (p < 0.01). Sixty-three per cent disagreed that doctors routinely report medical errors and 42 % disagreed that doctors routinely share information about medical errors and what caused them. Participants rated interactive features as the most positive elements of the programme. An online training programme on medical error improved self-rated knowledge, attitudes and skills in junior doctors and was deemed an effective learning tool. Perceptions of work issues such as a poor culture of error reporting among doctors may prevent improved attitudes being realised in practice. Online patient safety education has a role in practice-based initiatives aimed at developing professionalism and improving safety.

Intelligent Hardware-Enabled Sensor and Software Safety and Health Management for Autonomous UAS

NASA Technical Reports Server (NTRS)

Rozier, Kristin Y.; Schumann, Johann; Ippolito, Corey

2015-01-01

Unmanned Aerial Systems (UAS) can only be deployed if they can effectively complete their mission and respond to failures and uncertain environmental conditions while maintaining safety with respect to other aircraft as well as humans and property on the ground. We propose to design a real-time, onboard system health management (SHM) capability to continuously monitor essential system components such as sensors, software, and hardware systems for detection and diagnosis of failures and violations of safety or performance rules during the ight of a UAS. Our approach to SHM is three-pronged, providing: (1) real-time monitoring of sensor and software signals; (2) signal analysis, preprocessing, and advanced on-the- y temporal and Bayesian probabilistic fault diagnosis; (3) an unobtrusive, lightweight, read-only, low-power hardware realization using Field Programmable Gate Arrays (FPGAs) in order to avoid overburdening limited computing resources or costly re-certi cation of ight software due to instrumentation. No currently available SHM capabilities (or combinations of currently existing SHM capabilities) come anywhere close to satisfying these three criteria yet NASA will require such intelligent, hardwareenabled sensor and software safety and health management for introducing autonomous UAS into the National Airspace System (NAS). We propose a novel approach of creating modular building blocks for combining responsive runtime monitoring of temporal logic system safety requirements with model-based diagnosis and Bayesian network-based probabilistic analysis. Our proposed research program includes both developing this novel approach and demonstrating its capabilities using the NASA Swift UAS as a demonstration platform.

Development of a Home Food Safety Questionnaire Based on the PRECEDE Model: Targeting Iranian Women.

PubMed

Esfarjani, Fatemeh; Hosseini, Hedayat; Mohammadi-Nasrabadi, Fatemeh; Abadi, Alireza; Roustaee, Roshanak; Alikhanian, Haleh; Khalafi, Marjan; Kiaee, Mohammad Farhad; Khaksar, Ramin

2016-12-01

Food safety is an essential public health issue for all countries. This study was the first attempt to design and develop a home food safety questionnaire (HFSQ), in the conceptual framework of the PRECEDE (predisposing, reinforcing, and enabling constructs in educational diagnosis and evaluation) model, and to assess its validity and reliability. The HFSQ was developed by reviewing electronic databases and 12 focus group discussions with 96 women volunteers. Ten panel members reviewed the questionnaire, and the content validity ratio and content validity index were computed. Twenty women completed the HFSQ, and face validity was assessed. Women who were responsible for food handling in their households (n =320) were selected randomly from 10 health centers and completed the HFSQ based on the PRECEDE model. To examine the construct validity, a principal components factor analysis with varimax rotation was used. Internal consistency was determined with Cronbach's α. Reproducibility was checked by Kendall's τ after 4 weeks with 30 women. The developed HSFQ was considered acceptable with a content validity index of 0.88. Face validity revealed that 95% of the participants understood the questions and found them easy to answer, and 90% confirmed the appearance of the HFSQ and declared the layout acceptable. Principal component factor analysis revealed that the HFSQ could explain 33.7, 55.3, 34.8, and 60.0% of the total variance of the predisposing, reinforcing, practice, and enabling components, respectively. Cronbach's α was acceptable at 0.73. For Kendall's τ c , r = 0.89, with a 95% confidence interval of 0.85 to 0.93. The HFSQ developed based on the PRECEDE model met the standards of acceptable reliability and validity, which can be generalized to a wider population. These results can provide information for the development of effective communication strategies to promote home food safety.

9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

Code of Federal Regulations, 2013 CFR

2013-01-01

... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...

9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

Code of Federal Regulations, 2014 CFR

2014-01-01

... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...

9 CFR 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

Code of Federal Regulations, 2012 CFR

2012-01-01

... a prescribed test shall not be released. (a) Purity test. Final container samples of completed... § 113.26. (b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). (c) Potency test. Bulk or final container samples of...

Work zone safety analysis and modeling: a state-of-the-art review.

PubMed

Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Xie, Kun

2015-01-01

Work zone safety is one of the top priorities for transportation agencies. In recent years, a considerable volume of research has sought to determine work zone crash characteristics and causal factors. Unlike other non-work zone-related safety studies (on both crash frequency and severity), there has not yet been a comprehensive review and assessment of methodological approaches for work zone safety. To address this deficit, this article aims to provide a comprehensive review of the existing extensive research efforts focused on work zone crash-related analysis and modeling, in the hopes of providing researchers and practitioners with a complete overview. Relevant literature published in the last 5 decades was retrieved from the National Work Zone Crash Information Clearinghouse and the Transport Research International Documentation database and other public digital libraries and search engines. Both peer-reviewed publications and research reports were obtained. Each study was carefully reviewed, and those that focused on either work zone crash data analysis or work zone safety modeling were identified. The most relevant studies are specifically examined and discussed in the article. The identified studies were carefully synthesized to understand the state of knowledge on work zone safety. Agreement and inconsistency regarding the characteristics of the work zone crashes discussed in the descriptive studies were summarized. Progress and issues about the current practices on work zone crash frequency and severity modeling are also explored and discussed. The challenges facing work zone safety research are then presented. The synthesis of the literature suggests that the presence of a work zone is likely to increase the crash rate. Crashes are not uniformly distributed within work zones and rear-end crashes are the most prevalent type of crashes in work zones. There was no across-the-board agreement among numerous papers reviewed on the relationship between work zone crashes and other factors such as time, weather, victim severity, traffic control devices, and facility types. Moreover, both work zone crash frequency and severity models still rely on relatively simple modeling techniques and approaches. In addition, work zone data limitations have caused a number of challenges in analyzing and modeling work zone safety. Additional efforts on data collection, developing a systematic data analysis framework, and using more advanced modeling approaches are suggested as future research tasks.

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement.

PubMed

Spence Laschinger, Heather K; Leiter, Michael P

2006-05-01

To test a theoretical model of professional nurse work environments linking conditions for professional nursing practice to burnout and, subsequently, patient safety outcomes. The 2004 Institute of Medicine report raised serious concerns about the impact of hospital restructuring on nursing work environments and patient safety outcomes. Few studies have used a theoretical framework to study the nature of the relationships between nursing work environments and patient safety outcomes. Hospital-based nurses in Canada (N = 8,597) completed measures of worklife (Practice Environment Scale of the Nursing Work Index), burnout (Maslach Burnout Inventory-Human Service Scale), and their report of frequency of adverse patient events. Structural equation modeling analysis supported an extension of Leiter and Laschinger's Nursing Worklife Model. Nursing leadership played a fundamental role in the quality of worklife regarding policy involvement, staffing levels, support for a nursing model of care (vs medical), and nurse/physician relationships. Staffing adequacy directly affected emotional exhaustion, and use of a nursing model of care had a direct effect on nurses' personal accomplishment. Both directly affected patient safety outcomes. The results suggest that patient safety outcomes are related to the quality of the nursing practice work environment and nursing leadership's role in changing the work environment to decrease nurse burnout.

75 FR 39163 - Safety Zone; Illinois River, Mile 119.7 to 120.3

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... completed. Because of the dangers posed by the pyrotechnics used in this fireworks display, the safety zone... the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to...

Rodent Control Pesticide Safety Review

EPA Pesticide Factsheets

EPA completed a safety review in 2008 of rat and mouse poison products. Many companies' products have our safety measures that reduce risks to humans, pets, and non-target wildlife. Products must be sold with bait stations that securely contain the poison.

Independent Peer Review of Communications, Navigation, and Networking re-Configurable Testbed (CoNNeCT) Project Antenna Pointing Subsystem (APS) Integrated Gimbal Assembly (IGA) Structural Analysis

NASA Technical Reports Server (NTRS)

Raju, Ivatury S.; Larsen, Curtis E.; Pellicciotti, Joseph W.

2010-01-01

Glenn Research Center Chief Engineer's Office requested an independent review of the structural analysis and modeling of the Communications, Navigation, and Networking re-Configurable Testbed (CoNNeCT) Project Antenna Pointing Subsystem (APS) Integrated Gimbal Assembly (IGA) to be conducted by the NASA Engineering and Safety Center (NESC). At this time, the IGA had completed its critical design review (CDR). The assessment was to be a peer review of the NEi-NASTRAN1 model of the APS Antenna, and not a peer review of the design and the analysis that had been completed by the GRC team for CDR. Thus, only a limited amount of information was provided on the structural analysis. However, the NESC team had difficulty separating analysis concerns from modeling issues. The team studied the NASTRAN model, but did not fully investigate how the model was used by the CoNNeCT Project and how the Project was interpreting the results. The team's findings, observations, and NESC recommendations are contained in this report.

Orion MPCV Touchdown Detection Threshold Development and Testing

NASA Technical Reports Server (NTRS)

Daum, Jared; Gay, Robert

2013-01-01

A robust method of detecting Orion Multi-Purpose Crew Vehicle (MPCV) splashdown is necessary to ensure crew and hardware safety during descent and after touchdown. The proposed method uses a triple redundant system to inhibit Reaction Control System (RCS) thruster firings, detach parachute risers from the vehicle, and transition to the post-landing segment of the Flight Software (FSW). An in-depth trade study was completed to determine optimal characteristics of the touchdown detection method resulting in an algorithm monitoring filtered, lever-arm corrected, 200 Hz Inertial Measurement Unit (IMU) vehicle acceleration magnitude data against a tunable threshold using persistence counter logic. Following the design of the algorithm, high fidelity environment and vehicle simulations, coupled with the actual vehicle FSW, were used to tune the acceleration threshold and persistence counter value to result in adequate performance in detecting touchdown and sufficient safety margin against early detection while descending under parachutes. An analytical approach including Kriging and adaptive sampling allowed for a sufficient number of finite element analysis (FEA) impact simulations to be completed using minimal computation time. The combination of a persistence counter of 10 and an acceleration threshold of approximately 57.3 ft/s2 resulted in an impact performance factor of safety (FOS) of 1.0 and a safety FOS of approximately 2.6 for touchdown declaration. An RCS termination acceleration threshold of approximately 53.1 ft/s(exp)2 with a persistence counter of 10 resulted in an increased impact performance FOS of 1.2 at the expense of a lowered under-parachutes safety factor of 2.2. The resulting tuned algorithm was then tested on data from eight Capsule Parachute Assembly System (CPAS) flight tests, showing an experimental minimum safety FOS of 6.1. The formulated touchdown detection algorithm will be flown on the Orion MPCV FSW during the Exploration Flight Test 1 (EFT-1) mission in the second half of 2014.

Integrated Safety Analysis Teams

NASA Technical Reports Server (NTRS)

Wetherholt, Jonathan C.

2008-01-01

Today's complex systems require understanding beyond one person s capability to comprehend. Each system requires a team to divide the system into understandable subsystems which can then be analyzed with an Integrated Hazard Analysis. The team must have both specific experiences and diversity of experience. Safety experience and system understanding are not always manifested in one individual. Group dynamics make the difference between success and failure as well as the difference between a difficult task and a rewarding experience. There are examples in the news which demonstrate the need to connect the pieces of a system into a complete picture. The Columbia disaster is now a standard example of a low consequence hazard in one part of the system; the External Tank is a catastrophic hazard cause for a companion subsystem, the Space Shuttle Orbiter. The interaction between the hardware, the manufacturing process, the handling, and the operations contributed to the problem. Each of these had analysis performed, but who constituted the team which integrated this analysis together? This paper will explore some of the methods used for dividing up a complex system; and how one integration team has analyzed the parts. How this analysis has been documented in one particular launch space vehicle case will also be discussed.

Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.

PubMed

Vallet, Hélène; Seve, Pascal; Biard, Lucie; Baptiste Fraison, Jean; Bielefeld, Philip; Perard, Laurent; Bienvenu, Boris; Abad, Sébastien; Rigolet, Aude; Deroux, Alban; Sene, Damien; Perlat, Antoinette; Marie, Isabelle; Feurer, Elodie; Hachulla, Eric; Fain, Olivier; Clavel, Gaëlle; Riviere, Sophie; Bouche, Pierre-Alban; Gueudry, Julie; Pugnet, Gregory; Le Hoang, Phuc; Resche Rigon, Matthieu; Cacoub, Patrice; Bodaghi, Bahram; Saadoun, David

2016-06-01

To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis. This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated. The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083). Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy. © 2016, American College of Rheumatology.

Should palonosetron be a preferred 5-HT3 receptor antagonist for chemotherapy-induced nausea and vomiting? An updated systematic review and meta-analysis.

PubMed

Chow, Ronald; Warr, David G; Navari, Rudolph M; Tsao, May; Popovic, Marko; Chiu, Leonard; Milakovic, Milica; Lam, Henry; DeAngelis, Carlo

2018-05-23

Chemotherapy-induced nausea and vomiting (CINV) continues to be a common side effect of systemic anticancer therapy, decreasing quality of life and increasing resource utilization. The aim of this meta-analysis was to investigate the comparative efficacy and safety of palonosetron relative to other 5-HT 3 RAs. A literature search was carried out in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Full-text references were then screened and included in this meta-analysis if they were an RCT and had adequate data regarding one of the five primary endpoints-complete response (CR), complete control (CC), no emesis, no nausea, or no rescue medications. A total of 24 RCTs were included in this review. Palonosetron was statistically superior to other 5-HT 3 RAs for 10 of the 19 assessed endpoints. Only one endpoint-emesis in the overall phase-had noticeable more favorable data for palonosetron to the point that it approached the 10% risk difference (RD) threshold as specified by the MASCC/ESMO antiemetic panel; another two endpoints (CR in the overall phase and nausea in the delayed phase) approached the 10% threshold. Palonosetron seems to be more efficacious and safe than other 5-HT 3 RAs-statistically superior in 10 of 19 endpoints. It is, however, only clinically significant in one endpoint and approached clinically significant difference in another two endpoints. Within the limits of this meta-analysis, our results indicate that palonosetron may not be as superior in efficacy and safety as reported in a previous meta-analysis, and supports the recent MASCC/ESMO, ASCO, and NCCN guidelines in not generally indicating palonosetron as the 5-HT 3 RA of choice.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of complete EHS0470, General Employee Radiation Safety (on-line course). Escort is required for visitors who Safety (on-line course) ii. EHS0348 Chemical Hygiene and Safety (on-line course) iii. EHS0470 General

Annual Safety Education Review 1970.

ERIC Educational Resources Information Center

American Association for Health, Physical Education, and Recreation, Washington, DC.

This booklet presents articles completed in 1970 by the Division of Safety Education of the American Association for Health, Physical Education, and Recreation. The 11 articles deal with the following topics: a) the problem of apathy in safety education, b) the safety aspects of archery and riflery, c) weight training for high school girls, d)…

Achieving a climate for patient safety by focusing on relationships.

PubMed

Manojlovich, Milisa; Kerr, Mickey; Davies, Barbara; Squires, Janet; Mallick, Ranjeeta; Rodger, Ginette L

2014-12-01

Despite many initiatives, advances in patient safety remain uneven in part because poor relationships among health professionals have not been addressed. The purpose of this study was to determine whether relationships between health professionals contributed to a patient safety climate, after implementation of an intervention to improve inter-professional collaboration. This was a secondary analysis of data collected to evaluate the Interprofessional Model of Patient Care (IPMPC) at The Ottawa Hospital in Ontario, Canada, which consists of five sites. A series of generalized estimating equation models were generated, accounting for the clustering of responses by site. Thirteen health professionals including physicians, nurses, physiotherapists and others (n = 1896) completed anonymous surveys about 1 year after the IPMPC was introduced. The IPMPC was implemented to improve interdisciplinary collaboration. Reliable instruments were used to measure collaboration, respect, inter-professional conflict and patient safety climate. Collaboration (β = 0.13; P = 0.002) and respect (β = 1.07; P = 0.03) were significant independent predictors of patient safety climate. Conflict was an independent and significant inverse predictor of patient safety climate (β = -0.29; P = 0.03), but did not moderate linkages between collaboration and patient safety climate or between respect and patient safety climate. Through the IPMPC, all health professionals learned how to collaborate and build a patient safety climate, even in the presence of inter-professional conflict. Efforts by others to foster better work relationships may yield similar improvements in patient safety climate. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Safety, Health and Environmental Hazards Associated with Composites: A Complete Analysis

DTIC Science & Technology

1992-11-01

evolve (Ballinger 2). Likewise, important fiber materials such as glass, carbon/graphite, aramid ( Kevlar ), and boron are prevalent in the industry. Each...absorption. Skin irritation or sensitization may result from extended exposure (Ballinger 2). Polyurethanes and Urea-/ Phenol -formaldehyde - These resin systems...percent scrap in the formation of laminate lay-ups (Lee 24). Because of limited applications, this is regarded as waste. In the future, this level of waste

Review of Exploration Systems Development (ESD) Integrated Hazard Development Process. Volume 1; Appendices

NASA Technical Reports Server (NTRS)

Smiles, Michael D.; Blythe, Michael P.; Bejmuk, Bohdan; Currie, Nancy J.; Doremus, Robert C.; Franzo, Jennifer C.; Gordon, Mark W.; Johnson, Tracy D.; Kowaleski, Mark M.; Laube, Jeffrey R.

2015-01-01

The Chief Engineer of the Exploration Systems Development (ESD) Office requested that the NASA Engineering and Safety Center (NESC) perform an independent assessment of the ESD's integrated hazard development process. The focus of the assessment was to review the integrated hazard analysis (IHA) process and identify any gaps/improvements in the process (e.g., missed causes, cause tree completeness, missed hazards). This document contains the outcome of the NESC assessment.

Review of Exploration Systems Development (ESD) Integrated Hazard Development Process. Appendices; Volume 2

NASA Technical Reports Server (NTRS)

Smiles, Michael D.; Blythe, Michael P.; Bejmuk, Bohdan; Currie, Nancy J.; Doremus, Robert C.; Franzo, Jennifer C.; Gordon, Mark W.; Johnson, Tracy D.; Kowaleski, Mark M.; Laube, Jeffrey R.

2015-01-01

The Chief Engineer of the Exploration Systems Development (ESD) Office requested that the NASA Engineering and Safety Center (NESC) perform an independent assessment of the ESD's integrated hazard development process. The focus of the assessment was to review the integrated hazard analysis (IHA) process and identify any gaps/improvements in the process (e.g. missed causes, cause tree completeness, missed hazards). This document contains the outcome of the NESC assessment.

Theory-Driven Models for Correcting Fight or Flight Imbalance in Gulf War Illness

DTIC Science & Technology

2011-09-01

testing on software • Performed static and dynamic analysis on safety code Research Interests To understand how the nervous system operates, how...dynamics of these systems to reset control of the HPA-immune axis to normal. We have completed the negotiation of sub-awards to the CFIDS Association...We propose that severe physical or psychological insult to the endocrine and immune systems can displace these from a normal regulatory equilibrium

Comparing safety climate for nurses working in operating theatres, critical care and ward areas in the UK: a mixed methods study

PubMed Central

Tarling, Maggie; Jones, Anne; Murrells, Trevor; McCutcheon, Helen

2017-01-01

Objectives The main aim of the study was to explore the potential sources of variation and understand the meaning of safety climate for nursing practice in acute hospital settings in the UK. Design A sequential mixed methods design included a cross-sectional survey using the Safety Climate Questionnaire (SCQ) and thematic analysis of focus group discussions. Confirmatory factor analysis (CFA) was used to validate the factor structure of the SCQ. Factor scores were compared between nurses working in operating theatres, critical care and ward areas. Results from the survey and the thematic analysis were then compared and synthesised. Setting A London University. Participants 319 registered nurses working in acute hospital settings completed the SCQ and a further 23 nurses participated in focus groups. Results CFA indicated that there was a good model fit on some criteria (χ2=1683.699, df=824, p<0.001; χ2/df=2.04; root mean square error of approximation=0.058) but a less acceptable fit on comparative fit index which is 0.804. There was a statistically significant difference between clinical specialisms in management commitment (F (4,266)=4.66, p=0.001). Nurses working in operating theatres had lower scores compared with ward areas and they also reported negative perceptions about management in their focus group. There was significant variation in scores for communication across clinical specialism (F (4,266)=2.62, p=0.035) but none of the pairwise comparisons achieved statistical significance. Thematic analysis identified themes of human factors, clinical management and protecting patients. The system and the human side of caring was identified as a meta-theme. Conclusions The results suggest that the SCQ has some utility but requires further exploration. The findings indicate that safety in nursing practice is a complex interaction between safety systems and the social and interpersonal aspects of clinical practice. PMID:29084793

Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period.

PubMed

Weiden, Peter J; Du, Yangchun; Liu, Chih-Chin; Stanford, Arielle D

2018-06-26

Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL). This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed. In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. The 12-week completion rate was high (92.1%) and similar across the different preswitch oral antipsychotic groups. Overall, adverse event (AE) rates experienced over 12 weeks were modest; no AEs were considered serious. The most common AEs in the initiation phase were injection site pain (5.8%), insomnia (5.8%), and akathisia (3.2%). No apparent relationship was observed between preswitch medication and early-onset AEs. Mean Positive and Negative Syndrome Scale total scores remained stable during this period across preswitch antipsychotic groups. Switching from an oral antipsychotic to AL was feasible in an outpatient setting for patients with schizophrenia, and the 12-week retention rate was favorable.

Safety, immunogenicity, and efficacy of the ML29 reassortant vaccine for Lassa fever in small non-human primates✩

PubMed Central

Lukashevich, Igor S.; Carrion, Ricardo; Salvato, Maria S.; Mansfield, Keith; Brasky, Kathleen; Zapata, Juan; Cairo, Cristiana; Goicochea, Marco; Hoosien, Gia E.; Ticer, Anysha; Bryant, Joseph; Davis, Harry; Hammamieh, Rasha; Mayda, Maria; Jett, Marti; Patterson, Jean

2008-01-01

A single injection of ML29 reassortant vaccine for Lassa fever induces low, transient viremia, and low or moderate levels of ML29 replication in tissues of common marmosets depending on the dose of the vaccination. The vaccination elicits specific immune responses and completely protects marmosets against fatal disease by induction of sterilizing cell-mediated immunity. DNA array analysis of human peripheral blood mononuclear cells from healthy donors exposed to ML29 revealed that gene expression patterns in ML29-exposed PBMC and control, media-exposed PBMC, clustered together confirming safety profile of the ML29 in non-human primates. The ML29 reassortant is a promising vaccine candidate for Lassa fever. PMID:18692539

Final (Tier 1) environmental impact statement for the Galileo and Ulysses Missions

NASA Technical Reports Server (NTRS)

1988-01-01

Presented here is a Final (Tier 1) Environmental Impact Statement (EIS) addressing the potential environmental consequences associated with continuing the modifications of the Galileo and Ulysses spacecraft for launch using a booster/upper stage combination that is different from the one planned for use prior to the Challenger accident, while conducting the detailed safety and environmental analysis in order to preserve the October 1989 launch opportunity for Galileo and an October 1990 launch opportunity for Ulysses. While detailed safety and environmental analyses associated with the missions are underway, they currently are not complete. Nevertheless, sufficient information is available to enable a choice among the reconfiguration alternatives presented. Relevant assessments of the potential for environmental impacts are presented.

Towards Real-time, On-board, Hardware-Supported Sensor and Software Health Management for Unmanned Aerial Systems

NASA Technical Reports Server (NTRS)

Schumann, Johann; Rozier, Kristin Y.; Reinbacher, Thomas; Mengshoel, Ole J.; Mbaya, Timmy; Ippolito, Corey

2013-01-01

Unmanned aerial systems (UASs) can only be deployed if they can effectively complete their missions and respond to failures and uncertain environmental conditions while maintaining safety with respect to other aircraft as well as humans and property on the ground. In this paper, we design a real-time, on-board system health management (SHM) capability to continuously monitor sensors, software, and hardware components for detection and diagnosis of failures and violations of safety or performance rules during the flight of a UAS. Our approach to SHM is three-pronged, providing: (1) real-time monitoring of sensor and/or software signals; (2) signal analysis, preprocessing, and advanced on the- fly temporal and Bayesian probabilistic fault diagnosis; (3) an unobtrusive, lightweight, read-only, low-power realization using Field Programmable Gate Arrays (FPGAs) that avoids overburdening limited computing resources or costly re-certification of flight software due to instrumentation. Our implementation provides a novel approach of combining modular building blocks, integrating responsive runtime monitoring of temporal logic system safety requirements with model-based diagnosis and Bayesian network-based probabilistic analysis. We demonstrate this approach using actual data from the NASA Swift UAS, an experimental all-electric aircraft.

Commonalities in Transportation Fire Safety : Regulations, Research and Development, and Data Bases

DOT National Transportation Integrated Search

1980-01-01

This report presents a comprehensive review of current modal fire safety efforts within the U.S. Department of Transportation. Common fire safety problems and modal administration response are identified. Work completed includes a review of modal adm...

Annual report to Congress. Department of Energy activities relating to the Defense Nuclear Facilities Safety Board, calendar year 2000

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

None

2001-03-01

This Annual Report to the Congress describes the Department of Energy's activities in response to formal recommendations and other interactions with the Defense Nuclear Facilities Safety Board. During 2000, the Department completed its implementation and proposed closure of one Board recommendation and completed all implementation plan milestones associated with two additional Board recommendations. Also in 2000, the Department formally accepted two new Board recommendations and developed implementation plans in response to those recommendations. The Department also made significant progress with a number of broad-based safety initiatives. These include initial implementation of integrated safety management at field sites and within headquartersmore » program offices, issuance of a nuclear safety rule, and continued progress on stabilizing excess nuclear materials to achieve significant risk reduction.« less

Online continuing education course enhances nutrition and health professionals' knowledge of food safety issues of high-risk populations.

PubMed

Wallner, Stephanie; Kendall, Patricia; Hillers, Virginia; Bradshaw, Eva; Medeiros, Lydia C

2007-08-01

To develop and evaluate the efficacy of an online continuing education course for professionals who provide food safety information to high-risk populations. A 2-credit graduate-level class was converted into six web-based modules (overview of foodborne illness, immunology, pregnancy, human immunodeficiency virus, cancer and transplants, and lifecycle) and offered to nutrition and health professionals. Participants had 8 weeks to complete the modules, pre and post questionnaires, and course evaluation. Those who successfully completed the protocol received six continuing education units from one of three professional associations. Change in knowledge was measured using pre and post questionnaires. Course efficacy was evaluated using a post-course questionnaire. A convenience sample of 140 registered dietitians/dietetic technicians registered, nurses, and extension educators were recruited through professional conferences and electronic mailing lists to take the course. Analysis of variance was used to evaluate differences in knowledge scores for all groups across five main effects (attempt, module, profession, age, and education). Course evaluation responses were used to assess course effectiveness. For each module, knowledge scores increased significantly (P<0.001) from pre to post questionnaire. Overall, knowledge scores increased from 67.3% before the modules to 91.9% afterwards. Course evaluation responses were favorable, and participants indicated that course objectives were met. Online continuing education courses, such as "Food Safety Issues for High Risk Populations," seem to be a convenient, effective option for dietetics professionals, nurses, and extension educators seeking knowledge about food safety issues of high-risk populations. Online learning is a promising delivery approach for the continuing education of health professionals.

Bio-markers: traceability in food safety issues.

PubMed

Raspor, Peter

2005-01-01

Research and practice are focusing on development, validation and harmonization of technologies and methodologies to ensure complete traceability process throughout the food chain. The main goals are: scale-up, implementation and validation of methods in whole food chains, assurance of authenticity, validity of labelling and application of HACCP (hazard analysis and critical control point) to the entire food chain. The current review is to sum the scientific and technological basis for ensuring complete traceability. Tracing and tracking (traceability) of foods are complex processes due to the (bio)markers, technical solutions and different circumstances in different technologies which produces various foods (processed, semi-processed, or raw). Since the food is produced for human or animal consumption we need suitable markers to be stable and traceable all along the production chain. Specific biomarkers can have a function in technology and in nutrition. Such approach would make this development faster and more comprehensive and would make possible that food effect could be monitored with same set of biomarkers in consumer. This would help to develop and implement food safety standards that would be based on real physiological function of particular food component.

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Estimation of Inherent Safety Margins in Loaded Commercial Spent Nuclear Fuel Casks

DOE PAGES

Banerjee, Kaushik; Robb, Kevin R.; Radulescu, Georgeta; ...

