Evaluating the safety effects of signal improvements.

DOT National Transportation Integrated Search

2013-08-01

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

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

PubMed

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

2013-06-22

Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously. Netherlands Trial Register (NTR): NTR3343.

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

PubMed

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

2018-06-15

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

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety

PubMed Central

Waterson, Patrick; Robertson, Michelle M.; Cooke, Nancy J.; Militello, Laura; Roth, Emilie; Stanton, Neville A.

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. Practitioner Summary: We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a ‘roadmap’ for future work. PMID:25832121

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

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

PubMed

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

2016-08-17

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

Expert opinions on the acceptance of alternative methods in food safety evaluations: Formulating recommendations to increase acceptance of non-animal methods for kinetics.

PubMed

Punt, Ans; Bouwmeester, Hans; Schiffelers, Marie-Jeanne W A; Peijnenburg, Ad A C M

2018-02-01

Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.

PubMed

Goebel, Carsten; Aeby, Pierre; Ade, Nadège; Alépée, Nathalie; Aptula, Aynur; Araki, Daisuke; Dufour, Eric; Gilmour, Nicola; Hibatallah, Jalila; Keller, Detlef; Kern, Petra; Kirst, Annette; Marrec-Fairley, Monique; Maxwell, Gavin; Rowland, Joanna; Safford, Bob; Schellauf, Florian; Schepky, Andreas; Seaman, Chris; Teichert, Thomas; Tessier, Nicolas; Teissier, Silvia; Weltzien, Hans Ulrich; Winkler, Petra; Scheel, Julia

2012-06-01

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. Copyright © 2012 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2014-01-01

Vaccines are beneficial and universal tools to prevent infectious disease. Thus, safety of vaccines is strictly evaluated in the preclinical phase of trials and every vaccine batch must be tested by the National Control Laboratories according to the guidelines published by each country. Despite many vaccine production platforms and methods, animal testing for safety evaluation is unchanged thus far. We recently developed a systems biological approach to vaccine safety evaluation where identification of specific biomarkers in a rat pre-clinical study evaluated the safety of vaccines for pandemic H5N1 influenza including Irf7, Lgals9, Lgalsbp3, Cxcl11, Timp1, Tap2, Psmb9, Psme1, Tapbp, C2, Csf1, Mx2, Zbp1, Ifrd1, Trafd1, Cxcl9, β2m, Npc1, Ngfr and Ifi47. The current study evaluated whether these 20 biomarkers could evaluate the safety, batch-to-batch and manufacturer-to-manufacturer consistency of seasonal trivalent influenza vaccine using a multiplex gene detection system. When we evaluated the influenza HA vaccine (HAv) from four different manufactures, the biomarker analysis correlated to findings from conventional animal use tests, such as abnormal toxicity test. In addition, sensitivity of toxicity detection and differences in HAvs were higher and more accurate than with conventional methods. Despite a slight decrease in body weight caused by HAv from manufacturer B that was not statistically significant, our results suggest that HAv from manufacturer B is significantly different than the other HAvs tested with regard to Lgals3bp, Tapbp, Lgals9, Irf7 and C2 gene expression in rat lungs. Using the biomarkers confirmed in this study, we predicted batch-to-batch consistency and safety of influenza vaccines within 2 days compared with the conventional safety test, which takes longer. These biomarkers will facilitate the future development of new influenza vaccines and provide an opportunity to develop in vitro methods of evaluating batch-to-batch consistency and vaccine safety as an alternative to animal testing. PMID:25010690

Evaluation of Vacuum Blasting and Heat Guns as Methods for Abating Lead- Based Paint on Buildings

DTIC Science & Technology

1993-09-01

INCOMPATIBILITY - Contact with powerful oxidizing agents such as FLUORINE, CHLORINE TRIFLUORIDE , MANGANESE TRIOXIDE, OXYGEN DIFLUORIDE, MANGANESE...investigating new technologies for lead-based paint abatement. This research evaluates the effectiveness , safety, LEC1L•.T• and cost of vacuum abrasive...paint abatement. This research evaluates the effectiveness , safety, and cost of vacuum abrasive units and heat guns as methods of removing lead-based

Cycling transport safety quantification

NASA Astrophysics Data System (ADS)

Drbohlav, Jiri; Kocourek, Josef

2018-05-01

Dynamic interest in cycling transport brings the necessity to design safety cycling infrastructure. In las few years, couple of norms with safety elements have been designed and suggested for the cycling infrastructure. But these were not fully examined. The main parameter of suitable and fully functional transport infrastructure is the evaluation of its safety. Common evaluation of transport infrastructure safety is based on accident statistics. These statistics are suitable for motor vehicle transport but unsuitable for the cycling transport. Cycling infrastructure evaluation of safety is suitable for the traffic conflicts monitoring. The results of this method are fast, based on real traffic situations and can be applied on any traffic situations.

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

PubMed

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

2011-03-01

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

Evaluating Performance of Highway Safety Projects

DOT National Transportation Integrated Search

2016-12-01

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

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

PubMed

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

2014-02-01

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

Connecticut Department of Transportation safety techniques enhancement plan.

DOT National Transportation Integrated Search

2015-03-15

The Highway Safety Manual (HSM) defines a six-step cycle of safety management processes. This report evaluates the : Conncituct Department on how well conform to the six safety management steps. The methods recommended in the HSM : require additional...

Usability evaluation of a medication reconciliation tool: Embedding safety probes to assess users' detection of medication discrepancies.

PubMed

Russ, Alissa L; Jahn, Michelle A; Patel, Himalaya; Porter, Brian W; Nguyen, Khoa A; Zillich, Alan J; Linsky, Amy; Simon, Steven R

2018-06-01

An electronic medication reconciliation tool was previously developed by another research team to aid provider-patient communication for medication reconciliation. To evaluate the usability of this tool, we integrated artificial safety probes into standard usability methods. The objective of this article is to describe this method of using safety probes, which enabled us to evaluate how well the tool supports users' detection of medication discrepancies. We completed a mixed-method usability evaluation in a simulated setting with 30 participants: 20 healthcare professionals (HCPs) and 10 patients. We used factual scenarios but embedded three artificial safety probes: (1) a missing medication (i.e., omission); (2) an extraneous medication (i.e., commission); and (3) an inaccurate dose (i.e., dose discrepancy). We measured users' detection of each probe to estimate the probability that a HCP or patient would detect these discrepancies. Additionally, we recorded participants' detection of naturally occurring discrepancies. Each safety probe was detected by ≤50% of HCPs. Patients' detection rates were generally higher. Estimates indicate that a HCP and patient, together, would detect 44.8% of these medication discrepancies. Additionally, HCPs and patients detected 25 and 45 naturally-occurring discrepancies, respectively. Overall, detection of medication discrepancies was low. Findings indicate that more advanced interface designs are warranted. Future research is needed on how technologies can be designed to better aid HCPs' and patients' detection of medication discrepancies. This is one of the first studies to evaluate the usability of a collaborative medication reconciliation tool and assess HCPs' and patients' detection of medication discrepancies. Results demonstrate that embedded safety probes can enhance standard usability methods by measuring additional, clinically-focused usability outcomes. The novel safety probes we used may serve as an initial, standard set for future medication reconciliation research. More prevalent use of safety probes could strengthen usability research for a variety of health information technologies. Published by Elsevier Inc.

Method of Evaluating the Life Cycle Cost of Small Earth Dams Considering the Risk of Heavy Rainfall and Selection Method of the Optimum Countermeasure

NASA Astrophysics Data System (ADS)

Hori, Toshikazu; Mohri, Yoshiyuki; Matsushima, Kenichi; Ariyoshi, Mitsuru

In recent years the increase in the number of heavy rainfall occurrences such as through unpredictable cloudbursts have resulted in the safety of the embankments of small earth dams needing to be improved. However, the severe financial condition of the government and local autonomous bodies necessitate the cost of improving them to be reduced. This study concerns the development of a method of evaluating the life cycle cost of small earth dams considered to pose a risk and in order to improve the safety of the downstream areas of small earth dams at minimal cost. Use of a safety evaluation method that is based on a combination of runoff analysis, saturated and unsaturated seepage analysis, and slope stability analysis enables the probability of a dam breach and its life cycle cost with the risk of heavy rainfall taken into account to be calculated. Moreover, use of the life cycle cost evaluation method will lead to the development of a technique for selecting the method of the optimal improvement or countermeasures against heavy rainfall.

Canadian Pacific Railway Investigation of Safety-Related Occurrences Protocol considered helpful by both labor and management.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program sponsored an Alternative Safety Measures Program designed to explore alternative methods for evaluating whether safety programs improve safety outcomes and...

Canadian Pacific Railway mechanical services' 5-Alive safety program shows promise in reducing injuries.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program is sponsoring an Alternative Safety Measures Program to explore alternative methods for evaluating whether safety programs improve safety outcomes and the ...

[Industry regulation and its relationship to the rapid marketing of medical devices].

PubMed

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

The Use of Theatre Tours in Road Safety Education.

ERIC Educational Resources Information Center

Powney, Janet; And Others

The Scottish Road Safety Campaign and the Road Safety Council of Wales have made a large investment in theater tours as a method of providing road safety education. This study aimed to evaluate the effectiveness of a road safety message delivered by a theater group, Road Safety Officers (RSOs), or, teachers for pupils in upper secondary classes.…

On Some Methods in Safety Evaluation in Geotechnics

NASA Astrophysics Data System (ADS)

Puła, Wojciech; Zaskórski, Łukasz

2015-06-01

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

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

PubMed

Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

2006-04-01

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

Study on the evaluation method for fault displacement based on characterized source model

NASA Astrophysics Data System (ADS)

Tonagi, M.; Takahama, T.; Matsumoto, Y.; Inoue, N.; Irikura, K.; Dalguer, L. A.

2016-12-01

In IAEA Specific Safety Guide (SSG) 9 describes that probabilistic methods for evaluating fault displacement should be used if no sufficient basis is provided to decide conclusively that the fault is not capable by using the deterministic methodology. In addition, International Seismic Safety Centre compiles as ANNEX to realize seismic hazard for nuclear facilities described in SSG-9 and shows the utility of the deterministic and probabilistic evaluation methods for fault displacement. In Japan, it is required that important nuclear facilities should be established on ground where fault displacement will not arise when earthquakes occur in the future. Under these situations, based on requirements, we need develop evaluation methods for fault displacement to enhance safety in nuclear facilities. We are studying deterministic and probabilistic methods with tentative analyses using observed records such as surface fault displacement and near-fault strong ground motions of inland crustal earthquake which fault displacements arose. In this study, we introduce the concept of evaluation methods for fault displacement. After that, we show parts of tentative analysis results for deterministic method as follows: (1) For the 1999 Chi-Chi earthquake, referring slip distribution estimated by waveform inversion, we construct a characterized source model (Miyake et al., 2003, BSSA) which can explain observed near-fault broad band strong ground motions. (2) Referring a characterized source model constructed in (1), we study an evaluation method for surface fault displacement using hybrid method, which combines particle method and distinct element method. At last, we suggest one of the deterministic method to evaluate fault displacement based on characterized source model. This research was part of the 2015 research project `Development of evaluating method for fault displacement` by the Secretariat of Nuclear Regulation Authority (S/NRA), Japan.

Unmanned aircraft system sense and avoid integrity and continuity

NASA Astrophysics Data System (ADS)

Jamoom, Michael B.

This thesis describes new methods to guarantee safety of sense and avoid (SAA) functions for Unmanned Aircraft Systems (UAS) by evaluating integrity and continuity risks. Previous SAA efforts focused on relative safety metrics, such as risk ratios, comparing the risk of using an SAA system versus not using it. The methods in this thesis evaluate integrity and continuity risks as absolute measures of safety, as is the established practice in commercial aircraft terminal area navigation applications. The main contribution of this thesis is a derivation of a new method, based on a standard intruder relative constant velocity assumption, that uses hazard state estimates and estimate error covariances to establish (1) the integrity risk of the SAA system not detecting imminent loss of '"well clear," which is the time and distance required to maintain safe separation from intruder aircraft, and (2) the probability of false alert, the continuity risk. Another contribution is applying these integrity and continuity risk evaluation methods to set quantifiable and certifiable safety requirements on sensors. A sensitivity analysis uses this methodology to evaluate the impact of sensor errors on integrity and continuity risks. The penultimate contribution is an integrity and continuity risk evaluation where the estimation model is refined to address realistic intruder relative linear accelerations, which goes beyond the current constant velocity standard. The final contribution is an integrity and continuity risk evaluation addressing multiple intruders. This evaluation is a new innovation-based method to determine the risk of mis-associating intruder measurements. A mis-association occurs when the SAA system incorrectly associates a measurement to the wrong intruder, causing large errors in the estimated intruder trajectories. The new methods described in this thesis can help ensure safe encounters between aircraft and enable SAA sensor certification for UAS integration into the National Airspace System.

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

Findings From the National Machine Guarding Program–A Small Business Intervention

PubMed Central

Parker, David L.; 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 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. 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 12-month follow-up evaluation. Results: 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). Conclusions: Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees. PMID:27466709

75 FR 57027 - National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

... for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Reports: In Vitro Ocular Safety Testing Methods and Strategies, and Routine Use of Topical Anesthetics, Systemic...

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

NASA Astrophysics Data System (ADS)

Kozlovská, Mária; Struková, Zuzana

2013-06-01

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

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

PubMed

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

2015-08-01

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

Hazardous material transportation safety and security field operational test final evaluation plan : executive summary

DOT National Transportation Integrated Search

2003-03-17

The purpose of this effort is to independently evaluate the Battelle Operational Test Team to test methods for leveraging technology and operations to improve HAZMAT transport security, safety, and operational efficiency. As such, the preceding techn...

Teen worker safety training: methods used, lessons taught, and time spent.

PubMed

Zierold, Kristina M

2015-05-01

Safety training is strongly endorsed as one way to prevent teens from performing dangerous tasks at work. The objective of this mixed methods study was to characterize the safety training that teenagers receive on the job. From 2010 through 2012, focus groups and a cross-sectional survey were conducted with working teens. The top methods of safety training reported were safety videos (42 percent) and safety lectures (25 percent). The top lessons reported by teens were "how to do my job" and "ways to spot hazards." Males, who were more likely to do dangerous tasks, received less safety training than females. Although most teens are getting safety training, it is inadequate. Lessons addressing safety behaviors are missing, training methods used are minimal, and the time spent is insignificant. More research is needed to understand what training methods and lessons should be used, and the appropriate safety training length for effectively preventing injury in working teens. In addition, more research evaluating the impact of high-quality safety training compared to poor safety training is needed to determine the best training programs for teens. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

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

PubMed

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

2012-10-01

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

Evaluating the Safety of New Vaccines: Summary of a Workshop

PubMed Central

Ellenberg, Susan S.; Foulkes, Mary A.; Midthun, Karen; Goldenthal, Karen L.

2005-01-01

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions. PMID:15855455

Active drug safety surveillance: a tool to improve public health.

PubMed

Platt, Richard; Madre, Leanne; Reynolds, Robert; Tilson, Hugh

2008-12-01

Ensuring that drugs have an acceptable safety profile and are used safely is a major public health priority. The Centers for Education and Research on Therapeutics (CERTs) convened experts from academia, government, and industry to assess strategies to increase the speed and predictive value of generating and evaluating safety signals, and to identify next steps to improve the US system for identifying and evaluating potential safety signals. The CERTs convened a think tank comprising representatives of the groups noted above to address these goals. Participants observed that, with the increasing availability of electronic health data, opportunities have emerged to more accurately characterize and confirm potential safety issues. The gain for public health from a highly coordinated network of population-based databases for active surveillance is great and within reach, although operational questions remain. A collaborative network must create a working definition of a safety signal, screening algorithms, and criteria and strategies to confirm or refute a signal once identified through screening. Guidelines are needed for when and how to communicate a signal exists and is being evaluated, as well as the outcome of that evaluation. A public-private partnership to create a network of government and private databases to routinely evaluate and prioritize safety questions is in the public interest. Better methods are needed, and a knowledgeable workforce is required to conduct the surveillance and understand how to interpret the results. The international community will benefit from the availability of better methods and more experts. Copyright (c) 2008 John Wiley & Sons, Ltd.

Safety impact of engineering treatments on undivided rural roads.

PubMed

Pérez, I

2006-01-01

This article presents an evaluation of the safety impacts of four engineering treatments implemented in the Autonomous Community of Madrid (Spain): highway upgrading; updating and improvement of traffic signing; repainting of pavement markings and pavement resurfacings. This evaluation was carried out using the Empirical Bayes method with a comparison group. The functioning of a methodology to test the significance of the safety impact is described. The results show that highway upgrading has a positive and significant safety impact, while the updating and improvement of traffic signing, the repainting of road markings and pavement resurfacings do not exhibit a significant impact on safety.

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

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

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

PubMed

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

2016-05-05

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

Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review

PubMed Central

de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

2014-01-01

Aim: To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Methods: Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. Results: In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Conclusion: Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods. PMID:26770720

Structural safety evaluation of Gerber Arch Dam

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

Barrie, R.E.

1995-12-31

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

Data Analysis Approaches for the Risk-Informed Safety Margins Characterization Toolkit

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

Mandelli, Diego; Alfonsi, Andrea; Maljovec, Daniel P.

2016-09-01

In the past decades, several numerical simulation codes have been employed to simulate accident dynamics (e.g., RELAP5-3D, RELAP-7, MELCOR, MAAP). In order to evaluate the impact of uncertainties into accident dynamics, several stochastic methodologies have been coupled with these codes. These stochastic methods range from classical Monte-Carlo and Latin Hypercube sampling to stochastic polynomial methods. Similar approaches have been introduced into the risk and safety community where stochastic methods (such as RAVEN, ADAPT, MCDET, ADS) have been coupled with safety analysis codes in order to evaluate the safety impact of timing and sequencing of events. These approaches are usually calledmore » Dynamic PRA or simulation-based PRA methods. These uncertainties and safety methods usually generate a large number of simulation runs (database storage may be on the order of gigabytes or higher). The scope of this paper is to present a broad overview of methods and algorithms that can be used to analyze and extract information from large data sets containing time dependent data. In this context, “extracting information” means constructing input-output correlations, finding commonalities, and identifying outliers. Some of the algorithms presented here have been developed or are under development within the RAVEN statistical framework.« less

Evaluating the effectiveness of Behavior-Based Safety education methods for commercial vehicle drivers.

PubMed

Wang, Xuesong; Xing, Yilun; Luo, Lian; Yu, Rongjie

2018-08-01

Risky driving behavior is one of the main causes of commercial vehicle related crashes. In order to achieve safer vehicle operation, safety education for drivers is often provided. However, the education programs vary in quality and may not always be successful in reducing crash rates. Behavior-Based Safety (BBS) education is a popular approach found effective by numerous studies, but even this approach varies as to the combination of frequency, mode and content used by different education providers. This study therefore evaluates and compares the effectiveness of BBS education methods. Thirty-five drivers in Shanghai, China, were coached with one of three different BBS education methods for 13 weeks following a 13-week baseline phase with no education. A random-effects negative binomial (NB) model was built and calibrated to investigate the relationship between BBS education and the driver at-fault safety-related event rate. Based on the results of the random-effects NB model, event modification factors (EMF) were calculated to evaluate and compare the effectiveness of the methods. Results show that (1) BBS education was confirmed to be effective in safety-related event reduction; (2) the most effective method among the three applied monthly face-to-face coaching, including feedback with video and statistical data, and training on strategies to avoid driver-specific unsafe behaviors; (3) weekly telephone coaching using statistics and strategies was rated by drivers as the most convenient delivery mode, and was also significantly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

Methods for identifying high collision concentration locations (HCCL) for potential safety improvements : phase II, Evaluation of alternative methods for identifying HCCL.

DOT National Transportation Integrated Search

2011-01-01

The objective of network screening should ideally be to not only identify sites for safety : investigation but also to prioritize those sites efficiently. Using roadway, intersection, and : collision data from California, this study compared the perf...

Awareness of eSafety and Potential Online Dangers among Children and Teenagers

ERIC Educational Resources Information Center

Zilka, Gila Cohen

2017-01-01

Aim/Purpose: Awareness of eSafety and potential online dangers for children and teenagers. Background: The study examined eSafety among children and teenagers from their own perspectives, through evaluations of their awareness level of eSafety and of potential online dangers. Methodology: This is a mixed-method study with both quantitative and…

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

[Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

PubMed

Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

2011-10-01

To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

A 1064 nm dispersive Raman spectral imaging system for food safety and quality evaluation

USDA-ARS?s Scientific Manuscript database

Raman spectral imaging is an effective method to analyze and evaluate chemical composition and structure of a sample, and has many applications for food safety and quality research. This study developed a 1064 nm Raman spectral imaging system for surface and subsurface analysis of food samples. A 10...

Applications of near-infrared spectroscopy in food safety evaluation and control: a review of recent research advances.

PubMed

Qu, Jia-Huan; Liu, Dan; Cheng, Jun-Hu; Sun, Da-Wen; Ma, Ji; Pu, Hongbin; Zeng, Xin-An

2015-01-01

Food safety is a critical public concern, and has drawn great attention in society. Consequently, developments of rapid, robust, and accurate methods and techniques for food safety evaluation and control are required. As a nondestructive and convenient tool, near-infrared spectroscopy (NIRS) has been widely shown to be a promising technique for food safety inspection and control due to its huge advantages of speed, noninvasive measurement, ease of use, and minimal sample preparation requirement. This review presents the fundamentals of NIRS and focuses on recent advances in its applications, during the last 10 years of food safety control, in meat, fish and fishery products, edible oils, milk and dairy products, grains and grain products, fruits and vegetables, and others. Based upon these applications, it can be demonstrated that NIRS, combined with chemometric methods, is a powerful tool for food safety surveillance and for the elimination of the occurrence of food safety problems. Some disadvantages that need to be solved or investigated with regard to the further development of NIRS are also discussed.

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

PubMed

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

2017-03-04

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

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

The biological safety of condom material can be determined using an in vitro cell culture system.

PubMed

Motsoane, N A; Pretorius, E; Bester, M J; Becker, P J

2001-01-01

Latex products have long been recognized as a cause of latex protein allergy. The increased usage of latex gloves, with the consequent increased occurrence of latex allergies appears to have escalated with increasing awareness of the transmission of HIV-AIDS and other infections. The use of condoms as a means to prevent the transmission of STD's (sexually transmitted diseases) and HIV-AIDS has been widely promoted. Although extensive testing is done to evaluate the physical quality of condoms, no information is available regarding the biological safety of condoms. This study was undertaken to determine the effects of short-term exposure to physiological levels of condom surface material on cell viability (MTT assay) and cell growth (crystal violet assay). A direct contact cell culture testing method (FDA test method F813-83 used to evaluate the cytotoxic potential of medical materials and devices) was used. The modified test method was found to be a sensitive test system for the evaluation of the biological safety of condoms. This study reveals the importance of evaluating the biological safety of all condoms that are commercially available, because of the potential health risk that may be associated with prolonged use of certain types of condoms.

Evaluating the Effectiveness of Traditional Training Methods in Non-Traditional Training Programs for Adult Learners through a Pre-Test/Post-Test Comparison of Food Safety Knowledge

ERIC Educational Resources Information Center

Dodd, Caleb D.; Burris, Scott; Fraze, Steve; Doerfert, David; McCulloch, Abigail

2013-01-01

The incorporation of hot and cold food bars into grocery stores in an effort to capture a portion of the home meal replacement industry is presenting new challenges for retail food establishments. To ensure retail success and customer safety, employees need to be educated in food safety practices. Traditional methods of training are not meeting…

Did you have an impact? A theory-based method for planning and evaluating knowledge-transfer and exchange activities in occupational health and safety.

PubMed

Kramer, Desré M; Wells, Richard P; Carlan, Nicolette; Aversa, Theresa; Bigelow, Philip P; Dixon, Shane M; McMillan, Keith

2013-01-01

Few evaluation tools are available to assess knowledge-transfer and exchange interventions. The objective of this paper is to develop and demonstrate a theory-based knowledge-transfer and exchange method of evaluation (KEME) that synthesizes 3 theoretical frameworks: the promoting action on research implementation of health services (PARiHS) model, the transtheoretical model of change, and a model of knowledge use. It proposes a new term, keme, to mean a unit of evidence-based transferable knowledge. The usefulness of the evaluation method is demonstrated with 4 occupational health and safety knowledge transfer and exchange (KTE) implementation case studies that are based upon the analysis of over 50 pre-existing interviews. The usefulness of the evaluation model has enabled us to better understand stakeholder feedback, frame our interpretation, and perform a more comprehensive evaluation of the knowledge use outcomes of our KTE efforts.

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

PubMed

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

2018-01-01

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

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

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.

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

PubMed

Vinardell, M P

2015-03-01

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

Speeding in highway work zone: An Evaluation of methods of speed control.

PubMed

Ravani, Bahram; Wang, Chao

2018-04-01

Highway workers frequently work in close proximity of live traffic in highway work zones, traffic accidents therefore have devastating effects on worker safety. In order to reduce the potential for such accidents, methods involving use of advisory signs and police presence have been used to mitigate accident risks and improve safety for highway workers. This research evaluates the magnitude of the speeding problem in highway work zones and the effects of four levels of police presence on improving work zone safety. Speed data were collected in six different work zone locations in northern and southern California and used to determine the magnitude and nature of speeding problem in highway work zones. In addition data were collected over 11 test-days in four work zones with four levels of police presence: radar speed display with police decal and lighting, passive use of a police vehicle with radar speed display, passive use of a police vehicle without radar speed display, and active police speed enforcement near work zones. This paper analyzes this data using statistical methods to evaluate the effectiveness of these different methods of speed control on the safety of the work zone. Four Measures of Effectiveness (MOE) were used in this evaluation consisting of average speed reduction, speed variance, 85th percentile speed, and proportion of high speed vehicles. The results indicate that all levels of police presence provided statistically significant improvements in one or more of the MOEs. Copyright © 2018 Elsevier Ltd. All rights reserved.

Investigation of safety analysis methods using computer vision techniques

NASA Astrophysics Data System (ADS)

Shirazi, Mohammad Shokrolah; Morris, Brendan Tran

2017-09-01

This work investigates safety analysis methods using computer vision techniques. The vision-based tracking system is developed to provide the trajectory of road users including vehicles and pedestrians. Safety analysis methods are developed to estimate time to collision (TTC) and postencroachment time (PET) that are two important safety measurements. Corresponding algorithms are presented and their advantages and drawbacks are shown through their success in capturing the conflict events in real time. The performance of the tracking system is evaluated first, and probability density estimation of TTC and PET are shown for 1-h monitoring of a Las Vegas intersection. Finally, an idea of an intersection safety map is introduced, and TTC values of two different intersections are estimated for 1 day from 8:00 a.m. to 6:00 p.m.

Applying usability heuristics to radiotherapy systems.

PubMed

Chan, Alvita J; Islam, Mohammad K; Rosewall, Tara; Jaffray, David A; Easty, Anthony C; Cafazzo, Joseph A

2012-01-01

Heuristic evaluations have been used to evaluate safety of medical devices by identifying and assessing usability issues. Since radiotherapy treatment delivery systems often consist of multiple complex user-interfaces, a heuristic evaluation was conducted to assess the potential safety issues of such a system. A heuristic evaluation was conducted to evaluate the treatment delivery system at Princess Margaret Hospital (Toronto, Canada). Two independent evaluators identified usability issues with the user-interfaces and rated the severity of each issue. The evaluators identified 75 usability issues in total. Eighteen of them were rated as high severity, indicating the potential to have a major impact on patient safety. A majority of issues were found on the record and verify system, and many were associated with the patient setup process. While the hospital has processes in place to ensure patient safety, recommendations were developed to further mitigate the risks of potential consequences. Heuristic evaluation is an efficient and inexpensive method that can be successfully applied to radiotherapy delivery systems to identify usability issues and improve patient safety. Although this study was conducted only at one site, the findings may have broad implications for the design of these systems. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Blood alcohol test results of motor vehicle deaths as an evaluation method for the Fairfax Alcohol Safety Action Project.

DOT National Transportation Integrated Search

1973-01-01

The Fairfax Alcohol Safety Action Project (ASAP) was started following the June 1971 approval of the proposal and working plan submitted to the Department of Transportation by the Highway Safety Division of Virginia. A total of $2,123,000 was allocat...

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

PubMed

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

2015-01-01

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

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

PubMed

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

2015-02-01

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

Microbiological safety of commercial prime rib preparation methods: thermal inactivation of Salmonella spp. in mechanically tenderized beef roasts

USDA-ARS?s Scientific Manuscript database

A survey of food service operations in a medium-size Midwestern city was conducted to evaluate the microbiological safety of prime rib preparation methods relative to survival of Salmonella spp. in both intact and tenderized (non-intact) product. All six restaurants visited seared rib eye roasts (ai...

Improving patient safety through the systematic evaluation of patient outcomes

PubMed Central

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

2012-01-01

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

75 FR 25867 - National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-10

... validation studies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods... for nomination of test methods for validation studies, and guidelines for submission of test methods... for human and veterinary vaccine post-licensing potency and safety testing. Plenary and breakout...

Ensuring the validity of calculated subcritical limits

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

Clark, H.K.

1977-01-01

The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

PubMed

Ball, Robert; Horne, Dale; Izurieta, Hector; Sutherland, Andrea; Walderhaug, Mark; Hsu, Henry

2011-05-01

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

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

PubMed

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

2015-09-01

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

Training and action for patient safety: embedding interprofessional education for patient safety within an improvement methodology.

PubMed

Slater, Beverley L; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

2012-01-01

Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based training program that embeds patient safety within quality improvement methods. Kirkpatrick's "levels of evaluation" model was adopted to evaluate the program in health organizations across one city in the north of England. Questionnaires were used to assess reaction of participants to the program (Level 1). Improvements in patient safety knowledge and patient safety culture (Level 2) were assessed using a 12-item multiple-choice questionnaire and a culture questionnaire. Interviews and project-specific quantitative measurements were used to assess changes in professional practice and patient outcomes (Levels 3 and 4). All aspects of the program were positively received by participants. Few participants completed the MCQ at both time points, but those who did showed improvement in knowledge. There were some small but significant improvements in patient safety culture. Interviews revealed a number of additional benefits beyond the specific problems addressed. Most importantly, 8 of the 11 teams showed improvements in patient safety practices and/or outcomes. This program is an example of interprofessional education in practice and demonstrates that team-based learning using quality improvement methods is feasible and can be effective in improving patient safety, but requires time and space for participants. Alignment with continuing education arrangements could support mainstream adoption of this approach within organizations. Copyright © 2012 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

Inductive Double-Contingency Analysis of UO2 Powder Bulk Blending Operations at a Commercial Fuel Plant (U)

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

Skiles, S. K.

1994-12-22

An inductive double-contingency analysis (DCA) method developed by the criticality safety function at the Savannah River Site, was applied in Criticality Safety Evaluations (CSEs) of five major plant process systems at the Westinghouse Electric Corporation`s Commercial Nuclear Fuel Manufacturing Plant in Columbia, South Carolina (WEC-Cola.). The method emphasizes a thorough evaluation of the controls intended to provide barriers against criticality for postulated initiating events, and has been demonstrated effective at identifying common mode failure potential and interdependence among multiple controls. A description of the method and an example of its application is provided.

[Agricultural biotechnology safety assessment].

PubMed

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

2015-01-01

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

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

PubMed

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

2016-11-01

Pedestrians are the most vulnerable road users, and pedestrian safety has become a major research focus in recent years. Regarding the quality and quantity issues with collision data, conflict analysis using surrogate safety measures has become a useful method to study pedestrian safety. However, given the inequality between pedestrians and vehicles in encounters and the multiple interactions between pedestrians and vehicles, it is insufficient to simply use the same indicator(s) or the same way to aggregate indicators for all conditions. In addition, behavioral factors cannot be neglected. To better use information extracted from trajectories for safety evaluation and pay more attention on effects of behavioral factors, this paper develops a more sophisticated framework for pedestrian conflict analysis that takes pedestrian-vehicle interactions into consideration. A concept of three interaction patterns has been proposed for the first time, namely "hard interaction," "no interaction," and "soft-interaction." Interactions have been categorized under one of these patterns by analyzing profiles of speed and conflict indicators during the whole interactive processes. In this paper, a support vector machine (SVM) approach has been adopted to classify severity levels for a dataset including 1144 events extracted from three intersections in Shanghai, China, followed by an analysis of variable importance. The results revealed that different conflict indicators have different contributions to indicating the severity level under various interaction patterns. Therefore, it is recommended either to use specific conflict indicators or to use weighted indicator aggregation for each interaction pattern when evaluating pedestrian safety. The implementation has been carried out at the fourth crosswalk, and the results indicate that the proposed method can achieve a higher accuracy and better robustness than conventional methods. Furthermore, the method is helpful for better understanding underlying levels of safety from the behavioral perspective, which can also provide evidence for targeted traffic education on proper behaviors. Copyright © 2016 Elsevier Ltd. All rights reserved.