2016-06-15

We completed a novel assessment to determine the unquantified and uncredited safety margins (i.e., the difference between the licensing basis and as-loaded calculations) available in as-loaded spent nuclear fuel (SNF) casks. This assessment was performed as part of a broader effort to assess issues and uncertainties related to the continued safety of casks during extended storage and transportability following extended storage periods. Detailed analyses crediting the actual as-loaded cask inventory were performed for each of the casks at three decommissioned pressurized water reactor (PWR) sites to determine their characteristics relative to regulatory safety criteria for criticality, thermal, and shielding performance.more » These detailed analyses were performed in an automated fashion by employing a comprehensive and integrated data and analysis tool—Used Nuclear Fuel-Storage, Transportation & Disposal Analysis Resource and Data System (UNF-ST&DARDS). Calculated uncredited criticality margins from 0.07 to almost 0.30 Δk eff were observed; calculated decay heat margins ranged from 4 to almost 22 kW (as of 2014); and significant uncredited transportation dose rate margins were also observed. The results demonstrate that, at least for the casks analyzed here, significant uncredited safety margins are available that could potentially be used to compensate for SNF assembly and canister structural performance related uncertainties associated with long-term storage and subsequent transportation. The results also suggest that these inherent margins associated with how casks are loaded could support future changes in cask licensing to directly or indirectly credit the margins. Work continues to quantify the uncredited safety margins in the SNF casks loaded at other nuclear reactor sites.« less

Tiger Team Assessments seventeen through thirty-five: A summary and analysis. Volume 2

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

Not Available

1992-12-01

On June 27, 1989, the Secretary of Energy, Admiral James D. Watkins, US Navy (Retired), announced a 10-Point Plan to strengthen environmental, safety, and health (ES&H) programs and waste management activities at the US Department of Energy (DOE). The third initiative called for establishing an independent audit (the Tiger Teams) to assess DOE`s major operating facilities and laboratories. As of November 1992, all 35 Tiger Team Assessments were completed and formally reported to the Secretary. In May 1991 a report providing an analysis and summary of the findings and root causes identified by the first 16 Tiger Team Assessments wasmore » completed and submitted to the Secretary of Energy and to all DOE program managers. This document is intended to provide an easily used and easily understood summary and analysis of the information contained in Tiger Team Assessments numbers 17 through 35 to help DOE achieve ES&H excellence.« less

F14A System Safety Program Plan

DTIC Science & Technology

1981-09-03

by block number) Electromagnetic Pulse (EMP) Safety Plans Test Program EMP Testing F14 Aircraft Plans 20 ABSTRACT (Continue on reverse side if...compromising completion of the required experimental tasks. This document addresses the safety aspect of performing an Electromagnetic Pulse (EMP) test

Validation of the Dutch language version of the Safety Attitudes Questionnaire (SAQ-NL).

PubMed

Haerkens, Marck Htm; van Leeuwen, Wouter; Sexton, J Bryan; Pickkers, Peter; van der Hoeven, Johannes G

2016-08-15

As the first objective of caring for patients is to do no harm, patient safety is a priority in delivering clinical care. An essential component of safe care in a clinical department is its safety climate. Safety climate correlates with safety-specific behaviour, injury rates, and accidents. Safety climate in healthcare can be assessed by the Safety Attitudes Questionnaire (SAQ), which provides insight by scoring six dimensions: Teamwork Climate, Job Satisfaction, Safety Climate, Stress Recognition, Working Conditions and Perceptions of Management. The objective of this study was to assess the psychometric properties of the Dutch language version of the SAQ in a variety of clinical departments in Dutch hospitals. The Dutch version (SAQ-NL) of the SAQ was back translated, and analyzed for semantic characteristics and content. From October 2010 to November 2015 SAQ-NL surveys were carried out in 17 departments in two university and seven large non-university teaching hospitals in the Netherlands, prior to a Crew Resource Management human factors intervention. Statistical analyses were used to examine response patterns, mean scores, correlations, internal consistency reliability and model fit. Cronbach's α's and inter-item correlations were calculated to examine internal consistency reliability. One thousand three hundred fourteen completed questionnaires were returned from 2113 administered to health care workers, resulting in a response rate of 62 %. Confirmatory Factor Analysis revealed the 6-factor structure fit the data adequately. Response patterns were similar for professional positions, departments, physicians and nurses, and university and non-university teaching hospitals. The SAQ-NL showed strong internal consistency (α = .87). Exploratory analysis revealed differences in scores on the SAQ dimensions when comparing different professional positions, when comparing physicians to nurses and when comparing university to non-university hospitals. The SAQ-NL demonstrated good psychometric properties and is therefore a useful instrument to measure patient safety climate in Dutch clinical work settings. As removal of one item resulted in an increased reliability of the Working Conditions dimension, revision or deletion of this item should be considered. The results from this study provide researchers and practitioners with insight into safety climate in a variety of departments and functional positions in Dutch hospitals.

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

PubMed Central

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

2015-01-01

Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

PubMed

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

2015-05-01

A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

PubMed

Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

2015-11-01

To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (r<0.85 for all correlations), a measure of discriminant validity. The SUC-Safe and SUC-Prof scales were associated with participants' self-reported speaking up behaviour about safety and professionalism concerns (r=0.21, p<0.001 and r=0.22, p<0.001, respectively), a measure of concurrent validity, while teamwork and safety climate scales were not. We created and provided evidence for the reliability and validity of two measures (SUC-Safe and SUC-Prof scales) associated with self-reported speaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Parents' perceptions of the family climate for road safety.

PubMed

Taubman-Ben-Ari, Orit

2015-01-01

The current study examined the applicability of the Family Climate for Road Safety Scale (FCRSS; Taubman-Ben-Ari and Katz-Ben-Ami, 2013) to the parents of young drivers. The sample consisted of 549 parents and 234 of their children, all of whom completed the FCRSS. In addition, the parents completed the multidimensional driving style inventory (MDSI; Taubman-Ben-Ari et al., 2004) and provided background data (e.g., age, gender). Confirmatory factor analysis supported a slightly modified structure of the scale for parents. Examination of the correlations revealed significant weak to strong associations between parents' scores on the various FCRSS dimensions on the one hand, and their self-reported driving styles and offspring's perceptions of the family climate for safety on the other. The findings indicate that the FCRSS is suitable for use with the parents of young drivers, and that perceptions of the family climate are shared by the two generations. Furthermore, they show that family climate is related to parents' customary driving behavior, with the careful driving style positively related to the positive dimensions of the FCRSS. The discussion stresses the importance of the parents' influence on the manner in which their children drive, and the multifaceted nature of this influence. Moreover, it indicates the potential value of the FCRSS, both for research and for designing interventions and measuring their effectiveness. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed

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

2018-03-12

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

SU-E-T-469: Implementation of VAs Web-Based Radiotherapy Incident Reporting and Analysis System (RIRAS)

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

Kapoor, R; Palta, J; Hagan, M

Purpose: This Web-based Radiotherapy Incident Reporting and Analysis System (RIRAS) is a tool to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: VA’s National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and good-catch data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. This VA-Intranet based software design has made use of dataset taxonomies and data dictionaries defined in AAPM/ASTRO reports on error reporting. We used proven industrial and medicalmore » event reporting techniques to avoid several common problems faced in effective data collection such as incomplete data due to data entry fatigue by the reporters, missing data due to data difficult to obtain or not familiar to most reporters, missing reports due to fear of reprisal etc. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The analysis reports with corrective, learning actions are shared with the reporter/facility and made public to the community (after deidentification) as part of the learning process. Results: Till date 50 incident/good catches have been reported in RIRAS and we have completed analysis on 100% of these reports. This is done due to the fact that each reported incidents is investigated and a complete analysis/patient-safety-work-product report is generated by radiation oncology domain-experts. Conclusions Because of the completeness of the data, the system has enabled us to analyze process steps and track trends of major errors which in the future will lead to implementing system wide process improvement steps and safe standard operating procedures for each radiotherapy treatment modality/technique and fulfills our goal of “Effecting Quality While Treating Safely”. RIRAS developed and copyrighted by TSG Innovations Inc.« less

49 CFR 381.510 - May the FMCSA end a pilot program before its scheduled completion date?

Code of Federal Regulations, 2010 CFR

2010-10-01

... achieving a level of safety that is at least equivalent to the level of safety that would be achieved by... 49 Transportation 5 2010-10-01 2010-10-01 false May the FMCSA end a pilot program before its... Pilot Programs § 381.510 May the FMCSA end a pilot program before its scheduled completion date? The...

Rapid liquid chromatography-tandem mass spectrometry analysis of 4-hydroxynonenal for the assessment of oxidative degradation and safety of vegetable oils.

PubMed

Gabbanini, Simone; Matera, Riccardo; Valvassori, Alice; Valgimigli, Luca

2015-04-15

A novel method for the UHPLC-MS/MS analysis of (E)-4-hydroxynonenal (4-HNE) is described. The method is based on derivatization of 4-HNE with pentafluorophenylhydrazine (1) or 4-trifluoromethylphenylhydrazine (2) in acetonitrile in the presence of trifluoroacetic acid as catalyst at room temperature and allows complete analysis of one sample of vegetable oil in only 21 min, including sample preparation and chromatography. The method involving hydrazine 1, implemented in an ion trap instrument with analysis of the transition m/z 337→154 showed LOD=10.9 nM, average accuracy of 101% and precision ranging 2.5-4.0% RSD intra-day (2.7-4.1% RSD inter-day), with 4-HNE standard solutions. Average recovery from lipid matrices was 96.3% from vaseline oil, 91.3% from sweet almond oil and 105.3% from olive oil. The method was tested on the assessment of safety and oxidative degradation of seven samples of dietary oil (soybean, mixed seeds, corn, peanut, sunflower, olive) and six cosmetic-grade oils (avocado, blackcurrant, apricot kernel, echium, sesame, wheat germ) and effectively detected increased 4-HNE levels in response to chemical (Fenton reaction), photochemical, or thermal stress and aging, aimed at mimicking typical oxidation associated with storage or industrial processing. The method is a convenient, cost-effective and reliable tool to assess quality and safety of vegetable oils. Copyright © 2015 Elsevier B.V. All rights reserved.

Patient safety culture in China: a case study in an outpatient setting in Beijing

PubMed Central

Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

2014-01-01

Objectives To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. Methods A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. Results The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of ‘communication openness’ was identified as a major safety culture problem, and a perception of ‘penalty’ was the greatest barrier to the encouragement of error reporting. Cohesive ‘teamwork within units’, while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. Conclusions This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong ‘teamwork within units’, a common area of strength, could fuel the concealment of errors. PMID:24351971

The reasons for Chinese nursing staff to report adverse events: a questionnaire survey.

PubMed

Hong, Su; Li, QiuJie

2017-04-01

To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P < 0.001), safety climate (P < 0.001), teamwork climate (P < 0.001), overall the adverse event reporting perception scale score (P = 0.003) and importance or reporting (P = 0.002). The results confirmed that improvements in the patient safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

29 CFR 1952.101 - Developmental schedule.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... effective July 1, 1973. (b) Complete revision of all occupational safety and health codes as proposed within... budget. (e) Establishment of specific occupational safety and health goals by July 1, 1974. These goals...

29 CFR 1952.101 - Developmental schedule.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... effective July 1, 1973. (b) Complete revision of all occupational safety and health codes as proposed within... budget. (e) Establishment of specific occupational safety and health goals by July 1, 1974. These goals...

30 CFR 75.382 - Mechanical escape facilities.

Code of Federal Regulations, 2011 CFR

2011-07-01

....382 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.382 Mechanical escape... shall be run through one complete cycle of operation to determine that it is operating properly. (d) A...

An Innovative Multimedia Approach to Laboratory Safety

NASA Technical Reports Server (NTRS)

Anderson, M. B.; Constant, K. P.

1996-01-01

A new approach for teaching safe laboratory practices has been developed for materials science laboratories at Iowa State university. Students are required to complete a computerized safety tutorial and pass an exam before working in the laboratory. The safety tutorial includes sections on chemical, electrical, radiation, and high temperature safety. The tutorial makes use of a variety of interactions, including 'assembly' interactions where a student is asked to drag and drop items with the mouse (either labels or pictures) to an appropriate place on the screen (sometimes in a specific order). This is extremely useful for demonstrating safe lab practices and disaster scenarios. Built into the software is a record tracking scheme so that a professor can access a file that records which students have completed the tutorial and their scores on the exam. This paper will describe the development and assessment of the safety tutorials.

Mixed methods study on the use of and attitudes towards safety checklists in interventional radiology.

PubMed

Munn, Zachary; Giles, Kristy; Aromataris, Edoardo; Deakin, Anita; Schultz, Timothy; Mandel, Catherine; Peters, Micah Dj; Maddern, Guy; Pearson, Alan; Runciman, William

2018-02-01

The use of safety checklists in interventional radiology is an intervention aimed at reducing mortality and morbidity. Currently there is little known about their practical use in Australian radiology departments. The primary aim of this mixed methods study was to evaluate how safety checklists (SC) are used and completed in radiology departments within Australian hospitals, and attitudes towards their use as described by Australian radiologists. A mixed methods approach employing both quantitative and qualitative techniques was used for this study. Direct observations of checklist use during radiological procedures were performed to determine compliance. Medical records were also audited to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). A focus group with Australian radiologists was conducted to determine attitudes towards the use of checklists. Among the four participating radiology departments, overall observed mean completion of the components of the checklist was 38%. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were correct patient (80%) and procedure (60%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (64% completion) in comparison to the 38% observed. The focus group participants spoke of barriers to the use of checklists, including the culture of radiology departments. This is the first study of safety checklist use in radiology within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records. There remain significant barriers to the proper use of safety checklists in Australian radiology departments. © 2017 The Royal Australian and New Zealand College of Radiologists.

`G.A.T.E': Gap analysis for TTX evaluation

NASA Astrophysics Data System (ADS)

Cacciotti, Ilaria; Di Giovanni, Daniele; Pergolini, Alessandro; Malizia, Andrea; Carestia, Mariachiara; Palombi, Leonardo; Bellecci, Carlo; Gaudio, Pasquale

2016-06-01

A Table Top Exercise (TTX) gap analysis tool was developed with the aim to provide a complete, systematic and objective evaluation of TTXs organized in safety and security fields. A TTX consists in a discussion-based emergency management exercise, organized in a simulated emergency scenario, involving groups of players who are subjected to a set of solicitations (`injects'), in order to evaluate their emergency response abilities. This kind of exercise is devoted to identify strengths and shortfalls and to propose potential and promising changes in the approach to a particular situation. In order to manage the TTX derived data collection and analysis, a gap analysis tool would be very useful and functional at identifying the 'gap' between them and specific areas and actions for improvement, consisting the gap analysis in a comparison between actual performances and optimal/expected ones. In this context, a TTX gap analysis tool was designed, with the objective to provide an evaluation of Team players' competences and performances and TTX organization and structure. The influence of both the players' expertise and the reaction time (difference between expected time and time necessary to actually complete the injects) on the final evaluation of the inject responses was also taken into account.

The U. S. Department of Energy SARP review training program

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

Mauck, C.J.

1988-01-01

In support of its radioactive material packaging certification program, the U.S. Department of Energy (DOE) has established a special training workshop. The purpose of the two-week workshop is to develop skills in reviewing Safety Analysis Reports for Packagings (SARPs) and performing confirmatory analyses. The workshop, conducted by the Lawrence Livermore National Laboratory (LLNL) for DOE, is divided into two parts: methods of review and methods of analysis. The sessions covering methods of review are based on the DOE document, ''Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings'' (PRG). The sessions cover relevant DOE Orders and all areas ofmore » review in the applicable Nuclear Regulatory Commission (NRC) Regulatory Guides. The technical areas addressed include structural and thermal behavior, materials, shielding, criticality, and containment. The course sessions on methods of analysis provide hands-on experience in the use of calculational methods and codes for reviewing SARPs. Analytical techniques and computer codes are discussed and sample problems are worked. Homework is assigned each night and over the included weekend; at the conclusion, a comprehensive take-home examination is given requiring six to ten hours to complete.« less

75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... MCSAC will complete action on Task 10-02, regarding Fatigue Management Plans for Commercial Motor Vehicle Drivers. Additionally, the MCSAC will commence work on Task 11-01, regarding Patterns of Safety... officer, safety director, vehicle maintenance supervisor, and driver supervisor of a motor carrier...

29 CFR 1952.174 - Completion of developmental steps and certification.

Code of Federal Regulations, 2014 CFR

2014-07-01

... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.174 - Completion of developmental steps and certification.

Code of Federal Regulations, 2013 CFR

2013-07-01

... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.174 - Completion of developmental steps and certification.

Code of Federal Regulations, 2011 CFR

2011-07-01

... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.174 - Completion of developmental steps and certification.

Code of Federal Regulations, 2012 CFR

2012-07-01

... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

30 CFR 77.1906 - Hoists; daily inspection.

Code of Federal Regulations, 2011 CFR

2011-07-01

....1906 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES... shall be run by the hoist operator through one complete cycle of operation before any person is...

A novel briefing checklist at shift handoff in an emergency department improves situational awareness and safety event identification.

PubMed

Mullan, Paul C; Macias, Charles G; Hsu, Deborah; Alam, Sartaj; Patel, Binita

2015-04-01

Emergency department (ED) shift handoffs are sources of potential medical error, delays in care, and medicolegal liabilities. Few handoff studies exist in the ED literature. We aimed to describe the implementation of a standardized checklist for improving situational awareness during physician handoffs in a pediatric ED. This is a descriptive observational study in a large academic pediatric ED. Checklists were evaluated for rates of use, completion, and identification of potential safety events. We defined a complete checklist as 80% or more of items checked.  A user perception survey was used. After 1 year, all checklist users (residents, fellows, faculty, and charge nurses with ED experience before and after checklist implementation) were anonymously surveyed to assess the checklist's usability, perceived contributions to Institute of Medicine quality domains, and situational awareness. The electronically administered survey used Likert frequency scales. Of 732 handoffs, 98% used the checklist, and 89% were complete. A mean of 1.7 potential safety events were identified per handoff. The most frequent potential safety events were identification of intensive care unit-level patients in the ED (48%), equipment problems (46%), staffing issues (21%), and intensive care unit-level patients in transport (16%). Eighty-one subjects (88%) responded to the survey. The users agreed that the checklist promoted better communication, safety, efficiency, effective care, and situational awareness. The Physician Active Shift Signout in the Emergency Department briefing checklist was used often and at a high completion rate, frequently identifying potential safety events. The users found that it improved the quality of care and team communication. Future studies on outcomes and processes are needed.

Understanding safety climate in small automobile collision repair shops.

PubMed

Parker, David L; Brosseau, Lisa M; Bejan, Anca; Skan, Maryellen; Xi, Min

2014-01-01

In the United States, approximately 236,000 people work in 37,600 auto collision-repair businesses. Workers in the collision-repair industry may be exposed to a wide range of physical and chemical hazards. This manuscript examines the relationship of safety climate as reported by collision repair shop workers and owners to: (1) an independent business safety assessment, and (2) employee self-reported work practices. The study was conducted in the Twin Cities metropolitan area. A total of 199 workers from 49 collision shops completed a survey of self-reported work practices and safety climate. Surveys were completed by an owner or manager in all but three shops. In general, self-reported work practices were poor. Workers' scores on safety climate were uniformly lower than those of owners. For workers, there was no correlation between how well the business scored on an independent audit of business safety practices and the safety climate measures they reported. For owners, however, there was a positive correlation between safety climate scores and the business safety assessment. For workers, safety rules and procedures were associated with improved work practices for those engaged in both painting-related and body technician-related activities. The enforcement of safety rules and procedures emerged as a strong factor positively affecting self-reported work practices. These findings identify a simple, cost effective path to reducing hazards in small workplaces. © 2013 Wiley Periodicals, Inc.

33 CFR 159.131 - Safety: Incinerating device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.131 Safety.... Unitized incineration devices must completely burn to a dry, inert ash, a simultaneous defecation and...

Replacement of seam welded hot reheat pipe using narrow groove GTA machine welding

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

Richardson, R.R.; Yanes, J.; Bryant, R.

1995-12-31

Southern California Edison, recognizing a potential safety concern, scrutinized its existing seam welded hot reheat pipe manufactured by the same supplier as that which failed. Alternatives were narrowed to two in dealing with the installed seam welded pipe. The overriding consideration, however, was one of safety. With this in mind, the utility company evaluated replacement of the seam welded hot reheat pipe with seamless pipe or increasing the frequency of its inspection program. Although increased inspection was much costly, pipe replacement was chosen due to potential safety concerns with seam welded pipe even with more frequent inspection. The utility companymore » then proceeded to determine the most effective method to complete this work. Analysis showed machine-made (automatic) gas tungsten arc welds (GTAW) as the method of choice due to cleanliness and superior mechanical properties. In conjunction with this method, the narrow groove (3{degree} bevel) weld joint as opposed to the traditional groove (37 1/2{degree} bevel) was shown to provide significant technical advantages.« less

An overview of safety assessment, regulation, and control of hazardous material use at NREL

NASA Astrophysics Data System (ADS)

Nelson, B. P.; Crandall, R. S.; Moskowitz, P. D.; Fthenakis, V. M.

1992-12-01

This paper summarizes the methodology we use to ensure the safe use of hazardous materials at the National Renewable Energy Laboratory (NREL). First, we analyze the processes and the materials used in those processes to identify the hazards presented. Then we study federal, state, and local regulations and apply the relevant requirements to our operations. When necessary, we generate internal safety documents to consolidate this information. We design research operations and support systems to conform to these requirements. Before we construct the systems, we perform a semiquantitative risk analysis on likely accident scenarios. All scenarios presenting an unacceptable risk require system or procedural modifications to reduce the risk. Following these modifications, we repeat the risk analysis to ensure that the respective accident scenarios present an acceptable risk. Once all risks are acceptable, we conduct an operational readiness review (ORR). A management-appointed panel performs the ORR ensuring compliance with all relevant requirements. After successful completion of the ORR, operations can begin.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

PubMed

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

2018-05-02

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparison of Ahmed glaucoma valve implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis.

PubMed

HaiBo, Tan; Xin, Kang; ShiHeng, Lu; Lin, Liu

2015-01-01

To compare the efficacy and safety of Ahmed glaucoma valve implantation (AGV) with trabeculectomy in the management of glaucoma patients. A comprehensive literature search (PubMed, Embase, Google, and the Cochrane library) was performed, including a systematic review with meta-analysis of controlled clinical trials comparing AGV versus trabeculectomy. Efficacy estimates were the weighted mean differences (WMDs) for the percentage intraocular pressure reduction (IOPR %) from baseline to end-point, the reduction in glaucoma medications, and the odds ratios (ORs) for complete and qualified success rates. Safety estimates were the relative risks (RRs) for adverse events. All outcomes were reported with a 95% confidence interval (CI). Statistical analysis was performed using the RevMan 5.0 software. Six controlled clinical trials were included in this meta-analysis. There was no significant difference between the AGV and trabeculectomy in the IOPR% (WMD = -3.04, 95% CI: -8.36- 2.26; P = 0.26). The pooled ORs comparing AGV with trabeculectomy were 0.46 (0.22, 0.99) for the complete success rate (P = 0.05) and 0.97 (0.78-1.20) for the quantified success rate (P = 0.76). No significant difference in the reduction in glaucoma medicines was observed (WMD = 0.24; 95% CI: -0.27-0.76; P = 0.35). AGV was found to be associated with a significantly lower frequency of all adverse events (RR = 0.71; 95%CI: 1.14-0.97; p = 0.001) than trabeculectomy, while the most common complications did not differ significantly (all p> 0.05). AGV was equivalent to trabeculectomy in reducing the IOP, the number of glaucoma medications, success rates, and rates of the most common complications. However, AGV was associated with a significantly lower frequency of overall adverse events.

Data-driven management using quantitative metric and automatic auditing program (QMAP) improves consistency of radiation oncology processes.

PubMed

Yu, Naichang; Xia, Ping; Mastroianni, Anthony; Kolar, Matthew D; Chao, Samuel T; Greskovich, John F; Suh, John H

Process consistency in planning and delivery of radiation therapy is essential to maintain patient safety and treatment quality and efficiency. Ensuring the timely completion of each critical clinical task is one aspect of process consistency. The purpose of this work is to report our experience in implementing a quantitative metric and automatic auditing program (QMAP) with a goal of improving the timely completion of critical clinical tasks. Based on our clinical electronic medical records system, we developed a software program to automatically capture the completion timestamp of each critical clinical task while providing frequent alerts of potential delinquency. These alerts were directed to designated triage teams within a time window that would offer an opportunity to mitigate the potential for late completion. Since July 2011, 18 metrics were introduced in our clinical workflow. We compared the delinquency rates for 4 selected metrics before the implementation of the metric with the delinquency rate of 2016. One-tailed Student t test was used for statistical analysis RESULTS: With an average of 150 daily patients on treatment at our main campus, the late treatment plan completion rate and late weekly physics check were reduced from 18.2% and 8.9% in 2011 to 4.2% and 0.1% in 2016, respectively (P < .01). The late weekly on-treatment physician visit rate was reduced from 7.2% in 2012 to <1.6% in 2016. The yearly late cone beam computed tomography review rate was reduced from 1.6% in 2011 to <0.1% in 2016. QMAP is effective in reducing late completions of critical tasks, which can positively impact treatment quality and patient safety by reducing the potential for errors resulting from distractions, interruptions, and rush in completion of critical tasks. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Meta-analysis of the efficacy and safety of combined surgery in the management of eyes with coexisting cataract and open angle glaucoma.

PubMed

Jiang, Nan; Zhao, Gui-Qiu; Lin, Jing; Hu, Li-Ting; Che, Cheng-Ye; Wang, Qian; Xu, Qiang; Li, Cui; Zhang, Jie

2018-01-01

To conduct a systematic review and quantitative Meta-analysis of the efficacy and safety of combined surgery for the eyes with coexisting cataract and open angle glaucoma. We performed a systematic search of the related literature in the Cochrane Library, PubMed, EMBASE, Web of Science databases, CNKI, CBM and Wan Fang databases, with no limitations on language or publication date. The primary efficacy estimate was identified by weighted mean difference of the percentage of intraocular pressure reduction (IOPR%) from baseline to end-point, the percentage of number of glaucoma medications reduction from pre- to post-operation, and the secondary efficacy evaluations were performed by odds ratio (OR) and 95% confidence interval (CI) for complete and qualified success rate. Besides, ORs were applied to assess the tolerability of adverse incidents. Meta-analyses of fixed or random effect models were performed using RevMan software 5.2 to gather the consequences. Heterogeneity was evaluated by Chi 2 test and the I 2 measure. Ten studies enrolling 3108 patients were included. The combined consequences indicated that both glaucoma and combined cataract and glaucoma surgery significantly decreased IOP. For deep sclerectomy vs deep sclerectomy plus phacoemulsification and canaloplasty vs phaco-canaloplasty, the differences in IOPR% were not all statistically significant while trabeculotomy was detected to gain a quantitatively greater IOPR% compared with trabeculotomy plus phacoemulsification. Furthermore, there was no statistical significance in the complete and qualified success rate, and the rates of adverse incidents for trabeculotomy vs trabeculotomy plus phacoemulsification. Compared with trabeculotomy plus phacoemulsification, trabeculectomy alone is more effective in lowering IOP and the number of glaucoma medications, while the two surgeries can not demonstrate statistical differences in the complete success rate, qualified success rate, or incidence of adverse incidents.

Safety of Prior Endoscopic Mucosal Resection in Patients Receiving Radiofrequency Ablation of Barrett’s Esophagus

PubMed Central

Okoro, Ngozi I.; Tomizawa, Yutaka; Dunagan, Kelly T.; Lutzke, Lori S.; Wang, Kenneth K.; Prasad, Ganapathy A.

2011-01-01

BACKGROUND & AIMS Radiofrequency ablation (RFA) is safe and effective treatment for flat dysplasia associated with Barrett’s esophagus (BE). However, there are limited data on the safety of RFA in patients who had prior endoscopic mucosal resection (EMR), which might increase the risk of complications. We compared complications and histologic outcomes between patients who had EMR before RFA and those who received only RFA. METHODS We performed a retrospective analysis of data collected from patients treated for BE, associated with dysplasia or intramucosal cancer, at the Mayo Clinic in Rochester, Minnesota, from 1998–2009. Patients were divided into groups that had RFA after EMR (group 1, n = 44) or only RFA (group 2, n = 46). We compared the incidence of complications (strictures, bleeding, and esophageal perforation) and histologic features (complete resolution of dysplasia and complete resolution of intestinal metaplasia [CR-IM]) between groups. Logistic regression analysis was performed to assess predictors of stricture formation. RESULTS Stricture rates were 14% in group 1 and 9% in group 2 (odds ratio, 1.53; 95% confidence interval [CI], 0.26 –9.74). The rates of CR-IM were 43% in group 1 and 74% in group 2 (odds ratio, 0.33; 95% CI, 0.14 – 0.78). The rates of complete resolution of dysplasia were 76% in group 1 and 71% in group 2 (odds ratio, 1.28; 95% CI, 0.39 – 4.17). The adjusted odds ratio for CR-IM in group 1 (adjusting for age, segment length, and grade of dysplasia) was 0.50 (95% CI, 0.15–1.66). CONCLUSIONS Stricture rates among patients who receive only RFA are comparable to those of patients who had prior EMR. EMR appears safe to perform prior to RFA. PMID:22056303

[Analysis of the safety culture in a Cardiology Unit managed by processes].

PubMed

Raso-Raso, Rafael; Uris-Selles, Joaquín; Nolasco-Bonmatí, Andreu; Grau-Jornet, Guillermo; Revert-Gandia, Rosa; Jiménez-Carreño, Rebeca; Sánchez-Soriano, Ruth M; Chamorro-Fernández, Carlos I; Marco-Francés, Elvira; Albero-Martínez, José V

2017-04-04

Safety culture is one of the requirements for preventing the occurrence of adverse effects. However, this has not been studied in the field of cardiology. The aim of this study is to evaluate the safety culture in a cardiology unit that has implemented and certified an integrated quality and risk management system for patient safety. A cross-sectional observational study was conducted in 2 consecutive years, with all staff completing the Spanish version of the questionnaire, "Hospital Survey on Patient Safety Culture" of the "Agency for Healthcare Research and Quality", with 42 items grouped into 12 dimensions. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. The overall assessment out of a possible 5, was 4.5 in 2014 and 4.7 in 2015. Seven dimensions were identified as strengths. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions compared to national data, and in 8 of them compared to American data. The safety culture in a Cardiology Unit with an integrated quality and risk management patient safety system is high, and higher than nationally in all its dimensions and in most of them compared to the United States. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

30 CFR 57.3200 - Correction of hazardous conditions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... permitted in the affected area. Until corrective work is completed, the area shall be posted with a warning... Section 57.3200 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 Ground...

46 CFR 160.016-5 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...

46 CFR 160.016-5 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...

46 CFR 160.016-5 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...

46 CFR 160.016-5 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...

Safety of High Speed Magnetic Levitation Transportation Systems - Comparison of U.S. and Foreign Safety Requirements for Application to U.S. Maglev Systems

DOT National Transportation Integrated Search

1993-09-01

This report presents the results of a systematic review of the safety requirements selected for the German Transrapid : electromagnetic (EMS) type maglev system to determine their applicability and completeness with respect to the : construction and ...

Flat-plate solar array project. Volume 6: Engineering sciences and reliability

NASA Technical Reports Server (NTRS)

Ross, R. G., Jr.; Smokler, M. I.

1986-01-01

The Flat-Plate Solar Array (FSA) Project activities directed at developing the engineering technology base required to achieve modules that meet the functional, safety, and reliability requirements of large scale terrestrial photovoltaic systems applications are reported. These activities included: (1) development of functional, safety, and reliability requirements for such applications; (2) development of the engineering analytical approaches, test techniques, and design solutions required to meet the requirements; (3) synthesis and procurement of candidate designs for test and evaluation; and (4) performance of extensive testing, evaluation, and failure analysis of define design shortfalls and, thus, areas requiring additional research and development. A summary of the approach and technical outcome of these activities are provided along with a complete bibliography of the published documentation covering the detailed accomplishments and technologies developed.

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.

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

Boyack, B.E.

The PIUS reactor utilizes simplified, inherent, passive, or other innovative means to accomplish safety functions. Accordingly, the PIUS reactor is subject to the requirements of 10CFR52.47(b)(2)(i)(A). This regulation requires that the applicant adequately demonstrate the performance of each safety feature, interdependent effects among the safety features, and a sufficient data base on the safety features of the design to assess the analytical tools used for safety analysis. Los Alamos has assessed the quality and completeness of the existing and planned data bases used by Asea Brown Boveri to validate its safety analysis codes and other relevant data bases. Only amore » limited data base of separate effect and integral tests exist at present. This data base is not adequate to fulfill the requirements of 10CFR52.47(b)(2)(i)(A). Asea Brown Boveri has stated that it plans to conduct more separate effect and integral test programs. If appropriately designed and conducted, these test programs have the potential to satisfy most of the data base requirements of 10CFR52.47(b)(2)(i)(A) and remedy most of the deficiencies of the currently existing combined data base. However, the most important physical processes in PIUS are related to reactor shutdown because the PIUS reactor does not contain rodded shutdown and control systems. For safety-related reactor shutdown, PIUS relies on negative reactivity insertions from the moderator temperature coefficient and from boron entering the core from the reactor pool. Asea Brown Boveri has neither developed a direct experimental data base for these important processes nor provided a rationale for indirect testing of these key PIUS processes. This is assessed as a significant shortcoming. In preparing the conclusions of this report, test documentation and results have been reviewed for only one integral test program, the small-scale integral tests conducted in the ATLE facility.« less

DairyBeef: maximizing quality and profits--a consistent food safety message.

PubMed

Moore, D A; Kirk, J H; Klingborg, D J; Garry, F; Wailes, W; Dalton, J; Busboom, J; Sams, R W; Poe, M; Payne, M; Marchello, J; Looper, M; Falk, D; Wright, T

2004-01-01

To respond to meat safety and quality issues in dairy market cattle, a collaborative project team for 7 western states was established to develop educational resources providing a consistent meat safety and quality message to dairy producers, farm advisors, and veterinarians. The team produced an educational website and CD-ROM course that included videos, narrated slide sets, and on-farm tools. The objectives of this course were: 1) to help producers and their advisors understand market cattle food safety and quality issues, 2) help maintain markets for these cows, and 3) help producers identify ways to improve the quality of dairy cattle going to slaughter. DairyBeef. Maximizing Quality & Profits consists of 6 sections, including 4 core segments. Successful completion of quizzes following each core segment is required for participants to receive a certificate of completion. A formative evaluation of the program revealed the necessity for minor content and technological changes with the web-based course. All evaluators considered the materials relevant to dairy producers. After editing, course availability was enabled in February, 2003. Between February and May, 2003, 21 individuals received certificates of completion.

Risk appraisal of passing zones on two-lane rural highways and policy applications.

PubMed

Mwesige, Godfrey; Farah, Haneen; Koutsopoulos, Haris N

2016-05-01

Passing on two-lane rural highways is associated with risks of head-on collision resulting from unsafe completion of passing maneuvers in the opposite traffic lane. In this paper, we explore the use of time-to-collision (TTC) as a surrogate safety measure of the risk associated with passing maneuvers. Logistic regression models to predict the probability to end the passing maneuver with TTC less than 2 or 3s-threshold were developed with the time-gap from initiation of the maneuver to arrival of the opposite vehicle (effective accepted gap), and the passing duration as explanatory variables. The data used for model estimation was collected using stationary tripod-mounted camcorders at 19 passing zones in Uganda. Results showed that passing maneuvers completed with TTC less than 3s are unsafe and often involved sudden speed reduction, flashing headlights, and lateral shift to shoulders. Model sensitivity analysis was conducted for observed passing durations involving passenger cars or short trucks (2-3 axles), and long trucks (4-7 axles) as the passed vehicles for 3s TTC-threshold. Three risk levels were proposed based on the probability to complete passing maneuvers with TTC less than 3s for a range of opposite direction traffic volumes. Applications of the results for safety improvements of two-lane rural highways are also discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cardiac rehabilitation and the therapeutic environment: the importance of physical, social, and symbolic safety for programme participation among women.

PubMed

Sutton, Erica J; Rolfe, Danielle E; Landry, Mireille; Sternberg, Leonard; Price, Jennifer A D

2012-08-01

To report an exploration of the multidimensionality of safety in cardiac rehabilitation programmes as perceived by women who were enrolled in the Women's Cardiovascular Health Initiative in Toronto, Canada. Cardiovascular disease is the leading cause of death among women. Although cardiac rehabilitation is clinically effective, significantly fewer women than men participate in available programmes. The literature identifies factors affecting women's cardiac rehabilitation participation, and provides possible explanations for this gender disparity. Although safety is mentioned among the barriers to women's cardiac rehabilitation participation, the extent to which safety contributes to programme participation, completion, and maintenance remains under-explored in the cardiac rehabilitation literature. We conducted an exploratory qualitative study to examine the role safety and place play for women engaged in cardiac prevention and rehabilitation at the Women's Cardiovascular Health Initiative. Methods.  From 2005-2006, 14 participants engaged in semi-structured, qualitative interviews lasting 30-90 minutes. Discussions addressed women's experiences at the Women's Cardiovascular Health Initiative. Interview transcripts were analysed using thematic analysis. Three themes were developed: 'Safety', which was sub-categorized according to physical, social, and symbolic interpretations of safety, 'searching for a sense of place', and 'confidence and empowerment'. Feeling physically, socially, and symbolically safe in one's cardiac rehabilitation environment may contribute to programme adherence and exercise maintenance for women. Focusing on comprehensive notions of safety in future cardiac rehabilitation research could offer insight into why many women do not maintain an exercise regimen in currently structured cardiac rehabilitation and community programmes. © 2012 Blackwell Publishing Ltd.

Workplace Bullying, Job Stress, Intent to Leave, and Nurses' Perceptions of Patient Safety in South Korean Hospitals.

PubMed

Oh, Hyunjin; Uhm, Dong-Choon; Yoon, Young Joo

2016-01-01

Negative work environments influence the ability of nurses to provide optimal patient care in a safe environment. The purpose of the study was to test a model linking workplace bullying (WPB) and lateral violence (LV) with job stress, intent to leave, and, subsequently, nurse-assessed patient adverse outcomes (safety issues). This descriptive-correlational study examined the relationships between study variables and used a structural equation model to test the validity of the proposed theoretical framework. A convenience sample of 508 clinical nurses working in eight general hospitals in Daejeon, South Korea, completed a questionnaire on measures of WPB, LV, job stress, intent to leave, and nurse-assessed patient safety. Analysis of moment structures was used to estimate a set of three models with competing measurement structures for WPB and LV and the same structural model. Akaike Information Criterion was used for model selection. Among the three proposed models, the model with complex factor loadings was selected (WPB and LV were both associated with verbal abuse and physical threat). WPB directly and indirectly influenced nurse-assessed patient safety. Job stress directly influenced intent to leave, and intent to leave directly influenced nurse-assessed patient safety. The results of the study support the proposition that WPB, job stress, and intent to leave may be associated with nurse-perceived adverse outcomes (patient safety issues) in hospitals. Nurse perceptions of WPB were associated with nurse-assessed patient safety outcomes (adverse events) directly and through mediating job stress and intent to leave. LV was not associated with the mediators or nurse-assessed adverse outcomes (safety).

Food Safety Instruction Improves Knowledge and Behavior Risk and Protection Factors for Foodborne Illnesses in Pregnant Populations.

PubMed

Kendall, Patricia; Scharff, Robert; Baker, Susan; LeJeune, Jeffrey; Sofos, John; Medeiros, Lydia

2017-08-01

Objective This study compared knowledge and food-handling behavior after pathogen-specific (experimental treatment) versus basic food safety instruction (active control) presented during nutrition education classes for low-income English- and Spanish-language pregnant women. Methods Subjects (n = 550) were randomly assigned to treatment groups in two different locations in the United States. Food safety instruction was part of an 8-lesson curriculum. Food safety knowledge and behavior were measured pre/post intervention. Descriptive data were analyzed by Chi-Square or ANOVA; changes after intervention were analyzed by regression analysis. Results Knowledge improved after intervention in the pathogen-specific treatment group compared to active control, especially among Spanish-language women. Behavior change after intervention for the pathogen-specific treatment group improved for thermometer usage, refrigeration and consumption of foods at high risk for safety; however, all other improvements in behavior were accounted for by intervention regardless of treatment group. As expected, higher pre-instruction behavioral competency limited potential gain in behavior post-instruction due to a ceiling effect. This effect was more dominant among English-language women. Improvements were also linked to formal education completed, a partner at home, and other children in the home. Conclusions for Practice This study demonstrated that pathogen-specific food safety instruction leads to enhance knowledge and food handling behaviors that may improve the public health of pregnant women and their unborn children, especially among Spanish-language women. More importantly, food safety instruction, even at the most basic level, benefited pregnant women's food safety knowledge and food-handling behavior after intervention.

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...

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID:21859470

Safety Assessment for the Kozloduy National Disposal Facility in Bulgaria - 13507

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

Biurrun, E.; Haverkamp, B.; Lazaro, A.

2013-07-01

Due to the early decommissioning of four Water-Water Energy Reactors (WWER) 440-V230 reactors at the Nuclear Power Plant (NPP) near the city of Kozloduy in Bulgaria, large amounts of low and intermediate radioactive waste will arise much earlier than initially scheduled. In or-der to manage the radioactive waste from the early decommissioning, Bulgaria has intensified its efforts to provide a near surface disposal facility at Radiana with the required capacity. To this end, a project was launched and assigned in international competition to a German-Spanish consortium to provide the complete technical planning including the preparation of the Intermediate Safety Assessmentmore » Report. Preliminary results of operational and long-term safety show compliance with the Bulgarian regulatory requirements. The long-term calculations carried out for the Radiana site are also a good example of how analysis of safety assessment results can be used for iterative improvements of the assessment by pointing out uncertainties and areas of future investigations to reduce such uncertainties in regard to the potential radiological impact. The computer model used to estimate the long-term evolution of the future repository at Radiana predicted a maximum total annual dose for members of the critical group, which is carried to approximately 80 % by C-14 for a specific ingestion pathway. Based on this result and the outcome of the sensitivity analysis, existing uncertainties were evaluated and areas for reasonable future investigations to reduce these uncertainties were identified. (authors)« less

Health economics and outcomes methods in risk-based decision-making for blood safety.

PubMed

Custer, Brian; Janssen, Mart P

2015-08-01

Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making. © 2015 AABB.

Impact of Distracted Driving on Safety and Traffic Flow

PubMed Central

Stavrinos, Despina; Jones, Jennifer L.; Garner, Annie A.; Griffin, Russell; Franklin, Crystal A.; Ball, David; Welburn, Sharon C.; Ball, Karlene K.; Sisiopiku, Virginia P.; Fine, Philip R.

2015-01-01

Studies have documented a link between distracted driving and diminished safety; however, an association between distracted driving and traffic congestion has not been investigated in depth. The present study examined the behavior of teens and young adults operating a driving simulator while engaged in various distractions (i.e., cell phone, texting, and undistracted) and driving conditions (i.e., free flow, stable flow, and oversaturation). Seventy five participants 16 to 25 years of age (split into 2 groups: novice drivers and young adults) drove a STISIM simulator three times, each time with one of three randomly presented distractions. Each drive was designed to represent daytime scenery on a 4 lane divided roadway and included three equal roadway portions representing Levels of Service (LOS) A, C, and E as defined in the 2000 Highway Capacity Manual. Participants also completed questionnaires documenting demographics and driving history. Both safety and traffic flow related driving outcomes were considered. A Repeated Measures Multivariate Analysis of Variance was employed to analyze continuous outcome variables and a Generalized Estimate Equation (GEE) poisson model was used to analyze count variables. Results revealed that, in general more lane deviations and crashes occurred during texting. Distraction (in most cases, text messaging) had a significantly negative impact on traffic flow, such that participants exhibited greater fluctuation in speed, changed lanes significantly fewer times, and took longer to complete the scenario. In turn, more simulated vehicles passed the participant drivers while they were texting or talking on a cell phone than while undistracted. The results indicate that distracted driving, particularly texting, may lead to reduced safety and traffic flow, thus having a negative impact on traffic operations. No significant differences were detected between age groups, suggesting that all drivers, regardless of age, may drive in a manner that impacts safety and traffic flow negatively when distracted. PMID:23465745

Impact of distracted driving on safety and traffic flow.

PubMed

Stavrinos, Despina; Jones, Jennifer L; Garner, Annie A; Griffin, Russell; Franklin, Crystal A; Ball, David; Welburn, Sharon C; Ball, Karlene K; Sisiopiku, Virginia P; Fine, Philip R

2013-12-01

Studies have documented a link between distracted driving and diminished safety; however, an association between distracted driving and traffic congestion has not been investigated in depth. The present study examined the behavior of teens and young adults operating a driving simulator while engaged in various distractions (i.e., cell phone, texting, and undistracted) and driving conditions (i.e., free flow, stable flow, and oversaturation). Seventy five participants 16-25 years of age (split into 2 groups: novice drivers and young adults) drove a STISIM simulator three times, each time with one of three randomly presented distractions. Each drive was designed to represent daytime scenery on a 4 lane divided roadway and included three equal roadway portions representing Levels of Service (LOS) A, C, and E as defined in the 2000 Highway Capacity Manual. Participants also completed questionnaires documenting demographics and driving history. Both safety and traffic flow related driving outcomes were considered. A Repeated Measures Multivariate Analysis of Variance was employed to analyze continuous outcome variables and a Generalized Estimate Equation (GEE) Poisson model was used to analyze count variables. Results revealed that, in general more lane deviations and crashes occurred during texting. Distraction (in most cases, text messaging) had a significantly negative impact on traffic flow, such that participants exhibited greater fluctuation in speed, changed lanes significantly fewer times, and took longer to complete the scenario. In turn, more simulated vehicles passed the participant drivers while they were texting or talking on a cell phone than while undistracted. The results indicate that distracted driving, particularly texting, may lead to reduced safety and traffic flow, thus having a negative impact on traffic operations. No significant differences were detected between age groups, suggesting that all drivers, regardless of age, may drive in a manner that impacts safety and traffic flow negatively when distracted. Copyright © 2013 Elsevier Ltd. All rights reserved.

A procedure for seismic risk reduction in Campania Region

NASA Astrophysics Data System (ADS)

Zuccaro, G.; Palmieri, M.; Maggiò, F.; Cicalese, S.; Grassi, V.; Rauci, M.

2008-07-01

The Campania Region has set and performed a peculiar procedure in the field of seismic risk reduction. Great attention has been paid to public strategic buildings such as town halls, civil protection buildings and schools. The Ordinance 3274 promulgate in the 2004 by the Italian central authority obliged the owners of strategic buildings to perform seismic analyses within 2008 in order to check the safety of the structures and the adequacy to the use. In the procedure the Campania region, instead of the local authorities, ensure the complete drafting of seismic checks through financial resources of the Italian Government. A regional scientific technical committee has been constituted, composed of scientific experts, academics in seismic engineering. The committee has drawn up guidelines for the processing of seismic analyses. At the same time, the Region has issued a public competition to select technical seismic engineering experts to appoint seismic analysis in accordance with guidelines. The scientific committee has the option of requiring additional documents and studies in order to approve the safety checks elaborated. The Committee is supported by a technical and administrative secretariat composed of a group of expert in seismic engineering. At the moment several seismic safety checks have been completed. The results will be presented in this paper. Moreover, the policy to mitigate the seismic risk, set by Campania region, was to spend the most of the financial resources available on structural strengthening of public strategic buildings rather than in safety checks. A first set of buildings of which the response under seismic action was already known by data and studies of vulnerability previously realised, were selected for immediate retrofitting designs. Secondly, an other set of buildings were identified for structural strengthening. These were selected by using the criteria specified in the Guide Line prepared by the Scientific Committee and based on data obtained by the first set of safety checks. The strengthening philosophy adopt in the projects will be described in the paper.

29 CFR 1952.222 - Completed developmental steps.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Completed developmental steps. 1952.222 Section 1952.222... Completed developmental steps. (a) In accordance with § 1952.223(b), the Tennessee Occupational Safety and..., as having completed all developmental steps specified in its plan as approved on June 28, 1973, on or...

School-based prevention program associated with increased short- and long-term retention of safety knowledge.

PubMed

Klas, Karla S; Vlahos, Peter G; McCully, Michael J; Piche, David R; Wang, Stewart C

2015-01-01

Validation of program effectiveness is essential in justifying school-based injury prevention education. Although Risk Watch (RW) targets burn, fire, and life safety, its effectiveness has not been previously evaluated in the medical literature. Between 2007 and 2012, a trained fire service public educator (FSPE) taught RW to all second grade students in one public school district. The curriculum was delivered in 30-minute segments for 9 consecutive weeks via presentations, a safety smoke house trailer, a model-sized hazard house, a student workbook, and parent letters. A written pre-test (PT) was given before RW started, a post-test (PT#1) was given immediately after RW, and a second post-test (PT#2) was administered to the same students the following school year (ranging from 12 to 13 months after PT). Students who did not complete the PT or at least one post-test were excluded. Comparisons were made by paired t-test, analysis of variance, and regression analysis. After 183 (8.7%) were excluded for missing tests, 1,926 remaining students scored significantly higher (P = .0001) on PT#1 (mean 14.8) and PT#2 (mean 14.7) than the PT (mean 12.1). There was 1 FSPE and 36 school teachers with class size ranging from 10 to 27 (mean 21.4). Class size was not predictive of test score improvement (R = 0%), while analysis of variance showed that individual teachers trended toward some influence. This 6-year prospective study demonstrated that the RW program delivered by an FSPE effectively increased short-term knowledge and long-term retention of fire/life safety in early elementary students. Collaborative partnerships are critical to preserving community injury prevention education programs.

Nurses' perceptions and problems in the usability of a medication safety app.

PubMed

Ankem, Kalyani; Cho, Sookyung; Simpson, Diana

2017-10-16

The majority of medication apps support medication adherence. Equally, if not more important, is medication safety. Few apps report on medication safety, and fewer studies have been conducted with these apps. The usability of a medication safety app was tested with nurses to reveal their perceptions of the graphical user interface and to discover problems they encountered in using the app. Usability testing of the app was conducted with RN-BSN students and informatics students (n = 18). Perceptions of the graphical components were gathered in pretest and posttest questionnaires, and video recordings of the usability testing were transcribed. The significance of the difference in mean performance time for 8 tasks was tested, and qualitative analysis was deployed to identify problems encountered and to rate the severity of each problem. While all participants perceived the graphical user interface as easy to understand, nurses took significantly more time to complete certain tasks. More nurses found the medication app to be lacking in intuitiveness of user interface design, in capability to match real-world data, and in providing optimal information architecture. To successfully integrate mobile devices in healthcare, developers must address the problems that nurses encountered in use of the app.

Correlation between safety assessments in the driver-car interaction design process.

PubMed

Broström, Robert; Bengtsson, Peter; Axelsson, Jakob

2011-05-01

With the functional revolution in modern cars, evaluation methods to be used in all phases of driver-car interaction design have gained importance. It is crucial for car manufacturers to discover and solve safety issues early in the interaction design process. A current problem is thus to find a correlation between the formative methods that are used during development and the summative methods that are used when the product has reached the customer. This paper investigates the correlation between efficiency metrics from summative and formative evaluations, where the results of two studies on sound and navigation system tasks are compared. The first, an analysis of the J.D. Power and Associates APEAL survey, consists of answers given by about two thousand customers. The second, an expert evaluation study, was done by six evaluators who assessed the layouts by task completion time, TLX and Nielsen heuristics. The results show a high degree of correlation between the studies in terms of task efficiency, i.e. between customer ratings and task completion time, and customer ratings and TLX. However, no correlation was observed between Nielsen heuristics and customer ratings, task completion time or TLX. The results of the studies introduce a possibility to develop a usability evaluation framework that includes both formative and summative approaches, as the results show a high degree of consistency between the different methodologies. Hence, combining a quantitative approach with the expert evaluation method, such as task completion time, should be more useful for driver-car interaction design. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Dynamic Analysis of Darrieus Vertical Axis Wind Turbine Rotors

NASA Technical Reports Server (NTRS)

Lobitz, D. W.

1981-01-01

The dynamic response characteristics of the vertical axis wind turbine (VAWT) rotor are important factors governing the safety and fatigue life of VAWT systems. The principal problems are the determination of critical rotor speeds (resonances) and the assessment of forced vibration response amplitudes. The solution to these problems is complicated by centrifugal and Coriolis effects which can have substantial influence on rotor resonant frequencies and mode shapes. The primary tools now in use for rotor analysis are described and discussed. These tools include a lumped spring mass model (VAWTDYN) and also finite-element based approaches. The accuracy and completeness of current capabilities are also discussed.

Psychometric properties of the Norwegian version of the Safety Attitudes Questionnaire (SAQ), Generic version (Short Form 2006).

PubMed

Deilkås, Ellen T; Hofoss, Dag

2008-09-22

How to protect patients from harm is a question of universal interest. Measuring and improving safety culture in care giving units is an important strategy for promoting a safe environment for patients. The Safety Attitudes Questionnaire (SAQ) is the only instrument that measures safety culture in a way which correlates with patient outcome. We have translated the SAQ to Norwegian and validated the translated version. The psychometric properties of the translated questionnaire are presented in this article. The questionnaire was translated with the back translation technique and tested in 47 clinical units in a Norwegian university hospital. SAQ's (the Generic version (Short Form 2006) the version with the two sets of questions on perceptions of management: on unit management and on hospital management) were distributed to 1911 frontline staff. 762 were distributed during unit meetings and 1149 through the postal system. Cronbach alphas, item-to-own correlations, and test-retest correlations were calculated, and response distribution analysis and confirmatory factor analysis were performed, as well as early validity tests. 1306 staff members completed and returned the questionnaire: a response rate of 68%. Questionnaire acceptability was good. The reliability measures were acceptable. The factor structure of the responses was tested by confirmatory factor analysis. 36 items were ascribed to seven underlying factors: Teamwork Climate, Safety Climate, Stress Recognition, Perceptions of Hospital Management, Perceptions of Unit Management, Working conditions, and Job satisfaction. Goodness-of-Fit Indices showed reasonable, but not indisputable, model fit. External validity indicators - recognizability of results, correlations with "trigger tool"-identified adverse events, with patient satisfaction with hospitalization, patient reports of possible maltreatment, and patient evaluation of organization of hospital work - provided preliminary validation. Based on the data from Akershus University Hospital, we conclude that the Norwegian translation of the SAQ showed satisfactory internal psychometric properties. With data from one hospital only, we cannot draw strong conclusions on its external validity. Further validation studies linking the SAQ-scores to patient outcome data should be performed.

Clinical trial of an inhibitor of RAGE-Aβ interactions in Alzheimer disease.

PubMed

Galasko, Douglas; Bell, Joanne; Mancuso, Jessica Y; Kupiec, James W; Sabbagh, Marwan N; van Dyck, Christopher; Thomas, Ronald G; Aisen, Paul S

2014-04-29

To examine safety, tolerability, and efficacy of PF-04494700, an inhibitor of the receptor for advanced glycation end products (RAGE), in mild to moderate Alzheimer disease (AD). Double-blind, placebo-controlled trial at 40 academic centers (United States). Subjects with AD and Mini-Mental State Examination score 14-26 were randomized to PF-04494700 60 mg/day × 6 days, then 20 mg daily (high dose); 15 mg/day × 6 days, then 5 mg daily (low dose); or placebo, for 18 months. Clinical and laboratory measures were used to evaluate safety and tolerability. The primary efficacy measure was the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog). Secondary measures assessed clinical stage, function, behavior, MRI, and CSF biomarkers. A total of 399 subjects were randomized. In a prespecified interim analysis, when 50% of subjects had completed the 6-month visit, the high dose was associated with confusion, falls, and greater ADAS-cog decline and was discontinued. A second prespecified analysis compared low-dose and placebo groups for futility and safety approximately 12 months after all subjects were randomized. This analysis met criteria for futility, and treatment was discontinued. There were no safety concerns in the low-dose group. Analyses including post-futility data showed decreased decline on the ADAS-cog in the low-dose group at month 18. Other clinical and biomarker measures showed no differences between low-dose treatment and placebo. PF-04494700 at 20 mg/d was associated with increased adverse events and cognitive decline. At 5 mg/d, PF-04494700 had a good safety profile. A potential benefit for this low dose on the ADAS-cog is not conclusive, because of high dropout and discontinuation rates subsequent to the interim analyses. This study provides Class I evidence that in patients with AD high-dose PF-04494700 increased cognitive decline at 6 months and Class IV evidence that low-dose PF-04494700 slowed cognitive decline at 18 months.

Patient safety culture in China: a case study in an outpatient setting in Beijing.

PubMed

Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

2014-07-01

To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of 'communication openness' was identified as a major safety culture problem, and a perception of 'penalty' was the greatest barrier to the encouragement of error reporting. Cohesive 'teamwork within units', while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong 'teamwork within units', a common area of strength, could fuel the concealment of errors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

Safety of clinical and non-clinical decision makers in telephone triage: a narrative review.