Software Dependability and Safety Evaluations ESA's Initiative

NASA Astrophysics Data System (ADS)

Hernek, M.

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

Knowledge Acquisition Methods for the IHDS Diagnostic Review Expert System

DOT National Transportation Integrated Search

1997-12-01

The Federal Highway Administration's Interactive Highway Safety Design Model (IHSDM) is a suite of CADD-compatible programs that highway designers can use to evaluate the safety effects of various design alternatives. The IHSDM will include a Policy ...

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...

High Reliability and the Evaluation of ATC System Configuration by Communizing Resources

NASA Astrophysics Data System (ADS)

Yamamoto, Masanori

Automatic Train Control (ATC) in the railway signalling system is required high safety, high availability, reduction of unit, energy saving and cost reduction. This paper described the resources communization redundancy of the ATC system that shared the redundant units in preparation for common use units in order to accommodate with this issue by keeping safety and availability in the same level of conventional ATC. It was evaluated on N+2 redundant system which established 2 spares for the common use system N piece in transmission division. It was done the safety evaluation of the N+2 redundant system by way of hazard analysis of FTA method and safety issue was confirmed by FMEA. The new redundant system concludes that 19% of downsizing and 36% of the energy saving are surely possible.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

Reliability of Hull Girder Ultimate Strength of Steel Ships

NASA Astrophysics Data System (ADS)

Da-wei, Gao; Gui-jie, Shi

2018-03-01

Hull girder ultimate strength is an evaluation index reflecting the true safety margin or structural redundancy about container ships. Especially, after the hull girder fracture accident of the MOL COMFORT, the 8,000TEU class large container ship, on June 17 2013, larger container ship safety has been paid on much more attention. In this paper, different methods of calculating hull girder ultimate strength are firstly discussed and compared with. The bending ultimate strength can be analyzed by nonlinear finite element method (NFEM) and increment-iterative method, and also the shear ultimate strength can be analyzed by NFEM and simple equations. Then, the probability distribution of hull girder wave loads and still water loads of container ship are summarized. At last, the reliability of hull girder ultimate strength under bending moment and shear forces for three container ships is analyzed by using a first order method. The conclusions can be applied to give guidance for ship design and safety evaluation.

The Safety Attitudes of Senior Managers in the Chinese Coal Industry

PubMed Central

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-01-01

Introduction: Senior managers’ attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers′ attitudes towards safety in the Chinese coal industry. Method: We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions: Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers′ safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers′ unions not playing their role effectively. Practical Applications: We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry. PMID:27869654

The Safety Attitudes of Senior Managers in the Chinese Coal Industry.

PubMed

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-11-17

Introduction: Senior managers' attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers' attitudes towards safety in the Chinese coal industry. Method : We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions : Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers' safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers' unions not playing their role effectively. Practical Applications : We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry.

Pavement, bridge, and safety cost evaluation tool for overweight truck corridors serving coastal port regions and border ports of entry

DOT National Transportation Integrated Search

2017-08-01

To address the need for a rational but fast method to determine costs and a proposed permit fee, the research team developed the Stage 1 Expedient Analysis Method. The method was used to evaluate potential oversize/overweight (OS/OW) freight corridor...

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey

PubMed Central

Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

2016-01-01

Background Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. Objective To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. Methods A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. Results The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of “staff training and skills” were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. Conclusion The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety. PMID:27524887

Endoscopic non-technical skills team training: The next step in quality assurance of endoscopy training

PubMed Central

Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

2014-01-01

AIM: To investigate whether novel, non-technical skills training for Bowel Cancer Screening (BCS) endoscopy teams enhanced patient safety knowledge and attitudes. METHODS: A novel endoscopy team training intervention for BCS teams was developed and evaluated as a pre-post intervention study. Four multi-disciplinary BCS teams constituting BCS endoscopist(s), specialist screening practitioners, endoscopy nurses and administrative staff (A) from English BCS training centres participated. No patients were involved in this study. Expert multidisciplinary faculty delivered a single day’s training utilising real clinical examples. Pre and post-course evaluation comprised participants’ patient safety awareness, attitudes, and knowledge. Global course evaluations were also collected. RESULTS: Twenty-three participants attended and their patient safety knowledge improved significantly from 43%-55% (P ≤ 0.001) following the training intervention. 12/41 (29%) of the safety attitudes items significantly improved in the areas of perceived patient safety knowledge and awareness. The remaining safety attitude items: perceived influence on patient safety, attitudes towards error management, error management actions and personal views following an error were unchanged following training. Both qualitative and quantitative global course evaluations were positive: 21/23 (91%) participants strongly agreed/agreed that they were satisfied with the course. Qualitative evaluation included mandating such training for endoscopy teams outside BCS and incorporating team training within wider endoscopy training. Limitations of the study include no measure of increased patient safety in clinical practice following training. CONCLUSION: A novel comprehensive training package addressing patient safety, non-technical skills and adverse event analysis was successful in improving multi-disciplinary teams’ knowledge and safety attitudes. PMID:25516665

Field Application of the Micro Biological Survey Method for the Assessment of the Microbiological Safety of Different Water Sources in Horn of Africa and the Evaluation of the Effectiveness of Moringa Oleifera in Drinking Water Purification

PubMed Central

Losito, Francesca; Arienzo, Alyexandra; Somma, Daniela; Murgia, Lorenza; Stalio, Ottavia; Zuppi, Paolo; Rossi, Elisabetta; Antonini, Giovanni

2017-01-01

Water monitoring requires expensive instrumentations and skilled technicians. In developing Countries as Africa, the severe economic restrictions and lack of technology make water safety monitoring approaches applied in developed Countries, still not sustainable. The need to develop new methods that are suitable, affordable, and sustainable in the African context is urgent. The simple, economic and rapid Micro Biological Survey (MBS) method does not require an equipped laboratory nor special instruments and skilled technicians, but it can be very useful for routine water analysis. The aim of this work was the application of the MBS method to evaluate the microbiological safety of different water sources and the effectiveness of different drinking water treatments in the Horn of Africa. The obtained results have proved that this method could be very helpful to monitor water safety before and after various purification treatments, with the aim to control waterborne diseases especially in developing Countries, whose population is the most exposed to these diseases. In addition, it has been proved that Moringa oleifera water treatment is ineffective in decreasing bacterial load of Eritrea water samples. PMID:28748063

Field Application of the Micro Biological Survey Method for the Assessment of the Microbiological Safety of Different Water Sources in Horn of Africa and the Evaluation of the Effectiveness of Moringa Oleifera in Drinking Water Purification.

PubMed

Losito, Francesca; Arienzo, Alyexandra; Somma, Daniela; Murgia, Lorenza; Stalio, Ottavia; Zuppi, Paolo; Rossi, Elisabetta; Antonini, Giovanni

2017-06-23

Water monitoring requires expensive instrumentations and skilled technicians. In developing Countries as Africa, the severe economic restrictions and lack of technology make water safety monitoring approaches applied in developed Countries, still not sustainable. The need to develop new methods that are suitable, affordable, and sustainable in the African context is urgent. The simple, economic and rapid Micro Biological Survey (MBS) method does not require an equipped laboratory nor special instruments and skilled technicians, but it can be very useful for routine water analysis. The aim of this work was the application of the MBS method to evaluate the microbiological safety of different water sources and the effectiveness of different drinking water treatments in the Horn of Africa. The obtained results have proved that this method could be very helpful to monitor water safety before and after various purification treatments, with the aim to control waterborne diseases especially in developing Countries, whose population is the most exposed to these diseases. In addition, it has been proved that Moringa oleifera water treatment is ineffective in decreasing bacterial load of Eritrea water samples.

Development of procedures for identifying high-crash locations and prioritizing safety improvements

DOT National Transportation Integrated Search

2003-06-01

The objectives of this study were to review and analyze the current procedures for identifying high-crash locations and evaluating and prioritizing roadway safety improvements at high-crash locations, and to recommend improved methods. Several tasks ...

Development of procedures for identifying high-crash locations and prioritizing safety improvements.

DOT National Transportation Integrated Search

2003-06-01

The objectives of this study were to review and analyze the current procedures for identifying high-crash locations and evaluating and prioritizing roadway safety improvements at high-crash locations, and to recommend improved methods. Several tasks ...

10 CFR 963.13 - Preclosure suitability evaluation method.

Code of Federal Regulations, 2010 CFR

2010-01-01

... of the structures, systems, components, equipment, and operator actions intended to mitigate or... and the criteria in § 963.14. DOE will consider the performance of the system in terms of the criteria... protection standard. (b) The preclosure safety evaluation method, using preliminary engineering...

A novel evaluation method for building construction project based on integrated information entropy with reliability theory.

PubMed

Bai, Xiao-ping; Zhang, Xi-wei

2013-01-01

Selecting construction schemes of the building engineering project is a complex multiobjective optimization decision process, in which many indexes need to be selected to find the optimum scheme. Aiming at this problem, this paper selects cost, progress, quality, and safety as the four first-order evaluation indexes, uses the quantitative method for the cost index, uses integrated qualitative and quantitative methodologies for progress, quality, and safety indexes, and integrates engineering economics, reliability theories, and information entropy theory to present a new evaluation method for building construction project. Combined with a practical case, this paper also presents detailed computing processes and steps, including selecting all order indexes, establishing the index matrix, computing score values of all order indexes, computing the synthesis score, sorting all selected schemes, and making analysis and decision. Presented method can offer valuable references for risk computing of building construction projects.

Evaluation of the organisation and effectiveness of internal audits to govern patient safety in hospitals: a mixed-methods study

PubMed Central

van Gelderen, Saskia C; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; Robben, Paul B; Wollersheim, Hub C

2017-01-01

Objectives Hospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety. Design and setting A mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals. Results Response rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan–do–check–act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports. Conclusion This study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety. PMID:28698328

Health Monitoring and Evaluation of Long-Span Bridges Based on Sensing and Data Analysis: A Survey

PubMed Central

Zhou, Jianting; Li, Xiaogang; Xia, Runchuan; Yang, Jun; Zhang, Hong

2017-01-01

Aimed at the health monitoring and evaluation of bridges based on sensing technology, the monitoring contents of different structural types of long-span bridges were defined. Then, the definition, classification, selection principle, and installation requirements of the sensors were summarized. The concept was proposed that new adaptable long-life sensors could be developed by new theories and new effects. The principle and methods to select controlled sections and optimize the layout design of measuring points were illustrated. The functional requirements were elaborated on about the acquisition, transmission, processing, and management of sensing information. Some advanced concepts about the method of bridge safety evaluation were demonstrated and technology bottlenecks in the current safety evaluation were also put forward. Ultimately, combined with engineering practices, an application was carried out. The results showed that new, intelligent, and reliable sensor technology would be one of the main future development directions in the long-span bridge health monitoring and evaluation field. Also, it was imperative to optimize the design of the health monitoring system and realize its standardization. Moreover, it is a heavy responsibility to explore new thoughts and new concepts regarding practical bridge safety and evaluation technology. PMID:28300785

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

PubMed Central

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

2012-01-01

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

High-Throughput Toxicity Testing: New Strategies for ...

EPA Pesticide Factsheets

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct additives, and food contact substances. With the rapidly growing use of new food additives, as well as innovation in food contact substance development, an interest in exploring the use of high-throughput chemical safety testing approaches has emerged. Currently, the field of toxicology is undergoing a paradigm shift in how chemical hazards can be evaluated. Since there are tens of thousands of chemicals in use, many of which have little to no hazard information and there are limited resources (namely time and money) for testing these chemicals, it is necessary to prioritize which chemicals require further safety testing to better protect human health. Advances in biochemistry and computational toxicology have paved the way for animal-free (in vitro) high-throughput screening which can characterize chemical interactions with highly specific biological processes. Screening approaches are not novel; in fact, quantitative high-throughput screening (qHTS) methods that incorporate dose-response evaluation have been widely used in the pharmaceutical industry. For toxicological evaluation and prioritization, it is the throughput as well as the cost- and time-efficient nature of qHTS that makes it

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

PubMed

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

2014-03-01

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

Application of modified extended method in CREAM for safety inspector in coal mines

NASA Astrophysics Data System (ADS)

Wang, Jinhe; Zhang, Xiaohong; Zeng, Jianchao

2018-01-01

Safety inspector often performs duties in circumstances contributes to the oc currence of human failures. Therefore, the paper aims at quantifying human failure pro bability (HFP) of safety inspector during the coal mine operation with cognitive reliabi lity and error analysis method (CREAM). Whereas, some shortcomings of this approa ch that lacking considering the applicability of the common performance condition (C PC), and the subjective of evaluating CPC level which weaken the accuracy of the qua ntitative prediction results. A modified extended method in CREAM which is able to a ddress these difficulties with a CPC framework table is proposed, and the proposed me thodology is demonstrated by the virtue of a coal-mine accident example. The results a re expected to be useful in predicting HFP of safety inspector and contribute to the enh ancement of coal mine safety.

Development of a hazard-based method for evaluating the fire safety of passenger trains

DOT National Transportation Integrated Search

1999-01-01

The fire safety of U.S. passenger rail trains currently is addressed through small-scale flammability and smoke emission tests and performance criteria promulgated by the Federal Railroad Administration (FRA). The FRA approach relies heavily on test ...

Evaluation of Testing Methods to Develop Test Requirements for a Workstation Table Safety Standard

DOT National Transportation Integrated Search

2010-10-12

Investigations of passenger train accidents have revealed serious safety hazards associated with the thin, rigid tops of workstation tables, which are common fixtures aboard rail cars. Thoracic and abdominal injuries caused by occupant impact with wo...

Selected considerations of implementation of the GNSS

NASA Astrophysics Data System (ADS)

Cwiklak, Janusz; Fellner, Andrzej; Fellner, Radoslaw; Jafernik, Henryk; Sledzinski, Janusz

2014-05-01

The article describes analysis of the safety and risk for the implementation of precise approach procedures (Localizer Performance and Vertical Guidance - LPV) with GNSS sensor at airports in Warsaw and Katowice. There were used some techniques of the identification of threats (inducing controlled flight into terrain, landing accident, mid-air collision) and evaluations methods based on Fault Tree Analysis, probability of the risk, safety risk evaluation matrix and Functional Hazard Assesment. Also safety goals were determined. Research led to determine probabilities of appearing of threats, as well as allow compare them with regard to the ILS. As a result of conducting the Preliminary System Safety Assessment (PSSA), there were defined requirements essential to reach the required level of the safety. It is worth to underline, that quantitative requirements were defined using FTA.

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

NASA Astrophysics Data System (ADS)

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

2015-05-01

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

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

PubMed

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

2009-08-01

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

Application of Model Animals in the Study of Drug Toxicology

NASA Astrophysics Data System (ADS)

Song, Yagang; Miao, Mingsan

2018-01-01

Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

PubMed

Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

2017-03-15

Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

Contribution of European research to risk analysis.

PubMed

Boenke, A

2001-12-01

The European Commission's, Quality of Life Research Programme, Key Action 1-Health, Food & Nutrition is mission-oriented and aims, amongst other things, at providing a healthy, safe and high-quality food supply leading to reinforced consumer confidence in the safety, of European food. Its objectives also include the enhancing of the competitiveness of the European food supply. Key Action 1 is currently supporting a number of different types of European collaborative projects in the area of risk analysis. The objectives of these projects range from the development and validation of prevention strategies including the reduction of consumers risks; development and validation of new modelling approaches, harmonization of risk assessment principles methodologies and terminology; standardization of methods and systems used for the safety evaluation of transgenic food; providing of tools for the evaluation of human viral contamination of shellfish and quality control; new methodologies for assessing the potential of unintended effects of genetically modified (genetically modified) foods; development of a risk assessment model for Cryptosporidium parvum related to the food and water industries, to the development of a communication platform for genetically modified organism, producers, retailers, regulatory authorities and consumer groups to improve safety assessment procedures, risk management strategies and risk communication; development and validation of new methods for safety testing of transgenic food; evaluation of the safety and efficacy of iron supplementation in pregnant women, evaluation of the potential cancer-preventing activity of pro- and pre-biotic ('synbiotic') combinations in human volunteers. An overview of these projects is presented here.

[Delivery of twins by Cesarean section with the Misgav Ladach method].

PubMed

Oleszczuk, J; Leszczyńska-Gorzelak, B; Michalak, B; Pietras, G

2000-11-01

Between September 1998 and July 1999, 34 patients with twin pregnancy (79.1%) underwent cesarean section with Misgav Ladach method in the Department of Obstetrics and Perinatology of the Medical Academy in Lublin. The aim of this study was to evaluate safety and other advantages of the Misgav Ladach method. Body temperature, usage of antibiotics, analgesics, hematinics, and postoperative complications were evaluated in the postoperative course. No postoperative complications were noted at 32 patients (94.1%). 67.6% of patients did not receive antibiotics. Stitches were removed on the fourth p.o. day at 70.6% of patients. This study highlights the safety of the Misgav Ladach method, and points out some advantages like reduction of postoperative pain, speeded recovery, and no indication for transfusion.

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.

Designing Serious Games for Safety Education: "Learn to Brace" versus Traditional Pictorials for Aircraft Passengers.

PubMed

Chittaro, Luca

2016-05-01

Serious games for safety education (SGSE) are a novel tool for preparing people to prevent and\\or handle risky situations. Although several SGSE have been developed, design and evaluation methods for SGSE need to be better grounded in and guided by safety-relevant psychological theories. In particular, this paper focuses on threat appeals and the assessment of variables, such as safety locus of control, that influence human behavior in real risky situations. It illustrates how we took into account such models in the design and evaluation of "Learn to Brace", a first-of-its-kind serious game that deals with a major problem in aviation safety, i.e. the scarce effectiveness of the safety cards used by airlines. The study considered a sample of 48 users: half of them received instructions about the brace position through the serious game, the other half through a traditional safety card pictorial. Results showed that the serious game was much more effective than the traditional instructions both in terms of learning and of changing safety-relevant perceptions, especially safety locus of control and recommendation perception.

Developing a Methodology for Eliciting Subjective Probability Estimates During Expert Evaluations of Safety Interventions: Application for Bayesian Belief Networks

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.a

2005-01-01

The NASA Aviation Safety Program (AvSP) has defined several products that will potentially modify airline and/or ATC operations, enhance aircraft systems, and improve the identification of potential hazardous situations within the National Airspace System (NAS). Consequently, there is a need to develop methods for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the judgments to develop Bayesian Belief Networks (BBN's) that model the potential impact that specific interventions may have. Specifically, the present report summarizes methodologies for improving the elicitation of probability estimates during expert evaluations of AvSP products for use in BBN's. The work involved joint efforts between Professor James Luxhoj from Rutgers University and researchers at the University of Illinois. The Rutgers' project to develop BBN's received funding by NASA entitled "Probabilistic Decision Support for Evaluating Technology Insertion and Assessing Aviation Safety System Risk." The proposed project was funded separately but supported the existing Rutgers' program.

Safety Study of an Antimicrobial Peptide Lactocin 160, Produced by the Vaginal Lactobacillus rhamnosus

PubMed Central

Dover, Sara E.; Aroutcheva, Alla A.; Faro, S.; Chikindas, Michael L.

2007-01-01

Objective. To evaluate the safety of the antimicrobial peptide, lactocin 160. Methods. Lactocin 160, a product of vaginal probiotic Lactobacillus rhamnosus 160 was evaluated for toxicity and irritation. An in vitro human organotypic vaginal-ectocervical tissue model (EpiVaginal) was employed for the safety testing by determining the exposure time to reduce tissue viability to 50% (ET-50). Hemolytic activity of lactocin160 was tested using 8% of human erythrocyte suspension. Susceptibility of lactobacilli to lactocin160 was also studied. Rabbit vaginal irritation (RVI) model was used for an in vivo safety evaluation. Results. The ET-50 value was 17.5 hours for lactocin 160 (4.9 hours for nonoxynol 9, N9). Hemolytic activity of lactocin 160 was 8.2% (N9 caused total hemolysis). Lactobacilli resisted to high concentrations of peptide preparation. The RVI model revealed slight vaginal irritation. An average irritation index grade was evaluated as “none.” Conclusions. Lactocin 160 showed minimal irritation and has a good potential for intravaginal application. PMID:18273406

Evaluation of critical nuclear power plant electrical cable response to severe thermal fire conditions

NASA Astrophysics Data System (ADS)

Taylor, Gabriel James

The failure of electrical cables exposed to severe thermal fire conditions are a safety concern for operating commercial nuclear power plants (NPPs). The Nuclear Regulatory Commission (NRC) has promoted the use of risk-informed and performance-based methods for fire protection which resulted in a need to develop realistic methods to quantify the risk of fire to NPP safety. Recent electrical cable testing has been conducted to provide empirical data on the failure modes and likelihood of fire-induced damage. This thesis evaluated numerous aspects of the data. Circuit characteristics affecting fire-induced electrical cable failure modes have been evaluated. In addition, thermal failure temperatures corresponding to cable functional failures have been evaluated to develop realistic single point thermal failure thresholds and probability distributions for specific cable insulation types. Finally, the data was used to evaluate the prediction capabilities of a one-dimension conductive heat transfer model used to predict cable failure.

Effectiveness of maritime safety control in different navigation zones using a spatial sequential DEA model: Yangtze River case.

PubMed

Wu, Bing; Wang, Yang; Zhang, Jinfen; Savan, Emanuel Emil; Yan, Xinping

2015-08-01

This paper aims to analyze the effectiveness of maritime safety control from the perspective of safety level along the Yangtze River with special considerations for navigational environments. The influencing variables of maritime safety are reviewed, including ship condition, maritime regulatory system, human reliability and navigational environment. Because the former three variables are generally assumed to be of the same level of safety, this paper focuses on studying the impact of navigational environments on the level of safety in different waterways. An improved data envelopment analysis (DEA) model is proposed by treating the navigational environment factors as inputs and ship accident data as outputs. Moreover, because the traditional DEA model cannot provide an overall ranking of different decision making units (DMUs), the spatial sequential frontiers and grey relational analysis are incorporated into the DEA model to facilitate a refined assessment. Based on the empirical study results, the proposed model is able to solve the problem of information missing in the prior models and evaluate the level of safety with a better accuracy. The results of the proposed DEA model are further compared with an evidential reasoning (ER) method, which has been widely used for level of safety evaluations. A sensitivity analysis is also conducted to better understand the relationship between the variation of navigational environments and level of safety. The sensitivity analysis shows that the level of safety varies in terms of traffic flow. It indicates that appropriate traffic control measures should be adopted for different waterways to improve their safety. This paper presents a practical method of conducting maritime level of safety assessments under dynamic navigational environment. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

Tucker, C

1985-06-01

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

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

This Volume 3 of the NASA Safety Manual sets forth the basic elements and techniques for managing a system safety program and the technical methods recommended for use in developing a risk evaluation program that is oriented to the identification of hazards in aerospace hardware systems and the development of residual risk management information for the program manager that is based on the hazards identified. The methods and techniques described in this volume are in consonance with the requirements set forth in NHB 1700.1 (VI), Chapter 3. This volume and future volumes of the NASA Safety Manual shall not be rewritten, reprinted, or reproduced in any manner. Installation implementing procedures, if necessary, shall be inserted as page supplements in accordance with the provisions of Appendix A. No portion of this volume or future volumes of the NASA Safety Manual shall be invoked in contracts.

10 CFR 963.13 - Preclosure suitability evaluation method.

Code of Federal Regulations, 2011 CFR

2011-01-01

... to evaluate whether the geologic repository is likely to comply with the applicable radiation... prevent or mitigate the effects of postulated Category 1 and 2 event sequences. The preclosure safety... prevent accidents. ...

Cause for Concern: A Mixed-Methods Study of Campus Safety and Security Practices in United States-Mexico Border Institutions of Higher Education

ERIC Educational Resources Information Center

Holmes, Ryan Clevis

2014-01-01

Campus safety has been a source of concern since the 1990s. However, in 2007, the tragedy at the Virginia Polytechnic and State University sent a sense of alarm through many institutions of higher education. Immediately following this tragedy, institutions across the country began to evaluate and question their safety and security practices. While…

Program for developing and implementing a new approach to designing for fire safety in buildings

NASA Technical Reports Server (NTRS)

1975-01-01

The traditional method of providing for fire safety in buildings through reliance on codes and standards that prescribe specific measures to be taken in the design and construction of buildings to minimize the potential for a fire occurring and to protect property and life should a fire occur was evaluated. A new approach to designing for fire safety in buildings is outlined.

Bibliography on aircraft fire hazards and safety. Volume 2: Safety. Part 1: Key numbers 1 to 524

NASA Technical Reports Server (NTRS)

Pelouch, J. J., Jr. (Compiler); Hacker, P. T. (Compiler)

1974-01-01

Bibliographic citations are presented to describe and define aircraft safety methods, equipment, and criteria. Some of the subjects discussed are: (1) fire and explosion suppression using whiffle balls, (2) ultraviolet flame detecting sensors, (3) evaluation of flame arrestor materials for aircraft fuel systems, (4) crash fire prevention system for supersonic commercial aircraft, and (5) fire suppression for aerospace vehicles.

Evaluation of Human Reliability in Selected Activities in the Railway Industry

NASA Astrophysics Data System (ADS)

Sujová, Erika; Čierna, Helena; Molenda, Michał

2016-09-01

The article focuses on evaluation of human reliability in the human - machine system in the railway industry. Based on a survey of a train dispatcher and of selected activities, we have identified risk factors affecting the dispatcher`s work and the evaluated risk level of their influence on the reliability and safety of preformed activities. The research took place at the authors` work place between 2012-2013. A survey method was used. With its help, authors were able to identify selected work activities of train dispatcher's risk factors that affect his/her work and the evaluated seriousness of its influence on the reliability and safety of performed activities. Amongst the most important finding fall expressions of unclear and complicated internal regulations and work processes, a feeling of being overworked, fear for one's safety at small, insufficiently protected stations.

Assessment of safety culture among job positions in high-rise construction: a hybrid fuzzy multi criteria decision-making (FMCDM) approach.

PubMed

Ardeshir, A; Mohajeri, M

2018-06-01

The construction industry is known as one of the most dangerous industries, which not only requires sound operation of executive laws and regulations, but also necessitates the safety culture of all workers at workshops. Therefore, the aim of this research is to identify the factors of safety culture and ranking occupations in jobsites based on those factors in order to proactively improve the safety culture of construction projects and subsequently promote safety conditions and worksites. In this study, safety culture criteria are weighted by a combination of Fuzzy Decision Trail and Evaluation Laboratory and Fuzzy ANP methods. Next, different job positions in high-rise projects are ranked using the Fuzzy Technique for Order of Preference by Similarity to Ideal Solution method. Findings demonstrated that the project manager, site superintendent and supervisor occupations had the highest and labourers had the lowest level of safety culture in the high-rise construction industry. Furthermore, factors such as safety supervision and training must be considered more seriously in order to create a positive safety culture among workers.

[Anaesthetic security: evolution of ideas].

PubMed

Cherif, Ali; Daghfous, Mounir; Saîdi, Yosri

2008-11-01

The concept of risk has not clear neither in the media nor in the medical field. It appears important to us to bring details relating some definitions in the field of anaesthesia safety. This work aims to clarify the concepts of safety, of risk in a medical activity like the Anaesthesia. A search was carried out on Medline with the following key words: Risk anaesthetic, anaesthetic Safety, anaesthetic mortality. The definitions of risk, of acceptable risk taking account of social and economic considerations are brought in this text. The ways to evaluate safety and the methods to achieve it was developed. The indicator of quality more used to evaluate safety is anaesthetic mortality. Many difficulties exist with the interpretation of data on mortality. The standards of care are normally established according to the degree of necessary safety. Concurrently to these standards exist certainly the human error which is a phenomenon towards which must direct all the efforts of improvement of safety but more especially the errors of system which are found regularly in the analysis of accidents and incident. The identification of the failures is the mandatory step to achieve safety.

78 FR 8149 - Extension of a Currently Approved Information Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

... in achieving sustainable, systemic change that results in greater safety, permanency, and well-being... agreements. The cross-site evaluation uses a mixed-method, longitudinal approach. Data collection methods...

Method for selection of optimal road safety composite index with examples from DEA and TOPSIS method.

PubMed

Rosić, Miroslav; Pešić, Dalibor; Kukić, Dragoslav; Antić, Boris; Božović, Milan

2017-01-01

Concept of composite road safety index is a popular and relatively new concept among road safety experts around the world. As there is a constant need for comparison among different units (countries, municipalities, roads, etc.) there is need to choose an adequate method which will make comparison fair to all compared units. Usually comparisons using one specific indicator (parameter which describes safety or unsafety) can end up with totally different ranking of compared units which is quite complicated for decision maker to determine "real best performers". Need for composite road safety index is becoming dominant since road safety presents a complex system where more and more indicators are constantly being developed to describe it. Among wide variety of models and developed composite indexes, a decision maker can come to even bigger dilemma than choosing one adequate risk measure. As DEA and TOPSIS are well-known mathematical models and have recently been increasingly used for risk evaluation in road safety, we used efficiencies (composite indexes) obtained by different models, based on DEA and TOPSIS, to present PROMETHEE-RS model for selection of optimal method for composite index. Method for selection of optimal composite index is based on three parameters (average correlation, average rank variation and average cluster variation) inserted into a PROMETHEE MCDM method in order to choose the optimal one. The model is tested by comparing 27 police departments in Serbia. Copyright © 2016 Elsevier Ltd. All rights reserved.

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

2001-01-01

An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

Evaluation of the organisation and effectiveness of internal audits to govern patient safety in hospitals: a mixed-methods study.

PubMed

van Gelderen, Saskia C; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; Robben, Paul B; Wollersheim, Hub C

2017-07-10

Hospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety. A mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals. Response rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan-do-check-act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports. This study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A new 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

Safety assessment and detection method of genetically modified Chinese Kale (Brassica oleracea cv. alboglabra ).

PubMed

Lin, Chih-Hui; Lu, Chien-Te; Lin, Hsin-Tang; Pan, Tzu-Ming

2009-03-11

Sporamins are tuberous storage proteins and account for 80% of soluble protein in sweet potato tubers with trypsin-inhibitory activity. The expression of sporamin protein in transgenic Chinese kale (line BoA 3-1) conferred insecticidal activity toward corn earworm [ Helicoverpa armigera (Hubner)] in a previous report. In this study, we present a preliminary safety assessment of transgenic Chinese kale BoA 3-1. Bioinformatic and simulated gastric fluid (SGF) analyses were performed to evaluate the allergenicity of sporamin protein. The substantial equivalence between transgenic Chinese kale and its wild-type host has been demonstrated by the comparison of important constituents. A reliable real-time polymerase chain reaction (PCR) detection method was also developed to control sample quality. Despite the results of most evaluations in this study being negative, the safety of sporamin in transgenic Chinese kale BoA 3-1 was uncluded because of the allergenic risk revealed by bioinformatic analysis.

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Evaluation of Nurses' Acceptance of Screen Display Methods with Temporarily Non-Display for Privacy Protection.

PubMed

Niimi, Yukari; Ota, Katsumasa; Ikegami, Chikako

2018-01-01

The purpose of this study was to explore nurses' acceptance of a screen display method that temporarily hides patient information for privacy protection. Using a questionnaire, we asked nurses to evaluate the display method from the viewpoints of safety and efficiency with respect to 22 personal information items. The nurses were favorably interested in introducing the display method into their hospital system; however, their acceptance varied.

A bicycle safety index for evaluating urban street facilities.

PubMed

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

2015-01-01

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

An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions.

PubMed

Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J

2008-06-01

This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

[Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

PubMed

Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

2011-10-01

As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

Systematic strategies for the third industrial accident prevention plan in Korea.

PubMed

Kang, Young-sig; Yang, Sung-hwan; Kim, Tae-gu; Kim, Day-sung

2012-01-01

To minimize industrial accidents, it's critical to evaluate a firm's priorities for prevention factors and strategies since such evaluation provides decisive information for preventing industrial accidents and maintaining safety management. Therefore, this paper proposes the evaluation of priorities through statistical testing of prevention factors with a cause analysis in a cause and effect model. A priority matrix criterion is proposed to apply the ranking and for the objectivity of questionnaire results. This paper used regression method (RA), exponential smoothing method (ESM), double exponential smoothing method (DESM), autoregressive integrated moving average (ARIMA) model and proposed analytical function method (PAFM) to analyze trends of accident data that will lead to an accurate prediction. This paper standardized the questionnaire results of workers and managers in manufacturing and construction companies with less than 300 employees, located in the central Korean metropolitan areas where fatal accidents have occurred. Finally, a strategy was provided to construct safety management for the third industrial accident prevention plan and a forecasting method for occupational accident rates and fatality rates for occupational accidents per 10,000 people.

Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention

PubMed Central

Wiig, Siri; Ree, Eline; Johannessen, Terese; Strømme, Torunn; Storm, Marianne; Aase, Ingunn; Ullebust, Berit; Holen-Rabbersvik, Elisabeth; Hurup Thomsen, Line; Sandvik Pedersen, Anne Torhild; van de Bovenkamp, Hester; Bal, Roland; Aase, Karina

2018-01-01

Introduction Nursing homes and home care face challenges across different countries as people are living longer, often with chronic conditions. There is a lack of knowledge regarding implementation and impact of quality and safety interventions as most research evidence so far is generated in hospitals. Additionally, there is a lack of effective leadership tools for quality and safety improvement work in this context. Methods and analysis The aim of the ‘Improving Quality and Safety in Primary Care—Implementing a Leadership Intervention in Nursing Homes and Homecare’ (SAFE-LEAD) study is to develop and evaluate a research-based leadership guide for managers to increase quality and safety competence. The project applies a mixed-methods design and explores the implications of the leadership guide on managers’ and staffs’ knowledge, attitudes and practices. Four nursing homes and four home care services from different Norwegian municipalities will participate in the intervention. Surveys, process evaluation (interviews, observations) and document analyses will be conducted to evaluate the implementation and impact of the leadership intervention. A comparative study of Norway and the Netherlands will establish knowledge of the context dependency of the intervention. Ethics and dissemination The study is approved by the Norwegian Centre for Research Data (2017/52324 and 54855). The results will be disseminated through scientific articles, two PhD dissertations, an anthology, presentations at national and international conferences, and in social media, newsletters and in the press. The results will generate knowledge to inform leadership practices in nursing homes and home care. Moreover, the study will build new theory on leadership interventions and the role of contextual factors in nursing homes and home care. PMID:29599394

Brazed Joints Design and Allowables: Discuss Margins of Safety in Critical Brazed Structures

NASA Technical Reports Server (NTRS)

FLom, Yury

2009-01-01

This slide presentation tutorial discusses margins of safety in critical brazed structures. It reviews: (1) the present situation (2) definition of strength (3) margins of safety (4) design allowables (5) mechanical testing (6) failure criteria (7) design flowchart (8) braze gap (9) residual stresses and (10) delayed failures. This presentation addresses the strength of the brazed joints, the methods of mechanical testing, and our ability to evaluate the margins of safety of the brazed joints as it applies to the design of critical and expensive brazed assemblies.

A Real-time Evaluation of Human-based Approaches to Safety Testing: What We Can Do Now (TDS)

EPA Science Inventory

Despite ever-increasing efforts in early safety assessment in all industries, there are still many chemicals that prove toxic in humans. While greater use of human in vitro test methods may serve to reduce this problem, the formal validation process applied to such tests represen...

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

ERIC Educational Resources Information Center

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Promoting Fitness and Safety in Elementary Students: A Randomized Control Study of the Michigan Model for Health

ERIC Educational Resources Information Center

O'Neill, James M.; Clark, Jeffrey K.; Jones, James A.

2016-01-01

Background: In elementary grades, comprehensive health education curricula have demonstrated effectiveness in addressing singular health issues. The Michigan Model for Health (MMH) was implemented and evaluated to determine its impact on nutrition, physical fitness, and safety knowledge and skills. Methods: Schools (N = 52) were randomly assigned…

Pedestrian safety engineering and intelligent transportation system-based countermeasures program for reduced pedestrian fatalities, injuries, conflicts and other surrogate measures : Miami-Dade site.

DOT National Transportation Integrated Search

2008-08-25

This report presents the methods and key findings from the Miami-Dade comprehensive pedestrian safety planning and engineering project. It is one of three such projects in the nation funded by the Federal Highway Administration (FHWA) to evaluate: In...

Evaluation of a Stranger Safety Training Programme for Adults with Williams Syndrome

ERIC Educational Resources Information Center

Fisher, M. H.

2014-01-01

Background: Individuals with Williams syndrome (WS) are reported to display increased sociability towards strangers, leading to increased social vulnerability. No research has examined real life interactions of adults with WS towards strangers and no interventions have been implemented to teach stranger safety skills to this population. Method:…

Patient safety, quality of care, and knowledge translation in the intensive care unit.

PubMed

Needham, Dale M

2010-07-01

A large gap exists between the completion of clinical research demonstrating the benefit of new treatment interventions and improved patient outcomes resulting from implementation of these interventions as part of routine clinical practice. This gap clearly affects patient safety and quality of care. Knowledge translation is important for addressing this gap, but evaluation of the most appropriate and effective knowledge translation methods is still ongoing. Through describing one model for knowledge translation and an example of its implementation, insights can be gained into systematic methods for advancing the implementation of evidence-based interventions to improve safety, quality, and patient outcomes.

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

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

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

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

PubMed

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

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

A toxicity-based method for evaluating safety of reclaimed water for environmental reuses.

PubMed

Xu, Jianying; Zhao, Chuntao; Wei, Dongbin; Du, Yuguo

2014-10-01

A large quantity of toxic chemical pollutants possibly remains in reclaimed water due to the limited removal efficiency in traditional reclamation processes. It is not enough to guarantee the safety of reclaimed water using conventional water quality criteria. An integrated assessment method based on toxicity test is necessary to vividly depict the safety of reclaimed water for reuse. A toxicity test battery consisting of lethality, genotoxicity and endocrine disrupting effect was designed to screen the multiple biological effects of residual toxic chemicals in reclaimed water. The toxicity results of reclaimed water were converted into the equivalent concentrations of the corresponding positive reference substances (EQC). Simultaneously, the predicted no-effect concentration (PNEC) of each positive reference substance was obtained by analyzing the species sensitivity distribution (SSD) of toxicity data. An index "toxicity score" was proposed and valued as 1, 2, 3, or 4 depending on the ratio of the corresponding EQC to PNEC. For vividly ranking the safety of reclaimed water, an integrated assessment index "toxicity rank" was proposed, which was classified into A, B, C, or D rank with A being the safest. The proposed method was proved to be effective in evaluating reclaimed water samples in case studies. Copyright © 2014. Published by Elsevier B.V.

Validity and consistency assessment of accident analysis methods in the petroleum industry.

PubMed

Ahmadi, Omran; Mortazavi, Seyed Bagher; Khavanin, Ali; Mokarami, Hamidreza

2017-11-17

Accident analysis is the main aspect of accident investigation. It includes the method of connecting different causes in a procedural way. Therefore, it is important to use valid and reliable methods for the investigation of different causal factors of accidents, especially the noteworthy ones. This study aimed to prominently assess the accuracy (sensitivity index [SI]) and consistency of the six most commonly used accident analysis methods in the petroleum industry. In order to evaluate the methods of accident analysis, two real case studies (process safety and personal accident) from the petroleum industry were analyzed by 10 assessors. The accuracy and consistency of these methods were then evaluated. The assessors were trained in the workshop of accident analysis methods. The systematic cause analysis technique and bowtie methods gained the greatest SI scores for both personal and process safety accidents, respectively. The best average results of the consistency in a single method (based on 10 independent assessors) were in the region of 70%. This study confirmed that the application of methods with pre-defined causes and a logic tree could enhance the sensitivity and consistency of accident analysis.

42 CFR 82.15 - How will NIOSH evaluate the completeness and adequacy of individual monitoring data?

Code of Federal Regulations, 2010 CFR

2010-10-01

... OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES METHODS.... For internal exposure, the methods used to analyze bioassay samples will be reviewed to determine...

Drivers' biased perceptions of speed and safety campaign messages.

PubMed

Walton, D; McKeown, P C

2001-09-01

One hundred and thirteen drivers were surveyed for their perceptions of driving speed to compare self-reported average speed, perceived average-other speed and the actual average speed, in two conditions (50 and 100 kph zones). These contrasts were used to evaluate whether public safety messages concerning speeding effectively reach their target audience. Evidence is presented supporting the hypothesis that drivers who have a biased perception of their own speed relative to others are more likely to ignore advertising campaigns encouraging people not to speed. A method of self-other-actual comparisons detects biased perceptions when the standard method of self-other comparison does not. In particular, drivers exaggerate the perceived speed of others and this fact is masked using traditional methods. The method of manipulation is proposed as a way to evaluate the effect of future advertising campaigns, and a strategy for such campaigns is proposed based on the results of the self-other comparisons.

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 36.41 - Testing methods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Testing methods. 36.41 Section 36.41 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Requirements § 36.41 Testing methods. Mobile diesel-powered transportation equipment submitted for...

30 CFR 36.41 - Testing methods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Testing methods. 36.41 Section 36.41 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Requirements § 36.41 Testing methods. Mobile diesel-powered transportation equipment submitted for...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 36.41 - Testing methods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Testing methods. 36.41 Section 36.41 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Requirements § 36.41 Testing methods. Mobile diesel-powered transportation equipment submitted for...

30 CFR 36.41 - Testing methods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Testing methods. 36.41 Section 36.41 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Requirements § 36.41 Testing methods. Mobile diesel-powered transportation equipment submitted for...

30 CFR 36.41 - Testing methods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Testing methods. 36.41 Section 36.41 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Requirements § 36.41 Testing methods. Mobile diesel-powered transportation equipment submitted for...

An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.

PubMed

Lehman, H P; Chen, J; Gould, A L; Kassekert, R; Beninger, P R; Carney, R; Goldberg, M; Goss, M A; Kidos, K; Sharrar, R G; Shields, K; Sweet, A; Wiholm, B E; Honig, P K

2007-08-01

To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

ERIC Educational Resources Information Center

Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

2011-01-01

Objectives: To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods: A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results: Smokers reporting that the FDA does not evaluate cigarettes for…

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

PubMed

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

2009-01-01

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

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

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

[Ideas and methods on efficient screening of traditional medicines for anti-osteoporosis activity based on M-Act/Tox integrated evaluation using zebrafish].

PubMed

Wang, Mo; Ling, Jie; Chen, Ying; Song, Jie; Sun, E; Shi, Zi-Qi; Feng, Liang; Jia, Xiao-Bin; Wei, Ying-Jie

2017-11-01

The increasingly apparent liver injury problems of bone strengthening Chinese medicines have brought challenges for clinical application, and it is necessary to consider both effectiveness and safety in screening anti-osteoporosis Chinese medicines. Metabolic transformation is closely related to drug efficacy and toxicity, so it is significant to comprehensively consider metabolism-action/toxicity(M-Act/Tox) for screening anti-osteoporosis Chinese medicines. The current evaluation models and the number of compounds(including metabolites) severely restrict efficient screening in vivo. By referring to previous relevant research and domestic and abroad literature, zebrafish M-Act/Tox integrative method was put forward for efficiently screening anti-osteoporosis herb medicines, which has organically integrated zebrafish metabolism model, osteoporosis model and toxicity evaluation method. This method can break through the bottleneck and blind spots that trace compositions can't achieve efficient and integrated in vivo evaluation, and realize both efficient and comprehensive screening on anti-osteoporosis traditional medicines based on in vivo process taking both safety and effectiveness into account, which is significant to accelerate discovery of effective and safe innovative traditional Chinese medicines for osteoporosis. Copyright© by the Chinese Pharmaceutical Association.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion

PubMed Central

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-01-01

Introduction Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. Methods and analysis For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Ethics and dissemination Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. PMID:27733414

Systematic Review of Kinship Care Effects on Safety, Permanency, and Well-Being Outcomes

ERIC Educational Resources Information Center

Winokur, Marc A.; Holtan, Amy; Batchelder, Keri E.

2018-01-01

Objective: Children in out-of-home placements typically display more educational, behavioral, and psychological problems than do their peers. This systematic review evaluated the effect of kinship care placement compared to foster care placement on the safety, permanency, and well-being of children removed from the home for maltreatment. Methods:…

Safety. Fire Service Certification Series. Unit FSCS-FF-2-80.

ERIC Educational Resources Information Center

Pribyl, Paul F.

This training unit on safety is part of a 17-unit course package written to aid instructors in the development, teaching, and evaluation of fire fighters in the Wisconsin Fire Service Certification Series. The purpose stated for the 4-hour unit is to assist firefighters in understanding the hazards of their profession and some methods of reducing…

Effectiveness of the IMPACT:Ability Program to Improve Safety and Self-Advocacy Skills in High School Students with Disabilities

ERIC Educational Resources Information Center

Dryden, Eileen M.; Desmarais, Jeffery; Arsenault, Lisa

2014-01-01

Background: Individuals with disabilities experience higher rates of abuse than the nondisabled. Few evidence-based prevention interventions have been published despite a need for such work. This study evaluated IMPACT:Ability, a safety and self-advocacy training for individuals with cognitive and/or physical disabilities. Methods: A…

Twin Cities ramp meter evaluation : evaluation plan

DOT National Transportation Integrated Search

2000-09-25

The Minnesota Department of Transportation (Mn/DOT) uses ramp meters to manage freeway access on approximately 210 miles of freeways in the Twin Cities metropolitan area. Mn/DOT first tested ramp meters in 1969 as a method to optimize freeway safety ...

Using Space Syntax to Assess Safety in Public Areas - Case Study of Tarbiat Pedestrian Area, Tabriz-Iran

NASA Astrophysics Data System (ADS)

Cihangir Çamur, Kübra; Roshani, Mehdi; Pirouzi, Sania

2017-10-01

In studying the urban complex issues, simulation and modelling of public space use considerably helps in determining and measuring factors such as urban safety. Depth map software for determining parameters of the spatial layout techniques; and Statistical Package for Social Sciences (SPSS) software for analysing and evaluating the views of the pedestrians on public safety were used in this study. Connectivity, integration, and depth of the area in the Tarbiat city blocks were measured using the Space Syntax Method, and these parameters are presented as graphical and mathematical data. The combination of the results obtained from the questionnaire and statistical analysis with the results of spatial arrangement technique represents the appropriate and inappropriate spaces for pedestrians. This method provides a useful and effective instrument for decision makers, planners, urban designers and programmers in order to evaluate public spaces in the city. Prior to physical modification of urban public spaces, space syntax simulates the pedestrian safety to be used as an analytical tool by the city management. Finally, regarding the modelled parameters and identification of different characteristics of the case, this study represents the strategies and policies in order to increase the safety of the pedestrians of Tarbiat in Tabriz.

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.

Evaluating the Influence of Road Lighting on Traffic Safety at Accesses Using An Artificial Neural Network.

PubMed

Xu, Yueru; Ye, Zhirui; Wang, Yuan; Wang, Chao; Sun, Cuicui

2018-05-18

This paper focuses on the effect of road lighting on road safety at accesses and tries to quantitatively analyze the relationship between road lighting and road safety. An Artificial Neural Network (ANN) was applied in this study. This method is one of the most popular machine-learning methods in recent years and does not require any pre-defined assumptions. This method was applied using field data collected from ten road segments in Nanjing, Jiangsu Province, China. The results show that the impact of road lighting on road safety at accesses is significant. In addition, road lighting has greater influence when vehicle speeds are higher or the number of lanes is larger. A threshold illuminance was also found in this paper, and the results show that the safety level at accesses will become stable when reaching this value. The improvement of illuminance can decrease the speed variation among vehicles and improve the safety level. In addition, high-grade roads need better illuminance at accesses. A threshold value can also be obtained based on related variables and used to develop scientific guidelines for traffic management organizations.

Evaluation of Less-Flammable Insulation Fluids and Fire-Prevention Guidance for Transformers

NASA Astrophysics Data System (ADS)

Yamagishi, Akira; Sugawa, Osami

This paper concerns the definition and evaluation of less-flammable of insulation fluids for transformers. In particular it focuses on the ISO5660 cone calorimeter method, which is widely used as an evaluation method for the less-flammable of solids, and proposes that such method is also valid for quantitative evaluation of the less-flammable of insulating fluids. Quantifying the combustion characteristics of insulation fluids and analyzing the causes of fires can be said to be the first step toward implementing appropriate safety measures that will render electric utility equipment more fire retardant or fireproof in the future.

Development of the Likelihood of Low Glucose (LLG) algorithm for evaluating risk of hypoglycemia: a new approach for using continuous glucose data to guide therapeutic decision making.

PubMed

Dunn, Timothy C; Hayter, Gary A; Doniger, Ken J; Wolpert, Howard A

2014-07-01

The objective was to develop an analysis methodology for generating diabetes therapy decision guidance using continuous glucose (CG) data. The novel Likelihood of Low Glucose (LLG) methodology, which exploits the relationship between glucose median, glucose variability, and hypoglycemia risk, is mathematically based and can be implemented in computer software. Using JDRF Continuous Glucose Monitoring Clinical Trial data, CG values for all participants were divided into 4-week periods starting at the first available sensor reading. The safety and sensitivity performance regarding hypoglycemia guidance "stoplights" were compared between the LLG method and one based on 10th percentile (P10) values. Examining 13 932 hypoglycemia guidance outputs, the safety performance of the LLG method ranged from 0.5% to 5.4% incorrect "green" indicators, compared with 0.9% to 6.0% for P10 value of 110 mg/dL. Guidance with lower P10 values yielded higher rates of incorrect indicators, such as 11.7% to 38% at 80 mg/dL. When evaluated only for periods of higher glucose (median above 155 mg/dL), the safety performance of the LLG method was superior to the P10 method. Sensitivity performance of correct "red" indicators of the LLG method had an in sample rate of 88.3% and an out of sample rate of 59.6%, comparable with the P10 method up to about 80 mg/dL. To aid in therapeutic decision making, we developed an algorithm-supported report that graphically highlights low glucose risk and increased variability. When tested with clinical data, the proposed method demonstrated equivalent or superior safety and sensitivity performance. © 2014 Diabetes Technology Society.

Use of the false discovery rate for evaluating clinical safety data.

PubMed

Mehrotra, Devan V; Heyse, Joseph F

2004-06-01

Clinical adverse experience (AE) data are routinely evaluated using between group P values for every AE encountered within each of several body systems. If the P values are reported and interpreted without multiplicity considerations, there is a potential for an excess of false positive findings. Procedures based on confidence interval estimates of treatment effects have the same potential for false positive findings as P value methods. Excess false positive findings can needlessly complicate the safety profile of a safe drug or vaccine. Accordingly, we propose a novel method for addressing multiplicity in the evaluation of adverse experience data arising in clinical trial settings. The method involves a two-step application of adjusted P values based on the Benjamini and Hochberg false discovery rate (FDR). Data from three moderate to large vaccine trials are used to illustrate our proposed 'Double FDR' approach, and to reinforce the potential impact of failing to account for multiplicity. This work was in collaboration with the late Professor John W. Tukey who coined the term 'Double FDR'.

Probabilistic margin evaluation on accidental transients for the ASTRID reactor project

NASA Astrophysics Data System (ADS)

Marquès, Michel

2014-06-01

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

Patient safety culture and job stress among nurses in Mazandaran, Iran.

PubMed

Asefzadeh, Saeed; Kalhor, Rohollah; Tir, Mohammad

2017-12-01

Paying attention to patient safety is a basic right and a necessary issue in providing medical care, and failure to observe it leads to irreparable damage. One of the factors affecting an individuals' performance in an organization is stress, which also endangers their health. To determine the relationship between patient safety culture and levels of job stress among the nurses working in the hospitals affiliated with Mazandaran University of Medical Sciences. The present study was carried out using a cross-sectional method in the hospitals affiliated with Mazandaran University of Medical Sciences in 2016. A multistage stratified sampling method using a Morgan Table was employed to select 380 nurses as the study sample from among 3,180 nurses. They were selected by a multistage stratified sampling method. The study instruments were Stinemetz Standard Job Stress Questionnaire and Hospital Survey on Patient Safety Culture (HSOPSC). After the required data were collected, they were analyzed using descriptive and inferential statistical methods (Pearson correlation, independent-samples t-test, and ANOVA) through SPSS version 23. The results of the present study showed that 75% of the nurses experienced average and high levels of stress. Among different dimensions of safety culture, organizational learning and handoffs and transitions obtained the highest and the lowest scores, respectively (72.5 and 24.5). The mean score of safety culture dimensions was 51.52. The results of the Pearson correlation test showed that there was a direct significant relationship between different dimensions of safety culture among nurses and the level of stress (p≤0.05). According to the findings, patient safety should be considered as a strategic priority for the senior managers of the health system. In order to enhance patient safety, managers should pay special attention to evaluating safety culture in organizations that deliver health service, especially hospitals.

Reliability of digital reactor protection system based on extenics.

PubMed

Zhao, Jing; He, Ya-Nan; Gu, Peng-Fei; Chen, Wei-Hua; Gao, Feng

2016-01-01

After the Fukushima nuclear accident, safety of nuclear power plants (NPPs) is widespread concerned. The reliability of reactor protection system (RPS) is directly related to the safety of NPPs, however, it is difficult to accurately evaluate the reliability of digital RPS. The method is based on estimating probability has some uncertainties, which can not reflect the reliability status of RPS dynamically and support the maintenance and troubleshooting. In this paper, the reliability quantitative analysis method based on extenics is proposed for the digital RPS (safety-critical), by which the relationship between the reliability and response time of RPS is constructed. The reliability of the RPS for CPR1000 NPP is modeled and analyzed by the proposed method as an example. The results show that the proposed method is capable to estimate the RPS reliability effectively and provide support to maintenance and troubleshooting of digital RPS system.

Evaluation of a community based childhood injury prevention program.

PubMed Central

Bablouzian, L.; Freedman, E. S.; Wolski, K. E.; Fried, L. E.

1997-01-01

OBJECTIVES: This pilot study evaluates the effectiveness of a community based childhood injury prevention program on the reduction of home hazards. METHODS: High risk pregnant women, who were enrolled in a home visiting program that augments existing health and human services, received initial home safety assessments. Clients received education about injury prevention practices, in addition to receiving selected home safety supplies. Fourteen questions from the initial assessment tool were repeated upon discharge from the program. Matched analyses were conducted to evaluate differences from initial assessment to discharge. RESULTS: A significantly larger proportion of homes were assessed as safe at discharge, compared with the initial assessment, for the following hazards: children riding unbuckled in all auto travel, Massachusetts Poison Center sticker on the telephone, outlet plugs in all unused electrical outlets, safety latches on cabinets and drawers, and syrup of ipecac in the home. CONCLUSIONS: A community based childhood injury prevention program providing education and safety supplies to clients significantly reduced four home hazards for which safety supplies were provided. Education and promotion of the proper use of child restraint systems in automobiles significantly reduced a fifth hazard, children riding unbuckled in auto travel. This program appears to reduce the prevalence of home hazards and, therefore, to increase home safety. PMID:9113841

Evaluation of protein safety in the context of agricultural biotechnology.

PubMed

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

2008-05-01

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

Overview of the 2014 Edition of the International Handbook of Evaluated Reactor Physics Benchmark Experiments (IRPhEP Handbook)

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

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

2014-10-01

The International Reactor Physics Experiment Evaluation Project (IRPhEP) is a widely recognized world class program. The work of the IRPhEP is documented in the International Handbook of Evaluated Reactor Physics Benchmark Experiments (IRPhEP Handbook). Integral data from the IRPhEP Handbook is used by reactor safety and design, nuclear data, criticality safety, and analytical methods development specialists, worldwide, to perform necessary validations of their calculational techniques. The IRPhEP Handbook is among the most frequently quoted reference in the nuclear industry and is expected to be a valuable resource for future decades.

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

PubMed

Pauwels, Marleen; Rogiers, Vera

2004-06-15

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

In-Vehicle Safety Advisory And Warning System (Ivsaws), Volume II: Final Report

DOT National Transportation Integrated Search

2001-04-01

Methods for determining the workability of freshly mixed portland-cement concrete with slumps less than 51 mm (2 in) were investigated. Four potential methods to determine the workability of concrete were proposed for evaluation and development. The ...

Loss of Coolant Accident (LOCA) / Emergency Core Coolant System (ECCS Evaluation of Risk-Informed Margins Management Strategies for a Representative Pressurized Water Reactor (PWR)

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

Szilard, Ronaldo Henriques

A Risk Informed Safety Margin Characterization (RISMC) toolkit and methodology are proposed for investigating nuclear power plant core, fuels design and safety analysis, including postulated Loss-of-Coolant Accident (LOCA) analysis. This toolkit, under an integrated evaluation model framework, is name LOCA toolkit for the US (LOTUS). This demonstration includes coupled analysis of core design, fuel design, thermal hydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results.

Automated High-Speed Video Detection of Small-Scale Explosives Testing

NASA Astrophysics Data System (ADS)

Ford, Robert; Guymon, Clint

2013-06-01

Small-scale explosives sensitivity test data is used to evaluate hazards of processing, handling, transportation, and storage of energetic materials. Accurate test data is critical to implementation of engineering and administrative controls for personnel safety and asset protection. Operator mischaracterization of reactions during testing contributes to either excessive or inadequate safety protocols. Use of equipment and associated algorithms to aid the operator in reaction determination can significantly reduce operator error. Safety Management Services, Inc. has developed an algorithm to evaluate high-speed video images of sparks from an ESD (Electrostatic Discharge) machine to automatically determine whether or not a reaction has taken place. The algorithm with the high-speed camera is termed GoDetect (patent pending). An operator assisted version for friction and impact testing has also been developed where software is used to quickly process and store video of sensitivity testing. We have used this method for sensitivity testing with multiple pieces of equipment. We present the fundamentals of GoDetect and compare it to other methods used for reaction detection.

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and evaluating the results of such studies. Copyright © 2010 Elsevier B.V. All rights reserved.

Reducing fatalities and severe injuries on Florida's high-speed multi-lane arterial corridors : part IV, safety improvements on multilane arterials in Florida--a before and after evaluation, final report, April 2009.

DOT National Transportation Integrated Search

2009-03-28

This study examines the safety effects of the improvements made on multi-lane arterials. The improvements were divided into two categories: 1) corridor level improvements, and 2) intersection improvements. Empirical Bayes method, which is one of the ...

Identification of aggregates for Tennessee bituminous surface courses

NASA Astrophysics Data System (ADS)

Sauter, Heather Jean

Tennessee road construction is a major venue for federal and state spending. Tax dollars each year go to the maintenance and construction of roads. One aspect of highway construction that affects the public is the safety of its state roads. There are many factors that affect the safety of a given road. One factor that was focused on in this research was the polish resistance capabilities of aggregates. Several pre-evaluation methods have been used in the laboratory to predict what will happen in a field situation. A new pre-evaluation method was invented that utilized AASHTO T 304 procedure upscaled to accommodate surface bituminous aggregates. This new method, called the Tennessee Terminal Textural Condition Method (T3CM), was approved by Tennessee Department of Transportation to be used as a pre-evaluation method on bituminous surface courses. It was proven to be operator insensitive, repeatable, and an accurate indication of particle shape and texture. Further research was needed to correlate pre-evaluation methods to the current field method, ASTM E 274-85 Locked Wheel Skid Trailer. In this research, twenty-five in-place bituminous projects and eight source evaluations were investigated. The information gathered would further validate the T3CM and find the pre-evaluation method that best predicted the field method. In addition, new sources of aggregates for bituminous surface courses were revealed. The results of this research have shown T3CM to be highly repeatable with an overall coefficient of variation of 0.26% for an eight sample repeatability test. It was the best correlated pre-evaluation method with the locked wheel skid trailer method giving an R2 value of 0.3946 and a Pearson coefficient of 0.710. Being able to predict field performance of aggregates prior to construction is a powerful tool capable of saving time, money, labor, and possibly lives.

Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System.

PubMed

Yih, W Katherine; Maro, Judith C; Nguyen, Michael; Baker, Meghan A; Balsbaugh, Carolyn; Cole, David V; Dashevsky, Inna; Mba-Jonas, Adamma; Kulldorff, Martin

2018-06-01

The self-controlled tree-temporal scan statistic-a new signal-detection method-can evaluate whether any of a wide variety of health outcomes are temporally associated with receipt of a specific vaccine, while adjusting for multiple testing. Neither health outcomes nor postvaccination potential periods of increased risk need be prespecified. Using US medical claims data in the Food and Drug Administration's Sentinel system, we employed the method to evaluate adverse events occurring after receipt of quadrivalent human papillomavirus vaccine (4vHPV). Incident outcomes recorded in emergency department or inpatient settings within 56 days after first doses of 4vHPV received by 9- through 26.9-year-olds in 2006-2014 were identified using International Classification of Diseases, Ninth Revision, diagnosis codes and analyzed by pairing the new method with a standard hierarchical classification of diagnoses. On scanning diagnoses of 1.9 million 4vHPV recipients, 2 statistically significant categories of adverse events were found: cellulitis on days 2-3 after vaccination and "other complications of surgical and medical procedures" on days 1-3 after vaccination. Cellulitis is a known adverse event. Clinically informed investigation of electronic claims records of the patients with "other complications" did not suggest any previously unknown vaccine safety problem. Considering that thousands of potential short-term adverse events and hundreds of potential risk intervals were evaluated, these findings add significantly to the growing safety record of 4vHPV.

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

PubMed

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

[Trial of "Huber Plus" in outpatients with chemotherapy by blood port system].

PubMed

Matsumura, Natsuko; Tazumi, Keiko; Kouji, Keiko; Kondo, Motoi; Mizuki, Masao

2008-03-01

We evaluated the advantages and disadvantages of Huber Plus through three outpatients treated with central venous (CV) port chemotherapy (FOLFOX). One of the three outpatients first received chemotherapy with safety huber (Huber Plus) in this study, and the huber needle was changed from non-safety to a safety huber (Huber Plus) in two of the three outpatients. All three outpatients were taught about needle removal methods and port care. In patients? education, 1) we used a skin model and training CV port, and 2) dressing materials were used as film dressing plus three-point fixation by Fixomull stretch. As a result, the safety system assured zero incidents. Moreover, the evaluation revealed that operability and pain of Huber Plus were not clinical problems. We suggest that Huber Plus is applicable in outpatient chemotherapy and that our care plan with patients? education might become a standard treatment.

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

PubMed

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

2017-01-01

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

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

PubMed

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. 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.

Protocol for a mixed-methods study on leader-based interventions in construction contractors' safety commitments.

PubMed

Pedersen, Betina Holbaek; Dyreborg, Johnny; Kines, Pete; Mikkelsen, Kim Lyngby; Hannerz, Harald; Andersen, Dorte Raaby; Spangenberg, Søren

2010-06-01

Owing to high injury rates, safety interventions are needed in the construction industry. Evidence-based interventions tailored to this industry are, however, scarce. Leader-based safety interventions have proven more effective than worker-based interventions in other industries. To test a leader-based safety intervention for construction sites. The intervention consists of encouraging safety coordinators to provide feedback on work safety to the client and line management. The intention is to increase communication and interactions regarding safety within the line management and between the client and the senior management. It is hypothesised that this, in turn, will lead to increased communication and interaction about safety between management and coworkers as well as an increased on-site safety level. A group-randomised double-blinded case study of six Danish construction sites (three intervention sites and three control sites). The recruitment of the construction sites is performed continuously from January 2010 to June 2010. The investigation of each site lasts 20 continuous weeks. Confirmatory statistical analysis is used to test if the safety level increased, and if the probability of safety communications between management and coworkers increases as a consequence of the intervention. The data collection will be blinded. Qualitative methods are used to evaluate if communication and interactions about safety at all managerial levels, including the client, increase. (1) The proportion of safety-related communications out of all studied communications between management and coworkers. (2) The safety level index of the construction sites.

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

PubMed

Friedman, A J; Wheeler, J

1991-04-01

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

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

PubMed Central

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

2018-01-01

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

Infant toxicology: state of the science and considerations in evaluation of safety.

PubMed

Neal-Kluever, April; Aungst, Jason; Gu, Yan; Hatwell, Karen; Muldoon-Jacobs, Kristi; Liem, Ayesha; Ogungbesan, Adejoke; Shackelford, Mary

2014-08-01

Differences in the physiology and biological susceptibilities of adults and infants have led to growing interest in safety evaluation methods for exposures from infant formula packaging. In addition to potential physiological differences, infants aged 0-6 months may consume a sole source of food, infant formula or breast milk, and consume higher amounts of food relative to body weight compared to adults. While the duration of the exposure is short compared to the expected lifespan of the individual, it occurs during a period of important developmental processes. The purpose of this document is to (1) review key biological and exposure elements that may impact the evaluation of safety for food contact products intended for use by infants, (2) summarize the current reproductive and developmental toxicity testing protocols available, and (3) identify potential data gaps concerning this period of development. Published by Elsevier Ltd.

Fluorescence based spectral assessment of pork meat freshness

USDA-ARS?s Scientific Manuscript database

Development of sensitive, nondestructive measurement methods for meat freshness is necessary to ensure safe distribution of meat products in the continually growing meat market. Fluorescence spectral technology has been shown to be a promising measurement method for quality and safety evaluation of ...

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

Dallas, Michael J

2008-01-01

Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

PubMed

Anderson, Devon E; Watts, Bradley V

2013-09-01

Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

Narrative review of the UK Patient Safety Research Portfolio.