PubMed

Wheeler, Sheila Q; Greenberg, Mary E; Mahlmeister, Laura; Wolfe, Nicole

2015-09-01

Patient safety is a persistent problem in telephone triage research; however, studies have not differentiated between clinicians' and non-clinicians' respective safety. Currently, four groups of decision makers perform aspects of telephone triage: clinicians (physicians, nurses), and non-clinicians (emergency medical dispatchers (EMD) and clerical staff). Using studies published between 2002-2012, we applied Donabedian's structure-process-outcome model to examine groups' systems for evidence of system completeness (a minimum measure of structure and quality). We defined system completeness as the presence of a decision maker and four additional components: guidelines, documentation, training, and standards. Defining safety as appropriate referrals (AR) - (right time, right place with the right person), we measured each groups' corresponding AR rate percentages (outcomes). We analyzed each group's respective decision-making process as a safe match to the telephone triage task, based on each group's system structure completeness, process and AR rates (outcome). Studies uniformly noted system component presence: nurses (2-4), physicians (1), EMDs (2), clerical staff (1). Nurses had the highest average appropriate referral (AR) rates (91%), physicians' AR (82% average). Clerical staff had no system and did not perform telephone triage by standard definitions; EMDs may represent the use of the wrong system. Telephone triage appears least safe after hours when decision makers with the least complete systems (physicians, clerical staff) typically manage calls. At minimum, telephone triage decision makers should be clinicians; however, clinicians' safety calls for improvement. With improved training, standards and CDSS quality, the 24/7 clinical call center has potential to represent the national standard. © The Author(s) 2015.

29 CFR 1952.162 - Completion of developmental steps and certification.

Code of Federal Regulations, 2011 CFR

2011-07-01

... occupational safety and health issues specified in the plan on or before July 20, 1976. (n) Amendment to....162 Section 1952.162 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...) In accordance with the requirements of § 1952.163(b), the Iowa Occupational Safety and Health Act of...

76 FR 33641 - Safety Zone; The Pacific Grove Feast of Lanterns, Fireworks Display, Pacific Grove, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-09

... ensure the safety of participants and spectators from the dangers associated with the pyrotechnics... completed. Because of the dangers posed by the pyrotechnics used in these fireworks displays, the safety... property from the hazards associated with the pyrotechnics over the water. The Coast Guard has granted the...

The Development of a Vocational Safety Guide for Missouri's Practitioners. Final Report.

ERIC Educational Resources Information Center

Dyrenfurth, Michael; Linhardt, Richard

A project was conducted to develop a comprehensive vocational education safety guide for local administrators and teachers. To generate the guide, the following steps were completed: (1) a review of key related research, literature, and federal and state legislation, including vocational safety guides from 18 states; reference material from the…

29 CFR 1952.124 - Completion of developmental steps and certification.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements of § 1952.123(a) the Washington Industrial Safety and Health Act of 1973, hereinafter referred to....124 Section 1952.124 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... upgrading of salaries of safety personnel. (h) In accordance with § 1952.123(c) Washington has adopted rules...

29 CFR 1952.124 - Completion of developmental steps and certification.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements of § 1952.123(a) the Washington Industrial Safety and Health Act of 1973, hereinafter referred to....124 Section 1952.124 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... upgrading of salaries of safety personnel. (h) In accordance with § 1952.123(c) Washington has adopted rules...

29 CFR 1952.124 - Completion of developmental steps and certification.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements of § 1952.123(a) the Washington Industrial Safety and Health Act of 1973, hereinafter referred to....124 Section 1952.124 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... upgrading of salaries of safety personnel. (h) In accordance with § 1952.123(c) Washington has adopted rules...

78 FR 67326 - Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... 1625-AC05 Safety and Environmental Management System Requirements for Vessels on the U.S. Outer... ``Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental Shelf... of industry to ensure stakeholders have adequate time to submit complete responses. DATES: Comments...

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...

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

Food safety educational intervention positively influences college students' food safety attitudes, beliefs, knowledge, and self-reported practices.

PubMed

Yarrow, Linda; Remig, Valentina M; Higgins, Mary Meck

2009-01-01

In this study, the authors evaluated college students' food safety attitudes, beliefs, knowledge, and self-reported practices and explored whether these variables were positively influenced by educational intervention. Students (n=59), were mostly seniors, health or non-health majors, and responsible for meal preparation. Subjects completed a food safety questionnaire (FSQ) prior to educational intervention, which consisted of three interactive modules. Subjects completed module pre-, post-, and post-posttests. The FSQ was also administered after exposure to intervention and five weeks later to determine changes in food safety attitudes, beliefs, knowledge, and self-reported practices. Students' FSQ attitude scores increased from 114 to 122 (p < or = .001); FSQ belief and knowledge scores improved from 86 to 98 (p < or = .001) and from 11 to 13 (p < or = .001), respectively. Food safety knowledge was also measured by module pre- and posttests, and improved significantly after intervention for all students, with health majors having the greatest increase. Intervention resulted in improved food safety self-reported practices for health majors only. The educational intervention appeared effective in improving food safety beliefs and knowledge. For health majors, attitudes and some self-reported practices improved. For all areas, the strongest effects were seen in health majors.

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

Brunett, A. J.; Fei, T.; Strons, P. S.

The Transient Reactor Test Facility (TREAT), located at Idaho National Laboratory (INL), is a test facility designed to evaluate the performance of reactor fuels and materials under transient accident conditions. The facility, an air-cooled, graphite-moderated reactor designed to utilize fuel containing high-enriched uranium (HEU), has been in non-operational standby status since 1994. Currently, in support of the missions of the Department of Energy (DOE) National Nuclear Security Administration (NNSA) Material Management and Minimization (M3) Reactor Conversion Program, a new core design is being developed for TREAT that will utilize low-enriched uranium (LEU). The primary objective of this conversion effort ismore » to design an LEU core that is capable of meeting the performance characteristics of the existing HEU core. Minimal, if any, changes are anticipated for the supporting systems (e.g. reactor trip system, filtration/cooling system, etc.); therefore, the LEU core must also be able to function with the existing supporting systems, and must also satisfy acceptable safety limits. In support of the LEU conversion effort, a range of ancillary safety analyses are required to evaluate the LEU core operation relative to that of the existing facility. These analyses cover neutronics, shielding, and thermal hydraulic topics that have been identified as having the potential to have reduced safety margins due to conversion to LEU fuel, or are required to support the required safety analyses documentation. The majority of these ancillary tasks have been identified in [1] and [2]. The purpose of this report is to document the ancillary safety analyses that have been performed at Argonne National Laboratory during the early stages of the LEU design effort, and to describe ongoing and anticipated analyses. For all analyses presented in this report, methodologies are utilized that are consistent with, or improved from, those used in analyses for the HEU Final Safety Analysis Report (FSAR) [3]. Depending on the availability of historical data derived from HEU TREAT operation, results calculated for the LEU core are compared to measurements obtained from HEU TREAT operation. While all analyses in this report are largely considered complete and have been reviewed for technical content, it is important to note that all topics will be revisited once the LEU design approaches its final stages of maturity. For most safety significant issues, it is expected that the analyses presented here will be bounding, but additional calculations will be performed as necessary to support safety analyses and safety documentation. It should also be noted that these analyses were completed as the LEU design evolved, and therefore utilized different LEU reference designs. Preliminary shielding, neutronic, and thermal hydraulic analyses have been completed and have generally demonstrated that the various LEU core designs will satisfy existing safety limits and standards also satisfied by the existing HEU core. These analyses include the assessment of the dose rate in the hodoscope room, near a loaded fuel transfer cask, above the fuel storage area, and near the HEPA filters. The potential change in the concentration of tramp uranium and change in neutron flux reaching instrumentation has also been assessed. Safety-significant thermal hydraulic items addressed in this report include thermally-induced mechanical distortion of the grid plate, and heating in the radial reflector.« less

Impact of a community based fire prevention intervention on fire safety knowledge and behavior in elementary school children

PubMed Central

Hwang, V; Duchossois, G P; Garcia‐Espana, J F; Durbin, D R

2006-01-01

The objective of this study was to determine the impact of a community based fire prevention intervention directed only to parents on the fire safety knowledge and behavior in elementary school children. This was a prospective, quasi‐randomized controlled study in which third and fourth grade students from two elementary schools in an urban, poor, minority community completed knowledge/behavior surveys at baseline and following completion of the intervention. The intervention group received an in‐home visit from fire department personnel who installed free lithium smoke detectors and provided a fire escape plan. After accounting for a small difference in baseline summary scores of knowledge and behavior between the control and intervention groups, this study found a modest improvement in fire safety behavior among children whose families received a fire prevention intervention reflecting a change in household fire safety practices. However, there was no significant change in fire safety knowledge. PMID:17018679

Defining near misses: towards a sharpened definition based on empirical data about error handling processes.

PubMed

Kessels-Habraken, Marieke; Van der Schaaf, Tjerk; De Jonge, Jan; Rutte, Christel

2010-05-01

Medical errors in health care still occur frequently. Unfortunately, errors cannot be completely prevented and 100% safety can never be achieved. Therefore, in addition to error reduction strategies, health care organisations could also implement strategies that promote timely error detection and correction. Reporting and analysis of so-called near misses - usually defined as incidents without adverse consequences for patients - are necessary to gather information about successful error recovery mechanisms. This study establishes the need for a clearer and more consistent definition of near misses to enable large-scale reporting and analysis in order to obtain such information. Qualitative incident reports and interviews were collected on four units of two Dutch general hospitals. Analysis of the 143 accompanying error handling processes demonstrated that different incident types each provide unique information about error handling. Specifically, error handling processes underlying incidents that did not reach the patient differed significantly from those of incidents that reached the patient, irrespective of harm, because of successful countermeasures that had been taken after error detection. We put forward two possible definitions of near misses and argue that, from a practical point of view, the optimal definition may be contingent on organisational context. Both proposed definitions could yield large-scale reporting of near misses. Subsequent analysis could enable health care organisations to improve the safety and quality of care proactively by (1) eliminating failure factors before real accidents occur, (2) enhancing their ability to intercept errors in time, and (3) improving their safety culture. Copyright 2010 Elsevier Ltd. All rights reserved.

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of the system to be built. Shortly thereafter, as the system requirements are being defined, the second iteration of hazard analyses takes place, the systems hazard analysis (SHA). During the systems requirements phase, decisions are made as to what functions of the system will be the responsibility of software. This is the most critical time to affect the safety of the software. From this point, software safety analyses as well as software engineering practices are the main focus for assuring safe software. While many of the steps proposed in this paper seem like just sound engineering practices, they are the best technical and most cost effective means to assure safe software within a safe system.

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.

PubMed

Mazzaglia, Giampiero; Straus, Sabine M J; Arlett, Peter; da Silva, Daniela; Janssen, Heidi; Raine, June; Alteri, Enrica

2018-02-01

Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation. Information was obtained from risk management plans, study protocols, clinical study reports, and assessment reports of 157 medicinal products authorized for cardiovascular, endocrinology, and metabolic indications. We selected observational studies measuring, as outcomes of interest, the relationship between the RMMs in place and (1) implementation measures, such as clinical knowledge or physicians` compliance to recommendations contained in the RMMs; and (2) occurrence or reduced severity of the adverse drug reactions for which the RMMs were required. Of 59 eligible studies (24 completed, 35 ongoing), 44 assessed implementation measures, whereas only 15 assessed safety outcomes (1 study as a single endpoint and 14 studies with other endpoints). Fifty-one studies used non-experimental designs and 25 studies employed electronic healthcare databases for analysis. Of the 24 completed studies, 17 were considered satisfactory and supported immediate regulatory decision making, 6 were considered inconclusive and required new evaluations, and 1 was terminated early because new safety restrictions were required, thereby necessitating a new evaluation. Compliance with agreed deadlines was considered acceptable in 21 of 24 completed studies; the average time for a submission was 37 months (standard deviation ± 17), with differences observed by type of data source employed. Three important gaps in the evaluation plans of RMMs were identified: lack of early feedback on implementation, limited evaluation of safety outcomes, and inability to provide information on the effectiveness from an integrated measurement of different elements of a set of risk minimization tools. More robust evidence is needed to advance regulatory science and support more rapid adjustment of risk minimization strategies as needed.

An Examination of Safety Management Systems and Aviation Technologies in the Helicopter Emergency Medical Services Industry

NASA Astrophysics Data System (ADS)

Buckner, Steven A.

The Helicopter Emergency Medical Service (HEMS) industry has a significant role in the transportation of injured patients, but has experienced more accidents than all other segments of the aviation industry combined. With the objective of addressing this discrepancy, this study assesses the effect of safety management systems implementation and aviation technologies utilization on the reduction of HEMS accident rates. Participating were 147 pilots from Federal Aviation Regulations Part 135 HEMS operators, who completed a survey questionnaire based on the Safety Culture and Safety Management System Survey (SCSMSS). The study assessed the predictor value of SMS implementation and aviation technologies to the frequency of HEMS accident rates with correlation and multiple linear regression. The correlation analysis identified three significant positive relationships. HEMS years of experience had a high significant positive relationship with accident rate (r=.90; p<.05); SMS had a moderate significant positive relationship to Night Vision Goggles (NVG) (r=.38; p<.05); and SMS had a slight significant positive relationship with Terrain Avoidance Warning System (TAWS) (r=.234; p<.05). Multiple regression analysis suggested that when combined with NVG, TAWS, and SMS, HEMS years of experience explained 81.4% of the variance in accident rate scores (p<.05), and HEMS years of experience was found to be a significant predictor of accident rates (p<.05). Additional quantitative regression analysis was recommended to replicate the results of this study and to consider the influence of these variables for continued reduction of HEMS accidents, and to induce execution of SMS and aviation technologies from a systems engineering application. Recommendations for practice included the adoption of existing regulatory guidance for a SMS program. A qualitative analysis was also recommended for future study SMS implementation and HEMS accident rate from the pilot's perspective. A quantitative longitudinal study would further explore inferential relationships between the study variables. Current strategies should include the increased utilization of available aviation technology resources as this proactive stance may be beneficial for the establishment of an effective safety culture within the HEMS industry.

Technical/commercial feasibility study of the production of fuel-grade ethanol from corn: 100-million-gallon-per-year production facility in Myrtle Grove, Louisiana

NASA Astrophysics Data System (ADS)

1982-05-01

The technical and economic feasibility of producing motor fuel alcohol from corn in a 100 million gallon per year plant to be constructed in Myrtle Grove, Louisiana is evaluated. The evaluation includes a detailed process design using proven technology, a capital cost estimate for the plant, a detailed analysis of the annual operating cost, a market study, a socioeconomic, environmental, health and safety analysis, and a complete financial analysis. Several other considerations for production of ethanol were evaluated including: cogeneration and fuel to be used in firing the boilers; single by-products vs. multiple by-products; and use of boiler flue gas for by-product drying.

MO-F-16A-04: Case Study: Estimation of Peak Skin Dose Following a Physician Reported “High Dose” Case and Sentinel Event Considerations

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

Supanich, M; Chu, J; Wehmeyer, A

2014-06-15

Purpose: This work offers as a teaching example a reported high dose fluoroscopy case and the workflow the institution followed to self-report a radiation overdose sentinel event to the Joint Commission. Methods: Following the completion of a clinical case in a hybrid OR room with a reported air kerma of >18 Gy at the Interventional Reference Point (IRP) the physicians involved in the case referred study to the institution's Radiation Safety Committee (RSC) for review. The RSC assigned a Diagnostic Medical Physicist (DMP) to estimate the patient's Peak Skin Dose (PSD) and analyze the case. Following the DMP's analysis andmore » estimate of a PSD of >15 Gy the institution's adverse event committee was convened to discuss the case and to self-report the case as a radiation overdose sentinel event to the Joint Commission. The committee assigned a subgroup to perform the root cause analysis and develop institutional responses to the event. Results: The self-reporting of the sentinel event and the associated root cause analysis resulted in several institutional action items that are designed to improve process and safety. A formal reporting and analysis mechanism was adopted to review fluoroscopy cases with air kerma greater than 6 Gy at the IRP. An improved and formalized radiation safety training program for physicians using fluoroscopy equipment was implemented. Additionally efforts already under way to monitor radiation exposure in the Radiology department were expanded to include all fluoroscopy equipment capable of automated dose reporting. Conclusion: The adverse event review process and the root cause analysis following the self-reporting of the sentinel event resulted in policies and procedures that are expected to improve the quality and safe usage of fluoroscopy throughout the institution.« less

77 FR 40947 - Motor Carrier Safety Advisory Committee (MCSAC): Membership Solicitation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

.... Shannon L. Watson, Senior Advisor to the Associate Administrator for Policy, Federal Motor Carrier Safety....fmcsa.dot.gov/ , completed on-line and emailed to Shannon L. Watson, Senior Advisor to the Associate...

Radiation Safety System for SPIDER Neutral Beam Accelerator

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

Sandri, S.; Poggi, C.; Coniglio, A.

2011-12-13

SPIDER (Source for Production of Ion of Deuterium Extracted from RF Plasma only) and MITICA (Megavolt ITER Injector Concept Advanced) are the ITER neutral beam injector (NBI) testing facilities of the PRIMA (Padova Research Injector Megavolt Accelerated) Center. Both injectors accelerate negative deuterium ions with a maximum energy of 1 MeV for MITICA and 100 keV for SPIDER with a maximum beam current of 40 A for both experiments. The SPIDER facility is classified in Italy as a particle accelerator. At present, the design of the radiation safety system for the facility has been completed and the relevant reports havemore » been presented to the Italian regulatory authorities. Before SPIDER can operate, approval must be obtained from the Italian Regulatory Authority Board (IRAB) following a detailed licensing process. In the present work, the main project information and criteria for the SPIDER injector source are reported together with the analysis of hypothetical accidental situations and safety issues considerations. Neutron and photon nuclear analysis is presented, along with special shielding solutions designed to meet Italian regulatory dose limits. The contribution of activated corrosion products (ACP) to external exposure of workers has also been assessed. Nuclear analysis indicates that the photon contribution to worker external exposure is negligible, and the neutron dose can be considered by far the main radiation protection issue. Our results confirm that the injector has no important radiological impact on the population living around the facility.« less

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...

Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

PubMed

Lee, Eunjoo

2016-09-01

This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. 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.

A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

PubMed Central

Daud-Gallotti, Renata Mahfuz; Morinaga, Christian Valle; Arlindo-Rodrigues, Marcelo; Velasco, Irineu Tadeu; Arruda Martins, Milton; Tiberio, Iolanda Calvo

2011-01-01

INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59±1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54) offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical student clerkship. PMID:21876976

Impact of the time-out process on safety attitude in a tertiary neurosurgical department.

PubMed

McLaughlin, Nancy; Winograd, Deborah; Chung, Hallie R; Van de Wiele, Barbara; Martin, Neil A

2014-11-01

In July 2011, the UCLA Health System released its current time-out process protocol used across the Health System. Numerous interventions were performed to improve checklist completion and time-out process observance. This study assessed the impact of the current protocol for the time-out on healthcare providers' safety attitude and operating room safety climate. All members involved in neurosurgical procedures in the main operating room of the Ronald Reagan UCLA Medical Center were asked to anonymously complete an online survey on their overall perception of the time-out process. The survey was completed by 93 of 128 members of the surgical team. Overall, 98.9% felt that performing a pre-incision time-out improves patient safety. The majority of respondents (97.8%) felt that the team member introductions helped to promote a team spirit during the case. In addition, 93.5% felt that performing a time-out helped to ensure all team members were comfortable to voice safety concerns throughout the case. All respondents felt that the attending surgeon should be present during the time-out and 76.3% felt that he/she should lead the time-out. Unanimously, it was felt that the review of anticipated critical elements by the attending surgeon was helpful to respondents' role during the case. Responses revealed that although the time-out brings the team together physically, it does not necessarily reinforce teamwork. The time-out process favorably impacted team members' safety attitudes and perception as well as overall safety climate in neurosurgical ORs. Survey responses identified leadership training and teamwork training as two avenues for future improvement. Copyright © 2014 Elsevier Inc. All rights reserved.

Getting a Fresh Perspective on School Safety Audits

ERIC Educational Resources Information Center

Folks, Kenneth H.; Hirth, Marilyn A.

2009-01-01

For most people, a safety audit entails the completion of a long list of very routine, relatively mundane tasks because someone, somewhere, thought it was important. They usually comply grudgingly because it is yet another duty that has been added to their already full plate. Safety audits are usually required by insurance companies or some other…

Development of an Evaluation Tool for Online Food Safety Training Programs

ERIC Educational Resources Information Center

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

2011-01-01

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

75 FR 81464 - Safety Zone; Columbia River, The Dalles Lock and Dam

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

...-AA00 Safety Zone; Columbia River, The Dalles Lock and Dam AGENCY: Coast Guard, DHS. ACTION: Temporary... Columbia River in the vicinity of The Dalles Lock and Dam while the Army Corps of Engineers completes...; Columbia River, The Dalles Lock and Dam (a) Location. The following is a safety zone: All waters of the...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

75 FR 61354 - Safety Zone; Interstate 5 Bridge Repairs, Columbia River, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...-AA00 Safety Zone; Interstate 5 Bridge Repairs, Columbia River, Portland, OR AGENCY: Coast Guard, DHS... waters of the Columbia River due to repairs being made to the Interstate 5 Bridge. The safety zone is... would be contrary to public interest since the repairs to the Interstate 5 Bridge would be completed by...

29 CFR 1926.1410 - Power line safety (all voltages)-equipment operations closer than the Table A zone.

Code of Federal Regulations, 2011 CFR

2011-07-01

... accessories) to a complete stop; wind conditions; degree of sway in the power line; lighting conditions, and... 29 Labor 8 2011-07-01 2011-07-01 false Power line safety (all voltages)-equipment operations... FOR CONSTRUCTION Cranes and Derricks in Construction § 1926.1410 Power line safety (all voltages...

Work and Health among Latina Mothers in Farmworker Families

PubMed Central

Arcury, Thomas A.; Trejo, Grisel; Suerken, Cynthia K.; Grzywacz, Joseph G.; Ip, Edward H.; Quandt, Sara A.

2014-01-01

Background Work organization is important for the health of vulnerable workers, particularly women. This analysis describes work organization for Latinas in farmworker families and delineates the associations of work organization with health indicators. Methods 220 Latino women in farmworker families completed interviews from October 2012 - July 2013. Interviews addressed job structure, job demand, job control, and job support. Health measures included stress, depressive symptoms, physical activity, family conflict, and family economic security. Results Three-fifths of the women were employed. Several work organization dimensions, including shift, psychological demand, work safety climate, and benefits, were associated with participant health as expected, based on the work organization and job demands-control-support models. Conclusions Research should address women's health and specific work responsibilities. Occupational safety policy must consider the importance of work organization in the health of vulnerable workers. PMID:25742536

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...

Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

PubMed

Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

2014-01-10

The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

The influence of health policy and market factors on the hospital safety net.

PubMed

Bazzoli, Gloria J; Lindrooth, Richard C; Kang, Ray; Hasnain-Wynia, Romana

2006-08-01

To examine how the financial pressures resulting from the Balanced Budget Act (BBA) of 1997 interacted with private sector pressures to affect indigent care provision. American Hospital Association Annual Survey, Area Resource File, InterStudy Health Maintenance Organization files, Current Population Survey, and Bureau of Primary Health Care data. We distinguished core and voluntary safety net hospitals in our analysis. Core safety net hospitals provide a large share of uncompensated care in their markets and have large indigent care patient mix. Voluntary safety net hospitals provide substantial indigent care but less so than core hospitals. We examined the effect of financial pressure in the initial year of the 1997 BBA on uncompensated care for three hospital groups. Data for 1996-2000 were analyzed using approaches that control for hospital and market heterogeneity. All urban U.S. general acute care hospitals with complete data for at least 2 years between 1996 and 2000, which totaled 1,693 institutions. Core safety net hospitals reduced their uncompensated care in response to Medicaid financial pressure. Voluntary safety net hospitals also responded in this way but only when faced with the combined forces of Medicaid and private sector payment pressures. Nonsafety net hospitals did not exhibit similar responses. Our results are consistent with theories of hospital behavior when institutions face reductions in payment. They raise concern given continuing state budget crises plus the focus of recent federal deficit reduction legislation intended to cut Medicaid expenditures.

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

PubMed

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

2018-04-01

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

Advancing perinatal patient safety through application of safety science principles using health IT.

PubMed

Webb, Jennifer; Sorensen, Asta; Sommerness, Samantha; Lasater, Beth; Mistry, Kamila; Kahwati, Leila

2017-12-19

The use of health information technology (IT) has been shown to promote patient safety in Labor and Delivery (L&D) units. The use of health IT to apply safety science principles (e.g., standardization) to L&D unit processes may further advance perinatal safety. Semi-structured interviews were conducted with L&D units participating in the Agency for Healthcare Research and Quality's (AHRQ's) Safety Program for Perinatal Care (SPPC) to assess units' experience with program implementation. Analysis of interview transcripts was used to characterize the process and experience of using health IT for applying safety science principles to L&D unit processes. Forty-six L&D units from 10 states completed participation in SPPC program implementation; thirty-two (70%) reported the use of health IT as an enabling strategy for their local implementation. Health IT was used to improve standardization of processes, use of independent checks, and to facilitate learning from defects. L&D units standardized care processes through use of electronic health record (EHR)-based order sets and use of smart pumps and other technology to improve medication safety. Units also standardized EHR documentation, particularly related to electronic fetal monitoring (EFM) and shoulder dystocia. Cognitive aids and tools were integrated into EHR and care workflows to create independent checks such as checklists, risk assessments, and communication handoff tools. Units also used data from EHRs to monitor processes of care to learn from defects. Units experienced several challenges incorporating health IT, including obtaining organization approval, working with their busy IT departments, and retrieving standardized data from health IT systems. Use of health IT played an integral part in the planning and implementation of SPPC for participating L&D units. Use of health IT is an encouraging approach for incorporating safety science principles into care to improve perinatal safety and should be incorporated into materials to facilitate the implementation of perinatal safety initiatives.

NASA Software Safety Standard

NASA Technical Reports Server (NTRS)

Rosenberg, Linda

1997-01-01

If software is a critical element in a safety critical system, it is imperative to implement a systematic approach to software safety as an integral part of the overall system safety programs. The NASA-STD-8719.13A, "NASA Software Safety Standard", describes the activities necessary to ensure that safety is designed into software that is acquired or developed by NASA, and that safety is maintained throughout the software life cycle. A PDF version, is available on the WWW from Lewis. A Guidebook that will assist in the implementation of the requirements in the Safety Standard is under development at the Lewis Research Center (LeRC). After completion, it will also be available on the WWW from Lewis.

Study Gives Good Odds on Nuclear Reactor Safety

ERIC Educational Resources Information Center

Russell, Cristine

1974-01-01

Summarized is data from a recent study on nuclear reactor safety completed by Norman C. Rasmussen and others. Non-nuclear events are about 10,000 times more likely to produce large accidents than nuclear plants. (RH)

Offsite radiological consequence analysis for the bounding flammable gas accident

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

CARRO, C.A.

2003-03-19

The purpose of this analysis is to calculate the offsite radiological consequence of the bounding flammable gas accident. DOE-STD-3009-94, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'', requires the formal quantification of a limited subset of accidents representing a complete set of bounding conditions. The results of these analyses are then evaluated to determine if they challenge the DOE-STD-3009-94, Appendix A, ''Evaluation Guideline,'' of 25 rem total effective dose equivalent in order to identify and evaluate safety class structures, systems, and components. The bounding flammable gas accident is a detonation in a single-shell tank (SST).more » A detonation versus a deflagration was selected for analysis because the faster flame speed of a detonation can potentially result in a larger release of respirable material. As will be shown, the consequences of a detonation in either an SST or a double-shell tank (DST) are approximately equal. A detonation in an SST was selected as the bounding condition because the estimated respirable release masses are the same and because the doses per unit quantity of waste inhaled are generally greater for SSTs than for DSTs. Appendix A contains a DST analysis for comparison purposes.« less

Bacterial Diversity Analysis during the Fermentation Processing of Traditional Chinese Yellow Rice Wine Revealed by 16S rDNA 454 Pyrosequencing.