PubMed

Waring, Justin; Rowley, Emma; Dingwall, Robert; Palmer, Cecily; Murcott, Toby

2010-01-01

The UK Patient Safety Research Portfolio (PSRP) commissioned 38 studies investigating the threats to patient safety in various clinical settings and evaluating safety-related service interventions. This paper reviews 27 of these studies, drawing out emergent and cross-cutting themes in terms of theory, research methods and thematic findings. Given the diversity of PSRP studies, the paper takes a narrative approach that allows for qualitative description, interpretation and synthesis of the studies and their findings. The theoretical review shows the majority of PSRP studies draw upon a patient safety 'orthodoxy', developed from the concepts and models associated with the human factors approach. The methodological review shows that a diverse range of research designs and techniques have been utilized. Although many follow in the 'scientific' tradition, interpretative, mixed and innovative methods have been integral to research. The thematic review of findings highlights significant contributions to knowledge in the areas of 'people', 'organizations', and 'technology'. As well as identifying the various sources of risk in the organization and delivery of patient care, the studies also evaluate and make recommendations about service change and improvement. The PSRP has provided the foundations for significant theoretical, methodological and empirical advances in the area of patient safety. The findings and recommendations make important contributions to policy formulation and implementation as well as professional and managerial practice. Through this body of research the PSRP has supported the formation and growth of a thriving research community across academic, policy and professional communities.

The optimization of wireless power transmission: design and realization.

PubMed

Jia, Zhiwei; Yan, Guozheng; Liu, Hua; Wang, Zhiwu; Jiang, Pingping; Shi, Yu

2012-09-01

A wireless power transmission system is regarded as a practical way of solving power-shortage problems in multifunctional active capsule endoscopes. The uniformity of magnetic flux density, frequency stability and orientation stability are used to evaluate power transmission stability, taking into consideration size and safety constraints. Magnetic field safety and temperature rise are also considered. Test benches are designed to measure the relevent parameters. Finally, a mathematical programming model in which these constraints are considered is proposed to improve transmission efficiency. To verify the feasibility of the proposed method, various systems for a wireless active capsule endoscope are designed and evaluated. The optimal power transmission system has the capability to supply continuously at least 500 mW of power with a transmission efficiency of 4.08%. The example validates the feasibility of the proposed method. Introduction of novel designs enables further improvement of this method. Copyright © 2012 John Wiley & Sons, Ltd.

The Safety Course Design and Operations of Composite Overwrapped Pressure Vessels (COPV)

NASA Technical Reports Server (NTRS)

Saulsberry, Regor; Prosser, William

2015-01-01

Following a Commercial Launch Vehicle On-Pad COPV (Composite Overwrapped Pressure Vessels) failure, a request was received by the NESC (NASA Engineering and Safety Center) June 14, 2014. An assessment was approved July 10, 2014, to develop and assess the capability of scanning eddy current (EC) nondestructive evaluation (NDE) methods for mapping thickness and inspection for flaws. Current methods could not identify thickness reduction from necking and critical flaw detection was not possible with conventional dye penetrant (PT) methods, so sensitive EC scanning techniques were needed. Developmental methods existed, but had not been fully developed, nor had the requisite capability assessment (i.e., a POD (Probability of Detection) study) been performed.

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

Predicting the effectiveness of road safety campaigns through alternative research designs.

PubMed

Adamos, Giannis; Nathanail, Eftihia

2016-12-01

A large number of road safety communication campaigns have been designed and implemented in the recent years; however their explicit impact on driving behavior and road accident rates has been estimated in a rather low proportion. Based on the findings of the evaluation of three road safety communication campaigns addressing the issues of drinking and driving, seat belt usage, and driving fatigue, this paper applies different types of research designs (i.e., experimental, quasi-experimental, and non-experimental designs), when estimating the effectiveness of road safety campaigns, implements a cross-design assessment, and conducts a cross-campaign evaluation. An integrated evaluation plan was developed, taking into account the structure of evaluation questions, the definition of measurable variables, the separation of the target audience into intervention (exposed to the campaign) and control (not exposed to the campaign) groups, the selection of alternative research designs, and the appropriate data collection methods and techniques. Evaluating the implementation of different research designs in estimating the effectiveness of road safety campaigns, results showed that the separate pre-post samples design demonstrated better predictability than other designs, especially in data obtained from the intervention group after the realization of the campaign. The more constructs that were added to the independent variables, the higher the values of the predictability were. The construct that most affects behavior is intention, whereas the rest of the constructs have a lower impact on behavior. This is particularly significant in the Health Belief Model (HBM). On the other hand, behavioral beliefs, normative beliefs, and descriptive norms, are significant parameters for predicting intention according to the Theory of Planned Behavior (TPB). The theoretical and applied implications of alternative research designs and their applicability in the evaluation of road safety campaigns are provided by this study. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

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

Spacecraft and Navy Materials Flammability: Review of Some Concepts and Test Methods

NASA Technical Reports Server (NTRS)

Hirsch, David

2004-01-01

The agenda covered by this viewgraph presentation includes: 1) Concepts of Spacecraft Fire Safety; 2) Spacecraft materials flammability test methods; 3) Evaluation of flight hardware flammability; 4) Review of flammability data in conditions of interest to the Navy; 5) Overview of some flammability test methods recommended for the Navy.

Safety of tomatillos and products containing tomatillos canned by the water-bath canning method.

PubMed

McKee, L H; Remmenga, M D; Bock, M A

1998-01-01

Three studies were conducted to evaluate the safety of tomatillos and products containing tomatillos canned by the water-bath processing method. In the first study, plain tomatillos were processed for 25, 37.5, 50 and 62.5 min. In the second study, five tomatillo/onion combinations were prepared while five tomatillo/green chile combinations were prepared in the third study. pH evaluations were conducted to determine safety in all studies using pH 4.2 as the cut-off value. No differences in the pH of plain tomatillos were detected due to processing time. All jars of plain tomatillos had pH values below 4.1. All combinations of tomatillos/onions and tomatillos/green chile containing more than 50% tomatillo had pH values below the 4.2 cut-off value. Results of the three studies indicate (1) acidification of plain tomatillos is probably unnecessary for canning by the water-bath processing method and (2) combinations of acidic tomatillos and low-acid onions or green chile must contain more than 50% tomatillos to have a pH low enough for safe water-bath processing.

Evaluating "The Safe Living Guide": A Home Hazard Checklist for Seniors

ERIC Educational Resources Information Center

Sorcinelli, Andrea; Shaw, Lynn; Freeman, Andrew; Cooper, Kim

2007-01-01

Purpose: The purpose of this study was to evaluate the utility and reliability of a home hazard checklist published in Health Canada, "The Safe Living Guide: A Guide to Home Safety for Seniors" (2003). Methods: 76 community-dwelling seniors evaluated the guide, and inter-rater reliability was determined through comparison of ratings of…

A human reliability based usability evaluation method for safety-critical software

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

Boring, R. L.; Tran, T. Q.; Gertman, D. I.

2006-07-01

Boring and Gertman (2005) introduced a novel method that augments heuristic usability evaluation methods with that of the human reliability analysis method of SPAR-H. By assigning probabilistic modifiers to individual heuristics, it is possible to arrive at the usability error probability (UEP). Although this UEP is not a literal probability of error, it nonetheless provides a quantitative basis to heuristic evaluation. This method allows one to seamlessly prioritize and identify usability issues (i.e., a higher UEP requires more immediate fixes). However, the original version of this method required the usability evaluator to assign priority weights to the final UEP, thusmore » allowing the priority of a usability issue to differ among usability evaluators. The purpose of this paper is to explore an alternative approach to standardize the priority weighting of the UEP in an effort to improve the method's reliability. (authors)« less

A Roadmap for the Development of Alternative (Non-Animal) Methods for Systemic Toxicity Testing

EPA Science Inventory

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new prod...

Challenges in the Accurate Surveillance of Booster Seat and Bicycle Helmet Usage by Children: Lessons from the Field

PubMed Central

Pankratz, Curt; Warda, Lynne; Piotrowski, Caroline

2016-01-01

Motor vehicle collisions and bicycle collisions and falls are a leading cause of death by preventable injury for children. In order to design, implement and evaluate campaigns and programs aimed at improving child safety, accurate surveillance is needed. This paper examined the challenges that confront efforts to collect surveillance data relevant to child traffic safety, including observation, interview, and focus group methods. Strategies to address key challenges in order to improve the efficiency and accuracy of surveillance methods were recommended. The potential for new technology to enhance existing surveillance methods was also explored. PMID:27399749

Hotspots identification and ranking for road safety improvement: an alternative approach.

PubMed

Coll, Bronagh; Moutari, Salissou; Marshall, Adele H

2013-10-01

During the last decade, the concept of composite performance index, brought from economic and business statistics, has become a popular practice in the field of road safety, namely for the identification and classification of worst performing areas or time slots also known as hotspots. The overall quality of a composite index depends upon the complexity of phenomena of interest as well as the relevance of the methodological approach used to aggregate the various indicators into a single composite index. However, current aggregation methods used to estimate the composite road safety performance index suffer from various deficiencies at both the theoretical and operational level; these include the correlation and compensability between indicators, the weighting of the indicators as well as their high "degree of freedom" which enables one to readily manipulate them to produce desired outcomes (Munda and Nardo, 2003, 2005, 2009). The objective of this study is to contribute to the ongoing research effort on the estimation of road safety composite index for hotspots' identification and ranking. The aggregation method for constructing the composite road safety performance index introduced in this paper, strives to minimize the aforementioned deficiencies of the current approaches. Furthermore, this new method can be viewed as an intelligent decision support system for road safety performance evaluation, in order to prioritize interventions for road safety improvement. Copyright © 2013 Elsevier Ltd. All rights reserved.

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

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

PubMed

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

2013-01-01

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

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

An Evaluation of the Added Value of Co-Design in the Development of an Educational Game for Road Safety

ERIC Educational Resources Information Center

All, Anissa; Van Looy, Jan; Castellar, Elena Patricia Nuñez

2013-01-01

This study explores the added value of co-design in addition to other innovation research methods in the process of developing a serious game design document for a road safety game. The sessions aimed at exploring 4 aspects of a location-based game experience: themes, game mechanics, mobile phone applications and locations for mini-games. In…

A Randomised Controlled Trial Using Mobile Advertising to Promote Safer Sex and Sun Safety to Young People

ERIC Educational Resources Information Center

Gold, J.; Aitken, C. K.; Dixon, H. G.; Lim, M. S. C.; Gouillou, M.; Spelman, T.; Wakefield, M.; Hellard, M. E.

2011-01-01

Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the…

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture

PubMed Central

Bump, Gregory M.; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G.; Jasti, Harish; McCausland, Julie B.; Itri, Jason N.; Patel, Rita M.; Buchert, Andrew

2015-01-01

Background The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. Objective We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Methods Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Results Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Conclusions Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time. PMID:26217435

Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey.

PubMed

Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

2016-01-01

Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of "staff training and skills" were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety.

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

PubMed

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

2016-01-01

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

Critical Evaluation of Animal Alternative Tests for the Identification of Endocrine Active Substances

EPA Science Inventory

A significant amount of research is currently targeted to evaluate alternative test methods that may reduce, refine, or replace the use of animals, while ensuring human and environmental health and safety. It is important that the information gained from the alternative tests pr...

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.

Active Learning with Rationales for Identifying Operationally Significant Anomalies in Aviation

NASA Technical Reports Server (NTRS)

Sharma, Manali; Das, Kamalika; Bilgic, Mustafa; Matthews, Bryan; Nielsen, David Lynn; Oza, Nikunj C.

2016-01-01

A major focus of the commercial aviation community is discovery of unknown safety events in flight operations data. Data-driven unsupervised anomaly detection methods are better at capturing unknown safety events compared to rule-based methods which only look for known violations. However, not all statistical anomalies that are discovered by these unsupervised anomaly detection methods are operationally significant (e.g., represent a safety concern). Subject Matter Experts (SMEs) have to spend significant time reviewing these statistical anomalies individually to identify a few operationally significant ones. In this paper we propose an active learning algorithm that incorporates SME feedback in the form of rationales to build a classifier that can distinguish between uninteresting and operationally significant anomalies. Experimental evaluation on real aviation data shows that our approach improves detection of operationally significant events by as much as 75% compared to the state-of-the-art. The learnt classifier also generalizes well to additional validation data sets.

[Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

PubMed

He, Wei; Xie, Yanming; Wang, Yongyan

2011-12-01

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

Evaluation of Fission Product Critical Experiments and Associated Biases for Burnup Credit Validation

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

Mueller, Don; Rearden, Bradley T; Reed, Davis Allan

2010-01-01

One of the challenges associated with implementation of burnup credit is the validation of criticality calculations used in the safety evaluation; in particular the availability and use of applicable critical experiment data. The purpose of the validation is to quantify the relationship between reality and calculated results. Validation and determination of bias and bias uncertainty require the identification of sets of critical experiments that are similar to the criticality safety models. A principal challenge for crediting fission products (FP) in a burnup credit safety evaluation is the limited availability of relevant FP critical experiments for bias and bias uncertainty determination.more » This paper provides an evaluation of the available critical experiments that include FPs, along with bounding, burnup-dependent estimates of FP biases generated by combining energy dependent sensitivity data for a typical burnup credit application with the nuclear data uncertainty information distributed with SCALE 6. A method for determining separate bias and bias uncertainty values for individual FPs and illustrative results is presented. Finally, a FP bias calculation method based on data adjustment techniques and reactivity sensitivity coefficients calculated with the SCALE sensitivity/uncertainty tools and some typical results is presented. Using the methods described in this paper, the cross-section bias for a representative high-capacity spent fuel cask associated with the ENDF/B-VII nuclear data for 16 most important stable or near stable FPs is predicted to be no greater than 2% of the total worth of the 16 FPs, or less than 0.13 % k/k.« less

A usability evaluation toolkit for In-Vehicle Information Systems (IVISs).

PubMed

Harvey, Catherine; Stanton, Neville A; Pickering, Carl A; McDonald, Mike; Zheng, Pengjun

2011-05-01

Usability must be defined specifically for the context of use of the particular system under investigation. This specific context of use should also be used to guide the definition of specific usability criteria and the selection of appropriate evaluation methods. There are four principles which can guide the selection of evaluation methods, relating to the information required in the evaluation, the stage at which to apply methods, the resources required and the people involved in the evaluation. This paper presents a framework for the evaluation of usability in the context of In-Vehicle Information Systems (IVISs). This framework guides designers through defining usability criteria for an evaluation, selecting appropriate evaluation methods and applying those methods. These stages form an iterative process of design-evaluation-redesign with the overall aim of improving the usability of IVISs and enhancing the driving experience, without compromising the safety of the driver. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Improving safety climate through a communication and recognition program for construction: a mixed-methods study

PubMed Central

Sparer, Emily H; Catalano, Paul J; Herrick, Robert F; Dennerlein, Jack T

2016-01-01

Objectives This study aimed to evaluate the efficacy of a safety communication and recognition program (B-SAFE), designed to encourage improvement of physical working conditions and hazard reduction in construction. Methods A matched pair cluster randomized controlled trial was conducted on eight worksites (four received the B-SAFE intervention, four served as control sites) for approximately five months per site. Pre- and post-exposure worker surveys were collected at all sites (N=615, pre-exposure response rate of 74%, post-exposure response rate of 88%). Multi-level mixed-effect regression models evaluated the effect of B-SAFE on safety climate as assessed from surveys. Focus groups (N=6–8 workers/site) were conducted following data collection. Transcripts were coded and analyzed for thematic content using Atlas.ti (version 6). Results The mean safety climate score at intervention sites, as measured on a 0–50 point scale, increased 0.5 points (1%) between pre- and post-B-SAFE exposure, compared to control sites that decreased 0.8 points (1.6%). The intervention effect size was 1.64 (3.28%) (P-value=0.01) when adjusted for month the worker started on-site, total length of time on-site, as well as individual characteristics (trade, title, age, and race/ethnicity). At intervention sites, workers noted increased levels of safety awareness, communication, and teamwork compared to control sites. Conclusions B-SAFE led to many positive changes, including an improvement in safety climate, awareness, teambuilding, and communication. B-SAFE was a simple intervention that engaged workers through effective communication infrastructures and had a significant, positive effect on worksite safety. PMID:27158914

Subjective safety and self-confidence in prehospital trauma care and learning progress after trauma-courses: part of the prospective longitudinal mixed-methods EPPTC-trial.

PubMed

Häske, David; Beckers, Stefan K; Hofmann, Marzellus; Lefering, Rolf; Grützner, Paul A; Stöckle, Ulrich; Papathanassiou, Vassilios; Münzberg, Matthias

2017-08-14

Prehospital trauma care is stressful and requires multi-professional teamwork. A decrease in the number of accident victims ultimately affects the routine and skills and underlines the importance of effective training. Standardized courses, like PHTLS, are established for health care professionals to improve the prehospital care of trauma patients. The aim of the study was to investigate the subjective safety in prehospital trauma care and learning progress by paramedics in a longitudinal analysis. This was a prospective intervention trial and part of the mixed-method longitudinal EPPTC-trial, evaluating subjective and objective changes among participants and real patient care as a result of PHTLS courses. Participants were evaluated with pre/post questionnaires as well as one year after the course. We included 236 datasets. In the pre/post comparison, an increased performance could be observed in nearly all cases. The result shows that the expectations of the participants of the course were fully met even after one year (p = 0.002). The subjective safety in trauma care is significantly better even one year after the course (p < 0.001). Regression analysis showed that (ABCDE)-structure is decisive (p = 0.036) as well as safety in rare and common skills (both p < 0.001). Most skills are also rated better after one year. Knowledge and specific safety are assessed as worse after one year. The courses meet the expectations of the participants and increase the subjective safety in the prehospital care of trauma patients. ABCDE-structure and safety in skills are crucial. In the short term, both safety in skills and knowledge can be increased, but the courses do not have the power to maintain knowledge and specific subjective safety issues over a year. German Clinical Trials Register, ID DRKS00004713 , registered 14. February 2014.

Subtle Emotional Process in Early Childhood Pedagogy: Evaluating the Contribution of the Tavistock Observation Method

ERIC Educational Resources Information Center

Elfer, Peter

2017-01-01

Nursery experience is now common for young children and their families. Questions of quality have focussed mainly on safety and early learning. The roles of subtle emotional processes in daily pedagogic interactions have received surprisingly little attention. This paper discusses the Tavistock Observation Method (TOM), a naturalistic method of…

Drug safety data mining with a tree-based scan statistic.

PubMed

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

PubMed

Asturias, Edwin J; Wharton, Melinda; Pless, Robert; MacDonald, Noni E; Chen, Robert T; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N; Hartigan-Go, Kenneth; Zuber, Patrick L F

2016-06-17

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

Whole-surface round object imaging method using line-scan hyperspectral imaging system

USDA-ARS?s Scientific Manuscript database

To achieve comprehensive online quality and safety inspection of fruits, whole-surface sample presentation and imaging regimes must be considered. Specifically, a round object sample presentation method is under development to achieve effective whole-surface sample evaluation based on the use of a s...

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

PubMed Central

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

2014-01-01

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

Optical air data systems and methods

NASA Technical Reports Server (NTRS)

Spaeth, Lisa G. (Inventor); O'Brien, Martin (Inventor); Tang, Shoou-yu (Inventor); Acott, Phillip E. (Inventor); Caldwell, Loren M. (Inventor)

2011-01-01

Systems and methods for sensing air includes at least one, and in some embodiments three, transceivers for projecting the laser energy as laser radiation to the air. The transceivers are scanned or aligned along several different axes. Each transceiver receives laser energy as it is backscattered from the air. A computer processes signals from the transceivers to distinguish molecular scattered laser radiation from aerosol scattered laser radiation and determines air temperatures, wind speeds, and wind directions based on the scattered laser radiation. Applications of the system to wind power site evaluation, wind turbine control, traffic safety, general meteorological monitoring and airport safety are presented.

Road Infrastructure Safety Management in Poland

NASA Astrophysics Data System (ADS)

Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

2017-10-01

The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road stretch, road section, junction, etc.). The objective of the methods is to help road authorities to take rational decisions in the area of road safety and road infrastructure safety and understand the consequences occurring in the particular phases of road life cycle. To help with assessing the impact of a road project on the safety of related roads, a method was developed for long-term forecasts of accidents and accident cost estimation as well as a risk classification to identify risks that are not acceptable risks. With regard to road safety audits and road safety inspection, a set of principles was developed to identify risks and the basic classification of mistakes and omissions. This work has added to the Polish experience of preparing and implementing such tools within the competent road authorities.

Results of a community-based survey of construction safety climate for Hispanic workers

PubMed Central

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Background: Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. Objectives: To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. Methods: We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. Results: While contractors and construction supervisors’ (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30.6 vs 46.5%, P<0.05). Safety climate scores were not associated with English language ability or years lived in the United States. Conclusions: We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements. PMID:26145454

Collecting evidence from distributed sources to evaluate railway suicide and trespass prevention measures.

PubMed

Ryan, Brendan; Kallberg, Veli-Pekka; Rådbo, Helena; Havârneanu, Grigore M; Silla, Anne; Lukaschek, Karoline; Burkhardt, Jean-Marie; Bruyelle, Jean-Luc; El-Koursi, El-Miloudi; Beurskens, Eric; Hedqvist, Maria

2018-06-08

It can be difficult to select from available safety preventative measures, especially where there is limited evidence of effectiveness in different contexts. This paper describes application of a method to identify and evaluate wide-ranging preventative measures for rail suicide and trespass fatalities. Evidence from literature and industry sources was collated and reviewed in a two stage process to achieve consensus among experts on the likely effects of the measures and factors influencing their implementation. Multiple evaluation criteria were used to examine the measures from different perspectives. Fencing, awareness campaigns and different types of organisational initiatives were recommended for further testing. This is the first time evidence has been collected internationally across such a range of preventative measures. Commentary is provided on using this type of approach to select safety measures from a pool of prevention options, including how re-framing the scope of the exercise could identify alternative options for prevention. Practitioner summary. The findings give insight to how different measures work in different ways and how industry can consider this in strategic initiatives. The method could be used in future studies with different frames of reference (e.g. different timescales, level of ambition and safety context e.g. railway crossings or highway fatalities).

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

Evaluating the effectiveness of a radiation safety training intervention for oncology nurses: a pretest – intervention – posttest study

PubMed Central

Dauer, Lawrence T; Kelvin, Joanne F; Horan, Christopher L; St Germain, Jean

2006-01-01

Background Radiation, for either diagnosis or treatment, is used extensively in the field of oncology. An understanding of oncology radiation safety principles and how to apply them in practice is critical for nursing practice. Misconceptions about radiation are common, resulting in undue fears and concerns that may negatively impact patient care. Effectively educating nurses to help overcome these misconceptions is a challenge. Historically, radiation safety training programs for oncology nurses have been compliance-based and behavioral in philosophy. Methods A new radiation safety training initiative was developed for Memorial Sloan-Kettering Cancer Center (MSKCC) adapting elements of current adult education theories to address common misconceptions and to enhance knowledge. A research design for evaluating the revised training program was also developed to assess whether the revised training program resulted in a measurable and/or statistically significant change in the knowledge or attitudes of nurses toward working with radiation. An evaluation research design based on a conceptual framework for measuring knowledge and attitude was developed and implemented using a pretest-intervention-posttest approach for 15% of the study population of 750 inpatient registered oncology nurses. Results As a result of the intervention program, there was a significant difference in nurse's cognitive knowledge as measured with the test instrument from pretest (58.9%) to posttest (71.6%). The evaluation also demonstrated that while positive nursing attitudes increased, the increase was significant for only 5 out of 9 of the areas evaluated. Conclusion The training intervention was effective for increasing cognitive knowledge, but was less effective at improving overall attitudes. This evaluation provided insights into the effectiveness of training interventions on the radiation safety knowledge and attitude of oncology nurses. PMID:16762060

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

A blended supervision model in Australian general practice training.

PubMed

Ingham, Gerard; Fry, Jennifer

2016-05-01

The Royal Australian College of General Practitioners' Standards for general practice training allow different models of registrar supervision, provided these models achieve the outcomes of facilitating registrars' learning and ensuring patient safety. In this article, we describe a model of supervision called 'blended supervision', and its initial implementation and evaluation. The blended supervision model integrates offsite supervision with available local supervision resources. It is a pragmatic alternative to traditional supervision. Further evaluation of the cost-effectiveness, safety and effectiveness of this model is required, as is the recruitment and training of remote supervisors. A framework of questions was developed to outline the training practice's supervision methods and explain how blended supervision is achieving supervision and teaching outcomes. The supervision and teaching framework can be used to understand the supervision methods of all practices, not just practices using blended supervision.

Knowledge, attitudes and practices of food handlers in food safety: An integrative review.

PubMed

Zanin, Laís Mariano; da Cunha, Diogo Thimoteo; de Rosso, Veridiana Vera; Capriles, Vanessa Dias; Stedefeldt, Elke

2017-10-01

This study presents an overview of the relationship between knowledge, attitudes and practices (KAP) of food handlers with training in food safety, in addition to proposing reflections on the training of food handlers, considering its responsibility for food safety and health of consumers. The review was based on the integrative method. The descriptors used were: (food handler), (knowledge, attitudes and practice) and (training). Six databases were searched, 253 articles were consulted and 36 original articles were included. Fifty per cent of the articles pointed that there was no proper translation of knowledge into attitudes/practices or attitudes into practices after training. Knowledge, attitudes and practices of food handlers are important for identifying how efficient training in food safety is allowing prioritize actions in planning training. The evaluation of KAP is the first step to understand the food handler's point of view. After this evaluation other diagnostic strategies become necessary to enhance this understanding. Copyright © 2017. Published by Elsevier Ltd.

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

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

Rathbun, R.

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

42 CFR 82.15 - How will NIOSH evaluate the completeness and adequacy of individual monitoring data?

Code of Federal Regulations, 2012 CFR

2012-10-01

... adequacy of individual monitoring data? 82.15 Section 82.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES METHODS... adequacy of individual monitoring data? (a) NIOSH will evaluate the completeness and adequacy of an...

42 CFR 82.15 - How will NIOSH evaluate the completeness and adequacy of individual monitoring data?

Code of Federal Regulations, 2014 CFR

2014-10-01

... adequacy of individual monitoring data? 82.15 Section 82.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES METHODS... adequacy of individual monitoring data? (a) NIOSH will evaluate the completeness and adequacy of an...

42 CFR 82.15 - How will NIOSH evaluate the completeness and adequacy of individual monitoring data?

Code of Federal Regulations, 2011 CFR

2011-10-01

... adequacy of individual monitoring data? 82.15 Section 82.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES METHODS... adequacy of individual monitoring data? (a) NIOSH will evaluate the completeness and adequacy of an...

42 CFR 82.15 - How will NIOSH evaluate the completeness and adequacy of individual monitoring data?

Code of Federal Regulations, 2013 CFR

2013-10-01

... adequacy of individual monitoring data? 82.15 Section 82.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES METHODS... adequacy of individual monitoring data? (a) NIOSH will evaluate the completeness and adequacy of an...

Proposed test method for and evaluation of wheelchair seating system (WCSS) crashworthiness.

PubMed

van Roosmalen, L; Bertocci, G; Ha, D R; Karg, P; Szobota, S

2000-01-01

Safety of motor vehicle seats is of great importance in providing crash protection to the occupant. An increasing number of wheelchair users use their wheelchairs as motor vehicle seats when traveling. A voluntary standard requires that compliant wheelchairs be dynamically sled impact tested. However, testing to evaluate the crashworthiness of add-on wheelchair seating systems (WCSS) independent of their wheelchair frame is not addressed by this standard. To address this need, this study developed a method to evaluate the crash-worthiness of WCSS with independent frames. Federal Motor Vehicle Safety Standards (FMVSS) 207 test protocols, used to test the strength of motor vehicle seats, were modified and used to test the strength of three WCSS. Forward and rearward loads were applied at the WCSS center of gravity (CGSS), and a moment was applied at the uppermost point of the seat back. Each of the three tested WCSS met the strength requirements of FMVSS 207. Wheelchair seat-back stiffness was also investigated and compared to motor vehicle seat-back stiffness.

Considerations in the use of microneedles: pain, convenience, anxiety and safety.

PubMed

Jeong, Hye-Rin; Lee, Han-Sol; Choi, In-Jeong; Park, Jung-Hwan

2017-01-01

Transdermal delivery using microneedles is gaining increasing attention from pharmaceutical and cosmetic companies as one of the promising drug delivery methods. Microneedle products have recently become available on the market, and some of them are under evaluation for efficacy and safety. To be available in the market for cosmetic and therapeutic use, several factors should be considered, including pain, anxiety, convenience and safety. These factors are summarized and reviewed in this article according to type of microneedle. Various kinds of materials have been used for manufacturing microneedles and developing drug formulations for microneedles. Safety information about materials used for microneedles is summarized in terms of type of microneedles. In addition to their biocompatibility, mechanical safety is also discussed. This review can provide guidelines for designing microneedle products for proper use.

[Study toward practical use of oligonucleotide therapeutics].

PubMed

Inoue, Takao; Yoshida, Tokuyuki

2014-01-01

Over the past decade, oligonucleotide-based therapeutics such as antisense oligonucleotides and small interfering RNAs (siRNAs) have been developed extensively. For example, mipomersen (Kynamro; ISIS Pharmaceuticals), which is a second-generation antisense oligonucleotide administered by subcutaneous injection, has recently been approved by the FDA for the treatment of homozygous familial hypercholesterolemia. On the other hands, methods for the evaluation of quality, efficacy and safety of oligonucleotide therapeutics have not been fully discussed. Furthermore, the regulatory guidance specific for oligonucleotide therapeutics has not been established yet. Under these circumstances, we started to collaborate with Osaka University and PMDA to discuss regulatory science focused on oligonucleotide therapeutics. Through the collaboration, we would like to propose the possible design of quality evaluation and preclinical safety-evaluation of oligonucleotide therapeutics.

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

PubMed

Mithril, Charlotte; Dragsted, Lars Ove

2012-12-01

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

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.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

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

1998-01-01

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

Assessment of food safety practices of food service food handlers (risk assessment data): testing a communication intervention (evaluation of tools).

PubMed

Chapman, Benjamin; Eversley, Tiffany; Fillion, Katie; Maclaurin, Tanya; Powell, Douglas

2010-06-01

Globally, foodborne illness affects an estimated 30% of individuals annually. Meals prepared outside of the home are a risk factor for acquiring foodborne illness and have been implicated in up to 70% of traced outbreaks. The Centers for Disease Control and Prevention has called on food safety communicators to design new methods and messages aimed at increasing food safety risk-reduction practices from farm to fork. Food safety infosheets, a novel communication tool designed to appeal to food handlers and compel behavior change, were evaluated. Food safety infosheets were provided weekly to food handlers in working food service operations for 7 weeks. It was hypothesized that through the posting of food safety infosheets in highly visible locations, such as kitchen work areas and hand washing stations, that safe food handling behaviors of food service staff could be positively influenced. Using video observation, food handlers (n = 47) in eight food service operations were observed for a total of 348 h (pre- and postintervention combined). After the food safety infosheets were introduced, food handlers demonstrated a significant increase (6.7%, P < 0.05, 95% confidence interval) in mean hand washing attempts, and a significant reduction in indirect cross-contamination events (19.6%, P < 0.05, 95% confidence interval). Results of the research demonstrate that posting food safety infosheets is an effective intervention tool that positively influences the food safety behaviors of food handlers.

The impact of cooking methods on the nutritional quality and safety of chicken breaded nuggets.

PubMed

Gonçalves Albuquerque, Tânia; Oliveira, M Beatriz P P; Sanches-Silva, Ana; Cristina Bento, Ana; Costa, Helena S

2016-06-15

The impact of cooking methods (industrial pre-frying, deep-fat frying and baking) on the nutritional quality and safety of chicken breaded nugget samples from supermarket and commercial brands was evaluated. The changes in the quality characteristics (nutritional composition, fatty acids profile, cholesterol and salt) of the fried food and frying oil, after ten consecutive frying operations, were evaluated. The total fat content of nuggets varied between 10.9 and 22.7 g per 100 g of edible portion and the salt content ranged from 0.873 to 1.63 g per 100 g. Taking into account one portion of nuggets, the daily intake of salt can reach 49%, which can have a significant impact on the health of those who regularly consume this type of food, especially considering the prevalence of hypertension around the world. The analysed chicken breaded nuggets are rich in unsaturated fatty acids, which have been related with potential health benefits, namely regarding cardiovascular diseases. The cholesterol content of baked samples was two times higher when compared with the fried ones. The trans fatty acids and polar compounds contents of the frying oil used for frying significantly increased, but the values were still away from the maximum recommended by legal entities for its rejection. From a nutritional point of view, it is possible to conclude that the applied cooking methods can significantly influence the nutritional quality and safety of the analysed chicken breaded nuggets. This study will contribute to important knowledge on how the applied cooking methods can change the nutritional quality and safety of foods, namely of chicken nuggets, and can be very useful for dietary recommendations and nutritional assessment.

Calculations of reliability predictions for the Apollo spacecraft

NASA Technical Reports Server (NTRS)

Amstadter, B. L.