PubMed

Fang, Ruo-si; Dong, Ya-chen; Chen, Feng; Chen, Qi-he

2015-10-01

Rice wine is a traditional Chinese fermented alcohol drink. Spontaneous fermentation with the use of the Chinese starter and wheat Qu lead to the growth of various microorganisms during the complete brewing process. It's of great importance to fully understand the composition of bacteria diversity in rice wine in order to improve the quality and solve safety problems. In this study, a more comprehensive bacterial description was shown with the use of bacteria diversity analysis, which enabled us to have a better understanding. Rarefaction, rank abundance, alpha Diversity, beta diversity and principal coordinates analysis simplified their complex bacteria components and provide us theoretical foundation for further investigation. It has been found bacteria diversity is more abundant at mid-term and later stage of brewing process. Bacteria community analysis reveals there is a potential safety hazard existing in the fermentation, since most of the sequence reads are assigned to Enterobacter (7900 at most) and Pantoea (7336 at most), followed by Staphylococcus (2796 at most) and Pseudomonas (1681 at most). Lactic acid bacteria are rare throughout the fermentation process which is not in accordance with other reports. This work may offer us an opportunity to investigate micro ecological fermentation system in food industry. © 2015 Institute of Food Technologists®

29 CFR 1952.384 - Completed developmental steps.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Completed developmental steps. 1952.384 Section 1952.384 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION....384 Completed developmental steps. (a) In accordance with the requirements of § 1952.10, Puerto Rico's...

Practices and exploration on competition of molecular biological detection technology among students in food quality and safety major.

PubMed

Chang, Yaning; Peng, Yuke; Li, Pengfei; Zhuang, Yingping

2017-07-08

With the increasing importance in the application of the molecular biological detection technology in the field of food safety, strengthening education in molecular biology experimental techniques is more necessary for the culture of the students in food quality and safety major. However, molecular biology experiments are not always in curricula of Food quality and safety Majors. This paper introduced a project "competition of molecular biological detection technology for food safety among undergraduate sophomore students in food quality and safety major", students participating in this project needed to learn the fundamental molecular biology experimental techniques such as the principles of molecular biology experiments and genome extraction, PCR and agarose gel electrophoresis analysis, and then design the experiments in groups to identify the meat species in pork and beef products using molecular biological methods. The students should complete the experimental report after basic experiments, write essays and make a presentation after the end of the designed experiments. This project aims to provide another way for food quality and safety majors to improve their knowledge of molecular biology, especially experimental technology, and enhances them to understand the scientific research activities as well as give them a chance to learn how to write a professional thesis. In addition, in line with the principle of an open laboratory, the project is also open to students in other majors in East China University of Science and Technology, in order to enhance students in other majors to understand the fields of molecular biology and food safety. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):343-350, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.

Implementation intentions and colorectal screening: a randomized trial in safety-net clinics.

PubMed

Greiner, K Allen; Daley, Christine M; Epp, Aaron; James, Aimee; Yeh, Hung-Wen; Geana, Mugur; Born, Wendi; Engelman, Kimberly K; Shellhorn, Jeremy; Hester, Christina M; LeMaster, Joseph; Buckles, Daniel C; Ellerbeck, Edward F

2014-12-01

Low-income and racial/ethnic minority populations experience disproportionate colorectal cancer (CRC) burden and poorer survival. Novel behavioral strategies are needed to improve screening rates in these groups. The study aimed to test a theoretically based "implementation intentions" intervention for improving CRC screening among unscreened adults in urban safety-net clinics. Randomized controlled trial. Adults (N=470) aged ≥50 years, due for CRC screening, from urban safety-net clinics were recruited. The intervention (conducted in 2009-2011) was delivered via touchscreen computers that tailored informational messages to decisional stage and screening barriers. The computer then randomized participants to generic health information on diet and exercise (Comparison group) or "implementation intentions" questions and planning (Experimental group) specific to the CRC screening test chosen (fecal immunochemical test or colonoscopy). The primary study outcome was completion of CRC screening at 26 weeks based on test reports (analysis conducted in 2012-2013). The study population had a mean age of 57 years and was 42% non-Hispanic African American, 28% non-Hispanic white, and 27% Hispanic. Those receiving the implementation intentions-based intervention had higher odds (AOR=1.83, 95% CI=1.23, 2.73) of completing CRC screening than the Comparison group. Those with higher self-efficacy for screening (AOR=1.57, 95% CI=1.03, 2.39), history of asthma (AOR=2.20, 95% CI=1.26, 3.84), no history of diabetes (AOR=1.86, 95% CI=1.21, 2.86), and reporting they had never heard that "cutting on cancer" makes it spread (AOR=1.78, 95% CI=1.16, 2.72) were more likely to complete CRC screening. The results of this study suggest that programs incorporating an implementation intentions approach can contribute to successful completion of CRC screening even among very low-income and diverse primary care populations. Future initiatives to reduce CRC incidence and mortality disparities may be able to employ implementation intentions in large-scale efforts to encourage screening and prevention behaviors. Copyright © 2014. Published by Elsevier Inc.

Meta-Analysis of the Safety and Efficacy of Interferon Combined With Dacarbazine Versus Dacarbazine Alone in Cutaneous Malignant Melanoma.

PubMed

Xin, Yong; Huang, Qian; Zhang, Pei; Yang, Ming; Hou, Xiao-Yang; Tang, Jian-Qin; Zhang, Long Zhen; Jiang, Guan

2016-04-01

The aim of this study was to compare the efficacy and safety of interferon (IFN) combined with dacarbazine (DTIC) (experimental group) versus DTIC alone (control group) in cutaneous malignant melanoma. After searching all available databases, eligible articles were identified and subjected to quality assessment. Meta-analysis was performed using RevMan 5.3; combined relative risk (RR) and 95% confidence intervals (95% CIs) were calculated for survival rates, response rates, and adverse events. Eight randomized controlled trials published between 1990 and 2014 involving 795 patients were included in the meta-analysis. Compared with DTIC alone, IFN combined with DTIC significantly increased the overall response rate (RR = 1.59, 95% CI 1.21-2.08, P = 0.0008),the complete response rate (RR = 3.30, 95% CI 1.89-5.76, P < 0.0001), 2-year survival (RR = 1.59, 95% CI 0.99-2.54, P = 0.050) grade ≥3 hematologic toxicity (RR = 2.30, 95% CI 1.32-4.02, P = 0.003), neurotoxicity (RR = 18.15, 95% CI 5.34-61.74, P < 0.00001), and flu-like symptoms (RR = 6.31, 95% CI 1.95-20.39, P = 0.002). The partial response rate, grade ≥3 nausea and vomiting, treatment-related, and 1- and 3-year survival were not significantly different between IFN combined with DTIC and DTIC alone. IFN combined with DTIC may moderately improve the complete response rate, but increases the incidence of adverse events and has no significant effect on 1- and 3-year survival in cutaneous malignant melanoma.

Meta-Analysis of the Safety and Efficacy of Interferon Combined With Dacarbazine Versus Dacarbazine Alone in Cutaneous Malignant Melanoma

PubMed Central

Xin, Yong; Huang, Qian; Zhang, Pei; Yang, Ming; Hou, Xiao-Yang; Tang, Jian-Qin; Zhang, Long Zhen; Jiang, Guan

2016-01-01

Abstract The aim of this study was to compare the efficacy and safety of interferon (IFN) combined with dacarbazine (DTIC) (experimental group) versus DTIC alone (control group) in cutaneous malignant melanoma. After searching all available databases, eligible articles were identified and subjected to quality assessment. Meta-analysis was performed using RevMan 5.3; combined relative risk (RR) and 95% confidence intervals (95% CIs) were calculated for survival rates, response rates, and adverse events. Eight randomized controlled trials published between 1990 and 2014 involving 795 patients were included in the meta-analysis. Compared with DTIC alone, IFN combined with DTIC significantly increased the overall response rate (RR = 1.59, 95% CI 1.21–2.08, P = 0.0008),the complete response rate (RR = 3.30, 95% CI 1.89–5.76, P < 0.0001), 2-year survival (RR = 1.59, 95% CI 0.99–2.54, P = 0.050) grade ≥3 hematologic toxicity (RR = 2.30, 95% CI 1.32–4.02, P = 0.003), neurotoxicity (RR = 18.15, 95% CI 5.34–61.74, P < 0.00001), and flu-like symptoms (RR = 6.31, 95% CI 1.95–20.39, P = 0.002). The partial response rate, grade ≥3 nausea and vomiting, treatment-related, and 1- and 3-year survival were not significantly different between IFN combined with DTIC and DTIC alone. IFN combined with DTIC may moderately improve the complete response rate, but increases the incidence of adverse events and has no significant effect on 1- and 3-year survival in cutaneous malignant melanoma. PMID:27100429

Quantifying Pilot Contribution to Flight Safety During Dual Generator Failure

NASA Technical Reports Server (NTRS)

Etherington, Timothy J.; Kramer, Lynda J.; Kennedy, Kellie D.; Bailey, Randall E.; Last, Mary Carolyn

2017-01-01

Accident statistics cite flight crew error in over 60% of accidents involving transport category aircraft. Yet, a well-trained and well-qualified pilot is acknowledged as the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system. No data currently exists that quantifies the contribution of the flight crew in this role. Neither does data exist for how often the flight crew handles non-normal procedures or system failures on a daily basis in the National Airspace System. A pilot-in-the-loop high fidelity motion simulation study was conducted by the NASA Langley Research Center in partnership with the Federal Aviation Administration (FAA) to evaluate the pilot's contribution to flight safety during normal flight and in response to aircraft system failures. Eighteen crews flew various normal and non-normal procedures over a two-day period and their actions were recorded in response to failures. To quantify the human's contribution, crew complement was used as the experiment independent variable in a between-subjects design. Pilot actions and performance when one of the flight crew was unavailable were also recorded for comparison against the nominal two-crew operations. This paper details diversion decisions, perceived safety of flight, workload, time to complete pertinent checklists, and approach and landing results while dealing with a complete loss of electrical generators. Loss of electrical power requires pilots to complete the flight without automation support of autopilots, flight directors, or auto throttles. For reduced crew complements, the additional workload and perceived safety of flight was considered unacceptable.

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...

Failure Modes Effects and Criticality Analysis, an Underutilized Safety, Reliability, Project Management and Systems Engineering Tool

NASA Astrophysics Data System (ADS)

Mullin, Daniel Richard

2013-09-01

The majority of space programs whether manned or unmanned for science or exploration require that a Failure Modes Effects and Criticality Analysis (FMECA) be performed as part of their safety and reliability activities. This comes as no surprise given that FMECAs have been an integral part of the reliability engineer's toolkit since the 1950s. The reasons for performing a FMECA are well known including fleshing out system single point failures, system hazards and critical components and functions. However, in the author's ten years' experience as a space systems safety and reliability engineer, findings demonstrate that the FMECA is often performed as an afterthought, simply to meet contract deliverable requirements and is often started long after the system requirements allocation and preliminary design have been completed. There are also important qualitative and quantitative components often missing which can provide useful data to all of project stakeholders. These include; probability of occurrence, probability of detection, time to effect and time to detect and, finally, the Risk Priority Number. This is unfortunate as the FMECA is a powerful system design tool that when used effectively, can help optimize system function while minimizing the risk of failure. When performed as early as possible in conjunction with writing the top level system requirements, the FMECA can provide instant feedback on the viability of the requirements while providing a valuable sanity check early in the design process. It can indicate which areas of the system will require redundancy and which areas are inherently the most risky from the onset. Based on historical and practical examples, it is this author's contention that FMECAs are an immense source of important information for all involved stakeholders in a given project and can provide several benefits including, efficient project management with respect to cost and schedule, system engineering and requirements management, assembly integration and test (AI&T) and operations if applied early, performed to completion and updated along with system design.

Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women.

PubMed

Smith, Steven R; Prosser, Warren A; Donahue, David J; Morgan, Michael E; Anderson, Christen M; Shanahan, William R

2009-03-01

Lorcaserin (APD356) is a potent, selective 5-HT(2C) agonist with ~15-fold and 100-fold selectivity vs. 5-HT(2A) and 5-HT(2B) receptors, respectively. This study evaluated the safety and efficacy of lorcaserin for weight reduction in obese patients during a 12-week period. The randomized, double-blind, placebo-controlled, parallel-arm study enrolled 469 men and women between ages 18 and 65 and with BMI 30-45 kg/m(2). Patients received placebo, lorcaserin 10 mg q.d., lorcaserin 15 mg q.d., or lorcaserin 10 mg b.i.d. for 12 weeks, and were counseled to maintain their usual diet and activity. The primary end point was change in weight from baseline to day 85 by completer analysis. Safety analyses included echocardiograms at Screening and day 85/study exit. Lorcaserin was associated with progressive weight loss of 1.8 kg, 2.6 kg, and 3.6 kg at 10 mg q.d., 15 mg q.d., and 10 mg b.i.d., respectively, compared to placebo weight loss of 0.3 kg (P < 0.001 for each group). Similar results were seen by intent-to-treat last observation-carried forward (ITT-LOCF) analysis. The proportions of completers achieving > or =5% of initial body weight were 12.8, 19.5, 31.2, and 2.3% in the 10 mg q.d., 15 mg q.d., 10 mg b.i.d., and placebo groups, respectively. The most frequent adverse events (AEs) were transient headache, nausea, and dizziness. Echocardiograms showed no apparent drug-related effects on heart valves or pulmonary artery pressure (PAP). Lorcaserin was well tolerated and efficacious for weight reduction in this 12-week study. Longer-term trials employing behavior modification will be needed to more fully assess its safety and efficacy.

Driver Issues: Commercial Motor Vehicle Safety Literature Review

DOT National Transportation Integrated Search

2007-06-01

The objective of this project was to provide the Federal Motor Carrier Safety Administration (FMCSA) with a more complete understanding of the non-regulatory factors which make for safer commercial motor vehicle (CMV) drivers. Through the review of a...

Study of safety implications for shuttle launched spacecraft using fluorinated oxidizers. Volume 2: Executive summary

NASA Technical Reports Server (NTRS)

1975-01-01

An abbreviated version of the conclusions dealing with the safety implications of using liquid fluorinated oxidizers on space shuttle launched spacecraft was presented. The complete version was presented in volume 1.

Directory of DOT Fire Research, 1979 edition

DOT National Transportation Integrated Search

1980-12-01

This document presents the results of a survey of the fire safety projects conducted by the modal administrations of the U.S. Department of Transportation. Ongoing and recently completed modal fire safety projects for the period June 1978 to December...

29 CFR 1952.213 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 36 safety and 18 health compliance officers. After opportunity for public...

29 CFR 1952.233 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 23 safety and 14 health compliance officers. After opportunity for public...

29 CFR 1952.323 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 47 safety and 23 health compliance officers. After opportunity for public...

29 CFR 1952.93 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., in conjunction with OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 17 safety and 12 health compliance officers. After...

29 CFR 1952.223 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 22 safety and 14 health compliance officers. After opportunity for public...

29 CFR 1952.223 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 22 safety and 14 health compliance officers. After opportunity for public...

29 CFR 1952.343 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 6 safety and 2 health compliance officers. After opportunity for pulbic...

29 CFR 1952.353 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 9 safety and 6 health compliance officers. After opportunity for public...

29 CFR 1952.373 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 38 safety and 21 health compliance officers. After opportunity for public...

29 CFR 1952.203 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 31 safety and 12 health compliance officers. After opportunity for public...

29 CFR 1952.203 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 31 safety and 12 health compliance officers. After opportunity for public...

29 CFR 1952.343 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 6 safety and 2 health compliance officers. After opportunity for pulbic...

29 CFR 1952.373 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 38 safety and 21 health compliance officers. After opportunity for public...

29 CFR 1952.93 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., in conjunction with OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 17 safety and 12 health compliance officers. After...

29 CFR 1952.233 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 23 safety and 14 health compliance officers. After opportunity for public...

29 CFR 1952.323 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 47 safety and 23 health compliance officers. After opportunity for public...

29 CFR 1952.353 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 9 safety and 6 health compliance officers. After opportunity for public...

29 CFR 1952.213 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 36 safety and 18 health compliance officers. After opportunity for public...

Innovative tools and techniques in identifying highway safety improvement projects : project summary.

DOT National Transportation Integrated Search

2017-01-01

Researchers completed the following activities: - Reviewed the literature, state HSIP processes and practices, and HSIP tools used by various agencies. - Evaluated the applicability of safety assessment methods and tools used by other states and loca...

Occupational Health and Safety. Numeracy. Level 1. Level 2. Level 3. Support Materials for Agricultural Training.

ERIC Educational Resources Information Center

Batman, Kangan; Tully, Chris

This publication contains the three numeracy units of the three levels of Support Materials for Agricultural Training (SMAT) in the area of occupational health and safety: Level 1 (starting), 2 (continuing), and 3 (completing). The units are designed to help the learner improve his or her numeracy skills needed to deal with occupational safety and…

Food Safety Education Using an Interactive Multimedia Kiosk in a WIC Setting: Correlates of Client Satisfaction and Practical Issues

ERIC Educational Resources Information Center

Trepka, Mary Jo; Newman, Frederick L.; Huffman, Fatma G.; Dixon, Zisca

2010-01-01

Objective: To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Methods: Female clients or caregivers (n = 176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk.…

Pesticide Safety for Non-Certified Mixers, Loaders and Applicators = Uso Seguro de Pesticidas para Mezcladores, Cargadores y Aplicadores no Certificados.

ERIC Educational Resources Information Center

Poli, Bonnie; Fluker, Sam S.

Written in English and Spanish and completely illustrated, this manual provides basic safety information for pesticide workers. Mixers, loaders, and applicators work with pesticides at their greatest strength and have the highest risk of poisoning. Understanding the pesticide label is the first step to pesticide safety. The words…

Numerical Computation of Homogeneous Slope Stability

PubMed Central

Xiao, Shuangshuang; Li, Kemin; Ding, Xiaohua; Liu, Tong

2015-01-01

To simplify the computational process of homogeneous slope stability, improve computational accuracy, and find multiple potential slip surfaces of a complex geometric slope, this study utilized the limit equilibrium method to derive expression equations of overall and partial factors of safety. This study transformed the solution of the minimum factor of safety (FOS) to solving of a constrained nonlinear programming problem and applied an exhaustive method (EM) and particle swarm optimization algorithm (PSO) to this problem. In simple slope examples, the computational results using an EM and PSO were close to those obtained using other methods. Compared to the EM, the PSO had a small computation error and a significantly shorter computation time. As a result, the PSO could precisely calculate the slope FOS with high efficiency. The example of the multistage slope analysis indicated that this slope had two potential slip surfaces. The factors of safety were 1.1182 and 1.1560, respectively. The differences between these and the minimum FOS (1.0759) were small, but the positions of the slip surfaces were completely different than the critical slip surface (CSS). PMID:25784927

Numerical computation of homogeneous slope stability.

PubMed

Xiao, Shuangshuang; Li, Kemin; Ding, Xiaohua; Liu, Tong

2015-01-01

To simplify the computational process of homogeneous slope stability, improve computational accuracy, and find multiple potential slip surfaces of a complex geometric slope, this study utilized the limit equilibrium method to derive expression equations of overall and partial factors of safety. This study transformed the solution of the minimum factor of safety (FOS) to solving of a constrained nonlinear programming problem and applied an exhaustive method (EM) and particle swarm optimization algorithm (PSO) to this problem. In simple slope examples, the computational results using an EM and PSO were close to those obtained using other methods. Compared to the EM, the PSO had a small computation error and a significantly shorter computation time. As a result, the PSO could precisely calculate the slope FOS with high efficiency. The example of the multistage slope analysis indicated that this slope had two potential slip surfaces. The factors of safety were 1.1182 and 1.1560, respectively. The differences between these and the minimum FOS (1.0759) were small, but the positions of the slip surfaces were completely different than the critical slip surface (CSS).

Thermal overload protection for electric motors on safety-related motor-operated valves: Generic Issue II. E. 6. 1

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

Rothberg, O.

1988-06-01

NRC regulatory positions, as stated in Regulatory Guide 1.106, Revision 1, have been identified by the Office for Analysis and Evaluation of Operational Data (AEOD) as potential contributors to valve motor burnout. AEOD is particularly concerned about the allowed policy of bypassing thermal overload devices during normal or accident conditions. Regulatory Guide 1.106 favors compromising the function of thermal overload devices in favor of completing the safety-related action of valves. The purpose of this study was to determine if the guidance contained in Regulatory Guide 1.106 is appropriate and, if not, to recommend the necessary changes. This report describes thermalmore » overload devices commonly used to protect safety-related valve operator motors. The regulatory guidelines stated in Regulatory Guide 1.106 along with the limitations of thermal overload protection are discussed. Supplements and alternatives to thermal overload protection are also described. Findings and conclusions of several AEOD reports are discussed. Information obtained from the standard review plan, standard technical specifications, technical specifications from representative plants, and several papers are cited.« less

[Safety in intensive care medicine. Can we learn from aviation?].

PubMed

Graf, J; Pump, S; Maas, W; Stüben, U

2012-05-01

Safety is of extraordinary value in commercial aviation. Therefore, sophisticated and complex systems have been developed to ensure safe operation. Within this system, the pilots are of specific concern: they form the human-machine interface and have a special responsibility in controlling and monitoring all aircraft systems. In order to prepare pilots for their challenging task, specific selection of suitable candidates is crucial. In addition, for every commercial pilot regulatory requirements demand a certain number of simulator training sessions and check flights to be completed at prespecified intervals. In contrast, career choice for intensive care medicine most likely depends on personal reasons rather than eligibility or aptitude. In intensive care medicine, auditing, licensing, or mandatory training are largely nonexistent. Although knowledge of risk management and safety culture in aviation can be transferred to the intensive care unit, the diversity of corporate culture and tradition of leadership and training will represent a barrier for the direct transfer of standards or procedures. To accomplish this challenging task, the analysis of appropriate fields of action with regard to structural requirements and the process of change are essential.

RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Analysis of antigen conservation and inactivation of gamma-irradiated avian influenza virus subtype H9N2.

PubMed

Salehi, Bahareh; Motamedi-Sedeh, Farahnaz; Madadgar, Omid; Khalili, Iraj; Ghalyan Chi Langroudi, Arash; Unger, Hermann; Wijewardana, Viskam

2018-06-01

Avian influenza (AI) A subtype H9N2 virus belongs to Orthomyxoviridae family and causes low-pathogenic disease AI. The use of gamma-irradiated viral antigens has been developed in the production of effective vaccines. In this research, LPAIV H9N2 strain, A/Chicken/IRN/Ghazvin/2001, was multiplied on SPF eggs and irradiated by a Nordian gamma cell instrument. Irradiated and non-irradiated AI virus (AIV) samples were titrated by EID50 method and hemagglutinin (HA) antigen was analyzed by HA test as the WHO pattern method. Infectivity of irradiated virus was determined by egg inoculation method during four blind cultures. The results showed that after increasing the dose of gamma radiation, virus titer gradually decreased. D 10 value and optimum dose for complete virus inactivation were calculated by dose/response curve, 3.36 and 29.52 kGy, respectively. In addition, HA antigenicity of gamma-irradiated virus samples from 0 to 30 kGy was not changed. The results of safety test for gamma-irradiated AIV samples showed complete inactivation with gamma ray doses 30 and 35 kGy, without any multiplication on eggs after four blind cultures. According to the results of HA antigen assay and safety test, the gamma-irradiated and complete inactivated AIV subtype H9N2 is a good candidate as an inactivated immunogenic agent for poultry vaccination.

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...

Simulation of Mission Phases

NASA Technical Reports Server (NTRS)

Carlstrom, Nicholas Mercury

2016-01-01

This position with the Simulation and Graphics Branch (ER7) at Johnson Space Center (JSC) provided an introduction to vehicle hardware, mission planning, and simulation design. ER7 supports engineering analysis and flight crew training by providing high-fidelity, real-time graphical simulations in the Systems Engineering Simulator (SES) lab. The primary project assigned by NASA mentor and SES lab manager, Meghan Daley, was to develop a graphical simulation of the rendezvous, proximity operations, and docking (RPOD) phases of flight. The simulation is to include a generic crew/cargo transportation vehicle and a target object in low-Earth orbit (LEO). Various capsule, winged, and lifting body vehicles as well as historical RPOD methods were evaluated during the project analysis phase. JSC core mission to support the International Space Station (ISS), Commercial Crew Program (CCP), and Human Space Flight (HSF) influenced the project specifications. The simulation is characterized as a 30 meter +V Bar and/or -R Bar approach to the target object's docking station. The ISS was selected as the target object and the international Low Impact Docking System (iLIDS) was selected as the docking mechanism. The location of the target object's docking station corresponds with the RPOD methods identified. The simulation design focuses on Guidance, Navigation, and Control (GNC) system architecture models with station keeping and telemetry data processing capabilities. The optical and inertial sensors, reaction control system thrusters, and the docking mechanism selected were based on CCP vehicle manufacturer's current and proposed technologies. A significant amount of independent study and tutorial completion was required for this project. Multiple primary source materials were accessed using the NASA Technical Report Server (NTRS) and reference textbooks were borrowed from the JSC Main Library and International Space Station Library. The Trick Simulation Environment and User Training Materials version 2013.0 release was used to complete the Trick tutorial. Multiple network privilege and repository permission requests were required in order to access previous simulation models. The project was also an introduction to computer programming and the Linux operating system. Basic C++ and Python syntax was used during the completion of the Trick tutorial. Trick's engineering analysis and Monte Carlo simulation capabilities were observed and basic space mission planning procedures were applied in the conceptual design phase. Multiple professional development opportunities were completed in addition to project duties during this internship through the System for Administration, Training, and Education Resources for NASA (SATERN). Topics include: JSC Risk Management Workshop, CCP Risk Management, Basic Radiation Safety Training, X-Ray Radiation Safety, Basic Laser Safety, JSC Export Control, ISS RISE Ambassador, Basic SharePoint 2013, Space Nutrition and Biochemistry, and JSC Personal Protective Equipment. Additionally, this internship afforded the opportunity for formal project presentation and public speaking practice. This was my first experience at a NASA center. After completing this internship I have a much clearer understanding of certain aspects of the agency's processes and procedures, as well as a deeper appreciation from spaceflight simulation design and testing. I will continue to improve my technical skills so that I may have another opportunity to return to NASA and Johnson Space Center.

Design and analysis of a personnel blast shield for different explosives applications

NASA Astrophysics Data System (ADS)

Lozano, Eduardo

The use of explosives brings countless benefits to our everyday lives in areas such as mining, oil and gas exploration, demolition, and avalanche control. However, because of the potential destructive power of explosives, strict safety procedures must be an integral part of any explosives operation. The goal of this work is to provide a solution to protect against the hazards that accompany the general use of explosives, specifically in avalanche control. For this reason, a blast shield was designed and tested to protect the Colorado Department of Transportation personnel against these unpredictable effects. This document will develop a complete analysis to answer the following questions: what are the potential hazards from the detonation of high explosives, what are their effects, and how can we protect ourselves against them. To answer these questions theoretical, analytical, and numerical calculations were performed. Finally, a full blast shield prototype was tested under different simulated operational environments proving its effectiveness as safety device. The Colorado Department of Transportation currently owns more than fifteen shields that are used during every operation involving explosive materials.

Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors.

PubMed

Sowan, Azizeh Khaled; Reed, Charles Calhoun; Staggers, Nancy

2016-09-30

Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. The audit log is a function of current capabilities of the physiologic monitoring systems, monitor's configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices' log capacity.

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up.

PubMed

Kühn, Anna Luisa; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Rex, David E; Massari, Francesco; Tamura, Takamitsu; Howk, Mary; Brooks, Christopher; L'Heureux, Jenna; Gounis, Matthew J; Wakhloo, Ajay K; Puri, Ajit S

2017-12-01

Evaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs). Retrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months' follow-up and assessed intimal hyperplasia at follow-up. Twenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months' follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months' follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs. Treatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs. 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/.

EFFECT OF A ROAD SAFETY EDUCATION INTERVENTION ON ROAD SAFETY KNOWLEDGE OF UNIVERSITY DRIVERS IN IBADAN, NIGERIA.

PubMed

Olumide, A O; Owoaje, E T

2016-06-01

It is essential for drivers employed in the formal sector to have good knowledge of road safety in order to safeguard their lives and those of the staff they are employed to drive. The study was conducted to determine the effect of a road safety education intervention on road safety knowledge of drivers employed in the University of Ibadan, Nigeria. A quasi-experimental study of 98 intervention and 78 control drivers selected using a cluster sampling technique was conducted. The intervention comprised a two-day training on road safety and first aid. The drivers' knowledge of road safety was measured at baseline, immediately and 4-months post-intervention. Aggregate scores of road safety knowledge were computed giving minimum and maximum obtainable scores of 0 and 16 respectively. Change in mean scores over the three measurement periods was assessed using Repeated Measures Analysis of Variance (ANOVA). Independent t-test was used to compare the scores between intervention and control drivers at each of the assessment periods. Twenty-nine drivers did not complete the study (attrition rate = 16.5%). At baseline, mean road safety knowledge scores for the intervention and control drivers were 12.7±2.2 and 12.9± 2.3 (p = 0.510) respectively. Immediately and four months post intervention, the scores of the intervention drivers were 13.8±1.9 and 12.8±1.6; while scores for the controls were 13.3±2.0 and 13.2±1.8. Repeated measures ANOVA revealed that the increase in knowledge over the three assessment periods was not statistically significant. The intervention resulted in an initial increase in road safety knowledge of the intervention drivers. However, this was not sustained to the forth month post-intervention. This finding suggests periodic refresher trainings to sustain the knowledge acquired.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

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

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Optimal approach for complete liver tumor ablation using radiofrequency ablation: a simulation study.

PubMed

Givehchi, Sogol; Wong, Yin How; Yeong, Chai Hong; Abdullah, Basri Johan Jeet

2018-04-01

To investigate the effect of radiofrequency ablation (RFA) electrode trajectory on complete tumor ablation using computational simulation. The RFA of a spherical tumor of 2.0 cm diameter along with 0.5 cm clinical safety margin was simulated using Finite Element Analysis software. A total of 86 points inside one-eighth of the tumor volume along the axial, sagittal and coronal planes were selected as the target sites for electrode-tip placement. The angle of the electrode insertion in both craniocaudal and orbital planes ranged from -90° to +90° with 30° increment. The RFA electrode was simulated to pass through the target site at different angles in combination of both craniocaudal and orbital planes before being advanced to the edge of the tumor. Complete tumor ablation was observed whenever the electrode-tip penetrated through the epicenter of the tumor regardless of the angles of electrode insertion in both craniocaudal and orbital planes. Complete tumor ablation can also be achieved by placing the electrode-tip at several optimal sites and angles. Identification of the tumor epicenter on the central slice of the axial images is essential to enhance the success rate of complete tumor ablation during RFA procedures.

Nuclear criticality safety: 5-day training course

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

Schlesser, J.A.

1992-11-01

This compilation of notes is presented as a source reference for the criticality safety course. It represents the contributions of many people, particularly Tom McLaughlin, the course's primary instructor. At the completion of this training course, the attendee will: be able to define terms commonly used in nuclear criticality safety; be able to appreciate the fundamentals of nuclear criticality safety; be able to identify factors which affect nuclear criticality safety; be able to identify examples of criticality controls as used at Los Alamos; be able to identify examples of circumstances present during criticality accidents; be able to identify examples ofmore » computer codes used by the nuclear criticality safety specialist; be able to identify examples of safety consciousness required in nuclear criticality safety.« less

Formal testing and utilization of streaming media to improve flight crew safety knowledge.

PubMed

Bellazzini, Marc A; Rankin, Peter M; Quisling, Jason; Gangnon, Ronald; Kohrs, Mike

2008-01-01

Increased concerns over the safety of air medical transport have prompted development of novel ways to increase safety. The objective of our study was to determine if an Internet streaming media safety video increased crew safety knowledge. 23 out of 40 crew members took an online safety pre-test, watched a safety video specific to our program and completed immediate and long-term post-testing 6 months later. Mean pre-test, post-test and 6 month follow up test scores were 84.9%, 92.3% and 88.4% respectively. There was a statistically significant difference in all scores (p

Effectiveness of a quality-improvement program in improving management of primary care practices.

PubMed

Szecsenyi, Joachim; Campbell, Stephen; Broge, Bjoern; Laux, Gunter; Willms, Sara; Wensing, Michel; Goetz, Katja

2011-12-13

The European Practice Assessment program provides feedback and outreach visits to primary care practices to facilitate quality improvement in five domains (infrastructure, people, information, finance, and quality and safety). We examined the effectiveness of this program in improving management in primary care practices in Germany, with a focus on the domain of quality and safety. In a before-after study, 102 primary care practices completed a practice assessment using the European Practice Assessment instrument at baseline and three years later (intervention group). A comparative group of 102 practices was included that completed their first assessment using this instrument at the time of the intervention group's second assessment. Mean scores were based on the proportion of indicators for which a positive response was achieved by all of the practices, on a scale of 0 to 100. We found significant improvements in all domains between the first and second assessments in the intervention group. In the domain of quality and safety, improvements in scores (mean scores were based on the proportion of indicators for which a positive response was achieved by all of the practices, on a scale of 0 to 100) were observed in the following dimensions: complaint management (from a mean score of 51.2 at first assessment to 80.7 at second assessment); analysis of critical incidents (from 79.1 to 89.6); and quality development, quality policy (from 40.7 to 55.6). Overall scores at the time of the second assessment were significantly higher in the intervention group than in the comparative group. Primary care practices that completed the European Practice Assessment instrument twice over a three-year period showed improvements in practice management. Our findings show the value of the quality-improvement cycle in the context of practice assessment and the use of established organizational standards for practice management with the Europeaen Practice Assessment.

Effectiveness of a quality-improvement program in improving management of primary care practices

PubMed Central

Szecsenyi, Joachim; Campbell, Stephen; Broge, Bjoern; Laux, Gunter; Willms, Sara; Wensing, Michel; Goetz, Katja

2011-01-01

Background: The European Practice Assessment program provides feedback and outreach visits to primary care practices to facilitate quality improvement in five domains (infrastructure, people, information, finance, and quality and safety). We examined the effectiveness of this program in improving management in primary care practices in Germany, with a focus on the domain of quality and safety. Methods: In a before–after study, 102 primary care practices completed a practice assessment using the European Practice Assessment instrument at baseline and three years later (intervention group). A comparative group of 102 practices was included that completed their first assessment using this instrument at the time of the intervention group’s second assessment. Mean scores were based on the proportion of indicators for which a positive response was achieved by all of the practices, on a scale of 0 to 100. Results: We found significant improvements in all domains between the first and second assessments in the intervention group. In the domain of quality and safety, improvements in scores (mean scores were based on the proportion of indicators for which a positive response was achieved by all of the practices, on a scale of 0 to 100) were observed in the following dimensions: complaint management (from a mean score of 51.2 at first assessment to 80.7 at second assessment); analysis of critical incidents (from 79.1 to 89.6); and quality development, quality policy (from 40.7 to 55.6). Overall scores at the time of the second assessment were significantly higher in the intervention group than in the comparative group. Interpretation: Primary care practices that completed the European Practice Assessment instrument twice over a three-year period showed improvements in practice management. Our findings show the value of the quality-improvement cycle in the context of practice assessment and the use of established organizational standards for practice management with the Europeaen Practice Assessment. PMID:22043000

29 CFR 1956.62 - Completion of developmental steps and certification. [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Completion of developmental steps and certification. [Reserved] 1956.62 Section 1956.62 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... EMPLOYEE PLANS New Jersey § 1956.62 Completion of developmental steps and certification. [Reserved] ...

16 CFR 1102.42 - Disclaimers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Notice and Disclosure Requirements § 1102.42... Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The Database will contain a notice to...

16 CFR 1102.42 - Disclaimers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Notice and Disclosure Requirements § 1102.42... Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The Database will contain a notice to...

16 CFR 1102.42 - Disclaimers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Notice and Disclosure... of the contents of the Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The Database...

29 CFR 1952.103 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a...

29 CFR 1952.103 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a...

Improve safety of workers during highway construction and maintenance.

DOT National Transportation Integrated Search

2007-06-01

This study will focus on highway construction worker safety. Most all statistical data gathered will be from Kentucky construction workers, although the study is not limited by this. Studies of this nature have been completed previously, but most stu...

Transport company safety climate-The impact on truck driver behavior and crash involvement.

PubMed

Sullman, Mark J M; Stephens, Amanda N; Pajo, Karl

2017-04-03

The present study investigated the relationships between safety climate and driving behavior and crash involvement. A total of 339 company-employed truck drivers completed a questionnaire that measured their perceptions of safety climate, crash record, speed choice, and aberrant driving behaviors (errors, lapses, and violations). Although there was no direct relationship between the drivers' perceptions of safety climate and crash involvement, safety climate was a significant predictor of engagement in risky driving behaviors, which were in turn predictive of crash involvement. This research shows that safety climate may offer an important starting point for interventions aimed at reducing risky driving behavior and thus fewer vehicle collisions.

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.

Bayesian methodology incorporating expert judgment for ranking countermeasure effectiveness under uncertainty: example applied to at grade railroad crossings in Korea.

PubMed

Washington, Simon; Oh, Jutaek

2006-03-01

Transportation professionals are sometimes required to make difficult transportation safety investment decisions in the face of uncertainty. In particular, an engineer may be expected to choose among an array of technologies and/or countermeasures to remediate perceived safety problems when: (1) little information is known about the countermeasure effects on safety; (2) information is known but from different regions, states, or countries where a direct generalization may not be appropriate; (3) where the technologies and/or countermeasures are relatively untested, or (4) where costs prohibit the full and careful testing of each of the candidate countermeasures via before-after studies. The importance of an informed and well-considered decision based on the best possible engineering knowledge and information is imperative due to the potential impact on the numbers of human injuries and deaths that may result from these investments. This paper describes the formalization and application of a methodology to evaluate the safety benefit of countermeasures in the face of uncertainty. To illustrate the methodology, 18 countermeasures for improving safety of at grade railroad crossings (AGRXs) in the Republic of Korea are considered. Akin to "stated preference" methods in travel survey research, the methodology applies random selection and laws of large numbers to derive accident modification factor (AMF) densities from expert opinions. In a full Bayesian analysis framework, the collective opinions in the form of AMF densities (data likelihood) are combined with prior knowledge (AMF density priors) for the 18 countermeasures to obtain 'best' estimates of AMFs (AMF posterior credible intervals). The countermeasures are then compared and recommended based on the largest safety returns with minimum risk (uncertainty). To the author's knowledge the complete methodology is new and has not previously been applied or reported in the literature. The results demonstrate that the methodology is able to discern anticipated safety benefit differences across candidate countermeasures. For the 18 at grade railroad crossings considered in this analysis, it was found that the top three performing countermeasures for reducing crashes are in-vehicle warning systems, obstacle detection systems, and constant warning time systems.

3D Simulation of External Flooding Events for the RISMC Pathway

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

Prescott, Steven; Mandelli, Diego; Sampath, Ramprasad

2015-09-01

Incorporating 3D simulations as part of the Risk-Informed Safety Margins Characterization (RISMIC) Toolkit allows analysts to obtain a more complete picture of complex system behavior for events including external plant hazards. External events such as flooding have become more important recently – however these can be analyzed with existing and validated simulated physics toolkits. In this report, we describe these approaches specific to flooding-based analysis using an approach called Smoothed Particle Hydrodynamics. The theory, validation, and example applications of the 3D flooding simulation are described. Integrating these 3D simulation methods into computational risk analysis provides a spatial/visual aspect to themore » design, improves the realism of results, and can prove visual understanding to validate the analysis of flooding.« less

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.

Discontinuation of Tocolytics for Preterm Labor in an Academic Safety Net Hospital: Impact on the Duration of Betamethasone Exposure.

PubMed

Alston, Meredith J; Alexandrovic, Kara; Stiglich, Norma; Metz, Torri D

2016-01-01

To evaluate the impact of discontinuation of tocolytics on the completion of the corticosteroid course among preterm neonates in an academic safety net hospital. Retrospective cohort study of all singleton pregnancies with preterm labor resulting in delivery between 24 and 34 weeks' gestation at Denver Health Medical Center (DHMC) between 1/1/2004 and 5/31/2009. In January 2007 DHMC discontinued the use of tocolytic therapy for preterm labor. Study subjects were grouped based on whether their delivery occurred before or after the change in policy. Multivariable logistic regression was used to determine whether the use of tocolysis increased the odds of completion of the betamethasone while adjusting for cervical examination at admission. Of 169 infant/mother pairs who met inclusion criteria, 102 delivered prior to the discontinuation of tocolytics and 67 delivered after the discontinuation of tocolytics. Treatment with tocolysis increased the odds of completing the 48-hour betamethasone window (OR 2.59, 95% CI 1.16-5.79). Each centimeter increase in cervical dilation at the time of admission decreased the odds of completing the betamethasone window (OR 0.50, 95% CI 0.39-0.62). The use of tocolytics increased the odds of completion of the betamethasone window in an academic safety net hospital among neonates born between 24 and 34 weeks' gestation.

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...

Advanced Reactor PSA Methodologies for System Reliability Analysis and Source Term Assessment

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

Grabaskas, D.; Brunett, A.; Passerini, S.

Beginning in 2015, a project was initiated to update and modernize the probabilistic safety assessment (PSA) of the GE-Hitachi PRISM sodium fast reactor. This project is a collaboration between GE-Hitachi and Argonne National Laboratory (Argonne), and funded in part by the U.S. Department of Energy. Specifically, the role of Argonne is to assess the reliability of passive safety systems, complete a mechanistic source term calculation, and provide component reliability estimates. The assessment of passive system reliability focused on the performance of the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedback mechanisms of the metal fuel core. Themore » mechanistic source term assessment attempted to provide a sequence specific source term evaluation to quantify offsite consequences. Lastly, the reliability assessment focused on components specific to the sodium fast reactor, including electromagnetic pumps, intermediate heat exchangers, the steam generator, and sodium valves and piping.« less

The practical application of mishap data in Army aircraft system safety programs

NASA Technical Reports Server (NTRS)

Darrah, J. T., Jr.

1971-01-01

The means are discussed by which the the United States Army Board for Aviation Accident Research (USABAAR) now utilizes the vast store of historical accident data in the application of the system safety concept for developmental aircraft. USABAAR serves as the central agency for the Army Accident Prevention Program which includes the receipt, processing, and analysis of all data and information related to Army aircraft accident experience. It is pointed out that methods which served the cause of accident prevention so well in the past are no longer adequate and that traditional parameters used to measure mishap experience have become obsolete. USABAAR has developed, and recently put into use, completely revised accident reporting forms which greatly expand the scope and detail of information provided as a result of investigation. This and other factors which have resulted in an improved data system are discussed in detail.

[Infrastructure and adherence to hand hygiene: challenges to patient safety].

PubMed

Bathke, Janaína; de Cunico, Priscila Almeida; Maziero, Eliane Cristina Sanches; Cauduro, Fernanda Leticia Frates; Sarquis, Leila Maria Mansano; de Cruz, Elaine Drehmer Almeida

2013-06-01

Considering the importance of hands in the chain of transmission of microorganisms, this observational research investigated the material infrastructure and compliance of hand hygiene in an intensive care unit in the south of Brazil in 2010. The data was collected by direct non-participant observation and through the use of self-administered questionnaires to be completed by the 39 participants, which was analyzed with the assistance of the chi2 Test, descriptive statistics and quantitative discourse analysis. Although health professionals overestimate compliance rates, recognize the practice as relevant to the prevention of infection and refer there are no impeding factors, of the 1,277 opportunities observed, compliance was 26% and significantly lower before patient contact and the use of aseptic procedures than after patient contact: infrastructure was shown to be deficient. The results indicate risk to patient safety, and thus, the planning of corrective actions to promote hand washing is relevant.

Extravehicular activity welding experiment

NASA Technical Reports Server (NTRS)

Watson, J. Kevin

1989-01-01

The In-Space Technology Experiments Program (INSTEP) provides an opportunity to explore the many critical questions which can only be answered by experimentation in space. The objective of the Extravehicular Activity Welding Experiment definition project was to define the requirements for a spaceflight experiment to evaluate the feasibility of performing manual welding tasks during EVA. Consideration was given to experiment design, work station design, welding hardware design, payload integration requirements, and human factors (including safety). The results of this effort are presented. Included are the specific objectives of the flight test, details of the tasks which will generate the required data, and a description of the equipment which will be needed to support the tasks. Work station requirements are addressed as are human factors, STS integration procedures and, most importantly, safety considerations. A preliminary estimate of the cost and the schedule for completion of the experiment through flight and postflight analysis are given.

Integral throat entrance development, qualification and production for the Antares 3 nozzle

NASA Technical Reports Server (NTRS)

Clayton, F. I.; Dirling, R. B.; Eitman, D. A.; Loomis, W. C.

1982-01-01

Although design analyses of a G-90 graphite integral throat entrance for the Antares 3 solid rocket motor nozzle indicated acceptable margins of safety, the nozzle throat insert suffered a thermostructural failure during the first development firing. Subsequent re-analysis using properties measured on material from the same billet as the nozzle throat insert showed negative margins. Carbon-carbon was investigated and found to result in large positive margins of safety. The G-90 graphite was replaced by SAI fast processed 4-D material which uses Hercules HM 10000 fiber as the reinforcement. Its construction allows powder filling of the interstices after preform fabrication which accelerates the densification process. Allied 15V coal tar pitch is then used to complete densification. The properties were extensively characterized on this material and six nozzles were subjected to demonstration, development and qualification firings.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

PubMed

Lydon, Sinéad; Cupples, Margaret E; Hart, Nigel; Murphy, Andrew W; Faherty, Aileen; O'Connor, Paul

2016-01-01

Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT. The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method. The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care, may contribute to improved patient safety practices in primary care settings, and may inform future research on patient safety improvement initiatives.

Egg processing plant sanitation, SSOPs, and GMPs.

USDA-ARS?s Scientific Manuscript database

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

16 CFR § 1102.42 - Disclaimers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Notice and Disclosure Requirements § 1102.42... Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The Database will contain a notice to...

29 CFR 1952.263 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... State operating an approved State plan. In 1992, Michigan completed, in conjunction with OSHA, a reassessment of the levels initially established in 1980 and proposed revised benchmarks of 56 safety and 45...

29 CFR 1952.263 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... State operating an approved State plan. In 1992, Michigan completed, in conjunction with OSHA, a reassessment of the levels initially established in 1980 and proposed revised benchmarks of 56 safety and 45...

29 CFR 1952.363 - Compliance staffing benchmarks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... State operating an approved State plan. In May 1992, New Mexico completed, in conjunction with OSHA, a reassessment of the staffing levels initially established in 1980 and proposed revised benchmarks of 7 safety...

29 CFR 1952.363 - Compliance staffing benchmarks.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... State operating an approved State plan. In May 1992, New Mexico completed, in conjunction with OSHA, a reassessment of the staffing levels initially established in 1980 and proposed revised benchmarks of 7 safety...

Report: U.S. Chemical Safety and Hazard Investigation Board Needs to Complete More Timely Investigations

EPA Pesticide Factsheets

Report #13-P-0337, July 30, 2013. CSB does not have an effective management system to meet its established performance goal to “conduct incident investigations and safety studies concerning releases of hazardous chemical substances.”

Findings From the National Machine Guarding Program

PubMed Central

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

2017-01-01

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

Understanding road safety in Kenya: views of matatu drivers.

PubMed

Raynor, Nicolas J; Mirzoev, Tolib

2014-09-01

Road traffic accidents (RTAs) are estimated to cause 1.3 million deaths and 20-50 million injuries worldwide. Road safety is a challenge in Kenya with causes being multi-factorial. Matatus (minibuses) are involved in a large proportion of accidents. A literature review was completed to identify key issues and refine the scope of the study. The fieldwork included 20 semi-structured interviews with matatu drivers. All participants were male, with driving experience of 1-20 years. Thematic framework was used for analysis. Some unstructured observations on different road users and their behaviours were also recorded. Literature showed that the causes of RTAs in Kenya are multi-factorial, but that human factors play a large part. There is also an evidence gap concerning matatu drivers, who are key stakeholders in road safety. Fieldwork showed that the matatu industry creates financial pressures on drivers and an excessive level of competition, leading to dangerous driving. Corruption of traffic police appears to be a major barrier to improving road safety, as road safety legislation is not enforced, and bribery has become the cultural norm. The general public, including passengers and private vehicles owners, also cause problems by failing to understand their role in road safety and placing the blame on others. The key policy implication for improving road safety in Kenya is seeking measures to ensure responsibility by all road users through awareness raising in the short-term and reforming the matatu industry and addressing the root causes of corruption in the longer term. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Impact of intraoperative distractions on patient safety: a prospective descriptive study using validated instruments.

PubMed

Sevdalis, Nick; Undre, Shabnam; McDermott, James; Giddie, Jasdeep; Diner, Lila; Smith, Gillian

2014-04-01

There is emerging evidence indicating that distractions in the operating room (OR) are prevalent. Studies have shown a negative impact of distractions, but they have been conducted mostly with residents in simulated environments. We tested the hypothesis that intraoperative distractions are associated with deterioration in patient safety checks in the OR. We assessed 24 elective urologic procedures. Blinded trained assessors (two surgeons, one psychologist) used validated instruments to prospectively assess in vivo frequency and severity of distractions (related to communication, phones/pagers, equipment/provisions, OR environment, other hospital departments, or a member of the OR team) and completion of safety-related tasks (related to the patient, equipment, and communication). Descriptive and correlational analyses were conducted. Mean case duration was 70 min (mean intraoperative time 31 min). A mean of 4.0 communication distractions (range 0-9) and 2.48 other distractions (range 0-5) were recorded per case (distraction rate of one per 10 min). Distractions from external visitors (addressed to the entire team or the surgeon) and distractions due to lack of coordination between hospital departments were most disruptive. Regarding safety checks, patient tasks were completed most often (85-100 %) followed by equipment tasks (75-100 %) and communication tasks (55-90 %). Correlational analyses showed that more frequent/severe communication distractions were linked to lower completion of patient checks intraoperatively (median rho -0.56, p < 0.05). Distractions are prevalent in ORs and in this study were linked to deterioration in intraoperative patient safety checks. Surgeons should be mindful of their tolerance to distractions. Surgical leadership can help control distractions and reduce their potential impact on patient safety and performance.

Using Cognitive Work Analysis to Fit Decision Support Tools to Nurse Managers’ Work Flow

PubMed Central

Brewer, Barbara B.; Logue, Melanie D.; Gephart, Sheila; Verran, Joyce A.

2011-01-01

Purpose To better understand the environmental constraints on nurse managers that impact their need for and use of decision support tools, we conducted a Cognitive Work Analysis (CWA). A complete CWA includes system analyses at five levels: work domain, decision-making procedures, decision-making strategies, social organization/collaboration, and worker skill level. Here we describe the results of the Work Domain Analysis (WDA) portion in detail then integrate the WDA with other portions of the CWA, reported previously, to generate a more complete picture of the nurse manager’s work domain. Methods Data for the WDA were obtained from semi-structured interviews with nurse managers, division directors, CNOs, and other managers (n = 20) on 10 patient care units in 3 Arizona hospitals. The WDA described the nurse manager’s environment in terms of the constraints it imposes on the nurse manager’s ability to achieve targeted outcomes through organizational goals and priorities, functions, processes, as well as work objects and resources (e.g., people, equipment, technology, and data). Constraints were identified and summarized through qualitative thematic analysis. Results The results highlight the competing priorities, and external and internal constraints that today’s nurse managers must satisfy as they try to improve quality and safety outcomes on their units. Nurse managers receive a great deal of data, much in electronic format. Although dashboards were perceived as helpful because they integrated some data elements, no decision support tools were available to help nurse managers with planning or answering “what if” questions. The results suggest both the need for additional decision support to manage the growing complexity of the environment, and the constraints the environment places on the design of that technology if it is to be effective. Limitations of the study include the small homogenous sample and the reliance on interview data targeting safety and quality. PMID:21862397

Using Cognitive Work Analysis to fit decision support tools to nurse managers' work flow.

PubMed

Effken, Judith A; Brewer, Barbara B; Logue, Melanie D; Gephart, Sheila M; Verran, Joyce A

2011-10-01

To better understand the environmental constraints on nurse managers that impact their need for and use of decision support tools, we conducted a Cognitive Work Analysis (CWA). A complete CWA includes system analyses at five levels: work domain, decision-making procedures, decision-making strategies, social organization/collaboration, and worker skill level. Here we describe the results of the Work Domain Analysis (WDA) portion in detail then integrate the WDA with other portions of the CWA, reported previously, to generate a more complete picture of the nurse manager's work domain. Data for the WDA were obtained from semi-structured interviews with nurse managers, division directors, CNOs, and other managers (n = 20) on 10 patient care units in three Arizona hospitals. The WDA described the nurse manager's environment in terms of the constraints it imposes on the nurse manager's ability to achieve targeted outcomes through organizational goals and priorities, functions, processes, as well as work objects and resources (e.g., people, equipment, technology, and data). Constraints were identified and summarized through qualitative thematic analysis. The results highlight the competing priorities, and external and internal constraints that today's nurse managers must satisfy as they try to improve quality and safety outcomes on their units. Nurse managers receive a great deal of data, much in electronic format. Although dashboards were perceived as helpful because they integrated some data elements, no decision support tools were available to help nurse managers with planning or answering "what if" questions. The results suggest both the need for additional decision support to manage the growing complexity of the environment, and the constraints the environment places on the design of that technology if it is to be effective. Limitations of the study include the small homogeneous sample and the reliance on interview data targeting safety and quality. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

RIFM fragrance ingredient safety assessment, linalyl cinnamate, CAS Registry Number 78-37-5.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental toxicity endpoint was completed using linalool (CAS # 78-70-6), dehydrolinalool (CAS # 29171-20-8) and cinnamic acid (CAS # 621-82-9) as suitable read across analogs, which provided a MOE > 100. The repeated dose toxicity endpoint was completed using data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Crash risk and aberrant driving behaviors among bus drivers: the role of personality and attitudes towards traffic safety.

PubMed

Mallia, Luca; Lazuras, Lambros; Violani, Cristiano; Lucidi, Fabio

2015-06-01

Several studies have shown that personality traits and attitudes toward traffic safety predict aberrant driving behaviors and crash involvement. However, this process has not been adequately investigated in professional drivers, such as bus drivers. The present study used a personality-attitudes model to assess whether personality traits predicted aberrant self-reported driving behaviors (driving violations, lapses, and errors) both directly and indirectly, through the effects of attitudes towards traffic safety in a large sample of bus drivers. Additionally, the relationship between aberrant self-reported driving behaviors and crash risk was also assessed. Three hundred and one bus drivers (mean age=39.1, SD=10.7 years) completed a structured and anonymous questionnaire measuring personality traits, attitudes toward traffic safety, self-reported aberrant driving behaviors (i.e., errors, lapses, and traffic violations), and accident risk in the last 12 months. Structural equation modeling analysis revealed that personality traits were associated to aberrant driving behaviors both directly and indirectly. In particular altruism, excitement seeking, and normlessness directly predicted bus drivers' attitudes toward traffic safety which, in turn, were negatively associated with the three types of self-reported aberrant driving behaviors. Personality traits relevant to emotionality directly predicted bus drivers' aberrant driving behaviors, without any mediation of attitudes. Finally, only self-reported violations were related to bus drivers' accident risk. The present findings suggest that the hypothesized personality-attitudes model accounts for aberrant driving behaviors in bus drivers, and provide the empirical basis for evidence-based road safety interventions in the context of public transport. Copyright © 2015 Elsevier Ltd. All rights reserved.

What's gender got to do with it? Examining masculinities, health and safety and return to work in male dominated skilled trades.

PubMed

Stergiou-Kita, Mary; Mansfield, Elizabeth; Colantonio, Angela; Moody, Joel; Mantis, Steve

2016-06-16

Electrical injuries are a common cause of work-related injury in male dominated skilled trades. In this study we explored how issues of gender, masculinities and institutional workplace practices shape expectations of men and their choices when returning to work following a workplace electrical injury. Twelve workers, who suffered an electrical injury, and twelve employer representatives, completed semi-structured interviews. Using thematic analysis we identified key themes related to how masculinities influenced men's health and safety during the return to work process. Strong identification with worker roles can influence injured workers decisions to return to work 'too early'. A desire to be viewed as a strong, responsible, resilient worker may intersect with concerns about job loss, to influence participants' decisions to not report safety issues and workplace accidents, to not disclose post-injury work challenges, and to not request workplace supports. Institutionalized workplace beliefs regarding risk, de-legitimization of the severity of injuries, and the valorization of the "tough" worker can further re-enforce dominant masculine norms and influence return to work processes and health and safety practices. Workplaces are key sites where gender identities are constructed, affirmed and institutionalized. Further research is warranted to examine how established masculine norms and gendered workplace expectations can influence workplace health and safety in male dominated high risk occupations. Future research should also evaluate strategies that encourage men to discuss post-injury work challenges and request supports when work performance or health and safety issues arise during the return to work process.