1966-01-01

A new method of reliability prediction for complex systems is defined. Calculation of both upper and lower bounds are involved, and a procedure for combining the two to yield an approximately true prediction value is presented. Both mission success and crew safety predictions can be calculated, and success probabilities can be obtained for individual mission phases or subsystems. Primary consideration is given to evaluating cases involving zero or one failure per subsystem, and the results of these evaluations are then used for analyzing multiple failure cases. Extensive development is provided for the overall mission success and crew safety equations for both the upper and lower bounds.

Evaluating accident rates on Virginia's secondary road system.

DOT National Transportation Integrated Search

1973-01-01

In order to establish priorities for allocating highway funds available for safety improvements, an investigation was made of a method for ranking the state's counties according to their accident histories. Million vehicle miles traveled, registered ...

30 CFR 250.1606 - Control of wells.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL... and safest drilling technologies and state-of-the-art methods to evaluate and minimize the potential..., equipment, natural resources, and the environment. ...

30 CFR 250.1606 - Control of wells.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL... and safest drilling technologies and state-of-the-art methods to evaluate and minimize the potential..., equipment, natural resources, and the environment. ...

30 CFR 250.1606 - Control of wells.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL... and safest drilling technologies and state-of-the-art methods to evaluate and minimize the potential..., equipment, natural resources, and the environment. ...

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.

Environmental Evaluation of Soil Salinity with Various Watering Technologies Assessment.

PubMed

Seitkaziev, Adeubay; Shilibek, Kenzhegali; Fakhrudenova, Idiya; Salybayev, Satybaldy; Zhaparova, Sayagul; Duisenbayeva, Saule; Bayazitova, Zulfia; Aliya, Maimakova; Seitkazieva, Karlygash; Aubakirov, Hamit

2018-01-01

  The purpose of this study is to develop mathematical tools for evaluating the level of environmental safety of various watering technologies. A set of indicators, was developed with regard to the natural factors, the nature of the man-induced load, degradation type, and characteristics of the disruption of humification conditions. Thermal and physical characteristics of the soil, the state of its surface, and meteorological factors, including air temperature, relative humidity, precipitation, wind speed, solar radiation, etc. were studied with a view to determining the heat and air exchange in the soil. An environmental evaluation of the methods for saline land development was conducted with regard to the heat and moisture supply. This tool can be used to determine the level of environmental safety of soil salinization during the environmental evaluation of the investigation of soil salinity with various watering technologies.

Study of Evaluation OSH Management System Policy Based On Safety Culture Dimensions in Construction Project

NASA Astrophysics Data System (ADS)

Latief, Yusuf; Armyn Machfudiyanto, Rossy; Arifuddin, Rosmariani; Mahendra Fira Setiawan, R.; Yogiswara, Yoko

2017-07-01

Safety Culture in the construction industry is very influential on the socio economic conditions that resulted in the country’s competitiveness. Based on the data, the accident rate of construction projects in Indonesia is very high. In the era of the Asian Economic Community (AEC) Indonesian contractor is required to improve competitiveness, one of which is the implementation of the project without zero accident. Research using primary and secondary data validated the results of the literature experts and questionnaire respondents were analyzed using methods SmartPLS, obtained pattern of relationships between dimensions of safety culture to improve the performance of Safety. The results showed that the behaviors and Cost of Safety into dimensions that significantly affect the performance of safety. an increase in visible policy-based on Regulation of Public Work and Housing No 5/PRT/M/2014 to improve to lower the accident rate.

The effect of pre-enrichment media on the recovery and detection of Salmonella in feed

USDA-ARS?s Scientific Manuscript database

Current methodology for detecting Salmonella in feeds and feed ingredients are adapted from food safety methods. These methods do not take into account the stressed state of Salmonella in feed, presence of competing microorganisms nor the sample matrix. The objective was to evaluate four pre-enrichm...

30 CFR 33.35 - Methods of drilling; dust-collector unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Methods of drilling; dust-collector unit. 33.35 Section 33.35 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.35 - Methods of drilling; dust-collector unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Methods of drilling; dust-collector unit. 33.35 Section 33.35 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.35 - Methods of drilling; dust-collector unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Methods of drilling; dust-collector unit. 33.35 Section 33.35 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.35 - Methods of drilling; dust-collector unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Methods of drilling; dust-collector unit. 33.35 Section 33.35 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.35 - Methods of drilling; dust-collector unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Methods of drilling; dust-collector unit. 33.35 Section 33.35 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

SYNTHESIS OF METHODS FOR ESTIMATING PEDESTRIAN AND BICYCLIST EXPOSURE TO RISK AT AREAWIDE LEVELS AND ON SPECIFIC TRANSPORTATION FACILITIES

DOT National Transportation Integrated Search

2017-01-01

This report summarizes the variety of methods used to estimate and evaluate exposure to risk in pedestrian and bicyclist safety analyses. In the literature, the most common definition of risk was a measure of the probability of a crash to occur given...

Rationale, Design, and Methods of the Preschool ADHD Treatment Study (PATS)

ERIC Educational Resources Information Center

Kollins, Scott; Greenhill, Laurence; Swanson, James; Wigal, Sharon; Abikoff, Howard; McCracken, James; Riddle, Mark; McGough, James; Vitiello, Benedetto; Wigal, Tim; Skrobala, Anne; Posner, Kelly; Ghuman, Jaswinder; Davies, Mark; Cunningham, Charles; Bauzo, Audrey

2006-01-01

Objective: To describe the rationale and design of the Preschool ADHD Treatment Study (PATS). Method: PATS was a National Institutes of Mental Health-funded, multicenter, randomized, efficacy trial designed to evaluate the short-term (5 weeks) efficacy and long-term (40 weeks) safety of methylphenidate (MPH) in preschoolers with…

Survey of Cancer Patient Safety Culture: A Comparison of Chemotherapy and Oncology Departments of Teaching Hospitals of Tehran

PubMed Central

Raeissi, Pouran; Sharifi, Marziye; Khosravizadeh, Omid; Heidari, Mohammad

2017-01-01

Background: Patient safety culture plays an important role in healthcare systems, especially in chemotherapy and oncology departments (CODs), and its assessment can help to improve quality of services and hospital care. Objective: This study aimed to evaluate and compare items and dimensions of patient safety culture in the CODs of selected teaching hospitals of Iran and Tehran University of Medical Sciences. Materials and Methods: This descriptive-analytical cross-sectional survey was conducted during a six-month period on 270 people from chemotherapy and oncology departments selected through a cluster sampling method. All participants answered the standard questionnaire for “Hospital Survey of Patient Safety Culture” (HSOPSC). Statistical analyses were performed using SPSS/18 software. Results: The average score for patient safety culture was three for the majority of the studied CODs. Statistically significant differences were observed for supervisor actions, teamwork within various units, feedback and communications about errors, and the level of hospital management support. (p<0.05). Relationships between studied hospitals and patient safety culture were not statistically significant (p>0.05). Conclusion: Our results showed that the overall status of patient safety culture is not good in the studied CODs. In particular, teamwork across different units and organizational learning with continuous improvement were the only two properly operating items among 12 dimensions of patient safety culture. Therefore, systematic interventions are strongly required to promote communication. PMID:29072411

Safe surgery: validation of pre and postoperative checklists 1

PubMed Central

Alpendre, Francine Taporosky; Cruz, Elaine Drehmer de Almeida; Dyniewicz, Ana Maria; Mantovani, Maria de Fátima; Silva, Ana Elisa Bauer de Camargo e; dos Santos, Gabriela de Souza

2017-01-01

ABSTRACT Objective: to develop, evaluate and validate a surgical safety checklist for patients in the pre and postoperative periods in surgical hospitalization units. Method: methodological research carried out in a large public teaching hospital in the South of Brazil, with application of the principles of the Safe Surgery Saves Lives Programme of the World Health Organization. The checklist was applied to 16 nurses of 8 surgical units and submitted for validation by a group of eight experts using the Delphi method online. Results: the instrument was validated and it was achieved a mean score ≥1, level of agreement ≥75% and Cronbach’s alpha >0.90. The final version included 97 safety indicators organized into six categories: identification, preoperative, immediate postoperative, immediate postoperative, other surgical complications, and hospital discharge. Conclusion: the Surgical Safety Checklist in the Pre and Postoperative periods is another strategy to promote patient safety, as it allows the monitoring of predictive signs and symptoms of surgical complications and the early detection of adverse events. PMID:28699994

Quality management and perceptions of teamwork and safety climate in European hospitals.

PubMed

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Availability of Neutronics Benchmarks in the ICSBEP and IRPhEP Handbooks for Computational Tools Testing

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

Bess, John D.; Briggs, J. Blair; Ivanova, Tatiana

2017-02-01

In the past several decades, numerous experiments have been performed worldwide to support reactor operations, measurements, design, and nuclear safety. Those experiments represent an extensive international investment in infrastructure, expertise, and cost, representing significantly valuable resources of data supporting past, current, and future research activities. Those valuable assets represent the basis for recording, development, and validation of our nuclear methods and integral nuclear data [1]. The loss of these experimental data, which has occurred all too much in the recent years, is tragic. The high cost to repeat many of these measurements can be prohibitive, if not impossible, to surmount.more » Two international projects were developed, and are under the direction of the Organisation for Co-operation and Development Nuclear Energy Agency (OECD NEA) to address the challenges of not just data preservation, but evaluation of the data to determine its merit for modern and future use. The International Criticality Safety Benchmark Evaluation Project (ICSBEP) was established to identify and verify comprehensive critical benchmark data sets; evaluate the data, including quantification of biases and uncertainties; compile the data and calculations in a standardized format; and formally document the effort into a single source of verified benchmark data [2]. Similarly, the International Reactor Physics Experiment Evaluation Project (IRPhEP) was established to preserve integral reactor physics experimental data, including separate or special effects data for nuclear energy and technology applications [3]. Annually, contributors from around the world continue to collaborate in the evaluation and review of select benchmark experiments for preservation and dissemination. The extensively peer-reviewed integral benchmark data can then be utilized to support nuclear design and safety analysts to validate the analytical tools, methods, and data needed for next-generation reactor design, safety analysis requirements, and all other front- and back-end activities contributing to the overall nuclear fuel cycle where quality neutronics calculations are paramount.« less

Comparative evaluation of user interfaces for robot-assisted laser phonomicrosurgery.

PubMed

Dagnino, Giulio; Mattos, Leonardo S; Becattini, Gabriele; Dellepiane, Massimo; Caldwell, Darwin G

2011-01-01

This research investigates the impact of three different control devices and two visualization methods on the precision, safety and ergonomics of a new medical robotic system prototype for assistive laser phonomicrosurgery. This system allows the user to remotely control the surgical laser beam using either a flight simulator type joystick, a joypad, or a pen display system in order to improve the traditional surgical setup composed by a mechanical micromanipulator coupled with a surgical microscope. The experimental setup and protocol followed to obtain quantitative performance data from the control devices tested are fully described here. This includes sets of path following evaluation experiments conducted with ten subjects with different skills, for a total of 700 trials. The data analysis method and experimental results are also presented, demonstrating an average 45% error reduction when using the joypad and up to 60% error reduction when using the pen display system versus the standard phonomicrosurgery setup. These results demonstrate the new system can provide important improvements in terms of surgical precision, ergonomics and safety. In addition, the evaluation method presented here is shown to support an objective selection of control devices for this application.

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

PubMed

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

2016-01-01

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

Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial.

PubMed

White, Codi; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Walsh, Kerryann; Hawkins, Russell; Lines, Katrina; Webb, Haley

2018-06-11

Promoting young children's interpersonal safety knowledge, intentions confidence and skills is the goal of many child maltreatment prevention programs; however, evaluation of their effectiveness has been limited. In this study, a randomized controlled trial was conducted examining the effectiveness of the Australian protective behaviors program, Learn to be safe with Emmy and friends™ compared to a waitlist condition. In total, 611 Australian children in Grade 1 (5-7 years; 50% male) participated, with assessments at Pre-intervention, Post-intervention and a 6-month follow-up. This study also included a novel assessment of interpersonal safety skills through the Observed Protective Behaviors Test (OPBT). Analyses showed participating in Learn to be safe with Emmy and friends™ was effective post-program in improving interpersonal safety knowledge (child and parent-rated) and parent-rated interpersonal safety skills. These benefits were retained at the 6-month follow-up, with participating children also reporting increased disclosure confidence. However, Learn to be safe with Emmy and friends™ participation did not significantly impact children's disclosure intentions, safety identification skills, or interpersonal safety skills as measured by the OPBT. Future research may seek to evaluate the effect of further parent and teacher integration into training methods and increased use of behavioral rehearsal and modelling to more effectively target specific disclosure intentions and skills. Copyright © 2018 Elsevier Ltd. All rights reserved.

Prevention of accidental exposure in radiotherapy: the risk matrix approach.

PubMed

Vilaragut, J J; Duménigo, C; Delgado, J M; Morales, J; McDonnell, J D; Ferro, R; Ortiz López, P; Ramírez, M L; Pérez Mulas, A; Papadopulos, S; Gonçalves, M; López Morones, R; Sánchez Cayuela, C; Cascajo Castresana, A; Somoano, F; Álvarez, C; Guillén, A; Rodríguez, M; Pereira, P P; Nader, A

2013-02-01

Knowledge and lessons from past accidental exposures in radiotherapy are very helpful in finding safety provisions to prevent recurrence. Disseminating lessons is necessary but not sufficient. There may be additional latent risks for other accidental exposures, which have not been reported or have not occurred, but are possible and may occur in the future if not identified, analyzed, and prevented by safety provisions. Proactive methods are available for anticipating and quantifying risk from potential event sequences. In this work, proactive methods, successfully used in industry, have been adapted and used in radiotherapy. Risk matrix is a tool that can be used in individual hospitals to classify event sequences in levels of risk. As with any anticipative method, the risk matrix involves a systematic search for potential risks; that is, any situation that can cause an accidental exposure. The method contributes new insights: The application of the risk matrix approach has identified that another group of less catastrophic but still severe single-patient events may have a higher probability, resulting in higher risk. The use of the risk matrix approach for safety assessment in individual hospitals would provide an opportunity for self-evaluation and managing the safety measures that are most suitable to the hospital's own conditions.

77 FR 63317 - Extension of a Currently Approved Information Collection; Comment Request Proposed Projects

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-16

... in achieving sustainable, systemic change that results in greater safety, permanency, and well-being... agreements. The cross-site evaluation uses a mixed-method, longitudinal approach to examine the ICs (funded...

[Study on the optimization of monitoring indicators of drinking water quality during health supervision].

PubMed

Ye, Bixiong; E, Xueli; Zhang, Lan

2015-01-01

To optimize non-regular drinking water quality indices (except Giardia and Cryptosporidium) of urban drinking water. Several methods including drinking water quality exceed the standard, the risk of exceeding standard, the frequency of detecting concentrations below the detection limit, water quality comprehensive index evaluation method, and attribute reduction algorithm of rough set theory were applied, redundancy factor of water quality indicators were eliminated, control factors that play a leading role in drinking water safety were found. Optimization results showed in 62 unconventional water quality monitoring indicators of urban drinking water, 42 water quality indicators could be optimized reduction by comprehensively evaluation combined with attribute reduction of rough set. Optimization of the water quality monitoring indicators and reduction of monitoring indicators and monitoring frequency could ensure the safety of drinking water quality while lowering monitoring costs and reducing monitoring pressure of the sanitation supervision departments.

Implementation of team training in medical education in Denmark

PubMed Central

Ostergaard, H; Ostergaard, D; Lippert, A

2004-01-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed. PMID:15465962

Implementation of team training in medical education in Denmark.

PubMed

Østergaard, H T; Østergaard, D; Lippert, A

2004-10-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed.

Implementation of team training in medical education in Denmark.

PubMed

Østergaard, H T; Østergaard, D; Lippert, A

2008-10-01

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed.

Visual analytics for aviation safety: A collaborative approach to sensemaking

NASA Astrophysics Data System (ADS)

Wade, Andrew

Visual analytics, the "science of analytical reasoning facilitated by interactive visual interfaces", is more than just visualization. Understanding the human reasoning process is essential for designing effective visualization tools and providing correct analyses. This thesis describes the evolution, application and evaluation of a new method for studying analytical reasoning that we have labeled paired analysis. Paired analysis combines subject matter experts (SMEs) and tool experts (TE) in an analytic dyad, here used to investigate aircraft maintenance and safety data. The method was developed and evaluated using interviews, pilot studies and analytic sessions during an internship at the Boeing Company. By enabling a collaborative approach to sensemaking that can be captured by researchers, paired analysis yielded rich data on human analytical reasoning that can be used to support analytic tool development and analyst training. Keywords: visual analytics, paired analysis, sensemaking, boeing, collaborative analysis.

Validation of Safety-Critical Systems for Aircraft Loss-of-Control Prevention and Recovery

NASA Technical Reports Server (NTRS)

Belcastro, Christine M.

2012-01-01

Validation of technologies developed for loss of control (LOC) prevention and recovery poses significant challenges. Aircraft LOC can result from a wide spectrum of hazards, often occurring in combination, which cannot be fully replicated during evaluation. Technologies developed for LOC prevention and recovery must therefore be effective under a wide variety of hazardous and uncertain conditions, and the validation framework must provide some measure of assurance that the new vehicle safety technologies do no harm (i.e., that they themselves do not introduce new safety risks). This paper summarizes a proposed validation framework for safety-critical systems, provides an overview of validation methods and tools developed by NASA to date within the Vehicle Systems Safety Project, and develops a preliminary set of test scenarios for the validation of technologies for LOC prevention and recovery

Influenza vaccines: Evaluation of the safety profile

PubMed Central

Trombetta, Claudia Maria; Gianchecchi, Elena; Montomoli, Emanuele

2018-01-01

ABSTRACT The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated. Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults. The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods. PMID:29297746

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

Middle East food safety perspectives.

PubMed

Idriss, Atef W; El-Habbab, Mohammad S

2014-08-01

Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development. © 2014 Society of Chemical Industry.

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

Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series design.

PubMed

Zeng, Chan; Newcomer, Sophia R; Glanz, Jason M; Shoup, Jo Ann; Daley, Matthew F; Hambidge, Simon J; Xu, Stanley

2013-12-15

The self-controlled case series (SCCS) method is often used to examine the temporal association between vaccination and adverse events using only data from patients who experienced such events. Conditional Poisson regression models are used to estimate incidence rate ratios, and these models perform well with large or medium-sized case samples. However, in some vaccine safety studies, the adverse events studied are rare and the maximum likelihood estimates may be biased. Several bias correction methods have been examined in case-control studies using conditional logistic regression, but none of these methods have been evaluated in studies using the SCCS design. In this study, we used simulations to evaluate 2 bias correction approaches-the Firth penalized maximum likelihood method and Cordeiro and McCullagh's bias reduction after maximum likelihood estimation-with small sample sizes in studies using the SCCS design. The simulations showed that the bias under the SCCS design with a small number of cases can be large and is also sensitive to a short risk period. The Firth correction method provides finite and less biased estimates than the maximum likelihood method and Cordeiro and McCullagh's method. However, limitations still exist when the risk period in the SCCS design is short relative to the entire observation period.

The Stamp-in-Safety programme, an intervention to promote better supervision of children on childcare centre playgrounds: an evaluation in an urban setting.

PubMed

Chelvakumar, Gayathri; Sheehan, Karen; Hill, Amy L; Lowe, Danita; Mandich, Nicole; Schwebel, David C

2010-10-01

Using a non-equivalent control group design, this report evaluated a previously studied behavioural intervention, the Stamp-in-Safety programme, which is designed to reduce the injury risk for young children on playgrounds at childcare centres by increasing the quality of adult supervision and rewarding children for safe play. In an urban, commercial childcare centre, 71 children aged 3-5 years and 15 teachers participated. Primary outcome measures were teacher verbalisations (warnings, explanations, redirects), teacher location (core, outskirt, or fringe of playground), child risk-taking behaviours (using equipment appropriately) and the number of injuries on the playground. Analyses revealed that the intervention had a modest positive effect in promoting safer teacher and child playground behaviours. This study reaffirms previous results that the Stamp-in-Safety programme is an effective method to decrease the risk of playground injuries at childcare centres.

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Advancing Usability Evaluation through Human Reliability Analysis

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

Ronald L. Boring; David I. Gertman

2005-07-01

This paper introduces a novel augmentation to the current heuristic usability evaluation methodology. The SPAR-H human reliability analysis method was developed for categorizing human performance in nuclear power plants. Despite the specialized use of SPAR-H for safety critical scenarios, the method also holds promise for use in commercial off-the-shelf software usability evaluations. The SPAR-H method shares task analysis underpinnings with human-computer interaction, and it can be easily adapted to incorporate usability heuristics as performance shaping factors. By assigning probabilistic modifiers to heuristics, it is possible to arrive at the usability error probability (UEP). This UEP is not a literal probabilitymore » of error but nonetheless provides a quantitative basis to heuristic evaluation. When combined with a consequence matrix for usability errors, this method affords ready prioritization of usability issues.« less

Teaching home safety and survival skills to latch-key children: a comparison of two manuals and methods.

PubMed Central

Peterson, L

1984-01-01

I evaluated the influence of two training manuals on latch-key children's acquisition of home safety and survival skills. The widely used, discussion-oriented "Prepared for Today" manual was compared with a behaviorally oriented "Safe at Home" manual. Data were scored by response criteria developed by experts and by parents' and experts' ratings of children's spontaneous answers. With both methods of scoring, three behaviorally trained children demonstrated clear and abrupt increases in skill following training in each of seven trained modules, and these increases largely persisted in real world generalization probes and at 5-month follow-up. Smaller and less stable increases in skill were found in the three discussion-trained children across the seven modules; lower skill levels were also seen in real world generalization probes and at follow-up. Neither group of children demonstrated skill increases in home safety areas that were not explicitly trained. Both training methods produced small decreases in children's self-report of general anxiety and anxiety concerning home safety. Results are discussed in terms of their implications for cost-effective training of latch-key children. PMID:6511698

Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.

PubMed

Sahota, Tarjinder; Danhof, Meindert; Della Pasqua, Oscar

2016-05-01

Despite ongoing efforts to better understand the mechanisms underlying safety and toxicity, ~30% of the attrition in drug discovery and development is still due to safety concerns. Changes in current practice regarding the assessment of safety and toxicity are required to reduce late stage attrition and enable effective development of novel medicines. This review focuses on the implications of empirical evidence generation for the evaluation of safety and toxicity during drug development. A shift in paradigm is needed to (i) ensure that pharmacological concepts are incorporated into the evaluation of safety and toxicity; (ii) facilitate the integration of historical evidence and thereby the translation of findings across species as well as between in vitro and in vivo experiments and (iii) promote the use of experimental protocols tailored to address specific safety and toxicity questions. Based on historical examples, we highlight the challenges for the early characterisation of the safety profile of a new molecule and discuss how model-based methodologies can be applied for the design and analysis of experimental protocols. Issues relative to the scientific rationale are categorised and presented as a hierarchical tree describing the decision-making process. Focus is given to four different areas, namely, optimisation, translation, analytical construct and decision criteria. From a methodological perspective, the relevance of quantitative methods for estimation and extrapolation of risk from toxicology and safety pharmacology experimental protocols, such as points of departure and potency, is discussed in light of advancements in population and Bayesian modelling techniques (e.g. non-linear mixed effects modelling). Their use in the evaluation of pharmacokinetics (PK) and pharmacokinetic-pharmacodynamic relationships (PKPD) has enabled great insight into the dose rationale for medicines in humans, both in terms of efficacy and adverse events. Comparable benefits can be anticipated for the assessment of safety and toxicity profile of novel molecules. © The Author 2016. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Clinically relevant safety issues associated with St. John's wort product labels

PubMed Central

Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

2008-01-01

Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements. PMID:18637192

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

PubMed

Han, Sangjin

2016-01-01

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

Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards

PubMed Central

Singh, Hardeep; Classen, David C.; Sittig, Dean F.

2013-01-01

Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system. PMID:22080284

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Safety, effectiveness and comparability of professional skin cleansers.

PubMed

Terhaer, Flora K; Bock, Meike; Fartasch, Manigé; Gabard, Bernard; Elsner, Peter; Kleesz, Peter; Landeck, Lilla; Pohrt, Ute; Seyfarth, Florian; Schliemann, Sibylle; Diepgen, Thomas L; Zagrodnik, Fred; John, Swen Malte

2010-10-01

There are no widely-accepted methodical specifications with which to objectify cleansing effectiveness and skin compatibility of occuptional skin cleansing products in Europe. Therefore the German Social Insurance Agency (DGUV) initiated a study with the goal to evaluate such products in view of the potency and the safety of hand cleansers. A market analysis was a part of the project. The product descriptions and safety data sheets of 120 products (5-20/manufacturer) of 11 manufacturers were evaluated between 02/2008 and 04/2008. The manufacturers used mainly ingredients of low irritancy. The declaration of the applied ingredients was in the majority of the cases correctly labeled according to the INCI Declaration. Although there was documentation of skin tolerability for most products, the manufacturers used widely differing tests of skin compatibility. Evidences for cleansing effectiveness were not declared or have not been provided. One manufacturer even promised medical effects of its products. There was no uniform general classification of products making it difficult to identify characteristics of cleansers and choose between them. Presently, there are no commonly accepted criteria to classify products in view of cleansing effectiveness und skin compatibility. Generally accepted criteria and test methods are needed for the evaluation of hand cleansers in order to provide the possibility of transparency and comparability. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

Injury prevention counselling to improve safety practices by parents in Mexico.

PubMed Central

Mock, Charles; Arreola-Risa, Carlos; Trevino-Perez, Rodolfo; Almazan-Saavedra, Victoria; Zozaya-Paz, Jaime E.; Gonzalez-Solis, Reynaldo; Simpson, Kate; Rodriguez-Romo, Laura; Hernandez-Torre, Martin H.

2003-01-01

OBJECTIVES: To evaluate the effectiveness of educational counselling programmes aimed at increasing parents' practice of childhood safety in Monterrey, Mexico, and to provide information aimed at helping to improve the effectiveness of future efforts in this field. METHODS: Three different counselling programmes were designed to meet the needs of the upper, middle and lower socioeconomic strata. Evaluation involved the use of baseline questionnaires on parents' existing safety-related practices for intervention and control groups and the administration of corresponding questionnaires after the programmes had been carried out. FINDINGS: Data were obtained on 1124 children before counselling took place and on 625 after it had been given. Overall safety scores (% safe responses) increased from 54% and 65% for the lower and upper socioeconomic strata, respectively, before counselling to 62% and 73% after counselling (P <0.001 for all groups). Improvements occurred both for activities that required caution and for activities that required the use of safety-related devices (e.g. helmets, car seats). However, scores for the use of such devices remained suboptimal even after counselling and there were wide discrepancies between the socioeconomic strata. The post-counselling scores for the use of safety-related devices were 55%, 38% and 19% for the upper, middle and lower socioeconomic strata, respectively. CONCLUSIONS: Brief educational interventions targeting parents' practice of childhood safety improved safe behaviours. Increased attention should be given to specific safety-related devices and to the safety of pedestrians. Educational efforts should be combined with other strategies for injury prevention, such as the use of legislation and the improvement of environmental conditions. PMID:14576891

Investment appraisal using quantitative risk analysis.

PubMed

Johansson, Henrik

2002-07-01

Investment appraisal concerned with investments in fire safety systems is discussed. Particular attention is directed at evaluating, in terms of the Bayesian decision theory, the risk reduction that investment in a fire safety system involves. It is shown how the monetary value of the change from a building design without any specific fire protection system to one including such a system can be estimated by use of quantitative risk analysis, the results of which are expressed in terms of a Risk-adjusted net present value. This represents the intrinsic monetary value of investing in the fire safety system. The method suggested is exemplified by a case study performed in an Avesta Sheffield factory.

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

PubMed

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

2018-04-01

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

Non-federal applications of the Highway Performance Monitoring System

DOT National Transportation Integrated Search

1978-05-01

The report contains an experimental design to evaluate methods of providing safe and expeditious movement of traffic through or around construction and maintenance zones while providing safety for workers in these zones. Two types of construction/mai...

Field study evaluation of cepstrum coefficient speech analysis for fatigue in aviation cabin crew.

DOT National Transportation Integrated Search

2013-10-01

Impaired neurobehavioral performance induced by fatigue may compromise safety in 24-hr operational : environmentssuch as aviation. As such, non-invasive, reliable, and valid methods of objectively detecting : compromised performance capacity in opera...

Estimation of crossing conflict at signalized intersection using high-resolution traffic data : final report.

DOT National Transportation Integrated Search

2017-03-01

This project explores the possibility of using high-resolution traffic signal data to evaluate intersection safety. : Traditional methods using historical crash data collected from infrequently and randomly occurring vehicle : collisions can require ...

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

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

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

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

In Silico Prediction of Chemical Toxicity for Drug Design Using Machine Learning Methods and Structural Alerts

NASA Astrophysics Data System (ADS)

Yang, Hongbin; Sun, Lixia; Li, Weihua; Liu, Guixia; Tang, Yun

2018-02-01

For a drug, safety is always the most important issue, including a variety of toxicities and adverse drug effects, which should be evaluated in preclinical and clinical trial phases. This review article at first simply introduced the computational methods used in prediction of chemical toxicity for drug design, including machine learning methods and structural alerts. Machine learning methods have been widely applied in qualitative classification and quantitative regression studies, while structural alerts can be regarded as a complementary tool for lead optimization. The emphasis of this article was put on the recent progress of predictive models built for various toxicities. Available databases and web servers were also provided. Though the methods and models are very helpful for drug design, there are still some challenges and limitations to be improved for drug safety assessment in the future.

In Silico Prediction of Chemical Toxicity for Drug Design Using Machine Learning Methods and Structural Alerts

PubMed Central

Yang, Hongbin; Sun, Lixia; Li, Weihua; Liu, Guixia; Tang, Yun

2018-01-01

During drug development, safety is always the most important issue, including a variety of toxicities and adverse drug effects, which should be evaluated in preclinical and clinical trial phases. This review article at first simply introduced the computational methods used in prediction of chemical toxicity for drug design, including machine learning methods and structural alerts. Machine learning methods have been widely applied in qualitative classification and quantitative regression studies, while structural alerts can be regarded as a complementary tool for lead optimization. The emphasis of this article was put on the recent progress of predictive models built for various toxicities. Available databases and web servers were also provided. Though the methods and models are very helpful for drug design, there are still some challenges and limitations to be improved for drug safety assessment in the future. PMID:29515993

Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices.

PubMed

Gad, Shayne C; Schuh, JoAnn C L

2018-06-01

Safety ("biocompatibility") assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited-almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

Implementation of EPA's Worker Protection Standard training for agricultural laborers: an evaluation using North Carolina data.

PubMed Central

Arcury, T A; Quandt, S A; Austin, C K; Preisser, J; Cabrera, L F

1999-01-01

The US Environmental Protection Agency has promulgated a Worker Protection Standard which requires that farmworkers receive pesticide safety training. The implementation of these regulations has not been evaluated. Using data collected through personal interviews with 270 Hispanic farmworkers recruited from 35 labor sites in an eight-county area, the authors analyzed the extent to which farmworkers received pesticide safety training, characteristics of the training, and variations in knowledge and safety behavior. Approximately a third of the farmworkers reported having ever received information or training on pesticide safety, and 25.6% reported having received training in the year in which they were interviewed. Workers with H2A visas were significantly more likely to have received training than workers without these visas. The training received varied in location, duration, and language. Most included the use of a video, as well as verbal presentation, and most included printed materials. However, few workers knew the ways in which they could be exposed to pesticides or reported using any method to protect themselves from pesticide exposure. PMID:10590768

Assessing the 'system' in safe systems-based road designs: using cognitive work analysis to evaluate intersection designs.

PubMed

Cornelissen, M; Salmon, P M; Stanton, N A; McClure, R

2015-01-01

While a safe systems approach has long been acknowledged as the underlying philosophy of contemporary road safety strategies, systemic applications are sparse. This article argues that systems-based methods from the discipline of Ergonomics have a key role to play in road transport design and evaluation. To demonstrate, the Cognitive Work Analysis framework was used to evaluate two road designs - a traditional Melbourne intersection and a cut-through design for future intersections based on road safety safe systems principles. The results demonstrate that, although the cut-through intersection appears different in layout from the traditional intersection, system constraints are not markedly different. Furthermore, the analyses demonstrated that redistribution of constraints in the cut-through intersection resulted in emergent behaviour, which was not anticipated and could prove problematic. Further, based on the lack of understanding of emergent behaviour, similar design induced problems are apparent across both intersections. Specifically, incompatibilities between infrastructure, vehicles and different road users were not dealt with by the proposed design changes. The importance of applying systems methods in the design and evaluation of road transport systems is discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of Safety, Quality and Productivity in Construction

NASA Astrophysics Data System (ADS)

Usmen, M. A.; Vilnitis, M.

2015-11-01

This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

An open-label, single arm, phase III clinical study to evaluate the efficacy and safety of CJ smallpox vaccine in previously vaccinated healthy adults.