The Influence of Health Policy and Market Factors on the Hospital Safety Net

PubMed Central

Bazzoli, Gloria J; Lindrooth, Richard C; Kang, R ay; Hasnain-Wynia, R omana

2006-01-01

Objective To examine how the financial pressures resulting from the Balanced Budget Act (BBA) of 1997 interacted with private sector pressures to affect indigent care provision. Data Sources/Study Setting American Hospital Association Annual Survey, Area Resource File, InterStudy Health Maintenance Organization files, Current Population Survey, and Bureau of Primary Health Care data. Study Design We distinguished core and voluntary safety net hospitals in our analysis. Core safety net hospitals provide a large share of uncompensated care in their markets and have large indigent care patient mix. Voluntary safety net hospitals provide substantial indigent care but less so than core hospitals. We examined the effect of financial pressure in the initial year of the 1997 BBA on uncompensated care for three hospital groups. Data for 1996–2000 were analyzed using approaches that control for hospital and market heterogeneity. Data Collection/Extraction Methods All urban U.S. general acute care hospitals with complete data for at least 2 years between 1996 and 2000, which totaled 1,693 institutions. Principal Findings Core safety net hospitals reduced their uncompensated care in response to Medicaid financial pressure. Voluntary safety net hospitals also responded in this way but only when faced with the combined forces of Medicaid and private sector payment pressures. Nonsafety net hospitals did not exhibit similar responses. Conclusions Our results are consistent with theories of hospital behavior when institutions face reductions in payment. They raise concern given continuing state budget crises plus the focus of recent federal deficit reduction legislation intended to cut Medicaid expenditures. PMID:16899001

RIFM fragrance ingredient safety assessment, isobornyl isovalerate, CAS registry number 7779-73-9.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lapczynski, A; Liebler, D C; O'Brien, D; Parakhia, R; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2017-12-01

This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization potential, as well as, environmental safety. Data from the suitable read across analog isobornyl acetate (CAS # 125-12-2) show that this material is not genotoxic, provided a MOE > 100 for the repeated dose, developmental and reproductive endpoints, and does not have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (threshold of Toxicological Concern) for a Cramer Class II material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of an educational patient safety campaign on patients' safety behaviours and adverse events.

PubMed

Schwappach, David L B; Frank, Olga; Buschmann, Ute; Babst, Reto

2013-04-01

Rationale, aims and objectives  The study aims to investigate the effects of a patient safety advisory on patients' risk perceptions, perceived behavioural control, performance of safety behaviours and experience of adverse incidents. Method  Quasi-experimental intervention study with non-equivalent group comparison was used. Patients admitted to the surgical department of a Swiss large non-university hospital were included. Patients in the intervention group received a safety advisory at their first clinical encounter. Outcomes were assessed using a questionnaire at discharge. Odds ratios for control versus intervention group were calculated. Regression analysis was used to model the effects of the intervention and safety behaviours on the experience of safety incidents. Results  Two hundred eighteen patients in the control and 202 in the intervention group completed the survey (75 and 77% response rates, respectively). Patients in the intervention group were less likely to feel poorly informed about medical errors (OR = 0.55, P = 0.043). There were 73.1% in the intervention and 84.3% in the control group who underestimated the risk for infection (OR = 0.51, CI 0.31-0.84, P = 0.009). Perceived behavioural control was lower in the control group (meanCon  = 3.2, meanInt  = 3.5, P = 0.010). Performance of safety-related behaviours was unaffected by the intervention. Patients in the intervention group were less likely to experience any safety-related incident or unsafe situation (OR for intervention group = 0.57, CI 0.38-0.87, P = 0.009). There were no differences in concerns for errors during hospitalization. There were 96% of patients (intervention) who would recommend other patients to read the advisory. Conclusions  The results suggest that the safety advisory decreases experiences of adverse events and unsafe situations. It renders awareness and perceived behavioural control without increasing concerns for safety and can thus serve as a useful instrument for communication about safety between health care workers and patients. © 2012 Blackwell Publishing Ltd.

WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the sediment transport modeling task

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

Holt, V.L.; Baron, L.A.

1994-05-01

This site-specific Work Plan/Health and Safety Checklist (WP/HSC) is a supplement to the general health and safety plan (HASP) for Waste Area Grouping (WAG) 2 remedial investigation and site investigation (WAG 2 RI&SI) activities [Health and Safety Plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee (ORNL/ER-169)] and provides specific details and requirements for the WAG 2 RI&SI Sediment Transport Modeling Task. This WP/HSC identifies specific site operations, site hazards, and any recommendations by Oak Ridge National Laboratory (ORNL) health and safety organizations [i.e., Industrial Hygiene (IH),more » Health Physics (HP), and/or Industrial Safety] that would contribute to the safe completion of the WAG 2 RI&SI. Together, the general HASP for the WAG 2 RI&SI (ORNL/ER-169) and the completed site-specific WP/HSC meet the health and safety planning requirements specified by 29 CFR 1910.120 and the ORNL Hazardous Waste Operations and Emergency Response (HAZWOPER) Program Manual. In addition to the health and safety information provided in the general HASP for the WAG 2 RI&SI, details concerning the site-specific task are elaborated in this site-specific WP/HSC, and both documents, as well as all pertinent procedures referenced therein, will be reviewed by all field personnel prior to beginning operations.« less

Study on development and application of platform with students' safety based on SOA

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

RIFM fragrance ingredient safety assessment, 2-ethyl-1-hexanol, CAS registry number 104-76-7.

PubMed

Api, A M; Belsito, D; Bhatia, S; Bruze, M; Calow, P; Dagli, M L; Dekant, W; Fryer, A D; Kromidas, L; La Cava, S; Lalko, J F; Lapczynski, A; Liebler, D C; Penning, T M; Politano, V T; Ritacco, G; Salvito, D; Schultz, T W; Shen, J; Sipes, I G; Wall, B; Wilcox, D K

2016-11-01

The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic. Data from the suitable read across analog 2-butyloctan-1-ol (CAS # 3913-02-8) show that this material does not have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental and repeat dose toxicity endpoints were completed data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

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

Impact of the introduction of electronic prescribing on staff perceptions of patient safety and organizational culture.

PubMed

Davies, James; Pucher, Philip H; Ibrahim, Heba; Stubbs, Ben

2017-05-15

Electronic prescribing (EP) systems are online technology platforms by which medicines can be prescribed, administered, and stock controlled. The actual impact of EP on patient safety is not truly understood. This study seeks to assess the impact of the implementation of an EP system on safety culture, as well as assessing differences between clinical respondent groups and considering their implications. Staff completed a modified Safety Attitudes Questionnaire survey, 6 weeks following the introduction of EP across surgical services in a hospital in Dorset, England. Responses were assessed and differences between respondent groups compared. Rates of self-reported adverse events were compared before and after implementation. Overall response rate was 34.5%. There was no significant difference between usage patterns and previous experience with EP between user groups. Overall safety was felt to have been reduced by the introduction of EP. Significant differences between clinician and nonclinicians were seen in ability to discuss errors (3.23 ± 0.5 versus 2.8 ± 0.69, P = 0.004), drug chart access, and ease of medication prescribing. Regression analysis did not identify any confounding factors. Despite a significant reduction in the adverse event rate in other divisions of the hospital that did not implement EP at the same time, this same reduction was not seen in the surgical department. This is the first study to assess the impact of EP on safety culture using a validated assessment tool (Safety Attitudes Questionnaire). Overall safety culture deteriorated following introduction of EP. Problems with system usability/intuitiveness, nonstandardized implementation, and competence assessment strategies may have all contributed to this result. Centers seeking to implement EP in future must consider these factors to ensure a positive impact on patient safety and outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Discussion map and cooking classes: testing the effectiveness of teaching food safety to immigrants and refugees.

PubMed

Gold, Abby; Yu, Nan; Buro, Brandy; Garden-Robinson, Julie

2014-01-01

To evaluate the effectiveness of a food safety map as an educational method with English language learners. English language learner community members (n = 73) were assigned randomly to participate in 1 of 3 experimental conditions: food safety map, cooking class, and control. Participants in the food safety map and cooking class conditions completed a pre-education demographic and cooking history questionnaire, a post-education knowledge and intention questionnaire, and a 2-week post-cooking and food safety habits assessment. Participants in the control group received no educational training but completed the pre- and 2-week post-education assessments. The cooking class and the map class were both effective in increasing food safety knowledge. Specifically, by comparing with the control group, they significantly increased participants' knowledge of safely cooking large meat (χ² [df = 2, n = 66] = 40.87; P < .001; V* = .79) and correctly refrigerating cooked food (χ² [df = 2, n = 73] = 24.87, P < .001; V* = .58). The two class types generated similar positive educational effects on boosting food safety behavioral intention (measured right after the class). The data collected 2 weeks after the classes suggested that individuals who took the classes followed the suggested food behaviors more closely than those in the control group (P < .01). The food safety map is simple to use and prepare, beneficial for oral and visual learners, and inexpensive. Compared with a food safety cooking class, the map produces similar learning and behavioral outcomes. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

USDA's Corner

USDA-ARS?s Scientific Manuscript database

We have finally received funding for parts of a GLP compliant Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administered in feed to tilapia; we will again be working with the folks at AADAP on this study. A preliminary trial was completed in October/November to establi...

14 CFR 413.13 - Complete application.

Code of Federal Regulations, 2013 CFR

2013-01-01

... information required by this chapter, the FAA requires other information necessary for a determination that public health and safety, safety of property, and national security and foreign policy interests of the United States are protected during the conduct of a licensed or permitted activity, an applicant must...

14 CFR 413.13 - Complete application.

Code of Federal Regulations, 2012 CFR

2012-01-01

... information required by this chapter, the FAA requires other information necessary for a determination that public health and safety, safety of property, and national security and foreign policy interests of the United States are protected during the conduct of a licensed or permitted activity, an applicant must...

The Learning Needs of Older Adults.

ERIC Educational Resources Information Center

Purdie, Nola; Boulton-Lewis, Gillian

2003-01-01

Interviews with 17 older adults about learning needs and barriers resulted in a questionnaire completed by 160 elders. Most important needs were associated with transportation, health, and safety. Physical disabilities were the chief barrier. They felt most confident addressing health, safety, leisure, and transportation needs but not…

Safety improvement from edge lines on rural two-lane highways : tech summary.

DOT National Transportation Integrated Search

2012-01-01

The previous study "Impact of Edge Lines on Safety of Rural Two-Lane Highways" completed in 2005 concluded that, : with edge lines, centralization of a vehicle's position is more apparent during nighttime, which reduces the risk of runoff : -road (RO...

The 4Rs of Aquatic Rescue: educating the public about safety and risks of bystander rescue.

PubMed

Moran, Kevin; Webber, Jonathon; Stanley, Teresa

2017-09-01

From 1980 to 2014, 87 persons drowned in New Zealand while attempting to rescue others; all incidents occurred in open water and most (80%) fatalities were male. While bystander rescue has been promoted as a way of preventing drowning, little is known about the knowledge base that informs potential rescuers. This study utilized a family water safety programme to promote a resource entitled the 4Rs of Aquatic Rescue. Participants (n = 174) completed a pre-intervention survey and were then provided with information and access to electronic resources on safe bystander rescue techniques. Most respondents (71%) had never been taught rescue techniques, and males were more confident of their rescue ability. Upon completion of the programme, significant differences were evident in respondents' understanding of rescue safety, but this did not translate to greater confidence or disposition towards performing a rescue. Ways of promoting bystander safety around water are discussed and recommendations for future studies are made.

Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care.

PubMed

Alikani, Mina; Go, Kathryn J; McCaffrey, Caroline; McCulloh, David H

2014-11-01

To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction technology (ART) laboratory practice. Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for contemporary ART laboratory activities to determine adequate staffing levels. University-based and private ART programs. None. None. Human resource requirements for ART procedures. Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with the same requirements for the "traditional cycle" of the past. The latter required roughly 9 personnel hours, but a contemporary cycle can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel Calculator is introduced that can help determine staffing needs. The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human resources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a view to increasing the safety and efficiency of operations. The work could serve as the basis for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guidelines. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-09-01

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

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...

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

Introducing students to patient safety through an online interprofessional course.

PubMed

Blue, Amy V; Charles, Laurine; Howell, David; Koutalos, Yiannis; Mitcham, Maralynne; Nappi, Jean; Zoller, James

2010-01-01

Interprofessional education (IPE) is increasingly called upon to improve health care systems and patient safety. Our institution is engaged in a campus-wide IPE initiative. As a component of this initiative, a required online interprofessional patient-safety-focused course for a large group (300) of first-year medical, dental, and nursing students was developed and implemented. We describe our efforts with developing the course, including the use of constructivist and adult learning theories and IPE competencies to structure students' learning in a meaningful fashion. The course was conducted online to address obstacles of academic calendars and provide flexibility for faculty participation. Students worked in small groups online with a faculty facilitator. Thematic modules were created with associated objectives, online learning materials, and assignments. Students posted completed assignments online and responded to group members' assignments for purposes of group discussion. Students worked in interprofessional groups on a project requiring them to complete a root cause analysis and develop recommendations based on a fictional sentinel event case. Through project work, students applied concepts learned in the course related to improving patient safety and demonstrated interprofessional collaboration skills. Projects were presented during a final in-class session. Student course evaluation results suggest that learning objectives and content goals were achieved. Faculty course evaluation results indicate that the course was perceived to be a worthwhile learning experience for students. We offer the following recommendations to others interested in developing an in-depth interprofessional learning experience for a large group of learners: 1) consider a hybrid format (inclusion of some face-to-face sessions), 2) address IPE and broader curricular needs, 3) create interactive opportunities for shared learning and working together, 4) provide support to faculty facilitators, and 5) recognize your learners' educational level. The course has expanded to include students from additional programs for the current academic year.

Introducing students to patient safety through an online interprofessional course

PubMed Central

Blue, Amy V; Charles, Laurine; Howell, David; Koutalos, Yiannis; Mitcham, Maralynne; Nappi, Jean; Zoller, James

2010-01-01

Interprofessional education (IPE) is increasingly called upon to improve health care systems and patient safety. Our institution is engaged in a campus-wide IPE initiative. As a component of this initiative, a required online interprofessional patient-safety-focused course for a large group (300) of first-year medical, dental, and nursing students was developed and implemented. We describe our efforts with developing the course, including the use of constructivist and adult learning theories and IPE competencies to structure students’ learning in a meaningful fashion. The course was conducted online to address obstacles of academic calendars and provide flexibility for faculty participation. Students worked in small groups online with a faculty facilitator. Thematic modules were created with associated objectives, online learning materials, and assignments. Students posted completed assignments online and responded to group members’ assignments for purposes of group discussion. Students worked in interprofessional groups on a project requiring them to complete a root cause analysis and develop recommendations based on a fictional sentinel event case. Through project work, students applied concepts learned in the course related to improving patient safety and demonstrated interprofessional collaboration skills. Projects were presented during a final in-class session. Student course evaluation results suggest that learning objectives and content goals were achieved. Faculty course evaluation results indicate that the course was perceived to be a worthwhile learning experience for students. We offer the following recommendations to others interested in developing an in-depth interprofessional learning experience for a large group of learners: 1) consider a hybrid format (inclusion of some face-to-face sessions), 2) address IPE and broader curricular needs, 3) create interactive opportunities for shared learning and working together, 4) provide support to faculty facilitators, and 5) recognize your learners’ educational level. The course has expanded to include students from additional programs for the current academic year. PMID:23745069

Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp.

PubMed

Ly, Trang T; Breton, Marc D; Keith-Hynes, Patrick; De Salvo, Daniel; Clinton, Paula; Benassi, Kari; Mize, Benton; Chernavvsky, Daniel; Place, Jéróme; Wilson, Darrell M; Kovatchev, Boris P; Buckingham, Bruce A

2014-08-01

To determine the safety and efficacy of an automated unified safety system (USS) in providing overnight closed-loop (OCL) control in children and adolescents with type 1 diabetes attending diabetes summer camps. The Diabetes Assistant (DIAS) USS used the Dexcom G4 Platinum glucose sensor (Dexcom) and t:slim insulin pump (Tandem Diabetes Care). An initial inpatient study was completed for 12 participants to evaluate safety. For the main camp study, 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy (control conditions) per night over the course of a 5- to 6-day diabetes camp. Subjects completed 54 OCL nights and 52 control nights. On an intention-to-treat basis, with glucose data analyzed regardless of system status, the median percent time in range, from 70-150 mg/dL, was 62% (29, 87) for OCL nights versus 55% (25, 80) for sensor-augmented pump therapy (P = 0.233). A per-protocol analysis allowed for assessment of algorithm performance. The median percent time in range, from 70-150 mg/dL, was 73% (50, 89) for OCL nights (n = 41) versus 52% (24, 83) for control conditions (n = 39) (P = 0.037). There was less time spent in the hypoglycemic range <50, <60, and <70 mg/dL during OCL compared with the control period (P = 0.019, P = 0.009, and P = 0.023, respectively). The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Basset-Seguin, Nicole; Garbe, Claus; Gesierich, Anja; Lao, Christopher D; Miller, Chris; Mortier, Laurent; Murrell, Dedee F; Hamid, Omid; Quevedo, Jorge F; Hou, Jeannie; McKenna, Edward; Dimier, Natalie; Williams, Sarah; Schadendorf, Dirk; Hauschild, Axel

2017-05-16

In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC. One hundred four patients with measurable advanced BCC received oral vismodegib 150 mg once daily until disease progression or intolerable toxicity. The primary end point was IRF-assessed ORR. Secondary end points included ORR, duration of response (DOR), progression-free survival, overall survival (OS), and safety. At data cutoff (39 months after completion of accrual), 8 patients were receiving the study drug (69 patients in survival follow-up). Investigator-assessed ORR was 48.5% in the mBCC group (all partial responses) and 60.3% in the laBCC group (20 patients had complete response and 18 patients had partial response). ORRs were comparable across patient subgroups, including aggressive histologic subtypes (eg, infiltrative BCC). Median DOR was 14.8 months (mBCC) and 26.2 months (laBCC). Median OS was 33.4 months in the mBCC cohort and not estimable in the laBCC cohort. Adverse events remained consistent with clinical experience. Thirty-three deaths (31.7%) were reported; none were related to vismodegib. This long-term update of the ERIVANCE BCC trial demonstrated durability of response, efficacy across patient subgroups, and manageable long-term safety of vismodegib in patients with advanced BCC. This study was registered prospectively with Clinicaltrials.gov , number NCT00833417 on January 30, 2009.

Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial.

PubMed

Bohula, Erin A; Scirica, Benjamin M; Fanola, Christina; Inzucchi, Silvio E; Keech, Anthony; McGuire, Darren K; Smith, Steven R; Abrahamsen, Tim; Francis, Bruce H; Miao, Wenfeng; Perdomo, Carlos A; Satlin, Andrew; Wiviott, Stephen D; Sabatine, Marc S

2018-03-29

Lorcaserin, a selective serotonin 2C receptor agonist, is an effective pharmacologic weight-loss therapy that improves several cardiovascular risk factors. The long-term clinical cardiovascular and metabolic safety and efficacy in patients with elevated cardiovascular risk are unknown. CAMELLIA-TIMI 61 (NCT02019264) is a randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the safety and efficacy of lorcaserin with regard to major adverse cardiovascular events and progression to diabetes in overweight or obese patients at high cardiovascular risk. Overweight or obese patients either with established cardiovascular disease or with diabetes and at least 1 other cardiovascular risk factor were randomized in a 1:1 ratio to lorcaserin 10 mg twice daily or matching placebo. The primary safety objective is to assess for noninferiority of lorcaserin for the composite end point of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular event [MACE]) (with noninferiority defined as the upper bound of a 1-sided 97.5% CI excluding a hazard ratio of 1.4) compared with placebo assessed at an interim analysis with 460 adjudicated events. The efficacy objectives, assessed at study completion, will evaluate the superiority of lorcaserin for the primary composite end point of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, heart failure, or any coronary revascularization (MACE+) and the key secondary end point of conversion to diabetes. Recruitment began in January 2014 and was completed in November 2015 resulting in a total population of 12,000 patients. The trial is planned to continue until at least 1,401 adjudicated MACE+ events are accrued and the median treatment duration exceeds 2.5 years. CAMELLIA-TIMI 61 is investigating the safety and efficacy of lorcaserin for MACEs and conversion to diabetes in overweight or obese patients with established cardiovascular disease or multiple cardiovascular risk factors. Copyright © 2018. Published by Elsevier Inc.

Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

PubMed Central

Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

2013-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

PubMed

Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

2012-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

Human resource factors associated with workplace safety and health education of small manufacturing businesses in Korea.

PubMed

Park, Kyoung-Ok

2018-01-25

Human resources (HR) are essential indicators of safety and health (SH) status, and HR can be key sources of workplace safety management such as safety and health education at work (SHEW). This study analyzed significant HR factors associated with SHEW of small manufacturing businesses in Korea. The secondary data of the 2012 Korea Occupational Safety and Health Trend Survey were used to achieve this research purpose. A total of 2,089 supervisors or managers employed in the small manufacturing businesses completed the interview survey. Survey businesses were selected by multiple stratified sampling method based on industry code, business size, and region in Korea. The survey included workplace characteristics of HR and SHEW. SHEW was significantly related to business size, occupational injury incidence in the previous year, foreign and elderly worker employment, presence of site supervisors, and presence of SH committees (p <.05). SHEW for office workers, non-office workers, and newcomers was associated with business size, presence of site supervisors, and presence of SH committees in logistic regression analysis (p <.001). Businesses with 30-49 workers conducted SHEW 3.64 times more than did businesses with 5 to fewer than 10 workers. The companies that had occupational injuries in the previous year conducted SHEW 1.68 times more than the others. The businesses that had site supervisors and committees conducted SHEW 2.30 and 2.18 times more, respectively, than others. Site supervisors and SH committees were significant HR factors that improved SHEW in small manufacturing businesses.

Safety Analysis of Leishmania Vaccine Used in a Randomized Canine Vaccine/Immunotherapy Trial.

PubMed

Toepp, Angela; Larson, Mandy; Grinnage-Pulley, Tara; Bennett, Carolyne; Anderson, Michael; Parrish, Molly; Fowler, Hailie; Wilson, Geneva; Gibson-Corely, Katherine; Gharpure, Radhika; Cotter, Caitlin; Petersen, Christine

2018-05-01

In Leishmania infantum -endemic countries, controlling infection within dogs, the domestic reservoir, is critical to public health. There is a need for safe vaccines that prevent canine progression with disease and transmission to others. Protective vaccination against Leishmania requires mounting a strong, inflammatory, Type 1 response. Three commercially available canine vaccines on the global veterinary market use saponin or inflammatory antigen components (Letifend) as a strong pro-inflammatory adjuvant. There is very little information detailing safety of saponin as an adjuvant in field trials. Safety analyses for the use of vaccine as an immunotherapeutic in asymptomatically infected animals are completely lacking. Leishmania infantum , the causative agent of canine leishmaniasis, is enzootic within U.S. hunting hounds. We assessed the safety of LeishTec ® after use in dogs from two different clinical states: 1) without clinical signs and tested negative on polymerase chain reaction and serology or 2) without clinical signs and positive for at least one Leishmania diagnostic test. Vaccine safety was assessed after all three vaccinations to quantify the number and severity of adverse events. Vaccinated animals had an adverse event rate of 3.09%, whereas placebo animals had 0.68%. Receiving vaccine was correlated with the occurrence of mild, site-specific, reactions. Occurrence of severe adverse events was not associated with having received vaccine. Infected, asymptomatic animals did not have a higher rate of adverse events. Use of vaccination is, therefore, likely to be safe in infected, asymptomatic animals.

Inactivation and removal of influenza A virus H1N1 during the manufacture of plasma derivatives.

PubMed

Jeong, Eun Kyo; Sung, Hark Mo; Kim, In Seop

2010-11-01

Although transmission of pandemic influenza A virus H1N1 2009 is still occurring globally, little has been reported about how this outbreak has affected the safety of plasma derivatives. To evaluate the safety of plasma derivatives, dedicated virus clearance processes used during their production were investigated for their effectiveness in eliminating this virus of recent concern. In this study, influenza A virus H1N1 strain A/NWS/33 (H1N1) was chosen as a surrogate. H1N1 was completely inactivated by fraction IV fractionation as well as pasteurization during the manufacture of albumin. H1N1 was also effectively removed into the precipitate by fraction III fractionation and completely inactivated by low pH incubation as well as pasteurization during the manufacture of intravenous immunoglobulin. H1N1 was completely inactivated within 1 min of solvent/detergent treatment using 0.3% tri (n-butyl) phosphate and 1.0% Triton X-100 and also completely inactivated within 10 min of dry-heat treatment at 98 °C during the manufacture of factor VIII. H1N1 was completely removed by virus filtration process using Viresolve NFP filter and also completely inactivated by pasteurization during the manufacture of anti-thrombin III. These results indicate that all the virus clearance processes commonly used have sufficient H1N1 reducing capacity to achieve a high margin of safety. Copyright © 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Analysis of Loss-of-Coolant Accidents in the NIST Research Reactor - Early Phase

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

Baek, Joo S.; Diamond, David

A study of the fuel temperature during the early phase of a loss-of-coolant accident (LOCA) in the NIST research reactor (NBSR) was completed. Previous studies had been reported in the preliminary safety analysis report for the conversion of the NBSR from high-enriched uranium (HEU) fuel to low-enriched (LEU) fuel. Those studies had focused on the most vulnerable LOCA situation, namely, a double-ended guillotine break in the time period after reactor trip when water is drained from either the coolant channels inside the fuel elements or the region outside the fuel elements. The current study fills in a gap in themore » analysis which is the early phase of the event when there may still be water present but the reactor is at power or immediately after reactor trip and pumps have tripped. The calculations were done, for both the current HEU-fueled core and the proposed LEU core, with the TRACE thermal-hydraulic systems code. Several break locations and different break sizes were considered. In all cases the increase in the clad (or fuel meat) temperature was relatively small so that a large margin to the temperature threshold for blistering (the Safety Limit for the NBSR) remained.« less

Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study.

PubMed

Perl, Alexander E; Altman, Jessica K; Cortes, Jorge; Smith, Catherine; Litzow, Mark; Baer, Maria R; Claxton, David; Erba, Harry P; Gill, Stan; Goldberg, Stuart; Jurcic, Joseph G; Larson, Richard A; Liu, Chaofeng; Ritchie, Ellen; Schiller, Gary; Spira, Alexander I; Strickland, Stephen A; Tibes, Raoul; Ustun, Celalettin; Wang, Eunice S; Stuart, Robert; Röllig, Christoph; Neubauer, Andreas; Martinelli, Giovanni; Bahceci, Erkut; Levis, Mark

2017-08-01

Internal tandem duplication mutations in FLT3 are common in acute myeloid leukaemia and are associated with rapid relapse and short overall survival. The clinical benefit of FLT3 inhibitors in patients with acute myeloid leukaemia has been limited by rapid generation of resistance mutations, particularly in codon Asp835 (D835). We aimed to assess the highly selective oral FLT3 inhibitor gilteritinib in patients with relapsed or refractory acute myeloid leukaemia. In this phase 1-2 trial, we enrolled patients aged 18 years or older with acute myeloid leukaemia who either were refractory to induction therapy or had relapsed after achieving remission with previous treatment. Patients were enrolled into one of seven dose-escalation or dose-expansion cohorts assigned to receive once-daily doses of oral gilteritinib (20 mg, 40 mg, 80 mg, 120 mg, 200 mg, 300 mg, or 450 mg). Cohort expansion was based on safety and tolerability, FLT3 inhibition in correlative assays, and antileukaemic activity. Although the presence of an FLT3 mutation was not an inclusion criterion, we required ten or more patients with locally confirmed FLT3 mutations (FLT3 mut+ ) to be enrolled in expansion cohorts at each dose level. On the basis of emerging findings, we further expanded the 120 mg and 200 mg dose cohorts to include FLT3 mut+ patients only. The primary endpoints were the safety, tolerability, and pharmacokinetics of gilteritinib. Safety and tolerability were assessed in the safety analysis set (all patients who received at least one dose of gilteritinib). Responses were assessed in the full analysis set (all patients who received at least one dose of study drug and who had at least one datapoint post-treatment). Pharmacokinetics were assessed in a subset of the safety analysis set for which sufficient data for concentrations of gilteritinib in plasma were available to enable derivation of one or more pharmacokinetic variables. This study is registered with ClinicalTrials.gov, number NCT02014558, and is ongoing. Between Oct 15, 2013, and Aug 27, 2015, 252 adults with relapsed or refractory acute myeloid leukaemia received oral gilteritinib once daily in one of seven dose-escalation (n=23) or dose-expansion (n=229) cohorts. Gilteritinib was well tolerated; the maximum tolerated dose was established as 300 mg/day when two of three patients enrolled in the 450 mg dose-escalation cohort had two dose-limiting toxicities (grade 3 diarrhoea and grade 3 elevated aspartate aminotransferase). The most common grade 3-4 adverse events irrespective of relation to treatment were febrile neutropenia (97 [39%] of 252), anaemia (61 [24%]), thrombocytopenia (33 [13%]), sepsis (28 [11%]), and pneumonia (27 [11%]). Commonly reported treatment-related adverse events were diarrhoea (92 [37%] of 252]), anaemia (86 [34%]), fatigue (83 [33%]), elevated aspartate aminotransferase (65 [26%]), and increased alanine aminotransferase (47 [19%]). Serious adverse events occurring in 5% or more of patients were febrile neutropenia (98 [39%] of 252; five related to treatment), progressive disease (43 [17%]), sepsis (36 [14%]; two related to treatment), pneumonia (27 [11%]), acute renal failure (25 [10%]; five related to treatment), pyrexia (21 [8%]; three related to treatment), bacteraemia (14 [6%]; one related to treatment), and respiratory failure (14 [6%]). 95 people died in the safety analysis set, of which seven deaths were judged possibly or probably related to treatment (pulmonary embolism [200 mg/day], respiratory failure [120 mg/day], haemoptysis [80 mg/day], intracranial haemorrhage [20 mg/day], ventricular fibrillation [120 mg/day], septic shock [80 mg/day], and neutropenia [120 mg/day]). An exposure-related increase in inhibition of FLT3 phosphorylation was noted with increasing concentrations in plasma of gilteritinib. In-vivo inhibition of FLT3 phosphorylation occurred at all dose levels. At least 90% of FLT3 phosphorylation inhibition was seen by day 8 in most patients receiving a daily dose of 80 mg or higher. 100 (40%) of 249 patients in the full analysis set achieved a response, with 19 (8%) achieving complete remission, ten (4%) complete remission with incomplete platelet recovery, 46 (18%) complete remission with incomplete haematological recovery, and 25 (10%) partial remission INTERPRETATION: Gilteritinib had a favourable safety profile and showed consistent FLT3 inhibition in patients with relapsed or refractory acute myeloid leukaemia. These findings confirm that FLT3 is a high-value target for treatment of relapsed or refractory acute myeloid leukaemia; based on activity data, gilteritinib at 120 mg/day is being tested in phase 3 trials. Astellas Pharma, National Cancer Institute (Leukemia Specialized Program of Research Excellence grant), Associazione Italiana Ricerca sul Cancro. Copyright © 2017 Elsevier Ltd. All rights reserved.

Identifying knowledge activism in worker health and safety representation: A cluster analysis.

PubMed

Hall, Alan; Oudyk, John; King, Andrew; Naqvi, Syed; Lewchuk, Wayne

2016-01-01

Although worker representation in OHS has been widely recognized as contributing to health and safety improvements at work, few studies have examined the role that worker representatives play in this process. Using a large quantitative sample, this paper seeks to confirm findings from an earlier exploratory qualitative study that worker representatives can be differentiated by the knowledge intensive tactics and strategies that they use to achieve changes in their workplace. Just under 900 worker health and safety representatives in Ontario completed surveys which asked them to report on the amount of time they devoted to different types of representation activities (i.e., technical activities such as inspections and report writing vs. political activities such as mobilizing workers to build support), the kinds of conditions or hazards they tried to address through their representation (e.g., housekeeping vs. modifications in ventilation systems), and their reported success in making positive improvements. A cluster analysis was used to determine whether the worker representatives could be distinguished in terms of the relative time devoted to different activities and the clusters were then compared with reference to types of intervention efforts and outcomes. The cluster analysis identified three distinct groupings of representatives with significant differences in reported types of interventions and in their level of reported impact. Two of the clusters were consistent with the findings in the exploratory study, identified as knowledge activism for greater emphasis on knowledge based political activity and technical-legal representation for greater emphasis on formalized technical oriented procedures and legal regulations. Knowledge activists were more likely to take on challenging interventions and they reported more impact across the full range of interventions. This paper provides further support for the concepts of knowledge activism and technical-legal representation when differentiating the strategic orientations and impact of worker health and safety representatives, with important implications for education, political support and recruitment. © 2015 Wiley Periodicals, Inc.

Initiating Event Analysis of a Lithium Fluoride Thorium Reactor

NASA Astrophysics Data System (ADS)

Geraci, Nicholas Charles

The primary purpose of this study is to perform an Initiating Event Analysis for a Lithium Fluoride Thorium Reactor (LFTR) as the first step of a Probabilistic Safety Assessment (PSA). The major objective of the research is to compile a list of key initiating events capable of resulting in failure of safety systems and release of radioactive material from the LFTR. Due to the complex interactions between engineering design, component reliability and human reliability, probabilistic safety assessments are most useful when the scope is limited to a single reactor plant. Thus, this thesis will study the LFTR design proposed by Flibe Energy. An October 2015 Electric Power Research Institute report on the Flibe Energy LFTR asked "what-if?" questions of subject matter experts and compiled a list of key hazards with the most significant consequences to the safety or integrity of the LFTR. The potential exists for unforeseen hazards to pose additional risk for the LFTR, but the scope of this thesis is limited to evaluation of those key hazards already identified by Flibe Energy. These key hazards are the starting point for the Initiating Event Analysis performed in this thesis. Engineering evaluation and technical study of the plant using a literature review and comparison to reference technology revealed four hazards with high potential to cause reactor core damage. To determine the initiating events resulting in realization of these four hazards, reference was made to previous PSAs and existing NRC and EPRI initiating event lists. Finally, fault tree and event tree analyses were conducted, completing the logical classification of initiating events. Results are qualitative as opposed to quantitative due to the early stages of system design descriptions and lack of operating experience or data for the LFTR. In summary, this thesis analyzes initiating events using previous research and inductive and deductive reasoning through traditional risk management techniques to arrive at a list of key initiating events that can be used to address vulnerabilities during the design phases of LFTR development.

Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial.

PubMed

Hensley, Martee L; Patel, Shreyaskumar R; von Mehren, Margaret; Ganjoo, Kristen; Jones, Robin L; Staddon, Arthur; Rushing, Daniel; Milhem, Mohammed; Monk, Bradley; Wang, George; McCarthy, Sharon; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Demetri, George D

2017-09-01

Trabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%). Of 577 patients randomized 2:1 to receive trabectedin 1.5mg/m 2 by 24-hour IV infusion or dacarbazine 1g/m 2 by 20-120-minute IV infusion once every three weeks, 232 had uLMS (trabectedin: 144; dacarbazine: 88). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR: complete responses+partial responses+stable disease [SD] for at least 18weeks), duration of response (DOR), and safety. PFS for trabectedin was 4.0months compared with 1.5months for dacarbazine (hazard ratio [HR]=0.57; 95% CI 0.41-0.81; P=0.0012). OS was similar (trabectedin 13.4months vs. dacarbazine 12.9months, HR=0.89; 95% CI 0.65-1.24; P=0.51) between groups. ORR was 11% with trabectedin vs. 9% with dacarbazine (P=0.82). CBR for trabectedin was 31% vs. 18% with dacarbazine (P=0.05); median DOR was 6.5months for trabectedin vs. 4.1months for dacarbazine (P=0.32). Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients in the trabectedin group included transient aminotransferase (aspartate/alanine) elevations, anemia, leukopenia, and thrombocytopenia. In this post hoc subset analysis of patients with uLMS who had received prior anthracycline therapy, trabectedin treatment resulted in significantly longer PFS versus dacarbazine, with an acceptable safety profile. There was no difference in OS. Copyright © 2017. Published by Elsevier Inc.

Prospective Analysis of the Safety and Efficacy of Percutaneous Cryoablation for pT1NxMx Biopsy-Proven Renal Cell Carcinoma

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

Rodriguez, Ronald; Cizman, Ziga; Hong, Kelvin

2011-06-15

Purpose: Our objective was to determine the efficacy and safety of image-guided, percutaneous cryoablation for American Joint Committee on Cancer pT1ANxMx and pT1BNxMx biopsy-proven renal cell carcinoma (RCC). Materials and Methods: Computed tomography (CT)-guided, percutaneous cryoablation was used to treat 117 renal lesions in 113 consecutive patients with pT1NxMx RCC. All 117 ablations were included in the safety analysis, and complications were categorized according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Eighty-one lesions were biopsy-proven RCC and were included in the efficacy analysis. Technical success was defined as the 'ice-ball' covering the entire lesion plus amore » minimum 5-mm margin. Efficacy was defined as complete lack of enhancement and continuous decrease in size on subsequent follow-up imaging studies. Results: Technical success was 100%, with 15% of ablations requiring air or saline injection to prevent nontarget ablation. We recorded a 7% rate of clinically significant complications (CTCAE category {>=}2) and 0% mortality. Renal function was not adversely affected. Seventy percent of patients were discharged to home on the same day. Efficacy was 98.7% for a median follow-up of 67 weeks (range 7-172). For the subgroup of patients that reached a median follow-up of 2 (n = 59) and 3 years (n = 13), efficacy was 98.3 and 92.3%, respectively. Cancer specific survival was 100%. Conclusions: CT-guided, percutaneous cryoablation has an excellent safety and efficacy profile for stage T1A and T1B RCC; however, longer follow-up is needed to compare it with other nephron-sparing surgical treatments. It is a great option for nonsurgical patients, those in whom renal function cannot be further sacrificed, and those at risk for metachronous lesions.« less

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study

PubMed Central

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Background Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. Aim To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). Methods New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998–2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis – using only patients with complete data – and longitudinal MI – adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Results Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). Conclusion CC may substantially affect relative risk estimation in EMR-based drug safety studies, since missing data are not often completely at random. Little improvement was seen in these data in terms of power with the inclusion of longitudinal MI compared with cross-sectional MI. The strategy for handling missing data in drug safety studies can have a large impact on both risk estimates and precision.

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study.

PubMed

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998-2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis - using only patients with complete data - and longitudinal MI - adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). CC may substantially affect relative risk estimation in EMR-based drug safety studies, since missing data are not often completely at random. Little improvement was seen in these data in terms of power with the inclusion of longitudinal MI compared with cross-sectional MI. The strategy for handling missing data in drug safety studies can have a large impact on both risk estimates and precision.

Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

PubMed

Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

2015-03-01

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. © 2015 American Physical Therapy Association.

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

PubMed Central

Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

2015-01-01

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. PMID:25413621

Annual Safety Education Review 1972.

ERIC Educational Resources Information Center

American Association for Health, Physical Education, and Recreation, Washington, DC.

This booklet presents articles completed in 1972 by the Division of Safety Education of the American Association for Health, Physical Education, and Recreation. The introductory article contains the accomplishments of the division in 1971-72. The major points covered are planning conferences, conventions and meetings; revising the operating code…

Industry Leader Perceptions of Workplace Safety

ERIC Educational Resources Information Center

Dunlap, Erik Scott

2009-01-01

This study investigated the perceptions of workplace safety held by industry leaders who were near completion of a Master of Business Administration (MBA) degree. This was a qualitative study that utilized interpretivism as the theoretical framework. The study sought to answer four research questions. (1) How do participants conceptualize…

76 FR 33023 - Safety Advisory; Unauthorized Marking of Compressed Gas Cylinders

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

... cylinders. The cylinders were neither marked nor certified by an authorized independent inspection agency... mark, the cylinder did not undergo the complete series of safety tests and inspections required by the... contents under pressure during normal transportation and use. Extensive property damage, serious personal...

49 CFR 391.51 - General requirements for driver qualification files.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... Records § 391.51 General requirements for driver qualification files. (a) Each motor carrier shall...'s application for employment completed in accordance with § 391.21; (2) A copy of the motor vehicle...

Endoscopic papillectomy: risk factors for incomplete resection and recurrence during long-term follow-up.

PubMed

Ridtitid, Wiriyaporn; Tan, Damien; Schmidt, Suzette E; Fogel, Evan L; McHenry, Lee; Watkins, James L; Lehman, Glen A; Sherman, Stuart; Coté, Gregory A

2014-02-01

Endoscopic papillectomy is increasingly used as an alternative to surgery for ampullary adenomas and other noninvasive ampullary lesions. To measure short-term safety and efficacy of endoscopic papillectomy, define patient and lesion characteristics associated with incomplete endoscopic resection, and measure adenoma recurrence rates during long-term follow-up. Retrospective cohort study. Tertiary-care academic medical center. All patients who underwent endoscopic papillectomy for ampullary lesions between July 1995 and June 2012. Endoscopic papillectomy. Patient and lesion characteristics associated with incomplete endoscopic resection and ampullary adenoma-free survival analysis. We identified 182 patients who underwent endoscopic papillectomy, 134 (73.6%) having complete resection. Short-term adverse events occurred in 34 (18.7%). Risk factors for incomplete resection were jaundice at presentation (odds ratio [OR] 0.21; 95% confidence interval [CI] 0.07-0.69; P = .009), occult adenocarcinoma (OR 0.06; 95% CI, 0.01-0.36; P = .002), and intraductal involvement (OR 0.29; 95% CI, 0.11-0.75; P = .011). The en bloc resection technique was strongly associated with a higher rate of complete resection (OR 4.05; 95% CI, 1.71-9.59; P = .001). Among patients with ampullary adenoma who had complete resection (n = 107), 16 patients (15%) developed recurrence up to 65 months after resection. Retrospective analysis. Jaundice at presentation, occult adenocarcinoma in the resected specimen, and intraductal involvement are associated with a lower rate of complete resection, whereas en bloc papillectomy increases the odds of complete endoscopic resection. Despite complete resection, recurrence was observed up to 5 years after papillectomy, confirming the need for long-term surveillance. Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Interim report cyanide safety studies

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

Burger, L.L.; Scheele, R.D.

1988-09-30

Over the past few years several proposals have been prepared to investigate the potential hazard of ferrocyanide-nitrate reactions that may occur in some Hanford waste tanks. In 1988 Westinghouse Hanford Company (WHC) decided to perform some of the suggested experimental work. Based on the proposal submitted in July, 1988, it was agreed to do a portion of the work during FY 1988. This report summarizes the results of that work, provides a preliminary analysis of the results, and includes recommendations for further study. The work completed consists of a brief literature search, preparation and analysis of several cesium nickel ferrocyanide,more » Cs{sub 2}NiFe(CN){sub 6}, oxdiation studies using Differential Scanning Calorimetry (DSC) and Thermogravimetry (TG), and small scale explosion tests.« less

Analysis of routine pilot-controller communication

NASA Technical Reports Server (NTRS)

Morrow, Daniel G.; Lee, Alfred; Rodvold, Michelle

1990-01-01

Although pilot-controller communication is central to aviation safety, this area of aviation human factors has not been extensively researched. Most research has focused on what kinds of communication problems occur. A more complete picture of communication problems requires understanding how communication usually works in routine operations. A sample of routine pilot-controller communication in the TRACON environment is described. After describing several dimensions of routine communication, three kinds of communication problems are treated: inaccuracies such as incorrect readbacks, procedural deviations such as missing callsigns and readbacks, and nonroutine transactions where pilot and controller must deal with misunderstandings or other communication problems. Preliminary results suggest these problems are not frequent events in daily operations. However, analysis of the problems that do occur suggest some factors that may cause them.

Phase II evaluation of LY2603618, a first-generation CHK1 inhibitor, in combination with pemetrexed in patients with advanced or metastatic non-small cell lung cancer.

PubMed

Scagliotti, Giorgio; Kang, Jin Hyoung; Smith, David; Rosenberg, Richard; Park, Keunchil; Kim, Sang-We; Su, Wu-Chou; Boyd, Thomas E; Richards, Donald A; Novello, Silvia; Hynes, Scott M; Myrand, Scott P; Lin, Ji; Smyth, Emily Nash; Wijayawardana, Sameera; Lin, Aimee Bence; Pinder-Schenck, Mary

2016-10-01

Introduction LY2603618 is a selective inhibitor of checkpoint kinase 1 (CHK1) protein kinase, a key regulator of the DNA damage checkpoint, and is predicted to enhance the effects of antimetabolites, such as pemetrexed. This phase II trial assessed the overall response rate, safety, and pharmacokinetics (PK) of LY2603618 and pemetrexed in patients with non-small cell lung cancer (NSCLC). Methods In this open-label, single-arm trial, patients with advanced or metastatic NSCLC progressing after a prior first-line treatment regimen (not containing pemetrexed) and Eastern Cooperative Oncology Group performance status ≤2 received pemetrexed (500 mg/m(2), day 1) and LY2603618 (150 mg/m(2), day 2) every 21 days until disease progression. Safety was assessed using Common Terminology Criteria for Adverse Events v3.0. Serial blood samples were collected for PK analysis after LY2603618 and pemetrexed administration. Expression of p53, as measured by immunohistochemistry and genetic variant analysis, was assessed as a predictive biomarker of response. Results Fifty-five patients were enrolled in the study. No patients experienced a complete response; a partial response was observed in 5 patients (9.1 %; 90 % CI, 3.7-18.2) and stable disease in 20 patients (36.4 %). The median progression-free survival was 2.3 months (range, 0-27.1). Safety and PK of LY2603618 in combination with pemetrexed were favorable. No association between p53 status and response was observed. Conclusions There was no significant clinical activity of LY2603618 and pemetrexed combination therapy in patients with advanced NSCLC. The results were comparable with historical pemetrexed single-agent data, with similar safety and PK profiles being observed.

Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients.

PubMed

Turon, Marc; Fernandez-Gonzalo, Sol; Jodar, Mercè; Gomà, Gemma; Montanya, Jaume; Hernando, David; Bailón, Raquel; de Haro, Candelaria; Gomez-Simon, Victor; Lopez-Aguilar, Josefina; Magrans, Rudys; Martinez-Perez, Melcior; Oliva, Joan Carles; Blanch, Lluís

2017-12-01

Growing evidence suggests that critical illness often results in significant long-term neurocognitive impairments in one-third of survivors. Although these neurocognitive impairments are long-lasting and devastating for survivors, rehabilitation rarely occurs during or after critical illness. Our aim is to describe an early neurocognitive stimulation intervention based on virtual reality for patients who are critically ill and to present the results of a proof-of-concept study testing the feasibility, safety, and suitability of this intervention. Twenty critically ill adult patients undergoing or having undergone mechanical ventilation for ≥24 h received daily 20-min neurocognitive stimulation sessions when awake and alert during their ICU stay. The difficulty of the exercises included in the sessions progressively increased over successive sessions. Physiological data were recorded before, during, and after each session. Safety was assessed through heart rate, peripheral oxygen saturation, and respiratory rate. Heart rate variability analysis, an indirect measure of autonomic activity sensitive to cognitive demands, was used to assess the efficacy of the exercises in stimulating attention and working memory. Patients successfully completed the sessions on most days. No sessions were stopped early for safety concerns, and no adverse events occurred. Heart rate variability analysis showed that the exercises stimulated attention and working memory. Critically ill patients considered the sessions enjoyable and relaxing without being overly fatiguing. The results in this proof-of-concept study suggest that a virtual-reality-based neurocognitive intervention is feasible, safe, and tolerable, stimulating cognitive functions and satisfying critically ill patients. Future studies will evaluate the impact of interventions on neurocognitive outcomes. Trial registration Clinical trials.gov identifier: NCT02078206.

Calculation of the state of safety (SOS) for lithium ion batteries

NASA Astrophysics Data System (ADS)

Cabrera-Castillo, Eliud; Niedermeier, Florian; Jossen, Andreas

2016-08-01

As lithium ion batteries are adopted in electric vehicles and stationary storage applications, the higher number of cells and greater energy densities increases the risks of possible catastrophic events. This paper shows a definition and method to calculate the state of safety of an energy storage system based on the concept that safety is inversely proportional to the concept of abuse. As the latter increases, the former decreases to zero. Previous descriptions in the literature are qualitative in nature but don't provide a numerical quantification of the safety of a storage system. In the case of battery testing standards, they only define pass or fail criteria. The proposed state uses the same range as other commonly used state quantities like the SOC, SOH, and SOF, taking values between 0, completely unsafe, and 1, completely safe. The developed function combines the effects of an arbitrary number of subfunctions, each of which describes a particular case of abuse, in one or more variables such as voltage, temperature, or mechanical deformation, which can be detected by sensors or estimated by other techniques. The state of safety definition can be made more general by adding new subfunctions, or by refining the existing ones.

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

Curative embolization of pediatric intracranial arteriovenous malformations using Onyx: the role of new embolization techniques on patient outcomes.

PubMed

de Castro-Afonso, L H; Nakiri, G S; Oliveira, R S; Santos, M V; Santos, A C Dos; Machado, H R; Abud, D G

2016-06-01

Intracranial arteriovenous malformations (AVMs) are the most frequent cause of hemorrhagic strokes in the pediatric population. The study aim was to retrospectively assess the safety and efficacy of Onyx embolization with the intention to cure AVMs in a pediatric population. A retrospective analysis of all patients (<18 years) who underwent endovascular embolization using Onyx at our institution was conducted. The primary endpoint was the composite complete angiographic occlusion of AVM immediately after the last embolization session that had no procedure-related complication requiring emergency surgery. Secondary endpoints were angiographic occlusion rates, procedure-related complications, and clinical outcomes after treatment and at the 6-month follow-up Twenty-three patients (mean age, 11.7 years) underwent a total of 45 embolization sessions. The median Spetzler-Martin grade was 3 (range 1 to 4). The primary endpoint was achieved in 19 patients (82.6 %). Complete angiographic occlusion of the AVM was obtained in 21 patients (91.3 %) immediately after embolization and at the 6-month follow-up. Embolization-related complications were observed in three patients (13 %). None of the complications resulted in permanent functional disability or death. In two patients (8.7 %), the AVM could not be completely occluded by embolization alone and the patients were referred to radiosurgery and microsurgery, respectively. Onyx embolization of AVM in pediatric patients with the intention to cure resulted in high occlusion rates without increasing neurological disability or death. The development of new embolization techniques and devices seems to improve the safety of Onyx embolization.

Reversal of succinylcholine induced apnea with an organophosphate scavenging recombinant butyrylcholinesterase.

PubMed

Geyer, Brian C; Larrimore, Katherine E; Kilbourne, Jacquelyn; Kannan, Latha; Mor, Tsafrir S

2013-01-01

Concerns about the safety of paralytics such as succinylcholine to facilitate endotracheal intubation limit their use in prehospital and emergency department settings. The ability to rapidly reverse paralysis and restore respiratory drive would increase the safety margin of an agent, thus permitting the pursuit of alternative intubation strategies. In particular, patients who carry genetic or acquired deficiency of butyrylcholinesterase, the serum enzyme responsible for succinylcholine hydrolysis, are susceptible to succinylcholine-induced apnea, which manifests as paralysis, lasting hours beyond the normally brief half-life of succinylcholine. We hypothesized that intravenous administration of plant-derived recombinant BChE, which also prevents mortality in nerve agent poisoning, would rapidly reverse the effects of succinylcholine. Recombinant butyrylcholinesterase was produced in transgenic plants and purified. Further analysis involved murine and guinea pig models of succinylcholine toxicity. Animals were treated with lethal and sublethal doses of succinylcholine followed by administration of butyrylcholinesterase or vehicle. In both animal models vital signs and overall survival at specified intervals post succinylcholine administration were assessed. Purified plant-derived recombinant human butyrylcholinesterase can hydrolyze succinylcholine in vitro. Challenge of mice with an LD100 of succinylcholine followed by BChE administration resulted in complete prevention of respiratory inhibition and concomitant mortality. Furthermore, experiments in symptomatic guinea pigs demonstrated extremely rapid succinylcholine detoxification with complete amelioration of symptoms and no apparent complications. Recombinant plant-derived butyrylcholinesterase was capable of counteracting and reversing apnea in two complementary models of lethal succinylcholine toxicity, completely preventing mortality. This study of a protein antidote validates the feasibility of protection and treatment of overdose from succinylcholine as well as other biologically active butyrylcholinesterase substrates.

Multicenter review of robotic versus laparoscopic ventral hernia repair: is there a role for robotics?

PubMed

Walker, Peter A; May, Audriene C; Mo, Jiandi; Cherla, Deepa V; Santillan, Monica Rosales; Kim, Steven; Ryan, Heidi; Shah, Shinil K; Wilson, Erik B; Tsuda, Shawn

2018-04-01

The utilization of robotic platforms for general surgery procedures such as hernia repair is growing rapidly in the United States. A limited amount of data are available evaluating operative outcomes in comparison to standard laparoscopic surgery. We completed a retrospective review comparing robotic and laparoscopic ventral hernia repair to provide safety and outcomes data to help design a future prospective trial design. A retrospective review of 215 patients undergoing ventral hernia repair (142 robotic and 73 laparoscopic) was completed at two large academic centers. Primary outcome measure evaluated was recurrence. Secondary outcomes included incidence of primary fascial closure, and surgical site occurrences. Propensity for treatment match comparison demonstrated that robotic repair was associated with a decreased incidence of recurrence (2.1 versus 4.2%, p < 0.001) and surgical site occurrence (4.2 versus 18.8%, p < 0.001). This may be because robotic repair was associated with increased incidence of primary fascial closure (77.1 versus 66.7%, p < 0.01). Analysis of baseline patient populations showed that robotic repairs were completed on patients with lower body mass index (28.1 ± 3.6 versus 34.2 ± 6.4, p < 0.001) and fewer comorbidities. Our retrospective data show that robotic repair was associated with decreased recurrence and surgical site occurrence. However, the differences noted in the patient populations limit the interpretability of these results. As adoption of robotic ventral hernia repair increases, prospective trials need to be designed in order to investigate the efficacy, safety, and cost effectiveness of this evolving technique.

Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2.

PubMed

Oza, Amit M; Tinker, Anna V; Oaknin, Ana; Shapira-Frommer, Ronnie; McNeish, Iain A; Swisher, Elizabeth M; Ray-Coquard, Isabelle; Bell-McGuinn, Katherine; Coleman, Robert L; O'Malley, David M; Leary, Alexandra; Chen, Lee-May; Provencher, Diane; Ma, Ling; Brenton, James D; Konecny, Gottfried E; Castro, Cesar M; Giordano, Heidi; Maloney, Lara; Goble, Sandra; Lin, Kevin K; Sun, James; Raponi, Mitch; Rolfe, Lindsey; Kristeleit, Rebecca S

2017-11-01

An integrated analysis was undertaken to characterize the antitumor activity and safety profile of the oral poly(ADP-ribose) polymerase inhibitor rucaparib in patients with relapsed high-grade ovarian carcinoma (HGOC). Eligible patients from Study 10 (NCT01482715) and ARIEL2 (NCT01891344) who received a starting dose of oral rucaparib 600mg twice daily (BID) with or without food were included in these analyses. The integrated efficacy population included patients with HGOC and a deleterious germline or somatic BRCA1 or BRCA2 (BRCA1/2) mutation who received at least two prior chemotherapies and were sensitive, resistant, or refractory to platinum-based chemotherapy. The primary endpoint was investigator-assessed confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR) and progression-free survival (PFS). The integrated safety population included patients with HGOC who received at least one dose of rucaparib 600mg BID, irrespective of BRCA1/2 mutation status and prior treatments. In the efficacy population (n=106), ORR was 53.8% (95% confidence interval [CI], 43.8-63.5); 8.5% and 45.3% of patients achieved complete and partial responses, respectively. Median DOR was 9.2months (95% CI, 6.6-11.6). In the safety population (n=377), the most frequent treatment-emergent adverse events (AEs) were nausea, asthenia/fatigue, vomiting, and anemia/hemoglobin decreased. The most common grade ≥3 treatment-emergent AE was anemia/hemoglobin decreased. Treatment-emergent AEs led to treatment interruption, dose reduction, and treatment discontinuation in 58.6%, 45.9%, and 9.8% of patients, respectively. No treatment-related deaths occurred. Rucaparib has antitumor activity in advanced BRCA1/2-mutated HGOC and a manageable safety profile. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of an active learning module to teach hazard and risk in Hazard Analysis and Critical Control Points (HACCP) classes.

PubMed

Oyarzabal, Omar A; Rowe, Ellen

2017-04-01

The terms hazard and risk are significant building blocks for the organization of risk-based food safety plans. Unfortunately, these terms are not clear for some personnel working in food manufacturing facilities. In addition, there are few examples of active learning modules for teaching adult participants the principles of hazard analysis and critical control points (HACCP). In this study, we evaluated the effectiveness of an active learning module to teach hazard and risk to participants of HACCP classes provided by the University of Vermont Extension in 2015 and 2016. This interactive module is comprised of a questionnaire; group playing of a dice game that we have previously introduced in the teaching of HACCP; the discussion of the terms hazard and risk; and a self-assessment questionnaire to evaluate the teaching of hazard and risk. From 71 adult participants that completed this module, 40 participants (56%) provided the most appropriate definition of hazard, 19 participants (27%) provided the most appropriate definition of risk, 14 participants (20%) provided the most appropriate definitions of both hazard and risk, and 23 participants (32%) did not provide an appropriate definition for hazard or risk. Self-assessment data showed an improvement in the understanding of these terms (P < 0.05). Thirty participants (42%) stated that the most valuable thing they learned with this interactive module was the difference between hazard and risk, and 40 participants (65%) responded that they did not attend similar presentations in the past. The fact that less than one third of the participants answered properly to the definitions of hazard and risk at baseline is not surprising. However, these results highlight the need for the incorporation of modules to discuss these important food safety terms and include more active learning modules to teach food safety classes. This study suggests that active learning helps food personnel better understand important food safety terms that serve as building blocks for the understanding of more complex food safety topics.

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

PubMed Central

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

2016-01-01

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