PubMed

Kim, Nak-Hyun; Kang, Yu Min; Kim, Gayeon; Choe, Pyoeng Gyun; Song, Jin Su; Lee, Kwang-Hee; Seong, Baik-Lin; Park, Wan Beom; Kim, Nam Joong; Oh, Myoung-don

2013-10-25

The increased possibility of bioterrorism has led to reinitiation of smallpox vaccination. In Korea, more than 30 years have passed since the last smallpox vaccinations, and even people who were previously vaccinated are not regarded as adequately protected against smallpox. We evaluated the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy adults previously vaccinated against smallpox. We conducted an open label, single arm, phase III clinical trial to evaluate the efficacy and safety of CJ-50300. Healthy volunteers, previously vaccinated against smallpox, born between 1950 and 1978 were enrolled. CJ-50300 was administered with a bifurcated needle over the deltoid muscle according to the recommended method. The rate of the cutaneous take reaction, humoral immunogenicity, and safety of the vaccine was assessed. Of 145 individuals enrolled for vaccination, 139 completed the study. The overall rates of cutaneous take reactions and humoral immunogenicity were 95.0% (132/139) and 88.5% (123/139), respectively. Although 95.9% (139/145) reported adverse events related to vaccination, no serious adverse reactions were observed. CJ-50300 can be used safely and effectively in healthy adults previously vaccinated against smallpox. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Field Test of the World Health Organization Multi-Professional Patient Safety Curriculum Guide

PubMed Central

Farley, Donna; Zheng, Hao; Rousi, Eirini; Leotsakos, Agnès

2015-01-01

Introduction Although the importance of training in patient safety has been acknowledged for over a decade, it remains under-utilized and under-valued in most countries. WHO developed the Multi-professional Patient Safety Curriculum Guide to provide schools with the requirements and tools for incorporating patient safety in education. It was field tested with 12 participating schools across the six WHO regions, to assess its effectiveness for teaching patient safety to undergraduate and graduate students in a global variety of settings. Methods The evaluation used a combined prospective/retrospective design to generate formative information on the experiences of working with the Guide and summative information on the impacts of the Guide. Using stakeholder interviews and student surveys, data were gathered from each participating school at three times: the start of the field test (baseline), soon after each school started teaching, and soon after each school finished teaching. Results Stakeholders interviewed were strongly positive about the Guide, noting that it emphasized universally important patient safety topics, was culturally appropriate for their countries, and gave credibility and created a focus on patient safety at their schools. Student perceptions and attitudes regarding patient safety improved substantially during the field test, and their knowledge of the topics they were taught doubled, from 10.7% to 20.8% of correct answers on the student survey. Discussion This evaluation documented the effectiveness of the Curriculum Guide, for both ease of use by schools and its impacts on improving the patient safety knowledge of healthcare students. WHO should be well positioned to refine the contents of the Guide and move forward in encouraging broader use of the Guide globally for teaching patient safety. PMID:26406893

Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention.

PubMed

Wiig, Siri; Ree, Eline; Johannessen, Terese; Strømme, Torunn; Storm, Marianne; Aase, Ingunn; Ullebust, Berit; Holen-Rabbersvik, Elisabeth; Hurup Thomsen, Line; Sandvik Pedersen, Anne Torhild; van de Bovenkamp, Hester; Bal, Roland; Aase, Karina

2018-03-28

Nursing homes and home care face challenges across different countries as people are living longer, often with chronic conditions. There is a lack of knowledge regarding implementation and impact of quality and safety interventions as most research evidence so far is generated in hospitals. Additionally, there is a lack of effective leadership tools for quality and safety improvement work in this context. The aim of the 'Improving Quality and Safety in Primary Care-Implementing a Leadership Intervention in Nursing Homes and Homecare' (SAFE-LEAD) study is to develop and evaluate a research-based leadership guide for managers to increase quality and safety competence. The project applies a mixed-methods design and explores the implications of the leadership guide on managers' and staffs' knowledge, attitudes and practices. Four nursing homes and four home care services from different Norwegian municipalities will participate in the intervention. Surveys, process evaluation (interviews, observations) and document analyses will be conducted to evaluate the implementation and impact of the leadership intervention. A comparative study of Norway and the Netherlands will establish knowledge of the context dependency of the intervention. The study is approved by the Norwegian Centre for Research Data (2017/52324 and 54855). The results will be disseminated through scientific articles, two PhD dissertations, an anthology, presentations at national and international conferences, and in social media, newsletters and in the press. The results will generate knowledge to inform leadership practices in nursing homes and home care. Moreover, the study will build new theory on leadership interventions and the role of contextual factors in nursing homes and home care. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

Rapid and sensitive liquid chromatography-tandem mass spectrometric method for the quantitative determination of potentially harmful substance 5,5'-oxydimethylenebis (2-furfural) in traditional Chinese medicine injections.

PubMed

Zang, Qingce; Gao, Yang; Huang, Luojiao; He, Jiuming; Lin, Sheng; Jin, Hongtao; Zhang, Ruiping; Abliz, Zeper

2018-03-01

With the rapid development and wide application of traditional Chinese medicine injection (TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method has been developed and validated for the quantitative determination of potentially harmful substance 5,5'-oxydimethylenebis (2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column (150 mm × 2.1 mm, 5 µm) by gradient elution, using methanol-water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 mL/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/mL and linear over the range of 0.3-30 ng/mL ( r =0.9998). Intra- and inter-day precision for analyte was <9.52% RSD with recoveries in the range 88.0-109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

Development of a lane change risk index using vehicle trajectory data.

PubMed

Park, Hyunjin; Oh, Cheol; Moon, Jaepil; Kim, Seongho

2018-01-01

Surrogate safety measures (SSMs) have been widely used to evaluate crash potential, which is fundamental for the development of effective safety countermeasures. Unlike existing SSMs, which are mainly focused on the evaluation of longitudinal vehicle maneuvering leading to rear-end crashes, this study proposes a new method for estimating crash risk while a subject vehicle changes lanes, referred to as the lane change risk index (LCRI). A novel feature of the proposed methodology is its incorporation of the amount of exposure time to potential crash and the expected crash severity level by applying a fault tree analysis (FTA) to the evaluation framework. Vehicle interactions between a subject vehicle and adjacent vehicles in the starting lane and the target lane are evaluated in terms of crash potential during lane change. Vehicle trajectory data obtained from a traffic stream, photographed using a drone flown over a freeway segment, is used to investigate the applicability of the proposed methodology. This study compares the characteristics of compulsory and discretionary lane changes observed in a work zone section and a general section of a freeway using the LCRI. It is expected that the outcome of this study will be valuable in evaluating the effectiveness of various traffic operations and control strategies in terms of lane change safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

Application of resistivity monitoring to evaluate cement grouting effect in earth filled dam

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

Kim, Jin-Mo; Yoon, Wang-Jung

In this paper, we applied electrical resistivity monitoring method to evaluate the cement grouting effect. There are a lot of ways to evaluate cement grouting effect. In order to do this evaluation in a great safety, high efficiency, and lower cost, resistivity monitoring is found to be the most appropriate technique. In this paper we have selected a dam site from Korea to acquire resistivity monitoring data and compare the results of inversion to estimate the cement grouting effect.

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

PubMed

Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

2017-01-01

Machine learning methods may complement traditional analytic methods for medical device surveillance. Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%-20.9%; nonfatal ICD-related adverse events, 19.3%-26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%-37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k =0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k =-0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k =-0.042). Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

Using the Smooth Receiver Operating Curve (ROC) Method for Evaluation and Decision Making in Biometric Systems

DTIC Science & Technology

2014-07-01

partnership with Public Safety Canada. Led by Canada Border Services Agency partners included : Royal Canadian Mounted Police, Defence Research...Canada, as represented by the Minister of National Defence, 2014 © Sa Majesté la Reine (en droit du Canada), telle que représentée par le ministre de la...innovative technologies for public safety and security practitioners to achieve specific objectives; 4. Threats/Hazards F – Major trans-border criminal

Safety Evaluation of Crocin (a constituent of saffron) Tablets in Healthy Volunteers

PubMed Central

Mohamadpour, Amir Houshang; Ayati, Zahara; Parizadeh, Mohammad–Reza; Rajbai, Omid; Hosseinzadeh, Hossein

2013-01-01

Objective(s): Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. Materials and Methods: The study was a randomized, double-blind, placebo-controlled design consisting of one month treatment of crocin tablets. Volunteers who fulfilled inclusion and exclusion criteria were randomized into 2 groups of 22 each (males and females) and received 20 mg crocin tablets or placebo. General measures of health were recorded during the study such as hematological, biochemical, hormonal and urinary parameters in pre and post-treatment periods. Results: No major adverse events were reported during the trial. Crocin tablets did not change the above parameters except that it decreased amylase, mixed white blood cells and PTT in healthy volunteers after one month. Conclusion: This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period. PMID:23638291

Current concepts in simulation-based trauma education.

PubMed

Cherry, Robert A; Ali, Jameel

2008-11-01

The use of simulation-based technology in trauma education has focused on providing a safe and effective alternative to the more traditional methods that are used to teach technical skills and critical concepts in trauma resuscitation. Trauma team training using simulation-based technology is also being used to develop skills in leadership, team-information sharing, communication, and decision-making. The integration of simulators into medical student curriculum, residency training, and continuing medical education has been strongly recommended by the American College of Surgeons as an innovative means of enhancing patient safety, reducing medical errors, and performing a systematic evaluation of various competencies. Advanced human patient simulators are increasingly being used in trauma as an evaluation tool to assess clinical performance and to teach and reinforce essential knowledge, skills, and abilities. A number of specialty simulators in trauma and critical care have also been designed to meet these educational objectives. Ongoing educational research is still needed to validate long-term retention of knowledge and skills, provide reliable methods to evaluate teaching effectiveness and performance, and to demonstrate improvement in patient safety and overall quality of care.

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

PubMed

Robinson, Susan N; Neyens, David M; Diller, Thomas

Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

Safety assurance of cosmetics in Japan: current situation and future prospects.

PubMed

Inomata, Shinji

2014-01-01

The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.

PubMed

Gavin, Paul D; Simon, Lee S; Schlagheck, Thomas; Smith, Alisha J; Shakib, Sepehr

2017-07-01

To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM). Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h. Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed. A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application.

Design of a reusable kinetic energy absorber for an astronaut safety tether to be used during extravehicular activities on the Space Station

NASA Technical Reports Server (NTRS)

Borthwick, Dawn E.; Cronch, Daniel F.; Nixon, Glen R.

1991-01-01

The goal of this project is to design a reusable safety device for a waist tether which will absorb the kinetic energy of an astronaut drifting away from the Space Station. The safety device must limit the tension of the tether line in order to prevent damage to the astronaut's space suit or to the structure of the spacecraft. The tether currently used on shuttle missions must be replaced after the safety feature has been developed. A reusable tether for the Space Station would eliminate the need for replacement tethers, conserving space and mass. This report presents background information, scope and limitations, methods of research and development, alternative designs, a final design solution and its evaluation, and recommendations for further work.

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice.

PubMed

Oldenburg, J; Goudemand, J; Valentino, L; Richards, M; Luu, H; Kriukov, A; Gajek, H; Spotts, G; Ewenstein, B

2010-11-01

  Postauthorization safety surveillance of factor VIII (FVIII) concentrates is essential for assessing rare adverse event incidence. We determined safety and efficacy of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method, (rAHF-PFM)] during routine clinical practice. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Among 408 evaluable subjects, 386 (95%) received excellent/good efficacy ratings for all on-demand assessments; the corresponding number for subjects with previous FVIII inhibitors was 36/41 (88%). Among 276 evaluable subjects receiving prophylaxis continuously in the study, 255 (92%) had excellent/good ratings for all prophylactic assessments; the corresponding number for subjects with previous FVIII inhibitors was 41/46 (89%). Efficacy of surgical prophylaxis was excellent/good in 16/16 evaluable procedures. Among previously treated patients (PTPs) with >50 exposure days (EDs) and FVIII≤2%, three (0.75%) developed low-titre inhibitors. Two of these subjects had a positive inhibitor history; thus, the incidence of de novo inhibitor formation in PTPs with FVIII≤2% and no inhibitor history was 1/348 (0.29%; 95% CI, 0.01-1.59%). A PTP with moderate haemophilia developed a low-titre inhibitor. High-titre inhibitors were reported in a PTP with mild disease (following surgery), a previously untreated patient (PUP) with moderate disease (following surgery) and a PUP with severe disease. The favourable benefit/risk profile of rAHF-PFM previously documented in prospective clinical trials has been extended to include a broader range of haemophilia patients, many of whom would have been ineligible for registration studies. © 2010 Blackwell Publishing Ltd.

New geometric design consistency model based on operating speed profiles for road safety evaluation.

PubMed

Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

2013-12-01

To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Selection and Evaluation of Priority Domains in Global Energy Internet Standard Development Based on Technology Foresight

NASA Astrophysics Data System (ADS)

Jin, Yang; Ciwei, Gao; Jing, Zhang; Min, Sun; Jie, Yu

2017-05-01

The selection and evaluation of priority domains in Global Energy Internet standard development will help to break through limits of national investment, thus priority will be given to standardizing technical areas with highest urgency and feasibility. Therefore, in this paper, the process of Delphi survey based on technology foresight is put forward, the evaluation index system of priority domains is established, and the index calculation method is determined. Afterwards, statistical method is used to evaluate the alternative domains. Finally the top four priority domains are determined as follows: Interconnected Network Planning and Simulation Analysis, Interconnected Network Safety Control and Protection, Intelligent Power Transmission and Transformation, and Internet of Things.

Estimation of adhesive bond strength in laminated safety glass using guided mechanical waves

NASA Astrophysics Data System (ADS)

Huo, Shihong

Laminated safety glass is used in the automobile industry and in architectural applications. Laminated safety glass consists of a plastic interlayer, such as a layer of poly vinyl butyral (PVB) or Butacite, surrounded by two adjacent glass plates. The glass can be float glass, plate glass, tempered glass, or sheet glass, and the plastic interlayer is made of a viscoelastic material with relatively high damping. The level of adhesive bond strength between the plastic interlayer and the two adjacent glass plates has a significant role in the penetration resistance against flying objects and is a critical parameter towards ensuring the proper performance of safety glass. Therefore, estimation and control of adhesive bond levels in laminated safety glass is a critical issue. There are several destructive testing procedures used to quantify the adhesion level in laminated safety glass. These tests include the tension test, the peel test, the impact test, and the pummel test. All these tests have drawbacks including the pummel test method, which has been the most widely used in industry for over 80 years. The primary drawbacks of the pummel test method are that it is destructive and subjective (i.e., involves individual human judgment), which precludes this method for use as an on-line test method for quality control. Consequently, a quantitative nondestructive testing method to evaluate adhesion levels would be an asset to the laminated safety glass industry. In this study, adhesion levels in laminated safety glass samples, i.e., windshields, have been assessed using the guided mechanical wave method. To study the adhesive bond strength analytically, the imperfect interfaces between the plastic interlayer and the two adjacent glass plates in laminated safety glass are modeled using a bed of longitudinal and shear springs, and their stiffness characteristics are estimated using fracture mechanics and atomic force microscopy (AFM) surface measurements. The atomic force microscopy measurements are used to estimate the contact area at the imperfect interfaces between the plastic interlayer and the two adjacent glass plates for each of the laminates. The spring layers are then embedded in the global matrix method, which is used to predict the guided wave dispersion behavior of the laminated system. Based upon the guided wave energy velocity predictions for each of the laminates with different levels of adhesion, the S0 mode was selected as the most promising for use in nondestructively estimating adhesion levels in laminated safety glass. The predicted energy velocities (obtained using this multilayered model) were validated using guided wave energy velocity experimental measurements. The experimentally obtained velocity measurements are in good agreement with the predicted values. Guided wave attenuation in laminated safety glass is primarily due to the viscoelastic material properties of the PVB plastic interlayer. The attenuation properties of S1 mode were also explored to estimate the adhesive bond strength between the plastic interlayer and the two adjacent glass plates. Results show that the combination of both the energy velocity and attenuation methods has promise towards replacing the pummel test method to estimate the adhesion level in laminated safety glass.

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

PubMed

Hasan, Abid; Jha, Kumar Neeraj

2013-01-01

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

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

ERIC Educational Resources Information Center

Lowry, Carlee S.

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

Predictors of Attitudes Toward Non-Technical Skills in Farming.

PubMed

Irwin, Amy; Poots, Jill

2018-01-01

Farming is a high-risk sector with up to 170,000 worldwide fatalities reported per year; it is therefore vital to identify methods of mitigating the dangers of this industry. Research within high-risk industries, such as aviation, shipping, and agriculture, has identified the importance of non-technical skills (NTS) in maintaining effective, safe performance and reducing error and injury. However, there is a lack of research evaluating factors that may contribute to NTS attitudes and behaviors. As a first step to address this literature gap, the current study evaluated a range of individual and environmental factors as potential predictors of attitudes toward NTS in agriculture. A sample of 170 farmers from within the United Kingdom and Ireland were surveyed using an online questionnaire. The questionnaire included measures of personality, stress, attitudes toward safety (safety climate, motivation, and risk), environmental stressors (workload, work-life imbalance), and non-technical skills (team and lone worker). Attitudes toward safety climate, compliance, and motivation showed a significant association with both team-based and lone worker NTS. Conscientiousness correlated positively with the majority of the NTS elements. Multiple regression analysis indicated neuroticism and conscientiousness demonstrated capacity to predict NTS attitudes. Concerns about costs and equipment, attitudes toward safety climate, and safety motivation were also found to be significant predictors of NTS attitudes. The results indicate the utility of individual characteristics and environmental factors when predicting farming NTS attitudes. As a result, these elements could be important when evaluating engagement with NTS and developing NTS training initiatives in agriculture.

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

PubMed

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

2015-10-01

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

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.

A Heckman selection model for the safety analysis of signalized intersections

PubMed Central

Wong, S. C.; Zhu, Feng; Pei, Xin; Huang, Helai; Liu, Youjun

2017-01-01

Purpose The objective of this paper is to provide a new method for estimating crash rate and severity simultaneously. Methods This study explores a Heckman selection model of the crash rate and severity simultaneously at different levels and a two-step procedure is used to investigate the crash rate and severity levels. The first step uses a probit regression model to determine the sample selection process, and the second step develops a multiple regression model to simultaneously evaluate the crash rate and severity for slight injury/kill or serious injury (KSI), respectively. The model uses 555 observations from 262 signalized intersections in the Hong Kong metropolitan area, integrated with information on the traffic flow, geometric road design, road environment, traffic control and any crashes that occurred during two years. Results The results of the proposed two-step Heckman selection model illustrate the necessity of different crash rates for different crash severity levels. Conclusions A comparison with the existing approaches suggests that the Heckman selection model offers an efficient and convenient alternative method for evaluating the safety performance at signalized intersections. PMID:28732050

Thermal-hydraulic analysis capabilities and methods development at NYPA

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

Feltus, M.A.

1987-01-01

The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less

Bayesian Inference for NASA Probabilistic Risk and Reliability Analysis

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Kelly, Dana; Smith, Curtis; Vedros, Kurt; Galyean, William

2009-01-01

This document, Bayesian Inference for NASA Probabilistic Risk and Reliability Analysis, is intended to provide guidelines for the collection and evaluation of risk and reliability-related data. It is aimed at scientists and engineers familiar with risk and reliability methods and provides a hands-on approach to the investigation and application of a variety of risk and reliability data assessment methods, tools, and techniques. This document provides both: A broad perspective on data analysis collection and evaluation issues. A narrow focus on the methods to implement a comprehensive information repository. The topics addressed herein cover the fundamentals of how data and information are to be used in risk and reliability analysis models and their potential role in decision making. Understanding these topics is essential to attaining a risk informed decision making environment that is being sought by NASA requirements and procedures such as 8000.4 (Agency Risk Management Procedural Requirements), NPR 8705.05 (Probabilistic Risk Assessment Procedures for NASA Programs and Projects), and the System Safety requirements of NPR 8715.3 (NASA General Safety Program Requirements).

Farmworkers at the border: a bilingual initiative for occupational health and safety.

PubMed

Acosta, Martha Soledad Vela; Sechrest, Lee; Chen, Mei-Kuang

2009-01-01

Bilingual and bicultural occupational health and safety interventions for Hispanic farmworkers are extremely rare and, because of language barriers and cultural differences, issues important to their health and safety on the job remain unaddressed. We designed, conducted, and assessed the first bilingual occupational health and safety education program for farmworkers attending High School Equivalency Programs (HEPs). We took an interdisciplinary participatory approach by integrating educators and researchers with a community advisory board to guide development, evaluation, and implementation of Work Safely-Trabaje con Cuidado Curriculum (Curriculum), a bilingual occupational health and safety curriculum. We created a quasi-experimental design using mixed-method evaluation (quantitative and qualitative elements) via pre- and posttest comparisons, follow-up surveys, and focus groups assessing the Curriculum effect on knowledge, safety risk perception (SRP), and safety behavior. Focus groups and follow-up surveys reflected success and acceptance of the Curriculum among participating farmworkers under the study's logic model. Completion of the Curriculum resulted in statistically significant improvements in the combined score of knowledge and SRP at the posttest (p = 0.001) and follow-up survey (p = 0.02) in the intervention group. After completing this study, the Curriculum was permanently adopted by the two high school equivalency sites involved. The participatory approach resulted in integration of community and applied research partnership. The potential to expand use of this Curriculum by other HEP sites can further assess effectiveness and external validity among underserved minority groups.

Exploitation of molecular profiling techniques for GM food safety assessment.

PubMed

Kuiper, Harry A; Kok, Esther J; Engel, Karl-Heinz

2003-04-01

Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional non-GM counterparts, and profiling methods such as DNA/RNA microarray technologies, proteomics and metabolite profiling. The potential of profiling methods is obvious, but further exploration of specificity, sensitivity and validation is needed. Moreover, the successful application of profiling techniques to the safety evaluation of GM foods will require linked databases to be built that contain information on variations in profiles associated with differences in developmental stages and environmental conditions.

How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study

PubMed Central

2016-01-01

Introduction: First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997–2012. Methods: A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan–Meier survival curves assessed safety. Results: In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups. Discussion: Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class. PMID:28032825

Assessment of dietary intake of flavouring substances within the procedure for their safety evaluation: advantages and limitations of estimates obtained by means of a per capita method.

PubMed

Arcella, D; Leclercq, C

2005-01-01

The procedure for the safety evaluation of flavourings adopted by the European Commission in order to establish a positive list of these substances is a stepwise approach which was developed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and amended by the Scientific Committee on Food. Within this procedure, a per capita amount based on industrial poundage data of flavourings, is calculated to estimate the dietary intake by means of the maximised survey-derived daily intake (MSDI) method. This paper reviews the MSDI method in order to check if it can provide conservative intake estimates as needed at the first steps of a stepwise procedure. Scientific papers and opinions dealing with the MSDI method were reviewed. Concentration levels reported by the industry were compared with estimates obtained with the MSDI method. It appeared that, in some cases, these estimates could be orders of magnitude (up to 5) lower than those calculated considering concentration levels provided by the industry and regular consumption of flavoured foods and beverages. A critical review of two studies which had been used to support the statement that MSDI is a conservative method for assessing exposure to flavourings among high consumers was performed. Special attention was given to the factors that affect exposure at high percentiles, such as brand loyalty and portion sizes. It is concluded that these studies may not be suitable to validate the MSDI method used to assess intakes of flavours by European consumers due to shortcomings in the assumptions made and in the data used. Exposure assessment is an essential component of risk assessment. The present paper suggests that the MSDI method is not sufficiently conservative. There is therefore a clear need for either using an alternative method to estimate exposure to flavourings in the procedure or for limiting intakes to the levels at which the safety was assessed.

Test Methodology to Evaluate the Safety of Materials Using Spark Incendivity

NASA Technical Reports Server (NTRS)

Buhler, Charles; Calle, Carlos; Clements, Sid; Ritz, Mindy; Starnes, Jeff

2007-01-01

For many years scientists and engineers have been searching for the proper test method to evaluate an electrostatic risk for materials used in hazardous environments. A new test standard created by the International Electrotechnical Commission is a promising addition to conventional test methods used throughout industry. The purpose of this paper is to incorporate this test into a proposed new methodology for the evaluation of materials exposed to flammable environments. However, initial testing using this new standard has uncovered some unconventional behavior in materials that conventional test methods were thought to have reconciled. For example some materials tested at higher humidities were more susceptible to incendive discharges than at lower humidity even though the surface resistivity was lower.

Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

PubMed Central

2013-01-01

Background Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective. Methods/Design This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items. Discussion Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project, currently underway, will inform future efforts to validate and implement tools that can be used by health care organizations to improve the safety of EHR-enabled clinical work systems. PMID:23587208

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

Test and assessment method of Automotive Safety Systems (SSB) particularly to monitor traffic incidents

NASA Astrophysics Data System (ADS)

Pijanowski, B.; Łukjanow, S.; Burliński, R.

2016-09-01

The rapid development of telematics, particularly mobile telephony (GSM), wireless data transmission (GPRS) and satellite positioning (GPS) noticeable in the last decade, resulted in an almost unlimited growth of the possibilities for monitoring of mobile objects. These solutions are already widely used in the so-called “Intelligent Transport Systems” - ITS and affect a significant increase for road safety. The article describes a method of testing and evaluation of Car Safety Systems (Polish abbreviation - SSB) especially for monitoring traffic incidents, such as collisions and accidents. The algorithm of SSB testing process is also presented. Tests are performed on the dynamic test bench, part of which is movable platform with car security system mounted on it. Crash tests with a rigid obstacle are carried out instead of destructive attempts to crash test of the entire vehicle which is expensive. The tested system, depending on the simulated traffic conditions, is mounted in such a position and with the use of components, indicated by the manufacturer for the automotive safety system installation in a vehicle, for which it is intended. Then, the tests and assessments are carried out.

Economic Evaluation of “Pulse Dose” Radiofrequency in the Treatment of Occipital Neuralgia Headache

PubMed Central

Giovannini, Vittoria; Pusateri, Rachele; Russo, Viera; Viscardi, Daniela; Palomba, Rosa

2012-01-01

Headache occipital neuralgia is an example of pain-disease for which treatment both pharmacological protocols and invasive methods are used. Among the latter, the RF (Radiofrequency) pulse-dose has been of interest for the prospects of analgesic efficacy, safety and patient compliance, although at the moment only data concerning the pulsed RF and not the RF pulse-dose, that represents its evolution, are discussed in scientific literature. The purpose of this study is a “simple” economic evaluation of this method in headache occipital neuralgia. PMID:23905049

LANL seismic screening method for existing buildings

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

Dickson, S.L.; Feller, K.C.; Fritz de la Orta, G.O.

1997-01-01

The purpose of the Los Alamos National Laboratory (LANL) Seismic Screening Method is to provide a comprehensive, rational, and inexpensive method for evaluating the relative seismic integrity of a large building inventory using substantial life-safety as the minimum goal. The substantial life-safety goal is deemed to be satisfied if the extent of structural damage or nonstructural component damage does not pose a significant risk to human life. The screening is limited to Performance Category (PC) -0, -1, and -2 buildings and structures. Because of their higher performance objectives, PC-3 and PC-4 buildings automatically fail the LANL Seismic Screening Method andmore » will be subject to a more detailed seismic analysis. The Laboratory has also designated that PC-0, PC-1, and PC-2 unreinforced masonry bearing wall and masonry infill shear wall buildings fail the LANL Seismic Screening Method because of their historically poor seismic performance or complex behavior. These building types are also recommended for a more detailed seismic analysis. The results of the LANL Seismic Screening Method are expressed in terms of separate scores for potential configuration or physical hazards (Phase One) and calculated capacity/demand ratios (Phase Two). This two-phase method allows the user to quickly identify buildings that have adequate seismic characteristics and structural capacity and screen them out from further evaluation. The resulting scores also provide a ranking of those buildings found to be inadequate. Thus, buildings not passing the screening can be rationally prioritized for further evaluation. For the purpose of complying with Executive Order 12941, the buildings failing the LANL Seismic Screening Method are deemed to have seismic deficiencies, and cost estimates for mitigation must be prepared. Mitigation techniques and cost-estimate guidelines are not included in the LANL Seismic Screening Method.« less

Validation of a Preclinical Spinal Safety Model: Effects of Intrathecal Morphine in the Neonatal Rat

PubMed Central

Westin, B. David; Walker, Suellen M.; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L.

2010-01-01

Background Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long term function following intrathecal morphine in the neonatal rat. Methods Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P)3, 10 and 21. The relationship between injectate volume and segmental spread was assessed post mortem and by in-vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 minutes following intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis and glial response were evaluated 1 and 7 days following P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Results Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally-mediated analgesia at all ages with lower dose requirements in younger pups. High dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. Conclusions The therapeutic ratio for intrathecal morphine (toxic dose / antinociceptive dose) was at least 300 at P3, and at least 20 at P21 (latter doses limited by side effects). This data provides relative efficacy and safety data for comparison with other analgesic preparations and contributes supporting evidence for the validity of this preclinical neonatal safety model. PMID:20526189

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

DOT National Transportation Integrated Search

2009-06-01

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

Safety training for working youth: Methods used versus methods wanted.

PubMed

Zierold, Kristina M

2016-04-07

Safety training is promoted as a tool to prevent workplace injury; however, little is known about the safety training experiences young workers get on-the-job. Furthermore, nothing is known about what methods they think would be the most helpful for learning about safe work practices. To compare safety training methods teens get on the job to those safety training methods teens think would be the best for learning workplace safety, focusing on age differences. A cross-sectional survey was administered to students in two large high schools in spring 2011. Seventy percent of working youth received safety training. The top training methods that youth reported getting at work were safety videos (42%), safety lectures (25%), and safety posters/signs (22%). In comparison to the safety training methods used, the top methods youth wanted included videos (54%), hands-on (47%), and on-the-job demonstrations (34%). This study demonstrated that there were differences in training methods that youth wanted by age; with older youth seemingly wanting more independent methods of training and younger teens wanting more involvement. Results indicate that youth want methods of safety training that are different from what they are getting on the job. The differences in methods wanted by age may aid in developing training programs appropriate for the developmental level of working youth.

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Promotion of safety culture in Italian schools: effectiveness of interventions on student injuries.

PubMed

Bena, Antonella; Farina, Elena; Orengia, Manuela; Quarta, Denis

2016-08-01

Numerous safety promotion interventions in schools exist but these are rarely subject to impact evaluation. Few available studies are focused on intermediate outcomes. Our objective is to evaluate the impact of prevention interventions on school injuries in a number of schools in Italy. A pre-post-study with a control group was used. One hundred and three intervention units were selected; control units were selected randomly from those which did not implement safety projects. The general objective was to promote a safety culture by increasing expertise and knowledge, and by enabling the adoption of appropriate behavior. All projects combined various elements: training and educational, information and communication, as well as organizational. The projects evaluated in this article were specifically aimed at safety in indoor premises; they were implemented in 2009-10. Injury rates standardized by gender were calculated for 5 school years (from 2007/2008 to 2011/2012) stratified by type of school and place of occurrence. To assess the effectiveness the difference-in-differences method was used. Overall, 207 012 student-years and 2918 school injuries were considered. In all types of schools, the injury rates in indoor areas show a decreasing trend in the intervention units and an increasing trend in the control units. In high schools, there were no changes in the trend of injuries occurring in the gym and/or related to sports activities. The results suggest a positive short-term effect of the programs on injuries occurring in indoor premises. The quasi-experimental design has never been previously used to evaluate the effectiveness of a prevention program in schools. © The Author 2016. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Effectiveness evaluation of simulative workshops for newly licensed drivers.

PubMed

Rosenbloom, Tova; Eldror, Ehud

2014-02-01

The current study set to examine the effects of simulator use in driving instruction on newly licensed drivers, comparing the road safety knowledge and reported intended behavior, as well as the actual driving performance of new drivers. Participants consisted of 280 newly licensed driver, of which 140 whose drivers license training included additional simulator-based lessons, and 140 drivers whose training precluded simulator-based lessons. All drivers answered questionnaires pertaining to their intended safe driving behaviors (according to Ajzen's (2000) theory of planned behavior), and to their traffic safety knowledge. Of the initial sample, 40 drivers received actual driving performance evaluation by an expert driving instructor, as well as by in-vehicle data recorders (IVDRs). We assumed that safer drivers report safer driving intentions, demonstrate greater traffic safety knowledge, evaluated as safer drivers by the driving instructor, and display lower and stable driving parameters on the IVDRs. We hypothesized that theoretical driving studies combined with practical training on simulators will elevate the safety level of novices driving. Hierarchical regression analyses on driving intentions indicated that drivers who did not receive simulator-based lessons demonstrated safer driving intentions compared to drivers who received simulator-based lessons. This pattern possibly indicating the drivers who received simulator-based lessons felt more confident in their driving abilities compared to drivers who did not receive simulated training. No significant difference was found in traffic safety knowledge, or in the evaluation of the expert driving instructor. IDVR data comparisons indicated drivers who received simulator-based lessons braked more often and were less prone to headway events, suggesting a more responsive driving style. These findings do not point to any significant advantage or disadvantage of the current simulator-based driving training over other driving training methods. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of a mechanical stiffness gauge for compaction control of granular media.

DOT National Transportation Integrated Search

2001-12-01

The use of nuclear methods for compaction control is increasingly problematic for state highway agencies. Regulatory and safety issues have prompted agencies such as the New Mexico State Highway and Transportation Department to look for non-nuclear a...

ToxCast Communications and Outreach Strategy (SETAC)

EPA Science Inventory

US EPA's Chemical Safety for Sustainability Research Program has been using in vitro testing methods in an effort to accelerate the pace of chemical evaluations and address the significant lack of health and environmental data on the thousands of chemicals found in commonly used ...

Alternative methods for safety analysis and intervention for contracting commercial vehicles and drivers in Connecticut

DOT National Transportation Integrated Search

2012-06-01

This study evaluated Connecticuts current system for qualifying contractors for : the use of commercial vehicles on state contracts, identifies its impacts, and : makes recommendations on how the state should revise the current system. The : prima...

Nondestructive evaluation: A survey of NASA contributions, chapter 1, Chapter 11, cover page, acknowledgements, and contents

NASA Technical Reports Server (NTRS)

1972-01-01

A survey of nondestructive evaluation (NDE) technology, which is discussed in terms of popular demands for a greater degree of quality, reliability, and safety in industrial products, is presented as an overview of the NDE field to serve the needs of middle management. Three NDE methods are presented: acoustic emission, the use of coherent (laser)light, and ultrasonic holography.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Fire Safety Tests for Cesium-Loaded Spherical Resorcinol Formaldehyde Resin: Data Summary Report

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

Kim, Dong-Sang; Schweiger, Michael J.; Peterson, Reid A.

2012-09-01

A draft safety evaluation of the scenario for spherical resorcinol formaldehyde (SRF) resin fire inside the ion exchange column was performed by the Hanford Tank Waste Treatment and Immobilization Plant (WTP) Fire Safety organization. The result of this draft evaluation suggested a potential change of the fire safety classification for the Cesium Ion Exchange Process System (CXP) emergency elution vessels, equipment, and piping. To resolve this question, the fire properties of the SRF resin were measured by Southwest Research Institute (SwRI) through a subcontract managed by Pacific Northwest National Laboratory (PNNL). The results of initial fire safety tests on themore » SRF resin were documented in a previous report (WTP-RPT-218). The present report summarizes the results of additional tests performed by SwRI on the cesium-loaded SRF resin. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. The as-received SwRI report is attached to this report in the Appendix A. Where applicable, the precision and bias of each test method, as given by each American Society for Testing and Materials (ASTM) standard procedure, are included and compared with the SwRI test results of the cesium-loaded SRF resin.« less

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

PubMed

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Introduction of structural health and safety monitoring warning systems for Shenzhen-Hong Kong Western Corridor Shenzhen Bay Bridge

NASA Astrophysics Data System (ADS)

Li, N.; Zhang, X. Y.; Zhou, X. T.; Leng, J.; Liang, Z.; Zheng, C.; Sun, X. F.

2008-03-01

Though the brief introduction of the completed structural health and safety monitoring warning systems for Shenzhen-Hongkong western corridor Shenzhen bay highway bridge (SZBHMS), the self-developed system frame, hardware and software scheme of this practical research project are systematically discussed in this paper. The data acquisition and transmission hardware and the basic software based on the NI (National Instruments) Company virtual instruments technology were selected in this system, which adopted GPS time service receiver technology and so on. The objectives are to establish the structural safety monitoring and status evaluation system to monitor the structural responses and working conditions in real time and to analyze the structural working statue using information obtained from the measured data. It will be also provided the scientific decision-making bases for the bridge management and maintenance. Potential technical approaches to the structural safety warning systems, status identification and evaluation method are presented. The result indicated that the performance of the system has achieved the desired objectives, ensure the longterm high reliability, real time concurrence and advanced technology of SZBHMS. The innovate achievement which is the first time to implement in domestic, provide the reference for long-span bridge structural health and safety monitoring warning systems design.

A Semantic Approach with Decision Support for Safety Service in Smart Home Management

PubMed Central

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-01-01

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate. PMID:27527170

Effects of Different Types of Cognitive Training on Cognitive Function, Brain Structure, and Driving Safety in Senior Daily Drivers: A Pilot Study

PubMed Central

Taki, Yasuyuki; Kanno, Akitake; Akimoto, Yoritaka; Ihara, Mizuki; Yokoyama, Ryoichi; Kotozaki, Yuka; Sekiguchi, Atsushi; Takeuchi, Hikaru; Miyauchi, Carlos Makoto; Ogawa, Takeshi; Goto, Takakuni; Sunda, Takashi; Shimizu, Toshiyuki; Tozuka, Eiji; Hirose, Satoru; Nanbu, Tatsuyoshi; Kawashima, Ryuta

2015-01-01

Background. Increasing proportion of the elderly in the driving population raises the importance of assuring their safety. We explored the effects of three different types of cognitive training on the cognitive function, brain structure, and driving safety of the elderly. Methods. Thirty-seven healthy elderly daily drivers were randomly assigned to one of three training groups: Group V trained in a vehicle with a newly developed onboard cognitive training program, Group P trained with a similar program but on a personal computer, and Group C trained to solve a crossword puzzle. Before and after the 8-week training period, they underwent neuropsychological tests, structural brain magnetic resonance imaging, and driving safety tests. Results. For cognitive function, only Group V showed significant improvements in processing speed and working memory. For driving safety, Group V showed significant improvements both in the driving aptitude test and in the on-road evaluations. Group P showed no significant improvements in either test, and Group C showed significant improvements in the driving aptitude but not in the on-road evaluations. Conclusion. The results support the effectiveness of the onboard training program in enhancing the elderly's abilities to drive safely and the potential advantages of a multimodal training approach. PMID:26161000

A Semantic Approach with Decision Support for Safety Service in Smart Home Management.

PubMed

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-08-03

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate.

Large-scale road safety programmes in low- and middle-income countries: an opportunity to generate evidence.

PubMed

Hyder, Adnan A; Allen, Katharine A; Peters, David H; Chandran, Aruna; Bishai, David

2013-01-01

The growing burden of road traffic injuries, which kill over 1.2 million people yearly, falls mostly on low- and middle-income countries (LMICs). Despite this, evidence generation on the effectiveness of road safety interventions in LMIC settings remains scarce. This paper explores a scientific approach for evaluating road safety programmes in LMICs and introduces such a road safety multi-country initiative, the Road Safety in 10 Countries Project (RS-10). By building on existing evaluation frameworks, we develop a scientific approach for evaluating large-scale road safety programmes in LMIC settings. This also draws on '13 lessons' of large-scale programme evaluation: defining the evaluation scope; selecting study sites; maintaining objectivity; developing an impact model; utilising multiple data sources; using multiple analytic techniques; maximising external validity; ensuring an appropriate time frame; the importance of flexibility and a stepwise approach; continuous monitoring; providing feedback to implementers, policy-makers; promoting the uptake of evaluation results; and understanding evaluation costs. The use of relatively new approaches for evaluation of real-world programmes allows for the production of relevant knowledge. The RS-10 project affords an important opportunity to scientifically test these approaches for a real-world, large-scale road safety evaluation and generate new knowledge for the field of road safety.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

76 FR 454 - Hazardous Materials Transportation: Revisions of Special Permits Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... the agency to evaluate the applicant's fitness and the safety impact of operations that would be... applicant granted a special permit undergoes a safety fitness evaluation, further assuring the safety of... operations to enable the agency to evaluate the applicant's fitness and the safety impact of operations that...

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter–defibrillators

PubMed Central

Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

2017-01-01

Background Machine learning methods may complement traditional analytic methods for medical device surveillance. Methods and results Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=−0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=−0.042). Conclusion Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance. PMID:28860874

Evaluating the effectiveness of a peer-led education intervention to improve the patient safety attitudes of junior pharmacy students: a cross-sectional study using a latent growth curve modelling approach.

PubMed

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

2015-12-08

Despite the recognition that educating healthcare students in patient safety is essential, changing already full curricula can be challenging. Furthermore, institutions may lack the capacity and capability to deliver patient safety education, particularly from the start of professional practice studies. Using senior students as peer educators to deliver practice-based education can potentially overcome some of the contextual barriers in training junior students. Therefore, this study aimed to evaluate the effectiveness of a peer-led patient safety education programme for junior pharmacy students. A repeat cross-sectional design utilising a previously validated patient safety attitudinal survey was used to evaluate attitudes prior to, immediately after and 1 month after the delivery of a patient safety education programme. Latent growth curve (LGC) modelling was used to evaluate the change in attitudes of first-year students using second-year students as a comparator group. Undergraduate university students in Sydney, Australia. 175 first-year and 140 second-year students enrolled in the Bachelor of Pharmacy programme at the University of Sydney. An introductory patient safety programme was implemented into the first-year Bachelor of Pharmacy curriculum at the University of Sydney. The programme covered introductory patient safety topics including teamwork, communication skills, systems thinking and open disclosure. The programme consisted of 2 lectures, delivered by a senior academic, and a workshop delivered by trained final-year pharmacy students. A full LGC model was constructed including the intervention as a non-time-dependent predictor of change (χ(2) (51)=164.070, root mean square error of approximation=0.084, comparative fit index=0.913, standardised root mean square=0.056). First-year students' attitudes significantly improved as a result of the intervention, particularly in relation to internalising errors (p=0.010), questioning behaviours (p<0.001) and open disclosure (p=0.008). Peer-led education is an effective method that can be adopted to improve junior pharmacy students' attitudes towards patient safety. 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/

Aviation occupant survival factors: an empirical study of the SQ006 accident.

PubMed

Chang, Yu-Hern; Yang, Hui-Hua

2010-03-01

We present an empirical study of Singapore Airline (SIA) flight SQ006 to illustrate the critical factors that influence airplane occupant survivability. The Fuzzy Delphi Method was used to identify and rank the survival factors that may reduce injury and fatality in potentially survivable accidents. This is the first attempt by a group from both the public and private sectors in Taiwan to focus on cabin-safety issues related to survival factors. We designed a comprehensive survey based on our discussions with aviation safety experts. We next designed an array of important cabin-safety dimensions and then investigated and selected the critical survival factors for each dimension. Our findings reveal important cabin safety and survivability information that should provide a valuable reference for developing and evaluating aviation safety programs. We also believe that the results will be practical for designing cabin-safety education material for air travelers. Finally, the major contribution of this research is that it has identified 47 critical factors that influence accident survivability; therefore, it may encourage improvements that will promote more successful cabin-safety management. Copyright 2009 Elsevier Ltd. All rights reserved.

Sensitivity and specificity of the Eating Assessment Tool and the Volume-Viscosity Swallow Test for clinical evaluation of oropharyngeal dysphagia

PubMed Central

Rofes, L; Arreola, V; Mukherjee, R; Clavé, P

2014-01-01

Background Oropharyngeal dysphagia (OD) is an underdiagnosed digestive disorder that causes severe nutritional and respiratory complications. Our aim was to determine the accuracy of the Eating Assessment Tool (EAT-10) and the Volume-Viscosity Swallow Test (V-VST) for clinical evaluation of OD. Methods We studied 120 patients with swallowing difficulties and 14 healthy subjects. OD was evaluated by the 10-item screening questionnaire EAT-10 and the bedside method V-VST, videofluoroscopy (VFS) being the reference standard. The V-VST is an effort test that uses boluses of different volumes and viscosities to identify clinical signs of impaired efficacy (impaired labial seal, piecemeal deglutition, and residue) and impaired safety of swallow (cough, voice changes, and oxygen desaturation ≥3%). Discriminating ability was assessed by the AUC of the ROC curve and sensitivity and specificity values. Key Results According to VFS, prevalence of OD was 87%, 75.6% with impaired efficacy and 80.9% with impaired safety of swallow including 17.6% aspirations. The EAT-10 showed a ROC AUC of 0.89 for OD with an optimal cut-off at 2 (0.89 sensitivity and 0.82 specificity). The V-VST showed 0.94 sensitivity and 0.88 specificity for OD, 0.79 sensitivity and 0.75 specificity for impaired efficacy, 0.87 sensitivity and 0.81 specificity for impaired safety, and 0.91 sensitivity and 0.28 specificity for aspirations. Conclusions & Inferences Clinical methods for screening (EAT-10) and assessment (V-VST) of OD offer excellent psychometric proprieties that allow adequate management of OD. Their universal application among at-risk populations will improve the identification of patients with OD at risk for malnutrition and aspiration pneumonia. PMID:24909661

Effectiveness of two conventional methods for seismic retrofit of steel and RC moment resisting frames based on damage control criteria

NASA Astrophysics Data System (ADS)

Beheshti Aval, Seyed Bahram; Kouhestani, Hamed Sadegh; Mottaghi, Lida

2017-07-01

This study investigates the efficiency of two types of rehabilitation methods based on economic justification that can lead to logical decision making between the retrofitting schemes. Among various rehabilitation methods, concentric chevron bracing (CCB) and cylindrical friction damper (CFD) were selected. The performance assessment procedure of the frames is divided into two distinct phases. First, the limit state probabilities of the structures before and after rehabilitation are investigated. In the second phase, the seismic risk of structures in terms of life safety and financial losses (decision variables) using the recently published FEMA P58 methodology is evaluated. The results show that the proposed retrofitting methods improve the serviceability and life safety performance levels of steel and RC structures at different rates when subjected to earthquake loads. Moreover, these procedures reveal that financial losses are greatly decreased, and were more tangible by the application of CFD rather than using CCB. Although using both retrofitting methods reduced damage state probabilities, incorporation of a site-specific seismic hazard curve to evaluate mean annual occurrence frequency at the collapse prevention limit state caused unexpected results to be obtained. Contrary to CFD, the collapse probability of the structures retrofitted with CCB increased when compared with the primary structures.

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

PubMed

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

2014-02-01

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

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

DTIC Science & Technology

2005-01-01

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

Application of Poisson random effect models for highway network screening.

PubMed

Jiang, Ximiao; Abdel-Aty, Mohamed; Alamili, Samer

2014-02-01

In recent years, Bayesian random effect models that account for the temporal and spatial correlations of crash data became popular in traffic safety research. This study employs random effect Poisson Log-Normal models for crash risk hotspot identification. Both the temporal and spatial correlations of crash data were considered. Potential for Safety Improvement (PSI) were adopted as a measure of the crash risk. Using the fatal and injury crashes that occurred on urban 4-lane divided arterials from 2006 to 2009 in the Central Florida area, the random effect approaches were compared to the traditional Empirical Bayesian (EB) method and the conventional Bayesian Poisson Log-Normal model. A series of method examination tests were conducted to evaluate the performance of different approaches. These tests include the previously developed site consistence test, method consistence test, total rank difference test, and the modified total score test, as well as the newly proposed total safety performance measure difference test. Results show that the Bayesian Poisson model accounting for both temporal and spatial random effects (PTSRE) outperforms the model that with only temporal random effect, and both are superior to the conventional Poisson Log-Normal model (PLN) and the EB model in the fitting of crash data. Additionally, the method evaluation tests indicate that the PTSRE model is significantly superior to the PLN model and the EB model in consistently identifying hotspots during successive time periods. The results suggest that the PTSRE model is a superior alternative for road site crash risk hotspot identification. Copyright © 2013 Elsevier Ltd. All rights reserved.

A comparison among four tract dilation methods of percutaneous nephrolithotomy: a systematic review and meta-analysis.

PubMed

Dehong, Cao; Liangren, Liu; Huawei, Liu; Qiang, Wei

2013-11-01

The purpose of this study was to evaluate the efficacy and safety of the Amplatz dilation (AD), metal telescopic dilation (MTD), balloon dilation (BD), and one-shot dilation (OSD) methods for tract dilation during percutaneous nephrolithotomy (PCNL). Relevant eligible studies were identified using three electronic databases (Medline, EMBASE, and Cochrane CENTRAL). Database acquisition and quality evaluation were independently performed by two reviewers. Efficacy (stone-free rate, surgical duration, and tract dilatation fluoroscopy time) and safety (transfusion rate and hemoglobin decrease) were evaluated using Review Manager 5.2. Four randomized controlled trials and eight clinical controlled trials involving 6,820 patients met the inclusion criteria. The pooled result from a meta-analysis showed statistically significant differences in tract dilatation fluoroscopy time and hemoglobin decrease between the OSD and MTD groups, which showed comparable stone-free and transfusion rates. Significant differences in transfusion rate were found between the BD and MTD groups. Among patients without previous open renal surgery, those who underwent BD exhibited a lower blood transfusion rate and a shorter surgical duration compared with those who underwent AD. The OSD technique is safer and more efficient than the MTD technique for tract dilation during PCNL, particularly in patients with previous open renal surgery, resulting in a shorter tract dilatation fluoroscopy time and a lesser decrease in hemoglobin. The efficacy and safety of BD are better than AD in patients without previous open renal surgery. The OSD technique should be considered for most patients who undergo PCNL therapy.

"Failure-to-Identify" Hunting Incidents: A Resilience Engineering Approach.

PubMed

Bridges, Karl E; Corballis, Paul M; Hollnagel, Erik

2018-03-01

Objective The objective was to develop an understanding, using the Functional Resonance Analysis Method (FRAM), of the factors that could cause a deer hunter to misidentify their intended target. Background Hunting is a popular activity in many communities. However, hunters vary considerably based on training, experience, and expertise. Surprisingly, safety in hunting has not received much attention, especially failure-to-identify hunting incidents. These are incidents in which the hunter, after spotting and targeting their quarry, discharge their firearm only to discover they have been spotting and targeting another human, an inanimate object, or flora by mistake. The hunter must consider environment, target, time of day, weather, and many other factors-continuously evaluating whether the hunt should continue. To understand how these factors can relate to one another is fundamental to begin to understand how incidents happen. Method Workshops with highly experienced and active hunters led to the development of a FRAM model detailing the functions of a "Hunting FRAM." The model was evaluated for correctness based on confidential and anonymous near-miss event submissions by hunters. Results A FRAM model presenting the functions of a hunt was produced, evaluated, and accepted. Using the model, potential sources of incidents or other unintended outcomes were identified, which in turn helped to improve the model. Conclusion Utilizing principles of understanding and visualization tools of the FRAM, the findings create a foundation for safety improvements potentially through training or safety messages based on an increased understanding of the complexity of hunting.

Estimate variable importance for recurrent event outcomes with an application to identify hypoglycemia risk factors.

PubMed

Duan, Ran; Fu, Haoda

2015-08-30

Recurrent event data are an important data type for medical research. In particular, many safety endpoints are recurrent outcomes, such as hypoglycemic events. For such a situation, it is important to identify the factors causing these events and rank these factors by their importance. Traditional model selection methods are not able to provide variable importance in this context. Methods that are able to evaluate the variable importance, such as gradient boosting and random forest algorithms, cannot directly be applied to recurrent events data. In this paper, we propose a two-step method that enables us to evaluate the variable importance for recurrent events data. We evaluated the performance of our proposed method by simulations and applied it to a data set from a diabetes study. Copyright © 2015 John Wiley & Sons, Ltd.

Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

PubMed Central

Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

2015-01-01

We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

PRELIMINARY NUCLEAR CRITICALITY NUCLEAR SAFETY EVLAUATION FOR THE CONTAINER SURVEILLANCE AND STORAGE CAPABILITY PROJECT

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

Low, M; Matthew02 Miller, M; Thomas Reilly, T

2007-04-30

Washington Safety Management Solutions (WSMS) provides criticality safety services to Washington Savannah River Company (WSRC) at the Savannah River Site. One activity at SRS is the Container Surveillance and Storage Capability (CSSC) Project, which will perform surveillances on 3013 containers (hereafter referred to as 3013s) to verify that they meet the Department of Energy (DOE) Standard (STD) 3013 for plutonium storage. The project will handle quantities of material that are greater than ANS/ANSI-8.1 single parameter mass limits, and thus required a Nuclear Criticality Safety Evaluation (NCSE). The WSMS methodology for conducting an NCSE is outlined in the WSMS methods manual.more » The WSMS methods manual currently follows the requirements of DOE-O-420.1B, DOE-STD-3007-2007, and the Washington Savannah River Company (WSRC) SCD-3 manual. DOE-STD-3007-2007 describes how a NCSE should be performed, while DOE-O-420.1B outlines the requirements for a Criticality Safety Program (CSP). The WSRC SCD-3 manual implements DOE requirements and ANS standards. NCSEs do not address the Nuclear Criticality Safety (NCS) of non-reactor nuclear facilities that may be affected by overt or covert activities of sabotage, espionage, terrorism or other security malevolence. Events which are beyond the Design Basis Accidents (DBAs) are outside the scope of a double contingency analysis.« less

Development of a Novel Quantitative Adverse Outcome Pathway Predictive Model for Lung Cancer

EPA Science Inventory

Traditional methods for carcinogenicity testing are resource-intensive, retrospective, and time consuming. An increasing testing burden has generated interest in the adverse outcome pathway (AOP) concept as a tool to evaluate chemical safety in a more efficient, rapid and effecti...

A Method for Developing Standard Patient Education Program.

PubMed

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

2018-01-01

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

Innovations for the future of pharmacovigilance.

PubMed

Almenoff, June S

2007-01-01

Post-marketing pharmacovigilance involves the review and management of safety information from many sources. Among these sources, spontaneous adverse event reporting systems are among the most challenging and resource-intensive to manage. Traditionally, efforts to monitor spontaneous adverse event reporting systems have focused on review of individual case reports. The science of pharmacovigilance could be enhanced with the availability of systems-based tools that facilitate analysis of aggregate data for purposes of signal detection, signal evaluation and knowledge management. GlaxoSmithKline (GSK) recently implemented Online Signal Management (OSM) as a data-driven framework for managing the pharmacovigilance of marketed products. This pioneering work builds upon the strong history GSK has of innovation in this area. OSM is a software application co-developed by GSK and Lincoln Technologies that integrates traditional pharmacovigilance methods with modern quantitative statistical methods and data visualisation tools. OSM enables the rapid identification of trends from the individual adverse event reports received by GSK. OSM also provides knowledge-management tools to ensure the successful tracking of emerging safety issues. GSK has developed standard procedures and 'best practices' around the use of OSM to ensure the systematic evaluation of complex safety datasets. In summary, the implementation of OSM provides new tools and efficient processes to advance the science of pharmacovigilance.

Interpreting the biological relevance of bioinformatic analyses with T-DNA sequence for protein allergenicity.

PubMed

Harper, B; McClain, S; Ganko, E W

2012-08-01

Global regulatory agencies require bioinformatic sequence analysis as part of their safety evaluation for transgenic crops. Analysis typically focuses on encoded proteins and adjacent endogenous flanking sequences. Recently, regulatory expectations have expanded to include all reading frames of the inserted DNA. The intent is to provide biologically relevant results that can be used in the overall assessment of safety. This paper evaluates the relevance of assessing the allergenic potential of all DNA reading frames found in common food genes using methods considered for the analysis of T-DNA sequences used in transgenic crops. FASTA and BLASTX algorithms were used to compare genes from maize, rice, soybean, cucumber, melon, watermelon, and tomato using international regulatory guidance. Results show that BLASTX for maize yielded 7254 alignments that exceeded allergen similarity thresholds and 210,772 alignments that matched eight or more consecutive amino acids with an allergen; other crops produced similar results. This analysis suggests that each nontransgenic crop has a much greater potential for allergenic risk than what has been observed clinically. We demonstrate that a meaningful safety assessment is unlikely to be provided by using methods with inherently high frequencies of false positive alignments when broadly applied to all reading frames of DNA sequence. Copyright © 2012 Elsevier Inc. All rights reserved.

13C MRS of Human Brain at 7 Tesla Using [2-13C]Glucose Infusion and Low Power Broadband Stochastic Proton Decoupling

PubMed Central

Li, Shizhe; An, Li; Yu, Shao; Araneta, Maria Ferraris; Johnson, Christopher S.; Wang, Shumin; Shen, Jun

2015-01-01

Purpose 13C magnetic resonance spectroscopy (MRS) of human brain at 7 Tesla (T) may pose patient safety issues due to high RF power deposition for proton decoupling. The purpose of present work is to study the feasibility of in vivo 13C MRS of human brain at 7 T using broadband low RF power proton decoupling. Methods Carboxylic/amide 13C MRS of human brain by broadband stochastic proton decoupling was demonstrated on a 7 T scanner. RF safety was evaluated using the finite-difference time-domain method. 13C signal enhancement by nuclear Overhauser effect (NOE) and proton decoupling was evaluated in both phantoms and in vivo. Results At 7 T, the peak amplitude of carboxylic/amide 13C signals was increased by a factor of greater than 4 due to the combined effects of NOE and proton decoupling. The 7 T 13C MRS technique used decoupling power and average transmit power of less than 35 W and 3.6 W, respectively. Conclusion In vivo 13C MRS studies of human brain can be performed at 7 T well below the RF safety threshold by detecting carboxylic/amide carbons with broadband stochastic proton decoupling. PMID:25917936

Prerequisites of Colonoscopy

PubMed Central

Hong, Kyong Hee

2014-01-01

Colonoscopy is a widely accepted method for the evaluation of the colon and terminal ileum. Its diagnostic accuracy and therapeutic safety are influenced by prerequisites, including modulation of medication and bowel cleansing. Appropriate choices of sedative medication and bowel-cleansing regimen, together with diet modification, should be made based on the patient's underlying disease, age, and medication intake. Moreover, effective methods for patient education regarding bowel preparation should be considered. PMID:25133119

Safe and effective nursing shift handover with NURSEPASS: An interrupted time series.

PubMed

Smeulers, Marian; Dolman, Christine D; Atema, Danielle; van Dieren, Susan; Maaskant, Jolanda M; Vermeulen, Hester

2016-11-01

Implementation of a locally developed evidence based nursing shift handover blueprint with a bedside-safety-check to determine the effect size on quality of handover. A mixed methods design with: (1) an interrupted time series analysis to determine the effect on handover quality in six domains; (2) descriptive statistics to analyze the intercepted discrepancies by the bedside-safety-check; (3) evaluation sessions to gather experiences with the new handover process. We observed a continued trend of improvement in handover quality and a significant improvement in two domains of handover: organization/efficiency and contents. The bedside-safety-check successfully identified discrepancies on drains, intravenous medications, bandages or general condition and was highly appreciated. Use of the nursing shift handover blueprint showed promising results on effectiveness as well as on feasibility and acceptability. However, to enable long term measurement on effectiveness, evaluation with large scale interrupted times series or statistical process control is needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

NASA Astrophysics Data System (ADS)

Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

2017-10-01

Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

The Effectiveness of Insurer-Supported Safety and Health Engineering Controls in Reducing Workers’ Compensation Claims and Costs

PubMed Central

Wurzelbacher, Steven J.; Bertke, Stephen J.; Lampl, Michael P.; Bushnell, P. Timothy; Meyers, Alysha R.; Robins, David C.; Al-Tarawneh, Ibraheem S.

2015-01-01

Background This study evaluated the effectiveness of a program in which a workers’ compensation (WC) insurer provided matching funds to insured employers to implement safety/health engineering controls. Methods Pre- and post-intervention WC metrics were compiled for the employees designated as affected by the interventions within 468 employers for interventions occurring from 2003 to 2009. Poisson, two-part, and linear regression models with repeated measures were used to evaluate differences in pre- and post-data, controlling for time trends independent of the interventions. Results For affected employees, total WC claim frequency rates (both medical-only and lost-time claims) decreased 66%, lost-time WC claim frequency rates decreased 78%, WC paid cost per employee decreased 81%, and WC geometric mean paid claim cost decreased 30% post-intervention. Reductions varied by employer size, specific industry, and intervention type. Conclusions The insurer-supported safety/health engineering control program was effective in reducing WC claims and costs for affected employees. PMID:25223846

FDA pregnancy risk categories and the CPS

PubMed Central

Law, Ruth; Bozzo, Pina; Koren, Gideon; Einarson, Adrienne

2010-01-01

ABSTRACT QUESTION My patient is taking a medication for a chronic condition and has just found out that she is 6 weeks pregnant. The US Food and Drug Administration (FDA) has assigned this medication to pregnancy risk category D, and the Compendium of Pharmaceuticals and Specialties provides no additional data. How should I interpret this information, and how does the Motherisk Program evaluate the safety or risks of drug use in pregnancy? ANSWER Pregnancy safety data provided by the FDA pregnancy risk categories and the Compendium of Pharmaceuticals and Specialties are insufficient to guide clinical decisions on how to proceed with a pregnancy following exposure to a category D medication. The Motherisk Program creates peer-reviewed statements derived from the primary literature, and we examine fetal outcomes as well as the risk-benefit profile of maternal treatment when evaluating the safety of medication use in pregnancy. The FDA announced in May 2008 that it is dropping its pregnancy risk categories and adopting a method similar to the one we use at Motherisk. PMID:20228306

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

PubMed

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

2018-06-01

Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine traffic volumes, and speeds as a function of radii). The final models may help quantify the safety impact of different turbo-roundabout solutions. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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

2014-10-01

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

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

PubMed Central

Hu, Qizhou; Zhou, Zhuping; Sun, Xu

2014-01-01

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

Efficacy of Antimicrobial Agents for Food Contact Applications: Biological Activity, Incorporation into Packaging, and Assessment Methods: A Review.

PubMed

Mousavi Khaneghah, Amin; Hashemi, Seyed Mohammad Bagher; Eş, Ismail; Fracassetti, Daniela; Limbo, Sara

2018-07-01

Interest in the utilization of antimicrobial active packaging for food products has increased in recent years. Antimicrobial active packaging involves the incorporation of antimicrobial compounds into packaging materials, with the aim of maintaining or extending food quality and shelf life. Plant extracts, essential oils, organic acids, bacteriocins, inorganic substances, enzymes, and proteins are used as antimicrobial agents in active packaging. Evaluation of the antimicrobial activity of packaging materials using different methods has become a critical issue for both food safety and the commercial utilization of such packaging technology. This article reviews the different types of antimicrobial agents used for active food packaging materials, the main incorporation techniques, and the assessment methods used to examine the antimicrobial activity of packaging materials, taking into account their safety as food contact materials.

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

Tropkin, S. N.; Tlyasheva, R. R.; Bayazitov, M. I.; Kuzeev, I. R.

2018-03-01

Equipment of many oil and gas processing plants in the Russian Federation is considerably worn-out. This causes the decrease of reliability and durability of equipment and rises the accident rate. An air explosion is the one of the most dangerous cases for plants in oil and gas industry, usually caused by uncontrolled emission and inflammation of oil products. Air explosion can lead to significant danger for life and health of plant staff, so it necessitates safety device usage. A new type of a safety device is designed. Numerical simulation is necessary to analyse design parameters and performance of the safety device, subjected to air blast loading. Coupled fluid-structure interaction analysis is performed to determine strength of the protective device and its performance. The coupled Euler-Lagrange method, allowable in Abaqus by SIMULIA, is selected as the most appropriate analysis tool to study blast wave interaction with the safety device. Absorption factors of blast wave are evaluated for the safety device. This factors allow one to assess efficiency of the safety device, and its main structural component – dampener. Usage of CEL allowed one to model fast and accurately the dampener behaviour, and to develop the parametric model to determine safety device sizes.

Safety and efficacy of endoscopic submucosal dissection using IT knife nano with clip traction method for early esophageal squamous cell carcinoma.

PubMed

Kitagawa, Yoshiyasu; Suzuki, Takuto; Hara, Taro; Yamaguchi, Taketo

2018-01-01

Although endoscopic submucosal dissection (ESD) is an accepted and established treatment for early esophageal squamous cell carcinoma (EESCC), it is technically difficult, time consuming, and less safe than endoscopic mucosal resection. To perform ESD safely and more efficiently, we proposed a new technique of esophageal ESD using an IT knife nano with the clip traction method. This study aimed to evaluate the efficacy and safety of ESD using this new technique. We retrospectively reviewed all consecutive cases of esophageal ESD performed using an IT knife nano with the clip traction method at our hospital between March 2013 and January 2017. Therapeutic efficacy and safety were also assessed. A total of 103 patients underwent esophageal ESD using the IT knife nano with the clip traction method. In all cases, we performed en bloc resection. Complete resection was achieved in 100 cases (97.1%). The median operating time was 40 (range 13-230) min. No cases of perforation or delayed bleeding occurred. Although two cases (2.0%) of mediastinal emphysema occurred without visible perforation at endoscopy, all were successfully managed conservatively. The new technique of esophageal ESD using the IT knife nano with the clip traction method appears to be feasible, effective, and safe for EESCC treatment.

Safety reliability evaluation when vehicles turn right from urban major roads onto minor ones based on driver's visual perception.

PubMed

Yu, Bo; Chen, Yuren; Wang, Ruiyun; Dong, Yongjie

2016-10-01

Turning right has a significant impact on urban road traffic safety. Driving into the curve inappropriately or with improper turning speed often leads to a series of potential accidents and hidden dangers. For a long time, the design speed at intersections has been used to determine the physical radius of curbs and channelization, and drivers are expected to drive in accordance with the design speed. However, a large number of real vehicle tests show that for the road without an exclusive right-turn lane, there is not a good correlation between the physical radius of curbs and the turning right speeds. In this paper, shape parameters of the driver's visual lane model are put forward and they have relatively high correlations with right-turn speeds. Hence, an evaluation method about safety reliability of turning right from urban major roads onto minor ones based on driver's visual perception is proposed. For existing roads, the evaluation object could be real driving videos; for those under construction roads, the evaluation object could be visual scenes obtained from a driving simulation device. Findings in this research will make a contribution to the optimization of right-turn design at intersections and lead to the development of auxiliary driving technology. Copyright © 2015 Elsevier Ltd. All rights reserved.

Promoting Sun Safety Among US Postal Service Letter Carriers: Impact of a 2-Year Intervention

PubMed Central

Mayer, Joni A.; Slymen, Donald J.; Clapp, Elizabeth J.; Pichon, Latrice C.; Eckhardt, Laura; Eichenfield, Lawrence F.; Elder, John P.; Sallis, James F.; Weinstock, Martin A.; Achter, April; Balderrama, Cynthia; Galindo, Gabriel R.; Oh, Sam S.

2007-01-01

Objectives. We examined whether US Postal Service letter carriers who received a sun safety intervention would wear wide-brim hats and sunscreen significantly more often than those who did not receive the intervention. Methods. We used a 2-group randomized design with 2662 evaluation cohort participants from 70 US postal stations. Evaluations were conducted at baseline, 3 months, 1 year, and 2 years. Questionnaire items assessed occupational use of sun-screen and wide-brim hats. The 2-year sun safety intervention included the provision of wide-brim hats, accessible sunscreen, reminders, and 6 educational sessions. Results. At the 3-month follow-up evaluations, the odds ratio (OR) for regular sun-screen use was 2.8 times higher among the intervention group than among the control group (95% confidence interval [CI]=2.2, 3.5); at the 2-year follow-up evaluations, the rate was still significantly higher (OR=2.0; 95% CI=1.6, 2.6). Intervention group participants also had significantly higher rates of hat use, with the differences remaining consistent across all follow-ups (OR=2.9; 95% CI=2.3, 3.6). Conclusions. The intervention should be disseminated to postal stations nationwide and possibly to other occupational groups that work outdoors. PMID:17267715

Study of the Continuous Improvement Trend for Health, Safety and Environmental Indicators, after Establishment of Integrated Management System (IMS) in a Pharmaceutical Industry in Iran

PubMed Central

Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj

2015-01-01

Background Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. Aim This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. Materials and Methods First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Results Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Conclusion Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead. PMID:26557547

Multiple attribute decision making model and application to food safety risk evaluation.

PubMed

Ma, Lihua; Chen, Hong; Yan, Huizhe; Yang, Lifeng; Wu, Lifeng

2017-01-01

Decision making for supermarket food purchase decisions are characterized by network relationships. This paper analyzed factors that influence supermarket food selection and proposes a supplier evaluation index system based on the whole process of food production. The author established the intuitive interval value fuzzy set evaluation model based on characteristics of the network relationship among decision makers, and validated for a multiple attribute decision making case study. Thus, the proposed model provides a reliable, accurate method for multiple attribute decision making.

Evaluation of a pilot promotora program for Latino forest workers in southern Oregon.

PubMed

Bush, Diane E; Wilmsen, Carl; Sasaki, Timothy; Barton-Antonio, Dinorah; Steege, Andrea L; Chang, Charlotte

2014-07-01

Forest work, an occupation with some of the highest injury and illness rates, is conducted primarily by Latino immigrant workers. This study evaluates a pilot program where promotoras (lay community health educators) provided occupational health and safety trainings for Latino forest workers. Evaluation methods included a focus group, post-tests, and qualitative feedback. Community capacity to address working conditions increased through (i) increased leadership and community access to information and resources; and (ii) increased worker awareness of workplace health and safety rights and resources. Fear of retaliation remains a barrier to workers taking action; nevertheless, the promotoras supported several workers in addressing-specific workplace issues. For working conditions to significantly improve, major structural influences need to be addressed. A long-term, organizationally supported promotora program can play a key role in linking and supporting change at the individual, interpersonal and community levels, contributing to and supporting structural change. © 2014 Wiley Periodicals, Inc.

Ensuring Patient Safety in Care Transitions: An Empirical Evaluation of a Handoff Intervention Tool

PubMed Central

Abraham, Joanna; Kannampallil, Thomas; Patel, Bela; Almoosa, Khalid; Patel, Vimla L.

2012-01-01

Successful handoffs ensure smooth, efficient and safe patient care transitions. Tools and systems designed for standardization of clinician handoffs often focuses on ensuring the communication activity during transitions, with limited support for preparatory activities such as information seeking and organization. We designed and evaluated a Handoff Intervention Tool (HAND-IT) based on a checklist-inspired, body system format allowing structured information organization, and a problem-case narrative format allowing temporal description of patient care events. Based on a pre-post prospective study using a multi-method analysis we evaluated the effectiveness of HAND-IT as a documentation tool. We found that the use of HAND-IT led to fewer transition breakdowns, greater tool resilience, and likely led to better learning outcomes for less-experienced clinicians when compared to the current tool. We discuss the implications of our results for improving patient safety with a continuity of care-based approach. PMID:23304268

A Tool for the Automated Design and Evaluation of Habitat Interior Layouts

NASA Technical Reports Server (NTRS)

Simon, Matthew A.; Wilhite, Alan W.

2013-01-01

The objective of space habitat design is to minimize mass and system size while providing adequate space for all necessary equipment and a functional layout that supports crew health and productivity. Unfortunately, development and evaluation of interior layouts is often ignored during conceptual design because of the subjectivity and long times required using current evaluation methods (e.g., human-in-the-loop mockup tests and in-depth CAD evaluations). Early, more objective assessment could prevent expensive design changes that may increase vehicle mass and compromise functionality. This paper describes a new interior design evaluation method to enable early, structured consideration of habitat interior layouts. This interior layout evaluation method features a comprehensive list of quantifiable habitat layout evaluation criteria, automatic methods to measure these criteria from a geometry model, and application of systems engineering tools and numerical methods to construct a multi-objective value function measuring the overall habitat layout performance. In addition to a detailed description of this method, a C++/OpenGL software tool which has been developed to implement this method is also discussed. This tool leverages geometry modeling coupled with collision detection techniques to identify favorable layouts subject to multiple constraints and objectives (e.g., minimize mass, maximize contiguous habitable volume, maximize task performance, and minimize crew safety risks). Finally, a few habitat layout evaluation examples are described to demonstrate the effectiveness of this method and tool to influence habitat design.

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

PubMed Central

Ackerman, Janet M.; Dairkee, Shanaz H.; Fenton, Suzanne E.; Johnson, Dale; Navarro, Kathleen M.; Osborne, Gwendolyn; Rudel, Ruthann A.; Solomon, Gina M.; Zeise, Lauren; Janssen, Sarah

2015-01-01

Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015. Screening for chemical contributions to breast cancer risk: a case study for chemical safety evaluation. Environ Health Perspect 123:1255–1264; http://dx.doi.org/10.1289/ehp.1408337 PMID:26032647

Optimizing Safety, Fidelity and Usability of an Intelligent Clinical Support Tool (ICST) For Acute Hospital Care: an Australian Case Study Using a Multi-Method Delphi Process.

PubMed

Botti, Mari; Redley, Bernice; Nguyen, Lemai; Coleman, Kimberley; Wickramasinghe, Nilmini

2015-01-01

This research focuses on a major health priority for Australia by addressing existing gaps in the implementation of nursing informatics solutions in healthcare. It serves to inform the successful deployment of IT solutions designed to support patient-centered, frontline acute healthcare delivery by multidisciplinary care teams. The outcomes can guide future evaluations of the contribution of IT solutions to the efficiency, safety and quality of care delivery in acute hospital settings.

Iso standardization of theoretical activity evaluation method for low and intermediate level activated waste generated at nuclear power plants

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

Makoto Kashiwagi; Garamszeghy, Mike; Lantes, Bertrand

Disposal of low-and intermediate-level activated waste generated at nuclear power plants is being planned or carried out in many countries. The radioactivity concentrations and/or total quantities of long-lived, difficult-to-measure nuclides (DTM nuclides), such as C-14, Ni-63, Nb-94, α emitting nuclides etc., are often restricted by the safety case for a final repository as determined by each country's safety regulations, and these concentrations or amounts are required to be known and declared. With respect to waste contaminated by contact with process water, the Scaling Factor method (SF method), which is empirically based on sampling and analysis data, has been applied asmore » an important method for determining concentrations of DTM nuclides. This method was standardized by the International Organization for Standardization (ISO) and published in 2007 as ISO21238 'Scaling factor method to determine the radioactivity of low and intermediate-level radioactive waste packages generated at nuclear power plants' [1]. However, for activated metal waste with comparatively high concentrations of radioactivity, such as may be found in reactor control rods and internal structures, direct sampling and radiochemical analysis methods to evaluate the DTM nuclides are limited by access to the material and potentially high personnel radiation exposure. In this case, theoretical calculation methods in combination with empirical methods based on remote radiation surveys need to be used to best advantage for determining the disposal inventory of DTM nuclides while minimizing exposure to radiation workers. Pursuant to this objective a standard for the theoretical evaluation of the radioactivity concentration of DTM nuclides in activated waste, is in process through ISO TC85/SC5 (ISO Technical Committee 85: Nuclear energy, nuclear technologies, and radiological protection; Subcommittee 5: Nuclear fuel cycle). The project team for this ISO standard was formed in 2011 and is composed of experts from 11 countries. The project team has been conducting technical discussions on theoretical methods for determining concentrations of radioactivity, and has developed the draft International Standard of ISO16966 'Theoretical activation calculation method to evaluate the radioactivity of activated waste generated at nuclear reactors' [2]. This paper describes the international standardization process developed by the ISO project team, and outlines the following two theoretical activity evaluation methods:? Point method? Range method. (authors)« less

Organization of research team for nano-associated safety assessment in effort to study nanotoxicology of zinc oxide and silica nanoparticles

PubMed Central

Kim, Yu-Ri; Park, Sung Ha; Lee, Jong-Kwon; Jeong, Jayoung; Kim, Ja Hei; Meang, Eun-Ho; Yoon, Tae Hyun; Lim, Seok Tae; Oh, Jae-Min; An, Seong Soo A; Kim, Meyoung-Kon

2014-01-01

Currently, products made with nanomaterials are used widely, especially in biology, bio-technologies, and medical areas. However, limited investigations on potential toxicities of nanomaterials are available. Hence, diverse and systemic toxicological data with new methods for nanomaterials are needed. In order to investigate the nanotoxicology of nanoparticles (NPs), the Research Team for Nano-Associated Safety Assessment (RT-NASA) was organized in three parts and launched. Each part focused on different contents of research directions: investigators in part I were responsible for the efficient management and international cooperation on nano-safety studies; investigators in part II performed the toxicity evaluations on target organs such as assessment of genotoxicity, immunotoxicity, or skin penetration; and investigators in part III evaluated the toxicokinetics of NPs with newly developed techniques for toxicokinetic analyses and methods for estimating nanotoxicity. The RT-NASA study was carried out in six steps: need assessment, physicochemical property, toxicity evaluation, toxicokinetics, peer review, and risk communication. During the need assessment step, consumer responses were analyzed based on sex, age, education level, and household income. Different sizes of zinc oxide and silica NPs were purchased and coated with citrate, L-serine, and L-arginine in order to modify surface charges (eight different NPs), and each of the NPs were characterized by various techniques, for example, zeta potentials, scanning electron microscopy, and transmission electron microscopy. Evaluation of the “no observed adverse effect level” and systemic toxicities of all NPs were performed by thorough evaluation steps and the toxicokinetics step, which included in vivo studies with zinc oxide and silica NPs. A peer review committee was organized to evaluate and verify the reliability of toxicity tests, and the risk communication step was also needed to convey the current findings to academia, industry, and consumers. Several limitations were encountered in the RT-NASA project, and they are discussed for consideration for improvements in future studies. PMID:25565821

Organization of research team for nano-associated safety assessment in effort to study nanotoxicology of zinc oxide and silica nanoparticles.

PubMed

Kim, Yu-Ri; Park, Sung Ha; Lee, Jong-Kwon; Jeong, Jayoung; Kim, Ja Hei; Meang, Eun-Ho; Yoon, Tae Hyun; Lim, Seok Tae; Oh, Jae-Min; An, Seong Soo A; Kim, Meyoung-Kon

2014-01-01

Currently, products made with nanomaterials are used widely, especially in biology, bio-technologies, and medical areas. However, limited investigations on potential toxicities of nanomaterials are available. Hence, diverse and systemic toxicological data with new methods for nanomaterials are needed. In order to investigate the nanotoxicology of nanoparticles (NPs), the Research Team for Nano-Associated Safety Assessment (RT-NASA) was organized in three parts and launched. Each part focused on different contents of research directions: investigators in part I were responsible for the efficient management and international cooperation on nano-safety studies; investigators in part II performed the toxicity evaluations on target organs such as assessment of genotoxicity, immunotoxicity, or skin penetration; and investigators in part III evaluated the toxicokinetics of NPs with newly developed techniques for toxicokinetic analyses and methods for estimating nanotoxicity. The RT-NASA study was carried out in six steps: need assessment, physicochemical property, toxicity evaluation, toxicokinetics, peer review, and risk communication. During the need assessment step, consumer responses were analyzed based on sex, age, education level, and household income. Different sizes of zinc oxide and silica NPs were purchased and coated with citrate, L-serine, and L-arginine in order to modify surface charges (eight different NPs), and each of the NPs were characterized by various techniques, for example, zeta potentials, scanning electron microscopy, and transmission electron microscopy. Evaluation of the "no observed adverse effect level" and systemic toxicities of all NPs were performed by thorough evaluation steps and the toxicokinetics step, which included in vivo studies with zinc oxide and silica NPs. A peer review committee was organized to evaluate and verify the reliability of toxicity tests, and the risk communication step was also needed to convey the current findings to academia, industry, and consumers. Several limitations were encountered in the RT-NASA project, and they are discussed for consideration for improvements in future studies.

The incidence of coring with blunt versus sharp needles.

PubMed

Wani, Tariq; Wadhwa, Anupama; Tobias, Joseph D

2014-03-01

With the advent of safety needles to prevent inadvertent needle sticks in the operating room (OR), a potentially new issue has arisen. These needles may result in coring, or the shaving off of fragments of the rubber stopper, when the needle is pierced through the rubber stopper of the medication vial. These fragments may be left in the vial and then drawn up with the medication and possibly injected into patients. The current study prospectively evaluated the incidence of coring when blunt and sharp needles were used to pierce rubber topped vials. We also evaluated the incidence of coring in empty medication vials with rubber tops. The rubber caps were then pierced with either an18-gauge sharp hypodermic needle or a blunt plastic (safety) needle. Coring occurred in 102 of 250 (40.8%) vials when a blunt needle was used versus 9 of 215 (4.2%) vials with a sharp needle (P < 0.0001). A significant incidence of coring was demonstrated when a blunt plastic safety needle was used. This situation is potentially a patient safety hazard and methods to eliminate this problem are needed. Copyright © 2014 Elsevier Inc. All rights reserved.

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-01-01

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

[Comparison between rapid detection method of enzyme substrate technique and multiple-tube fermentation technique in water coliform bacteria detection].

PubMed

Sun, Zong-ke; Wu, Rong; Ding, Pei; Xue, Jin-Rong

2006-07-01

To compare between rapid detection method of enzyme substrate technique and multiple-tube fermentation technique in water coliform bacteria detection. Using inoculated and real water samples to compare the equivalence and false positive rate between two methods. Results demonstrate that enzyme substrate technique shows equivalence with multiple-tube fermentation technique (P = 0.059), false positive rate between the two methods has no statistical difference. It is suggested that enzyme substrate technique can be used as a standard method for water microbiological safety evaluation.

Development of indicators for measuring outcomes of water safety plans

PubMed Central

Lockhart, Gabriella; Oswald, William E.; Hubbard, Brian; Medlin, Elizabeth; Gelting, Richard J.

2015-01-01

Water safety plans (WSPs) are endorsed by the World Health Organization as the most effective method of protecting a water supply. With the increase in WSPs worldwide, several valuable resources have been developed to assist practitioners in the implementation of WSPs, yet there is still a need for a practical and standardized method of evaluating WSP effectiveness. In 2012, the Centers for Disease Control and Prevention (CDC) published a conceptual framework for the evaluation of WSPs, presenting four key outcomes of the WSP process: institutional, operational, financial and policy change. In this paper, we seek to operationalize this conceptual framework by providing a set of simple and practical indicators for assessing WSP outcomes. Using CDC’s WSP framework as a foundation and incorporating various existing performance monitoring indicators for water utilities, we developed a set of approximately 25 indicators of institutional, operational, financial and policy change within the WSP context. These outcome indicators hold great potential for the continued implementation and expansion of WSPs worldwide. Having a defined framework for evaluating a WSP’s effectiveness, along with a set of measurable indicators by which to carry out that evaluation, will help implementers assess key WSP outcomes internally, as well as benchmark their progress against other WSPs in their region and globally. PMID:26361540

Program evaluation of FHWA pedestrian and bicycle safety activities.

DOT National Transportation Integrated Search

2011-03-01

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

Towards standardized assessment of endoscope optical performance: geometric distortion

NASA Astrophysics Data System (ADS)

Wang, Quanzeng; Desai, Viraj N.; Ngo, Ying Z.; Cheng, Wei-Chung; Pfefer, Joshua

2013-12-01

Technological advances in endoscopes, such as capsule, ultrathin and disposable devices, promise significant improvements in safety, clinical effectiveness and patient acceptance. Unfortunately, the industry lacks test methods for preclinical evaluation of key optical performance characteristics (OPCs) of endoscopic devices that are quantitative, objective and well-validated. As a result, it is difficult for researchers and developers to compare image quality and evaluate equivalence to, or improvement upon, prior technologies. While endoscope OPCs include resolution, field of view, and depth of field, among others, our focus in this paper is geometric image distortion. We reviewed specific test methods for distortion and then developed an objective, quantitative test method based on well-defined experimental and data processing steps to evaluate radial distortion in the full field of view of an endoscopic imaging system. Our measurements and analyses showed that a second-degree polynomial equation could well describe the radial distortion curve of a traditional endoscope. The distortion evaluation method was effective for correcting the image and can be used to explain other widely accepted evaluation methods such as picture height distortion. Development of consensus standards based on promising test methods for image quality assessment, such as the method studied here, will facilitate clinical implementation of innovative endoscopic devices.

[A Phase 1 study of beta-methyl-p-(123I)-iodophenyl-pentadecanoic acid (123I-BMIPP)].

PubMed

Torizuka, K; Yonekura, Y; Nishimura, T; Tamaki, N; Uehara, T; Ikekubo, K; Hino, M

1991-07-01

Phase 1 study of beta-methyl-p-(123I)-iodophenylpentadecanoic acid (123I-BMIPP), a new radiopharmaceutical developed for the evaluation of myocardial fatty acid metabolism, was performed in six normal volunteers to evaluate its biodistribution and safety. After intravenous injection of 111 MBq of 123I-BMIPP, the agent accumulated to the myocardium rapidly (5.4 +/- 0.6% at 1.5 hr after injection) and was washed-out slowly (5.1 +/- 0.4% at 3.0hr). 123I-BMIPP demonstrated no significant accumulation to any specific organs other than myocardium, liver and muscle. Myocardium was clearly visualized in the planar and SPECT images obtained 30 min and 3 hrs after injection. The absorption doses from 123I-BMIPP estimated by MIRD method were lower than those from 201Tl in all organs. Neither adverse reactions nor abnormal clinical laboratory findings were found in the safety evaluation. These results suggest 123I-BMIPP is a promising agent for evaluating myocardial fatty acid metabolism.

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

PubMed

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

2016-10-25

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

Assessment of patient safety culture in clinical laboratories in the Spanish National Health System

PubMed Central

Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M.; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I.; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat

2015-01-01

Introduction There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. Material and methods A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. Results 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. Conclusions We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement. PMID:26525595

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

PubMed

Chaifetz, Ashley; Chapman, Benjamin

2015-11-01

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

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

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

PubMed

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

2018-06-01

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

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study.

PubMed

Harvey, James R; Lim, Yit; Murphy, John; Howe, Miles; Morris, Julie; Goyal, Amit; Maxwell, Anthony J

2018-06-01

Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization. A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety. Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues. Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study

PubMed Central

Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Background Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. Results From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9–6.6 m) and 5.4 months (95%CI 3.1–7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). Conclusions In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

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

A Family-Centered Rounds Checklist, Family Engagement, and Patient Safety: A Randomized Trial

PubMed Central

Jacobsohn, Gwen C.; Rajamanickam, Victoria P.; Carayon, Pascale; Kelly, Michelle M.; Wetterneck, Tosha B.; Rathouz, Paul J.; Brown, Roger L.

2017-01-01

BACKGROUND AND OBJECTIVES: Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs’ benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. METHODS: This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children’s Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. RESULTS: The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P < .001). Intervention rounds were significantly more likely to include asking the family (odds ratio [OR] = 2.43, P < .05) or health care team (OR = 4.28, P = .002) for questions and reading back orders (OR = 12.43, P < .001). Intervention families’ engagement and reports of safety climate were no different from usual care. However, performance of specific checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff’s communication openness and safety of handoffs and transitions. CONCLUSIONS: The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. PMID:28557720

Evaluation of Education and Outreach Methods and Strategies - A Case Study of a Web-Based Rail Safety Education Initiative

DOT National Transportation Integrated Search

2014-04-01

The U. S. Department of Transportations (U.S. DOT) Research and Innovative Technology Administrations (RITA) John A. Volpe National Transportation Systems Center (Volpe Center), under the direction of the U.S. DOT Federal Railroad Administratio...

CONTROL TECHNOLOGY EVALUATION FOR GASOLINE LOADING OF BARGES

EPA Science Inventory

The report gives results of a study to determine the feasibility, safety, and cost of methods to control the emission of hydrocarbon vapor during the loading of gasoline barges. Approximately 4 lb of hydrocarbons are emitted per 1000 gal. of gasoline loaded; annually about 1 mill...

Comparison of methods to determine the microbial quality of alternative irrigation waters

USDA-ARS?s Scientific Manuscript database

The availability of water for crop irrigation is decreasing due to droughts, population growth, and pollution. Implementation of Food Safety and Modernization Act (FSMA) for irrigation water standards discourages growers to use poor microbial quality water for produce crop irrigation. We evaluated m...

Measuring safety climate in elderly homes.

PubMed

Yeung, Koon-Chuen; Chan, Charles C

2012-02-01

Provision of a valid and reliable safety climate dimension brings enormous benefits to the elderly home sector. The aim of the present study was to make use of the safety climate instrument developed by OSHC to measure the safety perceptions of employees in elderly homes such that the factor structure of the safety climate dimensions of elderly homes could be explored. In 2010, surveys by mustering on site method were administered in 27 elderly homes that had participated in the "Hong Kong Safe and Healthy Residential Care Home Accreditation Scheme" organized by the Occupational Safety and Health Council. Six hundred and fifty-one surveys were returned with a response rate of 54.3%. To examine the factor structure of safety climate dimensions in our study, an exploratory factor analysis (EFA) using principal components analysis method was conducted to identify the underlying factors. The results of the modified seven-factor's safety climate structure extracted from 35 items better reflected the safety climate dimensions of elderly homes. The Cronbach alpha range for this study (0.655 to 0.851) indicated good internal consistency among the seven-factor structure. Responses from managerial level, supervisory and professional level, and front-line staff were analyzed to come up with the suggestion on effective ways of improving the safety culture of elderly homes. The overall results showed that managers generally gave positive responses in the factors evaluated, such as "management commitment and concern to safety," "perception of work risks and some contributory influences," "safety communication and awareness," and "safe working attitude and participation." Supervisors / professionals, and frontline level staff on the other hand, have less positive responses. The result of the lowest score in the factors - "perception of safety rules and procedures" underlined the importance of the relevance and practicability of safety rules and procedures. The modified OSHC safety climate tool provided better evidence of structural validity and reliability for use by elderly homes' decision makers as an indicator of employee perception of safety in their institution. The findings and suggestions in the study provide useful information for the management, supervisors/professionals and frontline level staff to cultivate the safety culture in the elderly home sector. Most important, elderly homes can use the modified safety climate scale to identify problem areas in their safety culture and safety management practices and then target these for intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

Process safety improvement--quality and target zero.

PubMed

Van Scyoc, Karl

2008-11-15

Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

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

PubMed

Jalayer, Mohammad; Zhou, Huaguo

2016-08-01

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

Development of a Universal Safety Behavior Management System for Coal Mine Workers

PubMed Central

LI, Jizu; LI, Yuejiao; LIU, Xiaoguang

2015-01-01

Background: In China, over 80% of all work-related deaths in the mining industry occur in coal mines and human factors constitute 85% of the direct causes of coal mine accidents, which indicates that significant shortcomings currently exist in the safety behavior management of Chinese coal mine workers. We aimed to verify the impact of human psychological behavior in coal mine accidents systematically through experimental study, theoretical analysis and management application. Methods: Four test instruments (Sensory and cognitive capacity test, Sixteen-Personal Factor Questionnaire, Symptom Checklist 90 Questionnaire and the supervisors’ evaluation) were employed from November 2013 to June 2014 to identify unsafe behavior factors, the self-established Questionnaire of Safety Behavior Norms (QSBN) was also used to propose the safety behavior countermeasures of coal mine employees. Results: The mental health of most coal mine workers’ is relatively poor. The sensory and cognitive capacity of those in different work posts varies greatly, as does the sense of responsibility. Workers are susceptible to external influences, and score low in site management. When the 16-PF and SCL-90 sensory and cognitive assessments were combined, the psychological index predictive power was greatest for estimating sense of efficiency and degree of satisfaction in internal evaluations, while at the same time lowest for estimating control of introversion-extroversion and stress character. Conclusion: The psychological indicators can predict part of employee safety behavior, and assist a coal mine enterprise to recruit staff, develop occupational safety norms and improve the working environment. PMID:26258088

Safety evaluation of centerline plus shoulder rumble strips.

DOT National Transportation Integrated Search

2015-06-01

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

Safety evaluation of wet reflective pavement markers.

DOT National Transportation Integrated Search

2015-09-01

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

Safety evaluation of wet-reflective pavement markings.

DOT National Transportation Integrated Search

2015-09-01

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

Safety evaluation of intersection conflict warning system.

DOT National Transportation Integrated Search

2016-06-01

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

A quantitative risk-assessment system (QR-AS) evaluating operation safety of Organic Rankine Cycle using flammable mixture working fluid.

PubMed

Tian, Hua; Wang, Xueying; Shu, Gequn; Wu, Mingqiang; Yan, Nanhua; Ma, Xiaonan

2017-09-15

Mixture of hydrocarbon and carbon dioxide shows excellent cycle performance in Organic Rankine Cycle (ORC) used for engine waste heat recovery, but the unavoidable leakage in practical application is a threat for safety due to its flammability. In this work, a quantitative risk assessment system (QR-AS) is established aiming at providing a general method of risk assessment for flammable working fluid leakage. The QR-AS covers three main aspects: analysis of concentration distribution based on CFD simulations, explosive risk assessment based on the TNT equivalent method and risk mitigation based on evaluation results. A typical case of propane/carbon dioxide mixture leaking from ORC is investigated to illustrate the application of QR-AS. According to the assessment results, proper ventilation speed, safe mixture ratio and location of gas-detecting devices have been proposed to guarantee the security in case of leakage. The results revealed that this presented QR-AS was reliable for the practical application and the evaluation results could provide valuable guidance for the design of mitigation measures to improve the safe performance of ORC system. Copyright © 2017 Elsevier B.V. All rights reserved.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Safety evaluation of increasing retroreflectivity of STOP signs

DOT National Transportation Integrated Search

2008-03-01

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

Safety evaluation of advance street name signs

DOT National Transportation Integrated Search

2009-06-01

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

Addressing prehospital patient safety using the science of injury prevention and control.

PubMed

Meisel, Zachary F; Hargarten, Stephen; Vernick, Jon

2008-01-01

There is inadequate information about the scope and character of adverse events in prehospital care. However, there is ample evidence to suggest that prehospital patient safety hazards are often unique and underrecognized. We first summarize what is currently understood about prehospital patient safety and identify the specific aspects of emergency medical services (EMS) care that may make conventional approaches to the evaluation and improvement of patient safety more difficult. Next we introduce the concept of using injury prevention and control science to analyze prehospital adverse events and to help develop EMS patient safety solutions. Injury prevention and control is a proven public health approach for the study and reduction of both intentional and unintentional injuries. It includes the use of a Haddon phase-factor matrix to identify possible interventions, especially environmental modifications that provide automatic protection. We demonstrate how this method can be used as a complementary approach in efforts to prevent injuries caused by prehospital adverse medical events.

Safety from Crime and Physical Activity among Older Adults: A Population-Based Study in Brazil

PubMed Central

Weber Corseuil, Maruí; Hallal, Pedro Curi; Xavier Corseuil, Herton; Jayce Ceola Schneider, Ione; d'Orsi, Eleonora

2012-01-01

Objective. To evaluate the association between safety from crime and physical activity among older adults. Methods. A population-based survey including 1,656 older adults (60+ years) took place in Florianopolis, Brazil, in 2009-2010. Commuting and leisure time physical activity were assessed through the long version of the International Physical Activity Questionnaire. Perception of safety from crime was assessed using the Neighbourhood Environment Walkability Scale. Results. Perceiving the neighbourhood as safe during the day was related to a 25% increased likelihood of being active in leisure time (95% CI 1.02–1.53); general perception of safety was also associated with a 25% increase in the likelihood of being active in leisure time (95% CI 1.01–1.54). Street lighting was related to higher levels of commuting physical activity (prevalence ratio: 1.89; 95% CI 1.28–2.80). Conclusions. Safety investments are essential for promoting physical activity among older adults in Brazil. PMID:22291723

Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

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

O'Hara, J.M.; Plott, C.; Milanski, J.

2009-09-30

The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance tomore » support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.« less

A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System.

PubMed

Bao, Yulong; Li, Yongle; Ding, Jiajie

2016-11-10

A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety.

A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI

PubMed Central

Kabil, J.; Belguerras, L.; Trattnig, S.; Pasquier, C.; Missoffe, A.

2016-01-01

Summary Objectives To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. Methods A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Results Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Conclusions Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges. PMID:27830244

A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System

PubMed Central

Bao, Yulong; Li, Yongle; Ding, Jiajie

2016-01-01

A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety. PMID:27834923

Parental safety concerns and active school commute: correlates across multiple domains in the home-to-school journey

PubMed Central

2014-01-01

Background Empirical evidence of the relationship between safety concerns and walking to school (WTS) is growing. However, current research offers limited understanding of the multiple domains of parental safety concerns and the specific mechanisms through which parents articulate safety concerns about WTS. A more detailed understanding is needed to inform environmental and policy interventions. This study examined the relationships between both traffic safety and personal safety concerns and WTS in the U.S. Methods This cross-sectional analysis examined data from the Texas Childhood Obesity Prevention Policy Evaluation (T-COPPE) project, an evaluation of state-wide obesity prevention policy interventions. All study data were from the survey (n = 830) of parents with 4th grade students attending 81 elementary schools across Texas, and living within two miles from their children's schools. Traffic safety and personal safety concerns were captured for the home neighborhood, en-route to school, and school environments. Binary logistic regression analysis was used to assess the odds of WTS controlling for significant covariates. Results Overall, 18% of parents reported that their child walked to school on most days of the week. For traffic safety, students were more likely to walk to school if their parent reported favorable perceptions about the following items in the home neighborhood environment: higher sidewalk availability, well maintained sidewalks and safe road crossings. For the route to school, the odds of WTS were higher for those who reported "no problem" with each one of the following: traffic speed, amount of traffic, sidewalks/pathways, intersection/crossing safety, and crossing guards, when compared to those that reported "always a problem". For personal safety in the en-route to school environment, the odds of WTS were lower when parents reported concerns about: stray or dangerous animals and availability of others with whom to walk. Conclusions Findings offered insights into the specific issues that drive safety concerns for elementary school children’s WTS behaviors. The observed associations between more favorable perceptions of safety and WTS provide further justification for practical intervention strategies to reduce WTS barriers that can potentially bring long-term physical activity and health benefits to school-aged children. PMID:24602213

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2017-03-01

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

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Safety evaluation of STOP AHEAD pavement markings

DOT National Transportation Integrated Search

2007-12-01

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

Safety evaluation of STOP AHEAD pavement markings

DOT National Transportation Integrated Search

2008-03-01

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

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

DOT National Transportation Integrated Search

2015-12-01

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